Of the 36 million US hospitalizations each year, 22% are surgical.¹ Although less frequent than medical hospitalizations, surgical hospitalizations are more than twice as costly.² Additionally, surgical hospitalizations are on average longer than medical hospitalizations.² Given the increased scrutiny on cost and efficiency of care, attention has turned to optimizing perioperative care. Hospitalists are well positioned to provide specific expertise in the complex interdisciplinary medical management of surgical patients.

In recent decades, multiple models of hospitalist involvement in perioperative care have evolved across the United States.^3-19 To consolidate knowledge and experience and to develop a framework for providing the best care for surgical patients, the Society of Hospital Medicine organized the Perioperative Care Work Group in 2015. This framework was designed for interdisciplinary collaboration in building and strengthening perioperative care programs.

The Society of Hospital Medicine recognized hospital medicine programs’ need for guidance in developing collaborative care in perioperative medicine and appointed the Perioperative Care Work Group in May 2015. Work group members are perioperative medicine experts from US medical centers. They have extensive knowledge of the literature as well as administrative and clinical experience in a variety of perioperative care models.

Topic Development. Initial work was focused on reviewing and discussing multiple models of perioperative care and exploring the roles that hospital medicine physicians have within these models. Useful information was summarized to guide hospitals and physicians in designing, implementing, and expanding patient-centric perioperative medicine services with a focus on preoperative and postoperative care. A final document was created; it outlines system-level issues in perioperative care, organized by perioperative phases.

Initial Framework. Group members submitted written descriptions of key issues in each of 4 phases: (1) preoperative, (2) day of surgery, (3) postoperative inpatient, and (4) postdischarge. These descriptions were merged and reviewed by the content experts. Editing and discussion from the entire group were incorporated into the final matrix, which highlighted (1) perioperative phase definitions, (2) requirements for patients to move to next phase, (3) elements of care coordination typically provided by surgery, anesthesiology, and medicine disciplines, (4) concerns and risks particular to each phase, (5) unique considerations for each phase, (6) suggested metrics of success, and (7) key questions for determining the effectiveness of perioperative care in an institution. All members provided final evaluation and editing.

Final Approval. The Perioperative Care Matrix for Inpatient Surgeries (PCMIS) was presented to the board of the Society of Hospital Medicine in fall 2015 and was approved for use in centering and directing discussions regarding perioperative care.

Models of Care. The Perioperative Care Work Group surveyed examples of hospitalist engagement in perioperative care and synthesized these into synopses of existing models of care for the preoperative, day-of-surgery, postoperative-inpatient, and postdischarge phases.

Defining Key Concepts and Issues

Hospitalists have participated in a variety of perioperative roles for more than a decade. Roles include performing in-depth preoperative assessments, providing oversight to presurgical advanced practice provider assessments, providing inpatient comanagement and consultation both before and after surgery, and providing postdischarge follow-up within the surgical period for medical comorbidities.

Although a comprehensive look at the entire perioperative period is important, 4 specific phases were defined to guide this work (Figure). The phases identified were based on time relative to surgery, with unique considerations as to the overall perioperative period. Concerns and potential risks specific to each phase were considered (Table 1).

Models of Care

Multiple examples of hospitalist involvement were collected to inform the program development guidelines. The specifics noted among the reviewed practice models are described here.

Preoperative. In some centers, all patients scheduled for surgery are required to undergo evaluation at the institution’s preoperative clinic. At most others, referral to the preoperative clinic is at the discretion of the surgical specialists, who have been informed of the clinic’s available resources. Factors determining whether a patient has an in-person clinic visit, undergoes a telephone-based medical evaluation, or has a referral deferred to the primary care physician (PCP) include patient complexity and surgery-specific risk. Patients who have major medical comorbidities (eg, chronic lung or heart disease) or are undergoing higher risk procedures (eg, those lasting >1 hour, laparotomy) most often undergo a formal clinic evaluation. Often, even for a patient whose preoperative evaluation is completed by a PCP, the preoperative nursing staff will call before surgery to provide instructions and to confirm that preoperative planning is complete. Confirmation includes ensuring that the surgery consent and preoperative history and physical examination documents are in the medical record, and that all recommended tests have been performed. If deficiencies are found, surgical and preoperative clinic staff are notified.

The United States is focused on sensible, high-value care. Perioperative care is burgeoning with opportunities for improvement, including reducing avoidable complications, developing systems for early recognition and treatment of complications, and streamlining processes to shorten length of stay and improve patient experience. The PCMIS provides the needed platform to catalyze detailed collaborative work between disciplines engaged in perioperative care.

As average age and level of medical comorbidity increase among surgical patients, hospitalists will increasingly be called on to assist in perioperative care. Hospitalists have long been involved in caring for medically complex surgical patients, through comanagement, consultation, and preoperative evaluations. As a provider group, hospitalists have comprehensive skills in quality and systems improvement, and in program development across hospital systems nationwide. Hospitalists have demonstrated their value by focusing on improving patient outcomes and enhancing patient engagement and experiences. Additionally, the perioperative period is fraught with multiple and complicated handoffs, a problem area for which hospital medicine has pioneered solutions and developed unique expertise. Hospital medicine is well prepared to provide skilled and proven leadership in the timely development, improvement, and expansion of perioperative care for this increasingly older and chronically ill population.

Hospitalists are established in multiple perioperative roles for high-risk surgical patients and have the opportunity to expand optimal patient-centric perioperative care systems working in close concert with surgeons and anesthesiologists. The basics of developing these systems include (1) assessing risk for medical complications, (2) planning for perioperative care, (3) developing programs aimed at risk reduction for preventable complications and early identification and intervention for unavoidable complications, and (4) guiding quality improvement efforts, including planning for frequent handoffs and transitions.

As a key partner in developing comprehensive programs in perioperative care, hospital medicine will continue to shape the future of hospital care for all patients. The PCMIS, as developed with support from the Society of Hospital Medicine, will aid efforts to achieve the best perioperative care models for our surgical patients.

Disclosures

Financial activities outside the submitted work: Drs. Pfeifer and Jaffer report payment for development of educational presentations; Dr. Grant reports payment for expert testimony pertaining to hospital medicine; Drs. Grant and Jaffer report royalties from publishing; Drs. Thompson, Pfiefer, Grant, Slawski, and Jaffer report travel expenses for speaking and serving on national committees; and Drs. Slawski and Jaffer serve on the board of the Society of Perioperative Assessment and Quality Improvement. The other authors have nothing to report.

Of the 36 million US hospitalizations each year, 22% are surgical.¹ Although less frequent than medical hospitalizations, surgical hospitalizations are more than twice as costly.² Additionally, surgical hospitalizations are on average longer than medical hospitalizations.² Given the increased scrutiny on cost and efficiency of care, attention has turned to optimizing perioperative care. Hospitalists are well positioned to provide specific expertise in the complex interdisciplinary medical management of surgical patients.

In recent decades, multiple models of hospitalist involvement in perioperative care have evolved across the United States.^3-19 To consolidate knowledge and experience and to develop a framework for providing the best care for surgical patients, the Society of Hospital Medicine organized the Perioperative Care Work Group in 2015. This framework was designed for interdisciplinary collaboration in building and strengthening perioperative care programs.

The Society of Hospital Medicine recognized hospital medicine programs’ need for guidance in developing collaborative care in perioperative medicine and appointed the Perioperative Care Work Group in May 2015. Work group members are perioperative medicine experts from US medical centers. They have extensive knowledge of the literature as well as administrative and clinical experience in a variety of perioperative care models.

Topic Development. Initial work was focused on reviewing and discussing multiple models of perioperative care and exploring the roles that hospital medicine physicians have within these models. Useful information was summarized to guide hospitals and physicians in designing, implementing, and expanding patient-centric perioperative medicine services with a focus on preoperative and postoperative care. A final document was created; it outlines system-level issues in perioperative care, organized by perioperative phases.

Initial Framework. Group members submitted written descriptions of key issues in each of 4 phases: (1) preoperative, (2) day of surgery, (3) postoperative inpatient, and (4) postdischarge. These descriptions were merged and reviewed by the content experts. Editing and discussion from the entire group were incorporated into the final matrix, which highlighted (1) perioperative phase definitions, (2) requirements for patients to move to next phase, (3) elements of care coordination typically provided by surgery, anesthesiology, and medicine disciplines, (4) concerns and risks particular to each phase, (5) unique considerations for each phase, (6) suggested metrics of success, and (7) key questions for determining the effectiveness of perioperative care in an institution. All members provided final evaluation and editing.

Final Approval. The Perioperative Care Matrix for Inpatient Surgeries (PCMIS) was presented to the board of the Society of Hospital Medicine in fall 2015 and was approved for use in centering and directing discussions regarding perioperative care.

Models of Care. The Perioperative Care Work Group surveyed examples of hospitalist engagement in perioperative care and synthesized these into synopses of existing models of care for the preoperative, day-of-surgery, postoperative-inpatient, and postdischarge phases.

Defining Key Concepts and Issues

Hospitalists have participated in a variety of perioperative roles for more than a decade. Roles include performing in-depth preoperative assessments, providing oversight to presurgical advanced practice provider assessments, providing inpatient comanagement and consultation both before and after surgery, and providing postdischarge follow-up within the surgical period for medical comorbidities.

Although a comprehensive look at the entire perioperative period is important, 4 specific phases were defined to guide this work (Figure). The phases identified were based on time relative to surgery, with unique considerations as to the overall perioperative period. Concerns and potential risks specific to each phase were considered (Table 1).

Models of Care

Multiple examples of hospitalist involvement were collected to inform the program development guidelines. The specifics noted among the reviewed practice models are described here.

Preoperative. In some centers, all patients scheduled for surgery are required to undergo evaluation at the institution’s preoperative clinic. At most others, referral to the preoperative clinic is at the discretion of the surgical specialists, who have been informed of the clinic’s available resources. Factors determining whether a patient has an in-person clinic visit, undergoes a telephone-based medical evaluation, or has a referral deferred to the primary care physician (PCP) include patient complexity and surgery-specific risk. Patients who have major medical comorbidities (eg, chronic lung or heart disease) or are undergoing higher risk procedures (eg, those lasting >1 hour, laparotomy) most often undergo a formal clinic evaluation. Often, even for a patient whose preoperative evaluation is completed by a PCP, the preoperative nursing staff will call before surgery to provide instructions and to confirm that preoperative planning is complete. Confirmation includes ensuring that the surgery consent and preoperative history and physical examination documents are in the medical record, and that all recommended tests have been performed. If deficiencies are found, surgical and preoperative clinic staff are notified.

The United States is focused on sensible, high-value care. Perioperative care is burgeoning with opportunities for improvement, including reducing avoidable complications, developing systems for early recognition and treatment of complications, and streamlining processes to shorten length of stay and improve patient experience. The PCMIS provides the needed platform to catalyze detailed collaborative work between disciplines engaged in perioperative care.

As average age and level of medical comorbidity increase among surgical patients, hospitalists will increasingly be called on to assist in perioperative care. Hospitalists have long been involved in caring for medically complex surgical patients, through comanagement, consultation, and preoperative evaluations. As a provider group, hospitalists have comprehensive skills in quality and systems improvement, and in program development across hospital systems nationwide. Hospitalists have demonstrated their value by focusing on improving patient outcomes and enhancing patient engagement and experiences. Additionally, the perioperative period is fraught with multiple and complicated handoffs, a problem area for which hospital medicine has pioneered solutions and developed unique expertise. Hospital medicine is well prepared to provide skilled and proven leadership in the timely development, improvement, and expansion of perioperative care for this increasingly older and chronically ill population.

Hospitalists are established in multiple perioperative roles for high-risk surgical patients and have the opportunity to expand optimal patient-centric perioperative care systems working in close concert with surgeons and anesthesiologists. The basics of developing these systems include (1) assessing risk for medical complications, (2) planning for perioperative care, (3) developing programs aimed at risk reduction for preventable complications and early identification and intervention for unavoidable complications, and (4) guiding quality improvement efforts, including planning for frequent handoffs and transitions.

As a key partner in developing comprehensive programs in perioperative care, hospital medicine will continue to shape the future of hospital care for all patients. The PCMIS, as developed with support from the Society of Hospital Medicine, will aid efforts to achieve the best perioperative care models for our surgical patients.

Disclosures

Financial activities outside the submitted work: Drs. Pfeifer and Jaffer report payment for development of educational presentations; Dr. Grant reports payment for expert testimony pertaining to hospital medicine; Drs. Grant and Jaffer report royalties from publishing; Drs. Thompson, Pfiefer, Grant, Slawski, and Jaffer report travel expenses for speaking and serving on national committees; and Drs. Slawski and Jaffer serve on the board of the Society of Perioperative Assessment and Quality Improvement. The other authors have nothing to report.

Of the 36 million US hospitalizations each year, 22% are surgical.¹ Although less frequent than medical hospitalizations, surgical hospitalizations are more than twice as costly.² Additionally, surgical hospitalizations are on average longer than medical hospitalizations.² Given the increased scrutiny on cost and efficiency of care, attention has turned to optimizing perioperative care. Hospitalists are well positioned to provide specific expertise in the complex interdisciplinary medical management of surgical patients.

In recent decades, multiple models of hospitalist involvement in perioperative care have evolved across the United States.^3-19 To consolidate knowledge and experience and to develop a framework for providing the best care for surgical patients, the Society of Hospital Medicine organized the Perioperative Care Work Group in 2015. This framework was designed for interdisciplinary collaboration in building and strengthening perioperative care programs.

The Society of Hospital Medicine recognized hospital medicine programs’ need for guidance in developing collaborative care in perioperative medicine and appointed the Perioperative Care Work Group in May 2015. Work group members are perioperative medicine experts from US medical centers. They have extensive knowledge of the literature as well as administrative and clinical experience in a variety of perioperative care models.

Topic Development. Initial work was focused on reviewing and discussing multiple models of perioperative care and exploring the roles that hospital medicine physicians have within these models. Useful information was summarized to guide hospitals and physicians in designing, implementing, and expanding patient-centric perioperative medicine services with a focus on preoperative and postoperative care. A final document was created; it outlines system-level issues in perioperative care, organized by perioperative phases.

Initial Framework. Group members submitted written descriptions of key issues in each of 4 phases: (1) preoperative, (2) day of surgery, (3) postoperative inpatient, and (4) postdischarge. These descriptions were merged and reviewed by the content experts. Editing and discussion from the entire group were incorporated into the final matrix, which highlighted (1) perioperative phase definitions, (2) requirements for patients to move to next phase, (3) elements of care coordination typically provided by surgery, anesthesiology, and medicine disciplines, (4) concerns and risks particular to each phase, (5) unique considerations for each phase, (6) suggested metrics of success, and (7) key questions for determining the effectiveness of perioperative care in an institution. All members provided final evaluation and editing.

Final Approval. The Perioperative Care Matrix for Inpatient Surgeries (PCMIS) was presented to the board of the Society of Hospital Medicine in fall 2015 and was approved for use in centering and directing discussions regarding perioperative care.

Models of Care. The Perioperative Care Work Group surveyed examples of hospitalist engagement in perioperative care and synthesized these into synopses of existing models of care for the preoperative, day-of-surgery, postoperative-inpatient, and postdischarge phases.

Defining Key Concepts and Issues

Hospitalists have participated in a variety of perioperative roles for more than a decade. Roles include performing in-depth preoperative assessments, providing oversight to presurgical advanced practice provider assessments, providing inpatient comanagement and consultation both before and after surgery, and providing postdischarge follow-up within the surgical period for medical comorbidities.

Although a comprehensive look at the entire perioperative period is important, 4 specific phases were defined to guide this work (Figure). The phases identified were based on time relative to surgery, with unique considerations as to the overall perioperative period. Concerns and potential risks specific to each phase were considered (Table 1).

Models of Care

Multiple examples of hospitalist involvement were collected to inform the program development guidelines. The specifics noted among the reviewed practice models are described here.

Preoperative. In some centers, all patients scheduled for surgery are required to undergo evaluation at the institution’s preoperative clinic. At most others, referral to the preoperative clinic is at the discretion of the surgical specialists, who have been informed of the clinic’s available resources. Factors determining whether a patient has an in-person clinic visit, undergoes a telephone-based medical evaluation, or has a referral deferred to the primary care physician (PCP) include patient complexity and surgery-specific risk. Patients who have major medical comorbidities (eg, chronic lung or heart disease) or are undergoing higher risk procedures (eg, those lasting >1 hour, laparotomy) most often undergo a formal clinic evaluation. Often, even for a patient whose preoperative evaluation is completed by a PCP, the preoperative nursing staff will call before surgery to provide instructions and to confirm that preoperative planning is complete. Confirmation includes ensuring that the surgery consent and preoperative history and physical examination documents are in the medical record, and that all recommended tests have been performed. If deficiencies are found, surgical and preoperative clinic staff are notified.

The United States is focused on sensible, high-value care. Perioperative care is burgeoning with opportunities for improvement, including reducing avoidable complications, developing systems for early recognition and treatment of complications, and streamlining processes to shorten length of stay and improve patient experience. The PCMIS provides the needed platform to catalyze detailed collaborative work between disciplines engaged in perioperative care.

As average age and level of medical comorbidity increase among surgical patients, hospitalists will increasingly be called on to assist in perioperative care. Hospitalists have long been involved in caring for medically complex surgical patients, through comanagement, consultation, and preoperative evaluations. As a provider group, hospitalists have comprehensive skills in quality and systems improvement, and in program development across hospital systems nationwide. Hospitalists have demonstrated their value by focusing on improving patient outcomes and enhancing patient engagement and experiences. Additionally, the perioperative period is fraught with multiple and complicated handoffs, a problem area for which hospital medicine has pioneered solutions and developed unique expertise. Hospital medicine is well prepared to provide skilled and proven leadership in the timely development, improvement, and expansion of perioperative care for this increasingly older and chronically ill population.

Hospitalists are established in multiple perioperative roles for high-risk surgical patients and have the opportunity to expand optimal patient-centric perioperative care systems working in close concert with surgeons and anesthesiologists. The basics of developing these systems include (1) assessing risk for medical complications, (2) planning for perioperative care, (3) developing programs aimed at risk reduction for preventable complications and early identification and intervention for unavoidable complications, and (4) guiding quality improvement efforts, including planning for frequent handoffs and transitions.

As a key partner in developing comprehensive programs in perioperative care, hospital medicine will continue to shape the future of hospital care for all patients. The PCMIS, as developed with support from the Society of Hospital Medicine, will aid efforts to achieve the best perioperative care models for our surgical patients.

Disclosures

Financial activities outside the submitted work: Drs. Pfeifer and Jaffer report payment for development of educational presentations; Dr. Grant reports payment for expert testimony pertaining to hospital medicine; Drs. Grant and Jaffer report royalties from publishing; Drs. Thompson, Pfiefer, Grant, Slawski, and Jaffer report travel expenses for speaking and serving on national committees; and Drs. Slawski and Jaffer serve on the board of the Society of Perioperative Assessment and Quality Improvement. The other authors have nothing to report.

It is estimated that there were more than 3.1 million women living in the U.S. with a history of invasive breast cancer as of January 1, 2014, and an additional 231,840 women will be newly diagnosed with invasive breast cancer in 2015.^1,2 The median age at the time of breast cancer diagnosis is 61 years. About 20% of breast cancers occur among women aged < 50 years, and 43% occur in women aged > 65 years.

The treatment and prognosis for breast cancer depend on the stage at diagnosis, the biologic characteristics of the tumor, and the age and health of the patient. The overall 5-year relative survival rate for female patients with breast cancer has improved from 75% to 90% from 1975 to 1977 and from 2003 to 2009, respectively, largely due to improvements in treatment (ie, chemotherapy, hormone therapy, and targeted drugs) and because of earlier diagnosis resulting from the widespread use of mammography and other screening tools.²

Estrogen Receptor-Positive Therapies

Women with breast cancer who test positive for hormone receptors are candidates for treatment with hormone therapy to reduce the likelihood of recurrence or as a core component of treatment for advanced disease. Currently available endocrine strategies for the treatment of estrogen receptor- (ER) positive breast cancer include targeting the ER with the antiestrogen drug tamoxifen. Another option is suppressing the amount of available ligand (estrogen) for the receptor either with gonadal suppression in premenopausal oophorectomy, or luteinizing hormonereleasing hormone agonists, or with the aromatase inhibitors (AIs) anastrozole, exemestane, and letrozole in postmenopausal women and by downregulating the receptor with fulvestrant. Given their proven efficacy and generally favorable adverse effect (AE) profile, these endocrine therapies are widely used in the treatment of both early-stage and recurrent and/or metastatic breast cancer.

Recent studies have offered new treatments for patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Innovative hormonal and targeted therapies for advanced disease as well as new data on adjuvant hormonal therapy for young high-risk patients are changing the available therapeutic options.

Advanced Metastatic Treatments

Treatment for metastatic hormone receptor-positive breast cancer has shifted from traditional cytotoxic chemotherapies to targeted therapeutic options. Most treatment guidelines, including the National Comprehensive Cancer Network guidelines, recommend targeted therapy with AIs or selective ER modulators rather than chemotherapy, except in the case of visceral crisis.³

Until recently, there had been relatively little guidance to inform which hormonal therapy was most appropriate. Aromatase inhibitors were generally reserved for postmenopausal women, whereas tamoxifen was preferred in premenopausal women.

Fulvestrant

The FDA initially approved fulvestrant, a hormone receptor downregulator, in 2002 at a 250-mg dose, following progression on an anti-estrogen therapy, such as tamoxifen in postmenopausal women with stage IV breast cancer. The FDA approval was based on similar response rates for the already approved agent anastrozole.⁴ However, pharmacokinetic findings from the phase 3 EFECT trial in 2008 prompted researchers to explore a 500-mg dose of fulvestrant.⁵

The recently published FIRST study is a phase 2, randomized, open-label study comparing fulvestrant 500 mg with anastrozole 1 mg as first-line hormonal therapy for postmenopausal women with hormone receptorpositive advanced breast cancer. Fulvestrant was given 500 mg once monthly with an extra dose given on day 14 of month 1. The trial enrolled 233 patients. The median time to progression was 23.4 months for fulvestrant and 13.1 months for anastrozole. These results translate into a 34% reduction in the risk of progression.⁶

These outcomes suggest that fulvestrant is as viable and perhaps even preferred first-line therapy for postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer. The impressive results from this trial are likely, because the study used the 500-mg dose of fulvestrant, which is twice the dose used in the original trials. However, the 500-mg dose has previously been studied, and long-term outcome data suggest both safety and efficiency. The large randomized, double-blinded phase 3 CONFIRM trial, published in 2013, compared the 250-mg dose with the 500-mg dose and found that the higher dose was associated with a 19% reduction in the risk of death and a 4.1 month increase in median overall survival (OS) without any new safety concerns.⁵

Palbociclib

The FDA recently granted accelerated approval to palbociclib in combination with letrozole for the first-line therapy of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women. Palbociclib is an oral small-molecular inhibitor of cyclindependent kinases 4 and 6. Preclinical data suggested synergy with anti-estrogen therapies and inhibition of breast cancer cell growth.7

A phase 2, open-label randomized trial (PALOMA-1/TRIO-18) enrolled 165 patients. Progression-free survival (PFS) was 20.2 months for the palbociclib plus letrozole arm and 10.2 months for the letrozole alone arm. Significant toxicities were noted in the palbociclib arm, including 54% of people experiencing grade 3 to 4 neutropenia (vs 1% in the letrozole arm), leukopenia in 19% (vs 0%) and fatigue in 4% (vs 1%). A phase 3 trial is currently enrolling patients.⁷ While we await the results of the phase 3 trial and long-term follow-up data, palbociclib plus letrozole is a new, viable option for metastatic hormone receptor-positive advanced breast cancer.

Although many practitioners will continue to reasonably use any AI or selective ER modulator when treating metastatic breast cancer, both fulvestrant and palbociclib in combination with letrozole are new evidence-based, first-line options worth considering.

Early-Stage Treatment Options

There are many acceptable therapeutic options for treating early stage breast cancer. Tamoxifen has traditionally been used in the adjuvant setting for premenopausal women, whereas AIs are often used in postmenopausal women. There has also been a long-standing debate about the role of ovarian suppression in premenopausal women.

The recently published phase 3 TEXT and SOFT trials attempted to provide answers to these long-standing therapeutic dilemmas. The SOFT trial randomly assigned 3,066 premenopausal women to 5 years of tamoxifen, 5 years of tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The TEXT trial randomly assigned 2,672 women to receive either exemestane plus ovarian suppression or tamoxifen plus ovarian suppression. The studies showed that subjecting all women receiving tamoxifen to ovarian suppression did not provide any significant benefit.^8,9

However, the subgroup of women with high-risk disease who required adjuvant chemotherapy and remained premenopausal experienced improved outcomes from ovarian suppression. This high-risk subgroup when given tamoxifen plus ovarian suppression had a 4.5% absolute reduction in breast cancer recurrence at 5 years compared with the group that received tamoxifen alone. When this high-risk subgroup was given exemestane plus ovarian suppression, the women had a 7.7% absolute reduction in breast cancer recurrence at 5 years compared with the group that received tamoxifen alone.⁸

Ovarian suppression resulted in significant additional AEs, including depression and menopausal symptoms. The authors of the study also pointed out the additional risk of hypertension, musculoskeletal AEs, and decreased bone density. Furthermore, the OS data from these studies are premature, because the patients had fewer AEs than initially anticipated; this resulted in an only 5% mortality at publication.

The study design also raised several interesting questions. The primary endpoint was disease-free survival. The authors defined this as the time from randomization to the first appearance of invasive recurrence of breast cancer (local, regional, or distant), invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without breast cancer recurrence or second invasive cancer. When studying adjuvant therapy for diseases, such as breast cancer, which carry long-term survival, studies often use PFS with various modified definitions as a surrogate marker for OS. Clinicians are then left to decide whether this surrogate marker is an accurate predictor of OS or other important clinical outcomes.

In the combined analysis of the TEXT and SOFT trials, only 60% of the first recurrences, second invasive cancers, or deaths involved recurrence of breast cancer
at a distant site.⁹ Because locally recurrent breast cancer is highly treatable and often curable, clinicians must ask whether the increased toxicities of ovarian suppression are worth the large number of women who experienced local recurrence given the still relatively small absolute reduction in recurrence risk.

Last, the study authors retrospectively reviewed data from the International Breast Cancer Study Group and U.S. Intergroup trials and concluded that women aged < 35 years were most likely to be at high-risk for AEs.^10,11 A subgroup analysis of women aged < 35 years in the SOFT trial noted that breast cancer recurred within 5 years in one-third of women receiving tamoxifen alone, whereas only in one-sixth of women receiving exemestane plus ovarian suppression.⁸ This is the basis for the conclusion that premenopausal women, particularly those aged < 35 years, with high-risk disease who receive chemotherapy and remain premenopausal after chemotherapy, benefit from ovarian suppression in combination with tamoxifen, and even more impressively from ovarian suppression combined with exemestane.

The problem is that the study did not risk-stratify patients based on those aged < 35 years, and the conclusion is based on a subgroup analysis using a primary endpoint that may not accurately predict OS. Nonetheless, although not definitive, the data from the TEXT and SOFT trials raise interesting therapeutic questions that require further study and certainly provide tempting therapeutic options in patients who are clinically at high risk for recurrence.

HER2-Positive Breast Cancer

Up to 20% of invasive breast cancers are a result of HER2 gene amplification or overexpression of the HER2 protein, a tyrosine kinase transmembrane receptor, resulting in a more aggressive phenotype and a poor prognosis. Anti-HER2 drugs have changed the landscape of the disease previously known as aggressive breast cancer with a poor survival rate.

Treatment with the anti-HER2 humanized monoclonal antibody trastuzumab in addition to chemotherapy, compared with chemotherapy alone, significantly improves PFS and OS among patients with HER2-positive metastatic as well as early breast cancer. However, in most patients with HER2-positive metastatic breast cancer, the disease progresses, highlighting the need for new, targeted therapies for advanced disease.

New Standard of Care

The original studies of trastuzumab showed improved OS in late-stage (metastatic) breast cancer from 20.3 to 25.1 months, and in early-stage breast cancer, it reduced the risk of cancer returning after surgery by an absolute risk of 9.5% and the risk of death by an absolute risk of 3%.

New therapies directed at HER2 are being developed, among them pertuzumab, a humanized monoclonal antibody that binds HER2 at a different epitope of the HER2 extracellular domain (subdomain 2) than that at which trastuzumab binds. Pertuzumab prevents HER2 from dimerizing with other ligand-activated HER receptors, most notably HER3. Like trastuzumab, pertuzumab stimulates antibody-dependent, cell-mediated cytotoxicity. Because pertuzumab and trastuzumab bind to different HER2 epitopes and have complementary mechanisms of action, these 2 agents, when given together, provide a more comprehensive blockade of HER2 signaling and result in greater antitumor activity than does either agent alone in HER2-positive tumor models.¹² In phase 2 studies, a pertuzumab–trastuzumab regimen has shown activity in patients with HER2-positive metastatic breast cancer and in patients with early breast cancer.¹³

In the phase 3 CLEOPATRA study, the combination of pertuzumab plus trastuzumab plus docetaxel, used as first-line treatment for HER2-positive metastatic breast cancer compared with placebo plus trastuzumab plus docetaxel, significantly prolonged PFS (18.5 months vs 12.4 months), with no increase in cardiac toxic effects.¹² In a recent updated follow-up of the CLEOPATRA study, the addition of pertuzumab to trastuzumab and docetaxel showed a significantly better median OS (56.5 months vs 40.8 months; hazard ratio, 0.68; P < .001).¹⁴ From these results, this combination regimen is now considered a first-line therapy for patients with HER2-positive metastatic breast cancer.

However, the cost of cancer treatment has become a mounting concern during the past decade, as new therapies come down the pipeline with ever-increasing price tags. Trastuzumab costs about $4,500 a month, and the newer pertuzumab runs about 30% higher, at $6,000 a month. For a full course of treatment, the cost of the pertuzumab and trastuzumab combination could go as high as $195,000, depending on the duration of therapy and the choice of taxanes.

Conclusions

The landscape of therapeutic options in high-risk, young patients with early-stage breast cancer as well as patients with advanced or metastatic disease is changing rapidly.

Clinicians now have 2 new first-line options for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer. A phase 3 trial demonstrated that fulvestrant monotherapy offers improved PFS and some improvement in OS compared with anastrazole in postmenopausal women. A phase 2 trial showed that palbociclib plus letrozole offers improved PFS in postmenopausal women. Based on the SOFT and TEXT trials, clinicians treating high-risk premenopausal women now have some data to inform the debate about whether ovarian suppression should be added to hormone therapy.

Based on the CLEOPATRA trial, clinicians can now consider combination pertuzumab and trastuzumab and docetaxel as first-line therapy for patients with HER2-positive metastatic breast cancer.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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It is estimated that there were more than 3.1 million women living in the U.S. with a history of invasive breast cancer as of January 1, 2014, and an additional 231,840 women will be newly diagnosed with invasive breast cancer in 2015.^1,2 The median age at the time of breast cancer diagnosis is 61 years. About 20% of breast cancers occur among women aged < 50 years, and 43% occur in women aged > 65 years.

The treatment and prognosis for breast cancer depend on the stage at diagnosis, the biologic characteristics of the tumor, and the age and health of the patient. The overall 5-year relative survival rate for female patients with breast cancer has improved from 75% to 90% from 1975 to 1977 and from 2003 to 2009, respectively, largely due to improvements in treatment (ie, chemotherapy, hormone therapy, and targeted drugs) and because of earlier diagnosis resulting from the widespread use of mammography and other screening tools.²

Estrogen Receptor-Positive Therapies

Women with breast cancer who test positive for hormone receptors are candidates for treatment with hormone therapy to reduce the likelihood of recurrence or as a core component of treatment for advanced disease. Currently available endocrine strategies for the treatment of estrogen receptor- (ER) positive breast cancer include targeting the ER with the antiestrogen drug tamoxifen. Another option is suppressing the amount of available ligand (estrogen) for the receptor either with gonadal suppression in premenopausal oophorectomy, or luteinizing hormonereleasing hormone agonists, or with the aromatase inhibitors (AIs) anastrozole, exemestane, and letrozole in postmenopausal women and by downregulating the receptor with fulvestrant. Given their proven efficacy and generally favorable adverse effect (AE) profile, these endocrine therapies are widely used in the treatment of both early-stage and recurrent and/or metastatic breast cancer.

Recent studies have offered new treatments for patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Innovative hormonal and targeted therapies for advanced disease as well as new data on adjuvant hormonal therapy for young high-risk patients are changing the available therapeutic options.

Advanced Metastatic Treatments

Treatment for metastatic hormone receptor-positive breast cancer has shifted from traditional cytotoxic chemotherapies to targeted therapeutic options. Most treatment guidelines, including the National Comprehensive Cancer Network guidelines, recommend targeted therapy with AIs or selective ER modulators rather than chemotherapy, except in the case of visceral crisis.³

Until recently, there had been relatively little guidance to inform which hormonal therapy was most appropriate. Aromatase inhibitors were generally reserved for postmenopausal women, whereas tamoxifen was preferred in premenopausal women.

Fulvestrant

The FDA initially approved fulvestrant, a hormone receptor downregulator, in 2002 at a 250-mg dose, following progression on an anti-estrogen therapy, such as tamoxifen in postmenopausal women with stage IV breast cancer. The FDA approval was based on similar response rates for the already approved agent anastrozole.⁴ However, pharmacokinetic findings from the phase 3 EFECT trial in 2008 prompted researchers to explore a 500-mg dose of fulvestrant.⁵

The recently published FIRST study is a phase 2, randomized, open-label study comparing fulvestrant 500 mg with anastrozole 1 mg as first-line hormonal therapy for postmenopausal women with hormone receptorpositive advanced breast cancer. Fulvestrant was given 500 mg once monthly with an extra dose given on day 14 of month 1. The trial enrolled 233 patients. The median time to progression was 23.4 months for fulvestrant and 13.1 months for anastrozole. These results translate into a 34% reduction in the risk of progression.⁶

These outcomes suggest that fulvestrant is as viable and perhaps even preferred first-line therapy for postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer. The impressive results from this trial are likely, because the study used the 500-mg dose of fulvestrant, which is twice the dose used in the original trials. However, the 500-mg dose has previously been studied, and long-term outcome data suggest both safety and efficiency. The large randomized, double-blinded phase 3 CONFIRM trial, published in 2013, compared the 250-mg dose with the 500-mg dose and found that the higher dose was associated with a 19% reduction in the risk of death and a 4.1 month increase in median overall survival (OS) without any new safety concerns.⁵

Palbociclib

The FDA recently granted accelerated approval to palbociclib in combination with letrozole for the first-line therapy of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women. Palbociclib is an oral small-molecular inhibitor of cyclindependent kinases 4 and 6. Preclinical data suggested synergy with anti-estrogen therapies and inhibition of breast cancer cell growth.7

A phase 2, open-label randomized trial (PALOMA-1/TRIO-18) enrolled 165 patients. Progression-free survival (PFS) was 20.2 months for the palbociclib plus letrozole arm and 10.2 months for the letrozole alone arm. Significant toxicities were noted in the palbociclib arm, including 54% of people experiencing grade 3 to 4 neutropenia (vs 1% in the letrozole arm), leukopenia in 19% (vs 0%) and fatigue in 4% (vs 1%). A phase 3 trial is currently enrolling patients.⁷ While we await the results of the phase 3 trial and long-term follow-up data, palbociclib plus letrozole is a new, viable option for metastatic hormone receptor-positive advanced breast cancer.

Although many practitioners will continue to reasonably use any AI or selective ER modulator when treating metastatic breast cancer, both fulvestrant and palbociclib in combination with letrozole are new evidence-based, first-line options worth considering.

Early-Stage Treatment Options

There are many acceptable therapeutic options for treating early stage breast cancer. Tamoxifen has traditionally been used in the adjuvant setting for premenopausal women, whereas AIs are often used in postmenopausal women. There has also been a long-standing debate about the role of ovarian suppression in premenopausal women.

The recently published phase 3 TEXT and SOFT trials attempted to provide answers to these long-standing therapeutic dilemmas. The SOFT trial randomly assigned 3,066 premenopausal women to 5 years of tamoxifen, 5 years of tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The TEXT trial randomly assigned 2,672 women to receive either exemestane plus ovarian suppression or tamoxifen plus ovarian suppression. The studies showed that subjecting all women receiving tamoxifen to ovarian suppression did not provide any significant benefit.^8,9

However, the subgroup of women with high-risk disease who required adjuvant chemotherapy and remained premenopausal experienced improved outcomes from ovarian suppression. This high-risk subgroup when given tamoxifen plus ovarian suppression had a 4.5% absolute reduction in breast cancer recurrence at 5 years compared with the group that received tamoxifen alone. When this high-risk subgroup was given exemestane plus ovarian suppression, the women had a 7.7% absolute reduction in breast cancer recurrence at 5 years compared with the group that received tamoxifen alone.⁸

Ovarian suppression resulted in significant additional AEs, including depression and menopausal symptoms. The authors of the study also pointed out the additional risk of hypertension, musculoskeletal AEs, and decreased bone density. Furthermore, the OS data from these studies are premature, because the patients had fewer AEs than initially anticipated; this resulted in an only 5% mortality at publication.

The study design also raised several interesting questions. The primary endpoint was disease-free survival. The authors defined this as the time from randomization to the first appearance of invasive recurrence of breast cancer (local, regional, or distant), invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without breast cancer recurrence or second invasive cancer. When studying adjuvant therapy for diseases, such as breast cancer, which carry long-term survival, studies often use PFS with various modified definitions as a surrogate marker for OS. Clinicians are then left to decide whether this surrogate marker is an accurate predictor of OS or other important clinical outcomes.

In the combined analysis of the TEXT and SOFT trials, only 60% of the first recurrences, second invasive cancers, or deaths involved recurrence of breast cancer
at a distant site.⁹ Because locally recurrent breast cancer is highly treatable and often curable, clinicians must ask whether the increased toxicities of ovarian suppression are worth the large number of women who experienced local recurrence given the still relatively small absolute reduction in recurrence risk.

Last, the study authors retrospectively reviewed data from the International Breast Cancer Study Group and U.S. Intergroup trials and concluded that women aged < 35 years were most likely to be at high-risk for AEs.^10,11 A subgroup analysis of women aged < 35 years in the SOFT trial noted that breast cancer recurred within 5 years in one-third of women receiving tamoxifen alone, whereas only in one-sixth of women receiving exemestane plus ovarian suppression.⁸ This is the basis for the conclusion that premenopausal women, particularly those aged < 35 years, with high-risk disease who receive chemotherapy and remain premenopausal after chemotherapy, benefit from ovarian suppression in combination with tamoxifen, and even more impressively from ovarian suppression combined with exemestane.

The problem is that the study did not risk-stratify patients based on those aged < 35 years, and the conclusion is based on a subgroup analysis using a primary endpoint that may not accurately predict OS. Nonetheless, although not definitive, the data from the TEXT and SOFT trials raise interesting therapeutic questions that require further study and certainly provide tempting therapeutic options in patients who are clinically at high risk for recurrence.

HER2-Positive Breast Cancer

Up to 20% of invasive breast cancers are a result of HER2 gene amplification or overexpression of the HER2 protein, a tyrosine kinase transmembrane receptor, resulting in a more aggressive phenotype and a poor prognosis. Anti-HER2 drugs have changed the landscape of the disease previously known as aggressive breast cancer with a poor survival rate.

Treatment with the anti-HER2 humanized monoclonal antibody trastuzumab in addition to chemotherapy, compared with chemotherapy alone, significantly improves PFS and OS among patients with HER2-positive metastatic as well as early breast cancer. However, in most patients with HER2-positive metastatic breast cancer, the disease progresses, highlighting the need for new, targeted therapies for advanced disease.

New Standard of Care

The original studies of trastuzumab showed improved OS in late-stage (metastatic) breast cancer from 20.3 to 25.1 months, and in early-stage breast cancer, it reduced the risk of cancer returning after surgery by an absolute risk of 9.5% and the risk of death by an absolute risk of 3%.

New therapies directed at HER2 are being developed, among them pertuzumab, a humanized monoclonal antibody that binds HER2 at a different epitope of the HER2 extracellular domain (subdomain 2) than that at which trastuzumab binds. Pertuzumab prevents HER2 from dimerizing with other ligand-activated HER receptors, most notably HER3. Like trastuzumab, pertuzumab stimulates antibody-dependent, cell-mediated cytotoxicity. Because pertuzumab and trastuzumab bind to different HER2 epitopes and have complementary mechanisms of action, these 2 agents, when given together, provide a more comprehensive blockade of HER2 signaling and result in greater antitumor activity than does either agent alone in HER2-positive tumor models.¹² In phase 2 studies, a pertuzumab–trastuzumab regimen has shown activity in patients with HER2-positive metastatic breast cancer and in patients with early breast cancer.¹³

In the phase 3 CLEOPATRA study, the combination of pertuzumab plus trastuzumab plus docetaxel, used as first-line treatment for HER2-positive metastatic breast cancer compared with placebo plus trastuzumab plus docetaxel, significantly prolonged PFS (18.5 months vs 12.4 months), with no increase in cardiac toxic effects.¹² In a recent updated follow-up of the CLEOPATRA study, the addition of pertuzumab to trastuzumab and docetaxel showed a significantly better median OS (56.5 months vs 40.8 months; hazard ratio, 0.68; P < .001).¹⁴ From these results, this combination regimen is now considered a first-line therapy for patients with HER2-positive metastatic breast cancer.

However, the cost of cancer treatment has become a mounting concern during the past decade, as new therapies come down the pipeline with ever-increasing price tags. Trastuzumab costs about $4,500 a month, and the newer pertuzumab runs about 30% higher, at $6,000 a month. For a full course of treatment, the cost of the pertuzumab and trastuzumab combination could go as high as $195,000, depending on the duration of therapy and the choice of taxanes.

Conclusions

The landscape of therapeutic options in high-risk, young patients with early-stage breast cancer as well as patients with advanced or metastatic disease is changing rapidly.

Clinicians now have 2 new first-line options for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer. A phase 3 trial demonstrated that fulvestrant monotherapy offers improved PFS and some improvement in OS compared with anastrazole in postmenopausal women. A phase 2 trial showed that palbociclib plus letrozole offers improved PFS in postmenopausal women. Based on the SOFT and TEXT trials, clinicians treating high-risk premenopausal women now have some data to inform the debate about whether ovarian suppression should be added to hormone therapy.

Based on the CLEOPATRA trial, clinicians can now consider combination pertuzumab and trastuzumab and docetaxel as first-line therapy for patients with HER2-positive metastatic breast cancer.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

It is estimated that there were more than 3.1 million women living in the U.S. with a history of invasive breast cancer as of January 1, 2014, and an additional 231,840 women will be newly diagnosed with invasive breast cancer in 2015.^1,2 The median age at the time of breast cancer diagnosis is 61 years. About 20% of breast cancers occur among women aged < 50 years, and 43% occur in women aged > 65 years.

The treatment and prognosis for breast cancer depend on the stage at diagnosis, the biologic characteristics of the tumor, and the age and health of the patient. The overall 5-year relative survival rate for female patients with breast cancer has improved from 75% to 90% from 1975 to 1977 and from 2003 to 2009, respectively, largely due to improvements in treatment (ie, chemotherapy, hormone therapy, and targeted drugs) and because of earlier diagnosis resulting from the widespread use of mammography and other screening tools.²

Estrogen Receptor-Positive Therapies

Women with breast cancer who test positive for hormone receptors are candidates for treatment with hormone therapy to reduce the likelihood of recurrence or as a core component of treatment for advanced disease. Currently available endocrine strategies for the treatment of estrogen receptor- (ER) positive breast cancer include targeting the ER with the antiestrogen drug tamoxifen. Another option is suppressing the amount of available ligand (estrogen) for the receptor either with gonadal suppression in premenopausal oophorectomy, or luteinizing hormonereleasing hormone agonists, or with the aromatase inhibitors (AIs) anastrozole, exemestane, and letrozole in postmenopausal women and by downregulating the receptor with fulvestrant. Given their proven efficacy and generally favorable adverse effect (AE) profile, these endocrine therapies are widely used in the treatment of both early-stage and recurrent and/or metastatic breast cancer.

Recent studies have offered new treatments for patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Innovative hormonal and targeted therapies for advanced disease as well as new data on adjuvant hormonal therapy for young high-risk patients are changing the available therapeutic options.

Advanced Metastatic Treatments

Treatment for metastatic hormone receptor-positive breast cancer has shifted from traditional cytotoxic chemotherapies to targeted therapeutic options. Most treatment guidelines, including the National Comprehensive Cancer Network guidelines, recommend targeted therapy with AIs or selective ER modulators rather than chemotherapy, except in the case of visceral crisis.³

Until recently, there had been relatively little guidance to inform which hormonal therapy was most appropriate. Aromatase inhibitors were generally reserved for postmenopausal women, whereas tamoxifen was preferred in premenopausal women.

Fulvestrant

The FDA initially approved fulvestrant, a hormone receptor downregulator, in 2002 at a 250-mg dose, following progression on an anti-estrogen therapy, such as tamoxifen in postmenopausal women with stage IV breast cancer. The FDA approval was based on similar response rates for the already approved agent anastrozole.⁴ However, pharmacokinetic findings from the phase 3 EFECT trial in 2008 prompted researchers to explore a 500-mg dose of fulvestrant.⁵

The recently published FIRST study is a phase 2, randomized, open-label study comparing fulvestrant 500 mg with anastrozole 1 mg as first-line hormonal therapy for postmenopausal women with hormone receptorpositive advanced breast cancer. Fulvestrant was given 500 mg once monthly with an extra dose given on day 14 of month 1. The trial enrolled 233 patients. The median time to progression was 23.4 months for fulvestrant and 13.1 months for anastrozole. These results translate into a 34% reduction in the risk of progression.⁶

These outcomes suggest that fulvestrant is as viable and perhaps even preferred first-line therapy for postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer. The impressive results from this trial are likely, because the study used the 500-mg dose of fulvestrant, which is twice the dose used in the original trials. However, the 500-mg dose has previously been studied, and long-term outcome data suggest both safety and efficiency. The large randomized, double-blinded phase 3 CONFIRM trial, published in 2013, compared the 250-mg dose with the 500-mg dose and found that the higher dose was associated with a 19% reduction in the risk of death and a 4.1 month increase in median overall survival (OS) without any new safety concerns.⁵

Palbociclib

The FDA recently granted accelerated approval to palbociclib in combination with letrozole for the first-line therapy of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women. Palbociclib is an oral small-molecular inhibitor of cyclindependent kinases 4 and 6. Preclinical data suggested synergy with anti-estrogen therapies and inhibition of breast cancer cell growth.7

A phase 2, open-label randomized trial (PALOMA-1/TRIO-18) enrolled 165 patients. Progression-free survival (PFS) was 20.2 months for the palbociclib plus letrozole arm and 10.2 months for the letrozole alone arm. Significant toxicities were noted in the palbociclib arm, including 54% of people experiencing grade 3 to 4 neutropenia (vs 1% in the letrozole arm), leukopenia in 19% (vs 0%) and fatigue in 4% (vs 1%). A phase 3 trial is currently enrolling patients.⁷ While we await the results of the phase 3 trial and long-term follow-up data, palbociclib plus letrozole is a new, viable option for metastatic hormone receptor-positive advanced breast cancer.

Although many practitioners will continue to reasonably use any AI or selective ER modulator when treating metastatic breast cancer, both fulvestrant and palbociclib in combination with letrozole are new evidence-based, first-line options worth considering.

Early-Stage Treatment Options

There are many acceptable therapeutic options for treating early stage breast cancer. Tamoxifen has traditionally been used in the adjuvant setting for premenopausal women, whereas AIs are often used in postmenopausal women. There has also been a long-standing debate about the role of ovarian suppression in premenopausal women.

The recently published phase 3 TEXT and SOFT trials attempted to provide answers to these long-standing therapeutic dilemmas. The SOFT trial randomly assigned 3,066 premenopausal women to 5 years of tamoxifen, 5 years of tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The TEXT trial randomly assigned 2,672 women to receive either exemestane plus ovarian suppression or tamoxifen plus ovarian suppression. The studies showed that subjecting all women receiving tamoxifen to ovarian suppression did not provide any significant benefit.^8,9

However, the subgroup of women with high-risk disease who required adjuvant chemotherapy and remained premenopausal experienced improved outcomes from ovarian suppression. This high-risk subgroup when given tamoxifen plus ovarian suppression had a 4.5% absolute reduction in breast cancer recurrence at 5 years compared with the group that received tamoxifen alone. When this high-risk subgroup was given exemestane plus ovarian suppression, the women had a 7.7% absolute reduction in breast cancer recurrence at 5 years compared with the group that received tamoxifen alone.⁸

Ovarian suppression resulted in significant additional AEs, including depression and menopausal symptoms. The authors of the study also pointed out the additional risk of hypertension, musculoskeletal AEs, and decreased bone density. Furthermore, the OS data from these studies are premature, because the patients had fewer AEs than initially anticipated; this resulted in an only 5% mortality at publication.

The study design also raised several interesting questions. The primary endpoint was disease-free survival. The authors defined this as the time from randomization to the first appearance of invasive recurrence of breast cancer (local, regional, or distant), invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without breast cancer recurrence or second invasive cancer. When studying adjuvant therapy for diseases, such as breast cancer, which carry long-term survival, studies often use PFS with various modified definitions as a surrogate marker for OS. Clinicians are then left to decide whether this surrogate marker is an accurate predictor of OS or other important clinical outcomes.

In the combined analysis of the TEXT and SOFT trials, only 60% of the first recurrences, second invasive cancers, or deaths involved recurrence of breast cancer
at a distant site.⁹ Because locally recurrent breast cancer is highly treatable and often curable, clinicians must ask whether the increased toxicities of ovarian suppression are worth the large number of women who experienced local recurrence given the still relatively small absolute reduction in recurrence risk.

Last, the study authors retrospectively reviewed data from the International Breast Cancer Study Group and U.S. Intergroup trials and concluded that women aged < 35 years were most likely to be at high-risk for AEs.^10,11 A subgroup analysis of women aged < 35 years in the SOFT trial noted that breast cancer recurred within 5 years in one-third of women receiving tamoxifen alone, whereas only in one-sixth of women receiving exemestane plus ovarian suppression.⁸ This is the basis for the conclusion that premenopausal women, particularly those aged < 35 years, with high-risk disease who receive chemotherapy and remain premenopausal after chemotherapy, benefit from ovarian suppression in combination with tamoxifen, and even more impressively from ovarian suppression combined with exemestane.

The problem is that the study did not risk-stratify patients based on those aged < 35 years, and the conclusion is based on a subgroup analysis using a primary endpoint that may not accurately predict OS. Nonetheless, although not definitive, the data from the TEXT and SOFT trials raise interesting therapeutic questions that require further study and certainly provide tempting therapeutic options in patients who are clinically at high risk for recurrence.

HER2-Positive Breast Cancer

Up to 20% of invasive breast cancers are a result of HER2 gene amplification or overexpression of the HER2 protein, a tyrosine kinase transmembrane receptor, resulting in a more aggressive phenotype and a poor prognosis. Anti-HER2 drugs have changed the landscape of the disease previously known as aggressive breast cancer with a poor survival rate.

Treatment with the anti-HER2 humanized monoclonal antibody trastuzumab in addition to chemotherapy, compared with chemotherapy alone, significantly improves PFS and OS among patients with HER2-positive metastatic as well as early breast cancer. However, in most patients with HER2-positive metastatic breast cancer, the disease progresses, highlighting the need for new, targeted therapies for advanced disease.

New Standard of Care

The original studies of trastuzumab showed improved OS in late-stage (metastatic) breast cancer from 20.3 to 25.1 months, and in early-stage breast cancer, it reduced the risk of cancer returning after surgery by an absolute risk of 9.5% and the risk of death by an absolute risk of 3%.

New therapies directed at HER2 are being developed, among them pertuzumab, a humanized monoclonal antibody that binds HER2 at a different epitope of the HER2 extracellular domain (subdomain 2) than that at which trastuzumab binds. Pertuzumab prevents HER2 from dimerizing with other ligand-activated HER receptors, most notably HER3. Like trastuzumab, pertuzumab stimulates antibody-dependent, cell-mediated cytotoxicity. Because pertuzumab and trastuzumab bind to different HER2 epitopes and have complementary mechanisms of action, these 2 agents, when given together, provide a more comprehensive blockade of HER2 signaling and result in greater antitumor activity than does either agent alone in HER2-positive tumor models.¹² In phase 2 studies, a pertuzumab–trastuzumab regimen has shown activity in patients with HER2-positive metastatic breast cancer and in patients with early breast cancer.¹³

In the phase 3 CLEOPATRA study, the combination of pertuzumab plus trastuzumab plus docetaxel, used as first-line treatment for HER2-positive metastatic breast cancer compared with placebo plus trastuzumab plus docetaxel, significantly prolonged PFS (18.5 months vs 12.4 months), with no increase in cardiac toxic effects.¹² In a recent updated follow-up of the CLEOPATRA study, the addition of pertuzumab to trastuzumab and docetaxel showed a significantly better median OS (56.5 months vs 40.8 months; hazard ratio, 0.68; P < .001).¹⁴ From these results, this combination regimen is now considered a first-line therapy for patients with HER2-positive metastatic breast cancer.

However, the cost of cancer treatment has become a mounting concern during the past decade, as new therapies come down the pipeline with ever-increasing price tags. Trastuzumab costs about $4,500 a month, and the newer pertuzumab runs about 30% higher, at $6,000 a month. For a full course of treatment, the cost of the pertuzumab and trastuzumab combination could go as high as $195,000, depending on the duration of therapy and the choice of taxanes.

Conclusions

The landscape of therapeutic options in high-risk, young patients with early-stage breast cancer as well as patients with advanced or metastatic disease is changing rapidly.

Clinicians now have 2 new first-line options for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer. A phase 3 trial demonstrated that fulvestrant monotherapy offers improved PFS and some improvement in OS compared with anastrazole in postmenopausal women. A phase 2 trial showed that palbociclib plus letrozole offers improved PFS in postmenopausal women. Based on the SOFT and TEXT trials, clinicians treating high-risk premenopausal women now have some data to inform the debate about whether ovarian suppression should be added to hormone therapy.

Based on the CLEOPATRA trial, clinicians can now consider combination pertuzumab and trastuzumab and docetaxel as first-line therapy for patients with HER2-positive metastatic breast cancer.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here to read the digital edition.

Consuming psyllium fiber significantly reduced the frequency, but not the severity, of abdominal pain in children with irritable bowel syndrome in a randomized, double-blind, placebo-controlled trial reported in the May issue of Clinical Gastroenterology and Hepatology (2016 Nov;14[11]:1667).

Psyllium therapy did not reduce the self-reported severity of abdominal pain, Robert J. Shulman, MD, of Baylor College of Medicine in Houston reported with his associates in Clinical Gastroenterology and Hepatology. Psyllium was associated with shifts in intestinal microbiota, compared with baseline, although the changes did not reach statistical significance when compared with placebo, the researchers added. “Further studies are needed to investigate the potential mechanism whereby psyllium decreases abdominal pain frequency in children with irritable bowel syndrome [IBS],” they wrote.

IBS affects up to 20% of school-aged children. Consuming psyllium is thought to improve abdominal pain and stooling symptoms in adults with IBS, but data are inconclusive, and few randomized trials have evaluated fiber in childhood IBS. Therefore, the investigators randomly assigned 103 children (average age, 13 years; standard deviation, 3 years) with IBS who had responded inadequately to an 8-day carbohydrate elimination diet to receive a single daily dose of either psyllium or placebo maltodextrin for 6 weeks. Children aged 7-11 years received 6 g of fiber, while those aged 12-18 years received 12 g of fiber. Patients filled out a daily pain and stool diary during a 2-week baseline assessment period and again during the final 2 weeks of the trial. They also underwent breath hydrogen and methane testing, gut permeability testing, and a stool microbiota assessment during the final weekend of treatment.

At baseline, the trial arms resembled each other in terms of frequency and severity of abdominal pain, psychological characteristics, percentage of normal stools, baseline hydrogen production, and gastrointestinal permeability, the researchers said. During the final 2 weeks of treatment, the psyllium arm reported an average of 8.2 (standard deviation, 1.2) fewer episodes of abdominal pain, compared with baseline, while the control arm reported a mean reduction of 4.1 (SD, 1.3) episodes of abdominal pain (P = .03). At the end of treatment, the arms did not significantly differ in percentage of breath hydrogen or methane production, gastrointestinal permeability, or percentage of normal stools or diarrhea. However, controls had a significantly greater reduction in constipation compared with the psyllium group (P = .048).

Stool microbiome assessments of 33 children revealed a trend toward a greater increase in Bacteroidetes and a greater decrease in Firmicutes bacteria in the fiber group, compared with the control group (P = .068). The fiber group was also “marginally enriched” in bacteria of class Bacteroidia, while the placebo group was enriched in bacteria of class Clostridia (P = .094). However, the groups did not differ at narrower taxonomic levels, the researchers said. A larger sample size might have facilitated better detection of differences between groups, such as in breath hydrogen production or interactions between abdominal pain and psychological symptoms, they added.

The study was supported in part by the National Institutes of Health, the Daffy’s Foundation, and the USDA/ARS. The investigators reported having no conflicts of interest.

Consuming psyllium fiber significantly reduced the frequency, but not the severity, of abdominal pain in children with irritable bowel syndrome in a randomized, double-blind, placebo-controlled trial reported in the May issue of Clinical Gastroenterology and Hepatology (2016 Nov;14[11]:1667).

Psyllium therapy did not reduce the self-reported severity of abdominal pain, Robert J. Shulman, MD, of Baylor College of Medicine in Houston reported with his associates in Clinical Gastroenterology and Hepatology. Psyllium was associated with shifts in intestinal microbiota, compared with baseline, although the changes did not reach statistical significance when compared with placebo, the researchers added. “Further studies are needed to investigate the potential mechanism whereby psyllium decreases abdominal pain frequency in children with irritable bowel syndrome [IBS],” they wrote.

IBS affects up to 20% of school-aged children. Consuming psyllium is thought to improve abdominal pain and stooling symptoms in adults with IBS, but data are inconclusive, and few randomized trials have evaluated fiber in childhood IBS. Therefore, the investigators randomly assigned 103 children (average age, 13 years; standard deviation, 3 years) with IBS who had responded inadequately to an 8-day carbohydrate elimination diet to receive a single daily dose of either psyllium or placebo maltodextrin for 6 weeks. Children aged 7-11 years received 6 g of fiber, while those aged 12-18 years received 12 g of fiber. Patients filled out a daily pain and stool diary during a 2-week baseline assessment period and again during the final 2 weeks of the trial. They also underwent breath hydrogen and methane testing, gut permeability testing, and a stool microbiota assessment during the final weekend of treatment.

At baseline, the trial arms resembled each other in terms of frequency and severity of abdominal pain, psychological characteristics, percentage of normal stools, baseline hydrogen production, and gastrointestinal permeability, the researchers said. During the final 2 weeks of treatment, the psyllium arm reported an average of 8.2 (standard deviation, 1.2) fewer episodes of abdominal pain, compared with baseline, while the control arm reported a mean reduction of 4.1 (SD, 1.3) episodes of abdominal pain (P = .03). At the end of treatment, the arms did not significantly differ in percentage of breath hydrogen or methane production, gastrointestinal permeability, or percentage of normal stools or diarrhea. However, controls had a significantly greater reduction in constipation compared with the psyllium group (P = .048).

Stool microbiome assessments of 33 children revealed a trend toward a greater increase in Bacteroidetes and a greater decrease in Firmicutes bacteria in the fiber group, compared with the control group (P = .068). The fiber group was also “marginally enriched” in bacteria of class Bacteroidia, while the placebo group was enriched in bacteria of class Clostridia (P = .094). However, the groups did not differ at narrower taxonomic levels, the researchers said. A larger sample size might have facilitated better detection of differences between groups, such as in breath hydrogen production or interactions between abdominal pain and psychological symptoms, they added.

The study was supported in part by the National Institutes of Health, the Daffy’s Foundation, and the USDA/ARS. The investigators reported having no conflicts of interest.

Consuming psyllium fiber significantly reduced the frequency, but not the severity, of abdominal pain in children with irritable bowel syndrome in a randomized, double-blind, placebo-controlled trial reported in the May issue of Clinical Gastroenterology and Hepatology (2016 Nov;14[11]:1667).

Psyllium therapy did not reduce the self-reported severity of abdominal pain, Robert J. Shulman, MD, of Baylor College of Medicine in Houston reported with his associates in Clinical Gastroenterology and Hepatology. Psyllium was associated with shifts in intestinal microbiota, compared with baseline, although the changes did not reach statistical significance when compared with placebo, the researchers added. “Further studies are needed to investigate the potential mechanism whereby psyllium decreases abdominal pain frequency in children with irritable bowel syndrome [IBS],” they wrote.

IBS affects up to 20% of school-aged children. Consuming psyllium is thought to improve abdominal pain and stooling symptoms in adults with IBS, but data are inconclusive, and few randomized trials have evaluated fiber in childhood IBS. Therefore, the investigators randomly assigned 103 children (average age, 13 years; standard deviation, 3 years) with IBS who had responded inadequately to an 8-day carbohydrate elimination diet to receive a single daily dose of either psyllium or placebo maltodextrin for 6 weeks. Children aged 7-11 years received 6 g of fiber, while those aged 12-18 years received 12 g of fiber. Patients filled out a daily pain and stool diary during a 2-week baseline assessment period and again during the final 2 weeks of the trial. They also underwent breath hydrogen and methane testing, gut permeability testing, and a stool microbiota assessment during the final weekend of treatment.

At baseline, the trial arms resembled each other in terms of frequency and severity of abdominal pain, psychological characteristics, percentage of normal stools, baseline hydrogen production, and gastrointestinal permeability, the researchers said. During the final 2 weeks of treatment, the psyllium arm reported an average of 8.2 (standard deviation, 1.2) fewer episodes of abdominal pain, compared with baseline, while the control arm reported a mean reduction of 4.1 (SD, 1.3) episodes of abdominal pain (P = .03). At the end of treatment, the arms did not significantly differ in percentage of breath hydrogen or methane production, gastrointestinal permeability, or percentage of normal stools or diarrhea. However, controls had a significantly greater reduction in constipation compared with the psyllium group (P = .048).

Stool microbiome assessments of 33 children revealed a trend toward a greater increase in Bacteroidetes and a greater decrease in Firmicutes bacteria in the fiber group, compared with the control group (P = .068). The fiber group was also “marginally enriched” in bacteria of class Bacteroidia, while the placebo group was enriched in bacteria of class Clostridia (P = .094). However, the groups did not differ at narrower taxonomic levels, the researchers said. A larger sample size might have facilitated better detection of differences between groups, such as in breath hydrogen production or interactions between abdominal pain and psychological symptoms, they added.

The study was supported in part by the National Institutes of Health, the Daffy’s Foundation, and the USDA/ARS. The investigators reported having no conflicts of interest.

The American College of Surgeons (ACS) has announced the launch of the new Surgeon Specific Registry (SSR), hosted by QuintilesIMS. The new SSR is set to go live in this spring. The latest version of the registry will have several enhanced features, including improved reporting capabilities, delegate-level access to enter data, and the ability to add custom fields for additional relevant variables.

To help you prepare for this transition, the SSR team will host several educational webinars to demonstrate the new system’s capabilities and features. The ACS encourages both current and potential users to participate. To view the available times and register for one of the upcoming webinars, visit the SSR News and Updates web page at facs.org/quality-programs/ssr/news.

Contact SSR@facs.org if you have any questions.
 

The American College of Surgeons (ACS) has announced the launch of the new Surgeon Specific Registry (SSR), hosted by QuintilesIMS. The new SSR is set to go live in this spring. The latest version of the registry will have several enhanced features, including improved reporting capabilities, delegate-level access to enter data, and the ability to add custom fields for additional relevant variables.

To help you prepare for this transition, the SSR team will host several educational webinars to demonstrate the new system’s capabilities and features. The ACS encourages both current and potential users to participate. To view the available times and register for one of the upcoming webinars, visit the SSR News and Updates web page at facs.org/quality-programs/ssr/news.

Contact SSR@facs.org if you have any questions.
 

The American College of Surgeons (ACS) has announced the launch of the new Surgeon Specific Registry (SSR), hosted by QuintilesIMS. The new SSR is set to go live in this spring. The latest version of the registry will have several enhanced features, including improved reporting capabilities, delegate-level access to enter data, and the ability to add custom fields for additional relevant variables.

To help you prepare for this transition, the SSR team will host several educational webinars to demonstrate the new system’s capabilities and features. The ACS encourages both current and potential users to participate. To view the available times and register for one of the upcoming webinars, visit the SSR News and Updates web page at facs.org/quality-programs/ssr/news.

Contact SSR@facs.org if you have any questions.
 

Applications for 2018 Alliance Scholar Awards Accepted through June 30

The Alliance for Clinical Trials in Oncology Foundation is accepting applications for the 2018 Alliance Scholar Awards. Applications must be submitted by 12:00 midnight (CST) on June 30.

Alliance Scholar Award applicants must be oncology junior faculty at Alliance institutions within five years of training (rank below associate professor) and have completed training in an oncology clinical specialty (medical, surgical, radiation, gynecologic, and so on). Additionally, proposals must include a letter of support from the appropriate Alliance Scientific Committee Chair to ensure the proposal is closely tied to the Alliance’s research agenda of the Alliance.

Alliance Scholar Award recipients will receive a two-year, non-renewable cancer research grant of $40,000 in direct costs per year, plus 10 percent in indirect costs for each of the two years. Successful applicants will be announced at the plenary session at the 2017 Alliance Fall Group Meeting held in Chicago, IL, November 2–4. Funding will begin approximately January 1, 2018. For application requirements and the link to the online submission portal, visit the Alliance Scholar Awards page on the Alliance website at http://bit.ly/1JMXkwS.

The Alliance/American College of Surgeons Clinical Research Program offers opportunities for surgeons to become involved in the research and development of evidence-based practices in surgical oncology. If you would like to participate in oncology clinical research or oncology-related projects, contact clinicalresearchprogram@facs.org.

Applications for 2018 Alliance Scholar Awards Accepted through June 30

The Alliance for Clinical Trials in Oncology Foundation is accepting applications for the 2018 Alliance Scholar Awards. Applications must be submitted by 12:00 midnight (CST) on June 30.

Alliance Scholar Award applicants must be oncology junior faculty at Alliance institutions within five years of training (rank below associate professor) and have completed training in an oncology clinical specialty (medical, surgical, radiation, gynecologic, and so on). Additionally, proposals must include a letter of support from the appropriate Alliance Scientific Committee Chair to ensure the proposal is closely tied to the Alliance’s research agenda of the Alliance.

Alliance Scholar Award recipients will receive a two-year, non-renewable cancer research grant of $40,000 in direct costs per year, plus 10 percent in indirect costs for each of the two years. Successful applicants will be announced at the plenary session at the 2017 Alliance Fall Group Meeting held in Chicago, IL, November 2–4. Funding will begin approximately January 1, 2018. For application requirements and the link to the online submission portal, visit the Alliance Scholar Awards page on the Alliance website at http://bit.ly/1JMXkwS.

The Alliance/American College of Surgeons Clinical Research Program offers opportunities for surgeons to become involved in the research and development of evidence-based practices in surgical oncology. If you would like to participate in oncology clinical research or oncology-related projects, contact clinicalresearchprogram@facs.org.

Applications for 2018 Alliance Scholar Awards Accepted through June 30

The Alliance for Clinical Trials in Oncology Foundation is accepting applications for the 2018 Alliance Scholar Awards. Applications must be submitted by 12:00 midnight (CST) on June 30.

Alliance Scholar Award applicants must be oncology junior faculty at Alliance institutions within five years of training (rank below associate professor) and have completed training in an oncology clinical specialty (medical, surgical, radiation, gynecologic, and so on). Additionally, proposals must include a letter of support from the appropriate Alliance Scientific Committee Chair to ensure the proposal is closely tied to the Alliance’s research agenda of the Alliance.

Alliance Scholar Award recipients will receive a two-year, non-renewable cancer research grant of $40,000 in direct costs per year, plus 10 percent in indirect costs for each of the two years. Successful applicants will be announced at the plenary session at the 2017 Alliance Fall Group Meeting held in Chicago, IL, November 2–4. Funding will begin approximately January 1, 2018. For application requirements and the link to the online submission portal, visit the Alliance Scholar Awards page on the Alliance website at http://bit.ly/1JMXkwS.

The Alliance/American College of Surgeons Clinical Research Program offers opportunities for surgeons to become involved in the research and development of evidence-based practices in surgical oncology. If you would like to participate in oncology clinical research or oncology-related projects, contact clinicalresearchprogram@facs.org.

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) is accepting nominations for the second annual Dr. Mary Edwards Walker Inspiring Women in Surgery Award, which will be presented at Clinical Congress 2017 in San Diego, CA. The award will be accorded in recognition of an individual’s significant contributions to the advancement of women in the field of surgery. Nominations are due April 30.

The award honors Dr. Mary Edwards Walker for the example she set for future generations as the first woman surgeon to serve as a U.S. Army physician and the only woman to ever receive the U.S. Armed Forces Medal of Honor for bravery.

Courtesy Library of Congress

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) is accepting nominations for the second annual Dr. Mary Edwards Walker Inspiring Women in Surgery Award, which will be presented at Clinical Congress 2017 in San Diego, CA. The award will be accorded in recognition of an individual’s significant contributions to the advancement of women in the field of surgery. Nominations are due April 30.

The award honors Dr. Mary Edwards Walker for the example she set for future generations as the first woman surgeon to serve as a U.S. Army physician and the only woman to ever receive the U.S. Armed Forces Medal of Honor for bravery.

Courtesy Library of Congress

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) is accepting nominations for the second annual Dr. Mary Edwards Walker Inspiring Women in Surgery Award, which will be presented at Clinical Congress 2017 in San Diego, CA. The award will be accorded in recognition of an individual’s significant contributions to the advancement of women in the field of surgery. Nominations are due April 30.

The award honors Dr. Mary Edwards Walker for the example she set for future generations as the first woman surgeon to serve as a U.S. Army physician and the only woman to ever receive the U.S. Armed Forces Medal of Honor for bravery.

Courtesy Library of Congress

Editor’s note: “Everything We Say and Do” is an informational series developed by the Society of Hospital Medicine’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experiences of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

What I say and do

I empower all of my patients by giving them the opportunity to consider advance care planning.

Why I do it

Everyone deserves advance care planning, and every health care encounter, including a hospitalization, is an opportunity to better identify and document patients’ wishes for care should they become unable to express them. If we wait for patients to develop serious advanced illness before having advance care planning conversations, we risk depriving them of the care they would want in these situations. Additionally, we place a huge burden on family members who may struggle with excruciatingly difficult decisions in the absence of guidance about their loved one’s wishes.

How I do it

I start by identifying which components of advance care planning each patient needs, using a simple algorithm (see figure). All of my patients are queried about code status, and I give them the opportunity to better understand the value of having a healthcare proxy and advance directives, if they are not already in place.

To introduce the concept of a health care proxy and advance directives, I ask, “Have you ever thought about who you might choose to make medical decisions on your behalf if you became too sick to make those decisions yourself?” Then, finally, I share the following information, usually referring to the blank advance directives document they received in their admission packet: “There is a valuable way to put your wishes about specific care options in writing so others will know your wishes if you’re unable to communicate with them. Would you like to talk about that right now?” Again, this gives the patient control of the situation and an opportunity to decline the conversation if they are not interested or comfortable at that time.

It’s important to document the nature and outcome of these conversations. Keep in mind, advance care planning discussions need not occur at the time of admission. In fact, admission may be the worst time for some patients, further underscoring the importance of documentation so that subsequent providers can see whether advance care planning has been addressed during the hospital stay.

Note: For useful educational resources that address goals-of-care conversations in patients toward the end of life, the Center to Advance Palliative Care (www.capc.org) has a number of educational courses that address these important communication skills.
 

Dr. Rudolph is vice president of physician development and patient experience for Sound Physicians, Tacoma, Wash. and chair of the SHM Patient Experience Committee .

Reference

1. Moss, A.H., Ganjoo, J, Sharma S, et al. Utility of the “Surprise” Question to Identify Dialysis Patients with High Mortality. Clinical Journal of the American Society of Nephrology: CJASN. 2008;3(5):1379-84. doi:10.2215/CJN.00940208.




 

Editor’s note: “Everything We Say and Do” is an informational series developed by the Society of Hospital Medicine’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experiences of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

What I say and do

I empower all of my patients by giving them the opportunity to consider advance care planning.

Why I do it

Everyone deserves advance care planning, and every health care encounter, including a hospitalization, is an opportunity to better identify and document patients’ wishes for care should they become unable to express them. If we wait for patients to develop serious advanced illness before having advance care planning conversations, we risk depriving them of the care they would want in these situations. Additionally, we place a huge burden on family members who may struggle with excruciatingly difficult decisions in the absence of guidance about their loved one’s wishes.

How I do it

I start by identifying which components of advance care planning each patient needs, using a simple algorithm (see figure). All of my patients are queried about code status, and I give them the opportunity to better understand the value of having a healthcare proxy and advance directives, if they are not already in place.

To introduce the concept of a health care proxy and advance directives, I ask, “Have you ever thought about who you might choose to make medical decisions on your behalf if you became too sick to make those decisions yourself?” Then, finally, I share the following information, usually referring to the blank advance directives document they received in their admission packet: “There is a valuable way to put your wishes about specific care options in writing so others will know your wishes if you’re unable to communicate with them. Would you like to talk about that right now?” Again, this gives the patient control of the situation and an opportunity to decline the conversation if they are not interested or comfortable at that time.

It’s important to document the nature and outcome of these conversations. Keep in mind, advance care planning discussions need not occur at the time of admission. In fact, admission may be the worst time for some patients, further underscoring the importance of documentation so that subsequent providers can see whether advance care planning has been addressed during the hospital stay.

Note: For useful educational resources that address goals-of-care conversations in patients toward the end of life, the Center to Advance Palliative Care (www.capc.org) has a number of educational courses that address these important communication skills.
 

Dr. Rudolph is vice president of physician development and patient experience for Sound Physicians, Tacoma, Wash. and chair of the SHM Patient Experience Committee .

Reference

1. Moss, A.H., Ganjoo, J, Sharma S, et al. Utility of the “Surprise” Question to Identify Dialysis Patients with High Mortality. Clinical Journal of the American Society of Nephrology: CJASN. 2008;3(5):1379-84. doi:10.2215/CJN.00940208.




 

Editor’s note: “Everything We Say and Do” is an informational series developed by the Society of Hospital Medicine’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experiences of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”

What I say and do

I empower all of my patients by giving them the opportunity to consider advance care planning.

Why I do it

Everyone deserves advance care planning, and every health care encounter, including a hospitalization, is an opportunity to better identify and document patients’ wishes for care should they become unable to express them. If we wait for patients to develop serious advanced illness before having advance care planning conversations, we risk depriving them of the care they would want in these situations. Additionally, we place a huge burden on family members who may struggle with excruciatingly difficult decisions in the absence of guidance about their loved one’s wishes.

How I do it

I start by identifying which components of advance care planning each patient needs, using a simple algorithm (see figure). All of my patients are queried about code status, and I give them the opportunity to better understand the value of having a healthcare proxy and advance directives, if they are not already in place.

To introduce the concept of a health care proxy and advance directives, I ask, “Have you ever thought about who you might choose to make medical decisions on your behalf if you became too sick to make those decisions yourself?” Then, finally, I share the following information, usually referring to the blank advance directives document they received in their admission packet: “There is a valuable way to put your wishes about specific care options in writing so others will know your wishes if you’re unable to communicate with them. Would you like to talk about that right now?” Again, this gives the patient control of the situation and an opportunity to decline the conversation if they are not interested or comfortable at that time.

It’s important to document the nature and outcome of these conversations. Keep in mind, advance care planning discussions need not occur at the time of admission. In fact, admission may be the worst time for some patients, further underscoring the importance of documentation so that subsequent providers can see whether advance care planning has been addressed during the hospital stay.

Note: For useful educational resources that address goals-of-care conversations in patients toward the end of life, the Center to Advance Palliative Care (www.capc.org) has a number of educational courses that address these important communication skills.
 

Dr. Rudolph is vice president of physician development and patient experience for Sound Physicians, Tacoma, Wash. and chair of the SHM Patient Experience Committee .

Reference

1. Moss, A.H., Ganjoo, J, Sharma S, et al. Utility of the “Surprise” Question to Identify Dialysis Patients with High Mortality. Clinical Journal of the American Society of Nephrology: CJASN. 2008;3(5):1379-84. doi:10.2215/CJN.00940208.




 

I recently had the good fortune to read a commentary written by Dr. Peter Angelos in ACS Surgery News entitled, The Right Choice? Surgeons, confidence, and humility (2017, February, p. 11). The essay touches on the philosophy, psychology, and attitudes that surgeons adopt and express in their daily interactions with the public.

The article refers to “the balance between lack of confidence and overconfidence, and between thoughtful introspection and paralyzing fear of future complications.” This is a critically important struggle in the mind of the surgeon. I would like to propose an exercise to bolster self-esteem in the psyche of the surgeon, particularly in the formative stages of one’s career, without fostering false or pathological bravado.

Dr. Chuback is a vascular surgeon in private practice in Paramus, N.J.

I recently had the good fortune to read a commentary written by Dr. Peter Angelos in ACS Surgery News entitled, The Right Choice? Surgeons, confidence, and humility (2017, February, p. 11). The essay touches on the philosophy, psychology, and attitudes that surgeons adopt and express in their daily interactions with the public.

The article refers to “the balance between lack of confidence and overconfidence, and between thoughtful introspection and paralyzing fear of future complications.” This is a critically important struggle in the mind of the surgeon. I would like to propose an exercise to bolster self-esteem in the psyche of the surgeon, particularly in the formative stages of one’s career, without fostering false or pathological bravado.

Dr. Chuback is a vascular surgeon in private practice in Paramus, N.J.

I recently had the good fortune to read a commentary written by Dr. Peter Angelos in ACS Surgery News entitled, The Right Choice? Surgeons, confidence, and humility (2017, February, p. 11). The essay touches on the philosophy, psychology, and attitudes that surgeons adopt and express in their daily interactions with the public.

The article refers to “the balance between lack of confidence and overconfidence, and between thoughtful introspection and paralyzing fear of future complications.” This is a critically important struggle in the mind of the surgeon. I would like to propose an exercise to bolster self-esteem in the psyche of the surgeon, particularly in the formative stages of one’s career, without fostering false or pathological bravado.

Dr. Chuback is a vascular surgeon in private practice in Paramus, N.J.

Editor’s note: This new series highlights the professional pathways of quality improvement leaders. This month features the story of Kevin O’Leary, MD, MS, SFHM, chief of hospital medicine at Northwestern University Feinberg School of Medicine in Chicago.

Kevin O’Leary, MD, MS, SFHM, chose a career path in hospital medicine for the reasons that attract many to the specialty – a love of “a little bit of everything, clinically” and the opportunity to problem-solve a diverse range of professional challenges on a daily basis.

While he encourages anyone with an interest in QI to seek additional training opportunities, he says personal qualities – tenacity, curiosity, and a willingness to collaborate—are better predictors of success. For those wondering how to get started, “look for a niche, an unmet need that is valuable to your organization, and fill it,” he advised. “You don’t have to be an expert in that area, but you can become one.”

Making strong connections within the hospital system is essential. Reach out to the contacts you know, he said, and if they are not the ones to help you solve the problem, they often know who can.

“That’s key to quality improvement success, as well as career success,” he said. “Find a mentor. It might be someone who is more senior within the hospitalist group, in medicine, or even outside the hospital. Meet with them regularly and ask them for feedback on your ideas.”

Newcomers to QI should embrace opportunities to change care and not get discouraged when a project has unintended outcomes.

“Failure is when a team never gets to the point of implementing the intervention or when a team doesn’t know whether the intervention has actually changed results,” he said. “Learning why an intervention isn’t effective can be as valuable as implementing one that is. If every project is successful, it just means that you’re not taking enough risks.”

Dr. O’Leary spends about 25% of his professional time providing clinical care, and another 15% meeting his responsibilities as division chief. He uses the other protected time in his schedule to lead QI and teach QI skills in programs like Northwestern Medicine’s Academy for Quality and Safety Improvement (AQSI).

As a former faculty member in SHM’s Quality and Safety Educator’s Academy (QSEA), he has trained medical educators to develop curricula in quality improvement and patient safety. He says both AQSI and QSEA are especially effective because they encourage interaction, which is valuable to professionals at all levels looking to advance their skill in QI.

“Even in a teaching capacity,” he noted, “what I learned from other faculty and participants in QSEA was critical.”

Residents and junior hospitalists often have the impression that they lack the skills to lead quality initiatives, but Dr. O’Leary says medical school provides the nuts and bolts – analytical skills, statistical knowledge, critical thinking. He encouraged hospitalists to move ahead, even without formal QI training.

“If you have strong interpersonal skills – the willingness to make friends and build connections – you will be successful,” he said.

It’s also an excellent way to learn about the ins and outs of the hospital system and the work of other departments and specialties. Dr. O’Leary especially enjoys that aspect of his work, as well as the ability to address systemic issues that he values.

“I get the greatest fulfillment from the opportunity to be creative … and to implement projects that are important to me and help patients,” he said. “As long as the projects align with organizational goals, I can usually find the support we need to be successful.”

Claudia Stahl is a content manager for the Society of Hospital Medicine.

Editor’s note: This new series highlights the professional pathways of quality improvement leaders. This month features the story of Kevin O’Leary, MD, MS, SFHM, chief of hospital medicine at Northwestern University Feinberg School of Medicine in Chicago.

Kevin O’Leary, MD, MS, SFHM, chose a career path in hospital medicine for the reasons that attract many to the specialty – a love of “a little bit of everything, clinically” and the opportunity to problem-solve a diverse range of professional challenges on a daily basis.

While he encourages anyone with an interest in QI to seek additional training opportunities, he says personal qualities – tenacity, curiosity, and a willingness to collaborate—are better predictors of success. For those wondering how to get started, “look for a niche, an unmet need that is valuable to your organization, and fill it,” he advised. “You don’t have to be an expert in that area, but you can become one.”

Making strong connections within the hospital system is essential. Reach out to the contacts you know, he said, and if they are not the ones to help you solve the problem, they often know who can.

“That’s key to quality improvement success, as well as career success,” he said. “Find a mentor. It might be someone who is more senior within the hospitalist group, in medicine, or even outside the hospital. Meet with them regularly and ask them for feedback on your ideas.”

Newcomers to QI should embrace opportunities to change care and not get discouraged when a project has unintended outcomes.

“Failure is when a team never gets to the point of implementing the intervention or when a team doesn’t know whether the intervention has actually changed results,” he said. “Learning why an intervention isn’t effective can be as valuable as implementing one that is. If every project is successful, it just means that you’re not taking enough risks.”

Dr. O’Leary spends about 25% of his professional time providing clinical care, and another 15% meeting his responsibilities as division chief. He uses the other protected time in his schedule to lead QI and teach QI skills in programs like Northwestern Medicine’s Academy for Quality and Safety Improvement (AQSI).

As a former faculty member in SHM’s Quality and Safety Educator’s Academy (QSEA), he has trained medical educators to develop curricula in quality improvement and patient safety. He says both AQSI and QSEA are especially effective because they encourage interaction, which is valuable to professionals at all levels looking to advance their skill in QI.

“Even in a teaching capacity,” he noted, “what I learned from other faculty and participants in QSEA was critical.”

Residents and junior hospitalists often have the impression that they lack the skills to lead quality initiatives, but Dr. O’Leary says medical school provides the nuts and bolts – analytical skills, statistical knowledge, critical thinking. He encouraged hospitalists to move ahead, even without formal QI training.

“If you have strong interpersonal skills – the willingness to make friends and build connections – you will be successful,” he said.

It’s also an excellent way to learn about the ins and outs of the hospital system and the work of other departments and specialties. Dr. O’Leary especially enjoys that aspect of his work, as well as the ability to address systemic issues that he values.

“I get the greatest fulfillment from the opportunity to be creative … and to implement projects that are important to me and help patients,” he said. “As long as the projects align with organizational goals, I can usually find the support we need to be successful.”

Claudia Stahl is a content manager for the Society of Hospital Medicine.

Editor’s note: This new series highlights the professional pathways of quality improvement leaders. This month features the story of Kevin O’Leary, MD, MS, SFHM, chief of hospital medicine at Northwestern University Feinberg School of Medicine in Chicago.

Kevin O’Leary, MD, MS, SFHM, chose a career path in hospital medicine for the reasons that attract many to the specialty – a love of “a little bit of everything, clinically” and the opportunity to problem-solve a diverse range of professional challenges on a daily basis.

While he encourages anyone with an interest in QI to seek additional training opportunities, he says personal qualities – tenacity, curiosity, and a willingness to collaborate—are better predictors of success. For those wondering how to get started, “look for a niche, an unmet need that is valuable to your organization, and fill it,” he advised. “You don’t have to be an expert in that area, but you can become one.”

Making strong connections within the hospital system is essential. Reach out to the contacts you know, he said, and if they are not the ones to help you solve the problem, they often know who can.

“That’s key to quality improvement success, as well as career success,” he said. “Find a mentor. It might be someone who is more senior within the hospitalist group, in medicine, or even outside the hospital. Meet with them regularly and ask them for feedback on your ideas.”

Newcomers to QI should embrace opportunities to change care and not get discouraged when a project has unintended outcomes.

“Failure is when a team never gets to the point of implementing the intervention or when a team doesn’t know whether the intervention has actually changed results,” he said. “Learning why an intervention isn’t effective can be as valuable as implementing one that is. If every project is successful, it just means that you’re not taking enough risks.”

Dr. O’Leary spends about 25% of his professional time providing clinical care, and another 15% meeting his responsibilities as division chief. He uses the other protected time in his schedule to lead QI and teach QI skills in programs like Northwestern Medicine’s Academy for Quality and Safety Improvement (AQSI).

As a former faculty member in SHM’s Quality and Safety Educator’s Academy (QSEA), he has trained medical educators to develop curricula in quality improvement and patient safety. He says both AQSI and QSEA are especially effective because they encourage interaction, which is valuable to professionals at all levels looking to advance their skill in QI.

“Even in a teaching capacity,” he noted, “what I learned from other faculty and participants in QSEA was critical.”

Residents and junior hospitalists often have the impression that they lack the skills to lead quality initiatives, but Dr. O’Leary says medical school provides the nuts and bolts – analytical skills, statistical knowledge, critical thinking. He encouraged hospitalists to move ahead, even without formal QI training.

“If you have strong interpersonal skills – the willingness to make friends and build connections – you will be successful,” he said.

It’s also an excellent way to learn about the ins and outs of the hospital system and the work of other departments and specialties. Dr. O’Leary especially enjoys that aspect of his work, as well as the ability to address systemic issues that he values.

“I get the greatest fulfillment from the opportunity to be creative … and to implement projects that are important to me and help patients,” he said. “As long as the projects align with organizational goals, I can usually find the support we need to be successful.”

Claudia Stahl is a content manager for the Society of Hospital Medicine.

Washington – Marijuana abuse was independently associated with an eye-opening doubled risk of acute MI in a large, retrospective, age-matched cohort study, Ahmad Tarek Chami, MD, reported at the annual meeting of the American College of Cardiology.

The link was strongest by far in young adult marijuana abusers, with an adjusted 3.2-fold increased risk of MI in 25- to 29-year-olds with marijuana abuse noted in their medical records, compared with age-matched controls and a 4.56-fold greater risk among the 30- to 34-year-old cannabis abusers, according to Dr. Chami of Case Western Reserve University in Cleveland.

Bruce Jancin/Frontline Medical News

bjancin@frontlinemedcom.com

Washington – Marijuana abuse was independently associated with an eye-opening doubled risk of acute MI in a large, retrospective, age-matched cohort study, Ahmad Tarek Chami, MD, reported at the annual meeting of the American College of Cardiology.

The link was strongest by far in young adult marijuana abusers, with an adjusted 3.2-fold increased risk of MI in 25- to 29-year-olds with marijuana abuse noted in their medical records, compared with age-matched controls and a 4.56-fold greater risk among the 30- to 34-year-old cannabis abusers, according to Dr. Chami of Case Western Reserve University in Cleveland.

Bruce Jancin/Frontline Medical News

bjancin@frontlinemedcom.com

Washington – Marijuana abuse was independently associated with an eye-opening doubled risk of acute MI in a large, retrospective, age-matched cohort study, Ahmad Tarek Chami, MD, reported at the annual meeting of the American College of Cardiology.

The link was strongest by far in young adult marijuana abusers, with an adjusted 3.2-fold increased risk of MI in 25- to 29-year-olds with marijuana abuse noted in their medical records, compared with age-matched controls and a 4.56-fold greater risk among the 30- to 34-year-old cannabis abusers, according to Dr. Chami of Case Western Reserve University in Cleveland.

Bruce Jancin/Frontline Medical News

bjancin@frontlinemedcom.com