Original Report

Background Trimodality treatment leads to improved survival for superior sulcus tumor (SST) patients. Not much is known about the impact of this treatment on arm function and patient quality of life.

Objective To analyze arm function and quality of life in SST patients undergoing trimodality treatment.

Methods This was a prospective cohort study of consecutive SST patients treated with trimodality treatment that was conducted between April 1, 2010 and October 31, 2012. We obtained informed consent for 20 of 22 eligible patients. The 36-item Short Form Health Survey (SF-36) and disabilities of the arm, shoulder, and hand (DASH) questionnaires were used to asses patient quality of life and subjective arm function at 0 (preoperative day), 3, and 12 months after trimodality treatment.

Results DASH scores were significantly lower at 3 and 12 months (P = .024 and P = .011) compared with preoperative scores. Significantly lower scores were reported for the SF-36 domains of physical functioning at 12 months (P = .020) and of physical role functioning at 3 months (P = .041), and significantly more pain was reported at 3 and 12 months (P = .006 and P = .019, respectively). Patients who underwent T1 nerve root resection had lower scores for the SF-36 domain health change at 3 months (P = .037) compared with those in whom the T1 root was spared. For all other domains no differences were found.

Limitations Small sample size; patient pre-chemoradiation function and quality of life unknown.

Conclusion Subjective arm function and patient quality of life is reduced following trimodality treatment. Resection of the T1 nerve root has no significant long-term effect on the subjective arm function and quality of life.

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Background Trimodality treatment leads to improved survival for superior sulcus tumor (SST) patients. Not much is known about the impact of this treatment on arm function and patient quality of life.

Objective To analyze arm function and quality of life in SST patients undergoing trimodality treatment.

Methods This was a prospective cohort study of consecutive SST patients treated with trimodality treatment that was conducted between April 1, 2010 and October 31, 2012. We obtained informed consent for 20 of 22 eligible patients. The 36-item Short Form Health Survey (SF-36) and disabilities of the arm, shoulder, and hand (DASH) questionnaires were used to asses patient quality of life and subjective arm function at 0 (preoperative day), 3, and 12 months after trimodality treatment.

Results DASH scores were significantly lower at 3 and 12 months (P = .024 and P = .011) compared with preoperative scores. Significantly lower scores were reported for the SF-36 domains of physical functioning at 12 months (P = .020) and of physical role functioning at 3 months (P = .041), and significantly more pain was reported at 3 and 12 months (P = .006 and P = .019, respectively). Patients who underwent T1 nerve root resection had lower scores for the SF-36 domain health change at 3 months (P = .037) compared with those in whom the T1 root was spared. For all other domains no differences were found.

Limitations Small sample size; patient pre-chemoradiation function and quality of life unknown.

Conclusion Subjective arm function and patient quality of life is reduced following trimodality treatment. Resection of the T1 nerve root has no significant long-term effect on the subjective arm function and quality of life.

Click on the PDF icon at the top of this introduction to read the full article.

Background Trimodality treatment leads to improved survival for superior sulcus tumor (SST) patients. Not much is known about the impact of this treatment on arm function and patient quality of life.

Objective To analyze arm function and quality of life in SST patients undergoing trimodality treatment.

Methods This was a prospective cohort study of consecutive SST patients treated with trimodality treatment that was conducted between April 1, 2010 and October 31, 2012. We obtained informed consent for 20 of 22 eligible patients. The 36-item Short Form Health Survey (SF-36) and disabilities of the arm, shoulder, and hand (DASH) questionnaires were used to asses patient quality of life and subjective arm function at 0 (preoperative day), 3, and 12 months after trimodality treatment.

Results DASH scores were significantly lower at 3 and 12 months (P = .024 and P = .011) compared with preoperative scores. Significantly lower scores were reported for the SF-36 domains of physical functioning at 12 months (P = .020) and of physical role functioning at 3 months (P = .041), and significantly more pain was reported at 3 and 12 months (P = .006 and P = .019, respectively). Patients who underwent T1 nerve root resection had lower scores for the SF-36 domain health change at 3 months (P = .037) compared with those in whom the T1 root was spared. For all other domains no differences were found.

Limitations Small sample size; patient pre-chemoradiation function and quality of life unknown.

Conclusion Subjective arm function and patient quality of life is reduced following trimodality treatment. Resection of the T1 nerve root has no significant long-term effect on the subjective arm function and quality of life.

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Background Complete remission (CR) in acute myeloid leukemia (AML) is defined as having ≤5% leukemic blast cells in the bone marrow and return of normal hematopoiesis after the first induction cycle. There is a subset of patients, however, who achieve reduction of leukemic blast cells with a subnormal platelet count, designated as CR with incomplete platelet recovery (platelet count, ≤100,000/mcL; normal, 150,000-450,000/mcL), which is associated with inferior outcomes when compared with CR. Furthermore, there is another subset of patients with CR but superior platelet counts (≥400,000/mcL) whose prognostic significance is unclear.

Objective To establish whether CR with superior platelet counts is associated with better outcomes and can be used as a separate entity for prognostication.

Methods A retrospective chart review of 104 cases of AML was conducted. The highest platelet count during days 25-35 from initiation of induction chemotherapy (designated as day 30 platelet count) was documented. A multivariate analysis for other factors such as age, sex, risk categories, day 14+ plasma cell count (average plasma cell percentage at days 14-21), infections, allogeneic bone marrow transplant, and remission status was done.

Results Day 30 platelet count was found to be an independent predictor of survival in AML. On the multivariate analysis, the subgroup with superior platelet counts (≥400,000/mcL) was found to be associated with better outcomes.

Limitations Results need to be validated in a larger cohort.

Conclusions CR with superior platelet recovery (≥400,000/mcL) is a unique subcategory in itself and has prognostic significance. This may help better assess response to chemotherapeutic agents and aid in further decision-making regarding treatment. 

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Background Complete remission (CR) in acute myeloid leukemia (AML) is defined as having ≤5% leukemic blast cells in the bone marrow and return of normal hematopoiesis after the first induction cycle. There is a subset of patients, however, who achieve reduction of leukemic blast cells with a subnormal platelet count, designated as CR with incomplete platelet recovery (platelet count, ≤100,000/mcL; normal, 150,000-450,000/mcL), which is associated with inferior outcomes when compared with CR. Furthermore, there is another subset of patients with CR but superior platelet counts (≥400,000/mcL) whose prognostic significance is unclear.

Objective To establish whether CR with superior platelet counts is associated with better outcomes and can be used as a separate entity for prognostication.

Methods A retrospective chart review of 104 cases of AML was conducted. The highest platelet count during days 25-35 from initiation of induction chemotherapy (designated as day 30 platelet count) was documented. A multivariate analysis for other factors such as age, sex, risk categories, day 14+ plasma cell count (average plasma cell percentage at days 14-21), infections, allogeneic bone marrow transplant, and remission status was done.

Results Day 30 platelet count was found to be an independent predictor of survival in AML. On the multivariate analysis, the subgroup with superior platelet counts (≥400,000/mcL) was found to be associated with better outcomes.

Limitations Results need to be validated in a larger cohort.

Conclusions CR with superior platelet recovery (≥400,000/mcL) is a unique subcategory in itself and has prognostic significance. This may help better assess response to chemotherapeutic agents and aid in further decision-making regarding treatment. 

Click on the PDF icon at the top of this introduction to read the full article.

Background Complete remission (CR) in acute myeloid leukemia (AML) is defined as having ≤5% leukemic blast cells in the bone marrow and return of normal hematopoiesis after the first induction cycle. There is a subset of patients, however, who achieve reduction of leukemic blast cells with a subnormal platelet count, designated as CR with incomplete platelet recovery (platelet count, ≤100,000/mcL; normal, 150,000-450,000/mcL), which is associated with inferior outcomes when compared with CR. Furthermore, there is another subset of patients with CR but superior platelet counts (≥400,000/mcL) whose prognostic significance is unclear.

Objective To establish whether CR with superior platelet counts is associated with better outcomes and can be used as a separate entity for prognostication.

Methods A retrospective chart review of 104 cases of AML was conducted. The highest platelet count during days 25-35 from initiation of induction chemotherapy (designated as day 30 platelet count) was documented. A multivariate analysis for other factors such as age, sex, risk categories, day 14+ plasma cell count (average plasma cell percentage at days 14-21), infections, allogeneic bone marrow transplant, and remission status was done.

Results Day 30 platelet count was found to be an independent predictor of survival in AML. On the multivariate analysis, the subgroup with superior platelet counts (≥400,000/mcL) was found to be associated with better outcomes.

Limitations Results need to be validated in a larger cohort.

Conclusions CR with superior platelet recovery (≥400,000/mcL) is a unique subcategory in itself and has prognostic significance. This may help better assess response to chemotherapeutic agents and aid in further decision-making regarding treatment. 

Click on the PDF icon at the top of this introduction to read the full article.

Background The 3 fluoroquinolone (FQ) antibiotics – ciprofoxacin, levofoxacin, and moxifoxacin – are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identified through novel collaborations between FQ-treated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists.

Objective To conduct basic science and clinical investigations of a newly identified adverse drug reaction, termed FQ-associated disability.

Methods 5 groups of C57BL/6 mice receiving the antibiotic ciprofoxacin in 10-mg increments (10 mg/kg-50 mg/kg) and 1 group of control mice were evaluated. The Southern Network on Adverse Reactions (SONAR) and a social network of FQ-treated persons with long-term NP toxicity (the Floxed Network) conducted a web-based survey. The clinical toxicity manifestations reported by 94 respondents to the web-based survey of persons who had received 1 or more doses of an FQ prescribed for any indication (generally at FDA-approved dosages) and who subsequently experienced possible adverse drug reactions were compared with adverse event information included on the product label for levofoxacin and with FQ-associated adverse events reported to the FDA’s MedWatch program.

Results Mice treated with ciprofoxacin had lower grip strengths, reduced balance, and depressive behavior compared with the controls. For the survey, 93 of 94 respondents reported FQ-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of FQ initiation or days to months of FQ discontinuation. The FDA Adverse Event Reporting System (FAERS) included 210,705 adverse events and 2,991 fatalities for FQs. Levofoxacin and ciprofoxacin toxicities were neurologic (30% and 26%, respectively), tendon damage (8% and 6%), and psychiatric (10% and 2%). In 2013, an FDA safety review reported that FQs affect mammalian topoisomerase II, especially in mitochondria. In 2013 and 2014, SONAR fled citizen petitions requesting black box revisions identifying neuropsychiatric toxicities and mitochrondrial toxicity as serious levofoxacin-associated adverse drug reactions. In 2015, FDA advisors recommended that FQ product labels be revised to include information about this newly identified disability syndrome termed “FQ-associated disability” (FQAD).

Limitations Basic science studies evaluated NP toxicity for only 1 FQ, ciprofoxacin.

Conclusion Pharmacovigilance investigators, a social network, and basic scientists can collaborate on pharmacovigilance investigations. Revised product labels describing a new serious adverse drug reaction, levofoxacin-associated long-term disability, as recommended by an FDA advisory committee, are advised.

Funding This work was funded partly by the National Cancer Institute (1R01CA165609-01A1), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Efficacy.

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Background The 3 fluoroquinolone (FQ) antibiotics – ciprofoxacin, levofoxacin, and moxifoxacin – are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identified through novel collaborations between FQ-treated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists.

Objective To conduct basic science and clinical investigations of a newly identified adverse drug reaction, termed FQ-associated disability.

Methods 5 groups of C57BL/6 mice receiving the antibiotic ciprofoxacin in 10-mg increments (10 mg/kg-50 mg/kg) and 1 group of control mice were evaluated. The Southern Network on Adverse Reactions (SONAR) and a social network of FQ-treated persons with long-term NP toxicity (the Floxed Network) conducted a web-based survey. The clinical toxicity manifestations reported by 94 respondents to the web-based survey of persons who had received 1 or more doses of an FQ prescribed for any indication (generally at FDA-approved dosages) and who subsequently experienced possible adverse drug reactions were compared with adverse event information included on the product label for levofoxacin and with FQ-associated adverse events reported to the FDA’s MedWatch program.

Results Mice treated with ciprofoxacin had lower grip strengths, reduced balance, and depressive behavior compared with the controls. For the survey, 93 of 94 respondents reported FQ-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of FQ initiation or days to months of FQ discontinuation. The FDA Adverse Event Reporting System (FAERS) included 210,705 adverse events and 2,991 fatalities for FQs. Levofoxacin and ciprofoxacin toxicities were neurologic (30% and 26%, respectively), tendon damage (8% and 6%), and psychiatric (10% and 2%). In 2013, an FDA safety review reported that FQs affect mammalian topoisomerase II, especially in mitochondria. In 2013 and 2014, SONAR fled citizen petitions requesting black box revisions identifying neuropsychiatric toxicities and mitochrondrial toxicity as serious levofoxacin-associated adverse drug reactions. In 2015, FDA advisors recommended that FQ product labels be revised to include information about this newly identified disability syndrome termed “FQ-associated disability” (FQAD).

Limitations Basic science studies evaluated NP toxicity for only 1 FQ, ciprofoxacin.

Conclusion Pharmacovigilance investigators, a social network, and basic scientists can collaborate on pharmacovigilance investigations. Revised product labels describing a new serious adverse drug reaction, levofoxacin-associated long-term disability, as recommended by an FDA advisory committee, are advised.

Funding This work was funded partly by the National Cancer Institute (1R01CA165609-01A1), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Efficacy.

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Background The 3 fluoroquinolone (FQ) antibiotics – ciprofoxacin, levofoxacin, and moxifoxacin – are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identified through novel collaborations between FQ-treated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists.

Objective To conduct basic science and clinical investigations of a newly identified adverse drug reaction, termed FQ-associated disability.

Methods 5 groups of C57BL/6 mice receiving the antibiotic ciprofoxacin in 10-mg increments (10 mg/kg-50 mg/kg) and 1 group of control mice were evaluated. The Southern Network on Adverse Reactions (SONAR) and a social network of FQ-treated persons with long-term NP toxicity (the Floxed Network) conducted a web-based survey. The clinical toxicity manifestations reported by 94 respondents to the web-based survey of persons who had received 1 or more doses of an FQ prescribed for any indication (generally at FDA-approved dosages) and who subsequently experienced possible adverse drug reactions were compared with adverse event information included on the product label for levofoxacin and with FQ-associated adverse events reported to the FDA’s MedWatch program.

Results Mice treated with ciprofoxacin had lower grip strengths, reduced balance, and depressive behavior compared with the controls. For the survey, 93 of 94 respondents reported FQ-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of FQ initiation or days to months of FQ discontinuation. The FDA Adverse Event Reporting System (FAERS) included 210,705 adverse events and 2,991 fatalities for FQs. Levofoxacin and ciprofoxacin toxicities were neurologic (30% and 26%, respectively), tendon damage (8% and 6%), and psychiatric (10% and 2%). In 2013, an FDA safety review reported that FQs affect mammalian topoisomerase II, especially in mitochondria. In 2013 and 2014, SONAR fled citizen petitions requesting black box revisions identifying neuropsychiatric toxicities and mitochrondrial toxicity as serious levofoxacin-associated adverse drug reactions. In 2015, FDA advisors recommended that FQ product labels be revised to include information about this newly identified disability syndrome termed “FQ-associated disability” (FQAD).

Limitations Basic science studies evaluated NP toxicity for only 1 FQ, ciprofoxacin.

Conclusion Pharmacovigilance investigators, a social network, and basic scientists can collaborate on pharmacovigilance investigations. Revised product labels describing a new serious adverse drug reaction, levofoxacin-associated long-term disability, as recommended by an FDA advisory committee, are advised.

Funding This work was funded partly by the National Cancer Institute (1R01CA165609-01A1), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Efficacy.

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Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.

Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.

Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.

Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.

Limitations This study is a retrospective analysis.

Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.

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Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.

Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.

Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.

Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.

Limitations This study is a retrospective analysis.

Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.

Click on the PDF icon at the top of this introduction to read the full article.

Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.

Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.

Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.

Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.

Limitations This study is a retrospective analysis.

Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.

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Background There is a paucity of literature comparing quality of life (QoL) before and after surgery in stage IA lung cancer, where surgical resection is the recommended curative treatment.

Objective To assess the impact of surgery on physical and mental health-related QoL in patients with stage IA lung cancer treated with surgical resection.

Methods Participants in the I-ELCAP cohort who were diagnosed with their first primary pathologic stage IA non-small-cell lung cancer, underwent surgery, and provided follow-up information on QoL 1 year later were included in the present analysis (N = 107). QoL information was collected using the SF-12 (12-item Short Form Health Survey), which generates 2 component scores related to mental health and physical health.

Results Statistical analyses indicated that physical health QoL was significantly worsened from before surgery to after surgery, whereas mental health QoL marginally improved from before to after surgery. Physical health QoL worsened for women from baseline to follow-up, but not for men. Only lobectomy (not limited resection) had an impact on QoL from before to after surgery.

Limitations Results are considered preliminary given the small sample size and multiple comparisons.

Conclusions The current study findings have implications for lung cancer health care professionals in regard to how they can most effectively present the possible impact of surgery on quality of life to this subset of patients in which disease has not yet significantly progressed.

Funding/sponsorship Gift from Sonia Lasry Gardner, in memory of her father, Moise Lasry. 

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Background There is a paucity of literature comparing quality of life (QoL) before and after surgery in stage IA lung cancer, where surgical resection is the recommended curative treatment.

Objective To assess the impact of surgery on physical and mental health-related QoL in patients with stage IA lung cancer treated with surgical resection.

Methods Participants in the I-ELCAP cohort who were diagnosed with their first primary pathologic stage IA non-small-cell lung cancer, underwent surgery, and provided follow-up information on QoL 1 year later were included in the present analysis (N = 107). QoL information was collected using the SF-12 (12-item Short Form Health Survey), which generates 2 component scores related to mental health and physical health.

Results Statistical analyses indicated that physical health QoL was significantly worsened from before surgery to after surgery, whereas mental health QoL marginally improved from before to after surgery. Physical health QoL worsened for women from baseline to follow-up, but not for men. Only lobectomy (not limited resection) had an impact on QoL from before to after surgery.

Limitations Results are considered preliminary given the small sample size and multiple comparisons.

Conclusions The current study findings have implications for lung cancer health care professionals in regard to how they can most effectively present the possible impact of surgery on quality of life to this subset of patients in which disease has not yet significantly progressed.

Funding/sponsorship Gift from Sonia Lasry Gardner, in memory of her father, Moise Lasry. 

Click on the PDF icon at the top of this introduction to read the full article.

Background There is a paucity of literature comparing quality of life (QoL) before and after surgery in stage IA lung cancer, where surgical resection is the recommended curative treatment.

Objective To assess the impact of surgery on physical and mental health-related QoL in patients with stage IA lung cancer treated with surgical resection.

Methods Participants in the I-ELCAP cohort who were diagnosed with their first primary pathologic stage IA non-small-cell lung cancer, underwent surgery, and provided follow-up information on QoL 1 year later were included in the present analysis (N = 107). QoL information was collected using the SF-12 (12-item Short Form Health Survey), which generates 2 component scores related to mental health and physical health.

Results Statistical analyses indicated that physical health QoL was significantly worsened from before surgery to after surgery, whereas mental health QoL marginally improved from before to after surgery. Physical health QoL worsened for women from baseline to follow-up, but not for men. Only lobectomy (not limited resection) had an impact on QoL from before to after surgery.

Limitations Results are considered preliminary given the small sample size and multiple comparisons.

Conclusions The current study findings have implications for lung cancer health care professionals in regard to how they can most effectively present the possible impact of surgery on quality of life to this subset of patients in which disease has not yet significantly progressed.

Funding/sponsorship Gift from Sonia Lasry Gardner, in memory of her father, Moise Lasry. 

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Background Enrollment rates onto cancer clinical trials are low and reflect a small subset of the population of which even fewer participants come from populations of racial or ethnic diversity or low socioeconomic status. There is a need to increase enrollment onto cancer clinical trials with a focus on recruitment of a diverse, underrepresented patient population.

Objective To use the electronic medical record (EMR) to understand the eligibility and enrollment rates for all available cancer trials in the ambulatory care setting at an urban safety net hospital to identify specific strategies for enhanced accrual onto cancer clinical trials of diverse and underserved patients.

Methods A clinical trial screening note was created for the EMR by the clinical trials office at an urban safety net hospital. 847 cancer clinical trial screening notes were extracted from the EMR between January 1, 2010 and December 31, 2010. During that time, 99 cancer trials were registered for accrual, including clinical treatment, survey, data repository, imaging, and symptom management trials. Data on eligibility, enrollment status, and relationship to sociodemographic status were compared.

Limitations This is a single-institution and retrospective study.

Conclusion The findings demonstrate that a formal process of tracking cancer clinical trial screens using an EMR can document baseline rates of institution-specific accrual patterns and identify targeted strategies for increasing cancer clinical trial enrollment among a vulnerable patient population. Offering nontreatment trials may be an important and strategic method of engaging this vulnerable population in clinical research.

Funding/sponsorship Boston Medical Center Minority-Based Community Clinical Oncology Program (NCI 1U-10CA129519- 01A1), Boston Me

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Background Enrollment rates onto cancer clinical trials are low and reflect a small subset of the population of which even fewer participants come from populations of racial or ethnic diversity or low socioeconomic status. There is a need to increase enrollment onto cancer clinical trials with a focus on recruitment of a diverse, underrepresented patient population.

Objective To use the electronic medical record (EMR) to understand the eligibility and enrollment rates for all available cancer trials in the ambulatory care setting at an urban safety net hospital to identify specific strategies for enhanced accrual onto cancer clinical trials of diverse and underserved patients.

Methods A clinical trial screening note was created for the EMR by the clinical trials office at an urban safety net hospital. 847 cancer clinical trial screening notes were extracted from the EMR between January 1, 2010 and December 31, 2010. During that time, 99 cancer trials were registered for accrual, including clinical treatment, survey, data repository, imaging, and symptom management trials. Data on eligibility, enrollment status, and relationship to sociodemographic status were compared.

Limitations This is a single-institution and retrospective study.

Conclusion The findings demonstrate that a formal process of tracking cancer clinical trial screens using an EMR can document baseline rates of institution-specific accrual patterns and identify targeted strategies for increasing cancer clinical trial enrollment among a vulnerable patient population. Offering nontreatment trials may be an important and strategic method of engaging this vulnerable population in clinical research.

Funding/sponsorship Boston Medical Center Minority-Based Community Clinical Oncology Program (NCI 1U-10CA129519- 01A1), Boston Me

Click on the PDF icon at the top of this introduction to read the full article.

Background Enrollment rates onto cancer clinical trials are low and reflect a small subset of the population of which even fewer participants come from populations of racial or ethnic diversity or low socioeconomic status. There is a need to increase enrollment onto cancer clinical trials with a focus on recruitment of a diverse, underrepresented patient population.

Objective To use the electronic medical record (EMR) to understand the eligibility and enrollment rates for all available cancer trials in the ambulatory care setting at an urban safety net hospital to identify specific strategies for enhanced accrual onto cancer clinical trials of diverse and underserved patients.

Methods A clinical trial screening note was created for the EMR by the clinical trials office at an urban safety net hospital. 847 cancer clinical trial screening notes were extracted from the EMR between January 1, 2010 and December 31, 2010. During that time, 99 cancer trials were registered for accrual, including clinical treatment, survey, data repository, imaging, and symptom management trials. Data on eligibility, enrollment status, and relationship to sociodemographic status were compared.

Limitations This is a single-institution and retrospective study.

Conclusion The findings demonstrate that a formal process of tracking cancer clinical trial screens using an EMR can document baseline rates of institution-specific accrual patterns and identify targeted strategies for increasing cancer clinical trial enrollment among a vulnerable patient population. Offering nontreatment trials may be an important and strategic method of engaging this vulnerable population in clinical research.

Funding/sponsorship Boston Medical Center Minority-Based Community Clinical Oncology Program (NCI 1U-10CA129519- 01A1), Boston Me

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Background Health care costs are rising. Identifying areas for health care utilization savings may reduce costs.

Objective To identify oncology patients receiving inpatient radiotherapy with the purpose of measuring length of stay (LoS) and hospital charges.

Methods During July 2013 the oncology service physicians at Mount Sinai Medical Center in New York City were surveyed daily to identify patients receiving inpatient radiation. Actual LoS, acuity LoS were determined from the chart review. Expected LoS was calculated using the University Healthsystem Consortium database. Charges associated with actual LoS, acuity LoS, and expected LoS were then reported. Actual and expected LoS were compared for inpatient radiotherapy and nonradiotherapy groups.

Results 7 patients were identified as having remained in the hospital to receive radiation treatment. In that cohort, the average actual LoS and charges per patient were 40.1 and $48,724, compared with acuity LoS and charges of 25.6 days and $34,089 and expected LoS and charges of 7.7 days and $10,028. Mean LoS and charges attributed to radiation alone amounted to 11 days and $12,514. The mean actual LoS of oncology patients admitted during the same time period who did not receive radiation was 6.7 days, compared with 40.1 days for patients who received radiation (P < .0001).

Limitations Inability to access actual reimbursement data prevented exact cost calculations, small sample size, and single-institution focus.

Conclusion Delivery of radiation therapy during inpatient hospitalization extends LoS and contributes to higher health care costs. Methods to facilitate the delivery of outpatient radiotherapy may result in cost savings.

Click on the PDF icon at the top of this introduction to read the full article.

Background Health care costs are rising. Identifying areas for health care utilization savings may reduce costs.

Objective To identify oncology patients receiving inpatient radiotherapy with the purpose of measuring length of stay (LoS) and hospital charges.

Methods During July 2013 the oncology service physicians at Mount Sinai Medical Center in New York City were surveyed daily to identify patients receiving inpatient radiation. Actual LoS, acuity LoS were determined from the chart review. Expected LoS was calculated using the University Healthsystem Consortium database. Charges associated with actual LoS, acuity LoS, and expected LoS were then reported. Actual and expected LoS were compared for inpatient radiotherapy and nonradiotherapy groups.

Results 7 patients were identified as having remained in the hospital to receive radiation treatment. In that cohort, the average actual LoS and charges per patient were 40.1 and $48,724, compared with acuity LoS and charges of 25.6 days and $34,089 and expected LoS and charges of 7.7 days and $10,028. Mean LoS and charges attributed to radiation alone amounted to 11 days and $12,514. The mean actual LoS of oncology patients admitted during the same time period who did not receive radiation was 6.7 days, compared with 40.1 days for patients who received radiation (P < .0001).

Limitations Inability to access actual reimbursement data prevented exact cost calculations, small sample size, and single-institution focus.

Conclusion Delivery of radiation therapy during inpatient hospitalization extends LoS and contributes to higher health care costs. Methods to facilitate the delivery of outpatient radiotherapy may result in cost savings.

Click on the PDF icon at the top of this introduction to read the full article.

Background Health care costs are rising. Identifying areas for health care utilization savings may reduce costs.

Objective To identify oncology patients receiving inpatient radiotherapy with the purpose of measuring length of stay (LoS) and hospital charges.

Methods During July 2013 the oncology service physicians at Mount Sinai Medical Center in New York City were surveyed daily to identify patients receiving inpatient radiation. Actual LoS, acuity LoS were determined from the chart review. Expected LoS was calculated using the University Healthsystem Consortium database. Charges associated with actual LoS, acuity LoS, and expected LoS were then reported. Actual and expected LoS were compared for inpatient radiotherapy and nonradiotherapy groups.

Results 7 patients were identified as having remained in the hospital to receive radiation treatment. In that cohort, the average actual LoS and charges per patient were 40.1 and $48,724, compared with acuity LoS and charges of 25.6 days and $34,089 and expected LoS and charges of 7.7 days and $10,028. Mean LoS and charges attributed to radiation alone amounted to 11 days and $12,514. The mean actual LoS of oncology patients admitted during the same time period who did not receive radiation was 6.7 days, compared with 40.1 days for patients who received radiation (P < .0001).

Limitations Inability to access actual reimbursement data prevented exact cost calculations, small sample size, and single-institution focus.

Conclusion Delivery of radiation therapy during inpatient hospitalization extends LoS and contributes to higher health care costs. Methods to facilitate the delivery of outpatient radiotherapy may result in cost savings.

Click on the PDF icon at the top of this introduction to read the full article.