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Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy
Background Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine.
Methods In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms.
Results Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, –13 percentage points to +25 percentage points). Given our study results, a true beneft from pyridoxine can be excluded. No difference in HFS grades was observed.
Limitations Single-institution study.
Conclusion Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.
*To read the full article, click on the PDF icon at the top of this introduction.
Background Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine.
Methods In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms.
Results Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, –13 percentage points to +25 percentage points). Given our study results, a true beneft from pyridoxine can be excluded. No difference in HFS grades was observed.
Limitations Single-institution study.
Conclusion Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.
*To read the full article, click on the PDF icon at the top of this introduction.
Background Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine.
Methods In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms.
Results Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, –13 percentage points to +25 percentage points). Given our study results, a true beneft from pyridoxine can be excluded. No difference in HFS grades was observed.
Limitations Single-institution study.
Conclusion Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.
*To read the full article, click on the PDF icon at the top of this introduction.
Understanding the experience of living with non–small-cell lung cancer (NSCLC): a qualitative study
Background As non–small-cell lung cancer (NSCLC) treatments improve and patients live longer, it is important to develop interventions to help patients live fuller lives. We sought to identify key components of quality of life (QOL) in determining therapeutic decision making and overall value of life extension in patients with NSCLC.
Methods Three focus groups (n = 16) and telephone interviews (n = 15) were conducted with NSCLC patients (N = 31) to explore symptoms considered important to QOL. A trade-off format was used to assess the value of life extension relative to QOL. Patients were asked to consider a hypothetical treatment option offering a modest (3 month) life extension.
Results Patients’ mean age was 61.6 years, 67.6% were women, 77.4% were white, and 48.4% had stage III/IV disease. In all, 68% of patients conceptualized emotions as symptoms of NSCLC. Key symptoms changed over time: Patients reported feeling shock and fear at diagnosis (74%), and feeling fear or loneliness during the beginning of therapy (55%). Additionally, patients who reported successfully connecting with other NSCLC patients (peers), support groups, and/or community members reported a positive shift in feelings (52%) as they continued therapy or moved into a posttherapy phase. Financially, 23% of patients reported being adversely affected by copayments, 36% by unexpected gaps in coverage, and 39% by other bills. Patients reported that the most important dimension driving their decision making about life-extending therapy was somatic (84%), followed by functional (32%), relational (23%), and emotional (10%) dimensions.
Limitations Study participants were likely to have received some education or support from the recruiting cancer advocacy and patient education/support organizations. In addition, participants were of a higher socioeconomic status than the average lung cancer patient population.
Conclusions Patients with NSCLC conflated emotional well-being after diagnosis with symptoms of their cancer and treatment toxicities. Somatic QOL concerns emerged ahead of functional, emotional, and relational QOL concerns as the dominant driver of therapeutic decision making.
Funding This study was funded by Daiichi Sankyo Inc.
Click on the PDF icon at the top of this introduction to read the full article.
Background As non–small-cell lung cancer (NSCLC) treatments improve and patients live longer, it is important to develop interventions to help patients live fuller lives. We sought to identify key components of quality of life (QOL) in determining therapeutic decision making and overall value of life extension in patients with NSCLC.
Methods Three focus groups (n = 16) and telephone interviews (n = 15) were conducted with NSCLC patients (N = 31) to explore symptoms considered important to QOL. A trade-off format was used to assess the value of life extension relative to QOL. Patients were asked to consider a hypothetical treatment option offering a modest (3 month) life extension.
Results Patients’ mean age was 61.6 years, 67.6% were women, 77.4% were white, and 48.4% had stage III/IV disease. In all, 68% of patients conceptualized emotions as symptoms of NSCLC. Key symptoms changed over time: Patients reported feeling shock and fear at diagnosis (74%), and feeling fear or loneliness during the beginning of therapy (55%). Additionally, patients who reported successfully connecting with other NSCLC patients (peers), support groups, and/or community members reported a positive shift in feelings (52%) as they continued therapy or moved into a posttherapy phase. Financially, 23% of patients reported being adversely affected by copayments, 36% by unexpected gaps in coverage, and 39% by other bills. Patients reported that the most important dimension driving their decision making about life-extending therapy was somatic (84%), followed by functional (32%), relational (23%), and emotional (10%) dimensions.
Limitations Study participants were likely to have received some education or support from the recruiting cancer advocacy and patient education/support organizations. In addition, participants were of a higher socioeconomic status than the average lung cancer patient population.
Conclusions Patients with NSCLC conflated emotional well-being after diagnosis with symptoms of their cancer and treatment toxicities. Somatic QOL concerns emerged ahead of functional, emotional, and relational QOL concerns as the dominant driver of therapeutic decision making.
Funding This study was funded by Daiichi Sankyo Inc.
Click on the PDF icon at the top of this introduction to read the full article.
Background As non–small-cell lung cancer (NSCLC) treatments improve and patients live longer, it is important to develop interventions to help patients live fuller lives. We sought to identify key components of quality of life (QOL) in determining therapeutic decision making and overall value of life extension in patients with NSCLC.
Methods Three focus groups (n = 16) and telephone interviews (n = 15) were conducted with NSCLC patients (N = 31) to explore symptoms considered important to QOL. A trade-off format was used to assess the value of life extension relative to QOL. Patients were asked to consider a hypothetical treatment option offering a modest (3 month) life extension.
Results Patients’ mean age was 61.6 years, 67.6% were women, 77.4% were white, and 48.4% had stage III/IV disease. In all, 68% of patients conceptualized emotions as symptoms of NSCLC. Key symptoms changed over time: Patients reported feeling shock and fear at diagnosis (74%), and feeling fear or loneliness during the beginning of therapy (55%). Additionally, patients who reported successfully connecting with other NSCLC patients (peers), support groups, and/or community members reported a positive shift in feelings (52%) as they continued therapy or moved into a posttherapy phase. Financially, 23% of patients reported being adversely affected by copayments, 36% by unexpected gaps in coverage, and 39% by other bills. Patients reported that the most important dimension driving their decision making about life-extending therapy was somatic (84%), followed by functional (32%), relational (23%), and emotional (10%) dimensions.
Limitations Study participants were likely to have received some education or support from the recruiting cancer advocacy and patient education/support organizations. In addition, participants were of a higher socioeconomic status than the average lung cancer patient population.
Conclusions Patients with NSCLC conflated emotional well-being after diagnosis with symptoms of their cancer and treatment toxicities. Somatic QOL concerns emerged ahead of functional, emotional, and relational QOL concerns as the dominant driver of therapeutic decision making.
Funding This study was funded by Daiichi Sankyo Inc.
Click on the PDF icon at the top of this introduction to read the full article.
Vitamin D deficiency in the oncology setting
Background Vitamin D deficiency is common in the United States. Regardless of whether or not vitamin D deficiency increases the risk of cancer and decreases survival of cancer, the established adverse impact of its deficiency on bone health is of particular concern for cancer patients. The extent of vitamin D deficiency is not well defined in the oncology setting, and there are no standardized protocols for screening and supplementation for individuals found to be deficient in vitamin D.
Objective To determine the prevalence of vitamin D deficiency as measured by levels of serum 25-hydroxyvitamin D (25[OH]D) in cancer patients at an outpatient oncology practice.
Methods A total of 177 patients representing a range of oncologic diagnoses were tested for 25(OH)D between January 1, 2011 and December 31, 2011. Suboptimal vitamin D levels were defined either as less than 20 ng/mL or less than 30 ng/mL, according to standards proposed by the Institute of Medicine and the Endocrine Society, respectively.
Limitations The point of testing was subjective to the clinician. Some patients may have had their vitamin D levels tested and treated elsewhere, therefore that data was not captured.
Results At baseline, 18.1% of patients tested had vitamin D levels of less than 20 ng/ml, and 49.1% of patients had vitamin D levels of less than 30 ng/ml. Follow-up rates were low. In all, 54% of patients with 25(OH)D levels of less than 30 ng/ml obtained a second reading, and only 38% of those patients achieved sufficient levels at the second reading.
Conclusion Vitamin D deficiency is prevalent in patients with cancer and should be monitored in patients who are at high risk for vitamin D deficiency or poor bone health.
Click on the PDF icon at the top of this introduction to read the full article.
Background Vitamin D deficiency is common in the United States. Regardless of whether or not vitamin D deficiency increases the risk of cancer and decreases survival of cancer, the established adverse impact of its deficiency on bone health is of particular concern for cancer patients. The extent of vitamin D deficiency is not well defined in the oncology setting, and there are no standardized protocols for screening and supplementation for individuals found to be deficient in vitamin D.
Objective To determine the prevalence of vitamin D deficiency as measured by levels of serum 25-hydroxyvitamin D (25[OH]D) in cancer patients at an outpatient oncology practice.
Methods A total of 177 patients representing a range of oncologic diagnoses were tested for 25(OH)D between January 1, 2011 and December 31, 2011. Suboptimal vitamin D levels were defined either as less than 20 ng/mL or less than 30 ng/mL, according to standards proposed by the Institute of Medicine and the Endocrine Society, respectively.
Limitations The point of testing was subjective to the clinician. Some patients may have had their vitamin D levels tested and treated elsewhere, therefore that data was not captured.
Results At baseline, 18.1% of patients tested had vitamin D levels of less than 20 ng/ml, and 49.1% of patients had vitamin D levels of less than 30 ng/ml. Follow-up rates were low. In all, 54% of patients with 25(OH)D levels of less than 30 ng/ml obtained a second reading, and only 38% of those patients achieved sufficient levels at the second reading.
Conclusion Vitamin D deficiency is prevalent in patients with cancer and should be monitored in patients who are at high risk for vitamin D deficiency or poor bone health.
Click on the PDF icon at the top of this introduction to read the full article.
Background Vitamin D deficiency is common in the United States. Regardless of whether or not vitamin D deficiency increases the risk of cancer and decreases survival of cancer, the established adverse impact of its deficiency on bone health is of particular concern for cancer patients. The extent of vitamin D deficiency is not well defined in the oncology setting, and there are no standardized protocols for screening and supplementation for individuals found to be deficient in vitamin D.
Objective To determine the prevalence of vitamin D deficiency as measured by levels of serum 25-hydroxyvitamin D (25[OH]D) in cancer patients at an outpatient oncology practice.
Methods A total of 177 patients representing a range of oncologic diagnoses were tested for 25(OH)D between January 1, 2011 and December 31, 2011. Suboptimal vitamin D levels were defined either as less than 20 ng/mL or less than 30 ng/mL, according to standards proposed by the Institute of Medicine and the Endocrine Society, respectively.
Limitations The point of testing was subjective to the clinician. Some patients may have had their vitamin D levels tested and treated elsewhere, therefore that data was not captured.
Results At baseline, 18.1% of patients tested had vitamin D levels of less than 20 ng/ml, and 49.1% of patients had vitamin D levels of less than 30 ng/ml. Follow-up rates were low. In all, 54% of patients with 25(OH)D levels of less than 30 ng/ml obtained a second reading, and only 38% of those patients achieved sufficient levels at the second reading.
Conclusion Vitamin D deficiency is prevalent in patients with cancer and should be monitored in patients who are at high risk for vitamin D deficiency or poor bone health.
Click on the PDF icon at the top of this introduction to read the full article.
Multimodality therapy for uterine serous carcinoma and the association with overall and relapse-free survival
Objective To identify prognostic factors for overall survival (OS) and relapse-free survival (RFS) for patients with uterine serous carcinoma.
Methods From January 1, 2000 to January 1, 2010, 44 patients with uterine serous carcinoma were analyzed to determine prognostic and predictive factors for OS and RFS using the Kaplan-Meier product-limit method and log-rank tests.
Results Median follow-up was 4.1 years, median OS was 4.2 years, 2-year OS was 83% and decreased to 48% at 5 years. Two-year RFS was 82% and decreased to 75% at 5 years. Age, stage, tumor size, tumor not arising from a polyp, parametrial involvement, lymphovascular invasion, and no adjuvant treatment were prognostic factors associated with shorter OS. Higher stage and parametrial involvement were prognostic factors associated with shorter RFS. Combined adjuvant chemotherapy and radiation therapy was significantly associated with longer OS rates.
Conclusions Adjuvant chemotherapy and radiation therapy as well as tumors arising from a polyp are associated with increased overall survival in patients with uterine serous carcinoma. Early-stage disease is associated with increased relapse-free and overall survival. Adjuvant chemotherapy with a platinum and paclitaxol-based regimen and radiation therapy should be attempted in patients with uterine serous carcinoma.
*To read the full article, click on the PDF icon at the top of this introduction.
Objective To identify prognostic factors for overall survival (OS) and relapse-free survival (RFS) for patients with uterine serous carcinoma.
Methods From January 1, 2000 to January 1, 2010, 44 patients with uterine serous carcinoma were analyzed to determine prognostic and predictive factors for OS and RFS using the Kaplan-Meier product-limit method and log-rank tests.
Results Median follow-up was 4.1 years, median OS was 4.2 years, 2-year OS was 83% and decreased to 48% at 5 years. Two-year RFS was 82% and decreased to 75% at 5 years. Age, stage, tumor size, tumor not arising from a polyp, parametrial involvement, lymphovascular invasion, and no adjuvant treatment were prognostic factors associated with shorter OS. Higher stage and parametrial involvement were prognostic factors associated with shorter RFS. Combined adjuvant chemotherapy and radiation therapy was significantly associated with longer OS rates.
Conclusions Adjuvant chemotherapy and radiation therapy as well as tumors arising from a polyp are associated with increased overall survival in patients with uterine serous carcinoma. Early-stage disease is associated with increased relapse-free and overall survival. Adjuvant chemotherapy with a platinum and paclitaxol-based regimen and radiation therapy should be attempted in patients with uterine serous carcinoma.
*To read the full article, click on the PDF icon at the top of this introduction.
Objective To identify prognostic factors for overall survival (OS) and relapse-free survival (RFS) for patients with uterine serous carcinoma.
Methods From January 1, 2000 to January 1, 2010, 44 patients with uterine serous carcinoma were analyzed to determine prognostic and predictive factors for OS and RFS using the Kaplan-Meier product-limit method and log-rank tests.
Results Median follow-up was 4.1 years, median OS was 4.2 years, 2-year OS was 83% and decreased to 48% at 5 years. Two-year RFS was 82% and decreased to 75% at 5 years. Age, stage, tumor size, tumor not arising from a polyp, parametrial involvement, lymphovascular invasion, and no adjuvant treatment were prognostic factors associated with shorter OS. Higher stage and parametrial involvement were prognostic factors associated with shorter RFS. Combined adjuvant chemotherapy and radiation therapy was significantly associated with longer OS rates.
Conclusions Adjuvant chemotherapy and radiation therapy as well as tumors arising from a polyp are associated with increased overall survival in patients with uterine serous carcinoma. Early-stage disease is associated with increased relapse-free and overall survival. Adjuvant chemotherapy with a platinum and paclitaxol-based regimen and radiation therapy should be attempted in patients with uterine serous carcinoma.
*To read the full article, click on the PDF icon at the top of this introduction.
Inexpensive solutions to enhance remote cancer care in community hospitals
Rapidly increasing volume and complexity of information used for multidisciplinary cancer treatment requires carefully evolving communications with programmatic planning, detailed evaluation, and new methodologies and technical approaches to enhance the impact and efficacy of medical conferencing systems. We designed, implemented, and evaluated cost-effective and appropriate remote learning optimize oncology practice techniques in community hospitals. Our experience over the course of more than 7 years demonstrated simple and inexpensive communication solutions for both professional and lay education, satisfying information-dense needs of multimodality cancer care. We describe how potential complexities may be resolved with inexpensive devices and software programs. Staff teamwork and creativity are always required to implement constantly evolving technologies. We provide both quantitative and qualitative data describing activities and resulting staff responses resulting in 6,520 personnel with more than 391 aggregate credit hours of continuing medical education and continuing education credit activities with enhanced collegial participant satisfaction levels and heightened interactions/professionalism among regional oncology staff. We noted significant cost reductions for communications in all our three partnered hospitals. We demonstrated both increased satisfaction levels and heightened levels of behavioral changes (Impacts) in participants. Always, activities must be cost effective and responsive to changing medical needs. Community focused efforts with regional partners should be similar, assuring evolving successes.
Click on the PDF icon at the top of this introduction to read the full article.
Rapidly increasing volume and complexity of information used for multidisciplinary cancer treatment requires carefully evolving communications with programmatic planning, detailed evaluation, and new methodologies and technical approaches to enhance the impact and efficacy of medical conferencing systems. We designed, implemented, and evaluated cost-effective and appropriate remote learning optimize oncology practice techniques in community hospitals. Our experience over the course of more than 7 years demonstrated simple and inexpensive communication solutions for both professional and lay education, satisfying information-dense needs of multimodality cancer care. We describe how potential complexities may be resolved with inexpensive devices and software programs. Staff teamwork and creativity are always required to implement constantly evolving technologies. We provide both quantitative and qualitative data describing activities and resulting staff responses resulting in 6,520 personnel with more than 391 aggregate credit hours of continuing medical education and continuing education credit activities with enhanced collegial participant satisfaction levels and heightened interactions/professionalism among regional oncology staff. We noted significant cost reductions for communications in all our three partnered hospitals. We demonstrated both increased satisfaction levels and heightened levels of behavioral changes (Impacts) in participants. Always, activities must be cost effective and responsive to changing medical needs. Community focused efforts with regional partners should be similar, assuring evolving successes.
Click on the PDF icon at the top of this introduction to read the full article.
Rapidly increasing volume and complexity of information used for multidisciplinary cancer treatment requires carefully evolving communications with programmatic planning, detailed evaluation, and new methodologies and technical approaches to enhance the impact and efficacy of medical conferencing systems. We designed, implemented, and evaluated cost-effective and appropriate remote learning optimize oncology practice techniques in community hospitals. Our experience over the course of more than 7 years demonstrated simple and inexpensive communication solutions for both professional and lay education, satisfying information-dense needs of multimodality cancer care. We describe how potential complexities may be resolved with inexpensive devices and software programs. Staff teamwork and creativity are always required to implement constantly evolving technologies. We provide both quantitative and qualitative data describing activities and resulting staff responses resulting in 6,520 personnel with more than 391 aggregate credit hours of continuing medical education and continuing education credit activities with enhanced collegial participant satisfaction levels and heightened interactions/professionalism among regional oncology staff. We noted significant cost reductions for communications in all our three partnered hospitals. We demonstrated both increased satisfaction levels and heightened levels of behavioral changes (Impacts) in participants. Always, activities must be cost effective and responsive to changing medical needs. Community focused efforts with regional partners should be similar, assuring evolving successes.
Click on the PDF icon at the top of this introduction to read the full article.
Virtual tumor boards: community–university collaboration to improve quality of care
Objective To develop and implement virtual interactive multidisciplinary cancer tumor boards (VTBs), created throughtelemedicine links between the University of California, Davis Cancer Center and community-based cancer care providers. Thegoal of this project was to facilitate communication among community and academic cancer specialists.
Materials and methods Four geographically remote sites were selected to participate with established disease-specific tumorboards of the UC Davis Cancer Center. Telemedicine links were created using dedicated T1 lines, and PolyCom HDX 9000 was used by the center for teleconference hosting. Participants were then surveyed on their perception of the benefit of VTBs.
Results The results across disease-specific virtual tumor boards show that most of the participants reported that the right amountof clinical information on the cases was presented and that new information was discussed that helped providers manage thecare of the patients.
Conclusions Teleconferencing of disease-specific tumor boards allowed providers in a geographically remote group ofproviders to make prospective, case-based treatment decisions that increased their knowledge of treatment options and facilitatedtheir decision making. This transfer of knowledge and experience speeds up the dissemination of rapidly evolving cancer care,which could lead to higher quality patient outcomes.
Click on the PDF icon at the top of this introduction to read the full article.
Objective To develop and implement virtual interactive multidisciplinary cancer tumor boards (VTBs), created throughtelemedicine links between the University of California, Davis Cancer Center and community-based cancer care providers. Thegoal of this project was to facilitate communication among community and academic cancer specialists.
Materials and methods Four geographically remote sites were selected to participate with established disease-specific tumorboards of the UC Davis Cancer Center. Telemedicine links were created using dedicated T1 lines, and PolyCom HDX 9000 was used by the center for teleconference hosting. Participants were then surveyed on their perception of the benefit of VTBs.
Results The results across disease-specific virtual tumor boards show that most of the participants reported that the right amountof clinical information on the cases was presented and that new information was discussed that helped providers manage thecare of the patients.
Conclusions Teleconferencing of disease-specific tumor boards allowed providers in a geographically remote group ofproviders to make prospective, case-based treatment decisions that increased their knowledge of treatment options and facilitatedtheir decision making. This transfer of knowledge and experience speeds up the dissemination of rapidly evolving cancer care,which could lead to higher quality patient outcomes.
Click on the PDF icon at the top of this introduction to read the full article.
Objective To develop and implement virtual interactive multidisciplinary cancer tumor boards (VTBs), created throughtelemedicine links between the University of California, Davis Cancer Center and community-based cancer care providers. Thegoal of this project was to facilitate communication among community and academic cancer specialists.
Materials and methods Four geographically remote sites were selected to participate with established disease-specific tumorboards of the UC Davis Cancer Center. Telemedicine links were created using dedicated T1 lines, and PolyCom HDX 9000 was used by the center for teleconference hosting. Participants were then surveyed on their perception of the benefit of VTBs.
Results The results across disease-specific virtual tumor boards show that most of the participants reported that the right amountof clinical information on the cases was presented and that new information was discussed that helped providers manage thecare of the patients.
Conclusions Teleconferencing of disease-specific tumor boards allowed providers in a geographically remote group ofproviders to make prospective, case-based treatment decisions that increased their knowledge of treatment options and facilitatedtheir decision making. This transfer of knowledge and experience speeds up the dissemination of rapidly evolving cancer care,which could lead to higher quality patient outcomes.
Click on the PDF icon at the top of this introduction to read the full article.
Characterization of skin reactions and pain reported by patients receiving radiation therapy for cancer at different sites
Background Skin reactions and pain are commonly reported side effects of radiation therapy (RT).
Objective To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain.
Methods A self-report survey—adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire—assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity of pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain.
Results Survey respondents (N = 106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (P ≤ .007). Patients receiving head/neck/brain RT reported increased skin problems (P < .0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (P = .066 and P = .122, respectively).
Limitations Small sample size, exploratory analyses, and nonvalidated measure.
Conclusions Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site while patients receiving head/neck/brain RT had increased skin problems but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain and that interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients.
Click on the PDF icon at the top of this introduction to read the full article.
Background Skin reactions and pain are commonly reported side effects of radiation therapy (RT).
Objective To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain.
Methods A self-report survey—adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire—assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity of pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain.
Results Survey respondents (N = 106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (P ≤ .007). Patients receiving head/neck/brain RT reported increased skin problems (P < .0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (P = .066 and P = .122, respectively).
Limitations Small sample size, exploratory analyses, and nonvalidated measure.
Conclusions Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site while patients receiving head/neck/brain RT had increased skin problems but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain and that interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients.
Click on the PDF icon at the top of this introduction to read the full article.
Background Skin reactions and pain are commonly reported side effects of radiation therapy (RT).
Objective To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain.
Methods A self-report survey—adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire—assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity of pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain.
Results Survey respondents (N = 106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (P ≤ .007). Patients receiving head/neck/brain RT reported increased skin problems (P < .0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (P = .066 and P = .122, respectively).
Limitations Small sample size, exploratory analyses, and nonvalidated measure.
Conclusions Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site while patients receiving head/neck/brain RT had increased skin problems but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain and that interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients.
Click on the PDF icon at the top of this introduction to read the full article.
Illness perceptions matter: understanding quality of life and advanced illness behaviors in female patients with late-stage cancer
Background Patients with late-stage cancer are living longer, making it important to understand factors that contribute to maintaining quality of life (QOL) and completing advanced illness behaviors (eg, advance directives).
Objective To examine whether illness perceptions—the cognitive beliefs that patients form about their cancer—may be more important guides to adjustment than clinical characteristics of the cancer.
Methods In a cross-sectional study, 105 female patients diagnosed with stage III (n 66) or IV (n 39) breast (n 44), gynecological (n 38), or lung (n 23) cancer completed self-report measures of illness perceptions, QOL, and advanced illness behaviors. Clinical data was obtained from medical records.
Results Despite modest associations, patients’ beliefs about the cancer were clearly unique from the clinical characteristics of the cancer. Illness perception variables accounted for a large portion of the variance (PS .01) for QOL and advanced illness behaviors, whereas clinical characteristics did not. QOL scores were predicted by patients’ reports of experiencing more cancer related symptoms (ie, illness identity), believing that their cancer is central to their self-identity, and higher income. Higher completion of advanced illness behaviors was predicted by higher income, the cancer being recurrent, and participants perceiving their cancer as more severe but also more understandable.
Limitations This study was limited by a cross-sectional design, small sample size, and focus on female patients.
Conclusion Addressing patients’ beliefs about their cancer diagnosis may provide important targets for intervention to improve QOL and illness behaviors in patients with late-stage cancer.
Click on the PDF icon at the top of this introduction to read the full article.
Background Patients with late-stage cancer are living longer, making it important to understand factors that contribute to maintaining quality of life (QOL) and completing advanced illness behaviors (eg, advance directives).
Objective To examine whether illness perceptions—the cognitive beliefs that patients form about their cancer—may be more important guides to adjustment than clinical characteristics of the cancer.
Methods In a cross-sectional study, 105 female patients diagnosed with stage III (n 66) or IV (n 39) breast (n 44), gynecological (n 38), or lung (n 23) cancer completed self-report measures of illness perceptions, QOL, and advanced illness behaviors. Clinical data was obtained from medical records.
Results Despite modest associations, patients’ beliefs about the cancer were clearly unique from the clinical characteristics of the cancer. Illness perception variables accounted for a large portion of the variance (PS .01) for QOL and advanced illness behaviors, whereas clinical characteristics did not. QOL scores were predicted by patients’ reports of experiencing more cancer related symptoms (ie, illness identity), believing that their cancer is central to their self-identity, and higher income. Higher completion of advanced illness behaviors was predicted by higher income, the cancer being recurrent, and participants perceiving their cancer as more severe but also more understandable.
Limitations This study was limited by a cross-sectional design, small sample size, and focus on female patients.
Conclusion Addressing patients’ beliefs about their cancer diagnosis may provide important targets for intervention to improve QOL and illness behaviors in patients with late-stage cancer.
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Background Patients with late-stage cancer are living longer, making it important to understand factors that contribute to maintaining quality of life (QOL) and completing advanced illness behaviors (eg, advance directives).
Objective To examine whether illness perceptions—the cognitive beliefs that patients form about their cancer—may be more important guides to adjustment than clinical characteristics of the cancer.
Methods In a cross-sectional study, 105 female patients diagnosed with stage III (n 66) or IV (n 39) breast (n 44), gynecological (n 38), or lung (n 23) cancer completed self-report measures of illness perceptions, QOL, and advanced illness behaviors. Clinical data was obtained from medical records.
Results Despite modest associations, patients’ beliefs about the cancer were clearly unique from the clinical characteristics of the cancer. Illness perception variables accounted for a large portion of the variance (PS .01) for QOL and advanced illness behaviors, whereas clinical characteristics did not. QOL scores were predicted by patients’ reports of experiencing more cancer related symptoms (ie, illness identity), believing that their cancer is central to their self-identity, and higher income. Higher completion of advanced illness behaviors was predicted by higher income, the cancer being recurrent, and participants perceiving their cancer as more severe but also more understandable.
Limitations This study was limited by a cross-sectional design, small sample size, and focus on female patients.
Conclusion Addressing patients’ beliefs about their cancer diagnosis may provide important targets for intervention to improve QOL and illness behaviors in patients with late-stage cancer.
Click on the PDF icon at the top of this introduction to read the full article.
Self-administration of romiplostim in patients with chronic immune thrombocytopenia
Background Romiplostim increases platelet counts in ITP and is typically injected at clinic visits.
Objective To estimate the efficacy and safety of romiplostim self-administration, we evaluated data from an open-label extension study in a post hoc analysis.
Methods Patients received weekly romiplostim with dose adjustments to target platelet counts of 50-200 x 109/L. Patients with a stable dose and platelet counts of 50-200 x 109/L for 3 or more weeks could begin self-administration if investigators deemed it appropriate, returning to study sites every 4 weeks.
Results Of 292 patients, 239 (82%) initiated self-administration for a median of 74 (Q1-Q3:56-164) weeks. Twenty-eight of the 239 (12%) discontinued self-administration (investigator or sponsor decision: 19, patient request: 6, noncompliance: 3). The median average weekly dose for patients self-administering romiplostim was 4.1 g/kg. The romiplostim dose was adjusted in 40 (17%) of the 239 patients in the first 8 weeks of self-administration; 84 (35%) in the first 6 months. Patients had a platelet response (more than 50 x 109/L) for a mean of 75.1% of weeks. The adverse event (AE) rate was 18.3/100 patient-weeks, with 0.8 serious AEs/100 patient-weeks. Fourteen AEs led to withdrawal; none related to self-administration.
Limitations The analysis was post hoc. Lack of a randomized comparator group may have resulted in differences between patient populations. No distinctions could be made between constant and intermittent self-administration or between adverse events occurring during self-administration or administration at the study site.
Conclusions Patients were able to maintain platelet responses for a mean of 75% of the time without new safety issues while self-administering romiplostim.
To read the full article, click on the PDF icon at the top of this introduction.
Background Romiplostim increases platelet counts in ITP and is typically injected at clinic visits.
Objective To estimate the efficacy and safety of romiplostim self-administration, we evaluated data from an open-label extension study in a post hoc analysis.
Methods Patients received weekly romiplostim with dose adjustments to target platelet counts of 50-200 x 109/L. Patients with a stable dose and platelet counts of 50-200 x 109/L for 3 or more weeks could begin self-administration if investigators deemed it appropriate, returning to study sites every 4 weeks.
Results Of 292 patients, 239 (82%) initiated self-administration for a median of 74 (Q1-Q3:56-164) weeks. Twenty-eight of the 239 (12%) discontinued self-administration (investigator or sponsor decision: 19, patient request: 6, noncompliance: 3). The median average weekly dose for patients self-administering romiplostim was 4.1 g/kg. The romiplostim dose was adjusted in 40 (17%) of the 239 patients in the first 8 weeks of self-administration; 84 (35%) in the first 6 months. Patients had a platelet response (more than 50 x 109/L) for a mean of 75.1% of weeks. The adverse event (AE) rate was 18.3/100 patient-weeks, with 0.8 serious AEs/100 patient-weeks. Fourteen AEs led to withdrawal; none related to self-administration.
Limitations The analysis was post hoc. Lack of a randomized comparator group may have resulted in differences between patient populations. No distinctions could be made between constant and intermittent self-administration or between adverse events occurring during self-administration or administration at the study site.
Conclusions Patients were able to maintain platelet responses for a mean of 75% of the time without new safety issues while self-administering romiplostim.
To read the full article, click on the PDF icon at the top of this introduction.
Background Romiplostim increases platelet counts in ITP and is typically injected at clinic visits.
Objective To estimate the efficacy and safety of romiplostim self-administration, we evaluated data from an open-label extension study in a post hoc analysis.
Methods Patients received weekly romiplostim with dose adjustments to target platelet counts of 50-200 x 109/L. Patients with a stable dose and platelet counts of 50-200 x 109/L for 3 or more weeks could begin self-administration if investigators deemed it appropriate, returning to study sites every 4 weeks.
Results Of 292 patients, 239 (82%) initiated self-administration for a median of 74 (Q1-Q3:56-164) weeks. Twenty-eight of the 239 (12%) discontinued self-administration (investigator or sponsor decision: 19, patient request: 6, noncompliance: 3). The median average weekly dose for patients self-administering romiplostim was 4.1 g/kg. The romiplostim dose was adjusted in 40 (17%) of the 239 patients in the first 8 weeks of self-administration; 84 (35%) in the first 6 months. Patients had a platelet response (more than 50 x 109/L) for a mean of 75.1% of weeks. The adverse event (AE) rate was 18.3/100 patient-weeks, with 0.8 serious AEs/100 patient-weeks. Fourteen AEs led to withdrawal; none related to self-administration.
Limitations The analysis was post hoc. Lack of a randomized comparator group may have resulted in differences between patient populations. No distinctions could be made between constant and intermittent self-administration or between adverse events occurring during self-administration or administration at the study site.
Conclusions Patients were able to maintain platelet responses for a mean of 75% of the time without new safety issues while self-administering romiplostim.
To read the full article, click on the PDF icon at the top of this introduction.
Assessment of physician compliance to liver function test monitoring guidance for patients treated with lapatinib
Background and objective A cumulative review of hepatobiliary abnormalities in the lapatinib clinical program resulted in inclusion of detailed instructions for liver function test (LFT) monitoring in the US prescribing information (label). We sought to determine whether or not physicians adhere to these recommended guidelines.
Methods A retrospective observational cohort study comprising 396 women with HER2 metastatic breast cancer who initiated lapatinib between March 1, 2007 and June 30, 2010. Data were captured from electronic medical records (EMR) of communitybased oncology practices. Patients were categorized by whether they initiated lapatinib before or after the label change; LFT monitoring was evaluated using a pre- versus post-label study design. We measured the proportion of patients who had LFTs within 30 days before lapatinib initiation, LFTs during each 6-week period of treatment, and lapatinib permanently withdrawn after experiencing an extreme LFT elevation.
Results Among 396 patients, 128 (32%) initiated lapatinib pre-label change, and 268 (68%) initiated post-label change. LFTs were conducted 30 days prior to lapatinib start in 82% post-label versus 63% pre-label change patients (P greater than .001). Testing during each 6-week treatment interval was higher in post-label change patients: 81% versus 68% pre-label change patients during the first 6 weeks of therapy (P equals .004), and 83% versus 62%, respectively, during weeks 18-24 (P equals .0103). Four patients experienced a severe LFT elevation: 2 pre-label patients who resumed treatment, and 2 post-label change patients with complete discontinuation.
Conclusions We demonstrated that LFT monitoring increased after the addition of detailed LFT guidance to the lapatinib label.
*Click on the link to the left for a PDF of the full article.
Background and objective A cumulative review of hepatobiliary abnormalities in the lapatinib clinical program resulted in inclusion of detailed instructions for liver function test (LFT) monitoring in the US prescribing information (label). We sought to determine whether or not physicians adhere to these recommended guidelines.
Methods A retrospective observational cohort study comprising 396 women with HER2 metastatic breast cancer who initiated lapatinib between March 1, 2007 and June 30, 2010. Data were captured from electronic medical records (EMR) of communitybased oncology practices. Patients were categorized by whether they initiated lapatinib before or after the label change; LFT monitoring was evaluated using a pre- versus post-label study design. We measured the proportion of patients who had LFTs within 30 days before lapatinib initiation, LFTs during each 6-week period of treatment, and lapatinib permanently withdrawn after experiencing an extreme LFT elevation.
Results Among 396 patients, 128 (32%) initiated lapatinib pre-label change, and 268 (68%) initiated post-label change. LFTs were conducted 30 days prior to lapatinib start in 82% post-label versus 63% pre-label change patients (P greater than .001). Testing during each 6-week treatment interval was higher in post-label change patients: 81% versus 68% pre-label change patients during the first 6 weeks of therapy (P equals .004), and 83% versus 62%, respectively, during weeks 18-24 (P equals .0103). Four patients experienced a severe LFT elevation: 2 pre-label patients who resumed treatment, and 2 post-label change patients with complete discontinuation.
Conclusions We demonstrated that LFT monitoring increased after the addition of detailed LFT guidance to the lapatinib label.
*Click on the link to the left for a PDF of the full article.
Background and objective A cumulative review of hepatobiliary abnormalities in the lapatinib clinical program resulted in inclusion of detailed instructions for liver function test (LFT) monitoring in the US prescribing information (label). We sought to determine whether or not physicians adhere to these recommended guidelines.
Methods A retrospective observational cohort study comprising 396 women with HER2 metastatic breast cancer who initiated lapatinib between March 1, 2007 and June 30, 2010. Data were captured from electronic medical records (EMR) of communitybased oncology practices. Patients were categorized by whether they initiated lapatinib before or after the label change; LFT monitoring was evaluated using a pre- versus post-label study design. We measured the proportion of patients who had LFTs within 30 days before lapatinib initiation, LFTs during each 6-week period of treatment, and lapatinib permanently withdrawn after experiencing an extreme LFT elevation.
Results Among 396 patients, 128 (32%) initiated lapatinib pre-label change, and 268 (68%) initiated post-label change. LFTs were conducted 30 days prior to lapatinib start in 82% post-label versus 63% pre-label change patients (P greater than .001). Testing during each 6-week treatment interval was higher in post-label change patients: 81% versus 68% pre-label change patients during the first 6 weeks of therapy (P equals .004), and 83% versus 62%, respectively, during weeks 18-24 (P equals .0103). Four patients experienced a severe LFT elevation: 2 pre-label patients who resumed treatment, and 2 post-label change patients with complete discontinuation.
Conclusions We demonstrated that LFT monitoring increased after the addition of detailed LFT guidance to the lapatinib label.
*Click on the link to the left for a PDF of the full article.