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Research and Reviews for the Practicing Oncologist
Methotrexate-induced erythema multiforme
Methotrexate (MTX) is a drug that is commonly used to treat a range of diseases, including inflammatory conditions and malignancies. Although it is effective as a therapy, it is not a benign drug and can have serious adverse effects. In this article, we report and discuss a case of MTX-induced erythema multiforme (EM)...
*Click on the link to the left for a PDF of the full article.
Methotrexate (MTX) is a drug that is commonly used to treat a range of diseases, including inflammatory conditions and malignancies. Although it is effective as a therapy, it is not a benign drug and can have serious adverse effects. In this article, we report and discuss a case of MTX-induced erythema multiforme (EM)...
*Click on the link to the left for a PDF of the full article.
Methotrexate (MTX) is a drug that is commonly used to treat a range of diseases, including inflammatory conditions and malignancies. Although it is effective as a therapy, it is not a benign drug and can have serious adverse effects. In this article, we report and discuss a case of MTX-induced erythema multiforme (EM)...
*Click on the link to the left for a PDF of the full article.
Plasmablastic lymphoma in the ileum
Plasmablastic lymphoma (PBL) is classified by the World Health Organization as a distinct type of diffuse large B-cell non-Hodgkin lymphoma, which is characterized by plasma cell differentiation and immunoblastic cell morphology.1 PBL usually develops in middle-aged adults, with the age at onset in one large series ranging from 35 to 55 years with male predominance.2-4 Although PBL has a strong affinity for the oral cavity, especially in HIV-positive patients, extraoral sites have also been reported.5-10 In this report, we describe an unusual case of PBL presented as multiple masses mostly located at the ileum, which resulted in small bowel obstruction.
*Click on the link to the left for a PDF of the full article.
Plasmablastic lymphoma (PBL) is classified by the World Health Organization as a distinct type of diffuse large B-cell non-Hodgkin lymphoma, which is characterized by plasma cell differentiation and immunoblastic cell morphology.1 PBL usually develops in middle-aged adults, with the age at onset in one large series ranging from 35 to 55 years with male predominance.2-4 Although PBL has a strong affinity for the oral cavity, especially in HIV-positive patients, extraoral sites have also been reported.5-10 In this report, we describe an unusual case of PBL presented as multiple masses mostly located at the ileum, which resulted in small bowel obstruction.
*Click on the link to the left for a PDF of the full article.
Plasmablastic lymphoma (PBL) is classified by the World Health Organization as a distinct type of diffuse large B-cell non-Hodgkin lymphoma, which is characterized by plasma cell differentiation and immunoblastic cell morphology.1 PBL usually develops in middle-aged adults, with the age at onset in one large series ranging from 35 to 55 years with male predominance.2-4 Although PBL has a strong affinity for the oral cavity, especially in HIV-positive patients, extraoral sites have also been reported.5-10 In this report, we describe an unusual case of PBL presented as multiple masses mostly located at the ileum, which resulted in small bowel obstruction.
*Click on the link to the left for a PDF of the full article.
Treatment patterns in HER2-/HR-positive postmenopausal women with metastatic breast cancer initiating first-line treatment in a community oncology setting in the US
Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.
Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.
Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.
Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.
Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.
Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.
*Click on the link to the left for a PDF of the full article.
Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.
Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.
Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.
Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.
Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.
Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.
*Click on the link to the left for a PDF of the full article.
Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.
Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.
Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.
Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.
Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.
Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.
*Click on the link to the left for a PDF of the full article.
Trastuzumab emtansine in advanced HER2-positive breast cancer
Trastuzumab emtansine is an antibody drug conjugate composed of trastuzumab (T) linked to a highly potent cytotoxic derivative of maytansine (DM1) by a stable linker (a nonreducible thioether, SMCC).1 DM1 binds to intracellular tubulin and prevents the assembly of microtubules, resulting in cell death. Trastuzumab targets the conjugate to the human epidermal growth factor receptor 2 (HER2) protein and the stable linker releases the cytotoxic agent only when the compound is internalized through receptor endocytosis. Trastuzumab emtansine (T-DM1) has been in found to be active in trastuzumab- and lapatinib-resistant disease, as well as in trastuzumab-naïve tumors...
*Click on the links to the left for PDFs of the full article and accompanying Commentary.
Trastuzumab emtansine is an antibody drug conjugate composed of trastuzumab (T) linked to a highly potent cytotoxic derivative of maytansine (DM1) by a stable linker (a nonreducible thioether, SMCC).1 DM1 binds to intracellular tubulin and prevents the assembly of microtubules, resulting in cell death. Trastuzumab targets the conjugate to the human epidermal growth factor receptor 2 (HER2) protein and the stable linker releases the cytotoxic agent only when the compound is internalized through receptor endocytosis. Trastuzumab emtansine (T-DM1) has been in found to be active in trastuzumab- and lapatinib-resistant disease, as well as in trastuzumab-naïve tumors...
*Click on the links to the left for PDFs of the full article and accompanying Commentary.
Trastuzumab emtansine is an antibody drug conjugate composed of trastuzumab (T) linked to a highly potent cytotoxic derivative of maytansine (DM1) by a stable linker (a nonreducible thioether, SMCC).1 DM1 binds to intracellular tubulin and prevents the assembly of microtubules, resulting in cell death. Trastuzumab targets the conjugate to the human epidermal growth factor receptor 2 (HER2) protein and the stable linker releases the cytotoxic agent only when the compound is internalized through receptor endocytosis. Trastuzumab emtansine (T-DM1) has been in found to be active in trastuzumab- and lapatinib-resistant disease, as well as in trastuzumab-naïve tumors...
*Click on the links to the left for PDFs of the full article and accompanying Commentary.
Facilitating quality in oncology
You must be the change you wish to see in the world.
– Mahatma Gandhi
In November 2012, the American Society of Clinical Oncology hosted its first annual Quality Care Symposium in San Diego. The attendants and presenters were like-minded individuals who were focused on systematically evaluating and improving cancer care. Throughout the symposium, Donabedian’s structure-process-outcome model was a recurring and unifying framework for evaluating quality metrics. No one questions the importance of improving the quality of care, but many other questions remain: What is quality care? How will it be measured? Will its measurement be comparable across practices? How can small systems that have figured out good solutions to quality care go about reproducing their models of quality care on a larger scale so that we all may benefit?
*Click on the links to the left for PDFs of the full editorial and related articles.
You must be the change you wish to see in the world.
– Mahatma Gandhi
In November 2012, the American Society of Clinical Oncology hosted its first annual Quality Care Symposium in San Diego. The attendants and presenters were like-minded individuals who were focused on systematically evaluating and improving cancer care. Throughout the symposium, Donabedian’s structure-process-outcome model was a recurring and unifying framework for evaluating quality metrics. No one questions the importance of improving the quality of care, but many other questions remain: What is quality care? How will it be measured? Will its measurement be comparable across practices? How can small systems that have figured out good solutions to quality care go about reproducing their models of quality care on a larger scale so that we all may benefit?
*Click on the links to the left for PDFs of the full editorial and related articles.
You must be the change you wish to see in the world.
– Mahatma Gandhi
In November 2012, the American Society of Clinical Oncology hosted its first annual Quality Care Symposium in San Diego. The attendants and presenters were like-minded individuals who were focused on systematically evaluating and improving cancer care. Throughout the symposium, Donabedian’s structure-process-outcome model was a recurring and unifying framework for evaluating quality metrics. No one questions the importance of improving the quality of care, but many other questions remain: What is quality care? How will it be measured? Will its measurement be comparable across practices? How can small systems that have figured out good solutions to quality care go about reproducing their models of quality care on a larger scale so that we all may benefit?
*Click on the links to the left for PDFs of the full editorial and related articles.
Data-driven changes, pathways, and physician buy-in
Improvements in the quality of health care don’t just happen. They’re created, in physician practices large and small, and driven by the desire to improve. Three oncologists, one in a solo practice, a second practicing in a midsize group, and a third in a large medical system, spoke at the 2012 ASCO Quality Care Symposium in San Diego about their quality-improvement initiatives — what they’re doing, how they’re doing it, and the obstacles they face in their efforts to improve the quality of cancer care.
*Click on the links to the left for a PDF of the full article and accompanying Commentary.
Improvements in the quality of health care don’t just happen. They’re created, in physician practices large and small, and driven by the desire to improve. Three oncologists, one in a solo practice, a second practicing in a midsize group, and a third in a large medical system, spoke at the 2012 ASCO Quality Care Symposium in San Diego about their quality-improvement initiatives — what they’re doing, how they’re doing it, and the obstacles they face in their efforts to improve the quality of cancer care.
*Click on the links to the left for a PDF of the full article and accompanying Commentary.
Improvements in the quality of health care don’t just happen. They’re created, in physician practices large and small, and driven by the desire to improve. Three oncologists, one in a solo practice, a second practicing in a midsize group, and a third in a large medical system, spoke at the 2012 ASCO Quality Care Symposium in San Diego about their quality-improvement initiatives — what they’re doing, how they’re doing it, and the obstacles they face in their efforts to improve the quality of cancer care.
*Click on the links to the left for a PDF of the full article and accompanying Commentary.
Clinical pathways: are we there yet?
For nearly a decade, The US Oncology Network has been on a journey toward the widespread use of evidence-based clinical pathways in oncology. The road has been sometimes rocky, and the path occasionally branching and uncertain. But we have recognized that enhancing value is good for all stakeholders and we are confident that with new collaborations and expanded access through technology we will be able to deliver high-quality cancer care to patients. When we introduced pathways, some payers voiced concern that our use of pathways would actually cost them more, not less. Furthermore, some oncologists were concerned that they would be forfeiting patient outcomes and their clinical freedom to choose their own treatments for their patients based on their medical judgment. The US Oncology Network has published reassuring data to address both of those concerns...
*Click on the links to the left for a PDF of the full article and accompanying Commentary.
For nearly a decade, The US Oncology Network has been on a journey toward the widespread use of evidence-based clinical pathways in oncology. The road has been sometimes rocky, and the path occasionally branching and uncertain. But we have recognized that enhancing value is good for all stakeholders and we are confident that with new collaborations and expanded access through technology we will be able to deliver high-quality cancer care to patients. When we introduced pathways, some payers voiced concern that our use of pathways would actually cost them more, not less. Furthermore, some oncologists were concerned that they would be forfeiting patient outcomes and their clinical freedom to choose their own treatments for their patients based on their medical judgment. The US Oncology Network has published reassuring data to address both of those concerns...
*Click on the links to the left for a PDF of the full article and accompanying Commentary.
For nearly a decade, The US Oncology Network has been on a journey toward the widespread use of evidence-based clinical pathways in oncology. The road has been sometimes rocky, and the path occasionally branching and uncertain. But we have recognized that enhancing value is good for all stakeholders and we are confident that with new collaborations and expanded access through technology we will be able to deliver high-quality cancer care to patients. When we introduced pathways, some payers voiced concern that our use of pathways would actually cost them more, not less. Furthermore, some oncologists were concerned that they would be forfeiting patient outcomes and their clinical freedom to choose their own treatments for their patients based on their medical judgment. The US Oncology Network has published reassuring data to address both of those concerns...
*Click on the links to the left for a PDF of the full article and accompanying Commentary.
A randomized, double-blind, placebo-controlled study of oral coenzyme Q 10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer
Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al
Background Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.
Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10 ’s effects on self-reported fatigue, depression, and quality of life (QOL).
Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.
Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).
Conclusions Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.
*For a PDF of the full article, click on the link to the left of this introduction.
Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al
Background Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.
Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10 ’s effects on self-reported fatigue, depression, and quality of life (QOL).
Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.
Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).
Conclusions Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.
*For a PDF of the full article, click on the link to the left of this introduction.
Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al
Background Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.
Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10 ’s effects on self-reported fatigue, depression, and quality of life (QOL).
Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.
Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).
Conclusions Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.
*For a PDF of the full article, click on the link to the left of this introduction.
Relationship between arm morbidity and patient-reported outcomes following surgery in women with node-negative breast cancer: NSABP protocol B-32
Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioningand health-related quality of life (HRQoL) has not been well-studied.
Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper extremity function, activities, and HRQoL.
Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparingsentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and armvolume were measured objectively. PROs included symptoms; arm function; limitations in social, recreational, occupational,and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariablelinear regression models.
Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM.
Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months).
Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL.
Click on the PDF icon at the top of this introduction to read the full article.
Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioningand health-related quality of life (HRQoL) has not been well-studied.
Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper extremity function, activities, and HRQoL.
Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparingsentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and armvolume were measured objectively. PROs included symptoms; arm function; limitations in social, recreational, occupational,and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariablelinear regression models.
Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM.
Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months).
Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL.
Click on the PDF icon at the top of this introduction to read the full article.
Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioningand health-related quality of life (HRQoL) has not been well-studied.
Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper extremity function, activities, and HRQoL.
Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparingsentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and armvolume were measured objectively. PROs included symptoms; arm function; limitations in social, recreational, occupational,and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariablelinear regression models.
Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM.
Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months).
Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL.
Click on the PDF icon at the top of this introduction to read the full article.
Prospective validation of a prediction tool for identifying patients at high risk for chemotherapy-induced nausea and vomiting
George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD
Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.
Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.
Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.
Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.
Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.
*For a PDF of the full article, click on the link to the left of this introduction.
George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD
Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.
Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.
Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.
Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.
Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.
*For a PDF of the full article, click on the link to the left of this introduction.
George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD
Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.
Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.
Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.
Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.
Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.
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