Physicians' Undecided Attitudes Toward Posthumous Reproduction: Fertility Preservation in Cancer Patients with a Poor Prognosis
Original research
Physicians' Undecided Attitudes Toward Posthumous Reproduction: Fertility Preservation in Cancer Patients with a Poor Prognosis
Gwendolyn P. Quinn, PhD; Caprice A. Knapp, PhD; Teri L. Malo, PhD; Jessica McIntyre, BA; Paul B. Jacobsen, PhD; Susan T. Vadaparampil, PhD
Abstract
Background
The American Society for Clinical Oncology (ASCO) established guidelines for fertility preservation for cancer patients. In a national study of US oncologists, we examined attitudes toward the use of fertility preservation among patients with a poor prognosis, focusing on attitudes toward posthumous reproduction.
Method
A cross-sectional survey was administered via mail and Internet to a stratified random sample of US oncologists. The survey measured demographics, knowledge, attitude, and practice behaviors regarding posthumous reproduction and fertility preservation with cancer patients of childbearing age.
Results
Only 16.2% supported posthumous parenting, whereas the majority (51.5%) did not have an opinion. Analysis of variance indicated that attitudes toward posthumous reproduction were significantly related to physician practice behaviors and were dependent on oncologists' knowledge of ASCO guidelines.
Conclusions
Physician attitudes may conflict with the recommended guidelines and may reduce the likelihood that some patients will receive information about fertility preservation. Further education may raise physicians' awareness of poor-prognostic patients' interest in pursuing this technology.
*For a PDF of the full article click in the link to the left of this introduction.
Physicians' Undecided Attitudes Toward Posthumous Reproduction: Fertility Preservation in Cancer Patients with a Poor Prognosis
Gwendolyn P. Quinn, PhD; Caprice A. Knapp, PhD; Teri L. Malo, PhD; Jessica McIntyre, BA; Paul B. Jacobsen, PhD; Susan T. Vadaparampil, PhD
Abstract
Background
The American Society for Clinical Oncology (ASCO) established guidelines for fertility preservation for cancer patients. In a national study of US oncologists, we examined attitudes toward the use of fertility preservation among patients with a poor prognosis, focusing on attitudes toward posthumous reproduction.
Method
A cross-sectional survey was administered via mail and Internet to a stratified random sample of US oncologists. The survey measured demographics, knowledge, attitude, and practice behaviors regarding posthumous reproduction and fertility preservation with cancer patients of childbearing age.
Results
Only 16.2% supported posthumous parenting, whereas the majority (51.5%) did not have an opinion. Analysis of variance indicated that attitudes toward posthumous reproduction were significantly related to physician practice behaviors and were dependent on oncologists' knowledge of ASCO guidelines.
Conclusions
Physician attitudes may conflict with the recommended guidelines and may reduce the likelihood that some patients will receive information about fertility preservation. Further education may raise physicians' awareness of poor-prognostic patients' interest in pursuing this technology.
*For a PDF of the full article click in the link to the left of this introduction.
Original research
Physicians' Undecided Attitudes Toward Posthumous Reproduction: Fertility Preservation in Cancer Patients with a Poor Prognosis
Gwendolyn P. Quinn, PhD; Caprice A. Knapp, PhD; Teri L. Malo, PhD; Jessica McIntyre, BA; Paul B. Jacobsen, PhD; Susan T. Vadaparampil, PhD
Abstract
Background
The American Society for Clinical Oncology (ASCO) established guidelines for fertility preservation for cancer patients. In a national study of US oncologists, we examined attitudes toward the use of fertility preservation among patients with a poor prognosis, focusing on attitudes toward posthumous reproduction.
Method
A cross-sectional survey was administered via mail and Internet to a stratified random sample of US oncologists. The survey measured demographics, knowledge, attitude, and practice behaviors regarding posthumous reproduction and fertility preservation with cancer patients of childbearing age.
Results
Only 16.2% supported posthumous parenting, whereas the majority (51.5%) did not have an opinion. Analysis of variance indicated that attitudes toward posthumous reproduction were significantly related to physician practice behaviors and were dependent on oncologists' knowledge of ASCO guidelines.
Conclusions
Physician attitudes may conflict with the recommended guidelines and may reduce the likelihood that some patients will receive information about fertility preservation. Further education may raise physicians' awareness of poor-prognostic patients' interest in pursuing this technology.
*For a PDF of the full article click in the link to the left of this introduction.
Acyclovir Prophylaxis Against Varicella Zoster Virus Reactivation in Multiple Myeloma Patients Treated With Bortezomib-Based Therapies: A Retrospective Analysis of 100 Patients
Original research
Acyclovir Prophylaxis Against Varicella Zoster Virus Reactivation in Multiple Myeloma Patients Treated With Bortezomib-Based Therapies: A Retrospective Analysis of 100 Patients
Abhisek Swaika, MD; Aneel Paulus, MD/ Kena C. Miller; MSN, FNP; Tamur Sher, MD; Nikolaos G. Almyroudis, MD; Donna Ball, NP; Margaret Wood; MSN; Aisha Masood, MD; Kelvin Lee, MD; Asher A. Chanan-Khan, MD
Abstract
Background
Previous studies have indicated that, in patients with multiple myeloma (MM), bortezomib is associated with an increased incidence of herpes zoster, resulting from reactivation of latent varicella zoster virus (VZV).
Objective
Our objective was to determine whether increased risk of VZV reactivation could be abrogated by using prophylactic acyclovir.
Methods
We retrospectively evaluated 100 consecutive MM patients treated with bortezomib-based therapies at the Roswell Park Cancer Institute for development of herpes zoster. Frontline and relapsed/refractory patients were included, and patients received bortezomib alone or in combination with agents such as doxorubicin, melphalan, or dexamethasone. All patients received >4 weeks of acyclovir prophylaxis (400 mg twice daily), which was initiated prior to starting treatment with bortezomib and discontinued 4 weeks following bortezomib.
Results
Median patient age was 62 years, 57% were male, and most (56%) had Durie-Salmon stage IIIA MM. None of the 100 MM patients receiving acyclovir prophylaxis developed herpes zoster during treatment with bortezomib, irrespective of patients receiving a wide variety of concomitant antimyeloma therapies and regardless of response to bortezomib-based therapy. One additional patient, found to be noncompliant with acyclovir therapy, experienced VZV reactivation, having received 3 cycles of bortezomib (3 weeks each cycle) in combination with cyclophosphamide and dexamethasone.
Limitations
Limitations of the study include its small size and retrospective nature.
Conclusions
The increased risk of VZV reactivation observed in previous studies of bortezomib-based therapy was completely abrogated in this series of patients who received prophylaxis with acyclovir.
*For a PDF of the full article click in the link to the left of this introduction.
Acyclovir Prophylaxis Against Varicella Zoster Virus Reactivation in Multiple Myeloma Patients Treated With Bortezomib-Based Therapies: A Retrospective Analysis of 100 Patients
Abhisek Swaika, MD; Aneel Paulus, MD/ Kena C. Miller; MSN, FNP; Tamur Sher, MD; Nikolaos G. Almyroudis, MD; Donna Ball, NP; Margaret Wood; MSN; Aisha Masood, MD; Kelvin Lee, MD; Asher A. Chanan-Khan, MD
Abstract
Background
Previous studies have indicated that, in patients with multiple myeloma (MM), bortezomib is associated with an increased incidence of herpes zoster, resulting from reactivation of latent varicella zoster virus (VZV).
Objective
Our objective was to determine whether increased risk of VZV reactivation could be abrogated by using prophylactic acyclovir.
Methods
We retrospectively evaluated 100 consecutive MM patients treated with bortezomib-based therapies at the Roswell Park Cancer Institute for development of herpes zoster. Frontline and relapsed/refractory patients were included, and patients received bortezomib alone or in combination with agents such as doxorubicin, melphalan, or dexamethasone. All patients received >4 weeks of acyclovir prophylaxis (400 mg twice daily), which was initiated prior to starting treatment with bortezomib and discontinued 4 weeks following bortezomib.
Results
Median patient age was 62 years, 57% were male, and most (56%) had Durie-Salmon stage IIIA MM. None of the 100 MM patients receiving acyclovir prophylaxis developed herpes zoster during treatment with bortezomib, irrespective of patients receiving a wide variety of concomitant antimyeloma therapies and regardless of response to bortezomib-based therapy. One additional patient, found to be noncompliant with acyclovir therapy, experienced VZV reactivation, having received 3 cycles of bortezomib (3 weeks each cycle) in combination with cyclophosphamide and dexamethasone.
Limitations
Limitations of the study include its small size and retrospective nature.
Conclusions
The increased risk of VZV reactivation observed in previous studies of bortezomib-based therapy was completely abrogated in this series of patients who received prophylaxis with acyclovir.
*For a PDF of the full article click in the link to the left of this introduction.
Original research
Acyclovir Prophylaxis Against Varicella Zoster Virus Reactivation in Multiple Myeloma Patients Treated With Bortezomib-Based Therapies: A Retrospective Analysis of 100 Patients
Abhisek Swaika, MD; Aneel Paulus, MD/ Kena C. Miller; MSN, FNP; Tamur Sher, MD; Nikolaos G. Almyroudis, MD; Donna Ball, NP; Margaret Wood; MSN; Aisha Masood, MD; Kelvin Lee, MD; Asher A. Chanan-Khan, MD
Abstract
Background
Previous studies have indicated that, in patients with multiple myeloma (MM), bortezomib is associated with an increased incidence of herpes zoster, resulting from reactivation of latent varicella zoster virus (VZV).
Objective
Our objective was to determine whether increased risk of VZV reactivation could be abrogated by using prophylactic acyclovir.
Methods
We retrospectively evaluated 100 consecutive MM patients treated with bortezomib-based therapies at the Roswell Park Cancer Institute for development of herpes zoster. Frontline and relapsed/refractory patients were included, and patients received bortezomib alone or in combination with agents such as doxorubicin, melphalan, or dexamethasone. All patients received >4 weeks of acyclovir prophylaxis (400 mg twice daily), which was initiated prior to starting treatment with bortezomib and discontinued 4 weeks following bortezomib.
Results
Median patient age was 62 years, 57% were male, and most (56%) had Durie-Salmon stage IIIA MM. None of the 100 MM patients receiving acyclovir prophylaxis developed herpes zoster during treatment with bortezomib, irrespective of patients receiving a wide variety of concomitant antimyeloma therapies and regardless of response to bortezomib-based therapy. One additional patient, found to be noncompliant with acyclovir therapy, experienced VZV reactivation, having received 3 cycles of bortezomib (3 weeks each cycle) in combination with cyclophosphamide and dexamethasone.
Limitations
Limitations of the study include its small size and retrospective nature.
Conclusions
The increased risk of VZV reactivation observed in previous studies of bortezomib-based therapy was completely abrogated in this series of patients who received prophylaxis with acyclovir.
*For a PDF of the full article click in the link to the left of this introduction.
Acyclovir Prophylaxis Against Varicella Zoster Virus Reactivation in Multiple Myeloma Patients Treated With Bortezomib-Based Therapies: A Retrospective Analysis of 100 Patients
Display Headline
Acyclovir Prophylaxis Against Varicella Zoster Virus Reactivation in Multiple Myeloma Patients Treated With Bortezomib-Based Therapies: A Retrospective Analysis of 100 Patients
Background Chemotherapy-induced nausea and vomiting (CINV) remain among the most frequently reported distressing side effects associated with anthracycline-based chemotherapy despite significant advances in antiemetic management. The main risk factor for severity of CINV is the emetogenic potential of the chemotherapeutic agents. However, patient-related risk factors have been identified, including genetic makeup. Although studies have noted that ethnicity influences nausea and vomiting in other contexts, there is a paucity of research regarding the impact of ethnicity on CINV. This study was undertaken to evaluate whether Asian women receiving anthracycline-based chemotherapy experience more CINV than non-Asians.
Methods A retrospective, comparative, correlational chart review was performed to abstract the relevant variables.
Results Data from a convenience sample of 358 women with breast cancer who received chemotherapy with doxorubicin between 2004 and 2008 at City of Hope in Duarte, California, were evaluated. The sample consisted of Caucasians (45%), Hispanics (27.7%), Asians (19.8%), and African Americans (7.5%). The results indicate that Asian women with breast cancer undergoing anthracycline-based chemotherapy experienced statistically significantly more clinically important CINV than their non-Asian counterparts.
Limitations The data were collected retrospectively, with a certain population distribution at a specific time.
Conclusion This study provides interesting preliminary evidence that Asian ethnicity plays a role in the development of severe CINV. When managing chemotherapy toxicities in women with breast cancer, health-care providers should tailor therapy to individual risk profiles. Specifically, consideration of antiemetic therapy should accommodate patient characteristics, such as Asian descent.
Click on the PDF icon at the top of this introduction to read the full article.
Background Chemotherapy-induced nausea and vomiting (CINV) remain among the most frequently reported distressing side effects associated with anthracycline-based chemotherapy despite significant advances in antiemetic management. The main risk factor for severity of CINV is the emetogenic potential of the chemotherapeutic agents. However, patient-related risk factors have been identified, including genetic makeup. Although studies have noted that ethnicity influences nausea and vomiting in other contexts, there is a paucity of research regarding the impact of ethnicity on CINV. This study was undertaken to evaluate whether Asian women receiving anthracycline-based chemotherapy experience more CINV than non-Asians.
Methods A retrospective, comparative, correlational chart review was performed to abstract the relevant variables.
Results Data from a convenience sample of 358 women with breast cancer who received chemotherapy with doxorubicin between 2004 and 2008 at City of Hope in Duarte, California, were evaluated. The sample consisted of Caucasians (45%), Hispanics (27.7%), Asians (19.8%), and African Americans (7.5%). The results indicate that Asian women with breast cancer undergoing anthracycline-based chemotherapy experienced statistically significantly more clinically important CINV than their non-Asian counterparts.
Limitations The data were collected retrospectively, with a certain population distribution at a specific time.
Conclusion This study provides interesting preliminary evidence that Asian ethnicity plays a role in the development of severe CINV. When managing chemotherapy toxicities in women with breast cancer, health-care providers should tailor therapy to individual risk profiles. Specifically, consideration of antiemetic therapy should accommodate patient characteristics, such as Asian descent.
Click on the PDF icon at the top of this introduction to read the full article.
Background Chemotherapy-induced nausea and vomiting (CINV) remain among the most frequently reported distressing side effects associated with anthracycline-based chemotherapy despite significant advances in antiemetic management. The main risk factor for severity of CINV is the emetogenic potential of the chemotherapeutic agents. However, patient-related risk factors have been identified, including genetic makeup. Although studies have noted that ethnicity influences nausea and vomiting in other contexts, there is a paucity of research regarding the impact of ethnicity on CINV. This study was undertaken to evaluate whether Asian women receiving anthracycline-based chemotherapy experience more CINV than non-Asians.
Methods A retrospective, comparative, correlational chart review was performed to abstract the relevant variables.
Results Data from a convenience sample of 358 women with breast cancer who received chemotherapy with doxorubicin between 2004 and 2008 at City of Hope in Duarte, California, were evaluated. The sample consisted of Caucasians (45%), Hispanics (27.7%), Asians (19.8%), and African Americans (7.5%). The results indicate that Asian women with breast cancer undergoing anthracycline-based chemotherapy experienced statistically significantly more clinically important CINV than their non-Asian counterparts.
Limitations The data were collected retrospectively, with a certain population distribution at a specific time.
Conclusion This study provides interesting preliminary evidence that Asian ethnicity plays a role in the development of severe CINV. When managing chemotherapy toxicities in women with breast cancer, health-care providers should tailor therapy to individual risk profiles. Specifically, consideration of antiemetic therapy should accommodate patient characteristics, such as Asian descent.
Click on the PDF icon at the top of this introduction to read the full article.
What Can I Do? Recommendations for Responding to Issues Identified by Patient-Reported Outcomes Assessments Used in Clinical Practice
How we do it
What Can I Do? Recommendations for Responding to Issues Identified by Patient-Reported Outcomes Assessments Used in Clinical Practice
Elizabeth F. Hughes, RN, BSN, CHPN,
Albert W. Wu, MD, MPH,
Michael A. Carducci, MD,
Claire F. Snyder, PhD
Received 4 October 2011. Accepted 21 February 2012. Available online 18 May 2012.
Abstract
There is increased interest in using patient-reported outcome (PRO) measures in routine clinical practice to improve patient management. The effectiveness of this intervention may be facilitated by providing suggestions to clinicians on how to address issues identified by the PROs. We sought to develop recommendations for clinicians on how to respond to issues covered by common cancer PRO questionnaires, including functional problems (eg, physical, social, emotional), symptoms (eg, diarrhea, pain), and needs (eg, patient care and support, information). The recommendations would be incorporated into a Web-based system for PRO assessment and reporting in use at our large, academic cancer center. To develop the recommendations, we conducted a multiphase, multidisciplinary, consensus process. We reviewed the literature and conducted one-on-one interviews with experts from various disciplines.
Experts included medical oncologists, radiation oncologists, nurses, an internist, a palliative care specialist, an outcomes researcher, a chaplain, a social worker, and patient advocates. These interviews elicited the experts' recommendations for addressing problems in common PRO domains. Finally, we held a panel meeting attended by all the experts to attain consensus on the recommendations. The final consensus suggestions recommend further assessment of the problem as a first step. Treatment suggestions range from medication adjustments to lifestyle modifications to referrals to other disciplines. Further research will test whether clinicians find these suggestions useful for patient management.
*For a PDF of the full article click in the link to the left of this introduction.
What Can I Do? Recommendations for Responding to Issues Identified by Patient-Reported Outcomes Assessments Used in Clinical Practice
Elizabeth F. Hughes, RN, BSN, CHPN,
Albert W. Wu, MD, MPH,
Michael A. Carducci, MD,
Claire F. Snyder, PhD
Received 4 October 2011. Accepted 21 February 2012. Available online 18 May 2012.
Abstract
There is increased interest in using patient-reported outcome (PRO) measures in routine clinical practice to improve patient management. The effectiveness of this intervention may be facilitated by providing suggestions to clinicians on how to address issues identified by the PROs. We sought to develop recommendations for clinicians on how to respond to issues covered by common cancer PRO questionnaires, including functional problems (eg, physical, social, emotional), symptoms (eg, diarrhea, pain), and needs (eg, patient care and support, information). The recommendations would be incorporated into a Web-based system for PRO assessment and reporting in use at our large, academic cancer center. To develop the recommendations, we conducted a multiphase, multidisciplinary, consensus process. We reviewed the literature and conducted one-on-one interviews with experts from various disciplines.
Experts included medical oncologists, radiation oncologists, nurses, an internist, a palliative care specialist, an outcomes researcher, a chaplain, a social worker, and patient advocates. These interviews elicited the experts' recommendations for addressing problems in common PRO domains. Finally, we held a panel meeting attended by all the experts to attain consensus on the recommendations. The final consensus suggestions recommend further assessment of the problem as a first step. Treatment suggestions range from medication adjustments to lifestyle modifications to referrals to other disciplines. Further research will test whether clinicians find these suggestions useful for patient management.
*For a PDF of the full article click in the link to the left of this introduction.
How we do it
What Can I Do? Recommendations for Responding to Issues Identified by Patient-Reported Outcomes Assessments Used in Clinical Practice
Elizabeth F. Hughes, RN, BSN, CHPN,
Albert W. Wu, MD, MPH,
Michael A. Carducci, MD,
Claire F. Snyder, PhD
Received 4 October 2011. Accepted 21 February 2012. Available online 18 May 2012.
Abstract
There is increased interest in using patient-reported outcome (PRO) measures in routine clinical practice to improve patient management. The effectiveness of this intervention may be facilitated by providing suggestions to clinicians on how to address issues identified by the PROs. We sought to develop recommendations for clinicians on how to respond to issues covered by common cancer PRO questionnaires, including functional problems (eg, physical, social, emotional), symptoms (eg, diarrhea, pain), and needs (eg, patient care and support, information). The recommendations would be incorporated into a Web-based system for PRO assessment and reporting in use at our large, academic cancer center. To develop the recommendations, we conducted a multiphase, multidisciplinary, consensus process. We reviewed the literature and conducted one-on-one interviews with experts from various disciplines.
Experts included medical oncologists, radiation oncologists, nurses, an internist, a palliative care specialist, an outcomes researcher, a chaplain, a social worker, and patient advocates. These interviews elicited the experts' recommendations for addressing problems in common PRO domains. Finally, we held a panel meeting attended by all the experts to attain consensus on the recommendations. The final consensus suggestions recommend further assessment of the problem as a first step. Treatment suggestions range from medication adjustments to lifestyle modifications to referrals to other disciplines. Further research will test whether clinicians find these suggestions useful for patient management.
*For a PDF of the full article click in the link to the left of this introduction.
Central Nervous System Complications of Cancer Therapy
Central Nervous System Complications of Cancer Therapy
Mikael L. Rinne, MD, PhD,
Eudocia Q. Lee, MD, MPH,
Patrick Y. Wen, MD
Received 16 July 2011. Accepted 15 November 2011. Available online 26 April 2012.
Abstract
As more effective therapies prolong the survival of patients with cancer, therapy-related toxicities, particularly those affecting the central nervous system (CNS) become increasingly important. CNS complications can cause significant morbidity and can limit the dose or duration of otherwise effective treatments. Because effects on the CNS are disabling and often permanent and treatments remain limited, it is important that clinicians recognize the effects of cancer therapy on the CNS. Cytotoxic chemotherapy and radiation are well-known causes of neurotoxicity, but there is increasing recognition that novel therapies are also sources of adverse effects on the CNS. This review highlights the CNS complications that result from radiation, chemotherapy, and novel therapeutics.
Central nervous system (CNS) toxicity is a significant source of morbidity in the treatment of patients with cancer. Radiation, traditional cytotoxic chemotherapy, and novel biologic and targeted therapies all have recognized CNS side effects; and the risks of neurotoxicity can increase with combination therapy.1 Some CNS complications appear during treatment, while others present months or even years later. When patients present with neurologic deficits, practitioners need to recognize the signs and symptoms of treatment-related toxicity in order to intervene early and minimize neurologic damage. Treatment-related CNS toxicity needs to be distinguished from other direct or indirect effects of cancer, including tumor invasion, metastasis, metabolic derangements, infections, and paraneoplastic neurologic syndromes.
*For a PDF of the full article and accompanying viewpoint by Ivo Tremont-Lukats, click in the links to the left of this introduction.
Central Nervous System Complications of Cancer Therapy
Mikael L. Rinne, MD, PhD,
Eudocia Q. Lee, MD, MPH,
Patrick Y. Wen, MD
Received 16 July 2011. Accepted 15 November 2011. Available online 26 April 2012.
Abstract
As more effective therapies prolong the survival of patients with cancer, therapy-related toxicities, particularly those affecting the central nervous system (CNS) become increasingly important. CNS complications can cause significant morbidity and can limit the dose or duration of otherwise effective treatments. Because effects on the CNS are disabling and often permanent and treatments remain limited, it is important that clinicians recognize the effects of cancer therapy on the CNS. Cytotoxic chemotherapy and radiation are well-known causes of neurotoxicity, but there is increasing recognition that novel therapies are also sources of adverse effects on the CNS. This review highlights the CNS complications that result from radiation, chemotherapy, and novel therapeutics.
Central nervous system (CNS) toxicity is a significant source of morbidity in the treatment of patients with cancer. Radiation, traditional cytotoxic chemotherapy, and novel biologic and targeted therapies all have recognized CNS side effects; and the risks of neurotoxicity can increase with combination therapy.1 Some CNS complications appear during treatment, while others present months or even years later. When patients present with neurologic deficits, practitioners need to recognize the signs and symptoms of treatment-related toxicity in order to intervene early and minimize neurologic damage. Treatment-related CNS toxicity needs to be distinguished from other direct or indirect effects of cancer, including tumor invasion, metastasis, metabolic derangements, infections, and paraneoplastic neurologic syndromes.
*For a PDF of the full article and accompanying viewpoint by Ivo Tremont-Lukats, click in the links to the left of this introduction.
Central Nervous System Complications of Cancer Therapy
Mikael L. Rinne, MD, PhD,
Eudocia Q. Lee, MD, MPH,
Patrick Y. Wen, MD
Received 16 July 2011. Accepted 15 November 2011. Available online 26 April 2012.
Abstract
As more effective therapies prolong the survival of patients with cancer, therapy-related toxicities, particularly those affecting the central nervous system (CNS) become increasingly important. CNS complications can cause significant morbidity and can limit the dose or duration of otherwise effective treatments. Because effects on the CNS are disabling and often permanent and treatments remain limited, it is important that clinicians recognize the effects of cancer therapy on the CNS. Cytotoxic chemotherapy and radiation are well-known causes of neurotoxicity, but there is increasing recognition that novel therapies are also sources of adverse effects on the CNS. This review highlights the CNS complications that result from radiation, chemotherapy, and novel therapeutics.
Central nervous system (CNS) toxicity is a significant source of morbidity in the treatment of patients with cancer. Radiation, traditional cytotoxic chemotherapy, and novel biologic and targeted therapies all have recognized CNS side effects; and the risks of neurotoxicity can increase with combination therapy.1 Some CNS complications appear during treatment, while others present months or even years later. When patients present with neurologic deficits, practitioners need to recognize the signs and symptoms of treatment-related toxicity in order to intervene early and minimize neurologic damage. Treatment-related CNS toxicity needs to be distinguished from other direct or indirect effects of cancer, including tumor invasion, metastasis, metabolic derangements, infections, and paraneoplastic neurologic syndromes.
*For a PDF of the full article and accompanying viewpoint by Ivo Tremont-Lukats, click in the links to the left of this introduction.
AIP: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Coenzyme Q10 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,
Susan Williford, MD,
Jeff Giguere, MD,
L. Astrid Garino, MD,
Michelle J. Naughton, PhD,
Mara Z. Vitolins, DrPH, RD,
Mark O. Lively, PhD,
Edward G. Shaw, MD, MA,
Wake Forest University Community Clinical Oncology Program Research Base
Abstract
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 oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued 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 μg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 μg/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 in the link to the left of this introduction.
Wake Forest University Community Clinical Oncology Program Research Base
Abstract
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 oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued 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 μg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 μg/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 in the link to the left of this introduction.
Glenn J. Lesser, MD
,
Doug Case, PhD,
Nancy Stark, RN, PhD,
Susan Williford, MD,
Jeff Giguere, MD,
L. Astrid Garino, MD,
Michelle J. Naughton, PhD,
Mara Z. Vitolins, DrPH, RD,
Mark O. Lively, PhD,
Edward G. Shaw, MD, MA,
Wake Forest University Community Clinical Oncology Program Research Base
Abstract
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 oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued 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 μg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 μg/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 in the link to the left of this introduction.
AIP: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Coenzyme Q10 to Relieve Self-Reported Treatment-Related Fatigue in Newly Diagnosed Patients with Breast Cancer
Display Headline
AIP: A Randomized, Double-Blind, Placebo-Controlled Study of Oral Coenzyme Q10 to Relieve Self-Reported Treatment-Related Fatigue in Newly Diagnosed Patients with Breast Cancer
The Patient Protection and Affordable Care Act is the most comprehensive reform of the United States’ health-care system since Medicare and Medicaid were created in the 1960s. The law will expand access to health insurance for millions of uninsured Americans, make that coverage more secure, and promote new delivery systems and payment paradigms that focus on prevention and high-quality care...
*For a PDF of the full article, click on the link to the left of this introduction.
The Patient Protection and Affordable Care Act is the most comprehensive reform of the United States’ health-care system since Medicare and Medicaid were created in the 1960s. The law will expand access to health insurance for millions of uninsured Americans, make that coverage more secure, and promote new delivery systems and payment paradigms that focus on prevention and high-quality care...
*For a PDF of the full article, click on the link to the left of this introduction.
The Patient Protection and Affordable Care Act is the most comprehensive reform of the United States’ health-care system since Medicare and Medicaid were created in the 1960s. The law will expand access to health insurance for millions of uninsured Americans, make that coverage more secure, and promote new delivery systems and payment paradigms that focus on prevention and high-quality care...
*For a PDF of the full article, click on the link to the left of this introduction.
The patent expiration of several biopharmaceuticals such as erythropoietin (erythropoiesis-stimulating agents, ESAs), granulocyte colony-stimulating factor (G-CSF, filgrastim) and others, has led to the emergence of biosimilar medicines. These are defined as copy versions of approved medicinal products with demonstrated similarity in physicochemical characteristics, efficacy, and safety based on a comprehensive comparability exercise. Strict guidelines for the development of biosimilars, ranging from preclinical to phase III trials and postmarketing studies, are already in place in Europe, and the United States Food and Drug Administration (FDA) recently issued draft guidance on biosimilars. A number of biosimilar ESAs and G-CSFs have been approved. Biosimilar monoclonal antibodies are an attractive target for development, with draft guidance from the European Medicines Agency currently under review. Biosimilar medicines may provide cost-effective alternatives to their branded counterparts, potentially benefitting public health by improving access to these medications. It is therefore important to raise awareness of these products among treating physicians. Furthermore, finalization of FDA guidance is important for the development of biosimilar medicines for the US market...
*For a PDF of the full article, click on the link to the left of this introduction.
The patent expiration of several biopharmaceuticals such as erythropoietin (erythropoiesis-stimulating agents, ESAs), granulocyte colony-stimulating factor (G-CSF, filgrastim) and others, has led to the emergence of biosimilar medicines. These are defined as copy versions of approved medicinal products with demonstrated similarity in physicochemical characteristics, efficacy, and safety based on a comprehensive comparability exercise. Strict guidelines for the development of biosimilars, ranging from preclinical to phase III trials and postmarketing studies, are already in place in Europe, and the United States Food and Drug Administration (FDA) recently issued draft guidance on biosimilars. A number of biosimilar ESAs and G-CSFs have been approved. Biosimilar monoclonal antibodies are an attractive target for development, with draft guidance from the European Medicines Agency currently under review. Biosimilar medicines may provide cost-effective alternatives to their branded counterparts, potentially benefitting public health by improving access to these medications. It is therefore important to raise awareness of these products among treating physicians. Furthermore, finalization of FDA guidance is important for the development of biosimilar medicines for the US market...
*For a PDF of the full article, click on the link to the left of this introduction.
The patent expiration of several biopharmaceuticals such as erythropoietin (erythropoiesis-stimulating agents, ESAs), granulocyte colony-stimulating factor (G-CSF, filgrastim) and others, has led to the emergence of biosimilar medicines. These are defined as copy versions of approved medicinal products with demonstrated similarity in physicochemical characteristics, efficacy, and safety based on a comprehensive comparability exercise. Strict guidelines for the development of biosimilars, ranging from preclinical to phase III trials and postmarketing studies, are already in place in Europe, and the United States Food and Drug Administration (FDA) recently issued draft guidance on biosimilars. A number of biosimilar ESAs and G-CSFs have been approved. Biosimilar monoclonal antibodies are an attractive target for development, with draft guidance from the European Medicines Agency currently under review. Biosimilar medicines may provide cost-effective alternatives to their branded counterparts, potentially benefitting public health by improving access to these medications. It is therefore important to raise awareness of these products among treating physicians. Furthermore, finalization of FDA guidance is important for the development of biosimilar medicines for the US market...
*For a PDF of the full article, click on the link to the left of this introduction.
Thyroid cancer is the most common malignancy of the endocrine system. Medullary thyroid cancer (MTC), an intermediate differentiated histotype of thyroid cancer, accounts for approximately 4% of all thyroid cancer cases in the United States. MTC tumors are characterized by increased activation of the proto-oncogene RET, which encodes a receptor tyrosine kinase that promotes cell growth, differentiation, and survival. RET mutations are present in almost all patients with hereditary MTC and in up to 50% of patients with sporadic MTC. MTC tumors also are characterized by overexpression of vascular endothelial growth factor receptors. Until recently, systemic therapy options for MTC treatment were limited. However, based on promising efficacy demonstrated in other solid tumor types, many oral tyrosine kinase inhibitors are being investigated for the treatment of patients with MTC. Recently, vandetanib was approved in the United States for the treatment of patients with symptomatic or progressive MTC with locally advanced or metastatic disease. Common adverse events associated with tyrosine kinase inhibitors under investigation for MTC include diarrhea, rash, hypertension, and QTc prolongation.
*For a PDF of the full article, click on the link to the left of this introduction.
Thyroid cancer is the most common malignancy of the endocrine system. Medullary thyroid cancer (MTC), an intermediate differentiated histotype of thyroid cancer, accounts for approximately 4% of all thyroid cancer cases in the United States. MTC tumors are characterized by increased activation of the proto-oncogene RET, which encodes a receptor tyrosine kinase that promotes cell growth, differentiation, and survival. RET mutations are present in almost all patients with hereditary MTC and in up to 50% of patients with sporadic MTC. MTC tumors also are characterized by overexpression of vascular endothelial growth factor receptors. Until recently, systemic therapy options for MTC treatment were limited. However, based on promising efficacy demonstrated in other solid tumor types, many oral tyrosine kinase inhibitors are being investigated for the treatment of patients with MTC. Recently, vandetanib was approved in the United States for the treatment of patients with symptomatic or progressive MTC with locally advanced or metastatic disease. Common adverse events associated with tyrosine kinase inhibitors under investigation for MTC include diarrhea, rash, hypertension, and QTc prolongation.
*For a PDF of the full article, click on the link to the left of this introduction.
Thyroid cancer is the most common malignancy of the endocrine system. Medullary thyroid cancer (MTC), an intermediate differentiated histotype of thyroid cancer, accounts for approximately 4% of all thyroid cancer cases in the United States. MTC tumors are characterized by increased activation of the proto-oncogene RET, which encodes a receptor tyrosine kinase that promotes cell growth, differentiation, and survival. RET mutations are present in almost all patients with hereditary MTC and in up to 50% of patients with sporadic MTC. MTC tumors also are characterized by overexpression of vascular endothelial growth factor receptors. Until recently, systemic therapy options for MTC treatment were limited. However, based on promising efficacy demonstrated in other solid tumor types, many oral tyrosine kinase inhibitors are being investigated for the treatment of patients with MTC. Recently, vandetanib was approved in the United States for the treatment of patients with symptomatic or progressive MTC with locally advanced or metastatic disease. Common adverse events associated with tyrosine kinase inhibitors under investigation for MTC include diarrhea, rash, hypertension, and QTc prolongation.
*For a PDF of the full article, click on the link to the left of this introduction.
Background: Triple-negative breast cancer (TNBC) has fewer treatment options and is associated with a poor prognosis in the metastatic and adjuvant setting.
Objective: To evaluate the impact of triple-negative (TN) status on disease recurrence and survival among stage I-III patients who were treated with adjuvant chemotherapy in a community-based clinical practice setting.
Methods: Data were extracted from the 2003-2008 Georgia Cancer Specialist Database. Stage I-III breast cancer patients who received adjuvant chemotherapy were followed from initial diagnosis until death, recurrence, or loss to follow-up. The influence of TN status on disease-free survival (DFS) and recurrence was assessed.
Results: The study included 1,572 patients, of whom 26.3% had TNBC. The 5-year DFS was 76.8% for TNBC patients and 89.0% for non-TNBC patients (P less than .001); 5-year recurrence rates were 18.8% for TNBC and 11.2% for non-TNBC (P less than .001). The adjusted likelihood for DFS was lower for TNBC patients (hazard ratio [HR], 0.37; P less than .001), and risk for recurrence was higher (HR, 2.85; P less than .001) compared with non-TNBC patients. In the subpopulation with confirmed race, the comparable adjusted HRs were 0.27 and 4.70 (P less than .001, for both), respectively. African American race was an independent risk factor for worse outcome.
Limitations: Some potential confounding factors are not accounted for in this study, including accessibility to health care, differences in chemotherapy type, dose intensity, and socioeconomic status.
Conclusions: Patients with stage I-III TNBC had shorter DFS and higher recurrence risk, despite having received chemotherapy. The results emphasize the need for more effective treatments.
*To read the full article, click on the PDF icon at the top of this introduction.
Background: Triple-negative breast cancer (TNBC) has fewer treatment options and is associated with a poor prognosis in the metastatic and adjuvant setting.
Objective: To evaluate the impact of triple-negative (TN) status on disease recurrence and survival among stage I-III patients who were treated with adjuvant chemotherapy in a community-based clinical practice setting.
Methods: Data were extracted from the 2003-2008 Georgia Cancer Specialist Database. Stage I-III breast cancer patients who received adjuvant chemotherapy were followed from initial diagnosis until death, recurrence, or loss to follow-up. The influence of TN status on disease-free survival (DFS) and recurrence was assessed.
Results: The study included 1,572 patients, of whom 26.3% had TNBC. The 5-year DFS was 76.8% for TNBC patients and 89.0% for non-TNBC patients (P less than .001); 5-year recurrence rates were 18.8% for TNBC and 11.2% for non-TNBC (P less than .001). The adjusted likelihood for DFS was lower for TNBC patients (hazard ratio [HR], 0.37; P less than .001), and risk for recurrence was higher (HR, 2.85; P less than .001) compared with non-TNBC patients. In the subpopulation with confirmed race, the comparable adjusted HRs were 0.27 and 4.70 (P less than .001, for both), respectively. African American race was an independent risk factor for worse outcome.
Limitations: Some potential confounding factors are not accounted for in this study, including accessibility to health care, differences in chemotherapy type, dose intensity, and socioeconomic status.
Conclusions: Patients with stage I-III TNBC had shorter DFS and higher recurrence risk, despite having received chemotherapy. The results emphasize the need for more effective treatments.
*To read the full article, click on the PDF icon at the top of this introduction.
Background: Triple-negative breast cancer (TNBC) has fewer treatment options and is associated with a poor prognosis in the metastatic and adjuvant setting.
Objective: To evaluate the impact of triple-negative (TN) status on disease recurrence and survival among stage I-III patients who were treated with adjuvant chemotherapy in a community-based clinical practice setting.
Methods: Data were extracted from the 2003-2008 Georgia Cancer Specialist Database. Stage I-III breast cancer patients who received adjuvant chemotherapy were followed from initial diagnosis until death, recurrence, or loss to follow-up. The influence of TN status on disease-free survival (DFS) and recurrence was assessed.
Results: The study included 1,572 patients, of whom 26.3% had TNBC. The 5-year DFS was 76.8% for TNBC patients and 89.0% for non-TNBC patients (P less than .001); 5-year recurrence rates were 18.8% for TNBC and 11.2% for non-TNBC (P less than .001). The adjusted likelihood for DFS was lower for TNBC patients (hazard ratio [HR], 0.37; P less than .001), and risk for recurrence was higher (HR, 2.85; P less than .001) compared with non-TNBC patients. In the subpopulation with confirmed race, the comparable adjusted HRs were 0.27 and 4.70 (P less than .001, for both), respectively. African American race was an independent risk factor for worse outcome.
Limitations: Some potential confounding factors are not accounted for in this study, including accessibility to health care, differences in chemotherapy type, dose intensity, and socioeconomic status.
Conclusions: Patients with stage I-III TNBC had shorter DFS and higher recurrence risk, despite having received chemotherapy. The results emphasize the need for more effective treatments.
*To read the full article, click on the PDF icon at the top of this introduction.
