Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
Original research
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
Previous Presentation: Presented in part at the annual meeting of the American Society of Clinical Oncology, Orlando, Florida, May 29–June 2, 2009.
Luigi Celio, MD
,
Angela Denaro, MD,
Francesco Agustoni, MD,
Emilio Bajetta, MD
Department of Medical Oncology, Fondazione IRCCS “Istituto Nazionale Tumori,” Milan, Italy
Received 11 February 2011. Accepted 16 June 2011. Available online 23 September 2011.
The non-inferiority of palonosetron plus 1-day versus 3-day dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) due to moderately emetogenic chemotherapy (MEC) has been previously demonstrated.
Objective
The objectives of this prespecified post hoc analysis were to demonstrate the non-inferiority hypothesis in an adjusted model for known risk factors (age, gender, alcohol consumption, and type of MEC [anthracycline plus cyclophosphamide (AC)–based versus other MEC]) for CINV and to explore the impact on antiemetic outcome of these risk factors.
Methods
Chemonaive patients (n = 324) with solid tumors were randomized to receive palonosetron 0.25 mg IV plus dexamethasone 8 mg IV on day 1 of chemotherapy or the same regimen followed by oral dexamethasone 8 mg on days 2 and 3. The primary end point was complete response (CR, no emesis and no rescue antiemetics) during the 5-day study period. A modified intention-to-treat approach was used for multivariable analysis.
Results
Non-inferiority of the 1-day regimen was confirmed even after adjusting for risk factors (risk difference −4.4%, 95% CI −14.1% to 5.4%; P = .381). Only age less than 50 years (P = .044) independently predicted a poor outcome of antiemetic treatment. However, most of the younger patients were women (1-day regimen 81.8%, 3-day regimen 88.4%) who underwent AC-based chemotherapy (1-day regimen 61.1%, 3-day regimen 71.0%). There were no significant between-treatment differences in the CR rate according to risk factors.
Conclusion
This analysis confirmed that the 1-day regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC.
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
Previous Presentation: Presented in part at the annual meeting of the American Society of Clinical Oncology, Orlando, Florida, May 29–June 2, 2009.
Luigi Celio, MD
,
Angela Denaro, MD,
Francesco Agustoni, MD,
Emilio Bajetta, MD
Department of Medical Oncology, Fondazione IRCCS “Istituto Nazionale Tumori,” Milan, Italy
Received 11 February 2011. Accepted 16 June 2011. Available online 23 September 2011.
The non-inferiority of palonosetron plus 1-day versus 3-day dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) due to moderately emetogenic chemotherapy (MEC) has been previously demonstrated.
Objective
The objectives of this prespecified post hoc analysis were to demonstrate the non-inferiority hypothesis in an adjusted model for known risk factors (age, gender, alcohol consumption, and type of MEC [anthracycline plus cyclophosphamide (AC)–based versus other MEC]) for CINV and to explore the impact on antiemetic outcome of these risk factors.
Methods
Chemonaive patients (n = 324) with solid tumors were randomized to receive palonosetron 0.25 mg IV plus dexamethasone 8 mg IV on day 1 of chemotherapy or the same regimen followed by oral dexamethasone 8 mg on days 2 and 3. The primary end point was complete response (CR, no emesis and no rescue antiemetics) during the 5-day study period. A modified intention-to-treat approach was used for multivariable analysis.
Results
Non-inferiority of the 1-day regimen was confirmed even after adjusting for risk factors (risk difference −4.4%, 95% CI −14.1% to 5.4%; P = .381). Only age less than 50 years (P = .044) independently predicted a poor outcome of antiemetic treatment. However, most of the younger patients were women (1-day regimen 81.8%, 3-day regimen 88.4%) who underwent AC-based chemotherapy (1-day regimen 61.1%, 3-day regimen 71.0%). There were no significant between-treatment differences in the CR rate according to risk factors.
Conclusion
This analysis confirmed that the 1-day regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC.
Original research
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
Previous Presentation: Presented in part at the annual meeting of the American Society of Clinical Oncology, Orlando, Florida, May 29–June 2, 2009.
Luigi Celio, MD
,
Angela Denaro, MD,
Francesco Agustoni, MD,
Emilio Bajetta, MD
Department of Medical Oncology, Fondazione IRCCS “Istituto Nazionale Tumori,” Milan, Italy
Received 11 February 2011. Accepted 16 June 2011. Available online 23 September 2011.
The non-inferiority of palonosetron plus 1-day versus 3-day dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) due to moderately emetogenic chemotherapy (MEC) has been previously demonstrated.
Objective
The objectives of this prespecified post hoc analysis were to demonstrate the non-inferiority hypothesis in an adjusted model for known risk factors (age, gender, alcohol consumption, and type of MEC [anthracycline plus cyclophosphamide (AC)–based versus other MEC]) for CINV and to explore the impact on antiemetic outcome of these risk factors.
Methods
Chemonaive patients (n = 324) with solid tumors were randomized to receive palonosetron 0.25 mg IV plus dexamethasone 8 mg IV on day 1 of chemotherapy or the same regimen followed by oral dexamethasone 8 mg on days 2 and 3. The primary end point was complete response (CR, no emesis and no rescue antiemetics) during the 5-day study period. A modified intention-to-treat approach was used for multivariable analysis.
Results
Non-inferiority of the 1-day regimen was confirmed even after adjusting for risk factors (risk difference −4.4%, 95% CI −14.1% to 5.4%; P = .381). Only age less than 50 years (P = .044) independently predicted a poor outcome of antiemetic treatment. However, most of the younger patients were women (1-day regimen 81.8%, 3-day regimen 88.4%) who underwent AC-based chemotherapy (1-day regimen 61.1%, 3-day regimen 71.0%). There were no significant between-treatment differences in the CR rate according to risk factors.
Conclusion
This analysis confirmed that the 1-day regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC.
Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
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Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later.
Original research
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
There is little research on the quality of life (QOL) and spiritual well-being (SWB) of women diagnosed with ovarian cancer and their spouses.
Objective
We compared the SWB and QOL of these women and their spouses over a 3-year period.
Methods
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later. All participants completed the Functional Assessment of Chronic Illness Therapy (FACIT)–Spiritual Well-Being–Expanded Version, Symptom Distress Scale, and open-ended questions about changes in their lives. Diagnosed women completed the FACIT-Ovarian and spouses the Caregiver Burden Interview and Linear Analog Self-Assessment scales.
Results
Women reported a high level of SWB over time. Spouses' SWB was significantly worse than the women's at 1 and 3 years (P ≤ .05). Insomnia, fatigue, and outlook/worry were problematic across time, with no significant differences between women and spouses except that women experienced more insomnia through 3 months (P = .02). Emotional well-being was compromised over time for the women but not their spouses until year 3. Physical and social well-being were compromised in spouses across time, while women's social well-being remained high and physical well-being was problematic only for the first year.
Limitations
Limitations include a small spouse sample and, due to the disease process, attrition over time.
Conclusions
Ovarian cancer has significant, but different, effects on women and spouses. Some effects are static, while others are not, which underscores the need for continual monitoring.
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later.
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later.
Original research
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
There is little research on the quality of life (QOL) and spiritual well-being (SWB) of women diagnosed with ovarian cancer and their spouses.
Objective
We compared the SWB and QOL of these women and their spouses over a 3-year period.
Methods
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later. All participants completed the Functional Assessment of Chronic Illness Therapy (FACIT)–Spiritual Well-Being–Expanded Version, Symptom Distress Scale, and open-ended questions about changes in their lives. Diagnosed women completed the FACIT-Ovarian and spouses the Caregiver Burden Interview and Linear Analog Self-Assessment scales.
Results
Women reported a high level of SWB over time. Spouses' SWB was significantly worse than the women's at 1 and 3 years (P ≤ .05). Insomnia, fatigue, and outlook/worry were problematic across time, with no significant differences between women and spouses except that women experienced more insomnia through 3 months (P = .02). Emotional well-being was compromised over time for the women but not their spouses until year 3. Physical and social well-being were compromised in spouses across time, while women's social well-being remained high and physical well-being was problematic only for the first year.
Limitations
Limitations include a small spouse sample and, due to the disease process, attrition over time.
Conclusions
Ovarian cancer has significant, but different, effects on women and spouses. Some effects are static, while others are not, which underscores the need for continual monitoring.
Original research
Spiritual Well-Being and Quality of Life of Women with Ovarian Cancer and Their Spouses
There is little research on the quality of life (QOL) and spiritual well-being (SWB) of women diagnosed with ovarian cancer and their spouses.
Objective
We compared the SWB and QOL of these women and their spouses over a 3-year period.
Methods
This is a descriptive, longitudinal study involving 70 women with ovarian cancer and 26 spouses. Questionnaires were completed postoperatively and by mail 3, 7, 12, 18, 24, and 36 months later. All participants completed the Functional Assessment of Chronic Illness Therapy (FACIT)–Spiritual Well-Being–Expanded Version, Symptom Distress Scale, and open-ended questions about changes in their lives. Diagnosed women completed the FACIT-Ovarian and spouses the Caregiver Burden Interview and Linear Analog Self-Assessment scales.
Results
Women reported a high level of SWB over time. Spouses' SWB was significantly worse than the women's at 1 and 3 years (P ≤ .05). Insomnia, fatigue, and outlook/worry were problematic across time, with no significant differences between women and spouses except that women experienced more insomnia through 3 months (P = .02). Emotional well-being was compromised over time for the women but not their spouses until year 3. Physical and social well-being were compromised in spouses across time, while women's social well-being remained high and physical well-being was problematic only for the first year.
Limitations
Limitations include a small spouse sample and, due to the disease process, attrition over time.
Conclusions
Ovarian cancer has significant, but different, effects on women and spouses. Some effects are static, while others are not, which underscores the need for continual monitoring.
National palliative care guidelines outline spiritual care as a domain of palliative care, yet patients' religiousness and/or spirituality (R/S) are underappreciated in the palliative oncology setting. Among patients with advanced cancer receiving palliative radiation therapy (RT), this study aims to characterize patient spirituality, religiousness, and religious coping; examine the relationships of these variables to quality of life (QOL); and assess patients' perceptions of spiritual care in the cancer care setting.
Methods
This is a multisite, cross-sectional survey of 69 patients with advanced cancer (response rate = 73%) receiving palliative RT. Scripted interviews assessed patient spirituality, religiousness, religious coping, QOL (McGill QOL Questionnaire), and perceptions of the importance of attention to spiritual needs by health providers. Multivariable models assessed the relationships of patient spirituality and R/S coping to patient QOL, controlling for other significant predictors of QOL.
Results
Most participants (84%) indicated reliance on R/S beliefs to cope with cancer. Patient spirituality and religious coping were associated with improved QOL in multivariable analyses (β = 10.57, P < .001 and β = 1.28, P = .01, respectively). Most patients considered attention to spiritual concerns an important part of cancer care by physicians (87%) and nurses (85%).
Limitations
Limitations include a small sample size, a cross-sectional study design, and a limited proportion of nonwhite participants (15%) from one US region.
Conclusion
Patients receiving palliative RT rely on R/S beliefs to cope with advanced cancer. Furthermore, spirituality and religious coping are contributors to better QOL. These findings highlight the importance of spiritual care in advanced cancer care.
*For a PDF of the full article click in the link to the left of this introduction.
National palliative care guidelines outline spiritual care as a domain of palliative care, yet patients' religiousness and/or spirituality (R/S) are underappreciated in the palliative oncology setting. Among patients with advanced cancer receiving palliative radiation therapy (RT), this study aims to characterize patient spirituality, religiousness, and religious coping; examine the relationships of these variables to quality of life (QOL); and assess patients' perceptions of spiritual care in the cancer care setting.
Methods
This is a multisite, cross-sectional survey of 69 patients with advanced cancer (response rate = 73%) receiving palliative RT. Scripted interviews assessed patient spirituality, religiousness, religious coping, QOL (McGill QOL Questionnaire), and perceptions of the importance of attention to spiritual needs by health providers. Multivariable models assessed the relationships of patient spirituality and R/S coping to patient QOL, controlling for other significant predictors of QOL.
Results
Most participants (84%) indicated reliance on R/S beliefs to cope with cancer. Patient spirituality and religious coping were associated with improved QOL in multivariable analyses (β = 10.57, P < .001 and β = 1.28, P = .01, respectively). Most patients considered attention to spiritual concerns an important part of cancer care by physicians (87%) and nurses (85%).
Limitations
Limitations include a small sample size, a cross-sectional study design, and a limited proportion of nonwhite participants (15%) from one US region.
Conclusion
Patients receiving palliative RT rely on R/S beliefs to cope with advanced cancer. Furthermore, spirituality and religious coping are contributors to better QOL. These findings highlight the importance of spiritual care in advanced cancer care.
*For a PDF of the full article click in the link to the left of this introduction.
Original research
The Role of Spirituality and Religious Coping in the Quality of Life of Patients With Advanced Cancer Receiving Palliative Radiation Therapy
National palliative care guidelines outline spiritual care as a domain of palliative care, yet patients' religiousness and/or spirituality (R/S) are underappreciated in the palliative oncology setting. Among patients with advanced cancer receiving palliative radiation therapy (RT), this study aims to characterize patient spirituality, religiousness, and religious coping; examine the relationships of these variables to quality of life (QOL); and assess patients' perceptions of spiritual care in the cancer care setting.
Methods
This is a multisite, cross-sectional survey of 69 patients with advanced cancer (response rate = 73%) receiving palliative RT. Scripted interviews assessed patient spirituality, religiousness, religious coping, QOL (McGill QOL Questionnaire), and perceptions of the importance of attention to spiritual needs by health providers. Multivariable models assessed the relationships of patient spirituality and R/S coping to patient QOL, controlling for other significant predictors of QOL.
Results
Most participants (84%) indicated reliance on R/S beliefs to cope with cancer. Patient spirituality and religious coping were associated with improved QOL in multivariable analyses (β = 10.57, P < .001 and β = 1.28, P = .01, respectively). Most patients considered attention to spiritual concerns an important part of cancer care by physicians (87%) and nurses (85%).
Limitations
Limitations include a small sample size, a cross-sectional study design, and a limited proportion of nonwhite participants (15%) from one US region.
Conclusion
Patients receiving palliative RT rely on R/S beliefs to cope with advanced cancer. Furthermore, spirituality and religious coping are contributors to better QOL. These findings highlight the importance of spiritual care in advanced cancer care.
*For a PDF of the full article click in the link to the left of this introduction.
In one of our previous articles, we discussed a study of screening for prostate cancer.1 Now we’re going to move up a bit, at least anatomically, and discuss a study of screening for lung cancer.2 We have previously defined ourselves as curmudgeons and skeptics; to those self-descriptions we now add a new term, “chutzpahniks.” For those of you who may be unfamiliar with that Yiddish term, it means people who have chutzpah, which was defined by Leo Rosten3 as: “that quality enshrined in a man who, having killed his mother and father, throws himself on the mercy of the court because he is an orphan.” Our chutzpah stems from the fact that we are criticizing the results of a study that was published in the New England Journal of Medicine and highly praised in an editorial in that journal.4 If we had less chutzpah, we wouldn’t contemplate such a critique, but then again, if we had less chutzpah, we—a clinical psychologist and a nuclear physicist—wouldn’t be writing articles in a cancer journal. So, on to the study...
To read the full article, click on the PDF icon above.
In one of our previous articles, we discussed a study of screening for prostate cancer.1 Now we’re going to move up a bit, at least anatomically, and discuss a study of screening for lung cancer.2 We have previously defined ourselves as curmudgeons and skeptics; to those self-descriptions we now add a new term, “chutzpahniks.” For those of you who may be unfamiliar with that Yiddish term, it means people who have chutzpah, which was defined by Leo Rosten3 as: “that quality enshrined in a man who, having killed his mother and father, throws himself on the mercy of the court because he is an orphan.” Our chutzpah stems from the fact that we are criticizing the results of a study that was published in the New England Journal of Medicine and highly praised in an editorial in that journal.4 If we had less chutzpah, we wouldn’t contemplate such a critique, but then again, if we had less chutzpah, we—a clinical psychologist and a nuclear physicist—wouldn’t be writing articles in a cancer journal. So, on to the study...
To read the full article, click on the PDF icon above.
In one of our previous articles, we discussed a study of screening for prostate cancer.1 Now we’re going to move up a bit, at least anatomically, and discuss a study of screening for lung cancer.2 We have previously defined ourselves as curmudgeons and skeptics; to those self-descriptions we now add a new term, “chutzpahniks.” For those of you who may be unfamiliar with that Yiddish term, it means people who have chutzpah, which was defined by Leo Rosten3 as: “that quality enshrined in a man who, having killed his mother and father, throws himself on the mercy of the court because he is an orphan.” Our chutzpah stems from the fact that we are criticizing the results of a study that was published in the New England Journal of Medicine and highly praised in an editorial in that journal.4 If we had less chutzpah, we wouldn’t contemplate such a critique, but then again, if we had less chutzpah, we—a clinical psychologist and a nuclear physicist—wouldn’t be writing articles in a cancer journal. So, on to the study...
To read the full article, click on the PDF icon above.
The projected increase in the number of cancer survivors will present unprecedented challenges for community-based practices, and the Institute of Medicine1 and the American College of Surgeons’ Commission on Cancer2 have made recommendations to meet the needs of this growing patient population. However, most community-based practices do not have the resources to implement the recommendations and will have to work closely with resources outside of the practice to develop financially viable and sustainable programs...
*For a PDF of the full article, click on the link to the left of this introduction.
The projected increase in the number of cancer survivors will present unprecedented challenges for community-based practices, and the Institute of Medicine1 and the American College of Surgeons’ Commission on Cancer2 have made recommendations to meet the needs of this growing patient population. However, most community-based practices do not have the resources to implement the recommendations and will have to work closely with resources outside of the practice to develop financially viable and sustainable programs...
*For a PDF of the full article, click on the link to the left of this introduction.
The projected increase in the number of cancer survivors will present unprecedented challenges for community-based practices, and the Institute of Medicine1 and the American College of Surgeons’ Commission on Cancer2 have made recommendations to meet the needs of this growing patient population. However, most community-based practices do not have the resources to implement the recommendations and will have to work closely with resources outside of the practice to develop financially viable and sustainable programs...
*For a PDF of the full article, click on the link to the left of this introduction.
Multiple myeloma (MM) is characterized by excess monoclonal plasma cells in the bone marrow (BM), in most cases associated with monoclonal protein in blood or urine. Nearly 50 years ago, the use of combined melphalan and prednisone was shown to extend median survival of patients with MM to 2-3 years. In an approach pioneered by Prof. Tim McElwain in the 1970s, high-dose melphalan followed by BM transplantation in the 1980s and peripheral blood stem cell rescue in the 1990s further increased median survival to 3-4 years. Since 1998, MM has represented a new paradigm in drug development due to the remarkable therapeutic efficacy of targeting tumor cells in their microenvironment1,2—an approach perhaps best exemplified by the use of the proteasome inhibitor bortezomib and immunomodulatory drugs (IMiDs) thalidomide and lenalidomide to target the MM cell in the BM microenvironment. This approach has rapidly translated from bench to bedside, producing six new Food and Drug Administration (FDA)-approved treatments in the past 7 years and a doubling of patient survival from 3-4 to 7-8 years as a direct result.3 My colleagues and I have made contributions in the areas of identifying novel targets in the tumor and microenvironment, confirming the activity of inhibitors directed at these targets, and then leading clinical trials assessing the efficacy and safety of these agents...
*For a PDF of the full article, click on the link to the left of this introduction.
Multiple myeloma (MM) is characterized by excess monoclonal plasma cells in the bone marrow (BM), in most cases associated with monoclonal protein in blood or urine. Nearly 50 years ago, the use of combined melphalan and prednisone was shown to extend median survival of patients with MM to 2-3 years. In an approach pioneered by Prof. Tim McElwain in the 1970s, high-dose melphalan followed by BM transplantation in the 1980s and peripheral blood stem cell rescue in the 1990s further increased median survival to 3-4 years. Since 1998, MM has represented a new paradigm in drug development due to the remarkable therapeutic efficacy of targeting tumor cells in their microenvironment1,2—an approach perhaps best exemplified by the use of the proteasome inhibitor bortezomib and immunomodulatory drugs (IMiDs) thalidomide and lenalidomide to target the MM cell in the BM microenvironment. This approach has rapidly translated from bench to bedside, producing six new Food and Drug Administration (FDA)-approved treatments in the past 7 years and a doubling of patient survival from 3-4 to 7-8 years as a direct result.3 My colleagues and I have made contributions in the areas of identifying novel targets in the tumor and microenvironment, confirming the activity of inhibitors directed at these targets, and then leading clinical trials assessing the efficacy and safety of these agents...
*For a PDF of the full article, click on the link to the left of this introduction.
Multiple myeloma (MM) is characterized by excess monoclonal plasma cells in the bone marrow (BM), in most cases associated with monoclonal protein in blood or urine. Nearly 50 years ago, the use of combined melphalan and prednisone was shown to extend median survival of patients with MM to 2-3 years. In an approach pioneered by Prof. Tim McElwain in the 1970s, high-dose melphalan followed by BM transplantation in the 1980s and peripheral blood stem cell rescue in the 1990s further increased median survival to 3-4 years. Since 1998, MM has represented a new paradigm in drug development due to the remarkable therapeutic efficacy of targeting tumor cells in their microenvironment1,2—an approach perhaps best exemplified by the use of the proteasome inhibitor bortezomib and immunomodulatory drugs (IMiDs) thalidomide and lenalidomide to target the MM cell in the BM microenvironment. This approach has rapidly translated from bench to bedside, producing six new Food and Drug Administration (FDA)-approved treatments in the past 7 years and a doubling of patient survival from 3-4 to 7-8 years as a direct result.3 My colleagues and I have made contributions in the areas of identifying novel targets in the tumor and microenvironment, confirming the activity of inhibitors directed at these targets, and then leading clinical trials assessing the efficacy and safety of these agents...
*For a PDF of the full article, click on the link to the left of this introduction.
Vemurafenib, an oral inhibitor of some mutated forms of the BRAF serine threonine kinase, was recently approved for the treatment of patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by an FDA- approved test. It is not recommended for use in patients with wild-type BRAF melanoma. The clinical trial supporting approval of vemurafenib (PLX4032) was performed in treatment-naïve patients with the V600E mutation as detected by the Cobas 4800 BRAF V600 Mutation Test. About 40%-60% of cutaneous melanomas have BRAF mutations that result in constitutive activation of downstream signaling through the MAPK pathway; about 90% of those carry the V600E mutation.
*For a PDF of the full article, click on the link to the left of this introduction.
Vemurafenib, an oral inhibitor of some mutated forms of the BRAF serine threonine kinase, was recently approved for the treatment of patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by an FDA- approved test. It is not recommended for use in patients with wild-type BRAF melanoma. The clinical trial supporting approval of vemurafenib (PLX4032) was performed in treatment-naïve patients with the V600E mutation as detected by the Cobas 4800 BRAF V600 Mutation Test. About 40%-60% of cutaneous melanomas have BRAF mutations that result in constitutive activation of downstream signaling through the MAPK pathway; about 90% of those carry the V600E mutation.
*For a PDF of the full article, click on the link to the left of this introduction.
Vemurafenib, an oral inhibitor of some mutated forms of the BRAF serine threonine kinase, was recently approved for the treatment of patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by an FDA- approved test. It is not recommended for use in patients with wild-type BRAF melanoma. The clinical trial supporting approval of vemurafenib (PLX4032) was performed in treatment-naïve patients with the V600E mutation as detected by the Cobas 4800 BRAF V600 Mutation Test. About 40%-60% of cutaneous melanomas have BRAF mutations that result in constitutive activation of downstream signaling through the MAPK pathway; about 90% of those carry the V600E mutation.
*For a PDF of the full article, click on the link to the left of this introduction.
Third-generation aromatase inhibitors (AIs) used in the treatment of hormone-responsive breast cancer are associated with arthralgia, which is the most common reason for treatment discontinuation. This review characterizes the observed arthralgia and describes its variable definitions in key clinical trials; its typical onset and duration; symptom management strategies; and symptom resolution. The symptomatic manifestations of AI-associated arthralgia are highly variable, with typical onset occurring 2-6 months after treatment initiation. Aromatase inhibitor-associated arthralgia is most often bilateral and symmetrical, involving hands and wrists. Other common locations include knees, hips, lower back, shoulders, and feet. To improve standardization of care as well as patient quality of life, we propose a diagnostic algorithm for the management of patients who receive AIs and who develop arthralgia or worsening symptoms from preexisting joint pain. We conclude that although arthralgia is often associated with AI therapy, prompt diagnosis and management of musculoskeletal symptoms may ensure continued AI treatment and improve quality of life...
*For a PDF of the full article, click on the link to the left of this introduction.
Third-generation aromatase inhibitors (AIs) used in the treatment of hormone-responsive breast cancer are associated with arthralgia, which is the most common reason for treatment discontinuation. This review characterizes the observed arthralgia and describes its variable definitions in key clinical trials; its typical onset and duration; symptom management strategies; and symptom resolution. The symptomatic manifestations of AI-associated arthralgia are highly variable, with typical onset occurring 2-6 months after treatment initiation. Aromatase inhibitor-associated arthralgia is most often bilateral and symmetrical, involving hands and wrists. Other common locations include knees, hips, lower back, shoulders, and feet. To improve standardization of care as well as patient quality of life, we propose a diagnostic algorithm for the management of patients who receive AIs and who develop arthralgia or worsening symptoms from preexisting joint pain. We conclude that although arthralgia is often associated with AI therapy, prompt diagnosis and management of musculoskeletal symptoms may ensure continued AI treatment and improve quality of life...
*For a PDF of the full article, click on the link to the left of this introduction.
Third-generation aromatase inhibitors (AIs) used in the treatment of hormone-responsive breast cancer are associated with arthralgia, which is the most common reason for treatment discontinuation. This review characterizes the observed arthralgia and describes its variable definitions in key clinical trials; its typical onset and duration; symptom management strategies; and symptom resolution. The symptomatic manifestations of AI-associated arthralgia are highly variable, with typical onset occurring 2-6 months after treatment initiation. Aromatase inhibitor-associated arthralgia is most often bilateral and symmetrical, involving hands and wrists. Other common locations include knees, hips, lower back, shoulders, and feet. To improve standardization of care as well as patient quality of life, we propose a diagnostic algorithm for the management of patients who receive AIs and who develop arthralgia or worsening symptoms from preexisting joint pain. We conclude that although arthralgia is often associated with AI therapy, prompt diagnosis and management of musculoskeletal symptoms may ensure continued AI treatment and improve quality of life...
*For a PDF of the full article, click on the link to the left of this introduction.
Community Oncology Podcast - HER2-positive metastatic breast cancer
Axitinib in renal cell carcinoma, pertuzumab plus trastuzumab and docetaxel in HER2-positive metastatic breast cancer, and models for including psychosocial services into community oncology practices are featured in the February podcast of Community Oncology, hosted by Editor-in-Chief Dr. David Henry.
Axitinib in renal cell carcinoma, pertuzumab plus trastuzumab and docetaxel in HER2-positive metastatic breast cancer, and models for including psychosocial services into community oncology practices are featured in the February podcast of Community Oncology, hosted by Editor-in-Chief Dr. David Henry.
Axitinib in renal cell carcinoma, pertuzumab plus trastuzumab and docetaxel in HER2-positive metastatic breast cancer, and models for including psychosocial services into community oncology practices are featured in the February podcast of Community Oncology, hosted by Editor-in-Chief Dr. David Henry.
State AGs Assess Health Reform's Individual Mandate
At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.
At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.
Reporter Alicia Ault has this video report:
At a recent forum, Virginia Attorney General Ken Cuccinelli and Massachusetts Attorney General Martha Coakley offered contrasting perspectives on the constitutionality of the federal Affordable Care Act's requirement that individuals must purchase health insurance.
