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Research and Reviews for the Practicing Oncologist
Comparison of antiemetic efficacy and safety of palonosetron vs ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children
Background Chemotherapy-induced nausea and vomiting (CINV) in children is a major side effect despite the use of combination antiemetic drugs.
Objective To compare the efficacy and safety profile of palonosetron, a second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, with ondansetron in the prevention of CINV in children.
Methods A prospective, randomized, crossover study was conducted in patients aged 2-18 years. 160 chemotherapy cycles, consisting of chemotherapy drugs with moderate- and high-emetogenic potential, were studied. The study group received a single dose of intravenous (IV) palonosetron 5 mcg/kg, and the standard group received IV ondansetron 5 mg/m2 every 8 hours while receiving chemotherapy. The patients were observed for vomiting, use of rescue antiemetic medications, and nausea from Day 1 0-72 hours after completion of each chemotherapy cycle. All adverse events during the study period were recorded.
Results The overall percentage of patients with complete response (CR) in the palonosetron and ondansetron groups were 60% and 56.2%, respectively (P = .631). The CR rates in the palonosetron and ondansetron groups were 75% and 70%, respectively, in the acute phase (P = .479), and 68.8% and 65%, respectively, in the delayed phase (P = .614). There was no statistically significant difference in the CR rates cross both groups.
Conclusion A single dose of palonosetron is noninferior to ondansetron in the prevention of CINV in children and can be considered as an alternative antiemetic drug. There was no significant difference in adverse effects between the palonosetron and ondansetron group.
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Background Chemotherapy-induced nausea and vomiting (CINV) in children is a major side effect despite the use of combination antiemetic drugs.
Objective To compare the efficacy and safety profile of palonosetron, a second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, with ondansetron in the prevention of CINV in children.
Methods A prospective, randomized, crossover study was conducted in patients aged 2-18 years. 160 chemotherapy cycles, consisting of chemotherapy drugs with moderate- and high-emetogenic potential, were studied. The study group received a single dose of intravenous (IV) palonosetron 5 mcg/kg, and the standard group received IV ondansetron 5 mg/m2 every 8 hours while receiving chemotherapy. The patients were observed for vomiting, use of rescue antiemetic medications, and nausea from Day 1 0-72 hours after completion of each chemotherapy cycle. All adverse events during the study period were recorded.
Results The overall percentage of patients with complete response (CR) in the palonosetron and ondansetron groups were 60% and 56.2%, respectively (P = .631). The CR rates in the palonosetron and ondansetron groups were 75% and 70%, respectively, in the acute phase (P = .479), and 68.8% and 65%, respectively, in the delayed phase (P = .614). There was no statistically significant difference in the CR rates cross both groups.
Conclusion A single dose of palonosetron is noninferior to ondansetron in the prevention of CINV in children and can be considered as an alternative antiemetic drug. There was no significant difference in adverse effects between the palonosetron and ondansetron group.
Click on the PDF icon at the top of this introduction to read the full article.
Background Chemotherapy-induced nausea and vomiting (CINV) in children is a major side effect despite the use of combination antiemetic drugs.
Objective To compare the efficacy and safety profile of palonosetron, a second-generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, with ondansetron in the prevention of CINV in children.
Methods A prospective, randomized, crossover study was conducted in patients aged 2-18 years. 160 chemotherapy cycles, consisting of chemotherapy drugs with moderate- and high-emetogenic potential, were studied. The study group received a single dose of intravenous (IV) palonosetron 5 mcg/kg, and the standard group received IV ondansetron 5 mg/m2 every 8 hours while receiving chemotherapy. The patients were observed for vomiting, use of rescue antiemetic medications, and nausea from Day 1 0-72 hours after completion of each chemotherapy cycle. All adverse events during the study period were recorded.
Results The overall percentage of patients with complete response (CR) in the palonosetron and ondansetron groups were 60% and 56.2%, respectively (P = .631). The CR rates in the palonosetron and ondansetron groups were 75% and 70%, respectively, in the acute phase (P = .479), and 68.8% and 65%, respectively, in the delayed phase (P = .614). There was no statistically significant difference in the CR rates cross both groups.
Conclusion A single dose of palonosetron is noninferior to ondansetron in the prevention of CINV in children and can be considered as an alternative antiemetic drug. There was no significant difference in adverse effects between the palonosetron and ondansetron group.
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Olaparib for BRCA-mutated advanced ovarian cancer
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It is not your mother/father’s ASCO anymore…
David Henry's JCSO podcast, May 2015
In his monthly podcast for The Journal of Community and Supportive Oncology, Dr David Henry looks at Original Reports on the treatment of metastatic breast cancer with nab-paclitaxel in the community practice setting; health professionals’ attitudes toward detecting and managing cancer-related anorexia-cachexia syndrome; the factors associated with symptom-related emergency department visits and hospital admissions during ambulatory cancer treatment; and differences in treatment between urban and rural women with hormone receptor-positive early-stage breast cancer. He also discusses a case report on a patient with severe chemotherapy-induced peripheral neuropathy who experienced a significant response to lacosamide, and Community Translations item using blinatumomab for hard-to-treat acute lymphoblastic leukemia.
BCP-ALL, CD19, CD3, dosage-schedule, nab-paclitaxel, metastatic breast cancer, MBC, human epidermal growth factor receptor 2, HER2–negative, anorexia-cachexia syndrome, CACS, non-small-cell lung cancer, NSCLC, symptom distress, quality of life, QoL, side effects, emergency department, ED, hospital admissions, HAs, emergency department visits, EDVs, symptom-related EDVs, sx-EDV/HAs, urban, rural, hormone receptor-positive, breast cancer, lacosamide, anticonvulsant, chemotherapy-induced peripheral neuropathy, CIPN, urothelial carcinoma,
MVAC, methotrexate, vincristine, adriamycin, cisplatin
In his monthly podcast for The Journal of Community and Supportive Oncology, Dr David Henry looks at Original Reports on the treatment of metastatic breast cancer with nab-paclitaxel in the community practice setting; health professionals’ attitudes toward detecting and managing cancer-related anorexia-cachexia syndrome; the factors associated with symptom-related emergency department visits and hospital admissions during ambulatory cancer treatment; and differences in treatment between urban and rural women with hormone receptor-positive early-stage breast cancer. He also discusses a case report on a patient with severe chemotherapy-induced peripheral neuropathy who experienced a significant response to lacosamide, and Community Translations item using blinatumomab for hard-to-treat acute lymphoblastic leukemia.
In his monthly podcast for The Journal of Community and Supportive Oncology, Dr David Henry looks at Original Reports on the treatment of metastatic breast cancer with nab-paclitaxel in the community practice setting; health professionals’ attitudes toward detecting and managing cancer-related anorexia-cachexia syndrome; the factors associated with symptom-related emergency department visits and hospital admissions during ambulatory cancer treatment; and differences in treatment between urban and rural women with hormone receptor-positive early-stage breast cancer. He also discusses a case report on a patient with severe chemotherapy-induced peripheral neuropathy who experienced a significant response to lacosamide, and Community Translations item using blinatumomab for hard-to-treat acute lymphoblastic leukemia.
BCP-ALL, CD19, CD3, dosage-schedule, nab-paclitaxel, metastatic breast cancer, MBC, human epidermal growth factor receptor 2, HER2–negative, anorexia-cachexia syndrome, CACS, non-small-cell lung cancer, NSCLC, symptom distress, quality of life, QoL, side effects, emergency department, ED, hospital admissions, HAs, emergency department visits, EDVs, symptom-related EDVs, sx-EDV/HAs, urban, rural, hormone receptor-positive, breast cancer, lacosamide, anticonvulsant, chemotherapy-induced peripheral neuropathy, CIPN, urothelial carcinoma,
MVAC, methotrexate, vincristine, adriamycin, cisplatin
BCP-ALL, CD19, CD3, dosage-schedule, nab-paclitaxel, metastatic breast cancer, MBC, human epidermal growth factor receptor 2, HER2–negative, anorexia-cachexia syndrome, CACS, non-small-cell lung cancer, NSCLC, symptom distress, quality of life, QoL, side effects, emergency department, ED, hospital admissions, HAs, emergency department visits, EDVs, symptom-related EDVs, sx-EDV/HAs, urban, rural, hormone receptor-positive, breast cancer, lacosamide, anticonvulsant, chemotherapy-induced peripheral neuropathy, CIPN, urothelial carcinoma,
MVAC, methotrexate, vincristine, adriamycin, cisplatin
Significant response to lacosamide in a patient with severe chemotherapy-induced peripheral neuropathy
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Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Treatment differences between urban and rural women with hormone receptor-positive early-stage breast cancer based on 21-gene assay recurrence score result
Symptom-related emergency department visits and hospital admissions during ambulatory cancer treatment
Background People with cancer experience symptoms related to the disease and treatments. Symptom distress has a negative impact on quality of life (QoL). Attending to symptoms and side effects of treatment promotes safe and effective delivery of therapies and may prevent or reduce emergency department visits (EDVs) and unplanned hospital admissions (HAs). There is limited evidence examining symptom-related EDVs or HAs (sx-EDV/HAs) and interventions in ambulatory oncology patients.
Objective To examine factors associated with sx-EDV/HAs in ambulatory oncology patients receiving chemotherapy and/or radiation.
Methods This secondary analysis used data from a randomized controlled trial of ambulatory oncology patients (n = 663) who received the web-based Electronic Self-Report Assessment – Cancer intervention (symptom self-monitoring, tailored education, and communication coaching) or usual care with symptom self-monitoring alone. Group differences were described by summary statistics and compared by t test. Factors associated with the odds of at least 1 sx-EDV/HA were modeled using logistic regression.
Results 98 patients had a total of 171 sx-EDV/HAs with no difference between groups. Higher odds of at least 1 sx-EDV/HA were associated with socioeconomic and clinical factors. The multivariable model indicated that work status, education level, treatment modality, and on-treatment Symptom Distress Scale-15 scores were significantly associated with having at least 1 sx-EDV/HA.
Limitations This is a secondary analysis not sized to determine cause and effect. The results have limited generalizability.
Conclusion Most patients did not experience a sx-EDV/HA. Demographic and clinical factors predicted a sx-EDV/HA.
Funding National Institute of Nursing Research, National Institutes of Health, R01 NR008726; 2008-2011
Click on the PDF icon at the top of this introduction to read the full article.
Background People with cancer experience symptoms related to the disease and treatments. Symptom distress has a negative impact on quality of life (QoL). Attending to symptoms and side effects of treatment promotes safe and effective delivery of therapies and may prevent or reduce emergency department visits (EDVs) and unplanned hospital admissions (HAs). There is limited evidence examining symptom-related EDVs or HAs (sx-EDV/HAs) and interventions in ambulatory oncology patients.
Objective To examine factors associated with sx-EDV/HAs in ambulatory oncology patients receiving chemotherapy and/or radiation.
Methods This secondary analysis used data from a randomized controlled trial of ambulatory oncology patients (n = 663) who received the web-based Electronic Self-Report Assessment – Cancer intervention (symptom self-monitoring, tailored education, and communication coaching) or usual care with symptom self-monitoring alone. Group differences were described by summary statistics and compared by t test. Factors associated with the odds of at least 1 sx-EDV/HA were modeled using logistic regression.
Results 98 patients had a total of 171 sx-EDV/HAs with no difference between groups. Higher odds of at least 1 sx-EDV/HA were associated with socioeconomic and clinical factors. The multivariable model indicated that work status, education level, treatment modality, and on-treatment Symptom Distress Scale-15 scores were significantly associated with having at least 1 sx-EDV/HA.
Limitations This is a secondary analysis not sized to determine cause and effect. The results have limited generalizability.
Conclusion Most patients did not experience a sx-EDV/HA. Demographic and clinical factors predicted a sx-EDV/HA.
Funding National Institute of Nursing Research, National Institutes of Health, R01 NR008726; 2008-2011
Click on the PDF icon at the top of this introduction to read the full article.
Background People with cancer experience symptoms related to the disease and treatments. Symptom distress has a negative impact on quality of life (QoL). Attending to symptoms and side effects of treatment promotes safe and effective delivery of therapies and may prevent or reduce emergency department visits (EDVs) and unplanned hospital admissions (HAs). There is limited evidence examining symptom-related EDVs or HAs (sx-EDV/HAs) and interventions in ambulatory oncology patients.
Objective To examine factors associated with sx-EDV/HAs in ambulatory oncology patients receiving chemotherapy and/or radiation.
Methods This secondary analysis used data from a randomized controlled trial of ambulatory oncology patients (n = 663) who received the web-based Electronic Self-Report Assessment – Cancer intervention (symptom self-monitoring, tailored education, and communication coaching) or usual care with symptom self-monitoring alone. Group differences were described by summary statistics and compared by t test. Factors associated with the odds of at least 1 sx-EDV/HA were modeled using logistic regression.
Results 98 patients had a total of 171 sx-EDV/HAs with no difference between groups. Higher odds of at least 1 sx-EDV/HA were associated with socioeconomic and clinical factors. The multivariable model indicated that work status, education level, treatment modality, and on-treatment Symptom Distress Scale-15 scores were significantly associated with having at least 1 sx-EDV/HA.
Limitations This is a secondary analysis not sized to determine cause and effect. The results have limited generalizability.
Conclusion Most patients did not experience a sx-EDV/HA. Demographic and clinical factors predicted a sx-EDV/HA.
Funding National Institute of Nursing Research, National Institutes of Health, R01 NR008726; 2008-2011
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Health professionals’ attitudes toward the detection and management of cancer-related anorexia-cachexia syndrome, and a proposal for standardized assessment
Conclusion Most oncologists and nurses recognize the core criteria for the CACS, although there may be under-recognition of the condition’s prevalence, particularly earlier in the course of treatment. There is considerable interest in adopting a brief assessment tool for screening, management, and referral of patient who are affected by or at-risk of CACS.
Supplemental material
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Conclusion Most oncologists and nurses recognize the core criteria for the CACS, although there may be under-recognition of the condition’s prevalence, particularly earlier in the course of treatment. There is considerable interest in adopting a brief assessment tool for screening, management, and referral of patient who are affected by or at-risk of CACS.
Supplemental material
Click on the PDF icon at the top of this introduction to read the full article.
Conclusion Most oncologists and nurses recognize the core criteria for the CACS, although there may be under-recognition of the condition’s prevalence, particularly earlier in the course of treatment. There is considerable interest in adopting a brief assessment tool for screening, management, and referral of patient who are affected by or at-risk of CACS.
Supplemental material
Click on the PDF icon at the top of this introduction to read the full article.
Treatment of metastatic breast cancer with nab-paclitaxel in the community practice setting: a US oncology survey
Blinatumomab for hard-to-treat form of acute lymphoblastic leukemia
The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).1 Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.2
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The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).1 Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.2
Click on the PDF icon at the top of this introduction to read the full article.
The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).1 Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.2
Click on the PDF icon at the top of this introduction to read the full article.