RANDOMISED COMPARISON OF PALONOSETRON AND ONDANSETRON BOTH COMBINED WITH DEXAMETHASONE IN PREVENTION OF EMESIS IN LYMPHOMA PATIENTS RECEIVING MODERATELY EMETOGENIC REGIMEN BENDAMUSTINE AND RITUXIMAB
(Abstract release date: 05/19/16)
EHA Library. Ptushkin V. 06/09/16; 132732; E1183
Prof. Vadim Ptushkin
Contributions
Contributions
Abstract
Abstract: E1183
Type: Eposter Presentation
Background
Palonosetron is a highly selective, second-generation 5-HT3 receptor antagonist with a prolonged half-life (40 hours) which makes it attractive in prevention of delayed nausea and vomiting. Bendamustine, a moderately emetogenic cytostatic drug is becoming increasingly used in treatment of lymphoid malignancies.
Aims
A randomized comparison of palonosetron and ondansetron both combined with dexamethasone in prevention of chemotherapy induced nausea and vomiting (CINV) in adult patients, receiving bendamustine and rituximab chemoimmunotherapy.
Methods
Data of 1st interim analysis are presented. The study included 23 patients with median age of 67 years (range 31 - 82 yrs), 13 males and 10 females. The patients did not received chemotherapy at least 6 months prior to inclusion. Ten patients had follicular lymphoma, 8 – chronic lymphocytic leukemia, 6 – marginal zone and other types of indolent lymphomas. The BR regimen consisted of rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1 and 2. Patients were randomly assigned to receive either a single intravenous bolus dose of palonosetron (0, 25 mg) on day 1 or ondansetron (8 mg on days 1 and 2 of each cycle) along with dexamethasone 30 min before administration of chemotherapy. CINV was assessed during 1st cycle of chemotherapy using MASCC Antiemesis Tool. Frequency and severity of acute (within 24 hours) and delayed (24 – 120 hours) emetogenic reactions were registered.
Results
Eleven patients received palonosetron and 12 ondansetron. Groups were comparable with regard to emetogenic risk factors including sex, age, kinetosis and alcohol use. Complete response (no emetic episodes and no rescue therapy) in acute phase was observed in 100% of patients receiving palonisetron and in 10/12 (83%) of patients receiving ondansetron. Complete response in delayed phase was achieved in all patients in palonosetron group and in 11/12 (92%) in ondansetron group. Complete protection (no emetic episodes, no rescue therapy, and no significant nausea [Likert scale 2 or less]) in acute phase was achieved in 10/11 (91%) patients in palonosetron group and in 5/12 (41%) in ondansetron group. In delayed phase complete protection of CINV was reported by 10/11 (91%) of patients receiving palonosetron and 6/12 (50%) of patients receiving ondansetron.
Conclusion
The frequency of delayed nausea in patients, receiving bendamustine is probably underestimated. Prevention of bendamustine induced nausea and vomiting with palonosetron merits further investigation.
Session topic: E-poster
Keyword(s): B cell lymphoma, Supportive care
Type: Eposter Presentation
Background
Palonosetron is a highly selective, second-generation 5-HT3 receptor antagonist with a prolonged half-life (40 hours) which makes it attractive in prevention of delayed nausea and vomiting. Bendamustine, a moderately emetogenic cytostatic drug is becoming increasingly used in treatment of lymphoid malignancies.
Aims
A randomized comparison of palonosetron and ondansetron both combined with dexamethasone in prevention of chemotherapy induced nausea and vomiting (CINV) in adult patients, receiving bendamustine and rituximab chemoimmunotherapy.
Methods
Data of 1st interim analysis are presented. The study included 23 patients with median age of 67 years (range 31 - 82 yrs), 13 males and 10 females. The patients did not received chemotherapy at least 6 months prior to inclusion. Ten patients had follicular lymphoma, 8 – chronic lymphocytic leukemia, 6 – marginal zone and other types of indolent lymphomas. The BR regimen consisted of rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1 and 2. Patients were randomly assigned to receive either a single intravenous bolus dose of palonosetron (0, 25 mg) on day 1 or ondansetron (8 mg on days 1 and 2 of each cycle) along with dexamethasone 30 min before administration of chemotherapy. CINV was assessed during 1st cycle of chemotherapy using MASCC Antiemesis Tool. Frequency and severity of acute (within 24 hours) and delayed (24 – 120 hours) emetogenic reactions were registered.
Results
Eleven patients received palonosetron and 12 ondansetron. Groups were comparable with regard to emetogenic risk factors including sex, age, kinetosis and alcohol use. Complete response (no emetic episodes and no rescue therapy) in acute phase was observed in 100% of patients receiving palonisetron and in 10/12 (83%) of patients receiving ondansetron. Complete response in delayed phase was achieved in all patients in palonosetron group and in 11/12 (92%) in ondansetron group. Complete protection (no emetic episodes, no rescue therapy, and no significant nausea [Likert scale 2 or less]) in acute phase was achieved in 10/11 (91%) patients in palonosetron group and in 5/12 (41%) in ondansetron group. In delayed phase complete protection of CINV was reported by 10/11 (91%) of patients receiving palonosetron and 6/12 (50%) of patients receiving ondansetron.
Conclusion
The frequency of delayed nausea in patients, receiving bendamustine is probably underestimated. Prevention of bendamustine induced nausea and vomiting with palonosetron merits further investigation.
Session topic: E-poster
Keyword(s): B cell lymphoma, Supportive care
Abstract: E1183
Type: Eposter Presentation
Background
Palonosetron is a highly selective, second-generation 5-HT3 receptor antagonist with a prolonged half-life (40 hours) which makes it attractive in prevention of delayed nausea and vomiting. Bendamustine, a moderately emetogenic cytostatic drug is becoming increasingly used in treatment of lymphoid malignancies.
Aims
A randomized comparison of palonosetron and ondansetron both combined with dexamethasone in prevention of chemotherapy induced nausea and vomiting (CINV) in adult patients, receiving bendamustine and rituximab chemoimmunotherapy.
Methods
Data of 1st interim analysis are presented. The study included 23 patients with median age of 67 years (range 31 - 82 yrs), 13 males and 10 females. The patients did not received chemotherapy at least 6 months prior to inclusion. Ten patients had follicular lymphoma, 8 – chronic lymphocytic leukemia, 6 – marginal zone and other types of indolent lymphomas. The BR regimen consisted of rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1 and 2. Patients were randomly assigned to receive either a single intravenous bolus dose of palonosetron (0, 25 mg) on day 1 or ondansetron (8 mg on days 1 and 2 of each cycle) along with dexamethasone 30 min before administration of chemotherapy. CINV was assessed during 1st cycle of chemotherapy using MASCC Antiemesis Tool. Frequency and severity of acute (within 24 hours) and delayed (24 – 120 hours) emetogenic reactions were registered.
Results
Eleven patients received palonosetron and 12 ondansetron. Groups were comparable with regard to emetogenic risk factors including sex, age, kinetosis and alcohol use. Complete response (no emetic episodes and no rescue therapy) in acute phase was observed in 100% of patients receiving palonisetron and in 10/12 (83%) of patients receiving ondansetron. Complete response in delayed phase was achieved in all patients in palonosetron group and in 11/12 (92%) in ondansetron group. Complete protection (no emetic episodes, no rescue therapy, and no significant nausea [Likert scale 2 or less]) in acute phase was achieved in 10/11 (91%) patients in palonosetron group and in 5/12 (41%) in ondansetron group. In delayed phase complete protection of CINV was reported by 10/11 (91%) of patients receiving palonosetron and 6/12 (50%) of patients receiving ondansetron.
Conclusion
The frequency of delayed nausea in patients, receiving bendamustine is probably underestimated. Prevention of bendamustine induced nausea and vomiting with palonosetron merits further investigation.
Session topic: E-poster
Keyword(s): B cell lymphoma, Supportive care
Type: Eposter Presentation
Background
Palonosetron is a highly selective, second-generation 5-HT3 receptor antagonist with a prolonged half-life (40 hours) which makes it attractive in prevention of delayed nausea and vomiting. Bendamustine, a moderately emetogenic cytostatic drug is becoming increasingly used in treatment of lymphoid malignancies.
Aims
A randomized comparison of palonosetron and ondansetron both combined with dexamethasone in prevention of chemotherapy induced nausea and vomiting (CINV) in adult patients, receiving bendamustine and rituximab chemoimmunotherapy.
Methods
Data of 1st interim analysis are presented. The study included 23 patients with median age of 67 years (range 31 - 82 yrs), 13 males and 10 females. The patients did not received chemotherapy at least 6 months prior to inclusion. Ten patients had follicular lymphoma, 8 – chronic lymphocytic leukemia, 6 – marginal zone and other types of indolent lymphomas. The BR regimen consisted of rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1 and 2. Patients were randomly assigned to receive either a single intravenous bolus dose of palonosetron (0, 25 mg) on day 1 or ondansetron (8 mg on days 1 and 2 of each cycle) along with dexamethasone 30 min before administration of chemotherapy. CINV was assessed during 1st cycle of chemotherapy using MASCC Antiemesis Tool. Frequency and severity of acute (within 24 hours) and delayed (24 – 120 hours) emetogenic reactions were registered.
Results
Eleven patients received palonosetron and 12 ondansetron. Groups were comparable with regard to emetogenic risk factors including sex, age, kinetosis and alcohol use. Complete response (no emetic episodes and no rescue therapy) in acute phase was observed in 100% of patients receiving palonisetron and in 10/12 (83%) of patients receiving ondansetron. Complete response in delayed phase was achieved in all patients in palonosetron group and in 11/12 (92%) in ondansetron group. Complete protection (no emetic episodes, no rescue therapy, and no significant nausea [Likert scale 2 or less]) in acute phase was achieved in 10/11 (91%) patients in palonosetron group and in 5/12 (41%) in ondansetron group. In delayed phase complete protection of CINV was reported by 10/11 (91%) of patients receiving palonosetron and 6/12 (50%) of patients receiving ondansetron.
Conclusion
The frequency of delayed nausea in patients, receiving bendamustine is probably underestimated. Prevention of bendamustine induced nausea and vomiting with palonosetron merits further investigation.
Session topic: E-poster
Keyword(s): B cell lymphoma, Supportive care
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