Sandip Mukhopadhyay1, Gagandeep Kwatra2, Pamela Alice K3, Dinesh Badyal2. 1. Faculty of Pharmacology & Assistant Coordinator of Pharmacovigilance, Department of Pharmacology, Burdwan Medical College, Burdwan, West Bengal, PIN-713102, India. sandipcmcl@gmail.com. 2. Department of Pharmacology, Christian Medical College, Ludhiana, Punjab, PIN-141008, India. 3. Department of Radiation Oncology, Christian Medical College, Ludhiana, Punjab, PIN-141008, India.
Abstract
PURPOSE: Even with the use of modern antiemetic drugs, chemotherapy-induced nausea and vomiting (CINV) is still a cause of great distress to the patients. Olanzapine, primarily marketed as an antipsychotic, was found to reduce nausea and vomiting in some chemotherapy patients. But it was never tested in Indian population with a diverse genetic background. The present study aims to evaluate the role of olanzapine in CINV in patients receiving platinum-based chemotherapy. METHODS: The study was a randomized, controlled, assessor-blinded study on 100 chemotherapy-naïve consenting patients receiving any one fromcisplatin, carboplatin or oxaliplatin. The control group (n = 50) received palonosetron and dexamethasone in the approved therapeutic dose from the day 1 of chemotherapy. The test group (n = 50) received additional olanzapine 10 mg/day from day 1 for five consecutive days. CINV and quality of life (QoL) were assessed. RESULTS:Vomiting was significantly less among the olanzapine-treated patients. Control of delayed emesis was significantly better in this group (complete response among 96 vs. 42 % in the control group, p value <0.0001). Incidence and severity of nausea was significantly less in this group. Failure of anti-CINV measure was 4 % in this group compared to 26 % of the patients of the control group during overall days 1-5. Though sedation was more in these olanzapine-treated patients, there was no dose-limiting adverse event. Quality of life was also better among the olanzapine-treated patients. CONCLUSION:Olanzapine was found to be effective as add-on in the control of CINV.
RCT Entities:
PURPOSE: Even with the use of modern antiemetic drugs, chemotherapy-induced nausea and vomiting (CINV) is still a cause of great distress to the patients. Olanzapine, primarily marketed as an antipsychotic, was found to reduce nausea and vomiting in some chemotherapy patients. But it was never tested in Indian population with a diverse genetic background. The present study aims to evaluate the role of olanzapine in CINV in patients receiving platinum-based chemotherapy. METHODS: The study was a randomized, controlled, assessor-blinded study on 100 chemotherapy-naïve consenting patients receiving any one from cisplatin, carboplatin or oxaliplatin. The control group (n = 50) received palonosetron and dexamethasone in the approved therapeutic dose from the day 1 of chemotherapy. The test group (n = 50) received additional olanzapine 10 mg/day from day 1 for five consecutive days. CINV and quality of life (QoL) were assessed. RESULTS:Vomiting was significantly less among the olanzapine-treated patients. Control of delayed emesis was significantly better in this group (complete response among 96 vs. 42 % in the control group, p value <0.0001). Incidence and severity of nausea was significantly less in this group. Failure of anti-CINV measure was 4 % in this group compared to 26 % of the patients of the control group during overall days 1-5. Though sedation was more in these olanzapine-treated patients, there was no dose-limiting adverse event. Quality of life was also better among the olanzapine-treated patients. CONCLUSION:Olanzapine was found to be effective as add-on in the control of CINV.
Entities:
Keywords:
Chemotherapy-induced nausea and vomiting; Olanzapine; Palonosetron; Platinum compounds
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