Medline ® Abstracts for References 123-126
of 'Prevention and treatment of chemotherapy-induced nausea and vomiting in adults'
Ondansetron versus chlorpromazine for preventing emesis in bone marrow transplant recipients: a double-blind randomized study.
Bosi A, Guidi S, Messori A, Saccardi R, Lombardini L, Vannucchi AM, Fanci R, Rossi-Ferrini P
J Chemother. 1993;5(3):191.
Ondansetron, a selective 5-HT3 antagonist, is known to be effective for preventing emesis induced by cisplatin and other antineoplastic agents. We undertook a randomized double-blind study in a series of bone marrow transplantation (BMT) recipients to assess the antiemetic efficacy and the safety of ondansetron in comparison with chlorpromazine, which was being used at our institution, as the standard antiemetic agent for the conditioning regimen. Forty patients submitted to BMT (21 autologous, 19 allogeneic) were included in the study. Patients were randomly assigned to receive ondansetron (as a loading dose of 8 mg iv one hour before the beginning of the conditioning regimen followed by a continuous infusion of 1 mg per hour for the whole treatment period) or chlorpromazine 60 mg/m2/day given by continuous infusion for the same period (maximum 8 days). Twenty patients were assigned to ondansetron, while 20 were assigned to chlorpromazine. The response rate in terms of antiemetic efficacy and in nausea control was similar between the two treatment groups. On the contrary the two groups differed significantly in regard to side-effects: patients receiving ondansetron experienced significantly less sedation (p = 0.002), the absence of extrapyramidal reactions (p<0.001) and no need for dose reduction (p<0.001) as compared with patients treated with chlorpromazine.
Bone Marrow Transplant Unit, Careggi Hospital, Florence, Italy.
Granisetron in the prevention of vomiting induced by conditioning for stem cell transplantation: a prospective randomized study.
Okamoto S, Takahashi S, Tanosaki R, Sakamaki H, Onozawa Y, Oh H, Miyawaki S, Kimura Y, Toyama K, Ikeda Y, Asano S
Bone Marrow Transplant. 1996;17(5):679.
We conducted a prospective randomized study to compare granisetron, a 5-hydroxytryptamine-3 receptor antagonist with standard anti-emetics (control group) consisting mainly of metoclopramide, in the prophylaxis of emesis induced by conditioning prior to stem cell transplantation. Fifty-eight patients were evaluable for analysis. The number of emetic episodes expressed in terms of patient-days was significantly lower in the granisetron group than in the control group (P<0.001). During the first 24 h of conditioning, 27 of the 31 patients (87.1%) in the granisetron group achieved control of emesis with less than three emetic episodes (major<or = ) a day compared with 37.0% in the control group (P<0.001). The same degree of emesis control was maintained throughout the conditioning period in 51.% of patients in the granisetron group compared with 0% in the control group (P<0.001). Adverse reactions were observed in 11.4% of patients in the granisetron group and in 25.9% in the control group. None of the events were serious. Based on these data, we conclude that granisetron is superior to standard antiemetics in protecting against the vomiting induced by conditioning for stem cell transplantation.
Department of Medicine, Keio University, Tokyo, Japan.
Randomized, double-blind comparison of a prochlorperazine-based versus a metoclopramide-based antiemetic regimen in patients undergoing autologous bone marrow transplantation.
Gilbert CJ, Ohly KV, Rosner G, Peters WP
BACKGROUND: Highly emetogenic combination alkylator therapy is routinely used in autologous bone marrow transplantation for treatment of eligible patients with solid tumors. Antiemetic therapy remains less than optimal in this setting.
METHODS: One hundred twenty-six patients with cancer receiving high dose cisplatin, cyclophosphamide, and carmustine with autologous bone marrow support were randomized to receive one of four double-blinded antiemetic regimens: 4-day continuous infusion prochlorperazine (6 mg/m2 intravenous [i.v.]loading dose followed by 1.5 mg/m2/hour) or metoclopramide (80 mg/m2 iv loading dose followed by 20 mg/m2/hr) each with either dronabinol 5 mg/m2 or placebo capsules for two doses before carmustine on the last day of chemotherapy. All subjects received scheduled lorazepam and diphenhydramine throughout the 4-day study period. Efficacy was measured by the Emetic Process Rating Scale and the Rhodes Index of Nausea and Vomiting (INV) Form 2.
RESULTS: One hundred six patients completed the study and were fully evaluable. The median number of emeticepisodes on the metoclopramide study arm were: 1 (0-7, day -6), 1 (0-6, day -5), 2 (0-9, day -4), and 2 (0-10, with dronabinol day -3) or 2 (0-7, no dronabinol day -3) and on the prochlorperazine study arm were: 4 (0-12, day -6), 0 (0-8, day -5), 0 (0-12, day -4) and 2.5 (0-9, with dronabinol day -3) or 2 (0-12, no dronabinol day -3). Metoclopramide was significantly better on the first day of therapy (day -6, P<.002) and prochlorperazine was significantly better on the third day of therapy (day -4, P<0.002). There was no significant difference among any of the four arms on the last day of chemotherapy (day -3), or when the median number of emetic episodes over the total study period were compared. The patients' assessment of nausea, vomiting, and retching on the INV Form 2 was consistent with the observer ratings. Toxicities requiring dose reduction or discontinuation of antiemetic drugs included diarrhea, cardiac arrhythmias, sedation, anxiety, and akathisia.
CONCLUSIONS: Both metoclopramide and prochlorperazine in combination with lorazepam and diphenhydramine offer good control of nausea and vomiting although the sedation and low risk for cardiac toxicity limit the regimen to an inpatient setting with close monitoring. No regimen was clearly superior during the entire treatment period but prochlorperazine offered more consistent control after the first day.
Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA.
Stiff P, Fox-Geiman M, Kiley K, et al. Aprepitant vs. placebo plus oral ondansetron and dexamethasone for the prevention of nausea and vomiting associated with highly emetogenic preparative regimens prior to hematopoietic stem cell transplantation; A prospective, randomized double-blind phase III trial. Blood (ASH Annual Meeting Abstracts) 2009; 114:2267.
no abstract available