Medline ® Abstracts for References 23,91-94
of 'Prevention and treatment of chemotherapy-induced nausea and vomiting in adults'
Effect of schedule and maintenance on the antiemetic efficacy of ondansetron combined with dexamethasone in acute and delayed nausea and emesis in patients receiving moderately emetogenic chemotherapy: a phase III trial by the National Cancer Institute of Canada Clinical Trials Group.
Kaizer L, Warr D, Hoskins P, Latreille J, Lofters W, Yau J, Palmer M, Zee B, Levy M, Pater J
J Clin Oncol. 1994;12(5):1050.
PURPOSE: This study examines whether the schedule of ondansetron significantly influences its antiemetic efficacy in the first 24 hours after chemotherapy, whether the administration of oral ondansetron after 24 hours is effective in preventing delayed emesis, and whether the efficacy of ondansetron is preserved over multiple courses of moderately emetogenic chemotherapy.
PATIENTS AND METHODS: A multicenter double-blind study randomized 302 cancer patients to one of three treatment arms. Arm A received dexamethasone 10 mg intravenously (i.v.) plus ondansetron (Zofran; Glaxo Canada Inc, Toronto, Canada) 8 mg i.v. prechemotherapy plus ondansetron 8 mg orally every 12 hours postchemotherapy for nine doses. Arm B received dexamethasone 10 mg i.v. plus ondansetron 16 mg i.v. prechemotherapy plus placebo orally postchemotherapy in the same schedule as arm A. Arm C received dexamethasone 10 mg i.v. plus ondansetron 8 mg prechemotherapy plus ondansetron 8 mg orally postchemotherapy for one dose followed by placebo orally every 12 hours for eight more doses. Response was assessed by the number of reported episodes of vomiting and by severity of nausea measured on a visual analog scale (VAS).
RESULTS: The two schedules of ondansetron used in the first 24 hours were no different in their antiemetic efficacy, with similar rates for complete responses (76.7% v 72.0%, P = .472), complete plus major responses (90.2% v 82.0%, P = .135), and severity of nausea (P = .348). Oral ondansetron after 24 hours was more effective than placebo in preventing delayed nausea and emesis, with superior rates of complete responses (59.6% v 42.1%, P = .012 by one-sided test), complete plus major responses (80.9% v 66.3%, P = .018 by one-sided test), and less severe nausea (9.2 mm v 18.6 mm on a 100-mm VAS, P = .002). The efficacy of ondansetron was maintained over subsequent courses of chemotherapy.
CONCLUSION: The schedule of ondansetron in the first 24 hours does not influence its efficacy. The use of oral maintenance ondansetron is effective in preventing delayed maintenance ondansetron is effective in preventing delayed nausea and emesis after moderately emetogenic chemotherapy.
Department of Medicine, Credit Valley Hospital, Mississauga; Ontario, Canada.
The role of the 5-HT3 antagonists ondansetron and dolasetron in the control of delayed onset nausea and vomiting in patients receiving moderately emetogenic chemotherapy.
Pater JL, Lofters WS, Zee B, Dempsey E, Walde D, Moquin JP, Wilson K, Hoskins P, Guevin RM, Verma S, Navari R, Krook JE, Hainsworth J, Palmer M, Chin C
Ann Oncol. 1997;8(2):181.
BACKGROUND: 5-HT3 antagonists are effective in reducing the acute nausea and vomiting caused by cancer chemotherapy. However, it is not clear whether continuing these agents beyond twenty four hours is useful in controlling emesis on days two to seven after chemotherapy.
PATIENTS AND METHODS: Four hundred seven patients receiving moderately emetogenic chemotherapy who had been given dexamethasone 8 mg i.v. and either ondansetron 32 mg i.v. or dolasetron 2.4 mg/kg i.v. were randomized to continue either an oral form of their 5-HT3 antagonist (ondansetron 8 mg b.i.d. or dolasetron 200 mg daily) plus dexamethasone 8 mg p.o. daily or dexamethasone alone for days two to seven. Endpoints assessed by self-report were: 1) complete control (no vomiting, no rescue medications, no missing data) of emesis; 2) nausea severity; and 3) quality-of-life as measured by the EORTC QLQ-C30.
RESULTS: Continuation of 5-HT3 antagonists improved slightly, but not significantly, the complete control rate (47% vs. 41%: P = 0.24 one-sided) after chemotherapy. However, mean nausea severity was significantly (P = 0.015 one sided) reduced (by 3 mm on a 10 cm scale) on the combined arm. Minimal differences in quality of life were observed.
CONCLUSION: The benefit of continuing 5-HT3 antagonists beyond 24 hours is modest and the merits of routine use in these circumstances debatable.
NCIC Clinical Trials Group, Queen's University, Kingston.
Hesketh PJ, Sanz-Altamira P, Bushey J, et al. Prospective evaluation of the incidence of nausea and vomiting in patients with colorectal cancer receiving oxaliplatin-based chemotherapy (abstract #9645). J Clin Oncol 2008; 26:9645.
no abstract available
Prospective evaluation of the incidence of delayed nausea and vomiting in patients with colorectal cancer receiving oxaliplatin-based chemotherapy.
Hesketh PJ, Sanz-Altamira P, Bushey J, Hesketh AM
Support Care Cancer. 2012;20(5):1043. Epub 2011 May 9.
PURPOSE: This study sought to prospectively determine the frequency of delayed nausea and vomiting with oxaliplatin-based chemotherapy following day 1 prophylaxis with a 5-HT-(3) receptor antagonist and dexamethasone.
METHODS: Patients with colon cancer,≥age 18, with a performance status≤2, receiving oxaliplatin (85-100 mg/m(2)) as part of a standard folinic acid, 5-fluorouracil, oxaliplatin regimen for the first time were eligible. All patients received a 5-HT(3) receptor antagonist and dexamethasone 20 mg on day 1 prior to oxaliplatin. No routine prophylaxis for delayed emesis was given. Antiemetic outcome was recorded in patient-completed diaries for the 120-h study period following oxaliplatin administration. Primary endpoint was frequency of delayed (24-120 h) emesis (vomiting/retching).
RESULTS: Forty-one patients were enrolled and 39 are evaluable. Median age was 70 (34-85) and the female/male ratio was 20:19. Four patients (10%) experienced vomiting or retching during the delayed period. One patient vomited during the first 24 h after oxaliplatin. The overall (120 h) no emesis rate was 87% (34/39). Twenty-one patients (54%) developed delayed nausea. Nine patients had moderate or severe nausea. Eighteen patients (46%) took rescue antiemetics during the delayed period. Delayed and overall complete response (no emesis or use of rescue antiemetics) rates were 54% and 49%, respectively.
CONCLUSIONS: The use of a 5-HT(3) antagonist and dexamethasone prior to oxaliplatin results in excellent control of nausea and vomiting (CR-90%) during the 24 h after chemotherapy. However, without further antiemetic treatment, complete response in the delayed period decreased to 54%. This study supports the need for routine antiemetic prophylaxis for delayed nausea and vomiting following oxaliplatin-based chemotherapy.
Department of Hematology and Oncology, Lahey Clinic Medical Center, 41 Mall Road, Burlington, MA 01805, USA. Paul.Hesketh@lahey.org
Prevalence of Delayed Nausea and/or Vomiting in Patients Treated With Oxaliplatin-Based Regimens for Colorectal Cancer.
Fleishman SB, Mahajan D, Rosenwald V, Nugent AV, Mirzoyev T
J Oncol Pract. 2012;8(3):136. Epub 2011 Dec 20.
PURPOSE: To measure the prevalence of nausea and vomiting 2 to 5 days after oxaliplatin-based chemotherapy.
PATIENTS AND METHODS: Sixty-four patients (55% men; 44% women) enrolled onto this cross-sectional study. Fifty-three (83%) had colon cancer and received oxaliplatin biweekly. Eleven (17%) had rectal cancer and received oxaliplatin weekly. We collected data on 23 patients for the first cycle and on 41 patients for the first two cycles, for a total of 105 cycles. Nausea and vomiting was graded using Common Toxicity Criteria. Patients maintained a 7-day postinfusion diary of nausea and vomiting and antiemetic use.
RESULTS: All patients received antiemetics and steroids on day 1 of each cycle. For patients with data collected for both cycles, the occurrence of nausea was the same during cycles one and two. Thirty-nine percent used rescue antiemetics in cycle one, and 34% did so in cycle two. Sixty-eight percent of men reported no nausea in cycle one compared with 33% of women; for cycle two, these figures were 67% and 36%, respectively. Eighty-nine percent of patients reported no vomiting in cycle one, and 85% did so in cycle two. Seven patients (11%) had a history of motion sickness; 13 of 28 women (46%) reported history of pregnancy-induced morning sickness. Palonosetron slightly but significantly reduced the occurrence of nausea. Female sex and history of chemotherapy were significant risk factors for nausea.
CONCLUSION: Delayed nausea associated with oxaliplatin was well controlled and evenly divided between grades 1 and 2; vomiting was rare. Factors associated with nausea were intrinsic to the patient and mostly unrelated to the antiemetics used. Sex and previous experience with emesis should be considered for efficient antiemetic management.
Beth Israel Medical Center and Roosevelt Hospital, Continuum Cancer Centers of New York, New York, NY.