Are more antiemetic trials with a placebo necessary? Report of patient data from randomized trials of placebo antiemetics with cisplatin Journal Article


Authors: Kris, M. G.; Cubeddu, L. X.; Gralla, R. J.; Cupissol, D.; Tyson, L. B.; Venkatraman, E.; Homesley, H. D.
Article Title: Are more antiemetic trials with a placebo necessary? Report of patient data from randomized trials of placebo antiemetics with cisplatin
Abstract: BACKGROUND. Because of the predictability of significant emesis after its use, cisplatin serves as the standard emetic stimulus for trials of antiemetic drugs. To define better the incidence, severity, and pattern of emesis that follows cisplatin, facilitate the testing of new agents, and obviate the need for further placebo-controlled trials for this indication, individual patient data were compiled from completed studies with placebo antiemetics and cisplatin. METHODS. The dine and number of emetic episodes during the 24 hours after cisplatin were obtained for 48 patients given a placebo antiemetic. Each was treated as part of a randomized, double-blind trial reported between 1981 and 1990. Emesis after antiemetic 'rescue' therapy was also assessed. RESULTS. Emesis occurred in 47 of 48 patients (98% observed rate, 95% confidence interval, 89-99%). The median number of emetic episodes during the 24 hours after cisplatin was 6. Emesis continued after rescue in 77% of patients. CONCLUSIONS. Cisplatin caused severe emesis that persisted despite rescue in placebo-treated patients. Using the data presented, any therapy preventing acute emesis in 8 or more of the 48 individuals receiving cisplatin > 50 mg/m2 was an active antiemetic (P = 0.05). The four trials discussed here documented the antiemetic effectiveness of granisetron, metoclopramide, and ondansetron. The placebo-treated patients studies can serve as a control group for testing new therapies. Because of the certainty of severe emesis after cisplatin, and the availability both of these data anti several proven drugs for this condition, prospective comparisons of antiemetics should employ active control medications.
Keywords: adult; cancer chemotherapy; clinical article; controlled study; aged; middle aged; clinical trial; cisplatin; doxorubicin; fluorouracil; placebo; antineoplastic agents; controlled clinical trial; etoposide; randomized controlled trial; vomiting; cyclophosphamide; drug screening; cancer research; drug research; randomized controlled trials; bleomycin; granisetron; ondansetron; malignant neoplastic disease; vindesine; antiemetic agent; antiemetics; mitomycin; double blind procedure; double-blind method; metoclopramide; placebos; humans; human; male; female; priority journal; article
Journal Title: Cancer
Volume: 78
Issue: 10
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 1996-11-15
Start Page: 2193
End Page: 2198
Language: English
DOI: 10.1002/(sici)1097-0142(19961115)78:10<2193::aid-cncr22>3.0.co;2-t
PUBMED: 8918414
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 22 November 2017 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Venkatraman Ennapadam Seshan
    283 Seshan
  2. Mark Kris
    585 Kris
  3. Leslie Tyson
    49 Tyson