Journal of Clinical Oncology, Vol 10, 706-717, Copyright © 1992 by American Society of Clinical Oncology
Improved therapeutic index of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide: final report by the Southwest Oncology Group of a phase III randomized trial in stages III and IV ovarian cancer [published erratum appears in J Clin Oncol 1992 Sep;10(9):1505]
DS Alberts, S Green, EV Hannigan, R O'Toole, D Stock-Novack, P Anderson, EA Surwit, VK Malvlya, WA Nahhas and CJ Jolles
University of Arizona Cancer Center, Tucson.
PURPOSE: To compare cisplatin-cyclophosphamide versus carboplatin-
cyclophosphamide as primary chemotherapy for stage III (suboptimal) and
stage IV ovarian cancer. PATIENTS AND METHODS: Three hundred forty-two
patients were randomly assigned to treatment with six courses of
intravenous (i.v.) cisplatin 100 mg/m2 plus i.v. cyclophosphamide 600
mg/m2, or i.v. carboplatin 300 mg/m2 plus i.v. cyclophosphamide 600 mg/m2.
RESULTS: The estimated median survivals were 17.4 and 20.0 months for the
cisplatin and carboplatin study arms, respectively. The null hypothesis of
a 30% survival superiority with the cisplatin arm was rejected at the P =
.02 level. Clinical response rates were 52% for the cisplatin arm and 61%
for the carboplatin arm. Pathologic complete response rates were similar
for both study arms. There was less thrombocytopenia on the cisplatin arm
(P less than .001); however, there was less nausea and emesis (P less than
or equal to .001 for courses 1 to 5), renal toxicity (P less than .001),
anemia (P = .01), hearing loss (P less than .001), tinnitus (P = .01),
neuromuscular toxicities (P = .001), and alopecia (P less than .001) on the
carboplatin arm. CONCLUSION: Carboplatin-cyclophosphamide proved to have a
significantly better therapeutic index than cisplatin- cyclophosphamide in
patients with stage III (suboptimal) and stage IV ovarian cancer.
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