Journal of Clinical Oncology, Vol 10, 718-726, Copyright © 1992 by American Society of Clinical Oncology
Cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide in advanced ovarian cancer: a randomized phase III study of the National Cancer Institute of Canada Clinical Trials Group
K Swenerton, J Jeffrey, G Stuart, M Roy, G Krepart, J Carmichael, P Drouin, R Stanimir, G O'Connell and G MacLean
National Cancer Institute of Canada Clinical Trials Group, Kingston, Canada.
PURPOSE: Given the potential for improved tolerance, a trial was initiated
to compare the toxicity and efficacy of a standard regimen of
cisplatin-cyclophosphamide (75 mg/m2 and 600 mg/m2, respectively) with an
experimental regimen of carboplatin-cyclophosphamide (300 mg/m2 and 600
mg/m2, respectively) in women with postoperative macroscopic residual
ovarian cancer. PATIENTS AND METHODS: Between 1985 and 1989, 447 (417
eligible) patients were randomized. Treatment arms were well balanced; most
patients had stage III (82%), grade 3 (54%) tumors with bulky residual
(greater than 2 cm in 59%), and good performance status (Eastern
Cooperative Oncology Group [ECOG] 0 or 1, 77%). Response was assessed after
six 4-week cycles. RESULTS: The treatments were equally deliverable, with
76% of patients completing their allocated regimen. The reported reasons
for failure to complete treatment differed; toxicity/refusal predominated
on the cisplatin arm, and progressive disease predominated on the
carboplatin arm (P = .0092). Cisplatin- treated patients were more likely
to develop neuropathy and nephropathy, and carboplatin patients experienced
myelosuppression, particularly thrombocytopenia. Efficacy was similar, with
no significant differences for the cisplatin and carboplatin arms in
clinical response rate (57% v 59% in those with measurable disease),
pathologic response rate (52% v 54% in those suitable for relaparotomy),
time to progression (median, 56 v 58 weeks), or overall survival (median,
100 weeks v 110 weeks). Time to progression and survival were predicted by
residual disease size, performance status, and treatment center (with those
treated at centers that accrued more patients doing better). CONCLUSION:
Neither regimen is optimal in that relapse remains the norm. It may be
inappropriate to expect that any single regimen can be an effective therapy
for all patients with advanced ovarian cancer. Both cisplatin and
carboplatin are likely to have a role in future treatment strategies.
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