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Sequential cisplatin-topotecan and carboplatin-paclitaxel increased toxicity with no improvement in efficacy in ovarian cancer
Hoskins P. J Natl Clin Oncol. 2010;DOI:10.1093/jnci/djq362.
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Results from a phase 3 study showed that cisplatin/topotecan followed by carboplatin/paclitaxel did not improve outcomes for patients with advanced ovarian cancer, but the regimen did increase hospitalizations and hematologic toxicities.
Chemotherapy-naïve women with recently diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer who had completed all planned primary surgery were eligible for the study. Researchers randomly assigned 409 patients to the experimental arm and 410 patients as controls.
Patients in the experimental arm were assigned to 50 mg/m2 cisplatin over 60 minutes followed by 0.75 mg/m2 IV topotecan for four cycles. Patients were then treated with four cycles of IV carboplatin and 175 mg/m2 paclitaxel at 3-week intervals.
Patients in the control arm were assigned to the same regimen of carboplatin plus 175 mg/m2 paclitaxel for eight cycles.
There was an 85% rate of grade 4 granulocytopenia in the experimental arm vs. 58% in the control arm. Just 6% of patients in the control arm experienced grade 3/grade 4 neutropenia febrile neutropenia or infection compared with 22% among the experimental arm.
Objective response was significantly lower in the experimental arm (67.9% vs. 77.2%). Overall, 66.3% of patients in the control arm had normalized CA125 within 3 months following random assignment compared with 57.5% in the experimental arm.
There was no statistically significant difference in PFS between the groups (HR=1.10; 95% CI, 0.94-1.28) or in reported quality of life.