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Platinum-Free Drug Combo Provides No Survival Benefit in Cervical Cancer Patients
In new study data presented at the 44th Annual Meeting of the Society of Gynecologic Oncology (SGO), a platinum-free regimen for advanced cervical cancer failed to improve survival compared with standard therapy.
Since many patients with recurrent cervical cancer may become resistant to platinum-based chemotherapy, researchers sought to determine whether non-platinum combination treatment with topotecan plus paclitaxel can improve overall survival (OS) compared with cisplatin plus paclitaxel in recurrent, persistent, or advanced cervical cancer.
A total of 452 patients were randomly assigned to receive cisplatin 50 mg/m2 plus paclitaxel 135–175 mg/m2 (CP arm) or topotecan 0.75 mg/m2 on days 1 to 3 plus paclitaxel 175 mg/m2 on day 1 (TP arm). Treatment cycles were repeated every 3 weeks until progression, unacceptable toxicity, and/or a complete response. OS was the primary endpoint.
A total of 229 patients received the CP backbone and 223 received the TP backbone. Seventy-five percent of the entire study group had previously received platinum (75.5% of the CP arm and 74% of the TP arm).
The TP-to-CP hazard ratio (HR) of death was 1.20 (P = 0.88). The median survival was 15.0 months in the CP arm versus 12.5 months in the TP arm, and the HR for progression-free survival was 1.39 (P = 0.0083), favoring CP. Moreover, the response rates at the time of analysis were 38.4% for CP-treated patients versus 28.7% for TP-treated patients (P = not significant).
The TP regimen was associated with significantly less grade-3 to grade-5 nausea, neuropathy, and metabolic toxicities but had a higher rate of leukopenia.
The authors concluded that the substitution of topotecan for cisplatin does not improve OS in patients with cervical carcinoma. They also noted that the treatment of recurrent, persistent, or advanced cervical cancer with either the CP or TP regimen should be predicated on toxicity screening.
Source: SGO Meeting Abstracts; March 9, 2013.