InterAACT: cisplatin and fluorouracil versus carboplatin and paclitaxel in advanced anal cancer
In the first randomised trial in advanced anal cancer, carboplatin with paclitaxel shrank tumours as often as cisplatin with fluorouracil but caused far fewer serious side effects and was followed by longer survival, so it became the standard chemotherapy.
Overview
International Rare Cancers Initiative randomised phase 2 trial in 60 centres: 91 patients with chemotherapy-naive inoperable locally recurrent or metastatic anal squamous cell carcinoma were randomised to cisplatin plus fluorouracil (46) or carboplatin plus weekly paclitaxel (45). The primary endpoint was best overall response rate by 24 weeks.
Response rates were 57 and 59 percent. Serious adverse events were more frequent with cisplatin-fluorouracil (62 against 36 percent). Median progression-free survival was 5.7 against 8.1 months and median overall survival 12.3 against 20 months (hazard ratio 2.00, p 0.014).
- Objective response 57 percent (95% CI 39.4 to 73.7) with cisplatin-fluorouracil versus 59 percent (42.1 to 74.4) with carboplatin-paclitaxel.
- Serious adverse events 62 versus 36 percent (p 0.016).
- Median overall survival 12.3 versus 20 months; hazard ratio 2.00 (1.15 to 3.47), p 0.014.
Carboplatin plus weekly paclitaxel is the chemotherapy backbone for advanced anal cancer and the base on which retifanlimab was added in POD1UM-303.
- Phase 2 with 91 patients; the survival difference was a secondary finding.
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