InterAACT: cisplatin and fluorouracil versus carboplatin and paclitaxel in advanced anal cancer

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).