InterAACT: cisplatin and fluorouracil versus carboplatin and paclitaxel in advanced anal cancer
The first randomised trial in advanced anal cancer found that carboplatin with paclitaxel shrank tumours about as often as the older cisplatin and fluorouracil combination, with fewer serious side effects and longer survival, and it became the standard first treatment.
Overview
International Rare Cancers Initiative randomised phase 2 trial of 91 patients with inoperable locally recurrent or metastatic anal squamous cell carcinoma, assigned to cisplatin plus fluorouracil or carboplatin plus weekly paclitaxel.
Objective response rates were similar (about 57 and 59 percent), but serious adverse events were fewer with carboplatin and paclitaxel and median overall survival was 20 months against 12.3 months. Carboplatin and paclitaxel was adopted as the reference first-line regimen and as the chemotherapy backbone for later immunotherapy trials.
- Objective response about 59 percent with carboplatin and paclitaxel versus 57 percent with cisplatin and fluorouracil.
- Median overall survival 20 months versus 12.3 months, with fewer serious adverse events.
Carboplatin and paclitaxel is the first-line chemotherapy for metastatic anal cancer, and the platform to which PD-1 antibodies such as retifanlimab were added.
- Small randomised phase 2 with response as the primary endpoint; the survival difference was a secondary finding.
- Accrual took years across many countries, reflecting how rare metastatic anal cancer is.
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