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The largest anal cancer trial ever run found that swapping mitomycin for cisplatin during radiotherapy did not help, that extra chemotherapy afterwards added nothing, and that tumours keep shrinking for months, so the decision to operate should wait until 26 weeks.
Randomised 2 by 2 factorial phase 3 trial of 940 patients with anal squamous cell carcinoma treated with radiotherapy (50.4 Gy in 28 fractions) plus fluorouracil, comparing concurrent mitomycin with cisplatin, and two cycles of maintenance cisplatin and fluorouracil with no maintenance.
Complete response rates at 26 weeks were about 90 percent in both chemotherapy arms and three-year progression-free survival was about 74 percent with and without maintenance. Because many tumours that had not fully responded at 11 weeks had done so by 26 weeks, the trial changed the timing of response assessment before salvage surgery.
Fluorouracil and mitomycin with radiotherapy remains the standard for localised anal cancer, without maintenance, and patients whose tumour has not vanished at three months should be watched to six months rather than sent straight to surgery.
Shares Mitomycin C, Fluorouracil (5-FU), Cisplatin.
Shares Fluorouracil (5-FU), Cisplatin.
Shares Fluorouracil (5-FU), Cisplatin.
Shares Mitomycin C, Fluorouracil (5-FU).
Shares Mitomycin C, Fluorouracil (5-FU), Cisplatin.
Shares Mitomycin C, Cisplatin.
Shares The Lancet Oncology, Cisplatin.
Shares Fluorouracil (5-FU), Cisplatin.