ACT II: mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for squamous cell carcinoma of the anus
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.
Overview
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.
- Complete response at 26 weeks in about 90 percent of patients whether mitomycin or cisplatin was given with fluorouracil.
- Maintenance chemotherapy did not improve three-year progression-free survival (about 74 versus 73 percent).
- Complete response rates rose from about 64 percent at 11 weeks to about 85 percent at 26 weeks in the same patients.
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.
- Radiotherapy was two-dimensional or three-dimensional rather than intensity-modulated, and used a single dose for all stages.
- Open-label design; the co-primary endpoint of complete response used clinical assessment.
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