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ACT II, the largest anal cancer trial, confirmed mitomycin-fluorouracil chemoradiation as the standard, showed that swapping in cisplatin or adding maintenance chemotherapy gave nothing, and taught doctors to wait six months before judging response.
ACT II randomised 940 patients with anal squamous cell carcinoma in a two-by-two design to mitomycin or cisplatin with fluorouracil during 50.4 Gy radiotherapy, and to two cycles of maintenance cisplatin-fluorouracil or none. Complete response at 26 weeks was about 90 percent in both chemotherapy arms and progression-free survival did not differ with maintenance (James and colleagues, Lancet Oncology 2013). The trial also showed that responses continue for months after chemoradiation, so assessment should wait 26 weeks before surgery is considered.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
940 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response at 26 weeksprimary | Mitomycin + fluorouracil + radiotherapy | 432 | 90.5% | - | 0.64 | link |
| Cisplatin + fluorouracil + radiotherapy | 431 | 89.6% | ||||
| Progression-free survival at 3 yearsprimary | Maintenance fluorouracil-cisplatin | 448 | 74% | 0.95 (0.75 to 1.21) | 0.70 | link |
| No maintenance | 492 | 73% |
Shares Radiosensitisers, Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), Cisplatin and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Cisplatin, IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Cisplatin, IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Radiosensitisers, IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.