EORTC 22861
Concomitant radiotherapy and chemotherapy versus radiotherapy alone in locally advanced anal cancer: phase III randomized trial of the EORTC Radiotherapy and Gastrointestinal Cooperative Groups (EORTC 22861)
Phase 3N = 110
- Population
- Patients with locally advanced anal cancer: T3-4 N0-3 or T1-2 N1-3
- Design
- Randomised phase III trial, 1987 to 1994, 110 patients randomised between radiotherapy alone and radiotherapy with chemotherapy. Radiotherapy: 45 Gy in 5 weeks (1.8 Gy daily), then after a 6-week rest a boost of 20 Gy for partial response or 15 Gy for complete response. Surgical resection was part of primary treatment if possible for patients who had not responded 6 weeks after 45 Gy or had residual palpable disease after completion. Chemotherapy: fluorouracil 750 mg/m2 daily by continuous infusion on days 1 to 5 and 29 to 33, and a single dose of mitomycin 15 mg/m2 on day 1.
- Arms
- Radiotherapy alone (control): 45 Gy in 5 weeks (1.8 Gy daily); after a 6-week rest a boost of 20 Gy (partial response) or 15 Gy (complete response)
- Radiotherapy with fluorouracil and mitomycin (experimental): The same radiotherapy plus fluorouracil 750 mg/m2 daily by continuous infusion on days 1 to 5 and 29 to 33 and mitomycin 15 mg/m2 on day 1
- People
- Bartelink H, senior author Pierart M, European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups
Δ Complete response of the primary tumour+26 points
Show the numbers
| Endpoint | Analysis | Radiotherapy with fluorouracil and mitomycin | Radiotherapy alone | Effect |
|---|---|---|---|---|
| Complete response of the primary tumourPatients randomised in the trial (110); the abstract does not state the analysis populationComplete remission rate; the abstract also gives the rate after surgical resections and does not state the timing of the assessment. | primaryBartelink 1997 | 80% | 54% | Complete remission rose from 54% with radiotherapy alone to 80% with radiotherapy and chemotherapy, and from 85% to 96% when results are considered after surgical resections. The abstract reports significant improvements in locoregional control (P = .02) and colostomy-free interval (P = .002) with combined treatment: the locoregional control rate improved by 18% at 5 years and the colostomy-free rate increased by 32% at that time (the abstract gives no arm-level values and does not say whether these are percentage points). No significant difference in severe side effects, although anal ulcers were more frequent with combined treatment. Event-free survival (free of locoregional progression, colostomy, severe side effects or death) improved significantly (P = .03) with combined treatment. The survival rate remained similar in both arms; 5-year survival was 56% for the whole group. |
| Endpoint | Analysis | Radiotherapy with fluorouracil and mitomycin | Radiotherapy alone | Effect |
|---|---|---|---|---|
| Complete response of the primary tumourPatients randomised in the trial (110); the abstract does not state the analysis populationComplete remission rate; the abstract also gives the rate after surgical resections and does not state the timing of the assessment. | primaryBartelink 1997 | 80% | 54% | Complete remission rose from 54% with radiotherapy alone to 80% with radiotherapy and chemotherapy, and from 85% to 96% when results are considered after surgical resections. The abstract reports significant improvements in locoregional control (P = .02) and colostomy-free interval (P = .002) with combined treatment: the locoregional control rate improved by 18% at 5 years and the colostomy-free rate increased by 32% at that time (the abstract gives no arm-level values and does not say whether these are percentage points). No significant difference in severe side effects, although anal ulcers were more frequent with combined treatment. Event-free survival (free of locoregional progression, colostomy, severe side effects or death) improved significantly (P = .03) with combined treatment. The survival rate remained similar in both arms; 5-year survival was 56% for the whole group. |
Appears in
Sources
Bartelink H, Roelofsen F, Eschwege F, Rougier P, Bosset JF, Gonzalez DG, et al. Concomitant radiotherapy and chemotherapy is superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the European Organization for Research and Treatment of Cancer Radiotherapy and Gastrointestinal Cooperative Groups. J Clin Oncol. 1997;15(5):2040-9.