ACCORD 03
Needs reviewInduction chemotherapy and dose intensification of the radiation boost in locally advanced anal canal carcinoma: final analysis of the randomized UNICANCER ACCORD 03 trial
Phase 3N = 307NCT00003652
- Population
- Patients with locally advanced anal canal carcinoma: tumours of 40 mm or more, or less than 40 mm with N1-3 M0 disease
- Design
- Randomised 2 × 2 factorial trial. Patients were randomly assigned to four arms: (A) two cycles of induction chemotherapy (fluorouracil 800 mg/m2/d by intravenous infusion on days 1 to 4 and 29 to 32 and cisplatin 80 mg/m2 on days 1 and 29), chemoradiotherapy and standard-dose boost; (B) induction chemotherapy, chemoradiotherapy and high-dose boost; (C) chemoradiotherapy and standard-dose boost (reference arm); (D) chemoradiotherapy and high-dose boost. Chemoradiotherapy was 45 Gy in 25 fractions over 5 weeks with fluorouracil and cisplatin during weeks 1 and 5; the standard boost was 15 Gy and the high-dose boost 20-25 Gy. 307 patients are reported, 283 of whom achieved full treatment; median follow-up 50 months.
- Primary endpoint
- Colostomy-free survival
- Arms
- Induction chemotherapy, chemoradiotherapy, standard boost (arm A) (experimental): Two cycles of fluorouracil and cisplatin induction, then 45 Gy in 25 fractions with fluorouracil and cisplatin, then a 15 Gy boost
- Induction chemotherapy, chemoradiotherapy, high-dose boost (arm B) (experimental): Two cycles of fluorouracil and cisplatin induction, then 45 Gy in 25 fractions with fluorouracil and cisplatin, then a 20-25 Gy boost
- Chemoradiotherapy, standard boost (arm C, reference) (control): 45 Gy in 25 fractions over 5 weeks with fluorouracil and cisplatin during weeks 1 and 5, then a 15 Gy boost
- Chemoradiotherapy, high-dose boost (arm D) (experimental): 45 Gy in 25 fractions over 5 weeks with fluorouracil and cisplatin during weeks 1 and 5, then a 20-25 Gy boost
- People
- Peiffert D, senior author Ducreux M, UNICANCER ACCORD 03
Δ 60-month Colostomy-free survival−7.5 points
Show the numbers
| Endpoint | Analysis | Induction chemotherapy, chemoradiotherapy, standard boost (arm A) / Induction chemotherapy, chemoradiotherapy, high-dose boost (arm B) / Chemoradiotherapy, high-dose boost (arm D) | Chemoradiotherapy, standard boost (arm C, reference) | Effect |
|---|---|---|---|---|
| Colostomy-free survival307 patients; 283 achieved full treatment | finalmedian follow-up 50 monthsPeiffert 2012 | 69.6% at 5 y | 77.1% at 5 y | 5-year colostomy-free survival in arms A, B, C and D. In the 2 × 2 factorial analysis, 5-year colostomy-free survival was 76.5% with induction chemotherapy (arms A and B) versus 75.0% without (arms C and D), P = .37; and 73.7% with the standard boost (arms A and C) versus 77.8% with the high-dose boost (arms B and D), P = .067. The authors found no advantage for either induction chemotherapy or the high-dose boost; they suggest that arm B, the most treatment-intense arm, should prompt further intensification studies. |
| Endpoint | Analysis | Induction chemotherapy, chemoradiotherapy, standard boost (arm A) / Induction chemotherapy, chemoradiotherapy, high-dose boost (arm B) / Chemoradiotherapy, high-dose boost (arm D) | Chemoradiotherapy, standard boost (arm C, reference) | Effect |
|---|---|---|---|---|
| Colostomy-free survival307 patients; 283 achieved full treatment | finalmedian follow-up 50 monthsPeiffert 2012 | 69.6% at 5 y | 77.1% at 5 y | 5-year colostomy-free survival in arms A, B, C and D. In the 2 × 2 factorial analysis, 5-year colostomy-free survival was 76.5% with induction chemotherapy (arms A and B) versus 75.0% without (arms C and D), P = .37; and 73.7% with the standard boost (arms A and C) versus 77.8% with the high-dose boost (arms B and D), P = .067. The authors found no advantage for either induction chemotherapy or the high-dose boost; they suggest that arm B, the most treatment-intense arm, should prompt further intensification studies. |
Appears in
Sources
Peiffert D, Tournier-Rangeard L, Gérard JP, Lemanski C, François E, Giovannini M, et al. Induction chemotherapy and dose intensification of the radiation boost in locally advanced anal canal carcinoma: final analysis of the randomized UNICANCER ACCORD 03 trial. J Clin Oncol. 2012;30(16):1941-8.