| Added by | mollevi |
|---|---|
| Group name | EquipeMY |
| Item Type | Journal Article |
| Title | Postoperative irinotecan in resected stage II-III rectal cancer: final analysis of the French R98 Intergroup trial? |
| Creator | Delbaldo et al. |
| Author | C. Delbaldo |
| Author | M. Ychou |
| Author | A. Zawadi |
| Author | J. Y. Douillard |
| Author | V. Guerin-Meyer |
| Author | P. Rougier |
| Author | O. Dupuis |
| Author | R. Faroux |
| Author | A. Jouhaud |
| Author | E. Quinaux |
| Author | M. Buyse |
| Author | P. Piedbois |
| Abstract | BACKGROUD: The R98 trial explores the addition of irinotecan to a 5-fluorouracil (5-FU) plus leucovorin (5-FU/LV) adjuvant regimen in optimally resected stages II-III rectal cancers. We report the updated long-term results. Disease-free survival (DFS) was the primary end point. PATIENST AND METHODS: Between March 1999 and December 2005, 357 patients were randomized: 178 in 5-FU/LV and 179 in LV5-FU2 + irinotecan arm. The trial was stratified by control arm: Mayo Clinic regimen or LV5-FU2 regimen. RESULTS: Three hundred and fifty-seven randomized patients were evaluable for efficacy. With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154]. The same was observed for overall survival (OS) (HR = 0.87, P = 0.433). The 5-year DFS was 58% in the control arm and 63% in the experimental arm. The 5-year OS was 74% in the control arm and 75% in the experimental arm. Patients allocated to the experimental arm had more grade 3-4 neutropenia when compared with the LV5-FU2 arm (33% versus 6%, P = 0.03), but not when compared with the Mayo Clinic arm (33% versus 36%, P = 0.84). Grade 3-4 diarrhoea tended to be higher in the experimental arm, but analyses stratified by control arm or by radiotherapy failed to show significant differences across strata (test for interaction P = 0.44). CONCLUSION: Even though a benefit of irinotecan in subgroups of patients cannot be excluded, due to early termination and lack of power, the study does not support the addition of irinotecan to 5-FU/LV in routine in patients with resected stage II-III rectal cancer. |
| Publication | Annals of Oncology: Official Journal of the European Society for Medical Oncology |
| Volume | 26 |
| Issue | 6 |
| Pages | 1208-1215 |
| Date | Jun 2015 |
| Journal Abbr | Ann. Oncol. |
| Language | eng |
| DOI | 10.1093/annonc/mdv135 |
| ISSN | 1569-8041 |
| Short Title | Postoperative irinotecan in resected stage II-III rectal cancer |
| Library Catalog | PubMed |
| Extra | PMID: 25739671 |
| Tags | 5-fluorouracil, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Chemotherapy, Adjuvant, clinic, Disease Progression, Disease-Free Survival, Early Termination of Clinical Trials, Female, Fluorouracil, France, Humans, irinotecan, Leucovorin, Male, Middle Aged, Neoplasm Staging, phase III, Rectal Neoplasms, Risk Factors, Survival Analysis, Time Factors, Treatment Outcome |
| Date Added | 2018/11/13 - 17:25:32 |
| Date Modified | 2019/05/21 - 14:56:05 |
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