| Added by | André Pèlegrin |
|---|---|
| Group name | EquipeAP |
| Item Type | Journal Article |
| Title | Late toxicities and clinical outcome at 5?years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer |
| Creator | Azria et al. |
| Author | D. Azria |
| Author | J. Doyen |
| Author | M. Jarlier |
| Author | I. Martel-Lafay |
| Author | C. Hennequin |
| Author | P. Etienne |
| Author | V. Vendrely |
| Author | G. de La Roche |
| Author | X. Mirabel |
| Author | B. Denis |
| Author | L. Mineur |
| Author | J. Berdah |
| Author | M. Mahé |
| Author | Y. Bécouarn |
| Author | O. Dupuis |
| Author | G. Lledo |
| Author | J. Seitz |
| Author | L. Bedenne |
| Author | S. Gourgou-Bourgade |
| Author | B. Juzyna |
| Author | T. Conroy |
| Author | J. Gérard |
| Abstract | Background: Outcome of intermediate risk rectal cancer may be improved by the addition of oxaliplatin during 5-fluoruracil concomitant neoadjuvant chemoradiotherapy. The purpose of this study is to analyze the main clinical results of the ACCORD12 trial (NCT00227747) in rectal cancer after 5?years of follow-up. Patients and methods: Inclusion criteria were as follows: rectal adenocarcinoma accessible to digital examination staged T3-T4 Nx M0 (or T2 Nx distal anterior rectum). Two neoadjuvant chemoradiotherapy regimens were randomized: CAP45 (RT 45?Gy?+?capecitabine) and CAPOX50 (RT 50?Gy?+?capecitabine and oxaliplatin). Main end point was sterilization of the operative specimen. Acute and late toxicities were prospectively analyzed with dedicated questionnaires. Results: Between November 2005 and July 2008, 598 patients were included in the trial. After a median follow-up of 60.2?months, there was no difference between treatment arms in multivariate analysis either for disease-free survival or overall survival (OS) [P?=?0.9, hazard ratio (HR)=1.02; 95% confidence interval (CI), 0.76-1.36 and P?=?0.3, HR?=?0.87; 95% CI, 0.66-1.15, respectively]. There was also no difference of local control in univariate analysis (P?=?0.7, HR?=?0.92; 95% CI, 0.51-1.66). Late toxicities were acceptable with 1.6% G3 anal incontinence, and <1% G3 diarrhea, G3 rectal bleeding, G3 stenosis, G3-4 pain, G3 urinary incontinence, G3 urinary retention and G3 skeletal toxicity. There was a slight increase of erectile dysfunction over time with a 63% rate of erectile dysfunction at 5?years. There was no significant statistical difference for these toxicities between treatment arms. Conclusions: The CAPOX50 regimen did not improve local control, disease-free survival and overall survival in the ACCORD12 trial. Late toxicities did not differ between treatment arms. |
| Publication | Annals of Oncology: Official Journal of the European Society for Medical Oncology |
| Volume | 28 |
| Issue | 10 |
| Pages | 2436-2442 |
| Date | Oct 01, 2017 |
| Journal Abbr | Ann. Oncol. |
| Language | eng |
| DOI | 10.1093/annonc/mdx351 |
| ISSN | 1569-8041 |
| Library Catalog | PubMed |
| Extra | PMID: 28961836 |
| Tags | Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Chemoradiotherapy, Adjuvant, clinic, clinique hors équipe, Disease-Free Survival, Female, Humans, intermediate risk, Male, Middle Aged, neoadjuvant, Neoadjuvant Therapy, Organoplatinum Compounds, oxaliplatin, Rectal Neoplasms, Survival Rate |
| Date Added | 2018/08/28 - 11:20:11 |
| Date Modified | 2019/05/14 - 12:17:06 |
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