Short course chemotherapy followed by concomitant chemoradiotherapy and surgery in locally advanced rectal cancer : a randomized multicentric phase II study

Maréchal; Vos, B.; Polus, M.; Peeters, M.; et al.

doi:10.1093/ANNONC/MDR473

Title

Short course chemotherapy followed by concomitant chemoradiotherapy and surgery in locally advanced rectal cancer : a randomized multicentric phase II study

Author

Maréchal

Vos, B.

Polus, M.

Peeters, M.

et al.

Abstract

Background: Induction chemotherapy has been suggested to impact on preoperative chemoradiation efficacy in locally advanced rectal cancer (LARC). To evaluate in LARC patients, the feasibility and efficacy of a short intense course of induction oxaliplatin before preoperative chemoradiotherapy (CRT). Patients and methods: Patients with T2-T4/N+ rectal adenocarcinoma were randomly assigned to arm Apreoperative CRT with 5-fluorouracil (5-FU) continuous infusion followed by surgeryor arm Binduction oxaliplatin, folinic acid and 5-FU followed by CRT and surgery. The primary end point was the rate of ypT0-1N0 stage achievement. Results: Fifty seven patients were randomly assigned (arm A/B: 29/28) and evaluated for planned interim analysis. On an intention-to-treat basis, the ypT0-1N0 rate for arms A and B were 34.5% (95% CI: 17.2% to 51.8%) and 32.1% (95% CI: 14.8% to 49.4%), respectively, and the study therefore was closed prematurely for futility. There were no statistically significant differences in other end points including pathological complete response, tumor regression and sphincter preservation. Completion of the preoperative CRT sequence was similar in both groups. Grade 3/4 toxicity was significantly higher in arm B. Conclusions: Short intense induction oxaliplatin is feasible in LARC patients without compromising the preoperative CRT completion, although the current analysis does not indicate increased locoregional impact on standard therapy.

Language

English

Source (journal)

Annals of oncology / European Society for Medical Oncology. - Amsterdam

Publication

Amsterdam : 2012

ISSN

0923-7534

DOI

10.1093/ANNONC/MDR473

Volume/pages

23 :6 (2012) , p. 1525-1530