The INTERACT Trial: Long-term results of a randomised trial on preoperative capecitabine-based radiochemotherapy intensified by concomitant boost or oxaliplatin, for cT2 (distal)-cT3 rectal cancer.

Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols / administration & dosage Capecitabine / administration & dosage Chemoradiotherapy / methods Female Humans Male Middle Aged Oxaliplatin / administration & dosage Oxaloacetates / administration & dosage Prospective Studies Rectal Neoplasms / mortality

Boost Chemoradiation Oxaliplatin Pathologic complete response Preoperative radiochemotherapy Rectal cancer

Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

ISSN: 1879-0887

Titre abrégé: Radiother Oncol

Pays: Ireland

ID NLM: 8407192

Informations de publication

Date de publication:
05 2019

Historique:

received: 11 09 2018

revised: 26 11 2018

accepted: 30 11 2018

entrez: 22 4 2019

pubmed: 22 4 2019

medline: 14 3 2020

Statut: ppublish

Résumé

Capecitabine-based radiochemotherapy (cbRCT) is standard for preoperative long-course radiochemotherapy of locally advanced rectal cancer. This prospective, parallel-group, randomised controlled trial investigated two intensification regimens. cT4 lesions were excluded. pathological outcome (TRG 1-2) among arms. Low-located cT2N0-2M0, cT3N0-2M0 (up to 12 cm from anal verge) presentations were treated with cbRCT randomly intensified by either radiotherapy boost (Xelac arm) or multidrug concomitant chemotherapy (Xelox arm). Xelac: concomitant boost to bulky site (45 Gy/1.8 Gy/die, 5 sessions/week to the pelvis, +10 Gy at 1 Gy twice/week to the bulky) plus concurrent capecitabine (1650 mg/mq/die). Xelox: 45 Gy to the pelvis + 5.4 Gy/1.8 Gy/die, 5 sessions/week to the bulky site + concurrent capecitabine (1300 mg/mq/die) and oxaliplatin (130 mg/mq on days 1,19,38). Surgery was planned 7-9 weeks after radiochemotherapy. From June 2005 to September 2013, 534 patients were analysed: 280 in Xelac, 254 in Xelox arm. Xelox arm presented higher G ≥ 3 haematologic (p = 0.01) and neurologic toxicity (p < 0.001). Overall, 98.5% patients received curative surgery. The tumour regression grade distribution did not differ between arms (p = 0.102). TRG 1+2 rate significantly differed: Xelac arm 61.7% vs. Xelox 52.3% (p = 0.039). Pathological complete response (ypT0N0) rates were 24.4 and 23.8%, respectively (p non-significant). Median follow-up:5.62 years. Five-year disease-free survival rate were 74.7% (Xelac) and 73.8% (Xelox), respectively (p = 0.444). Five-year overall survival rate were 80.4% (Xelac) and 85.5% (Xelox), respectively (p = 0.155). Xelac arm significantly obtained higher TRG1-2 rates. No differences were found about clinical outcome. Because of efficacy on TRG, inferior toxicity and good compliance, Xelac schedules or similar radiotherapy dose intensification schemes could be considered as reference treatments for cT3 lesions.

Sections du résumé

BACKGROUND AND PURPOSE

PRIMARY OBJECTIVE

pathological outcome (TRG 1-2) among arms.

MATERIALS AND METHODS

Low-located cT2N0-2M0, cT3N0-2M0 (up to 12 cm from anal verge) presentations were treated with cbRCT randomly intensified by either radiotherapy boost (Xelac arm) or multidrug concomitant chemotherapy (Xelox arm). Xelac: concomitant boost to bulky site (45 Gy/1.8 Gy/die, 5 sessions/week to the pelvis, +10 Gy at 1 Gy twice/week to the bulky) plus concurrent capecitabine (1650 mg/mq/die). Xelox: 45 Gy to the pelvis + 5.4 Gy/1.8 Gy/die, 5 sessions/week to the bulky site + concurrent capecitabine (1300 mg/mq/die) and oxaliplatin (130 mg/mq on days 1,19,38). Surgery was planned 7-9 weeks after radiochemotherapy.

RESULTS

From June 2005 to September 2013, 534 patients were analysed: 280 in Xelac, 254 in Xelox arm. Xelox arm presented higher G ≥ 3 haematologic (p = 0.01) and neurologic toxicity (p < 0.001). Overall, 98.5% patients received curative surgery. The tumour regression grade distribution did not differ between arms (p = 0.102). TRG 1+2 rate significantly differed: Xelac arm 61.7% vs. Xelox 52.3% (p = 0.039). Pathological complete response (ypT0N0) rates were 24.4 and 23.8%, respectively (p non-significant). Median follow-up:5.62 years. Five-year disease-free survival rate were 74.7% (Xelac) and 73.8% (Xelox), respectively (p = 0.444). Five-year overall survival rate were 80.4% (Xelac) and 85.5% (Xelox), respectively (p = 0.155).

CONCLUSION

Xelac arm significantly obtained higher TRG1-2 rates. No differences were found about clinical outcome. Because of efficacy on TRG, inferior toxicity and good compliance, Xelac schedules or similar radiotherapy dose intensification schemes could be considered as reference treatments for cT3 lesions.

Identifiants

DOI: 10.1016/j.radonc.2018.11.023 PMID: 31005204

pubmed: 31005204

pii: S0167-8140(18)33618-1

doi: 10.1016/j.radonc.2018.11.023

pii:

doi:

Substances chimiques

Oxaloacetates 0

Oxaliplatin 04ZR38536J

Capecitabine 6804DJ8Z9U

Banques de données

ClinicalTrials.gov

['NCT01653301']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

110-118