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.
Radiother Oncol
; 134: 110-118, 2019 05.
Article
en En
| MEDLINE
| ID: mdl-31005204
BACKGROUND AND PURPOSE: 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. PRIMARY OBJECTIVE: pathological outcome (TRG 1-2) among arms. MATERIALS AND METHODS: Low-located cT2N0-2M0, cT3N0-2M0 (up to 12â¯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 (45â¯Gy/1.8â¯Gy/die, 5 sessions/week to the pelvis, +10â¯Gy at 1â¯Gy twice/week to the bulky) plus concurrent capecitabine (1650â¯mg/mq/die). Xelox: 45â¯Gy to the pelvisâ¯+â¯5.4â¯Gy/1.8â¯Gy/die, 5 sessions/week to the bulky siteâ¯+â¯concurrent capecitabine (1300â¯mg/mq/die) and oxaliplatin (130â¯mg/mq on days 1,19,38). Surgery was planned 7-9â¯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 Gâ¯≥â¯3 haematologic (pâ¯=â¯0.01) and neurologic toxicity (pâ¯<â¯0.001). Overall, 98.5% patients received curative surgery. The tumour regression grade distribution did not differ between arms (pâ¯=â¯0.102). TRG 1+2 rate significantly differed: Xelac arm 61.7% vs. Xelox 52.3% (pâ¯=â¯0.039). Pathological complete response (ypT0N0) rates were 24.4 and 23.8%, respectively (p non-significant). Median follow-up:5.62â¯years. Five-year disease-free survival rate were 74.7% (Xelac) and 73.8% (Xelox), respectively (pâ¯=â¯0.444). Five-year overall survival rate were 80.4% (Xelac) and 85.5% (Xelox), respectively (pâ¯=â¯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.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Oxaloacetatos
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Neoplasias del Recto
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Protocolos de Quimioterapia Combinada Antineoplásica
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Quimioradioterapia
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Capecitabina
Tipo de estudio:
Clinical_trials
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Observational_studies
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Risk_factors_studies
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Radiother Oncol
Año:
2019
Tipo del documento:
Article
País de afiliación:
Italia
Pais de publicación:
Irlanda