Literature DB >> 22079731

Four-week neoadjuvant intensity-modulated radiation therapy with concurrent capecitabine and oxaliplatin in locally advanced rectal cancer patients: a validation phase II trial.

Leire Arbea1, Rafael Martínez-Monge, Juan A Díaz-González, Marta Moreno, Javier Rodríguez, Jose Luis Hernández, Jesús Javier Sola, Luis Isaac Ramos, Jose Carlos Subtil, Jorge Nuñez, Ana Chopitea, Mauricio Cambeiro, Miren Gaztañaga, Jesús García-Foncillas, Javier Aristu.   

Abstract

PURPOSE: To validate tolerance and pathological complete response rate (pCR) of a 4-week preoperative course of intensity-modulated radiation therapy (IMRT) with concurrent capecitabine and oxaliplatin (CAPOX) in patients with locally advanced rectal cancer. METHODS AND MATERIALS: Patients with T3 to T4 and/or N+ rectal cancer received preoperative IMRT (47.5 Gy in 19 fractions) with concurrent capecitabine (825 mg/m(2) b.i.d., Monday to Friday) and oxaliplatin (60 mg/m(2) on Days 1, 8, and 15). Surgery was scheduled 4 to 6 weeks after the completion of chemoradiation. Primary end points were toxicity and pathological response rate. Local control (LC), disease-free survival (DFS), and overall survival (OS) were also analyzed.
RESULTS: A total of 100 patients were evaluated. Grade 1 to 2 proctitis was observed in 73 patients (73%). Grade 3 diarrhea occurred in 9% of the patients. Grade 3 proctitis in 18% of the first 50 patients led to reduction of the dose per fraction to 47.5 Gy in 20 treatments. The rate of Grade 3 proctitis decreased to 4% thereafter (odds ratio, 0.27). A total of 99 patients underwent surgery. A pCR was observed in 13% of the patients, major response (96-100% of histological response) in 48%, and pN downstaging in 78%. An R0 resection was performed in 97% of the patients. After a median follow-up of 55 months, the LC, DFS, and OS rates were 100%, 84%, and 87%, respectively.
CONCLUSIONS: Preoperative CAPOX-IMRT therapy (47.5 Gy in 20 fractions) is feasible and safe, and produces major pathological responses in approximately 50% of patients.
Copyright © 2012 Elsevier Inc. All rights reserved.

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Year:  2011        PMID: 22079731     DOI: 10.1016/j.ijrobp.2011.06.2008

Source DB:  PubMed          Journal:  Int J Radiat Oncol Biol Phys        ISSN: 0360-3016            Impact factor:   7.038


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Journal:  Gastrointest Cancer Res       Date:  2012-11

2.  Clinical significance of cellular and acellular mucin pools in rectal carcinoma following preoperative chemoradiotherapy.

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4.  Patterns and management of distant failure in locally advanced rectal cancer: a cohort study.

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5.  Predictors of Pathologic Complete Response Following Neoadjuvant Chemoradiotherapy for Rectal Cancer.

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8.  Preoperative intensity-modulated radiotherapy with a simultaneous integrated boost combined with Capecitabine in locally advanced rectal cancer: short-term results of a multicentric study.

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Journal:  Medicine (Baltimore)       Date:  2016-05       Impact factor: 1.889

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