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BMC Cancer
Published in: BMC Cancer 1/2015

Open Access 01-12-2015 | Research article

Phase II study of preoperative bevacizumab, capecitabine and radiotherapy for resectable locally-advanced rectal cancer

Authors: Margarita García, Mercedes Martinez-Villacampa, Cristina Santos, Valentin Navarro, Alex Teule, Ferran Losa, Aleydis Pisa, Maria Cambray, Gemma Soler, Laura Lema, Esther Kreisler, Agnes Figueras, Xavier San Juan, Francesc Viñals, Sebastiano Biondo, Ramon Salazar

Published in: BMC Cancer | Issue 1/2015

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Abstract

Background

To evaluate whether the addition of bevacizumab (BVZ) to capecitabine-based chemoradiotherapy in the preoperative treatment of locally advanced rectal cancer (LARC) improves efficacy measured by the pathological complete response (pCR) rate.

Methods

A phase II two-step design was performed. Patients received four cycles of therapy consisting of: BVZ 10 mg/kg in first infusion on day 1 and 5 mg/kg on days 15, 29, 43, capecitabine 1800 mg/m2/day 5 days per week during radiotherapy, which consisted of external-beam irradiation (45 Gy in 1.8 Gy dose per session over 5 sessions/week for 5 weeks). Six to eight weeks after completion of all therapies surgery was undergone. To profile the biological behaviour during BVZ treatment we measured molecular biomarkers before treatment, during BVZ monotherapy, and during and after combination therapy. Microvessel density (MVD) was measured after surgery.

Results

Forty-three patients were assessed and 41 were included in the study. Three patients achieved a pathological complete response (3/40: 7.5%) and 27 (67.5%) had a pathological partial response, (overall pathological response rate of 75%). A further 8 patients (20%) had stable disease, giving a disease control rate of 95%. Downstaging occurred in 31 (31/40: 77.5%) of the patients evaluated. This treatment resulted in an actuarial 4-year disease-free and overall survival of 85.4 and 92.7% respectively. BVZ with chemoradiotherapy showed acceptable toxicity. No correlations were observed between biomarker results and efficacy variables.

Conclusion

BVZ with capecitabine and radiotherapy seem safe and active and produce promising survival results in LARC.

Trial registration

ClinicalTrials.gov Identifier NCT00847119. Trial registration date: February 18, 2009.
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Metadata
Title
Phase II study of preoperative bevacizumab, capecitabine and radiotherapy for resectable locally-advanced rectal cancer
Authors
Margarita García
Mercedes Martinez-Villacampa
Cristina Santos
Valentin Navarro
Alex Teule
Ferran Losa
Aleydis Pisa
Maria Cambray
Gemma Soler
Laura Lema
Esther Kreisler
Agnes Figueras
Xavier San Juan
Francesc Viñals
Sebastiano Biondo
Ramon Salazar
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2015
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-015-1052-0

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