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Clinical Trial
. 2010;15(8):845-51.
doi: 10.1634/theoncologist.2010-0030. Epub 2010 Jul 28.

A safety and survival analysis of neoadjuvant bevacizumab with standard chemoradiation in a phase I/II study compared with standard chemoradiation in locally advanced rectal cancer

Affiliations
Clinical Trial

A safety and survival analysis of neoadjuvant bevacizumab with standard chemoradiation in a phase I/II study compared with standard chemoradiation in locally advanced rectal cancer

Christopher G Willett et al. Oncologist. 2010.

Abstract

Introduction: Bevacizumab is increasingly being tested with neoadjuvant regimens in patients with localized cancer, but its effects on metastasis and survival remain unknown. This study examines the long-term outcome of clinical stage II/III rectal cancer patients treated in a prospective phase II study of bevacizumab with chemoradiation and surgery. As a benchmark, we used data from an analysis of 42 patients with locally advanced rectal cancer treated with a contemporary approach of preoperative fluoropyrimidine-based radiation therapy.

Materials and methods: Outcome analyses were performed on 32 patients treated prospectively with neoadjuvant bevacizumab, 5-fluorouracil, radiation therapy, and surgery as well as 42 patients treated with standard fluoropyrimidine-based chemoradiation.

Results: Overall survival, disease-free survival, and local control showed favorable trends in patients treated with bevacizumab with chemoradiation followed by surgery. Acute and postoperative toxicity appeared acceptable.

Conclusions: Neoadjuvant bevacizumab with standard chemoradiation and surgery shows promising long-term efficacy and safety profiles in locally advanced rectal cancer patients.

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Conflict of interest statement

Disclosures: Christopher G. Willett: Honoraria: Roche; Dan G. Duda: None; Marek Ancukiewicz: None; Mira Shah:None; Brian G. Czito: Research funding/contracted research: Genentech; Rex Bentley: None; Martin Poleski: None; Hiroshi Fujita: None; Gregory Y. Lauwers: None; Madeline Carroll: None; Douglas Tyler: None; Christopher Mantyh: None; Paul Shellito: None; Daniel C. Chung: None; Jeffrey W. Clark: None; Rakesh K. Jain: Consultant/advisory role: Millennium, Dyax, AstraZeneca, Regeneron, SynDevRx (uncompensated); Honoraria: Pfizer (honorarium for lecture); Research funding/contracted research: Dyax, AstraZeneca; Ownership interest: SynDevRx.

This article discusses unlabeled, investigational, or alternative use of bevacizumab with radiotherapy in the treatment of rectal cancer.

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the independent peer reviewers.

Figures

Figure 1.
Figure 1.
Overall survival, disease-free survival, freedom from distant metastases, and local control from the National Cancer Institute #5642 study (bevacizumab group). Shown are Kaplan–Meier estimates of disease-free survival (A), overall survival (B), freedom from distant metastases (C), and local control (D).
Figure 2.
Figure 2.
Overall survival, disease-free survival, freedom from distant metastases, and local control from the Duke #10254 study (control group). Shown are Kaplan–Meier estimates of disease-free survival (A), overall survival (B), freedom from distant metastases (C), and local control (D).

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