Originally published as JCO Early Release 10.1200/JCO.2009.21.8529 on July 27 2009

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Phase II Study of Bevacizumab With Concurrent Capecitabine and Radiation Followed by Maintenance Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer: Radiation Therapy Oncology Group RTOG 0411

From the Department of Radiation Oncology and Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX; Radiation Therapy Oncology Group, Philadelphia, PA; Department of Radiation Oncology, University of Maryland, Baltimore, MD; Department of Medical Oncology, Brown University, Providence, RI; Department of Radiation Oncology, University of Virginia, Charlottesville, VA; Department of Radiation Oncology, Emory University, Atlanta, GA; and Department of Radiation Oncology, Duke University, Durham, NC.

Corresponding author: Christopher H. Crane, MD, Dept of Radiation Oncology, Unit 97, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030; e-mail: ccrane{at}mdanderson.org.

Purpose The primary objective of this study was to assess the 1-year survival of patients with locally advanced, unresectable pancreatic cancer treated with the combination of bevacizumab, capecitabine, and radiation. Secondary end points were toxicity, progression-free survival (PFS), and response rate (RR).

Patients and Methods Patients with locally advanced pancreatic cancer without duodenal invasion were treated with 50.4 Gy per 28 fractions to the gross tumor with concurrent capecitabine 825 mg/m² orally twice daily on days of radiation and bevacizumab 5 mg/kg on days 1, 15, and 29 followed by maintenance gemcitabine 1 g/m² weekly for 3 weeks and bevacizumab 5 mg/kg every 2 weeks, both in 4-week cycles until progression. Treatment plans were reviewed for quality assurance (QA).

Results Between January 2005 and February 2006, 82 eligible patients were treated. The median and 1-year survival rates were 11.9 months (95% CI, 9.9 to 14.0 months) and 47% (95% CI, 36% to 57%). Median PFS was 8.6 months (95% CI, 6.9 to 10.5), and RR was 26%. Overall, 35.4% of patients had grade 3 or greater treatment-related gastrointestinal toxicity (22.0% during chemoradiotherapy, 13.4% during maintenance chemotherapy). Unacceptable radiotherapy protocol deviations (ie, inappropriately generous volume contoured) correlated with grade 3 or greater gastrointestinal toxicity during chemoradiotherapy (45% v 18%; adjusted odds ratio, 3.7; 95% CI, 0.98 to 14.1; P = .05).

Conclusion The addition of bevacizumab to chemoradiotherapy followed by bevacizumab and gemcitabine resulted in a similar median survival to previous Radiation Therapy Oncology Group studies in patients with locally advanced pancreatic cancer. Prospective QA may help limit toxicity in future trials.

Supported by Grants No. RTOG U10 CA21661, CCOP U10 CA37422, and Stat U10 CA32115 from the National Cancer Institute and by Genentech through the National Cancer Institute (provided bevacizumab).

Presented at 49th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, October 28, 2007 to November 1, 2007, Los Angeles, CA.

This contents of this manuscript are the sole responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

Clinical trial information can be found for the following: NCT00114179 [ClinicalTrials.gov] .

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