Phase II trial of preoperative radiation with concurrent capecitabine, oxaliplatin, and bevacizumab followed by surgery and postoperative 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX), and bevacizumab in patients with locally advanced rectal cancer: 5-year clinical outcomes of a trial of the ECOG-ACRIN Cancer Research Group (E3204).

Authors

null

Jerome Carl Landry

Emory University, Winship Cancer Institute, Atlanta, GA

Jerome Carl Landry , Yang Feng , Roshan Sudhir Prabhu , Steven J. Cohen , Charles A. Staley , Richard M. Whittington , Elin R. Sigurdson , Halla Sayed Nimeiri , Udit N. Verma , Al Bowen Benson III

Organizations

Emory University, Winship Cancer Institute, Atlanta, GA, Dana-Farber Cancer Institute, Boston, MA, Southeast Radiation Oncology Group, Charlotte, NC, Fox Chase Cancer Center, Philadelphia, PA, Winship Cancer Institute of Emory University, Atlanta, GA, VA New Jersey Healthcare System, East Orange, NJ, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, The University of Texas Southwestern Medical Center, Dallas, TX

Research Funding

NIH

Background: As previously reported, the regimen of preoperative capecitabine, oxaliplatin, and bevacizumab with radiation therapy (RT) followed by surgery and postoperative 5-FU, leucovorin, oxaliplatin (FOLFOX) andbevacizumabfor locally advanced rectal cancer did not improve pathologic complete response (path CR) rates. However, the effect of an intensified adjuvant regimen is not reflected in path CR. The purpose of this report is to describe the 5-year oncologic outcomes of this regimen. Methods: Fifty-seven patients (pts) with resectable T3/T4 rectal adenocarcinoma were enrolled. Preoperative treatment: capecitabine (825 mg/m² bid M-F), oxaliplatin (50 mg/m² weekly), bevacizumab (5 mg/kg D1,15,29), and RT (50.4 Gy). Surgery was performed by 8 weeks after neoadjuvant therapy. Beginning 8 – 12 weeks after surgery, patients received FOLFOX plus bevacizumab (5 mg/kg) Q2 weeks for 12 cycles. Results: Fifty-three of 57 enrolled pts were eligible and included in the analysis. Most patients were clinical (c)T3 (92%) and cN positive (64%). Of the 48 patients who underwent curative surgery, 26 (54%) began adjuvant chemotherapy. After a median follow-up period of 41 months, the 5-year overall survival (OS) rate for all patients was 80% (90% confidence interval (CI) [67%, 92%]). Only 2 patients experienced cancer recurrence, 1 distant and 1 loco-regional, respectively. The 5-year recurrence free survival rate (RFS) was 81% (90% CI [68%, 94%]). Conclusions: Despite the path CR primary endpoint of this trial not being reached, the 5-year OS and RFS rates were excellent. However, as previously reported, the neoadjuvant and surgical toxicity of this regimen was significant and was the primary reason for the low compliance with adjuvant systemic therapy. Due to the lack of an improvement in the path CR rate, the substantial associated toxicity, and negative phase III trials of adjuvant bevacizumab in colon cancer, this regimen cannot be recommended for further study. Clinical trial information: NCT00321685

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer

Clinical Trial Registration Number

NCT00321685

Citation

J Clin Oncol 33, 2015 (suppl; abstr 3592)

DOI

10.1200/jco.2015.33.15_suppl.3592

Abstract #

3592

Poster Bd #

85

Abstract Disclosures