Journal article
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204)
ONCOLOGIST, v 25(5), pp E798-E807
May 2020
PMID: 31852811
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background The addition of bevacizumab to chemotherapy improved outcomes for patients with metastatic colon cancer. E5204 was designed to test whether the addition of bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery, could improve overall survival (OS) in patients with stage II/III adenocarcinoma of the rectum. Subjects, Materials, and Methods Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled. Patients were randomized to mFOLFOX6 (Arm A) or mFOLFOX6 with bevacizumab (Arm B) administered every 2 weeks for 12 cycles. Results E5204 registered only 355 patients (17% of planned accrual goal) as it was terminated prematurely owing to poor accrual. At a median follow-up of 72 months, there was no difference in 5-year overall survival (88.3% vs. 83.7%) or 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. The rate of treatment-related grade >= 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%, p = .029).The most common grade 3-4 treatment-related AEs were neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue. Conclusion At 17% of its planned accrual, E5204 did not meet its primary endpoint. The addition of bevacizumab to FOLFOX6 in the adjuvant setting did not significantly improve OS in patients with stage II/III rectal cancer. Implications for Practice At 17% of its planned accrual, E5204 was terminated early owing to poor accrual. At a median follow-up of 72 months, there was no significant difference in 5-year overall survival (88.3% vs. 83.7%) or in 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. Despite significant advances in the treatment of rectal cancer, especially in improving local control rates, the risk of distant metastases and the need to further improve quality of life remain a challenge. Strategies combining novel agents with chemoradiation to improve both distant and local control are needed.
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- Title
- Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204)
- Publication Details
- ONCOLOGIST, v 25(5), pp E798-E807
- Publisher
- WILEY; HOBOKEN
- Grant note
- This study was coordinated by the ECOG-ACRIN Cancer Research Group (Peter J. O'Dwyer, M.D. and Mitchell D. Schnall, M.D., Ph.D., Group Co-Chairs) and included participation from Alliance for Clinical Trials in Oncology, NRG Oncology, SWOG Cancer Research Network, Canadian Cancer Trials Group. It was supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: CA180820, CA180794, CA180863, CA180888, CA180790, CA189863, CA180821,CA180838, CA180844, CA180847, CA180853, CA180818, CA180867, CA189872, CA189867, CA180868,CA189819, CA189828, CA189858, CA180858, CA180863, and the Canadian Cancer Society 704970. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. Oxaliplatin was provided by Sanofi-Aventis Pharmaceuticals
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Drexel University
- Web of Science ID
- WOS:000503104400001
- Scopus ID
- 2-s2.0-85077031070
- Other Identifier
- 991021860678804721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Oncology