Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: ECOG 3204

Landry, J.C.; Feng, Y.; Cohen, S.J.; Staley, C.; Whittington, R.; Sigurdson, E.R.; Nimeiri, H.; Verma, U.; Prabhu, R.S.; Benson, A.B.

doi:10.1016/j.ijrobp.2012.07.373

Cited by 2 publications

(2 citation statements)

References 6 publications

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“…If at least 4 pathologic CRs were observed among the first 23 eligible patients, 34 additional patients (assuming 32 would be eligible) would be entered in the second stage. Five of the first 15 patients (33%) who completed preoperative therapy and surgery demonstrated a pathologic CR after the first stage of accrual, and the decision was made to continue to the second stage 15. If 12 or more pathologic CRs are seen in the 55 eligible patients, the treatment will be considered promising.…”

Section: Methodsmentioning

confidence: 99%

Phase 2 study 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: ECOG 3204

Landry

Feng

Cohen

et al. 2013

Cancer

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Background Recent studies have demonstrated the feasibility of combining oxaliplatin with 5-FU or capecitibine and radiation therapy (RT). The addition of bevacizumab to chemotherapy improves overall survival for metastatic disease. We initiated a phase II trial to evaluate preoperative capecitabine, oxaliplatin, and bevacizumab with RT followed by surgery and postoperative 5-FU, leucovorin, oxaliplatin (FOLFOX) and bevacizumab for locally advanced rectal cancer. Methods Fifty-seven patients (pts) with resectable T3/T4 rectal adenocarcinoma were enrolled. Preoperative treatment was 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 6 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-four of 57 enrolled pts were eligible. Forty-nine (91%) pts completed preoperative therapy and underwent surgery. Nine pts (17%, 90% CI: [9%-27%]) achieved pathologic complete response (path CR). Thirty-two pts (59%) experienced pathologic tumor downstaging. Fifty-three percent and 15% of pts experienced worst grade 3 and grade 4 acute toxicity, respectively. Forty-seven percent of pts who underwent surgery experienced a surgical complication. Conclusions The primary endpoint of a 30% path CR rate was not reached, however the majority of patients experienced pathologic downstaging with this regimen. Increased wound healing delays and complications may have been related to the addition of bevacizumab, oxaliplatin, or both. Continued observation of these patients will establish the long term morbidity and efficacy of this combined modality approach.

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Section: Methodsmentioning

confidence: 99%

Phase 2 study 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: ECOG 3204

Landry

Feng

Cohen

et al. 2013

Cancer

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“…Three postoperative wound complications requiring surgical intervention were reported. Preliminary results from the phase 2 ECOG study 3,204 were presented in 2009 [38]. In this study, patients with stage II or III rectal cancer received radiation (total dose: 50.4 Gy) with concurrent capecitabine, weekly oxaliplatin, and bevacizumab (days 1, 15, and 29).…”

Section: Use Of Novel and Molecular-targeted Therapies In Rectal Cancmentioning

confidence: 99%

Update on Treatment Advances in Combined-Modality Therapy for Anal and Rectal Carcinomas

et al. 2011

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Concurrent radiation therapy and chemotherapy is the primary treatment for patients with squamous cell tumors of the anal canal, and is also employed in the neoadjuvant setting for patients with stage II and III adenocarcinoma of the rectum. There is constant clinical study involving modifications of chemoradiotherapy regimens in an effort to maximize tumor responses while reducing normal tissue toxicity. This review will discuss established regimens as well as newer and novel treatment approaches to treatment of anal and rectal cancer.

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Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: ECOG 3204

Cited by 2 publications

References 6 publications

Phase 2 study 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: ECOG 3204

Phase 2 study 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: ECOG 3204

Update on Treatment Advances in Combined-Modality Therapy for Anal and Rectal Carcinomas

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