Neoadjuvant Chemotherapy Without Routine Use of Radiation Therapy for Patients With Locally Advanced Rectal Cancer: A Pilot Trial

• DOI: 10.1200/jco.2013.51.7904
• Publication Date: 2014-01-14T02:37:29Z
• Authors: Deborah Schrag; Martin R. Weiser; Karyn A. Goodman; Mithat Gon̈en; Ellen Hollywood; Andrea Cercek; Diane L. Reidy-La...; Marc J. Gollub; Jinru Shia; Jose G. Guillem; Larissa K.F. Temple; Philip B. Paty; Leonard B. Saltz
• Keywords: Adult; Male; Organoplatinum Compounds; Leucovorin; Pilot Projects; Chemoradiotherapy, Adjuvant; Adenocarcinoma; Middle Aged; Antibodies, Monoclonal, Humanized; Disease-Free Survival; Neoadjuvant Therapy; 3. Good health; Bevacizumab; 03 medical and health sciences; 0302 clinical medicine; Chemotherapy, Adjuvant; Antineoplastic Combined Chemotherapy Protocols; Humans; Female; Radiotherapy, Adjuvant; Fluorouracil; Aged; Neoplasm Staging

Although neoadjuvant chemoradiotherapy achieves low local recurrence rates in clinical stages II to III rectal cancer, it delays administration of optimal chemotherapy. We evaluated preoperative infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX)/bevacizumab with selective rather than consistent use chemoradiotherapy.Thirty-two patients cancer participated this single-center phase trial. All were candidates for anterior resection total mesorectal excision (TME). Patients receive six cycles FOLFOX, bevacizumab included 1 4. stable/progressive disease have radiation before TME, whereas responders immediate TME. Postoperative was planned if R0 not achieved. FOLFOX × 6 recommended, but adjuvant regimens left clinician discretion. The primary outcome rate.Between April 2007 December 2008, 32 (100%) study participants had resections. Two did complete chemotherapy secondary cardiovascular toxicity. Both then Of 30 completing chemotherapy, all tumor regression TME without chemoradiotherapy. pathologic response rate alone 8 (25%; 95% CI, 11% 43%). 4-year 0% (95% 11%); the disease-free survival 84% 67% 94%).For selected does seem compromise outcomes. Preoperative Radiation or Selective Evaluation Before Chemotherapy (PROSPECT), a randomized trial validate experience, is now open US cooperative group network.