• Angelita Habr-Gama, Jorge Sabbaga, Joaquim Gama-Rodrigues, Guilherme P São Julião, Igor Proscurshim, Patricia Bailão Aguilar, Wladimir Nadalin, and Rodrigo O Perez.
• 1 Angelita & Joaquim Gama Institute, Sao Paulo, Brazil 2 Clinical Oncology Division, Instituto do Cancer do Estado de São Paulo (ICESP), Sao Paulo, Brazil 3 Department of Gastroenterology, Colorectal Surgery Division, University of São Paulo School of Medicine, Sao Paulo, Brazil 4 Department of Radiology, Radiation Oncology Division, University of São Paulo School of Medicine, Sao Paulo, Brazil 5 Radiation Oncology Division, Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil 6 Ludwig Institute for Cancer Research, São Paulo Branch, Sao Paulo, Brazil.
• Dis. Colon Rectum. 2013 Oct 1; 56 (10): 1109-17.

BackgroundNo immediate surgery (Watch and Wait) has been considered in select patients with complete clinical response after neoadjuvant chemoradiation to avoid postoperative morbidity and functional disorders after radical surgery.ObjectiveThe purpose of this study was to demonstrate the long-term results of patients who had a complete clinical response following an alternative chemoradiation regimen and were managed nonoperatively.DesignThis is a prospective study.SettingsThis study was conducted at a single center.PatientsSeventy consecutive patients with T2-4N0-2M0 distal rectal cancer were studied. Neoadjuvant chemoradiotherapy included 54 Gy and 5-fluorouracil/leucovorin delivered in 6 cycles every 21 days. Patients were assessed for tumor response at 10 weeks from radiation completion. Patients with incomplete clinical response were referred to immediate surgery. Patients with complete clinical response were not immediately operated on and were monitored.Main Outcome MeasuresThe primary outcomes measured were the initial complete clinical response rates after 10 weeks and the sustained complete clinical response rates after 12 months from chemoradiotherapy.ResultsOne patient died during chemoradiotherapy because of cardiac complications. Forty-seven (68%) patients had initial complete clinical response. Of these, 8 developed local regrowth within the first 12 months of follow-up (17%). Thirty-nine sustained complete clinical response at a median follow-up of 56 months (57%). An additional 4 patients (10%) developed late local recurrences (>12 months of follow-up). Overall, 35 patients never underwent surgery (50%).LimitationsThis study is limited by the short follow-up and small sample size.ConclusionExtended chemoradiation therapy with additional chemotherapy cycles and 54 Gy of radiation may result in over 50% of sustained (>12 months) complete clinical response rates that may ultimately avoid radical rectal resection. Local failures occur more frequently during the initial 12 months of follow-up in up to 17% of cases, whereas late recurrences are less common but still possible, leading to 50% of patients who never required surgery. Strict follow-up may allow salvage therapy in the majority of these patients (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A113.).

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