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Watch and Wait Approach Following Extended Neoadjuvant Chemoradiation for Distal Rectal Cancer: Are We Getting Closer to Anal Cancer Management?

Habr-Gama, Angelita M.D., Ph.D.1; Sabbaga, Jorge M.D., Ph.D.1,2; Gama-Rodrigues, Joaquim M.D., Ph.D.1; São Julião, Guilherme P. M.D.3; Proscurshim, Igor M.D.1; Bailão Aguilar, Patricia M.D., Ph.D.4,5; Nadalin, Wladimir M.D., Ph.D.4,5; Perez, Rodrigo O. M.D., Ph.D.1,3,6

doi: 10.1097/DCR.0b013e3182a25c4e
Original Contributions: Colorectal/Anal Neoplasia

BACKGROUND: No 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.

OBJECTIVE: The 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.

DESIGN: This is a prospective study.

SETTINGS: This study was conducted at a single center.

PATIENTS: Seventy 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 MEASURES: The 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.

RESULTS: One 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%).

LIMITATIONS: This study is limited by the short follow-up and small sample size.

CONCLUSION: Extended 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,

Supplemental Digital Content is available in the text.

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

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (

Financial Disclosure: None reported.

Podium presentation at the meeting of the American Society of Colon and Rectal Surgeons, Phoenix, AZ, April 27 to May 1, 2013.

Correspondence: Angelita Habr-Gama, M.D., Ph.D., Rua Manoel da Nóbrega 1564, São Paulo - SP, ZIP 04001-005, Brazil. E-mail:

© 2013 The American Society of Colon and Rectal Surgeons