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Nonoperative Management of Rectal Cancer With Complete Clinical Response After Neoadjuvant Therapy

Smith, James D. MD*; Ruby, Jeannine A. MD*; Goodman, Karyn A. MD; Saltz, Leonard B. MD; Guillem, José G. MD*; Weiser, Martin R. MD*; Temple, Larissa K. MD*; Nash, Garrett M. MD*; Paty, Philip B. MD*

doi: 10.1097/SLA.0b013e3182759f1c
Original Articles

Introduction: Nonoperative management (NOM) of rectal cancer after a complete clinical response (cCR) to neoadjuvant therapy is controversial. In this article, we retrospectively reviewed the outcomes of patients managed with selective NOM after a cCR to neoadjuvant treatment and compared these with patients who underwent standard rectal resection with a pathological complete response (pCR).

Methods: Patients completing neoadjuvant chemoradiotherapy (CRT) for stage I to III rectal cancer between January 2006 and August 2010 were retrospectively reviewed. Median follow-up was calculated in months after completion of CRT.

Results: Thirty-two patients (median follow-up 28 months) were treated by NOM after a cCR. Among 265 treated by CRT and rectal resection, 57 patients (22%) had a pCR and formed the control group (median follow-up 43 months). Factors associated with selective use of NOM included lower pretreatment stage, older age, and distal tumor location (P < 0.05). In the NOM group, 6 recurred locally (median 11 months, range 7–14), 3 of whom also had concurrent distant recurrence. All 6 local failures were controlled by salvage rectal resection with no further local recurrence of disease (median follow-up 17 months). In the rectal resection/pCR group, there were no local failures. The 2-year distant disease-free survival (88% vs 98%, P = 0.27) and overall survival (96% vs 100%, P = 0.56) were similar for NOM and rectal resection/pCR groups.

Conclusions: Rectal resection was successfully avoided in 81% of patients selected for NOM. When combined with salvage surgery, NOM appears to achieve similar local and distant disease control compared with patients with a pCR treated by rectal resection. Longer follow-up and prospective trials are warranted to evaluate this promising treatment option.

We retrospectively reviewed outcomes of patients managed nonoperatively after complete clinical response to neoadjuvant treatment versus patients undergoing standard rectal resection with pathological complete response (pCR). When combined with salvage surgery, nonoperative management appears to achieve similar local and distant disease control as standard rectal resection with pCR. Longer follow-up and prospective trials are warranted.

*Departments of Surgery

Radiation Oncology

Medical Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY.

Reprints: Philip B. Paty, MD, Department of Surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, Room C-1081, New York, NY 10065. E-mail:

Disclosure: The authors declare no conflicts of interest.

© 2012 Lippincott Williams & Wilkins, Inc.