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Non-Operative Management of Rectal Cancer with Complete Clinical Response Following Neoadjuvant Therapy
James D Smith*, Jeannine A. Ruby*, Karyn Goodman*, Leonard Saltz*, Josť G Guillem, Martin R Weiser, Larissa K Temple*, Garrett M Nash*, Philip B Paty
Memorial Sloan Kettering Cancer Center, New York, NY

Non-operative management (NOM) of rectal cancer following a complete clinical response (cCR) to neoadjuvant chemoradiation is controversial. This study evaluates the outcomes of selective NOM following a cCR to neoadjuvant treatment compared to management by standard rectal resection (RR) with a pathological complete response (pCR).
Patients completing neoadjuvant therapy for Stage I-III rectal cancer between January 2006 and August 2010 were evaluated. Median follow-up (MFU) was calculated in months after completion of radiotherapy.
Among 311 total patients, 279 (90%) underwent standard RR with 71 pCRs (24%, MFU 38 months). The remaining 32 patients (10%, MFU 23 months) were selected for NOM following a cCR. Factors associated with selected use of NOM were a lower pre-treatment stage, older age, and more distal tumors (P<0.05). In the NOM group, 6 recurred locally (17%, median 11 months, range 7 - 14), two of whom presented with synchronous distant recurrence. All 6 local failures were controlled by salvage RR with no further local recurrence of disease (MFU 11 months). In the RR/pCR group, there were no local failures. The 3 year rates for distant metastasis (11% v. 9%, P=0.63) and overall survival (88% v. 96%, P=0.44) were similar for NOM and RR/pCR groups.
Selective NOM successfully avoided RR in 83% of patients. When combined with salvage surgery, NOM appears to achieve similar local and distant disease control compared to patients treated by RR/pCR. Long term follow-up and prospective trials are warranted to evaluate this promising treatment option.

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