Complete Neoadjuvant Treatment for Rectal Cancer (CONTRE) study: Long Term Results.
*Yaphet Tilahun, *Howard Safran, *Matthew Vrees, Adam Klipfel, *Leslie Roth, Steven Schechter, *Justin Yu, *Kayla Rosati, *Thomas Dipetrillo, Nishit Shah
Warren Alpert Medical School, Providence, RI
Objective: Despite national guidelines, recent studies have shown poor compliance of adjuvant chemotherapy use after neoadjuvant chemoradiation and surgery for locally advanced rectal cancer. This has prompted examination of optimizing the neoadjuvant regimen employed in this setting. We have previously reported the feasibility of primary chemotherapy followed by chemoradiation and surgery in the CONTRE study. Here we sought to examine our long-term results. Design: Prospective study. Setting: Two tertiary care hospitals Patients: Patients with stage II or III rectal cancer by MRI/endorectal ultrasound received 8 cycles of FOLFOX followed by chemoradiation consisting of capecitabine concurrent with 50.4 Gy radiation therapy. Surgery was performed 6 to 10 weeks after chemoradiation. Main outcome measures: Local recurrence (LR), distant metastases (DM), disease free survival (DFS) and overall survival (OS) were assessed. Results: Thirty-six patients enrolled between August 2010 and June 2013 (median age 61y). Pathologic complete response (ypT0, N0) was achieved in 33% (12/36) of patients. In the perioperative period, one patient developed an anastomotic leak but no patients required surgical re-intervention. At median follow-up of 58.5 months, LR and DM were 8% (3/36) and 19% (7/36) respectively. The median 5-year DFS and OS were 72.3% and 75% respectively. Conclusion: In this study the delivery of neoadjuvant chemotherapy followed by chemoradiation and surgery produced results comparable to nationally reported outcomes. Specifically, delaying surgery from time of diagnosis did not have a negative impact on long-term outcomes. This strategy may not only improve compliance but potentially treat micrometastases in locally advanced rectal cancer. Our findings support the pursuit of larger phase III trials in assessing use of neoadjuvant chemotherapy.
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