학술논문
Consolidation mFOLFOX6 Chemotherapy After Chemoradiotherapy Improves Survival in Patients With Locally Advanced Rectal Cancer
Document Type
article
Author
Marco, Michael R; Zhou, Lihong; Patil, Sujata; Marcet, Jorge E; Varma, Madhulika G; Oommen, Samuel; Cataldo, Peter A; Hunt, Steven R; Kumar, Anjali; Herzig, Daniel O; Fichera, Alessandro; Polite, Blase N; Hyman, Neil H; Ternent, Charles A; Stamos, Michael J; Pigazzi, Alessio; Dietz, David; Yakunina, Yuliya; Pelossof, Raphael; Garcia-Aguilar, Julio
Source
Diseases of the Colon & Rectum. 61(10)
Subject
Language
Abstract
BackgroundAdding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the proportion of rectal cancer patients with a pathological complete response.ObjectiveThe purpose of this study was to analyze disease-free and overall survival.DesignThis was a nonrandomized phase II trial.SettingsThe study was conducted at multiple institutions.PatientsFour sequential study groups with stage II or III rectal cancer were included.InterventionAll of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6.Main outcome measuresThe trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study.ResultsOf 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004,