The multicenter phase II FACT trial demonstrated that modified FOLFOX6 (mFOLFOX6) was efficacious treatment for stage II/III rectal cancer patients with a T3/T4 tumor (Koike J, et al. Cancer Chemother Pharmacol 2017). We now reported the disease free survival (DFS) and overall suravival (OS) after a median follow-up of more than 3 years.
Patients received four 2-week cycles of mFOLFOX6 therapy (oxaliplatin at 85 mg/m2 + l-leucovorin at 200 mg/m2 + fluorouracil as a 400 mg/m2 bolus followed by infusion of 2,400 mg/m2 over 46 hours, all on Day 1). They were evaluated by computed tomography after completion of the fourth cycle. If there was no disease progression, two additional cycles were administered and then surgery was performed. Adjuvant chemotherapy was generally administered for 6 months using various regimens at the discretion of the physician.
At a median follow-up of 42.8 months, median DFS from registration of clinical trials was 42.2 months, and median DFS from surgery was 38.9 months. Median survival time (MST) from registration of clinical trials was 42.8 months, and OS from surgery was 38.9 months. The safety profile was almost similar to previous analysis results.
Neoadjuvant chemotherapy using mFOLFOX6 for stage II/III rectal cancer patients with a T3/T4 tumor was well tolerated, as previously reported. In this trial, neoadjuvant mFOLFOX6 showed improved median DFS and MST.