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Adjuvant FOLFOX extended DFS in locally advanced rectal cancer
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The addition of oxiliplatin to fluorouracil and leucovorin extended DFS among patients with locally advanced rectal cancer who underwent preoperative chemotherapy and total mesorectal excision, according to results of a randomized phase 2 study.
Adjuvant chemotherapy for rectal cancer is controversial, particularly among patients who underwent preoperative chemotherapy. Adjuvant chemotherapy with fluorouracil and leucovorin is commonly used.
The addition of oxiliplatin to fluorouracil and leucovorin — which creates a regimen known as FOLFOX — has not been evaluated in rectal cancer but is a standard adjuvant regimen for colon cancer, according to background information provided by researchers.
Yong Sang Hong, MD, of the department of oncology at Asan Medical Center at University of Ulsan College of Medicine in Seoul, South Korea, and colleagues conducted an open-label, multicenter study to assess the safety and efficacy of adjuvant FOLFOX vs. fluorouracil and leucovorin alone.
Hong and colleagues enrolled 321 patients with locally advanced, stage II or stage III rectal cancer. All patients had undergone preoperative fluoropyrimidine-based chemoradiotherapy and total mesorectal excision.
Researchers randomly assigned patients in a 1:1 fashion to eight cycles of FOLFOX (oxiliplatin 85 mg/m2, leucovorin 200 mg/m2 and fluorouracil bolus 400 mg/m2 on day 1, and fluorouracil infusion 2,400 mg/m2 for 46 hours, every 2 weeks), or four cycles of fluorouracil and leucovorin alone (fluorouracil 380 mg/m2 and leucovorin 20 mg/m2 on days 1 through 5, every 4 weeks).
Three-year DFS served as the primary outcome.
After a median follow-up of 38.2 months, 141 patents assigned FOLFOX arm and 141 patients assigned fluorouracil plus leucovorin completed all cycles of adjuvant chemotherapy.
Researchers reported a higher rate of 3-year DFS in the FOLFOX arm (71.6% vs. 62.9%; HR=0.65, 0.43-0.99).
Patients assigned FOLFOX experienced significantly higher rates of any-grade neutropenia, thrombocytopenia, fatigue, nausea and sensory neuropathy. However, incidence of those events at grade 3 and grade 4 were comparable between treatment arms.
Patients assigned FOLFOX experienced higher rates of grade ≥3 neutropenia (36% vs. 26%) and leucopenia (8% vs. 5%). Patients assigned fluorouracil plus leucovorin experienced higher rates of grade ≥3 febrile neutropenia (3% vs. <1%) and diarrhea (3% vs. 1%).
Disclosure: The study was funded by the South Korean Ministry of Health and Welfare.
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