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A Randomized Phase II Study of Leucovorin/5-Fluorouracil with or without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-Resected, Node-Positive Esophageal Squamous Cell Carcinoma / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment ; : 816-823, 2017.
Article in English | WPRIM | ID: wpr-129209
ABSTRACT

PURPOSE:

The optimal perioperative treatment for resectable esophageal squamous cell carcinoma (ESCC) remains controversial. We evaluated the efficacy and safety of leucovorin and 5-fluorouracil (LV5FU2) and LV5FU2 plus oxaliplatin (FOLFOX) combination chemotherapies administered adjuvantly for curatively-resected, node-positive ESCC. MATERIALS AND

METHODS:

Patients with pathologically node-positive esophageal cancer after curative R0 resection were enrolled and randomly assigned to receive LV5FU2 or FOLFOX biweekly for up to eight cycles. The primary endpoint was disease-free survival (DFS).

RESULTS:

Between 2011 and 2015, 62 patients were randomized into the two treatment groups (32 in the LV5FU2 arm and 30 in the FOLFOX arm). The median age was 60 years and both groups had similar pathologic characteristics in tumor, nodal status, and location. Treatment completion rates were similarly high in both groups. The DFS rate at 12 months was 67% in the LV5FU2 group and 63% in the FOLFOX group with a hazard ratio of 1.3 (95% confidence interval [CI], 0.66 to 2.62). After a median follow-up period of 27 months, the median DFS was 29.6 months (95% CI, 4.9 to 54.2) in the LV5FU2 arm and 16.8 months (95% CI, 7.5 to 26.1) in the FOLFOX arm (p=0.428), respectively, while the median overall survival was not reached in either arm. Grade 3 or 4 neutropenia was more frequent in patients in the FOLFOX arm than the LV5FU2 arm (20.0% vs. 3.1%).

CONCLUSION:

The addition of oxaliplatin (FOLFOX) did not lead to better efficacy compared to LV5FU2 chemotherapy in an adjuvant setting in node-positive ESCC patients.
Subject(s)

Full text: Available Index: WPRIM (Western Pacific) Main subject: Arm / Esophageal Neoplasms / Carcinoma, Squamous Cell / Leucovorin / Follow-Up Studies / Chemotherapy, Adjuvant / Disease-Free Survival / Drug Therapy / Drug Therapy, Combination / Epithelial Cells Type of study: Controlled clinical trial / Observational study / Prognostic study / Risk factors Limits: Humans Language: English Journal: Cancer Research and Treatment Year: 2017 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Arm / Esophageal Neoplasms / Carcinoma, Squamous Cell / Leucovorin / Follow-Up Studies / Chemotherapy, Adjuvant / Disease-Free Survival / Drug Therapy / Drug Therapy, Combination / Epithelial Cells Type of study: Controlled clinical trial / Observational study / Prognostic study / Risk factors Limits: Humans Language: English Journal: Cancer Research and Treatment Year: 2017 Type: Article