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Clinical Trial
. 2017 Jul;49(3):816-823.
doi: 10.4143/crt.2016.417. Epub 2016 Nov 9.

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

Sung Hee Lim  1   2 , Young Mog Shim  3 , Se Hoon Park  2 , Hong Kwan Kim  3 , Young Soo Choi  3 , Myung-Ju Ahn  2 , Keunchil Park  2 , Jae Ill Zo  3 , Jong-Mu Sun  2
Affiliations
Clinical Trial

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

Sung Hee Lim et al. Cancer Res Treat. 2017 Jul.

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.

Keywords: Adjuvant chemotherapy; Esophageal neoplasms; FOLFOX.

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Conflict of interest statement

Conflict of interest relevant to this article was not reported.

Figures

Fig. 1.
Fig. 1.
CONSORT diagram of the study design and participants. LV5FU2, leucovorin and 5-fluorouracil; FOLFOX, fluorouracil, leucovorin, and oxaliplatin; ITT, intention-to-treat.
Fig. 2.
Fig. 2.
(A) Kaplan-Meier curves of disease-free survival for patients who received FOLFOX or LV5FU2 (median disease-free survival, 16.8 months in the FOLFOX arm vs. 29.6 months in the LV5FU2 arm). (B) Kaplan-Meier curves of overall survival of all patients according to treatment arm (median overall survival was not reached in either arm). FOLFOX, fluorouracil, leucovorin, and oxaliplatin; LV5FU2, leucovorin and 5-fluorouracil.
See this image and copyright information in PMC

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