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BMC Cancer. 2018 Mar 5;18(1):252. doi: 10.1186/s12885-018-4039-9.

A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma.

Author information

1
Department of Internal Medicine, Seoul National University Hospital, 101 Daehang-ro, Jongno-gu, Seoul, 110-744, South Korea.
2
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.
3
Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
4
Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, South Korea.
5
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
6
Department of Internal Medicine, Seoul National University Hospital, 101 Daehang-ro, Jongno-gu, Seoul, 110-744, South Korea. kimty@snu.ac.kr.
7
Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea. kimty@snu.ac.kr.

Abstract

BACKGROUND:

Oxaliplatin is a platinum derivative that has shown efficacy in advanced hepatocellular carcinoma. S-1 is an oral fluoropyrimidine that has substituted for 5-fluorouracil in many cancers. This was a multicenter, open-label, single-arm phase II trial that evaluated the efficacy of S-1 and oxaliplatin (SOX) in advanced hepatocellular carcinoma. All patients included in the present study were systemic treatment-naïve. Prior treatment with sorafenib was allowed, but other treatments were not.

METHODS:

Patients received S-1 (40 mg/m2 twice daily from day 1-14) and oxaliplatin (130 mg/m2 on day 1) every 3 weeks. The primary end point was time to progression (TTP). Secondary end points included progression-free survival, overall survival (OS), response rate, and safety profile.

RESULTS:

Thirty six patients with advanced hepatocellular carcinoma were included in this study. The median TTP was 3.0 months (95% confidence interval (CI), 0.75-5.25), and the median OS was 10.3 months (95% CI, 6.4-14.3). Bone metastasis was associated with poorer TTP and OS. The efficacy of SOX was unaffected by prior sorafenib or locoregional therapy. The objective response rate was 13.9%. No grade 4 toxicity or death from adverse events occurred. The most common grade 3 toxicities were neutropenia (13.9%), thrombocytopenia (13.9%), and diarrhea (8.3%).

CONCLUSIONS:

Although this trial did not meet its primary end point, the SOX regimen showed comparable efficacy and safety to the 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) regimen. As the SOX regimen is easier for patients, SOX may be a reasonable substitute for FOLFOX in hepatocellular carcinoma.

TRIAL REGISTRATION:

Clinicaltrials.gov NCT01429961 . Registered 7 September 2011.

KEYWORDS:

Chemotherapy; Hepatocellular carcinoma; Oxaliplatin; Phase II; S-1

PMID:
29506478
PMCID:
PMC5838934
DOI:
10.1186/s12885-018-4039-9
[Indexed for MEDLINE]
Free PMC Article

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