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S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial - 04/08/20

Doi : 10.1016/S1470-2045(20)30315-6 
Yoon-Koo Kang, ProfMD a, Keisho Chin, MD b, Hyun Cheol Chung, ProfMD c, Shigenori Kadowaki, MD d, Sang Cheul Oh, ProfMD e, Norisuke Nakayama, MD f, Keun-Wook Lee, MD g, Hiroki Hara, MD h, Ik-Joo Chung, MD i, Masahiro Tsuda, MD j, Se Hoon Park, ProfMD k, Hisashi Hosaka, MD l, Shuichi Hironaka, MD m, Yoshinori Miyata, MD n, Min-Hee Ryu, ProfMD a, Hideo Baba, ProfMD o, Ichinosuke Hyodo, ProfMD p, Yung-Jue Bang, ProfMD q, Narikazu Boku, MD r, ⁎
a Department of Oncology, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea 
b Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan 
c Division of Medical Oncology, Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea 
d Department of Clinical Oncology, Aichi Cancer Centre Hospital, Aichi, Japan 
e Department of Oncology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea 
f Department of Gastroenterology, Kanagawa Cancer Centre, Kanagawa, Japan 
g Division of Haematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea 
h Department of Gastroenterology, Saitama Cancer Centre, Saitama, Japan 
i Department of Haematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, South Korea 
j Department of Gastroenterological Oncology, Hyogo Cancer Centre, Hyogo, Japan 
k Department of Medicine, Division of Haematology-Oncology, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea 
l Department of Gastroenterology, Gunma Prefectural Cancer Centre, Gunma, Japan 
m Clinical Trial Promotion Department, Chiba Cancer Centre, Chiba, Japan 
n Department of Medical Oncology, Saku Central Hospital Advanced Care Centre, Nagano, Japan 
o Department of Gastroenterological Surgery, Kumamoto University, Kumamoto, Japan 
p Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan 
q Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea 
r Division of Gastrointestinal Medical Oncology, National Cancer Centre Hospital, Tokyo, Japan 

* Correspondence to: Dr Narikazu Boku, Division of Gastrointestinal Medical Oncology, National Cancer Centre Hospital, Tokyo 104-0045, Japan Division of Gastrointestinal Medical Oncology National Cancer Centre Hospital Tokyo 104-0045 Japan

Summary

Background

S-1 plus leucovorin and oxaliplatin showed promising efficacy for treatment of advanced gastric cancer in a randomised phase 2 study. We aimed to evaluate the efficacy and safety of oral TAS-118 (S-1 plus leucovorin) and oxaliplatin versus S-1 plus cisplatin in patients with advanced gastric cancer.

Methods

We did a randomised, open-label, phase 3 trial in 62 centres across Japan and South Korea. Patients aged 20 years or older, with a histologically confirmed advanced gastric cancer with negative or unknown HER2 status, with Eastern Cooperative Oncology Group performance status of 0 or 1, measurable or evaluable metastatic lesions, and no previous treatment were randomly assigned (1:1) via an interactive web response system using the minimisation method, stratified by performance status, presence of a measurable lesion, and country, to receive TAS-118 (S-1 40–60 mg and leucovorin 25 mg orally twice daily for 7 days) plus oxaliplatin (85 mg/m2 intravenously on day 1) every 2 weeks, or S-1 (40–60 mg orally twice daily) for 21 days plus cisplatin (60 mg/m2 intravenously on day 1 or 8) every 5 weeks. The primary endpoint was overall survival in patients who had advanced gastric cancer with measurable or evaluable metastatic lesions and who received the study drug. Safety was assessed in all patients who received the study drug. This study was registered at ClinicalTrials.gov, NCT02322593.

Findings

Between Jan 28, 2015, and Dec 5, 2016, 711 patients were randomised to TAS-118 plus oxaliplatin (n=356) or S-1 plus cisplatin (n=355). 11 untreated patients and 19 ineligible patients were excluded from the primary analysis (TAS-118 plus oxaliplatin group n=347, S-1 plus cisplatin group n=334) following recommendation from the independent data monitoring committee. After median follow-up of 26·0 months (IQR 22·0–32·8), median overall survival was 16·0 months (95% CI 13·8–18·3) in the TAS-118 plus oxaliplatin group and 15·1 months (95% CI 13·6–16·4) in the S-1 plus cisplatin group (hazard ratio 0·83, 95% CI 0·69–0·99; p=0·039). The most common grade 3 or higher adverse events in the 352 patients in the TAS-118 plus oxaliplatin group and the 348 patients in the S-1 plus cisplatin group were anaemia (56 [16%] vs 64 [18%]), neutropenia (54 [15%] vs 88 [25%]), decreased appetite (53 [15%] vs 46 [13%]), diarrhoea (33 [9%] vs 15 [4%]), and peripheral sensory neuropathy (30 [9%] vs one [<1%]). Serious adverse events were observed in 155 (44%) of 352 patients in the TAS-118 plus oxaliplatin group and 159 (46%) of 348 patients in the S-1 plus cisplatin group. Two treatment-related deaths occurred in the TAS-118 plus oxaliplatin group (pulmonary tuberculosis and viral pneumonia).

Interpretation

TAS-118 plus oxaliplatin showed a clinically meaningful improvement in efficacy compared with S-1 plus cisplatin, and could be considered a new first-line treatment option for advanced gastric cancer in Asian patients.

Funding

Taiho Pharmaceutical and Yakult Honsha.

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Vol 21 - N° 8

P. 1045-1056 - août 2020 Retour au numéro
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