Phase II study of S-1 plus oxaliplatin (OX) at dose of 130 mg/m2 (SOX130) in Japanese patients (pts) with advanced gastric cancer (AGC).

Medientyp: E-Artikel

Titel: Phase II study of S-1 plus oxaliplatin (OX) at dose of 130 mg/m2 (SOX130) in Japanese patients (pts) with advanced gastric cancer (AGC)

Beteiligte: Kito, Yosuke; Machida, Nozomu; Hamauchi, Satoshi; Tsushima, Takahiro; Todaka, Akiko; Yokota, Tomoya; Yamazaki, Kentaro; Fukutomi, Akira; Onozawa, Yusuke; Tsuji, Kunihiro; Doyama, Hisashi; Haraguchi, Yutaka; Nakashima, Koji; Kunieda, Kenji; Taku, Keisei; Mori, Keita; Yasui, Hirofumi

Erschienen: American Society of Clinical Oncology (ASCO), 2017

Sprache: Englisch

DOI: 10.1200/jco.2017.35.4_suppl.112

ISSN: 0732-183X; 1527-7755

Schlagwörter: Cancer Research ; Oncology

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Beschreibung: 112 Background: The phase III G-SOX trial had adopted SOX100 due to high incidence of thrombocytopenia in the previous phase I/II study, and failed to demonstrate the non-inferiority of SOX100 to S-1 plus cisplatin in chemotherapy-naïve Japanese pts with AGC. However, OX 130 mg/m2 has been approved for AGC in Japan since Sep 2014 on the evidence of the REAL-2 trial. Therefore, we conducted a study to evaluate the feasibility of SOX130 in Japanese AGC pts. Methods: This is a single-arm, open-label, multicenter, phase II study. Pts with unresectable or recurrent adenocarcinoma of stomach, no prior chemotherapy and ECOG PS 0 or 1 were treated with SOX130 (S-1 80-120 mg/day according to BSA for 2 weeks, OX 130 mg/m2 on day 1, every 3 weeks). The primary endpoint was the 3-cycle completion rate, defined as the proportion of pts who receive at least 80% of the planned OX dose for the first 3-cycle. We set the threshold 3-cycle completion rate at 50% and the expected rate at 75%. A sample size of 23 pts was needed with 80% power at a 5% α-level (one-sided). Results: From April 2015 to June 2016, 25 pts were enrolled. Pts’ characteristics were as follows: median age 64.5 years (range, 32-76), male/female 21/4, PS 0/1 15/10, unresectable/recurrent 21/4, and intestinal/diffuse 7/18. The 3-cycle completion rate was 72.0% (90% CI 53.8-86.1%). Among the 12 pts with measurable lesions, objective response rate and disease control rate were 58.3% and 83.3%, respectively. With a median follow-up period of 5.2 months, median progression-free survival was 7.5 months. Grade 3 adverse events were anorexia (n = 5), anemia (n = 3), thrombocytopenia (n = 2), neutropenia (n = 1) and nausea (n = 1). No treatment-related death was observed. Conclusions: SOX130 could be a first-line treatment option even in Japanese AGC pts. Clinical trial information: UMIN000016973.

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