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17.05.2019 | Original Article

Multicenter phase II study of trastuzumab with S-1 plus oxaliplatin for chemotherapy-naïve, HER2-positive advanced gastric cancer

Zeitschrift:
Gastric Cancer
Autoren:
Daisuke Takahari, Keisho Chin, Naoki Ishizuka, Atsuo Takashima, Keiko Minashi, Shigenori Kadowaki, Tomohiro Nishina, Takako Eguchi Nakajima, Kenji Amagai, Nozomu Machida, Masahiro Goto, Keisei Taku, Takeru Wakatsuki, Hirokazu Shoji, Shuichi Hironaka, Narikazu Boku, Kensei Yamaguchi
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s10120-019-00973-5) contains supplementary material, which is available to authorized users.

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Abstract

Background

Trastuzumab with cisplatin and fluoropyrimidines improves overall survival (OS) in patients with HER2-positive advanced gastric cancer (AGC). S-1 plus oxaliplatin (SOX) is one of the standard regimens for HER2-negative AGC in Japan. However, few studies have evaluated trastuzumab combined with SOX in patients with HER2-positive AGC.

Methods

This was a multicenter, phase II study conducted at 10 institutions in Japan. Patients with HER2-positive AGC received S-1 twice a day on days 1–14 and oxaliplatin and trastuzumab on day 1 of a 21-day cycle. The primary endpoint was the confirmed overall response rate (ORR), and the secondary endpoints were OS, progression-free survival (PFS), and safety. The sample size was 75 to have 90% power with an alpha error of 0.1 (one-sided), expecting an ORR of 65% and threshold of 50%.

Results

From June 2015 to January 2018, 75 patients were enrolled. The ORR was 70.7% [95% confidence interval (CI) 59.0–80.6]. The median OS and PFS were estimated as 18.1 months (95% CI 15.6–26.5) and 8.8 months (95% CI 7.4–12.2), respectively. The major grade 3 or 4 adverse events were sensory neuropathy (16.0%) and neutropenia (10.7%).

Conclusions

Trastuzumab with SOX had promising activity with well-tolerated toxicities for patients with HER2-positive AGC.

Clinical trial registration

UMIN000017602.

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Zusatzmaterial
Supplementary material 1 (DOCX 25 kb)
10120_2019_973_MOESM1_ESM.docx
Supplementary material 2 (DOCX 17 kb)
10120_2019_973_MOESM2_ESM.docx
Literatur
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