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Background <p>Trastuzumab-based chemotherapy is the standard first-line treatment for HER2-positive advanced gastric cancer. While biosimilars of trastuzumab have demonstrated equivalent efficacy in breast cancer, their clinical utility in gastric cancer remains poorly characterized. The TROX study evaluated the efficacy and safety of a trastuzumab biosimilar (CT-P6) combined with SOX or CapeOX in this population.</p> Methods <p>This multicenter, open-label, non-comparative phase II trial enrolled patients with HER2-positive unresectable or recurrent gastric cancer who had not received prior chemotherapy. Patients were randomized to receive CT-P6 with either SOX (S-1 and oxaliplatin) or CapeOX (capecitabine and oxaliplatin). The primary endpoint was overall response rate (ORR), with a threshold ORR of 43% based on prior trastuzumab trials. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.</p> Results <p>From May 2019 to November 2022, 67 patients were randomized; 34 in the SOX arm and 32 in the CapeOX arm were included in the efficacy analysis. The overall ORR was 77.3% (90% CI: 68.8–85.8%), exceeding the predefined threshold. The median PFS and OS were 9.0&#xa0;months (95% CI: 6.5–10.7) and 18.6&#xa0;months (95% CI: 15.1–23.1), respectively. Grade 3–4 adverse events included hypokalemia (18.2%), neutropenia (15.2%), anorexia (12.1%), and peripheral neuropathy (10.6%). No treatment-related deaths were reported.</p> Conclusions <p>CT-P6 combined with SOX or CapeOX demonstrated high efficacy and manageable toxicity as first-line therapy for HER2-positive gastric cancer. This study supports the clinical use of trastuzumab biosimilars as cost-effective alternatives to originator biologics in gastric cancer treatment.</p>

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Efficacy and safety of trastuzumab biosimilar CT-P6 plus SOX or CapeOX in HER2-positive advanced gastric cancer: a multicenter phase II KSCC-TROX study

  • 期刊论文

  • 发表日期：

    2026年3月23日

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  • Eiji Oki,
  • Teppei Yamada,
  • Tomomi Kashiwada,
  • Hideto Sonoda,
  • Masato Kataoka,
  • Hirofumi Kawanaka,
  • Yasushi Tsuji,
  • Akitaka Makiyama,
  • Mitsuhiko Ota,
  • Qingjiang Hu,
  • Koji Ando,
  • Yasuo Tsuda,
  • Mototsugu Shimokawa,
  • Tomoharu Yoshizumi

摘要

Background

Trastuzumab-based chemotherapy is the standard first-line treatment for HER2-positive advanced gastric cancer. While biosimilars of trastuzumab have demonstrated equivalent efficacy in breast cancer, their clinical utility in gastric cancer remains poorly characterized. The TROX study evaluated the efficacy and safety of a trastuzumab biosimilar (CT-P6) combined with SOX or CapeOX in this population.

Methods

This multicenter, open-label, non-comparative phase II trial enrolled patients with HER2-positive unresectable or recurrent gastric cancer who had not received prior chemotherapy. Patients were randomized to receive CT-P6 with either SOX (S-1 and oxaliplatin) or CapeOX (capecitabine and oxaliplatin). The primary endpoint was overall response rate (ORR), with a threshold ORR of 43% based on prior trastuzumab trials. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

Results

From May 2019 to November 2022, 67 patients were randomized; 34 in the SOX arm and 32 in the CapeOX arm were included in the efficacy analysis. The overall ORR was 77.3% (90% CI: 68.8–85.8%), exceeding the predefined threshold. The median PFS and OS were 9.0 months (95% CI: 6.5–10.7) and 18.6 months (95% CI: 15.1–23.1), respectively. Grade 3–4 adverse events included hypokalemia (18.2%), neutropenia (15.2%), anorexia (12.1%), and peripheral neuropathy (10.6%). No treatment-related deaths were reported.

Conclusions

CT-P6 combined with SOX or CapeOX demonstrated high efficacy and manageable toxicity as first-line therapy for HER2-positive gastric cancer. This study supports the clinical use of trastuzumab biosimilars as cost-effective alternatives to originator biologics in gastric cancer treatment.