Prospective Cohort Study of Trastuzumab Biosimilar CT-P6 in HER2-Positive Gastric Cancer: Japanese Real-World Outcomes.
코호트
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
171 patients (130 male, 41 female) with HER2-positive unresectable advanced or recurrent gastric cancer.
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[CONCLUSIONS] In this cohort study, CT-P6 demonstrated sufficient efficacy and no new safety concerns in HER2-positive advanced gastric cancer, serving as a cost-effective alternative to originator trastuzumab. [TRIAL REGISTRATION] Japan Registry of Clinical Trials, Trial ID: jRCT2071230094 (November 2023).
[INTRODUCTION] CT-P6, the first trastuzumab biosimilar, was approved on the basis of data limited to human epidermal growth factor receptor-2 (HER2)-positive early breast cancer.
- 연구 설계 cohort study
APA
Taniguchi H, Nishikawa K, et al. (2025). Prospective Cohort Study of Trastuzumab Biosimilar CT-P6 in HER2-Positive Gastric Cancer: Japanese Real-World Outcomes.. Oncology and therapy, 13(2), 485-503. https://doi.org/10.1007/s40487-025-00341-7
MLA
Taniguchi H, et al.. "Prospective Cohort Study of Trastuzumab Biosimilar CT-P6 in HER2-Positive Gastric Cancer: Japanese Real-World Outcomes.." Oncology and therapy, vol. 13, no. 2, 2025, pp. 485-503.
PMID
40338476
Abstract
[INTRODUCTION] CT-P6, the first trastuzumab biosimilar, was approved on the basis of data limited to human epidermal growth factor receptor-2 (HER2)-positive early breast cancer. Usage for other indications was granted by extrapolation, and post-approval clinical studies were conducted to confirm the effect of CT-P6 in HER2-positive gastric cancer.
[METHODS] After approval in Japan in 2018, a prospective post-marketing surveillance was conducted in 171 patients (130 male, 41 female) with HER2-positive unresectable advanced or recurrent gastric cancer. The safety and efficacy of CT-P6 were evaluated over 1 year.
[RESULTS] CT-P6 was primarily combined with fluoropyrimidine and/or platinum agents. Adverse events occurred in 151 patients (88.3%), with 55 patients (32.2%) experiencing grade 3 or higher. Infusion reactions occurred in 12.3%. Four cardiac disorders were reported: two of grade 1 cardiac dysfunction and two of severe ischemic heart disease. Interstitial lung disease was reported in four patients (2.3%). The objective response rate was 34.4%, and the disease control rate was 82.4%. The progression-free survival (PFS) was 7.4 months. Significant risk factors for PFS included gastroesophageal junction, ≥ 3 metastases, no gastrectomy, prior chemotherapy, and no platinum agent.
[CONCLUSIONS] In this cohort study, CT-P6 demonstrated sufficient efficacy and no new safety concerns in HER2-positive advanced gastric cancer, serving as a cost-effective alternative to originator trastuzumab.
[TRIAL REGISTRATION] Japan Registry of Clinical Trials, Trial ID: jRCT2071230094 (November 2023).
[METHODS] After approval in Japan in 2018, a prospective post-marketing surveillance was conducted in 171 patients (130 male, 41 female) with HER2-positive unresectable advanced or recurrent gastric cancer. The safety and efficacy of CT-P6 were evaluated over 1 year.
[RESULTS] CT-P6 was primarily combined with fluoropyrimidine and/or platinum agents. Adverse events occurred in 151 patients (88.3%), with 55 patients (32.2%) experiencing grade 3 or higher. Infusion reactions occurred in 12.3%. Four cardiac disorders were reported: two of grade 1 cardiac dysfunction and two of severe ischemic heart disease. Interstitial lung disease was reported in four patients (2.3%). The objective response rate was 34.4%, and the disease control rate was 82.4%. The progression-free survival (PFS) was 7.4 months. Significant risk factors for PFS included gastroesophageal junction, ≥ 3 metastases, no gastrectomy, prior chemotherapy, and no platinum agent.
[CONCLUSIONS] In this cohort study, CT-P6 demonstrated sufficient efficacy and no new safety concerns in HER2-positive advanced gastric cancer, serving as a cost-effective alternative to originator trastuzumab.
[TRIAL REGISTRATION] Japan Registry of Clinical Trials, Trial ID: jRCT2071230094 (November 2023).