|
1
|
Taniguchi H, Nishikawa K, Haneji T, Izawa N, Imamura H, Yamaguchi H. Prospective Cohort Study of Trastuzumab Biosimilar CT-P6 in HER2-Positive Gastric Cancer: Japanese Real-World Outcomes. Oncol Ther 2025:10.1007/s40487-025-00341-7. [PMID: 40338476 DOI: 10.1007/s40487-025-00341-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Accepted: 04/09/2025] [Indexed: 05/09/2025] Open
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).
Collapse
Affiliation(s)
- Hiroya Taniguchi
- Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan
| | - Kiyohiro Nishikawa
- Quality and Pharmacovigilance Division, Pharmaceuticals Group, Nippon Kayaku Co., Ltd., 2-1-1 Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.
- Asajes Ventures, 3-11-5 Nihonbashi Honcho, Chuo-ku, Tokyo, 103-0023, Japan.
| | - Tatsuo Haneji
- Quality and Pharmacovigilance Division, Pharmaceuticals Group, Nippon Kayaku Co., Ltd., 2-1-1 Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan
| | - Naoki Izawa
- Department of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
| | - Hiroshi Imamura
- Department of Digestive Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibaharacho, Toyonaka, Osaka, 560-8565, Japan
| | - Hironori Yamaguchi
- Department of Surgery, Division of Gastroenterological, General and Transplant Surgery, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
| |
Collapse
|
|
2
|
Kim TH, Do Cho H, Choi YW, Lee HW, Kang SY, Jeong GS, Choi JH, Ahn MS, Sheen SS. Trastuzumab-based palliative chemotherapy for HER2-positive gastric cancer: a single-center real-world data. BMC Cancer 2021; 21:325. [PMID: 33771119 PMCID: PMC7995795 DOI: 10.1186/s12885-021-08058-2] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/27/2021] [Accepted: 03/15/2021] [Indexed: 12/12/2022] Open
Abstract
Background Since the results of the ToGA trial were published, trastuzumab-based chemotherapy has been used as the standard first-line treatment for HER2-positive recurrent or primary metastatic gastric cancer (RPMGC). However, the real-world data has been rarely reported. Therefore, we investigated the outcomes of trastuzumab-based chemotherapy in a single center. Methods This study analyzed the real-world data of 47 patients with HER2-positive RPMGC treated with trastuzumab-based chemotherapy in a single institution. Results With the median follow-up duration of 18.8 months in survivors, the median overall survival (OS) and progression-free survival were 12.8 and 6.9 months, respectively, and the overall response rate was 64%. Eastern Cooperative Oncology Group performance status 2 and massive amount of ascites were independent poor prognostic factors for OS, while surgical resection before or after chemotherapy was associated with favorable OS, in multivariate analysis. In addition, 5 patients who underwent conversion surgery after chemotherapy demonstrated an encouraging median OS of 30.8 months, all with R0 resection. Conclusions Trastuzumab-based chemotherapy in patients with HER2-positive RPMGC in the real world demonstrated outcomes almost comparable to those of the ToGA trial. Moreover, conversion surgery can be actively considered in fit patients with a favorable response after trastuzumab-based chemotherapy.
Collapse
Affiliation(s)
- Tae-Hwan Kim
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea
| | - Hun Do Cho
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea
| | - Yong Won Choi
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea
| | - Hyun Woo Lee
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea
| | - Seok Yun Kang
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea
| | - Geum Sook Jeong
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea
| | - Jin-Hyuk Choi
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea.
| | - Mi Sun Ahn
- Department of Hematology-Oncology, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea.
| | - Seung-Soo Sheen
- Department of Pulmonology and Critical Care Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 443-380, South Korea
| |
Collapse
|