Differences in efficacy of biweekly irinotecan plus cisplatin versus irinotecan alone in second-line treatment of advanced gastric cancer with or without prior gastrectomy

Kazuhiro Nishikawa; Wasaburo Koizumi; Akira Tsuburaya; Motoko Suzuki; Satoshi Morita; Kazumasa Fujitani; Yusuke Akamaru; Ken Shimada; Hisashi Hosaka; Ken Nishimura; Takaki Yoshikawa; Toshimasa Tsujinaka; Junichi Sakamoto

doi:10.1007/s10147-024-02661-6

Differences in efficacy of biweekly irinotecan plus cisplatin versus irinotecan alone in second-line treatment of advanced gastric cancer with or without prior gastrectomy

Int J Clin Oncol. 2024 Nov 25. doi: 10.1007/s10147-024-02661-6. Online ahead of print.

Authors

Affiliations

¹ Cancer Treatment Center, Osaka International Medical & Science Center, Osaka Keisatsu Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan. kazuno13@hotmail.co.jp.
² Kitasato University, 1-15-3, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan.
³ Department of Surgery, AOI Nanasawa Rehabilitation Hospital, Atsugi, Japan.
⁴ Department of Data Science, National Cancer Center Hospital East, Chiba, Japan.
⁵ Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54, Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8397, Japan.
⁶ Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi,Sumiyoshi-ku, Osaka, 558-0056, Japan.
⁷ Department of Surgery, Osaka Rosai Hospital, 1179-3 Nagasonecho, Kita-ku, Sakai City, Osaka, 591-8025, Japan.
⁸ Department of Internal Medicine, Division of Medical Oncology, Showa University Koto Toyosu Hospital, 5-1-38 Toyosu, Koto-ku, Tokyo, 135-8577, Japan.
⁹ Department of Gastroenterology, Gunma Prefectural Cancer Center, 617-1, Takahayashinishi-cho, Ohta, 373-0828, Japan.
¹⁰ Department of Oncology, Kitasato University Kitasato Institute Hospital, 5-9-1, Shirokane, Minato-ku, Tokyo, 108-8642, Japan.
¹¹ Department of Gastric Surgery, The National Hospital Organization National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
¹² Izumi City General Hospital, 4-5-1, Wakecho, Izumi, Osaka, 594-0073, Japan.
¹³ Tokai Central Hospital, 4-6-2, Sohara Higashijimacho, Kakamigahara, 504-8601, Japan.

PMID: 39585516
DOI: 10.1007/s10147-024-02661-6

Abstract

Background: Biweekly irinotecan plus cisplatin combination therapy (BIRIP) and irinotecan monotherapy (IRI) are both expectable second-line chemotherapy (SLC) options for treating advanced gastric cancer (AGC). Although many patients receiving SLC have undergone gastrectomy, the impact of gastrectomy on SLC remains unclear, and the impact of gastrectomy may vary from regimen to regimen.

Patients and methods: A total of 290 eligible patients registered in two randomized phase III trials evaluating BIRIP (IRI, 60 mg/m²; CDDP, 30 mg/m², q2w) or IRI (150 mg/m², q2w) for patients with AGC was classified into the prior gastrectomy subgroup (PGG) or the no gastrectomy subgroup (NGG). We performed a subgroup analysis to evaluate the impact of gastrectomy on second-line BIRIP and IRI.

Results: The BIRIP demonstrated significantly longer OS (11.1 vs. 6.8 months; HR 0.64; P = 0.026) and PFS (3.7 vs. 2.3 months; HR 0.54; P = 0.003) than the IRI, as well as better ORR (23.5% vs. 7.1%, P = 0.046) and DCR (74.5% vs. 47.6%, P = 0.010) in NGG. Although in PGG, the BIRIP failed to demonstrate differences in OS (13.8 vs. 13.8 months; HR 0.94; P = 0.722), PFS (4.9 vs. 4.5 months; HR 0.82; P = 0.194), ORR (18.3% vs. 20.5%) and DCR (70.4% vs. 65.1%). The incidence of grade 3 or worse adverse events did not differ except for a high incidence of anemia in the BIRIP group in PGG.

Conclusions: BIRIP was an effective treatment option that may improve survival outcomes among patients with AGC without previous gastrectomy.

Clinical trial registration: UMIN000025367.

Keywords: Advanced gastric cancer; Biweekly irinotecan plus cisplatin; Gastrectomy; Irinotecan; Second-line chemotherapy.