Real-world effectiveness of third- or later-line treatment in Japanese patients with HER2-positive,unresectable, recurrent or metastatic gastric cancer: a retrospective observational study |
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Authors: | Sakai Daisuke Omori Takeshi Fumita Soichi Fujita Junya Kawabata Ryohei Matsuyama Jin Yasui Hisateru Hirao Motohiro Kawase Tomono Kishi Kentaro Taniguchi Yoshiki Miyazaki Yasuhiro Kawada Junji Satake Hironaga Miura Tomoko Miyake Akimitsu Kurokawa Yukinori Yamasaki Makoto Yamada Tomomi Satoh Taroh Eguchi Hidetoshi Doki Yuichiro |
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Affiliation: | 1.Osaka University Graduate School of Medicine, Suita, Japan ;2.Osaka International Cancer Institute, Osaka, Japan ;3.Kindai University, Osakasayama, Japan ;4.Sakai City Medical Center, Sakai, Japan ;5.Osaka Rosai Hospital, Sakai, Japan ;6.Higashiosaka City Medical Center, Higashiosaka, Japan ;7.Kobe City Medical Center General Hospital, Kobe, Japan ;8.National Hospital Organization Osaka National Hospital, Osaka, Japan ;9.Toyonaka Municipal Hospital, Toyonaka, Japan ;10.Osaka Police Hospital, Osaka, Japan ;11.Saiseikai Senri Hospital, Suita, Japan ;12.Osaka General Medical Center, Osaka, Japan ;13.Yao Municipal Hospital, Yao, Japan ;14.Kansai Medical University, Hirakata, Japan ;15.Daiichi Sankyo Co., Ltd., Tokyo, Japan ;16.Osaka University Hospital, Suita, Japan ; |
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Abstract: | Background Real-world evidence on the preference for and effectiveness of third- or later-line (3L +) monotherapy for HER2-positive gastric cancer is limited in Japan. This study evaluated the utility of nivolumab, irinotecan, and trifluridine/tipiracil (FTD/TPI) monotherapy as 3L + treatment in Japanese patients with HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer who were previously treated with trastuzumab. MethodsIn this multicenter, retrospective, observational study (20 centers), data of eligible patients were extracted from medical records (September 22, 2017–March 31, 2020), with follow-up until June 30, 2020. Outcomes included overall survival (OS), real-world progression-free survival (rwPFS), time to treatment failure (TTF), objective response rate (ORR; complete response [CR] + partial response [PR]), and disease control rate (DCR). ResultsOf 127 enrolled patients, the overall analysis population comprised 117 patients (median [range] age, 71 [38–89] years). The most commonly prescribed 3L + monotherapy was nivolumab (n = 100), followed by irinotecan (n = 12) and FTD/TPI (n = 5). The median (95% confidence interval [CI]) OS, rwPFS, and TTF were 6.2 (4.5–8.0), 1.9 (1.5–2.3), and 1.8 (1.5–2.2) months, respectively, at median (range) 150 (25–1007) days of follow-up. The ORR (CR + PR) and DCR were 9.0% (1% + 8%) and 32.0%, respectively. Factors such as higher neutrophil–lymphocyte ratio (≥ 2.54), Glasgow prognostic score (≥ 1), Eastern Cooperative Oncology Group performance status (ECOG PS; ≥ 2), and hepatic metastasis significantly impacted OS. ConclusionsThe observed OS in this study for HER2-positive G/GEJ cancer was shorter than that reported previously, suggesting that the effectiveness of nivolumab, irinotecan, or FTD/TPI as 3L + therapy may be limited. |
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