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

Autor: Daisuke Sakai, Takeshi Omori, Soichi Fumita, Junya Fujita, Ryohei Kawabata, Jin Matsuyama, Hisateru Yasui, Motohiro Hirao, Tomono Kawase, Kentaro Kishi, Yoshiki Taniguchi, Yasuhiro Miyazaki, Junji Kawada, Hironaga Satake, Tomoko Miura, Akimitsu Miyake, Yukinori Kurokawa, Makoto Yamasaki, Tomomi Yamada, Taroh Satoh, Hidetoshi Eguchi, Yuichiro Doki
Rok vydání: 2022
Předmět:
Zdroj: International Journal of Clinical Oncology. 27:1154-1163
ISSN: 1437-7772
1341-9625
Popis: 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. Methods In 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). Results Of 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. Conclusions The 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.
Databáze: OpenAIRE
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