Clinical features as potential prognostic factors in patients treated with nivolumab for highly pretreated metastatic gastric cancer: A multicenter retrospective study

Although nivolumab (anti-programmed cell death-1 antibody) is a promising approach for advanced gastric cancer (AGC), the response rate remains limited. The aim of this multicenter retrospective study was to determine if clinical features could serve as prognostic factors of the efficacy of nivolumab in patients with AGC.
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Clinical features as potential prognostic factors in patients treated with nivolumab for highly pretreated metastatic gastric cancer: A multicenter retrospective studySanoetal. BMC Cancer (2022) 22:22https://doi.org/10.1186/s12885-021-09118-3 RESEARCH ARTICLE Open AccessClinical features aspotential prognosticfactors inpatients treated withnivolumabforhighly pretreated metastatic gastric cancer:amulticenter retrospective studyAkihikoSano1  , MakotoSohda1*, NobuhiroNakazawa1, YasunariUbukata1, KengoKuriyama1, AkiharuKimura1,NorimichiKogure1, HisashiHosaka2, AtsushiNaganuma3, MasanoriSekiguchi4, KanaSaito5, KyoichiOgata1,MakotoSakai1, HiroomiOgawa1, KenShirabe1and HiroshiSaeki1  Abstract  Background:  Although nivolumab (anti-programmed cell death-1 antibody) is a promising approach for advanced gastric cancer (AGC), the response rate remains limited. The aim of this multicenter retrospective study was to deter- mine if clinical features could serve as prognostic factors of the efficacy of nivolumab in patients with AGC. Methods:  Fifty-eight patients with AGC who were treated with nivolumab as a third or later line from October 2017 to December 2018 at any of five clinical sites were enrolled in the study. The correlation between the best over- all response and clinical features was investigated. Overall survival and progression-free survival after initiation of nivolumab were calculated and clinical features that could be predictors of the prognosis were sought. Results:  The disease control rate (DCR) for nivolumab was 36.2% and was significantly correlated with perfor- mance status (p = 0.021), metastasis to one organ (p = 0.006), and grade 2 or higher immune-related adverse events (p = 0.027). There was also a significant association between response to nivolumab and ability to receive subsequent chemotherapy (p = 0.022). In the analysis of overall survival, the following variables were identified as being signifi- cantly associated with a poor outcome: Eastern Cooperative Oncology Group performance status ≥1, prior treat- ment with trastuzumab, no immune-related adverse events, lack of a response to nivolumab, and inability to receive subsequent chemotherapy. Conclusion:  The findings of this study suggest that nivolumab may be ineffective for AGC in patients with poor performance status and those with a history of treatment with trastuzumab. Keywords:  Nivolumab, Advanced gastric cancer, Performance status, Trastuzumab, Immune-related adverse events Background Despite the recent advent of various anticancer drugs, there is still no cure for unresectable advanced or recur- rent gastric cancer (AGC). According to the Japanese*Correspondence: msohda@gunma-u.ac.jp gastric cancer treatment guidelines [1], oral fluoropy-1 Department ofGeneral Surgical Science, Gunma University Graduate rimidine plus platinum is the standard first-line chemo-School ofMedicine, 3‑39‑22 Showa‑machi, Maebashi, Gunma 371‑8511,Japan therapy for human epidermal growth factor receptor 2Full list of author information is available at the end of the article (HER2)-negative unresectable AGC [2–6]. In contrast, © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://​creat​iveco​mmons.​org/​licen​ses/​by/4.​0/. The Creative Commons Public Domain Dedication waiver (http://​creat​iveco​ mmons.​org/​publi​cdoma​in/​zero/1.​0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.Sanoetal. BMC Cancer (2022) 22:22 Page 2 of 12trastuzumab is recommended in combination with first- regimens, and therapies before initiating treatment withline chemotherapy in patients with HER-2-positive AGC nivolumab.based on the results of the ToGA trial [7]. For second-linechemotherapy, paclitaxel plus ramucirumab, an anti-vas- Treatment andassessmentcular endothelial growth factor receptor 2 antibody, was Nivolumab was administered intravenously at a dose ofshown to be superior to weekly paclitaxel ...