PMID- 37304303 OWN - NLM STAT- MEDLINE DCOM- 20230613 LR - 20230614 IS - 1664-3224 (Electronic) IS - 1664-3224 (Linking) VI - 14 DP - 2023 TI - PD-1 inhibitors-based second-line therapy for metastatic gastric cancer. PG - 1136437 LID - 10.3389/fimmu.2023.1136437 [doi] LID - 1136437 AB - BACKGROUND: Metastatic gastric cancer (MGC) patients with progression on first-line treatment still have poor outcomes on chemotherapy. The KEYNOTE-061 study demonstrated that pembrolizumab, a PD-1inhibitor, was not better than paclitaxel as second-line therapy for MGC. Herein, we explored the efficacy and safety of PD-1inhibitor based treatment for MGC patients in the second line. METHODS: In this observational, retrospective study, we enrolled MGC patients treated with anti-PD-1 based therapy as second-line in our hospital. We primarily assessed the treatment's efficacy and safety. We also evaluated the relationship between clinical features and outcomes using univariate and multivariate analyses. RESULTS: We enrolled 129 patients with an objective response rate (ORR) of 16.3% and a disease control rate (DCR) of 79.1%. Patients treated with PD-1inhibitor combined with chemotherapy and anti-angiogenic agents had ORR of 19.6% and higher DCR of 94.1%. The median progression-free survival (PFS) was 4.10 months, and the median overall survival (OS) was 7.60 months. In univariate analysis, patients treated with PD-1inhibitor combined with chemotherapy and anti-angiogenic agents and with prior anti-PD-1 history were significantly associated with favorable PFS and OS. In the multivariate analysis, different combination therapy and prior anti-PD-1 history were independent prognosis biomarkers for PFS and OS. Grade 3 or 4 treatment-related adverse events (TRAEs) occurred in 28 (21.7%) patients. Common adverse events (AEs) included fatigue, hyper/hypothyroidism, neutrophil decrease, anemia, skin reactions, proteinuria, and hypertension. We did not observe treatment-related deaths. CONCLUSION: Our current results indicated that PD-1-inhibitor and chemo-anti-angiogenic agents combination therapy and prior PD-1 treatment history might improve clinical activity for GC immunotherapy as second-line treatment with acceptable safety profiles. Further studies are needed to verify those outcomes for MGC in other centers. CI - Copyright (c) 2023 Gou, Zhang, Wang and Dai. FAU - Gou, Miaomiao AU - Gou M AD - Medical Oncology Department, The Fifth Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China. FAU - Zhang, Yong AU - Zhang Y AD - Medical Oncology Department, The Second Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China. FAU - Wang, Zhikuan AU - Wang Z AD - Medical Oncology Department, The Fifth Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China. FAU - Dai, Guanghai AU - Dai G AD - Medical Oncology Department, The Fifth Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China. LA - eng PT - Journal Article PT - Observational Study DEP - 20230522 PL - Switzerland TA - Front Immunol JT - Frontiers in immunology JID - 101560960 RN - 0 (Immune Checkpoint Inhibitors) RN - 0 (Angiogenesis Inhibitors) SB - IM MH - Humans MH - *Immune Checkpoint Inhibitors/adverse effects MH - Retrospective Studies MH - *Stomach Neoplasms/drug therapy MH - Combined Modality Therapy MH - Immunotherapy MH - Angiogenesis Inhibitors PMC - PMC10251434 OTO - NOTNLM OT - PD-1 inhibitors OT - angiogenesis OT - immunotherapy OT - metastatic gastric cancer OT - second-line therapy COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/06/12 06:42 MHDA- 2023/06/13 06:42 PMCR- 2023/01/01 CRDT- 2023/06/12 04:07 PHST- 2023/01/04 00:00 [received] PHST- 2023/05/05 00:00 [accepted] PHST- 2023/06/13 06:42 [medline] PHST- 2023/06/12 06:42 [pubmed] PHST- 2023/06/12 04:07 [entrez] PHST- 2023/01/01 00:00 [pmc-release] AID - 10.3389/fimmu.2023.1136437 [doi] PST - epublish SO - Front Immunol. 2023 May 22;14:1136437. doi: 10.3389/fimmu.2023.1136437. eCollection 2023.