Nivolumab Combined with Chemotherapy in FGFR2 and PD-L1 Co-Expressing Metastatic Gastric Cancer: A Prospective Phase 2 NIVOFGFR2 Study.

IF 1.6 Q4 ONCOLOGY

Journal of Gastrointestinal Cancer Pub Date : 2025-01-11 DOI:10.1007/s12029-025-01172-5

Ilya Tsimafeyeu, Gunel Musayeva, Samira Mahmudova, Nana Otkhozoria, Bahadur Abbasov, Alisher Kahharov, Fuad Guliyev

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引用次数: 0

Abstract

Background: Immunotherapy is increasingly significant in treating metastatic gastric cancer. This prospective phase 2 study investigates the efficacy and safety of combining nivolumab with chemotherapy in patients with metastatic gastric cancer co-expressing FGFR2 and PD-L1.

Methods: Eligible patients were aged 18 years or older, with previously untreated HER-2 negative, PD-L1 positive, and FGFR2 positive metastatic gastric adenocarcinoma. Patients received nivolumab (360 mg every 3 weeks) in combination with chemotherapy (CAPOX: capecitabine 1000 mg/m² twice daily on days 1-14 and oxaliplatin 130 mg/m² on day 1, every 3 weeks). Tumor assessments were conducted using RECIST v1.1 every 8 weeks for 48 weeks, then every 12 weeks. The primary endpoint was the 1-year progression-free survival (PFS) rate. Secondary endpoints included median PFS, overall survival (OS), objective response rate (ORR), and grade ≥ 3 adverse events (AEs).

Results: From June 2022 to October 2023, 194 patients were assessed for eligibility, with 23 patients enrolled and treated. At a median follow-up of 17.3 months, the 1-year PFS rate was 30.4%, with a median PFS of 6.0 months (95% CI, 4.3-7.7). The median OS was 15.1 months (95% CI, 13.2-16.8). The ORR was 21.7%, with one complete response and four partial responses. Grade 3 or higher TRAEs were reported in 34.8% of patients, primarily associated with chemotherapy. No treatment-related deaths occurred.

Conclusions: While the primary endpoint of improved 1-year PFS rate was not met, the study offers valuable insights into the potential benefits of combining nivolumab with chemotherapy in FGFR2 and PD-L1 co-expressing metastatic gastric cancer. Future research should optimize patient selection, assess combined immunotherapy and targeted anti-FGFR2 therapy, and further investigate the role of subsequent treatments to maximize therapeutic benefits.

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尼武单抗联合化疗治疗FGFR2和PD-L1共表达的转移性胃癌：一项前瞻性2期NIVOFGFR2研究

背景：免疫疗法在转移性胃癌的治疗中越来越重要。这项前瞻性2期研究调查了nivolumab联合化疗在转移性胃癌患者中共表达FGFR2和PD-L1的疗效和安全性。方法：符合条件的患者年龄为18岁或以上，既往未接受治疗的HER-2阴性，PD-L1阳性和FGFR2阳性转移性胃腺癌。患者接受纳武单抗（360 mg/ 3周）联合化疗（CAPOX：卡培他滨1000 mg/m2，每日2次，1-14天，奥沙利铂130 mg/m2，第1天，每3周）。采用RECIST v1.1进行肿瘤评估，每8周进行一次，连续48周，然后每12周进行一次。主要终点是1年无进展生存（PFS）率。次要终点包括中位PFS、总生存期（OS）、客观缓解率（ORR）和≥3级不良事件（ae）。结果：从2022年6月到2023年10月，194例患者被评估为合格，其中23例患者入组并接受治疗。在17.3个月的中位随访中，1年PFS率为30.4%，中位PFS为6.0个月（95% CI, 4.3-7.7）。中位OS为15.1个月（95% CI, 13.2-16.8）。ORR为21.7%，1例完全缓解，4例部分缓解。34.8%的患者报告了3级或更高级别的trae，主要与化疗相关。无治疗相关死亡发生。结论：虽然改善的1年PFS率的主要终点未达到，但该研究提供了有价值的见解，说明在FGFR2和PD-L1共表达的转移性胃癌中，联合纳沃单抗与化疗的潜在益处。未来的研究应优化患者选择，评估联合免疫治疗和靶向抗fgfr2治疗，并进一步研究后续治疗的作用，以最大限度地提高治疗效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Gastrointestinal Cancer ONCOLOGY-

CiteScore

3.80

自引率

0.00%

发文量

121

期刊介绍： The Journal of Gastrointestinal Cancer is a multidisciplinary medium for the publication of novel research pertaining to cancers arising from the gastrointestinal tract.The journal is dedicated to the most rapid publication possible.The journal publishes papers in all relevant fields, emphasizing those studies that are helpful in understanding and treating cancers affecting the esophagus, stomach, liver, gallbladder and biliary tree, pancreas, small bowel, large bowel, rectum, and anus. In addition, the Journal of Gastrointestinal Cancer publishes basic and translational scientific information from studies providing insight into the etiology and progression of cancers affecting these organs. New insights are provided from diverse areas of research such as studies exploring pre-neoplastic states, risk factors, epidemiology, genetics, preclinical therapeutics, surgery, radiation therapy, novel medical therapeutics, clinical trials, and outcome studies.In addition to reports of original clinical and experimental studies, the journal also publishes: case reports, state-of-the-art reviews on topics of immediate interest or importance; invited articles analyzing particular areas of pancreatic research and knowledge; perspectives in which critical evaluation and conflicting opinions about current topics may be expressed; meeting highlights that summarize important points presented at recent meetings; abstracts of symposia and conferences; book reviews; hypotheses; Letters to the Editors; and other items of special interest, including:Complex Cases in GI Oncology: This is a new initiative to provide a forum to review and discuss the history and management of complex and involved gastrointestinal oncology cases. The format will be similar to a teaching case conference where a case vignette is presented and is followed by a series of questions and discussion points. A brief reference list supporting the points made in discussion would be expected.