Retrospective analysis for efficacy and safety of nivolumab in advanced gastric cancer patients (pts) with malignant ascites.

Authors

null

Akinori Sugaya

Division of Medical Oncology, Ibaraki Prefectural Hospital, Kasama, Japan

Akinori Sugaya , Shunsuke Ueyama , Hirosumi Suzuki , Takeshi Yamada , Yoshiyuki Yamamoto , Toshikazu Moriwaki , Ichinosuke Hyodo

Organizations

Division of Medical Oncology, Ibaraki Prefectural Hospital, Kasama, Japan, Division of Gastroenterology, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan, Division of Gastroenterology, Faculty of Medicine, University of Tsukuba Hospital, Tsukuba, Japan, Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan, University of Tsukuba, Tsukuba, Japan

Research Funding

No funding received
None

Background: Nivolumab is a standard of care as the later-line therapy for advanced gastric cancer. However, there are few data about efficacy and safety of nivolumab for pts with malignant ascites. Methods: We conducted a multicenter retrospective study for pts with advanced gastric cancer who received nivolumab alone from Oct. 2017 to Feb. 2019. Pts were divided into two groups; high ascites burden (HAB) with moderate or massive ascites and non-HAB with none or a small amount of localized ascites at pelvis and/or liver surface. Results: A total of 72 pts (23 pts with HAB and 49 pts with non-HAB) were evaluable. The HAB group had more pts with young (median 62 vs 70 years), female (35 vs 14 %), no prior gastrectomy (63 vs 35 %) and poor performance status (PS > 1; 26 vs 10 %), compared to the non-HAB group. Disease control rate was 44% (95% CI 23-64%) in the HAB group and 57% (95% CI 43-71%) in the non-HAB group. Ascites decreased in 4 pts (17%) and completely disappeared in 2 pts (8.7%) in the HAB group. These 6 pts were all male and had prior ramucirumab treatment with a mean neutrophil-lymphocyte ratio 2.1 (from 0.85 to 3.7) at the initiation of nivolumab. After 5 months of follow up period, disease progression or death events for progression-free survival (PFS) occurred in 74% of the HAB group and 53% of the non-HAB group. Median PFS was 1.0 (95%CI 0.5-1.5) and 2.6 (95%CI 0.9-7.4) months in pts with HAB and non-HAB, respectively. PFS rates at 6 months were 31% in the HAB group and 33% in the non-HAB group. Immune-related adverse events occurred in 26% of the HAB group and 16% of the non-HAB group including one and two pts with grade 3 or 4 events, respectively. There was no treatment-related death in both groups. Conclusions: Although pts with HAB showed trends of worse outcomes compared with those with non-HAB, nivolumab was suggested to provide a survival benefit to some pts with HAB, and was tolerable in the HAB group.

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Esophageal and Gastric Cancer and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 392)

Abstract #

392

Poster Bd #

F3

Abstract Disclosures