Retrospective analysis for the efficacy and safety of nivolumab in advanced gastric cancer patients according to ascites
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ORIGINAL ARTICLE
Retrospective analysis for the efficacy and safety of nivolumab in advanced gastric cancer patients according to ascites burden Hirosumi Suzuki1 · Takeshi Yamada1 · Akinori Sugaya2 · Shunsuke Ueyama3 · Yoshiyuki Yamamoto1 · Toshikazu Moriwaki1 · Ichinosuke Hyodo1 Received: 16 May 2020 / Accepted: 9 October 2020 © Japan Society of Clinical Oncology 2020
Abstract Background Nivolumab is a standard later-line therapy for advanced gastric cancer (AGC). However, few reports exist about its efficacy and safety in patients with massive ascites. Methods We retrospectively collected clinical data from 72 AGC patients who received nivolumab administration at least once from Oct 2017 to Feb 2019 and studied their clinical outcomes dividing into two groups: 50 patients with no or localized ascites in the pelvic cavity or liver surface (LAB: low ascites burden) and 22 patients with massive ascites (HAB: high ascites burden). Results Median overall survival (OS) was 5.3 months (95% CI 3.4–7.3) in the LAB group and 2.5 months (95% CI 0.0–5.0) in the HAB group. Multivariate Cox regression analysis for OS revealed blood neutrophil-to-lymphocyte ratio (hazard ratio 0.40, 95% CI 0.20–0.83, p = 0.013) as an independent prognostic factor. Response rates in the patients with measurable lesions were 16% (7/43) and 8% (1/12) in the LAB and HAB groups, respectively. Ascites decreased or disappeared in 6 HAB patients (27%) and these responders had a prolonged OS of median 9.7 months (95% CI 3.6–15.8). The median time to ascites response was 1.3 months (95% CI 0.8–1.9). These responders have lower neutrophil-to-lymphocyte ratios than 5.0 at the start of nivolumab. Immune-related adverse events occurred in 23% of HAB and 18% of LAB patients. Conclusions Nivolumab could improve massive ascites and confer survival benefit for some AGC patients. Considering a similar incidence of immune-related adverse events, it would be a recommended treatment option for AGC with massive ascites. Keywords Gastric cancer · Nivolumab · Ascites
Introduction Peritoneal metastasis is the most frequent metastasis in advanced gastric or gastroesophageal junction cancer (AGC) [1]. Despite recent advances in systemic chemotherapy, the prognosis of gastric cancer with peritoneal metastasis is poor [2–6]. Approximately, 40% of patients with peritoneal * Takeshi Yamada [email protected] 1
Division of Gastroenterology, University of Tsukuba Hospital, 2‑1‑1, Amakubo, Tsukuba, Ibaraki 305‑8576, Japan
2
Division of Gastroenterology, Ibaraki Prefectural Central Hospital, 6528, Koibuchi, Kasama, Ibaraki, Japan
3
Division of Gastroenterology, Tsuchiura Kyodo Hospital, 4‑1‑1, Ootsuno, Tsuchiura, Ibaraki, Japan
metastasis have malignant ascites accompanying clinical symptoms such as abdominal pain, vomiting, and difficulty with ingestion that worsen performance status (PS) and complicate chemotherapy [7, 8]. Worldwide, the standard chemotherapy for AGC is first oral fluoropyrimidine plus platinum [with trastuzumab for human epid
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