Abstract
BackgroundThe present study was conducted to analyze the clinical efficacy and safety of sintilimab as second-line or above therapy for patients with advanced or metastatic gastric cancer.MethodsPatients with advanced or metastatic gastric cancer that progressed after prior systemic therapies and treated with sintilimab from March 2019 to July 2020 were retrospectively analyzed in this study. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.ResultsFifty-two patients with advanced or metastatic gastric cancer received sintilimab monotherapy or combination therapy after they failed from prior systemic therapies. Eight patients achieved partial response (PR), 26 patients had stable disease (SD), and 18 patients had progressive disease (PD). The ORR and DCR were 15.4% (8/52) and 65.4% (34/52), respectively. Median PFS was 2.5 months (95% CI = 2.0–3.0), and median OS was 5.8 months (95% CI = 4.9–6.7). The ORR and DCR were 30.0% (6/20) and 80.0% (16/20), respectively, in intestinal subtype, which were superior than in non-intestinal subtype (ORR: 6.3%, DCR: 56.3%). Patients with intestinal subtype obtained longer PFS (4.0 vs. 1.9) and OS (9.0 vs. 4.1) than those with non-intestinal subtype. The incidence of grade 3–4 adverse events was 44.2%.ConclusionsSintilimab monotherapy or combination therapy provides a feasible therapeutic strategy for patients with advanced or metastatic gastric cancer who failed from prior systemic therapies. The efficacy of sintilimab in intestinal subtype was superior than that in non-intestinal subtype.
Highlights
Most cases of gastric cancer are advanced at diagnosis, the prognosis is extremely poor, and there is a lack of effective treatment
From March 2019 to July 2020, patients with advanced or metastatic gastric cancer who failed from prior systemic therapies at Henan Cancer Hospital were retrospectively analyzed
Eligibility criteria were as follows: 1) patients with gastric cancer that progressed after first-line chemotherapy and treated with sintilimab as second-line or above therapy; 2) Eastern Cooperative Oncology Group (ECOG) performance status 0/1; 3) measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), at least one lesion can be measured by imaging examination, and the lesion measured by spiral CT or MRI is ≥10 mm; and 4) adequate organ function
Summary
Most cases of gastric cancer are advanced at diagnosis, the prognosis is extremely poor, and there is a lack of effective treatment. Medical treatment, including chemotherapy and targeted therapy, is currently the main treatment for advanced or metastatic gastric cancer. As an emerging treatment method, immunotherapy is the current research hotspot, and it is hoped that it can further improve the curative effect of advanced gastric cancer [5]. Based on the ATTRACTION-02 and KEYNOTE-059 studies, nivolumab and pembrolizumab have been approved in advanced gastric cancer in Japan and the United States as third-line treatment, respectively [6, 7]. The present study was conducted to analyze the clinical efficacy and safety of sintilimab as second-line or above therapy for patients with advanced or metastatic gastric cancer
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