Clinical efficacy and safety of sintilimab plus oral vinorelbine as first-line treatment for newly diagnosed stage IIIB–IV nonsmall cell lung cancer patients with performance status 2 or age ≥75 years

This study aimed to evaluate the efficacy and safety of sintilimab combined with oral vinorelbine in newly diagnosed patients with stage IIIb to IV nonsmall cell lung cancer (NSCLC) who had an Eastern Cooperative Oncology Group performance status (PS) of 2 or over 75 years of age during the initial treatment. This prospective single-center single-arm study enrolled patients with histologically confirmed NSCLC. Eligible patients were administered sintilimab and vinorelbine. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR) and disease control rate (DCR). Furthermore, this study assessed indicators of treatment response and safety. From September 2020 to December 2023, 60 eligible patients were enrolled in the Respiratory Department of Shanxi Cancer Hospital. Following treatment, PFS was 9.1 months, and ORR and DCR were 39.6 and 63.79%, respectively. In addition, there was a reduction in blood tumor marker levels and enhanced immune function. Adverse reactions had a relatively low incidence and primarily consisted of grade 1-2 cases. Sintilimab plus oral vinorelbine showed promising efficacy and safety as a first-line treatment strategy for patients with NSCLC with PS 2 or elderly patients. It also optimizes immune function in patients with NSCLC.