WCLC 2025 - Posters & ePosters-P3.18.44 Oral Metronomic Vinorelbine and PD-1 Inhibitors in Elderly Patients With Non-Small Cell Cancer

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This open-label, non-randomized phase 2 study investigated the efficacy and safety of combining oral metronomic vinorelbine with PD-1 inhibitors in elderly patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC). The study enrolled 19 patients, 14 of whom received this combination as first-line treatment.<br /><br />Patients older than 80 years received a reduced vinorelbine dose (20 mg weekly), while others received 40 mg weekly, combined with PD-1 inhibitors every three weeks. The primary endpoint was objective response rate (ORR), with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and safety.<br /><br />Results showed an ORR of 31.5% and a DCR of 78.9%. Median PFS for all patients was six months, with a longer median PFS observed in first-line treatment patients (7 months) versus those receiving treatment in later lines (2 months). Median overall survival (OS) was not reached at the time of reporting. Although patients with PD-L1 tumor proportion score (TPS) ≥1% had numerically longer PFS compared to those with TPS <1% (7 months vs. 3 months), this difference was not statistically significant.<br /><br />Treatment was generally well tolerated; the most common adverse events were immune-related hypothyroidism (21%) and other endocrinopathies (15.8%). Only one patient experienced a grade 3 or higher adverse event (liver function impairment), attributed to concurrent anti-tuberculosis therapy. No treatment-related deaths occurred.<br /><br />The study concludes that oral metronomic vinorelbine combined with PD-1 inhibitors is an effective, safe, and convenient treatment option for elderly patients with advanced NSCLC. Given these promising findings, the authors recommend a large-scale randomized phase 3 trial to validate the results and potentially establish this regimen as a standard of care in this patient population.

Asset Subtitle

Maojing Guan

Meta Tag

Speaker Maojing Guan

Topic Clinical Trials in Progress

Keywords

oral metronomic vinorelbine

PD-1 inhibitors

elderly patients

non-small cell lung cancer

phase 2 study

objective response rate

progression-free survival

immune-related hypothyroidism

treatment safety

first-line therapy