331P - A single-arm, open-label, prospective, single-center clinical study on the treatment of patinum-resistant relapse small cell lung cancer with nab-paclitaxel combined with apatinib

Background

Patinum-resistant relapse small cell lung cancer (PRRSCLC) refers to patients who experience disease progression during first-line chemotherapy or within 3 months after its cessation according to ESMO Guidelines. Currently, treatment options for PRRSCLC are limited and outcomes are very poor for these patients. This study aims to evaluate the efficacy and safety profile of nab-paclitaxel combined with apatinib as second-line therapy for PRRSCLC.

Methods

All subjects received nab-paclitaxel via intravenous infusion at a dose of 130 mg/m², on days 1 and 8, every 3 weeks (q3w). Apatinib was administered at 250 mg once daily (qd), every 3 weeks (q3w). After four cycles of treatment with albumin-bound paclitaxel combined with apatinib, apatinib monotherapy at 250 mg was continued until disease progression, intolerable toxicity, or other reasons specified in the protocol.

Primary Objective: Progression-free survival (PFS) of nab-paclitaxel combined with apatinib in the treatment of PRRSCLC. The efficacy was evaluated every 2 cycles (6 weeks).

Results

Twenty-two patients were enrolled. In 20 efficacy-evaluable patients, the ORR was 25.0% (5/20); the disease control rate was 80.0% (16/20). The median follow-up time was 5.5 months. The median PFS was 5.3 months (95% CI, 3.13 to 8.38). The median overall survival was 14.4 months (95% CI, 5.26 to NE). Furthermore, 100% of the patients experienced treatment-related adverse events. The most frequent treatment-related adverse events were myelosuppression (95%), bilirubin increased (35%) and peripheral neurotoxicity (30%).

Patient characteristics (N=20)