Abstract
OBJECTIVE: This study aimed to assess the safety and efficacy of generic nab-paclitaxel in the Chinese population in a real-world setting. METHODS: This prospective, multicenter, observational study enrolled patients with malignancies who received any generic nab-paclitaxel-based regimens in China. The primary endpoint was safety, and secondary endpoint was objective response rate (ORR). Logistic regression was used to explore risk factors for adverse events (AEs) of special interest (AESIs). RESULTS: Between September 2019 and April 2023, 1168 patients were enrolled and evaluated for safety, and 602 were assessed for tumor response. Of 1168 patients, 169 (14.5%) received generic nab-paclitaxel monotherapy, and 999 (85.5%) received generic nab-paclitaxel-based combination therapy. Grade 3-4 AEs occurred in 19.3% (225/1168) patients, most commonly including neutrophil count decreased (7.6%), anemia (5.8%), and white blood cell decreased (5.7%). In subgroup analysis, peripheral sensory neuropathy was observed frequently in breast cancer (45.6%). Multivariate analysis showed that patients receiving combination therapy and ≥ 4 treatment cycles (OR, 1.925; 95% CI 1.363-2.719; p < 0.001) were more susceptible to the AESIs. CONCLUSIONS: This study demonstrates a promising safety and efficacy of generic nab-paclitaxel-based regimens for Chinese patients with malignancies in a real-world setting, providing valuable insights for clinical decision-making. CLINICAL TRIALS: gov NCT04060290.