Polymeric micellar paclitaxel (Pm-Pac) prolonged overall survival for NSCLC patients without pleural metastasis.

Nanoparticle polymeric micellar paclitaxel (Pm-Pac) has been demonstrated to have a safety profile and efficacy in advanced non-small cell lung cancer (NSCLC) patients. However, whether Pm-Pac could prolong overall survival (OS) for specific advanced NSCLC patients is still unknown. In the present study, a total of 448 patients were randomly assigned (2:1) by the permuted block algorithm to receive Pm-Pac plus cisplatin or solvent-based paclitaxel (Sb-Pac) plus cisplatin (NCT02667743). We performed subgroup analysis based on metastatic status to identify the potential benefit patients. Our results indicated that the metastatic profiles were similar between the Sb-Pac plus cisplatin cohort and the Pm-Pac plus cisplatin cohort. Several subgroups (Metastases = 2, Bone metastasis, No pleural metastasis, etc.) were observed to have increased progression-free survival (PFS) due to Pm-Pac plus cisplatin. Importantly, we found the first evidence that Pm-Pac potentially prolonged OS with a favourable safety profile in NSCLC patients without pleural metastasis. Collectively, this study provides a novel perspective on the development of nanomedicine to investigate chemotherapeutic efficacy and toxicity and provides the first clinical evidence that Pm-Pac administration not only prolongs PFS but also prolongs OS with a favourable safety profile in advanced NSCLC patients without pleural metastasis.