Weekly albumin-bound paclitaxel/cisplatin versus gemcitabine/cisplatin as first-line therapy for patients with advanced non-small-cell lung cancer: A phase II open-label clinical study

Objective: The aim of this trial was to compare both the efficacy and the safety of a weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus cisplatin vs. gemcitabine plus cisplatin in patients with advanced non-small-cell lung cancer (NSCLC).

Methods: A total of 84 participants received either 100 mg/m² nab-paclitaxel each week on d 1, 8 and 15 of a 28 day cycle, as well as cisplatin 75 mg/m² on d 1 every three weeks (nab-TP arm); or gemcitabine 1,000 mg/m² on d 1 and 8, plus cisplatin 75 mg/m² on d 1 every three weeks (GP arm). The primary end point was progression-free survival (PFS). The secondary end points were overall response rate (ORR) and overall survival (OS).

Results: According to our analysis, the median PFS was 4.8 months for the nab-TP arm vs. 5.2 months for the GP arm (P=0.55). Analysis showed the median OS was 14.6 months for participants who were in the nab-TP arm vs. 15.1 months for those in the GP arm (P=0.94). Besides, nab-TP showed OS advantages over GP in patients harboring epidermal growth factor receptor (EGFR) mutation (26.7 vs. 15.3 months, P=0.046) and patients with a performance status of 0 (23.5 vs. 14.7 months, P=0.020). It was found that incidences of drug-related grade 3 or 4 toxicities were comparable between the two treatment arms.

Conclusions: Therefore, it can be seen that weekly nab-TP treatment has a similar efficacy and tolerability to GP treatment for patients who are undergoing their first-line treatment for NSCLC. It could be that survival differences among platinum doublets in the context of both EGFR mutation and performance status have the potential to be the basis for our further clinical trials.