MO2-13-1Randomized phase II trial of CBDCA+nab-PTX vs CDDP+GEM in patients with chemo-naïve squamous cell lung cancer: NJLCG1302

Abstract Background The subset analysis of CA031 trial showed a significant improvement of overall response rate (ORR) for carboplatin (CBDCA) plus weekly nab-paclitaxel (CnP) versus CBDCA plus paclitaxel in patients (pts) with squamous cell histology (41% vs 24%). We conducted a phase II study comparing CnP to cisplatin plus gemcitabine (CG), one of the standard regimens in pts with squamous cell lung cancer (SCC). Methods Chemo-naive stage IIIB/IV or postoperative recurrent SCC pts were randomly assigned to receive either cisplatin (80 mg/m2) on day 1 plus gemcitabine (1000 mg/m2) on days 1, 8 every 3 weeks or CBDCA (AUC 6 mg/ml/min) on day 1 plus nab-PTX (75 mg/m2) on days 1, 8, 15 every 3 weeks. The primary endpoint was ORR. Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and toxicity. Assuming that an ORR of 40% in eligible pts indicates potential usefulness and ORR of 20% is the lower limit of interest, the estimated accrual was 32 pts in each arm. Allowing for dropouts, the accrual goal was determined to be 35 pts in each arm (alpha, 0.05; beta, 0.20). Results Between June 2013 and October 2018, 71 pts were enrolled and assigned to CG arm (n = 35) and CnP arm (n = 36). The median follow-up time was 10.2 months. At data cutoff, ORR was 40% (95% confidence interval [CI]: 24.5-55.5) in CG arm and 47% (95%CI: 31.7-62.7) in CnP arm. DCR was 74% in CG arm and 80% in CnP arm. Median PFS was 4.6 months in CG arm and 4.3 months in CnP arm. Median OS was 10.9 months in CG arm and 10.0 months in CnP arm. Of the grade 3 or higher adverse events, anemia was more common in CnP arm (CG, 17% and CnP, 53%). There was one treatment-related death in CG arm and no treatment-related death in CnP arm. Conclusions In this study, both CnP and CG arms met the primary endpoint. Carboplatin-based CnP regimen was likely to be equivalent to CG for SCC.