A Randomized Controlled Phase Ⅱ Study of Nab-Paclitaxel vs. Paclitaxel plus Cisplatin in Concomitant Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Abstract

To evaluate the efficacy and safety of concomitant chemoradiotherapy with nab-paclitaxel and cisplatin in patients with locally advanced non-small cell lung cancer (NSCLC). This study (NCT04284215) is a prospective, phase II, randomized controlled study, and the patients are enrolled in a ratio of 1:1 in the study with patients treat-naïve locally advanced stage III non-small cell lung cancer.in comparison with paclitaxel plus cisplatin, the regimen of nab-paclitaxel plus cisplatin was use in the treatment of DT:69 Gy/46f.Nab-paclitaxel 40mg/m2/week (4-6 weeks in total) and cisplatin 75mg/m2 for 2 cycles. paclitaxel 175mg/m2 d1, cisplatin 75mg/m2 for 2 cycles. The primary endpoints are ORR and treatment-induced toxicity of concurrent chemoradiotherapy, and the secondary endpoints are PFS and OS. A total of 68 patients (1:1) were randomized from March 3, 2019 to August 23, 2021.Sixty-five patients received concomitant chemoradiotherapy according to the study protocol, including 32 patients in the nab-paclitaxel group and 33 patients in the paclitaxel group. There was no significant difference in ORR between the two groups (84.4% vs. 73.7%, p = 0.411).There was no difference in median PFS between the two groups (14 months (95% CI 14.60-22.93) vs. 12 months (95% CI 13.15-22.74), P = 0.521).The incidence of grade III-IV leukopenia and neutropenia, fatigue, nausea, vomiting and other toxic and adverse reactions in the nab-paclitaxel group were significantly lower than those in the paclitaxel group (P<0.006, P<0.000, 0.016, 0.021, 0.019) CONCLUSION: Compared with paclitaxel plus cisplatin regimen, the combination of nab-paclitaxel plus cisplatin regimen has no significant difference in ORR and PFS, but significantly reduces the incidence of grade III-IV granulocytopenia and gastrointestinal reactions.