EP1.01-20 A Single-Arm Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel Monotherapy After Standard Therapy for Advanced NSCLC

Abstract

Few studies have investigated the clinical efficacy of later-line treatments after standard therapy for advanced non-small cell lung cancer (NSCLC). Nanoparticle albumin-bound paclitaxel was one of the useful option for treatment of NSCLC. We conducted PII trial for evaluating the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) following standard therapy for advanced NSCLC. The eligible patients having adequate organ functions with performance status 0−2 were enrolled after completing standard therapy. Standard therapy defined as chemotherapy including docetaxel and pemetrexed in patients with non-squamous cell lung cancer or docetaxel in patients with squamous cell lung cancer. After the ICI nivolumab was approved by the Ministry of Health, Labor and Welfare of Japan in December 2015, standard therapy was defined as including ICIs treatment. They received weekly nab-paclitaxel 100 mg/m2 intravenously on days 1, 8, and 15 every 3 weeks. The primary end point was objective response rate (ORR). Median progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated as secondary end points. This trial was discontinued because of late accrual. Twenty-two patients were enrolled from April 2013 and February 2019. All patients received chemotherapy including docetaxel and Six patients received ICIs treatment. Median follow-up interval was 6.7 months. The total ORR was 22.7% [95% CI: 7.8−45.4] and disease control rate (DCR) was 81.8% [95% CI: 59.7−94.8]. Median PFS was 3.4 months [95% CI: 2.3−4.1] and median OS was 7.4 months [95% CI: 4.2−10.7]. Hematological AEs of Grade 3/4 included anemia (18%), leukopenia (18%), and neutropenia (32%), and the most frequent nonhematological AEs were fatigue (50%) and peripheral neuropathy (36.4%). Severe AEs related to treatment were observed in only one patient. Although all patients received chemotherapy including docetaxel before protocol treatment, our tral suggested nab-paclitaxel may be a safe and effective later-line chemotherapeutic option for previously treated advanced NSCLC after standard of chemotherapies based on other trials.