A single-arm phase II trial of weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) monotherapy after standard of chemotherapy for previously treated advanced non-small cell lung cancer

• DOI: 10.1007/s00280-019-03843-0
• Publication Date: 2019-04-16T13:04:43Z
• Authors: Yasuhiro Kato; Yusuke Okuma; Kageaki Watanabe; Makiko Yomota; Shoko Kawai; Yukio Hosomi; Tatsuru Okamura
• Keywords: Adult; Male; Lung Neoplasms; Paclitaxel; Middle Aged; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Albumins; Carcinoma, Non-Small-Cell Lung; Humans; Original Article; Female; Aged

Few studies have investigated the clinical efficacy of third- and later-line of chemotherapy after standard chemotherapy for previously treated advanced non-small cell lung cancer (NSCLC). We prospectively evaluated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) following standard chemotherapies for previously treated advanced NSCLC.The eligible patients having adequate organ functions with performance status 0-2 were enrolled after completing standard chemotherapy. 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. 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]. Median follow-up interval was 6.7 months hematological AEs of Grade 3/4 included anemia (18%), leukopenia (18%), and neutropenia (32%), while the most frequent nonhematological AEs were fatigue (50%) and peripheral neuropathy (36.4%). Severe AEs related to treatment were observed in only one patient.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.