Single-arm,one-center, exploratory clinical trial of albumin-bound paclitaxel second and more line therapy for advanced non-small cell lung cancer

doi:10.12092/j.issn.1009-2501.2019.11.011

Abstract

Abstract:

AIM: To explore the efficacy and safety of second and more line treatment with albumin-bound paclitaxel for advanced non-small cell lung cancer. METHODS: From Oct 2012 to Dec 2015, a total of 63 patients with advanced non-small cell lung cancer who had failed previously first-line and more line treatment were enrolled in this study. The patients were treated with 130 mg/m2 intravenous infusion albumin-binding paclitaxel on day 1 and day 8, 21 days one cycle. The efficacy was evaluated every 2 cycles, and adverse reactions were recorded using the CTCAE4.03 version. Patients were followed up by telephone to obtain prognostic data after disease progression. RESULTS:All of the 63 patients were available for efficacy evaluation, among them, complete remission (CR) 0 case, partial remission (PR) 15 case, stable disease (SD) 21 case, progression disease (PD) 27 case. Objective response rate (ORR) was 23.81%, disease control rate (DCR) was 57.14%, median Progression-free survival (PFS) of the 63 patients was 3.9 months (95%CI: 3.1-5.2), median Overall survival (OS) was 9.3 months (95%CI: 7.8-10.4). In terms of safety analysis, the major grade 2 and above adverse reactions were neutropenia, thrombocytopenia, alopecia and peripheral neurotoxicity, and the overall adverse reactions were tolerable. CONCLUSION:The second and more line treatment with albumin-bound paclitaxel in patients with advanced non-small cell lung cancer has superior efficacy and controllable adverse events, which is expected to become the second-line treatment standard regimens for advanced NSCLC.

Key words: non-small cell lung cancer, albumin bound paclitaxel, efficacy, safety

CLC Number:

YANG Ke, LI Junling, DU Bin, TIAN Zhongqiu, JING Xiujuan. Single-arm,one-center, exploratory clinical trial of albumin-bound paclitaxel second and more line therapy for advanced non-small cell lung cancer[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2019, 24(11): 1281-1286.

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