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A phase I/II trial of weekly nab‐paclitaxel for pretreated non‐small‐cell lung cancer patients without epidermal growth factor receptor mutations and anaplastic lymphoma kinase rearrangement
Author(s) -
Harada Daijiro,
Kozuki Toshiyuki,
Nogami Naoyuki,
Bessho Akihiro,
Hosokawa Shinobu,
Fukamatsu Nobuaki,
Hotta Katsuyuki,
Ohashi Kadoaki,
Kubo Toshio,
Yoshioka Hiroshige,
Yokoyama Toshihide,
Sone Naoyuki,
Kuyama Shoichi,
Kudo Kenichiro,
Yasugi Masayuki,
Takigawa Nagio,
Oze Isao,
Kiura Katsuyuki
Publication year - 2019
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/ajco.13147
Subject(s) - medicine , anaplastic lymphoma kinase , lung cancer , neutropenia , oncology , gastroenterology , epidermal growth factor receptor , cancer , chemotherapy , malignant pleural effusion
Aim We investigated the efficacy, safety and optimal schedule of nanoparticle albumin‐bound paclitaxel monotherapy as second‐ or third‐line treatment for non‐small‐cell lung cancer patients without epidermal growth factor receptor mutation and anaplastic lymphoma kinase rearrangement. Methods Patients with pretreated advanced non‐small‐cell lung cancer without epidermal growth factor receptor mutation and anaplastic lymphoma kinase rearrangement were included. The patients were administered 100 mg/m 2 of nanoparticle albumin‐bound paclitaxel on days 1, 8, 15 and 22 (level 0) or on days 1, 8 and 15 (level –1) every 4 weeks during phase I of the trial. The primary endpoint was objective response rate. The estimated objective response rate was 15% and the threshold was 5% with an α error of 0.05 and β error of 0.2 in phase II. Results The recommended schedule was determined as level –1 in phase I. The characteristics of the 55 patients enrolled in phase II were as follows: median age = 66 years, male/female = 40/15, second/third line = 34/21 and adenocarcinoma/squamous cell carcinoma/large cell carcinoma/others = 34/17/2/2. Objective response rate was 7.3% (95% confidence interval, 2.0–17.6%). Median progression‐free survival was 3.4 months. Treatment‐related grade 3 or 4 toxicities were neutropenia (36.4%), febrile neutropenia (5.5%) and pulmonary infection (3.6%). Three patients had grade 2 pneumonitis and one treatment‐related death occurred due to adult respiratory distress syndrome. Conclusion This study failed to meet predefined primary endpoints for pretreated patients with advanced non‐small‐cell lung cancer without epidermal growth factor receptor mutation and anaplastic lymphoma kinase rearrangement.