NDLI: A single-arm phase II study of nab-paclitaxel for patients with chemorefractory non-small cell lung cancer

Content Provider	Springer Nature : BioMed Central
Author	Tanaka, Hisashi Taima, Kageaki Morimoto, Takeshi Tanaka, Yoshihito Itoga, Masamichi Nakamura, Kunihiko Hayashi, Akihito Kumagai, Mika Yasugahira, Hideo Mikuniya, Megumi Okudera, Koichi Takanashi, Shingo Tasaka, Sadatomo
Abstract	Background We aimed to evaluate the efficacy and safety of nab-paclitaxel in patients with refractory advanced non-small cell lung cancer who failed previous chemotherapy. Methods Patients were required to have an Eastern Cooperative Oncology Group performance status of 0–2 and adequate organ function. Patients received nab-paclitaxel, 100 mg/m2 i.v. on days 1, 8, and 15 every 4 weeks. The primary endpoint was the overall response rate. Secondary endpoints were the progression-free survival time, overall survival, and the toxicity profile. Results From July 2013 to July 2015, a total of 31 patients were enrolled. Fourteen patients received nab-paclitaxel as a second-line and 17 received it as an over third-line therapy. Each patient received a median of 5 treatment cycles (range, 1–11). The overall response rate was 19.3% (95% confidence interval, 9.1–36.2%) (complete response (n = 0), partial response (n = 6), stable disease (n = 17), and progressive disease (n = 8)). The median progression-free survival time was 4.5 months (95% confidence interval 3.5–6.3 months), median overall survival time was 15.7 months, and 1-year survival rate was 54.8%. Most common grade 3 or 4 non-hematological toxicities were elevated aspartate transaminase level (3.2%) and sensory neuropathy (9.6%). Neutropenia was the most common grade 3 or 4 adverse events (38.6%), and febrile neutropenia developed in 12.9% patients. No treatment-related deaths were observed in this study. Conclusion Primary endpoint was met. Single agent nab-paclitaxel showed significant clinical efficacy and manageable toxicities for patients with chemorefractory advanced non-small cell lung cancer even if late line setting. Trial registration UMIN000011696 . The date of registration was July 11th, 2013.
Related Links	https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-017-3684-8.pdf
Ending Page	6
Page Count	6
Starting Page	1
File Format	HTM / HTML
ISSN	14712407
DOI	10.1186/s12885-017-3684-8
Journal	BMC Cancer
Issue Number	1
Volume Number	17
Language	English
Publisher	BioMed Central
Publisher Date	2017-10-16
Access Restriction	Open
Subject Keyword	Cancer Research Oncology Surgical Oncology Health Promotion and Disease Prevention Biomedicine Medicine Public Health Lung cancer Nab-paclitaxel Refractory Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Cancer Research Oncology Genetics
Journal Impact Factor	3.4/2023
5-Year Journal Impact Factor	3.8/2023

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