Standard versus low-dose nab-paclitaxel in previously treated patients with advanced non-small cell lung cancer: A randomized phase II trial (JMTO LC14-01).

Abstract

BACKGROUND:

Nab-paclitaxel (nab-PTX) has better transfer to tumor tissue than cremophor-based paclitaxel. It suggests that the optimum dose of nab-PTX might be lower than the dose and schedule that is widely used. We designed a randomized phase II trial to examine the clinical utility and safety of nab-PTX in patients with previously treated advanced non-small cell lung cancer (NSCLC).

METHODS:

Patients were randomly allocated (1:1) to receive nab-PTX monotherapy at 100 mg/m2 (group A) or 70 mg/m2 (group B). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and adverse events (AEs).

RESULTS:

Finally, 81 patients were randomized. Similar results were observed in both groups for PFS (3.75 vs. 3.71 months), OS (13.50 vs. 16.13 months), or ORR (20.5% vs. 23.1%). The incidences of grade 3 or worse AEs were 57.5% in group A and 41.5% in group B. The proportion of serious side effects was 10.0% in group A and 4.9% in group B.

CONCLUSION:

Both standard dose and low dose of nab-PTX monotherapy are active for previously treated NSCLC patients with better safety profile. Therefore, nab-PTX 70 mg/m2 dose and schedule in the trial would be a reasonable option.

• Authors: Susumu Takeuchi, Kaoru Kubota, Shunichi Sugawara, Satoshi Teramukai, Rintaro Noro, Kei Fujikawa, Takashi Hirose, Shinji Atagi, Seigo Minami, Shinichiro Iida, Hiroshi Kuraishi, Tomoiki Aiba, Yuji Minegishi, Masaru Matsumoto, Masahiro Seike, Akihiko Gemma, Masaaki Kawahara, Japan-Multinational Trial Organization (JMTO)
• Journal: Cancer medicine (Cancer Med) Vol. 12 Issue 8 Pg. 9133-9143 (04 2023) ISSN: 2045-7634 [Electronic] United States
• PMID: 36807519 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Chemical References

• 130-nm albumin-bound paclitaxel
• Paclitaxel
• Albumins

Topics

• Humans
• Carcinoma, Non-Small-Cell Lung (pathology)
• Lung Neoplasms (pathology)
• Paclitaxel
• Albumins (adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)