Dataset Information

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.

SUBMITTER: Takeuchi S

PROVIDER: S-EPMC10166935 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

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).

Takeuchi Susumu S Kubota Kaoru K Sugawara Shunichi S Teramukai Satoshi S Noro Rintaro R Fujikawa Kei K Hirose Takashi T Atagi Shinji S Minami Seigo S Iida Shinichiro S Kuraishi Hiroshi H Aiba Tomoiki T Minegishi Yuji Y Matsumoto Masaru M Seike Masahiro M Gemma Akihiko A Kawahara Masaaki M

Cancer medicine 20230221 8

<h4>Background</h4>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).<h4>Methods</h4>Patients were randomly allocated (1:1) to receive nab-PTX monotherapy at 100 mg/m<sup>2</ ...[more]

PMID: 36807519

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Dataset Information

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).

Background

Methods

Results

Conclusion

Publications

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).

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