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Clinical Trial
. 2019 Aug;84(2):351-358.
doi: 10.1007/s00280-019-03843-0. Epub 2019 Apr 16.

A single-arm phase II trial of weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) monotherapy after standard of chemotherapy for previously treated advanced non-small cell lung cancer

Yasuhiro Kato  1   2 , Yusuke Okuma  3 , Kageaki Watanabe  3 , Makiko Yomota  3 , Shoko Kawai  3 , Yukio Hosomi  3 , Tatsuru Okamura  3
Affiliations
Clinical Trial

A single-arm phase II trial of weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) monotherapy after standard of chemotherapy for previously treated advanced non-small cell lung cancer

Yasuhiro Kato et al. Cancer Chemother Pharmacol. 2019 Aug.

Abstract

Background: Few studies have investigated the clinical efficacy of third- and later-line of chemotherapy after standard chemotherapy for previously treated advanced non-small cell lung cancer (NSCLC). We prospectively evaluated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) following standard chemotherapies for previously treated advanced NSCLC.

Methods: The eligible patients having adequate organ functions with performance status 0-2 were enrolled after completing standard chemotherapy. They received weekly nab-paclitaxel 100 mg/m2 intravenously on days 1, 8, and 15 every 3 weeks. The primary end point was objective response rate (ORR). Median progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated as secondary end points.

Results: This trial was discontinued because of late accrual. Twenty two patients were enrolled from April 2013 and February 2019. The total ORR was 22.7% [95% CI 7.8-45.4] and disease control rate (DCR) was 81.8% [95% CI 59.7-94.8]. Median PFS was 3.4 months [95% CI 2.3-4.1] and median OS was 7.4 months [95% CI 4.2-10.7]. Median follow-up interval was 6.7 months hematological AEs of Grade 3/4 included anemia (18%), leukopenia (18%), and neutropenia (32%), while the most frequent nonhematological AEs were fatigue (50%) and peripheral neuropathy (36.4%). Severe AEs related to treatment were observed in only one patient.

Conclusion: Nab-paclitaxel may be a safe and effective later-line chemotherapeutic option for previously treated advanced NSCLC after standard of chemotherapies based on other trials.

Keywords: Advanced non-small cell lung cancer; Chemotherapy; Later line setting; Nanoparticle albumin-bound paclitaxel.

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Conflict of interest statement

YH and YO have received honoraria from TAIHO PHARMACEUTICAL. The other authors declare no conflicts of interest associated with this manuscript.

Figures

Fig. 1
Fig. 1
Response to nab-PTX presented as waterfall plot of greatest percentage change in target lesion size from baseline
Fig. 2
Fig. 2
Kaplan–Meier curves for PFS (a) and OS (b) of all patients enrolled in this trial
See this image and copyright information in PMC

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