An open-label feasibility study of nintedanib combined with docetaxel in Japanese patients with locally advanced or metastatic lung adenocarcinoma after failure of first-line chemotherapy.

Cancer Chemother Pharmacol 2018 10 3;82(4):685-694. Epub 2018 Aug 3.

Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.

Purpose: This open-label feasibility study assessed the tolerability of nintedanib 200 mg in combination with docetaxel 75 mg/m as a starting dose in Japanese patients with a body surface area (BSA) < 1.5 m and locally advanced or metastatic lung adenocarcinoma.

Methods: Eligible patients received docetaxel 75 mg/m every 21 days and nintedanib administered at 200 mg twice daily (bid), starting on day 2 of each cycle. Treatment was continued until disease progression or undue toxicity. The primary endpoint was the number of patients experiencing dose-limiting toxicities (DLTs) in cycle 1 (days 1-21).

Results: Of 10 treated patients, 2 patients (20%) experienced DLTs during cycle 1. These DLTs were grade 3 liver enzyme elevations [alanine aminotransferase (2 patients) and aspartate aminotransferase (2 patients)], and grade 2 hyperbilirubinemia (1 patient). Nine patients met the predefined criteria for nintedanib 200 mg bid plus docetaxel 75 mg/m to be considered a tolerable starting dose. All patients experienced ≥ 1 adverse event (AE) during the treatment period (all drug-related), but no patients experienced AEs that led to discontinuation of nintedanib. Of the five serious AEs reported during treatment, none were drug-related. There was no apparent effect of nintedanib on the pharmacokinetics of docetaxel. The objective response and disease control rates were 40 and 70%, respectively.

Conclusion: Nintedanib 200 mg bid plus docetaxel 75 mg/m is a tolerable starting dose in Japanese patients with a BSA < 1.5 m with locally advanced or metastatic lung adenocarcinoma. CLINICALTRIALS.

Gov Number: NCT02300298.

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http://link.springer.com/10.1007/s00280-018-3649-x
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http://dx.doi.org/10.1007/s00280-018-3649-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132853PMC
October 2018
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