Abstract
PurposeThis open-label feasibility study assessed the tolerability of nintedanib 200 mg in combination with docetaxel 75 mg/m2 as a starting dose in Japanese patients with a body surface area (BSA) < 1.5 m2 and locally advanced or metastatic lung adenocarcinoma.MethodsEligible patients received docetaxel 75 mg/m2 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).ResultsOf 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/m2 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.ConclusionNintedanib 200 mg bid plus docetaxel 75 mg/m2 is a tolerable starting dose in Japanese patients with a BSA < 1.5 m2 with locally advanced or metastatic lung adenocarcinoma.ClinicalTrials.gov numberNCT02300298.
Highlights
Prior to 2016, effective second-line treatment options in nonsmall cell lung cancer (NSCLC), in patients with adenocarcinoma who are not eligible for epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-targeted therapy, were limited [1, 2]
Patient 2 was able to be retreated with a reduced nintedanib dose of 150 mg bid in combination with docetaxel 75 mg/m2, and completed cycle 2 without further dose-limiting toxicities (DLTs); they went on to receive 6 cycles of combination therapy
All patients with target lesions at baseline (7 patients) achieved disease control. This open-label feasibility trial was conducted to determine the tolerability of nintedanib 200 mg bid in combination with docetaxel 75 mg/m2 as a starting dose in Japanese patients with a body surface area (BSA) < 1.5 m2 and locally advanced or metastatic lung after the failure of platinum-based chemotherapy
Summary
Prior to 2016, effective second-line treatment options in nonsmall cell lung cancer (NSCLC), in patients with adenocarcinoma who are not eligible for epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-targeted therapy, were limited [1, 2]. Despite recent Food and Drug Administration approval of the immunotherapies nivolumab, pembrolizumab, and atezolizumab in this setting, there remains a clinical need for treatment options with better efficacy than docetaxel in patients with. Nintedanib, in combination with docetaxel, is approved in the European Union and other countries for the treatment of patients with locally advanced, metastatic, or locally recurrent NSCLC of adenocarcinoma histology after first-line chemotherapy [8, 9]. The efficacy and safety of nintedanib combined with docetaxel was confirmed in the phase III LUME-Lung 1 trial, in which the median overall survival of patients with adenocarcinoma who
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