Use of Nintedanib/Docetaxel in Advanced Nonsquamous Lung Cancer: Phase III Trial Results

By: Kayci Reyer
Posted: Tuesday, February 15, 2022

According to findings from the REFRACT GFPC 02-15 study presented in Lung Cancer, the combination treatment of the kinase inhibitor nintedanib plus docetaxel did not meet the criteria for minimal efficacy in patients with advanced nonsquamous non–small cell lung cancer. However, Alain Vergnenegre, MD, PhD, of Centre Hospitalier Universitaire Limoges, France, and colleagues noted that the treatment did demonstrate a survival benefit in a subgroup of patients who were refractory to first-line platin-based chemotherapy.

The multicenter, phase II study included 59 patients from 23 treatment centers. On 3-week cycles, all patients received 75 mg/m² of intravenous docetaxel on day 1 followed by 400 mg of daily oral nintedanib on days 2 to 21. Patients were eligible to receive either nintedanib or docetaxel monotherapy after receiving four cycles of combination therapy. The threshold for minimal efficacy was a 50% progression-free survival rate. At 12 weeks, the progression-free survival rate was 39.6%; at 12 months, the rate was 11.8%. Median progression-free survival was 2.7 months.

Median overall survival rates were 32.1% at 12 months and 27.6% at 18 months. Median overall survival was 6.9 months. Among patients with an extremely poor prognosis, the 12-month progression-free survival rate was 11.8%, and the overall survival rates were 32.1% at 12 months and 27.6% at 18 months. More than half of the study patients (53.7%; n = 29) experienced one or more serious treatment-related adverse events, and 12 patients (22%) discontinued treatment of at least one therapy due to adverse events.

“Although our results did not achieve the predefined primary endpoint in terms of [progression-free survival] at 12 weeks, the results for median [progression-free survival] and [overall survival] are encouraging if the poor prognosis of the patient population is considered,” concluded the authors.

Disclosure: The study authors reported no conflicts of interest.

Lung Cancer