Docetaxel Plus Intercalated Erlotinib Versus Docetaxel Alone in Nonsquamous Lung Cancer
Posted: Thursday, October 21, 2021
The addition of intercalated erlotinib to docetaxel therapy appears to have detrimental effects in patients with relapsed metastasized nonsquamous non–small cell lung cancer (NSCLC), according to the recent findings of the randomized phase III NVALT-18 clinical trial. Joachim G.J.V. Aerts, MD, of the Erasmus MC Cancer Institute, the Netherlands, and colleagues published these results in the journal Lung Cancer.
“These data strongly discourage the clinical use or further investigation of the docetaxel plus intercalated erlotinib regimen in (EGFR and ALK wild-type) nonsquamous NSCLC,” the authors wrote.
A total of 45 patients with relapsed nonsquamous NSCLC who had received platinum-based chemotherapy and/or a checkpoint inhibitor were included in this trial. Participants were randomly assigned 1:1 to the control arm (75 mg/m2 of docetaxel on day 1 every 21 days) or the treatment arm (75 mg/m2 of docetaxel on day 1 plus 150 mg/day of erlotinib on days 2–16 every 21 days).
The researchers found that patients in the control arm had a median progression-free survival of 4 months (95% confidence interval [CI] = 1.5–7.1 months). Patients in the experimental arm had a median progression-free survival of 1.9 months (95% CI = 1.4–3.5 months).
The study ended early due to slow accrual, but the decision to stop the study was made before any data were analyzed. Simulations based on the results from the first 45 patients indicated the study most likely would have been stopped if the researchers had continued the trial until the first preplanned interim analysis.
According to the authors, earlier preclinical and phase II studies of docetaxel plus intercalated erlotinib included many patients with unknown mutational status and used erlotinib monotherapy as maintenance therapy. They posited that this could explain the better outcomes of previous studies with this investigation regimen compared with the NVALT-18 trial.
Disclosure: The study authors reported no conflicts of interest.