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Docetaxel plus nintedanib effective second-line therapy for NSCLC
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The addition of nintedanib to docetaxel extended PFS among patients with non–small cell lung cancer who progressed after first-line chemotherapy, according to results of a randomized, multicenter, double blind phase 3 study.
Results also indicated the addition of nintedanib (BIBF 1120, Boehringer Ingelheim) — an oral triple angiokinase inhibitor — to docetaxel improved OS among patients with adenocarcinoma histology.
The analysis included 1,314 patients with stage IIIB or IV recurrent disease. Researchers randomly assigned 655 patients to 75 mg/m2 docetaxel on day 1, plus 200 mg nintedanib twice daily on days 2 through 21, every 3 weeks. Researchers assigned the other 659 patients to docetaxel plus placebo.
PFS served as the primary endpoint. OS served as the secondary endpoint. Median follow-up was 7.1 months (interquartile range, 3.8-11).
Patients who received nintedanib demonstrated significantly improved median PFS (3.4 months vs. 2.7 months; HR=0.79; 95% CI, 0.68-0.92).
Researchers conducted OS analyses after a median follow-up of 31.7 months (interquartile range, 27.8-36.1).
Overall, nintedanib was not associated with a statistically significant improvement in OS (10.1 months vs. 9.1 months; HR=0.94; 95% CI, 0.83-1.05).
However, among patients with adenocarcinoma histology, those who received nintedanib (n=322) demonstrated significantly improved median OS compared with those assigned placebo (n=336; 12.6 months vs. 10.3 months; HR=0.83; 95% CI, 0.7-0.99).
Among patients with adenocarcinoma who progressed within 9 months of first-line chemotherapy initiation, those assigned nintedanib (n=206) experienced improved median OS compared with those assigned placebo (n=199; 10.9 months vs. 7.9 months; HR=0.75; 95% CI, 0.6-0.92).
More patients in the nintedanib arm experienced grade ≥3 diarrhea (6.6% vs. 2.6%), reversible alanine aminotransferase increases (7.8% vs. 0.9%) and reversible aspartate aminotransferase increases (3.4% vs. 0.5%).
Thirty-five patients in the nintedanib arm and 25 in the placebo arm died from adverse events. The deaths were possibly unrelated to progressive disease, researchers said.
More patients in the nintedanib arm died of sepsis (5 vs. 1) and respiratory failure (4 vs. 0), whereas more patients in the placebo arm died of pneumonia (7 vs. 2) and pulmonary embolism (3 vs. 0).
Disclosure: The study was funded by Boehringer Ingelheim.
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