Chemotherapy remains the standard of care for patients with advanced non–small cell lung cancer who have wild-type EGFR tumors, according to study findings.
“Our results unequivocally show that, although neither docetaxel nor erlotinib are magic bullets for second-line treatment of NSCLC, a cytotoxic approach to treatment of patients with NSCLC is still the best option in the absence of a clear therapeutic target,” the researchers wrote.
Although erlotinib (Tarceva; Genentech, Astellas) has been the recommended therapy for patients with NSCLC, the efficacy for treating patients with EGFR wild-type tumors is undetermined, according to background information in the study.
For this reason, researchers set out to compare the efficacy of erlotinib vs. standard second-line chemotherapy with docetaxel in 222 patients with metastatic NSCLC who had wild-type EGFR tumors and underwent prior treatment with a platinum-based chemotherapy.
Researchers randomly assigned 112 patients to 150 mg oral erlotinib daily. The other 110 patients received 75 mg/m² docetaxel IV once every 21 days or 35 mg/m² on days 1, 8 and 15 for every 28 days. OS in the intention-to-treat population served as the primary outcome measure.
Median OS was 8.2 months (95% CI, 5.8–10.9) among patients assigned docetaxel compared with 5.4 months (95% CI, 4.5–6.8) among those assigned erlotinib (adjusted HR=0.73; 95% CI, 0.53–1.0).
PFS was 2.9 months (95% CI, 2.4–3.8) with docetaxel vs. 2.4 months (95% CI, 2.1–2.6) with erlotinib (adjusted HR=0.71; 95% CI, 0.53–0.95).
The most common grade 3 and 4 adverse event was low absolute neutrophil count, which occurred in 20% of patients assigned docetaxel and no patients assigned erlotinib).
In an accompanying editorial, Jacek Jassem, MD, PhD, and Rafał Dziadziuszko, MD, PhD, both of the department of oncology and radiotherapy at the Medical University of Gdańsk in Poland, wrote: “Do the results mean that chemotherapy remains the only option for patients with wild-type EGFR disease? Not necessarily. Within the past decade, several molecular changes have been identified that drive NSCLC growth and survival, many of which are promising therapeutic targets.”
Additional molecular subtyping of wild-type EGFR tumors may help identify which patients are suitable for alternative therapies, Jassem and Dziadziuszko added.
“The clinical application of biomarker-driven therapeutic strategies will also be helped by the introduction of high-throughput multiplex genotyping, which will enable simultaneous sequencing and measuring copy numbers of hundreds of genes from only nanograms of cancer cell DNA,” they wrote.
For more information:
- Garassino MC. Lancet Oncol. 2013;doi:10.1016/S1470-2045(13)70310-3.
- Jassem J. Lancet Oncol. 2013;doi:10.1016/S1470-2045(13)70352-8.
Disclosure: The researchers report consulting roles with Amgen, Boehringer Ingelheim, Eli Lilly and Roche.