Afatinib Improves Outcomes vs Gefitinib in Treatment-naïve EGFR-mutant NSCLC

Afatinib significantly improved outcomesin treatment-naïve patients with EGFR-mutant non-small cell lung cancer.
Afatinib significantly improved outcomesin treatment-naïve patients with EGFR-mutant non-small cell lung cancer.

Afatinib significantly improved outcomes compared with gefitinib in treatment-naïve patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC), a study published in the journal The Lancet Oncology has shown.1

Afatinib is an irreversible ErbB family blocker while gefitinib is a reversible EGFR kinase inhibitor. Both are indicated for the first-line treatment of EGFR mutation-positive NSCLC. Therefore, researchers sought to compare the efficacy and safety of afatinib with that of gefitinib in this patient population.

For the international, open-label, phase 2b LUX-Lung 7 trial, researchers enrolled 319 treatment-naïve patients with stage IIIB or IV NSCLC who harbor a common EGFR mutation. Participants were randomly assigned 1:1 to receive afatinib 40 mg orally daily or gefitinib 250 mg orally daily until disease progression, or beyond if deemed beneficial by the investigator.

Continue Reading Below

Results showed that at a median follow-up of 27.3 months, median progression-free survival was 11.0 months (95% CI, 10.6-12.9) with afatinib vs 10.9 months (95% CI, 9.1-11.5) with gefitinib (HR, 0.73; 95% CI, 0.57-0.95; P=.017).

Median time to treatment failure was 13.7 months (95% CI, 11.9-15.0) and 11.5 months (95% CI, 10.1-13.1), respectively (HR, 0.73; 95% CI, 0.58-0.92; P=.0073). Overall survival data are not yet mature.

In terms of safety, the most common treatment-related grade 3 or 4 adverse events with afatinib were diarrhea and rash/acne, while the most frequently reported with gefitinib included liver enzyme elevation. Serious treatment-related adverse events occurred in 11% of afatinib-treated patients and 4% of patients in the gefitinib group.

In each treatment arm, 6% of patients discontinued treatment due to drug-related toxicities. One patient in the gefitinib arm died as a result of treatment-related hepatic and renal failure.

The findings demonstrate that afatinib significantly improved progression-free survival and time to treatment failure as compared with gefitinib, with a manageable tolerability profile. These results may ultimately influence clinical decision making in this population of treatment-naïve patients harboring an EGFR mutation.

REFERENCE

1. Park K, Tan E-H, O'Byrne K, et al. Afatinib versus gefitinib as first-line treatment of patients withEGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial [published online ahead of print April 12, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)30033-X.
Loading links....
You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs