PS 2-3 NSCLC

NEW YORK (Reuters Health) Apr 30 - Chemotherapy-naive patients with advanced non-small-cell lung cancer (NSCLC) and low performance status achieve similar results with gefitinib, gemcitabine, or docetaxel, French researchers reported online April 18th in Lung Cancer.

For patients with performance status (PS) 3, "based on our results, I would not recommend any chemotherapy, although gefitinib might represent an option for patients harboring EGFR mutations," senior author Dr. Denis Moro-Sibilot from CHU Grenoble, Grenoble, France told Reuters Health by email. "For PS 2, there is a trend favoring docetaxel."

Dr. Moro-Sibilot and colleagues compared monotherapy with gefitinib, gemcitabine, or docetaxel for first-line management of advanced NSCLC in 125 patients at PS 2 or 3, in a randomized phase II open-label trial.

Mortality rates were similar with gefitinib (46.5%), gemcitabine (40.5%), and docetaxel (40.5%). There were only 3 treatment-related deaths, including 2 in the docetaxel arm as a result of febrile neutropenia and 1 in the gefitinib arm from respiratory failure and lung infiltration.

Treatment-related adverse events occurred with similar frequency in the 3 treatment arms, but grade 3 or 4 adverse events affected significantly more patients in the docetaxel arm (56%) than in the gefitinib (23%) or gemcitabine (29%) arms.

Median progression-free survival (the primary end point) was similar with gefitinib (1.9 months), gemcitabine (2.0 months), and docetaxel (2.0 months), whereas median overall survival trended higher with docetaxel (3.5 months) than with gefitinib (2.2 months) or gemcitabine (2.4 months).

When examined separately, PS 2 patients had a median survival of 3.0 with gefitinib, 3.1 months with gemcitabine, and 6.6 months with docetaxel group (p = ns), whereas PS 3 patients had median survival times, respectively, of 1.9, 1.8, and 1.1 months (p = ns).

As for future studies, Dr. Moro-Sibilot said, "At the moment we are discussing several options, including combinations of chemotherapy and targeted agents. Pemetrexed has to be studied in that population of patients, too."

Lung Cancer 2010.