Pemetrexed plus gemcitabine versus gemcitabine plus carboplatin in patients with advanced nonoperable NSCLC: A randomized phase II study.

Abstract

e18039 Background: The standard first-line treatment of inoperable Non-Small Cell Lung Cancer (NSCLC) is a combination of two drugs, one of which should be a platinum drug. We investigated a combination of two modern drugs without platinum in a single institute randomized study. Methods: Consecutive patients with NSCLC, stage III B inoperable or IV, PS 0-2, September 2006-October 2009, were randomized to pemetrexed, 500 mg/m2 + gemcitabine, 1,500 mg/m2 every second week (PG arm), or gemcitabine, 1,250 mg/m2 day 1 and 8 and carboplatin 5 AUC day 1 every 3 weeks (GC arm). Unless progression of disease, toxicity, or withdrawal of consent, 6 courses were given in the PG arm and 4 courses in the AG arm. Results: Forty-seven patients were randomized to the PG and 50 to the GC arm. Three patients were excluded, leaving 46 in the PG and 48 in the GC arm. In the PG arm, 22% stopped treatment due to side effects, and 4% in the GC arm. The only lethal side effect was seen in the GC arm. In the PG arm, 20% stopped treatment because of progressive disease vs. 24% in the GC. In the PG, 21 had a PR and 1 a CR (48% OR), while 15 had PR and no one CR in the GC group (31%). TTP was similar in both groups (3 months), but 11 PG patients (24%) had a TTP > 6 months while in the GC group only 2 (4%) had so. Conclusions: Despite the higher dose intensity in the PG arm, the majority tolerated the treatment. There was a tendency to more responses and a longer TTP in the PG arm. Further analyses are therefore warranted. It seems, however, that platinum-free drug regimens can give as good results as those with platinum. No significant financial relationships to disclose.