A phase II trial of biweekly pemetrexed (P) and gemcitabine (G) in the first-line treatment (tx) of patients (pts) with advanced non-small cell lung cancer (NSCLC)

Abstract

17054 Background: P and G are active and well-tolerated non-platinum agents used in the tx of NSCLC. Previous trials have combined P and G in the first-line NSCLC setting using a 21D schedule. This trial examined the safety and activity of biweekly P/G. Methods: Theprimary endpoints of this single center community-based phase II study were toassess the safety and response rate (RR) of P/G in pts with previously untreated stage III (unresectable) or IV NSCLC. Tx included: P 500mg/m2 IV D1 and G 1500mg/m2 IV D1 Q 14D for 8–12 cycles. Pts also received folate and B12 prophylaxis. Pts were restagedafter 4 cycles. Eligibility included:measurable disease, ECOG PS 0–2, adequate organ function, informed consent, and no active brain metastases. Analysis was by intent to treat. Results: Thirty-five pts were enrolled between 5/05 and 8/05. The median follow-upis 6 months (3.5–7.5 months). Baseline characteristics include: medianage 65 years (41–85); male/female, 71%/29%; ECOG PS 0,1,2:17%/71%/12%; and histology, adenocarcinoma (34%), large cell (29%), squamous (11%), mixed or not specified (26%). The median number of cycles delivered was 8 (1–12). Grade (G)3/4 non-hematologic toxicity included:chest pain (6%), constipation (6%), fatigue (17%), hypercalcemia (6%), dyspnea (9%), and tachyarrhythmia (9%). G3/4 hematologic toxicity included: neutropenia(51%), anemia (8%), and thrombocytopenia (3%). G3/4 febrile neutropenia occurred in 14%. There were notx-related deaths. Response data are availablefor 35 pts. Complete/partial responses for all pts were observed in 0 pts/7pts, respectively, for an overall RR of 20% (95% CI 10%-36%, 1 pt unconfirmed by RECIST criteria). Fifty-four percentof pts had stable disease, and 14% had disease progression(4 pts were unevaluable.) Six-month progression-free survival (PFS) andoverall survival (OS) were 51% and 67%, respectively. Median PFS and OS have not been reached. Conclusions: Biweekly P/G is a safe and well-tolerated regimen with RRsimilar to other standard first-line regimens for the tx of pts with advanced NSCLC, and further study is warranted. Median and 1-year PFSand OS endpoints have not been reached in this trial. [Table: see text]