Abstract
7074 Background: P (Alimta), a multitargeted antifolate, inhibits thymidylate synthase, dihydrofolate reductase and glycinamide ribonucleotide formyl transferase. P and cisplatin are synergistic in preclinical models. Response rates (RR) of 39–45% were noted in Phase II P/cisplatin studies (Shepherd, Cancer, 2001; Manegold, Ann Oncol, 2000) with 1-year survival (1YS) of 50% in chemonaive advanced NSCLC. Substituting C for cisplatin may improve the toxicity profile yet maintain efficacy. The primary objective of this study was determination of the RR of PC in advanced chemonaive NSCLC pts. Methods: Eligibility criteria: zubrod performance status (PS) ≤1, chemonaive stage IIIB/IV. Treatment was P 500mg/m2 IV D1 followed by C AUC=6 IV D 1 Q 3 wks X 6 cycles. All pts received folic acid, vitamin B12 and steroid prophylaxis. Results: All are evaluable for toxicity; 3 pts remain on treatment. Pt characteristics: median age=62 (31–80), 31 male, stage IIIa=1/IIIb=3/IV=46, PS 0=5/1=46. Grade (G) 3/4 hematologic to...
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