Pemetrexed in combination with cisplatin or carboplatin as adjuvant chemotherapy in early-stage NSCLC

Abstract

7565 Background: Platinum based chemotherapy after complete resection of stage I-IIIa non-small cell lung cancer (NSCLC) has improved 5-yr survival by 4–15%. Pemetrexed (P) in combination with cisplatin (C) or carboplatin (Carb) has shown to be effective and safe in first-line Tx of advanced NSCLC, thus being a promising option in the adjuvant setting. Methods: Multicenter, open phase 2 in pts with resected stage Ib/II NSCLC. Pts were randomized to P (500 mg/m2)+C (75mg/m2) or P (500 mg/m2)+Carb (AUC5) d1 q3 wks, for 4 cycles; adequate organ function and ECOG PS 0–1 required. Primary endpoint was feasibility of the regimen defined as compliance to 4 Tx cycles with ≥ 95% of planned dose without ≥ Grade 3 toxicities (tox) at 30 d after last infusion. A regimen was deemed feasible if the rate (feasible pts/total pts) was >60%. Results: Please see Table for results. Conclusions: According to the strict definitions in this protocol neither regimen was feasible. The reason was poor compliance with at least one of the components that defined feasibility, but dose intensity and % pts completing cycle 4 was notably high, compared to other adjuvant trials. P+C was the more favourable regimen concerning feasibility and tolerability. In terms of tolerability pemetrexed could be combined with either platinum compound. [Table: see text] [Table: see text]