Abstract
5554 Background: Pemetrexed yielded an objective response rate of 26.5% in a phase II study for patients (pts) with locally advanced or metastatic HNSCC (Br J Ca 2001;85:649). Pemetrexed plus gemcitabine has demonstrated evidence of additive or synergistic antitumor effects in preclinical models, and encouraging efficacy against HNSCC (CCR 2008;14:6310) in a phase I study that evaluated an every two week schedule of these agents Methods: This was a single-institution, single-arm, open-label phase II study. Eligible pts had R/M HNSCC, Karnofsky score ≥70, and adequate hematologic, metabolic and renal function. No more than 2 prior cytotoxic regimens for R/M HNSCC were allowed. The study regimen was pemetrexed 500 mg/m2 intravenously (IV) plus gemcitabine 1,250 mg/m2 IV every two weeks, with vitamin B12 and folate support. Objective response rate by RECIST criteria was the primary endpoint (target response rate ≥30%); secondary endpoints were overall survival and safety/tolerability Results: 26 pts were enrolled: all had received prior radiotherapy; half prior cytotoxic chemotherapy for R/M disease. Among 25 pts who received therapy, there were no grade 5 events; ≥grade 3 toxicities occurring in >20% of pts included neutropenia (24%), lymphopenia (84% [64% grade 3]), and anemia (24%). The RECIST partial response (PR) rate was 16% (4/25); there were no complete responses. Five additional patients (20%) experienced objective tumor reductions of >20% but <30% (but <RECIST PR). Median overall survival was 8.8 months Conclusions: The outlined regimen of pemetrexed plus gemcitabine is feasible and has an acceptable side effect profile in pts with R/M HNSCC, but the observed response rate was less than our desired target. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly
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