Annals of Oncology 14:1543-1548, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Phase II study of pemetrexed disodium (Alimta®) administered with oral folic acid in patients with advanced gastric cancer
1 Medical Oncology Unit B and Department of Radiology, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy; 2 University of Texas Southwestern Medical Center at Dallas, Dallas, TX; 3 Eli Lilly Italia, Sesto Fiorentino, Italy; 4 Eli Lilly & Co., Indianapolis, IN, USA
Received 21 February 2003; revised 27 May 2003; accepted 4 June 2003
Background:
The aim of this study was to assess the activity of pemetrexed in patients with advanced gastric cancer.
Patients and methods:
Thirty-eight eligible patients (median age 60 years) received pemetrexed 500 mg/m2 every 3 weeks. Since toxicity was considerable in the first six patients, the protocol was amended to supplement subsequent patients with oral folic acid (5 mg/day on days –2 to +2 of every cycle).
Results:
Among 36 stage IV patients evaluable for efficacy (six non-supplemented\30 supplemented), there were two complete and six partial responses. The response rate was 21% (95% confidence interval 8% to 32%) according to intention-to-treat analysis. All responding patients were in the supplemented group. The median duration of response was 4.6 months and the median survival was 7.8 months. Five of six non-supplemented patients (83%) developed grade 3/4 neutropenia; two (33%) unsupplemented patients discontinued; two (33%) patients died due to toxicity. In the supplemented group, 12 of 32 patients (37%) had grade 3/4 neutropenia. None of the supplemented patients discontinued treatment due to hematological toxicity. Severe non-hematological toxicities were infrequent.
Conclusions:
The activity of pemetrexed is promising in light of the tumor burden in these patients (all patients were stage IV and 39% had three or more organs involved). Toxicities were remarkably decreased with folic acid supplementation. Combination studies are warranted.
Key words: folic acid, gastric cancer, pemetrexed, phase II trial
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