Abstract
14099 Background: Our group recently published a phase II trial of GEM infused at fixed dose-rate of 10 mg/m2/min over 100 min in patients with advanced PDAC and BTC. (Cancer September 15,2005). Given the promising results obtained in the first 40 pts, we expanded the cohort under an observational protocol and this is the report of such experience. Methods: From April 2002 to September 2005, 106 advanced PDAC (n = 75) or BTC (n = 31) pts (median age: 63 yrs, range 28–82; M/F: 48/58; PDAC/BTC: 75/31; LA/Met: 36/70; PS 0/1/2/3: 31/53/17/5) were treated with GEM 1000 mg/m2 at the fixed dose-rate of 10 mg/m2/min for 7 consecutive wks and weekly × 3 q4 wks thereafter (FDR-GEM). All patients and 1154 treatment weeks were evaluable for toxicity, 100 were evaluable for response, 87 patients were evaluable for clinical benefit response (CBR) according to Burris criteria, and 56 patients had elevated CA19.9 serum levels at entry. Results: From April 2002 to September 2005, 106 advanced PDAC (n = 75) or BTC (n = 31) pts (median age: 63 yrs, range 28–82; M/F: 48/58; PDAC/BTC: 75/31; LA/Met: 36/70; PS 0/1/2/3: 31/53/17/5) were treated with GEM 1000 mg/m2 at the fixed dose-rate of 10 mg/m2/min for 7 consecutive wks and weekly × 3 q4 wks thereafter (FDR-GEM). All patients and 1154 treatment weeks were evaluable for toxicity, 100 were evaluable for response, 87 patients were evaluable for clinical benefit response (CBR) according to Burris criteria, and 56 patients had elevated CA19.9 serum levels at entry. Conclusions: The results obtained with FDR-GEM in a series of 106 consecutive pts confirm previous results obtained in smaller series and suggest that pharmacokinetically rationale GEM scheduling may improve its therapeutic index. FDR-Gem may constitute a viable alternative to standard Gem infusion as first-line treatment in advanced PDAC and BTC. No significant financial relationships to disclose.
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