Long-term results of concurrent gemcitabine (G) and radiotherapy (GRT) for locally advanced (LA) or high-risk resected (R) pancreatic cancer

4101 Background: G is active against pancreatic carcinoma and is a potent radiosensitizer. We present extended follow up data from a phase I/II study of patients treated with combination GRT. Methods: Eligible patients had either LA or high-risk resected [R] pancreatic cancer [positive nodes or positive margin]. 28 were enrolled in a Phase I study of increasing doses of radiotherapy (35 Gy [n = 7]/43.75 Gy [n = 11]/52.5 Gy [n = 10] given over 4, 5 or 6 weeks, respectively in 1.75 Gy fractions) concurrently with 40 mg/m 2 gemcitabine biweekly. Subsequently 35 were treated with induction gemcitabine (G) 1000 mg/m 2 7/8 weeks followed by concurrent bi-weekly gemcitabine (40 mg/m 2 ) with 52.5 Gy (30 fractions of 1.75 Gy over 6 weeks). In total there were 63 patients (31 LA and 32 R) treated between March 1999–July 2001. Results: In the LA population the best response observed was CR - 1, PR - 2, SD - 10, PD - 10. GRT was not delivered to 8 patients due to progression on G alone (n = 5) or patient request (n = 3). By intent to treat analysis, the median survival in LA disease was 15.1 months and the 2 year survival was 19%. In the resected population the median time to progression was 14.3 months, the median survival was 17.9 months and the 5 year survival was 19%. The treatment was generally well tolerated during both the induction G and the GRT ( Table ). Conclusion: Survival for both LA and HR patients with this concurrent gemcitabine radiotherapy regimen is promising and warrants further investigation. [Table: see text] No significant financial relationships to disclose.