Abstract
4524 Background: Gemcitabine is the mainstay of Rx for pts with APC. Practice guidelines encourage participation in trials after disease progression. We evaluated Rx after APC progression for pts in CALGB 80303 a randomized trial of gemcitabine + bevacizumab (GB) or placebo (GP). Methods: Of the 552 pts who began GP or GB Rx, 457 had comprehensive medical record review. Of these 355 progressed on protocol Rx. We evaluated post-progression Rx for these 355 pts - the record review (RecR) group. We also phoned a subgroup of 126 pts to inquire about Rx delivered at sites other than the accruing center - the record review & interview group (RecR + I) to determine whether any Rx had been administered and the specific agents used. Results: ChemoRx after progression on gemcitabine was distinctly uncommon. Based on RecR 239/355=67.3% and on RecR + I, 70/126=55.6% of pts received no chemoRx after progression on the study Rx. These proportions did not vary based on Rx assignment. Worse ECOG performance status at baseline and older age were associated with lower likelihood of post progression Rx. Notably, 99/355=27.9% of pts died within 4 weeks of progression. Conclusions: After progression on a clinical trial of gemcitabine Rx, <half of pts receive 2nd line Rx and remarkably few (<2%) receive further experimental Rx. Given the lack of well established Rx options, there appear to be lost opportunities for participation in early phase clinical trials. Coordinated strategies for second line Rx options might increase the evidence base for this challenging malignancy. Patterns of Post-Progression ChemoRx after Progression on Gemcitabine ± Bevacizumab in APC. [Table: see text] [Table: see text]
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