Abstract
4578 Background: Vascular endothelial growth factor (VEGF) expression is present in BTCs and is associated with poor survival. We performed a phase II study to examine the efficacy and tolerability of GEM and OX in combination with B (GEMOX-B) in patients (pts) with advanced BTCs. We also assessed the use of FDG-PET as an early indicator of response following treatment. Methods: Eligibility criteria included unresectable or metastatic measurable BTCs, 0–1 prior chemotherapy regimens, performance status ≤ 2, and adequate organ functions. Pts were treated with all 3 drugs intravenously on days 1 and 15 every 28 days (one cycle): B was given first at 10 mg/kg, followed by GEM at 1000 mg/m2 as a dose-rate infusion at 10 mg/m2/minute, and OX at 85 mg/m2. Whole body FDG-PET scan was obtained at baseline and at the end of cycle 2. The primary endpoint of the study was progression-free survival (PFS). Results: The planned 35 pts (25 cholangiocarcinoma and 10 gallbladder carcinoma) were enrolled: median age = 60 (25–82), M/F = 21/14, median ECOG 1. All pts were evaluable for toxicity and 29 were evaluable for response. Treatment related grade 3–4 toxicities included neutropenia (20%), ALT (17%), neuropathy (14%), hypertension (11%), AST (9%), anorexia (9%), and thrombocytopenia (9%). 13 pts (45%) had a partial response (PR) and an additional 10 pts (34%) had stable disease (SD). With a median follow up of 9.9 months, the median overall survival was 13.2 months (95% CI, 7.3 to 20.5 months), and the median PFS was 7.0 months (95% CI, 5.4 to 9.6 months). The mean baseline SUVmax was 5.72±2.01 and post-treatment SUVmax was 3.73±1.88 with a median 36.4% decrease (n=32). The difference in SUV changes between the groups with PR/SD and progressive disease was statistically significant (p=0.006). An increase in adjusted post- to pre-treatment SUV increased the risk for tumor progression (hazard ratio=3.054). Conclusions: GEMOX-B demonstrated significant antitumor activity with tolerable safety profiles in patients with advanced BTCs. FDG-PET showed significant early decreases in SUVmax following treatment, and these changes correlated with tumor response and time to tumor progression. [Table: see text]
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