To: tuck who wrote (893 ) 1/24/2004 10:31:42 AM From: Extra Pale Read Replies (1) | Respond to of 1005 Tuck, The gnvc results appear to be on patients with locally advanced cancer vs GEM/CIS with 73% liver metastasis. Seems like TNFerade would have small markets if useful only in non-metastic situations. From your Gemzar link: Methods: 195 pts with histologically documented pancreatic carcinoma were randomized to receive either GEM 1,000 mg/m2 plus CIS 50 mg/m2 on d1,15 of a 28-day schedule (arm A, 96 pts) or GEM 1,000 mg/m2 on d1,8,15 of a 28-day schedule (arm B, 99 pts). Results: 195 pts were enrolled. Pt characteristics were balanced between arms A and B with regard to age (59 vs. 61 yrs), Karnofsky PS (70 each), and liver metastasis (65% vs 66%). Disease: locally advanced (27.1% of pts), metastatic (72.9%). The median number of cycles administered was 4 in arm A (range 1-20) and 3 in arm B (range 1-15). WHO grade 3/4 toxicities (per patient analysis) in arms A and B included: anemia 2.2% vs 3.2%, leukopenia 8.8% vs 8.5%, thrombopenia 5.5% vs 9.5%, mucositis 3.3% vs 3.2%, nausea/vomiting 20.9% vs 6.4%, grade 3 diarrhea 3.3% vs 6.4%, respectively. After 75% of the pts died, median survival was 8.3 mos in arm A, and 6.0 mos in arm B that reached a level of significance in the Wilcoxon test (P=0.046), but not in the log-rank analysis (P=0.12). Progression-free survival was markedly superior for the GEM/CIS combination with 5.4 mos vs. 2.8 mos (P<0.01, log-rank test). The analysis of tumor response is still pending. Conclusion: The combined use of GEM/CIS prolonged progression-free and overall survival in locally advanced and metastatic pancreatic cancer when compared to single-agent gemcitabine. Apart from nausea and vomiting, toxicity between treatment arms was comparable.