In the MPACT trial, 861 patients with stage IV pancreatic cancer with metastatic disease who did not receive prior treatment were randomly assigned to either albumin-bound-paclitaxel 125 mg/m2, sequential gemcitabine 1000 mg/m2 (n=431), or gemcitabine only (n=430). Patients receiving treatment until disease progression had computed tomography scans every 8 weeks. Median OS was 8.5 months in the combination treatment group and 6.7 months in the gemcitabine group (HR=0.72; P<0.0001), while median disease-free survival was 5.5 months in the albumin-bound-paclitaxel group vs. 3.7 months in the gemcitabine group (HR=0.69; P<0.001). Panelists also reported that this treatment regimen was well tolerated. The most common ≥ grade 3 hematologic adverse events (AEs) reported in the combination therapy group compared with the monotherapy group were neutropenia (38% vs. 27%), leukopenia (31% vs. 16%), thrombocytopenia (13% vs. 9%) and anemia (13% vs. 12%). Fatigue (17% vs. 7%) and peripheral neuropathy (17% vs. <1%) were the most common non-hematologic AEs. Although clinicians used an albumin-bound-paclitaxel/gemcitabine regimen for metastatic disease based on trial results prior to FDA approval, experts remain hesitant to recommend this regimen in adjuvant therapy because of the lack of further studies. "I think it's a temptation to do this ...... [because] after surgery, the recurrence rate is extremely high," Professor Ramesh K. Ramanathan (director of the Division of Clinical Trials Medicine at the Virginia G. Piper Cancer Center, Division of Translational Medicine Associate Director) said. "We are more hesitant to use this regimen in clinical trials because of the phenomena we have observed in other areas." Ramanathan cited several examples of colon cancer where this treatment option proved effective in patients with metastatic lesions, and studies that have shifted to adjuvant therapy early in treatment have stumbled somewhat. The panelists agreed that new treatment strategies are needed for patients with pancreatic cancer. About 20 to 25 percent of these diagnosed tumor types are going to undergo the Whipple procedure (i.e., pancreaticoduodenectomy), Arena said. Despite this approach to prolong survival, the recurrence rate is as high as 85 percent within two years of surgery. arena also noted that the 5-year survival rate for patients with pancreatic cancer is only 5 percent. "It's not just an academic issue; it's also a reality."