Hi Yooper61, yea it is about time for another "Ella Update" enjoy reading her research. I hope the upcoming UOB trial start is delayed just a tad more to enable them to perhaps use cohort 8 dosage, if it is deemed safe but perhaps they are comfortable with the cohort 7 dosage based on talks with Dr. Menon as he believed it to be in that dosage range where efficacy would be anticipated/probable.
I did some quick checking tonight about the 4+ month period before disease progression period for the pancreatic patient and noted this from a study back in 2000. I bolded sections.
"Patients with locally advanced and metastatic pancreatic carcinoma have a poor prognosis and suffer debilitating disease-related symptoms. Historically, single-agent 5-fluorouracil (5-FU) has been a frequently used treatment that has produced tumor response rates in the range of 0–19% (since 1985 when computed tomography [CT] assessment of tumor response became standard) and a median survival of 4.2–5.5 months.1 A review of the literature on investigational new drugs (28 Phase II trials involving 25 agents) showed that, to date, there has been no improvement in patient outcome, with a median objective response rate of 0% (range, 0–14%) and a median survival of 3 months (range, 2–8.3 months).2
Gemcitabine (GEMZAR; Eli Lilly and Company, Indianapolis, IN) is a novel nucleoside analog with activity across a broad range of solid tumors.3 The activity of gemcitabine in pancreatic carcinoma was assessed in early Phase II trials. In a United States study of 44 patients, Casper and colleagues reported an objective response rate of 11% and a median survival of 5.6 months.4 In a European study of 34 patients, Carmichael and colleagues reported a tumor response rate of 6.3% and a median survival of 6.3 months.5 Both study groups reported symptomatic improvements in their patients that were greater than suggested by the objective tumor response rates.
I believe it's likely, although we cannot conclude, the pancreatic patient in the Kevetrin study may very well have previously used 5FU and/or Gemcitabine. Thus the additional 4+ months of stable disease/no progression was significant, especially for them. I know we cannot make predictions based on a single patients response but I also think they would really look at this particular patients tumor characteristics (DF is good at tumor DNA sequencing/mapping) to see if future studies should include more pancreatic cancer patients with similar tumor characteristics.
AI
