Your thoughts on the possibility of Peregrine stretching out the reporting on our trial until the first quarter?
Could that give us the double that we are looking for??
Just a follow up.How do they figure out what patient gets Bavi? i know if it was me I would be twisting arms to make sure that I would in the Gem +Bavi part of trial.
FTM, great find on the Pancreatic meta-analysis article, and your followup chart. If Bavi can come anywhere close to doubling MOS here, like it did in 2nd-Line NSCLC, it would be utterly amazing. BTW, I found this excellent 4-2012 article on Pancreatic options: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3325521 - see more below.
By FTM 9-21-12 iHub #93509http://tinyurl.com/72tvnfj http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79790425 More data on advanced pancreatic cancer trials. A new paper out. 9-16-12: “Role of gemcitabine-based combination therapy in the management of advanced pancreatic cancer: A meta-analysis of randomized trials” European Journal of Cancer http://www.sciencedirect.com/science/article/pii/S0959804912006818 BACKGROUND Pancreatic cancer is the 4th leading cause of cancer-related death worldwide. Gemcitabine is the mainstay treatment for advanced disease. However, almost all up-to-date trials, that evaluated the benefit of gemcitabine-combination schedules, failed to demonstrate an improvement in overall survival (OS). In this study, we performed a systematic review and a meta-analysis of randomized clinical trials (RCTs) to investigate the efficacy and safety of gemcitabine-based combination regimens as compared to gemcitabine alone in the management of pancreatic cancer. FINDINGS: 34 trials for a total of 10,660 patients were selected and included in the final analysis. The analysis showed that combination chemotherapy confers benefit in terms of OS (HR: 0.93; 95% confidence interval (CI): 0.89–0.97; p = 0.001). Here is Table 1 from this paper showing 34 randomized trials. Every trial used GEM as the control arm, and the combination treatment arms all used GEM + something.
Here I took the 32 with survival numbers and put them in a spreadsheet to calculate the mean and std. deviation across the 32 trials. This gives us an idea of the variation across trials with different patient groups and treatments added to GEM. It doesn't look too good. The treatment MOS is only 11% longer than the control mean. There are a few outliers. The two best are with the drug S-1 [S-1 is an oral fluoropyrimidine prodrug]. If Bavi+GEM could double survival it would be a major improvement. - - - - - - - Good recent article on Pancreatic Cancer treatment options: 4-2012: “Adjuvant & Neoadjuvant Treatment In Pancreatic Cancer” - World J Gastroenterol, p1565–1572 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3325521 “Pancreatic Cancer is one of the most aggressive human malignancies, ranking 4th among causes for cancer-related death in the Western world including the U.S.. Surgical resection offers the only chance of cure, but only 15-20% of cases are potentially resectable at presentation… Unlike most of the more frequent causes of cancer mortality (lung, colon, prostate, breast) whose death rates are declining, the death rate for pancreatic cancer is relatively stable. The poor prognosis is reflected by a MOS of 5-8 mos and a 5-year survival of less than 5% when all stages are combined. . . In the last years, new fluoropyrimidines that mimic the effect of a continuous infusion of 5-FU have been approved. One of the most common but not available in all countries is S-1, an orally active fluoropyrimidine, with favorable antitumor activity in gemcitabine-refractory disease.”
= = = = = = = = = = = = = = = = = I. Phase II Bavi+GEM vs. Front-Line Adv. PANCREATIC (randomized, unblinded) Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01272791 (15 U.S. + 4 Ukraine = 19 as of 6-7-2012) …9-21-12: FTM's post showing 32 Pancreatic Trials results ('02-'11) - MOS for GEM-alone: 4.5-9.1 mos. http://tinyurl.com/8nqtpac ……"The treatment mean OS is only 11% longer than the ctl mean. There are a few outliers. The 2 best are with the drug S-1. If Bavi+GEM could double survival it would be a major improvement. " ...6-25-12: Enrollment complete. http://tinyurl.com/72tvnfj ...6-20-12: Early data (cutoff=6/6/12 bavi=15 ctl=17) presented at AACR Pancreatic Conf. http://tinyurl.com/77m9fw2 ......"Top-line results expected towards the end of 2012"
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