Biotech Values

[jellybean]

I didn't have time yesterday to dig all this out for you, but this is why I think your discussion is silly.

Trials are ongoing to answer this question. Until the final results are in, should the world not use a test that improves screening relative to the FIT and has the potential to reduce the rate of CRC?

The Colonprev trial has the hard endpoint of reduction of death by colon cancer at 10 years. The trial was started in 2009 to compare biennial FIT to a one time colonoscopy and should answer the question of whether repeat screening by stool sample is additive. And, this is why the FDA gave EXAS a-noninferior-to-FIT primary endpoint to the Deep-C trial. Yes, EXAS hit the endpoint (I believe they said almost double to FIT, but you will have to confirm that), and the secondary endpoint showing superiority to FIT. http://www.clinicaltrials.gov/ct2/show/NCT00906997?term=colonprev&rank=1

Here is the NEJM article for the Colonprev trial that reports the initial colonoscopy v FIT findings. http://www.nejm.org/doi/full/10.1056/NEJMoa1108895

Even in that trial, compliance was statistically significantly higher for FIT v colonoscopy. In fact among the 26,703 patients assigned to colonoscopy, 5649 accepted the proposal, 1706 requested FIT and only 4953 completed their colososcopy resulting in a participation rate of 24.6%. that is the problem with colonoscopy and why healthcare would like to find a better and less invasive test.

Colonoscopy versus Fecal Immunochemical Testing in Colorectal-Cancer Screening
Enrique Quintero, M.D., Ph.D., et al for the COLONPREV Study Investigators
N Engl J Med 2012; 366:697-706February 23, 2012DOI: 10.1056/NEJMoa1108895

METHODS
In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we compared one-time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects. The primary outcome was the rate of death from colorectal cancer at 10 years. This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening. Study outcomes were analyzed in both intention-to-screen and as-screened populations.

RESULTS
The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001). Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99). Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001).

CONCLUSIONS
Subjects in the FIT group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group.