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Re: the_underwriter post# 12555

Thursday, 03/22/2007 3:36:25 PM

Thursday, March 22, 2007 3:36:25 PM

Post# of 347009
underwriter, Avastin plus Docetaxel:

(The Peregrine bavi combo trial (most likely) used Docetaxel plus bavituximab in breast cancer patients.)



Here's a phase 2 trial, (what's typically termed an "efficacy trial", as opposed to a phase 1 "safety" trial), using avastin in combo w/Docetaxel

Purpose: To evaluate the safety and efficacy of bevacizumab and weekly docetaxel as first- or second-line therapy in patients with metastatic breast cancer (MBC).

(These patients were not nearly "as far gone" as the PPHM Indian trial. As a first or second-line therapy, docetaxel can really accomplish something, statistically speaking ...)

Anyway..........

Get a load of the toxicities! (Serious- grade 3 & 4). (7%)—pulmonary embolus! Yeouch!
Look at those percentages....

and note the overall response, (complete + partial + stable), in folks who were NOT resistant to the chemo, they had NOT failed chemo...


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Results: One-hundred fifty-eight treatment cycles were administered with a median of six cycles (range 1-15 cycles) per patient. The most common grade 4 toxicities per patient were as follows: 2 (7%)—pulmonary embolus, 1 (4%)—febrile neutropenia, and 1 (4%)—infection; grade 3 toxicities were 4 (15%)—neutropenia, 4 (15%)—fatigue, 2 (7%)—neuropathy, 2 (7%)—athralgias, 2 (7%)—stomatitis, 1 (7%)—pleural effusion, and 1 (4%)—hypertension. The overall response rate was 52% [95% confidence interval (95% CI), 32-71%], median response duration was 6.0 months (95% CI, 4.6-6.5 months), and the median progression-free survival was 7.5 months (95% CI, 6.2-8.3 months). In hypothesis-generating univariate and limited multivariate analyses, E-selectin was statistically significantly associated with response to the combination.


http://clincancerres.aacrjournals.org/cgi/content/abstract/12/10/3124



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What you see there is similar ORR to the glimpse we got today, but the Avastin was in a way easier trial- first & second-line therapy, and Avastin had really scary side effects...


BY THE WAY - Those results are not that different to Docetaxel alone.....


LOL - and then there's Cetuximab (Erbitux)!....

Don't get me started.
talk about scary side effects........




Bavi should use the Guiness slogan,
"Bavi is good for you" :)


j
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