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Monday, December 14, 2009 12:10:03 PM
I could be wrong but my understanding is that patients get a one week rest period between cycles
No, there is no rest period between cycles. A 21 day cycle means every 21 days the therapy is repeated.
Patients were randomly assigned to receive paclitaxel at a dose of 200 mg per square meter of body-surface area and carboplatin at a dose calculated to produce an area under the concentration–time curve of 6.0 mg per milliliter per minute, administered intravenously on day 1, or paclitaxel and carboplatin plus bevacizumab at a dose of 15 mg per kilogram given intravenously on day 1.15 Chemotherapy was repeated every 21 days for a total of six cycles unless there was evidence of disease progression or intolerance of the study treatment. Patients in the paclitaxel–carboplatin–bevacizumab group continued to receive bevacizumab monotherapy every 3 weeks until evidence of disease progression or unacceptable toxic effects developed. [/b]
Irregardless, bavi's PFS of 6.5 months is similar to avastin's 6.2 months. The median number of treatment cycles in the avastin trial was seven. This was most likely six cycles of chemo/avastin and just one additional cycle of avastin as a mono therapy.
Yes, exactly. So on average, the combination of paclitaxel + carboplatin and avastin = 1 extra cycle of chemo + an additional cycle of avastin as monotherapy.
The median number of cycles of therapy was five in the paclitaxel–carboplatin group and seven in the paclitaxel–carboplatin–bevacizumab group (including the cycles of bevacizumab monotherapy). Of the 407 patients starting treatment with paclitaxel and carboplatin plus bevacizumab for whom we had adequate information on the duration of treatment, 215 (53%) continued with bevacizumab monotherapy, and of these, 107 (50%) received more than five cycles of monotherapy
In my opinion the current bavi phase 2 protocols have a flaw that I hope gets dealt with.
With regards to this post you made, I feel you've hit on an important point ragarding bavi's MOA. You are correct with regards to bavi monotherapy being stopped once disease progression is established, and I agree this could be a flaw which could result in a lower overall survival number. If bavi truly is immunostimulatory on its own, then you would assume bavi's benefit might continue even after progression, resulting in a longer overall survival. I think we will have to wait for more data concerning overall survival in the current phase 2 study. Perhaps the numbers are compelling enough that this concern does not need to be addressed until a later time.
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