Bevacizumab (Avastin)

Property	Information
Drug Name	Bevacizumab (Avastin)
FDA Approval	Yes, for recurrent glioblastoma
Used for	Glioblastoma
Clinical Trial Phase	Phase III
Clinical Trial Explanation	Not specified
Common Side Effects	Hypertension, proteinuria, and hemorrhage
OS without	Not specified
OS with	AVAglio trial: 16.8 months; RTOG trial: 15.7 months
PFS without	Not specified
PFS with	Not specified
Usefulness Rating	4
Usefulness Explanation	Not specified
Toxicity Level	3
Toxicity Explanation	Bevacizumab has an intermediate level of toxicity. Although it is a powerful medication against glioblastoma, it can have serious side effects including high blood pressure (hypertension), presence of excess proteins in the urine (proteinuria), and bleeding (hemorrhage). These side effects can impact your general health and daily activities. Therefore, this treatment needs regular monitoring by your health care provider and should be used with caution.

Notes: Avastin improves PFS when used initially, but no significant benefit for overall survival compared to Avastin given at recurrence.

From Ben Williams Book: The most notable development in drug combinations has been the addition of the anti- angiogenic drug, Avastin (also known as bevacizumab), to the standard Stupp protocol. As will be discussed later, Avastin has FDA approval for the treatment of glioblastomas that have recurred or progressed after initial treatment. Several clinical trials have now investigated its combination with the gold standard Temodar protocol.

Recently, there have been two large randomized phase III clinical trials comparing

the Stupp protocol and the Stupp protocol + Avastin, for newly diagnosed patients. In the first of these (70), known as the AVAglio trial, median PFS was 10.6 months for those receiving Avastin versus 6.2 months for those receiving only the Stupp protocol, a statistically significant difference. However, median overall survival was not different (16.8 months vs. 16.7 months). It should be noted that patients in the control group

typically received Avastin after tumor progression occurred, so that the comparison was

really between Avastin given early versus Avastin given only after recurrence. Additional results were that 72% of the Avastin group was alive at one year, compared to 66% of the control group, while two year survival was 34% vs. 30%.

In the second of these large trials (71), conducted by the RTOG consortium, the design was essentially similar to the AVAglio trial, as were the results. Median PFS was 10 months for those receiving Avastin vs. 7.3 months for the control group (again statistically significant), while median overall survival was 15.7 months for the Avastin group compared to 16.1 months for the control, a nonsignificant difference.

The best interpretation of these results is that patients have a longer time without tumor progression, and presumably a better quality of life, when Avastin is used as part of the initial treatment. However, there is no benefit for overall survival, when compared to withholding Avastin until recurrence is detected. An additional feature of the results, not emphasized by the authors of the reports, is that the overall survival times were not notably better, and in many cases worse, than those obtained when the Stupp protocol is combined with various other treatment agents.Property "Has original text" (as page type) with input value "The most notable development in drug combinations has been the addition of the anti-</br>angiogenic drug, Avastin (also known as bevacizumab), to the standard Stupp protocol.</br>As will be discussed later, Avastin has FDA approval for the treatment of glioblastomas</br>that have recurred or progressed after initial treatment. Several clinical trials have now</br>investigated its combination with the gold standard Temodar protocol.</br></br>Recently, there have been two large randomized phase III clinical trials comparing</br></br>the Stupp protocol and the Stupp protocol + Avastin, for newly diagnosed patients. In the</br>first of these (70), known as the AVAglio trial, median PFS was 10.6 months for those</br>receiving Avastin versus 6.2 months for those receiving only the Stupp protocol, a</br>statistically significant difference. However, median overall survival was not different</br>(16.8 months vs. 16.7 months). It should be noted that patients in the control group</br></br></br>typically received Avastin after tumor progression occurred, so that the comparison was</br></br>really between Avastin given early versus Avastin given only after recurrence. Additional</br>results were that 72% of the Avastin group was alive at one year, compared to 66% of the</br>control group, while two year survival was 34% vs. 30%.</br></br>In the second of these large trials (71), conducted by the RTOG consortium, the design</br>was essentially similar to the AVAglio trial, as were the results. Median PFS was 10</br>months for those receiving Avastin vs. 7.3 months for the control group (again statistically</br>significant), while median overall survival was 15.7 months for the Avastin group</br>compared to 16.1 months for the control, a nonsignificant difference.</br></br>The best interpretation of these results is that patients have a longer time without tumor</br>progression, and presumably a better quality of life, when Avastin is used as part of the</br>initial treatment. However, there is no benefit for overall survival, when compared to</br>withholding Avastin until recurrence is detected. An additional feature of the results, not</br>emphasized by the authors of the reports, is that the overall survival times were not</br>notably better, and in many cases worse, than those obtained when the Stupp protocol is</br>combined with various other treatment agents." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.

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