Phase II data from the GOG (Gynecologic Oncology Group) for recurrent ovarian/primary peritoneal cancers, an ongoing similar confirmatory study, and an ongoing Phase III primary trial suggest that this is a true advance and may be part of future gold standard therapy.
Efficacy of Avastin alone (no concommitant chemo) in ovarian and primary peritoneal Cancer shows an approximate 18% objective response rate, almost 40% progression free survival at 6 months is 10.25 months. This was in patients with a disease free interval of 6.5 months after primary chemo. So, for a biological agent alone, these are very promising results.
The downside: serious adverse events included gastrointestinal perforations, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, nephrotic syndrome, congestive heart failure, pain, diarrhea and leukopenia, brain stem encephalopathy and nasal septal perforation. When complications occur with this medication, they can be severe and life threatening.
Avastin is not used wthin a month of major surgery and it is not clear how long to wait before the possibility of secondary surgery after Avastin. the half life of the drug is about 20 days, so it stays around in the body for quite a while in therapeutic doses.
It has shown activity in a number of other cancers. Is it the magic bullet? No. But it shows promise for additive effect and potentially greater cure rates and disease free intervals. More studies are needed and are ongoing/coming up.
UPDATE Jan 2006
The good news is that Avastin has been elevated to a Phase III GOG trial for Ovarian cancer. The protocol examines how effective Avastin + chemo is vs. chemo alone in those patients who have had a sub-optimal tumor debulking surgery (N.B. "Sub-optimal" means that the surgeon was unable to remove the tumor(s) down to a size of 1cm or less).
The bad news is that there have been reports of bowel perforations with the use of Avastin. This has mainly been in patients who have intestinal cancer. However, the exact mechanism is unclear and any patient thinking about this treatment must be aware that this is a possible complication.
Update Feb 2007
The ongoing GOG trial is now open for OPTIMAL as well as sub-optimal postsurgical patients. This is a promising drug but given the substantial risk of severe side-effects should be used for FDA approved indications ( metastatic lung or colorectal cancer) or on clinical trial only.
Update Feb 2008
The GOG trial is still ongoing as a Phase III study for optimal and suboptimal ovarian and primary peritoneal cancer patients.
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