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Ovarian Cancer (Expert Forum)
avastin
Answered by
Annekathryn Goodman, M.D. - Gynecologic Cancers, Complex Gynecologic, Surgeries, Palliative Care, Acupuncture
Massachusetts General Hospital Cancer Center
Boston - MA
avastin
by ehr, Dec 31, 2007 01:00PM
My CA125 has been rising quite rapidly after taxol stopped working its magic over the last 7 months. I went for a PtCt and quite surprisingly it was clear. in fact some of the disease preogression noted on a PtCt 7 months ago has all but vanished. Feeling good, working and busy all day I would love to continue without further treatments fora while - DX in 2002 stage 4 and have had basically non stop treatments for 2+ years after a decent remission. My doctor wants to start an Avastin regimen every three weeks. We are having some difficulty having it approved by insurance but my doctor assures me that it will be approved and we will start this friday. Where does Avastin stand in the treatment of OC. Is it still considered investigational. My doctor says he has had quite alot of success with it. Are the side effects with Avastin more difficult than Taxol was (not terrible) Thank you for all your help
Doctor's Answer
by Annekathryn Goodman, M.D., Jan 01, 2008 11:33AM
, Jan 01, 2008 11:33AM
Hi there,
When I look at the literature on avastin, I come to the conclusion that we just do not know yet. There are ongoing studies using avastin in combination with taxol and carboplatin, or as you are going to get - as a maintenance therapy, or in recurrence. I have pasted the best summary I can find which is reporting on the data from the annual American society of clinical oncology ASCO 2005 meeting. There really has not been any new data since then. I think it is going to be another 5 years before we really have hard proof one way or the other if avastin adds to survival for women with ovarian cancer. In the mean time, we do use it.
Side effect include hypertension, bleeding, blood clots, renal failure, and bowel perforation.
take care
ORLANDO, May 17, 2005-Avastin (bevacizumab), an angiogenesis inhibitor approved for use in metastatic colorectal cancer, induces high response rates and prolongs progression-free survival in women with relapsed ovarian cancer, according to two phase II studies presented here.
Action Points
* Discuss with patients who ask about the new therapies being tested and developed for recurrent ovarian cancer, including Avastin. Point out that these are preliminary phase II studies and results thus cannot be compared directly with other therapies.
* Counsel patients with recurrent ovarian cancer who are interested on the possibility of enrolling in a clinical trial testing Avastin therapy.
* This study was published as an abstract and presented at a conference either as an oral or poster presentation. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
The first of the preliminary studies tested a combination of Avastin and low-dose daily cyclophosphamide. Such frequent, low dosing has been shown in preclinical models to have an anti-angiogenesis effect that is superior to that of standard maximum-tolerated dosing. The study results were presented on Sunday by Agustin Garcia, M.D., of Cedars-Sinai Medical Center in Los Angeles, on behalf of the California Cancer Coalition.
The combination of Avastin and metronomic chemotherapy induced a near complete and sustained inhibition of tumor growth in preclinical models, said Dr. Garcia.
Twenty-nine women with measurable relapsed ovarian cancer all had had at least one prior treatment for recurrent disease. The median was two prior therapies for the group. With a median follow-up of 8.1 months, 17 women have progressed. The median time to progression was 7.5 months, and the six month progression-free survival was 57% (±10%).
None of the patients had a complete response, but eight (28%) achieved a partial response and 18 (62%) had stable disease. The median duration of response was 4.9 months, with a range of 3.7 to 6.3 months.
Given the promising results, the researchers are proceeding with the second stage of the phase II trial. Accrual was completed in March with 66 patients, said Dr. Garcia.
In the second trial, which was presented Monday by Robert A. Burger M.D., of the University of California at Irvine, the Gynecologic Oncology Group tested Avastin monotherapy in patients with measurable, relapsed ovarian cancer. All patients had at least one prior chemotherapy treatment for recurrent disease.
Although Avastin monotherapy has not induced strong responses in most cancers, the GOG team decided to proceed with the single-agent trial because of the "very striking preclinical data in this disease site," said Dr. Burger.
With 62 patients enrolled, the overall response rate was 17.7% (90% CI, 10.3% to 27.7%) by RECIST criteria. Three patients (4.8%) had a complete response, eight (12.9%) had a partial response, and 34 (54.8%) had stable disease. The median response duration was 10.25 months.
Progression free survival at six months was 38.0% (90% CI, 28.3% to 49.9%), with two patients still pending. Fourteen patients remain on therapy.
Toxicities in both trials were manageable, with hypertension and thrombosis occurring in a limited number of patients in each trial, which is consistent with other trials using Avastin. There were no grade 3 or 4 bleeding events in either trial.
Both research teams are planning to continue trials on Avastin. The Gynecologic Oncology Group is currently designing a phase III trial to test single agent therapy.
"These were phase II trials, so they were not comparator trials, but both of them showed response rates and improvement in progression-free survival at six months that were higher than historical controls," said Carolyn D. Runowicz, M.D., director of the University of Connecticut Cancer Center and president-elect of American Cancer Society.
"That suggests that we have a very active agent in ovarian cancer, even in women with advanced, recurrent, difficult-to-treat disease," she said. "The next step is to move it up front to first line therapy" for recurrent disease.
Researchers know that VEGF is overexpressed in a significant percentage of ovarian cancers and correlates with the development of ascites, malignant progression, and poor prognosis.
What isn't yet clear is how to prospectively identify the women who are likely to respond to anti-angiogenesis therapy. To find out, both groups are working to identify biological correlates of response in tumor samples collected from the patients in these trials.
Primary source: 2005 ASCO Annual Meeting Proceedings (Supplement to the J of Clinical Oncology), Abstract 5000.
When I look at the literature on avastin, I come to the conclusion that we just do not know yet. There are ongoing studies using avastin in combination with taxol and carboplatin, or as you are going to get - as a maintenance therapy, or in recurrence. I have pasted the best summary I can find which is reporting on the data from the annual American society of clinical oncology ASCO 2005 meeting. There really has not been any new data since then. I think it is going to be another 5 years before we really have hard proof one way or the other if avastin adds to survival for women with ovarian cancer. In the mean time, we do use it.
Side effect include hypertension, bleeding, blood clots, renal failure, and bowel perforation.
take care
ORLANDO, May 17, 2005-Avastin (bevacizumab), an angiogenesis inhibitor approved for use in metastatic colorectal cancer, induces high response rates and prolongs progression-free survival in women with relapsed ovarian cancer, according to two phase II studies presented here.
Action Points
* Discuss with patients who ask about the new therapies being tested and developed for recurrent ovarian cancer, including Avastin. Point out that these are preliminary phase II studies and results thus cannot be compared directly with other therapies.
* Counsel patients with recurrent ovarian cancer who are interested on the possibility of enrolling in a clinical trial testing Avastin therapy.
* This study was published as an abstract and presented at a conference either as an oral or poster presentation. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
The first of the preliminary studies tested a combination of Avastin and low-dose daily cyclophosphamide. Such frequent, low dosing has been shown in preclinical models to have an anti-angiogenesis effect that is superior to that of standard maximum-tolerated dosing. The study results were presented on Sunday by Agustin Garcia, M.D., of Cedars-Sinai Medical Center in Los Angeles, on behalf of the California Cancer Coalition.
The combination of Avastin and metronomic chemotherapy induced a near complete and sustained inhibition of tumor growth in preclinical models, said Dr. Garcia.
Twenty-nine women with measurable relapsed ovarian cancer all had had at least one prior treatment for recurrent disease. The median was two prior therapies for the group. With a median follow-up of 8.1 months, 17 women have progressed. The median time to progression was 7.5 months, and the six month progression-free survival was 57% (±10%).
None of the patients had a complete response, but eight (28%) achieved a partial response and 18 (62%) had stable disease. The median duration of response was 4.9 months, with a range of 3.7 to 6.3 months.
Given the promising results, the researchers are proceeding with the second stage of the phase II trial. Accrual was completed in March with 66 patients, said Dr. Garcia.
In the second trial, which was presented Monday by Robert A. Burger M.D., of the University of California at Irvine, the Gynecologic Oncology Group tested Avastin monotherapy in patients with measurable, relapsed ovarian cancer. All patients had at least one prior chemotherapy treatment for recurrent disease.
Although Avastin monotherapy has not induced strong responses in most cancers, the GOG team decided to proceed with the single-agent trial because of the "very striking preclinical data in this disease site," said Dr. Burger.
With 62 patients enrolled, the overall response rate was 17.7% (90% CI, 10.3% to 27.7%) by RECIST criteria. Three patients (4.8%) had a complete response, eight (12.9%) had a partial response, and 34 (54.8%) had stable disease. The median response duration was 10.25 months.
Progression free survival at six months was 38.0% (90% CI, 28.3% to 49.9%), with two patients still pending. Fourteen patients remain on therapy.
Toxicities in both trials were manageable, with hypertension and thrombosis occurring in a limited number of patients in each trial, which is consistent with other trials using Avastin. There were no grade 3 or 4 bleeding events in either trial.
Both research teams are planning to continue trials on Avastin. The Gynecologic Oncology Group is currently designing a phase III trial to test single agent therapy.
"These were phase II trials, so they were not comparator trials, but both of them showed response rates and improvement in progression-free survival at six months that were higher than historical controls," said Carolyn D. Runowicz, M.D., director of the University of Connecticut Cancer Center and president-elect of American Cancer Society.
"That suggests that we have a very active agent in ovarian cancer, even in women with advanced, recurrent, difficult-to-treat disease," she said. "The next step is to move it up front to first line therapy" for recurrent disease.
Researchers know that VEGF is overexpressed in a significant percentage of ovarian cancers and correlates with the development of ascites, malignant progression, and poor prognosis.
What isn't yet clear is how to prospectively identify the women who are likely to respond to anti-angiogenesis therapy. To find out, both groups are working to identify biological correlates of response in tumor samples collected from the patients in these trials.
Primary source: 2005 ASCO Annual Meeting Proceedings (Supplement to the J of Clinical Oncology), Abstract 5000.
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