Adding cancer drug Avastin to standard chemotherapy doubled the length of time a certain group of advanced ovarian cancer patients lived without their disease getting worse, according to results of a clinical trial.
The study involved 361 women whose cancer had stopped responding to traditional platinum-based chemotherapy.
After a median follow-up of 13.5 months, 75 percent of Avastin patients had a recurrence of cancer, compared to 91 percent of those who received chemotherapy alone.
The median time to disease progression or death was 6.7 months in the combination group and 3.4 months in the chemotherapy group.
“A lot of drugs have been tested in this situation,” said Dr Eric Pujade-Lauraine, head of Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, an ovarian cancer clinical trials cooperative group based in Paris.
“It is the first time that a Phase 3 trial has shown a significant difference,” said Pujade-Lauraine, the study’s lead investigator.
What Does Avastin Treat?
Avastin is approved for:
- Metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU–based chemotherapy for metastatic cancer
- Advanced nonsquamous non–small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease
- Metastatic kidney cancer (mRCC) when used with interferon alfa
- Glioblastoma (GBM) in adult patients whose cancer has progressed after prior treatment. The effectiveness of Avastin in GBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people previously treated for GBM
The study, to be presented on Saturday at a meeting here of the American Society of Clinical Oncology, involved 361 women whose cancer had stopped responding to traditional platinum-based chemotherapy.
Avastin, developed by Roche’s Genentech unit, is an antibody that blocks the growth of blood vessels tumors need to survive and grow. It is approved in the U.S. for treating glioblastoma, colorectal, lung and kidney cancers.
Avastin unlikely to get ovarian cancer approval after disappointing studies
The cancer drug Avastin has come under fire in recent years as studies have showed it doesn’t prolong life for patients with breast cancer and may cause nasty side effects. The controversy culminated in an FDA decision in November to revoke the drug’s approval for treating breast cancer.
Avastin is still approved to treat certain types of colon, lung, kidney, and brain cancer, and just last week Avastin won approval in Europe for treating ovarian cancer. But two new studies that looked closely at the drug’s effectiveness for treating women with ovarian cancer did not show promising results. The studies found Avastin did not improve survival for most ovarian cancer patients and kept their disease from worsening for only a few months - while giving the patients more side effects.
One study, led by Dr. Robert Burger, a gynecologic oncologist at Fox Chase Cancer Center in Philadelphia, involved nearly 1,900 women with advanced ovarian cancer given one of three treatment combinations. The time until the disease got worse was a median of 10 months in those given just chemotherapy. Adding Avastin improved that time frame by just one to four months for the other two groups.
Avastin is not right for everyone. Talk to your doctor if you:
- Are pregnant, may be pregnant, or are breast-feeding. Avastin may harm the fetus or a child that is nursing. If you stop Avastin, you should keep using birth control for at least 6 months after your last dose before trying to become pregnant
- Are undergoing surgery. Don’t take Avastin for at least 28 days before or after surgery and until surgical wounds are fully healed
If you have any questions about your condition or treatment, talk to your doctor.
Survival was similar among the groups, and side effects, including high blood pressure, stomach and gut problems, were higher among those on Avastin.
In the other study, British researchers looked at more than 1,500 ovarian cancer patients who were given chemo with or without Avastin. The drug kept cancer at bay just one to two months longer than chemo alone did, with more cases of high blood pressure. There was a trend toward improved survival for those on Avastin, but the difference was too small to say the drug was responsible.