WEDNESDAY, Dec. 28 (HealthDay News) — Two new studies suggest
that the drug Avastin may lengthen progression-free survival by about four
months for women with ovarian cancer.
What isn’t clear yet is whether adding Avastin (bevacizumab) will make
a difference in overall survival. One study suggested it would, while the
other study didn’t find a difference in overall survival between two
treatment groups.
“The bottom-line results are a 28 percent reduction in disease
progression with patients on continued bevacizumab compared to the
standard treatment group. There was a 3.8 month median difference in
progression-free survival,” said Dr. Robert Burger, author of one of the
studies and director of the Women’s Cancer Center at Fox Chase Cancer
Center in Philadelphia.
“We still have to fine-tune or optimize this sort of new paradigm of
treatment. This regimen [chemotherapy plus continued Avastin] could be
considered a frontline option for patients with advanced ovarian cancer.
However, there are some risks to the treatment, and we haven’t shown an
impact on overall survival. But, in the European trial, they saw an
overall survival benefit,” Burger added.
“I think the difficult reality is that these studies are not
clear-cut,” said Dr. Len Lichtenfeld, deputy chief medical officer for the
American Cancer Society. “The improvements in progression are modest and
appear to be greater for women who have worse disease. What this
ultimately means is that it’s absolutely important for doctors treating
women with advanced ovarian cancer to read these studies very carefully so
they know who may benefit and the risks of treatment, and to counsel their
patients very carefully before moving forward with Avastin treatment,”
Lichtenfeld explained.
“This is not a case where treatment can be initiated in every woman.
The benefits for many women are modest at best,” he added.
Results of both studies are published in the Dec. 29 issue of the
New England Journal of Medicine. The studies were funded by Roche
and Genentech (a Roche-owned company). Burger said Genentech played no
role in the study design or analysis.
Burger’s study included almost 1,900 women with newly diagnosed stage 3
or stage 4 epithelial ovarian cancer. All of the women had undergone
surgery to remove as much cancer as possible. They were then randomly
assigned to one of three treatment groups: standard treatment including
paclitaxel and carboplatin chemotherapy; the Avastin-initiation group that
included the standard chemotherapy and Avastin for the second through
sixth treatment cycle; and the Avastin maintenance group that included
chemotherapy plus Avastin for up to the 22nd treatment cycle.
The average progression-free survival was 10.3 months for the standard
group, 11.2 months for the Avastin-initiation group and just over 14
months for the Avastin-maintenance group. There was no difference in
overall survival for the three groups.
The European study included more than 1,500 women with varying types of
ovarian cancer. Most had epithelial ovarian cancer, but the severity
ranged from early-stage disease to stage 4. Seventy percent of the women
enrolled in this study had stage 3 or stage 4 cancer.
The women were randomly assigned to receive either standard
chemotherapy treatment or chemotherapy plus Avastin for up to 12 cycles of
chemotherapy. The dose of Avastin used in this trial was half of what was
used in Burger’s trial.
Progression-free survival was 20.3 months for the standard group and
21.8 months for the standard therapy plus Avastin. In women who were
considered at high risk for progression, the progression-free survival was
14.5 months on standard therapy and 18.1 months with the addition of
Avastin. Overall survival in high-risk women was 28.8 months for women on
standard chemotherapy and 36.6 months for standard therapy plus
Avastin.
High blood pressure is a common side effect of Avastin, but Burger said
that in most cases, it can be controlled with blood pressure medication.
Another serious side effect associated with Avastin is bowel perforation,
which means a hole opens in the bowel wall. This side effect occurred in
fewer than 3 percent of women treated, but occurred twice as much in women
taking Avastin.
Published reports peg the cost of the drug at somewhere between $4,000
and $9,000 a month, depending on co-pay assistance that’s available from
Genentech, Avastin’s manufacturer. In a previous study, another research
group looked at the cost effectiveness of treatment with Avastin in
Burger’s trial and found the standard treatment arm of the trial cost $2.5
million. Treating the Avastin-initiation group cost $21.4 million and the
Avastin-maintenance group cost $78.3 million, according to the study,
which was published in the March 7 issue of the Journal of Clinical
Oncology. And, most of those costs came directly from the cost of the
medication. Those researchers concluded that Avastin was not a
cost-effective medication.
“We don’t want cost to be a deciding factor, but for many women with
ovarian cancer, cost may be a significant factor, and it needs to be
weighed in the equation,” Lichtenfeld said.
Avastin isn’t approved in the United States for the treatment of
ovarian cancer, so some insurance companies may balk at paying for it.
Plus, the U.S. Food and Drug Administration pulled Avastin’s approval for
the treatment of metastatic breast cancer in November because the FDA
found the risks of the drug outweighed its modest benefits. Avastin is
still approved for the treatment of some types of colon, lung, kidney and
brain cancer in the United States.
However, the drug was just approved by the European Union for use in
ovarian cancer in combination with chemotherapy.
More information
Learn more about ovarian cancer and its treatment from the
U.S. National Cancer Institute.
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