Avastin plus interferon almost doubled patients' time without disease progression, study

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http://health.usnews.com/usnews/health/healthday/071221/new-combo-treatment-extends-kidney-cancer-survival.htm

New Combo Treatment Extends Kidney Cancer Survival
Avastin plus interferon almost doubled patients' time without disease
progression, study found
By Steven Reinberg
Posted 12/21/07

FRIDAY, Dec 21 (HealthDay News) -- A combination treatment with two drugs,
Avastin (bevacizumab) plus interferon, extends the life of patients with
kidney cancer, European researchers report.

"Based on the result of earlier trials, there is already considerable
enthusiasm to use bevacizumab as a new drug for treating kidney cancer
patients," noted Dr. Mayer Fishman, an assistant professor in the
department of interdisciplinary oncology at the Moffitt Cancer Center of
the University of South Florida in Tampa. He was not involved in the
study.

Publication of large trials such as this can be expected to support the
more widespread use of new drugs such as bevacizumab for kidney cancer
therapy, Fishman said.

The study was funded by F. Hoffmann-La Roche Ltd., the maker of Avastin.
It is published in the Dec. 22/29 issue of The Lancet.

In a phase III trial, Dr. Bernard Escudier from the Institute Gustave
Roussy in Villejuif, France, and colleagues randomly assigned 649 patients
with kidney cancer to receive Avastin and interferon or interferon plus a
placebo.

Among those receiving combined therapy, 114 died compared with 137 of
those receiving interferon alone. Moreover, patients taking Avastin plus
interferon survived without any signs of disease progression for an
average of 10.2 months. That's almost double the 5.4-month average
progression-free survival for those on interferon alone.

"This treatment [bevacizumab plus interferon] is clearly comparable with
the most active treatment, and with a very good safety profile, will
provide new options for renal cancer patients," Escudier's group
concluded.

As more and more targeted drugs are developed, and as more combinations
are possible, and as immune treatments become more sophisticated,
"optimism is building that we will see more and more substantial impacts
on kidney cancer treatment," Fishman said.

"This can result in better survival and better quality of life for
survivors. On the other hand, with more and more drugs and combinations,
it may become harder to see the impact of an individual drug," he added.

Another expert lauded the paper.

"This article provides another outstanding example of how a greater
understanding of the biology of kidney cancer can lead to successful
treatments that delay tumor growth," said Dr. James Brugarolas, an
assistant professor in the division of oncology at the Simmons
Comprehensive Cancer Center at the University of Texas Southwestern
Medical Center at Dallas.

"An important question that remains to be addressed is whether bevacizumab
alone would offer similar benefit with respect to slowing down tumor
progression as the bevacizumab/interferon combination, with perhaps less
toxicity," Brugarolas said.
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A larger multi-centre North American trial is ongoing, but not
recruiting.
http://clinicaltrials.gov/ct2/show/NCT00072046
OBJECTIVES:

Primary

* Compare the overall survival of patients with advanced renal cell
carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with
bevacizumab.

Secondary

* Compare the time to disease progression and objective response rates
in patients treated with these regimens.
* Determine the toxicity of interferon alfa-2b in combination with
bevacizumab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified
according to prior nephrectomy (yes vs no) and number of risk factors for
disease progression (0 vs 1-2 vs 3 or more). Patients are randomized to 1
of 2 treatment arms.

* Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three
times a week.
* Arm II: Patients receive interferon alfa-2b as in arm I and
bevacizumab IV over 30-90 minutes on days 1 and 15.

In both arms, courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then annually for up
to 10 years after study entry.

PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be
accrued for this study within 3 years.
RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere
with the growth of tumor cells. Bevacizumab may stop the growth of tumor
cells by stopping blood flow to the tumor. It is not yet known whether
interferon alfa-2b is more effective with or without bevacizumab in
treating advanced renal cell carcinoma (kidney cancer).

PURPOSE: This randomized phase III trial is studying interferon alfa-2b
and bevacizumab to see how well they work compared to interferon alfa-2b
alone in treating patients with advanced renal cell carcinoma.

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