MedPage (KC) 03 Jun 09
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ASCO: Results 'Striking' for New Kidney Cancer Drug
ORLANDO, June 3 -- An investigational oral angiogenesis inhibitor reduced the risk of tumor progression by 54% in advanced renal cell carcinoma, a researcher said here. Action Points Explain to interested patients that this study reported promising results from a trial of a new angiogenesis inhibitor for the treatment of kidney cancer.
Note that this is an interim analysis and that more study is needed. Also explain that the drug has not yet been approved for use.
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. In an interim analysis of a phase III trial, pazopanib also had a significantly better response rate than placebo, according to Cora Sternberg, M.D., of San Camillo Forlanini Hospital in Rome.
The oral drug -- an inhibitor of the vascular endothelial growth factor and platelet derived growth factors receptors, as well as the cytokine receptor c-kit -- also appeared to offer an overall survival advantage, Dr. Sternberg said at the annual meeting of the American Society of Clinical Oncology.
The study was conducted in 22 countries at 80 centers, Dr. Sternberg said, and enrolled 435 patients between April 2006 and April 2007. They were randomized in a two-to-one fashion to either 800 milligrams a day of pazopanib or a matching placebo.
Initially, she said, the study was designed to enroll patients pretreated with cytokine therapy, but with the advent of the tyrosine kinase inhibitors, it was redrafted to allow treatment-naive patients to enroll.
The primary endpoint was progression-free survival, Dr. Stenberg said, and overall -- as of May 23, 2008 -- patients in the pazopanib arm had a median progression-free survival of 9.2 months, compared with 4.2 for placebo.
Those figures yielded a hazard ratio for progression of 0.46 (95% CI 0.34 to 0.62, P<0.0000001), Dr. Sternberg said.
The figures were even better when the analysis was restricted to patients who had not been treated before -- a 60% reduction in the risk of progression that was significant at P<0.001.
Pretreated patients also did well, with a 46% reduction in the risk of progression that was significant at P<0.001.
Indeed, Dr. Sternberg said, progression-free survival was significantly better in all prespecified subgroups, regardless of age, sex, performance status, or risk category.
Overall, the tumor response rate was 30% in the pazopanib patients and 3% among those getting placebo. The median duration of response was 59 weeks, she said, at the 2008 cutoff date.
An interim analysis of overall survival showed a 27% reduction in the risk of death that was significant at P=0.02, Dr. Sternberg said.
The drug had a higher toxicity rate than placebo, with 92% of pazopanib patients reporting any adverse event, compared with 74% of placebo patients.
There were 33 grade 3 events among the pazopanib patients, compared with 14 among those getting placebo.
However, Dr. Sternberg said, the "class effects" of the drug -- such as proteinuria, hand-foot syndrome, and mucositis -- "were extremely low with pazopanib."
There were no differences between the arms on three different health-related, quality-of-life measures, she added.
The improvement in progression-free survival is "striking," said Nicholas Vogelzang, M.D., of the Nevada Cancer Institute, who discussed the report during an oral symposium.
Such an improvement has been seen with earlier members of the class, he said, and leaves "no question that these are highly active agents."
He added that the tumor response rates were also very striking and noted a "good long duration of response of over a year."
The study was supported by GlaxoSmithKline, which is developing the drug. The researchers reported financial links to the company. Dr. Vogelzang reported financial links with Allos, Ambit, Amgen, Bayer, Celgene (U), Genentech, Keryx (U), Novartis, Onyx, Pfizer, Wilex, Arqule, Clinical Care Options, Cougar, Imedex, Lippincott Williams and Wilkins, Argos, AstraZeneca, Endocyte, GlaxoSmithKline, Keryx, and Medarex.
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