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【drug-news】新药物抵抗肾癌
New Drugs Make Inroads Against Kidney Cancer
01.10.07, 12:00 AM ET
WEDNESDAY, Jan. 10 (HealthDay News) -- Two new drugs may offer people with metastatic kidney cancer a chance to slow the progression of their disease and perhaps even live longer.
New research, reported in the Jan. 11 issue of the New England Journal of Medicine, details the phase III clinical trials of the drugs sunitinib and sorafenib -- two compounds that work in a similar manner, suppressing a genetic defect that turns off one of the body's normal tumor-suppressor genes.
The first study found progression-free survival was increased to 11 months for the drug sunitinib, compared to five months for the current standard-care medication interferon alfa, in previously untreated patients with metastatic kidney cancer. The second study found that progression-free survival in patients with metastatic cancer that had already been treated with interferon alfa was increased to 5.5 months if they took the drug sorafenib, compared with 2.8 months for those taking a placebo.
"Kidney cancer has always been regarded as a cancer in which there was no progress," explained the lead author of the sunitinib study, Dr. Robert Motzer, an attending physician at Memorial Sloan-Kettering Cancer Center in New York City. "Based on a better understanding of tumor biology, this new medication (sunitinib) was developed, and it has remarkable activity that has resulted in a complete change in the way we treat this cancer."
Motzer added that sunitinib is now "the new standard of care for metastatic kidney cancer."
Dr. James Brugarolas, an assistant professor of oncology at the University of Texas Southwestern Medical Center at Dallas, said the two new drugs represented "a major step forward in our fight against kidney cancer that was made possible by obtaining a greater understanding of the molecular genetics and biology of the disease. These drugs are clearly effective against the tumor. They make it shrink, but do not make it disappear."
Brugarolas, who wrote an accompanying editorial in the same issue of the journal, added, "We now have three therapies that have been approved by the FDA for kidney cell carcinoma, and the fourth is coming."
Motzer and his colleagues compared the use of sunitinib to what was considered the standard of care at the time, interferon alfa. Their study included 750 patients with metastatic kidney cancer who had previously been untreated.
The study volunteers were randomly assigned to receive either repeated six-week cycles of oral sunitinib or injected interferon alfa three times weekly. Study medications were provided by sunitinib's manufacturer, Pfizer Inc.
Sunitinib had a response rate of 31 percent, versus 6 percent for interferon alfa. The time of progression-free survival was also increased in the sunitinib group -- 11 months compared to five months for the interferon alfa group. Additionally, patients in the sunitinib group also reported a better quality of life than those in the interferon group.
Motzer said the researchers didn't design the study to look at survival time as an endpoint, and that it may be difficult to get such data from this trial, because many of those on interferon alfa later switched to sunitinib.
The second study focused on treating patients who had already been unsuccessfully treated with interferon alfa. This study included 903 people with metastatic kidney cancer who were randomly selected to receive either oral sorafenib or a placebo. The researchers reported receiving support from Bayer and Onyx Pharmaceuticals, the makers of sorafenib.
Partial responses -- considered the best response in this trial -- were reported in 10 percent of those taking sorafenib, versus only 2 percent of those on a placebo. The average progression-free survival was 5.5 months for the sorafenib group, compared to 2.8 months for those in the placebo group.
Both drugs, as with most cancer-fighting medications, can have serious side effects. Diarrhea, skin rash or sores and increased blood pressure were some of the adverse effects of both drugs.
"Both drugs have the capacity to slow down or shrink the tumor size. Clearly, they have activity against the tumor, and I expect that will translate to improvements in life expectancy, but the data isn't available yet," said Brugarolas, who pointed out that the toxicity of the drugs may affect any gains in life expectancy.
While both drugs work in a similar manner, affecting the genetic mutation that turns off a tumor-suppressing gene, both Brugarolas and Motzer said they couldn't compare the two medications because they haven't been tested in head-to-head trials, and they've both been studied in different patient populations.
More information
To learn more about kidney cancer and the treatments available, visit the National Cancer Institute. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 WEDNESDAY, Jan. 10 (HealthDay News) -- Two new drugs may offer people with metastatic kidney cancer a chance to slow the progression of their disease and perhaps even live longer.
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作者:admin@医学,生命科学 2011-03-24 21:20
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