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发表于 2008-3-14 07:32:24
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来自： 美国
主要是因为鳞癌效果不好，对其它肺癌还没有定论。
Nexavar Dropped From Lung Cancer Trial
Featured Article
Main Category: Clinical Trials / Drug Trials
Also Included In: Pharma Industry / Biotech Industry; Cancer / Oncology; Lung Cancer
Article Date: 19 Feb 2008 - 3:00 PST
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have
stopped a late stage trial of their cancer drug Nexavar (sorafenib) in
patients with nonsmall-cell lung cancer (NSCLC), because it was not
showing the hoped for increase in survival.
Following a planned interim analysis, the trial's independent data
monitoring committee (DMC) concluded that the drug was not going to
meet the trial's main goal of improving overall survival.
In the phase 3 trial, a group of patients with squamous cell carcinoma
of the lung who took the drug in combination with chemotherapy drugs
carboplatin and paclitaxel showed a higher rate of death than a group
that received chemotherapy alone.
The trial, which is called ESCAPE (Evaluation of Sorafenib, Carboplatin
And Paclitaxel Efficacy in NSCLC), was otherwise showing safety events
generally in line with those previously reported, said Bayer in a press
statement.
The two drug companies are giving the DMC information to health
authorities and other investigators studying the effects of Nexavar and
will also be presenting the findings of the trial at a forthcoming
scientific meeting.
The companies will also be reviewing the findings of this trial,
including the DMC review, to see if they impact any other ongoing lung
cancer trials using Nexavar.
Vice president of Therapeutic Area Oncology at Bayer HealthCare
Pharmaceuticals, Dr Susan Kelley said that they were disappointed with
this result, but the two companies were still very much committed to
widening the scope of Nexavar in treating as many cancers as possible
and will continue to extend trials to other cancers.
"Nexavar has proven significant clinical benefit for patients with
liver cancer and advanced kidney cancer and we will continue to
investigate its potential across a wide variety of tumors," said Kelley.
The ESCAPE study was a multicentre, randomized, double-blind, placebo
controlled phase 3 trial involving more than 900 NSCLC patients at over
140 clinics in North and South America, Europe and Asia.
The main outcome sought was overall survival, but secondary endpoints
included progression-free survival, tumour response, quality of life,
and drug safety.
The participants had not received any systematic anti-cancer treatment
for lung cancer before the trial, which was open to patients with all
types of NSCLC, including squamous cell carcinoma or adenocarcinomas.
The patients were randomized to a drug group and a control (placebo)
group. The drug group was given 400 mg of Nexavar, orally, twice a day,
while the control group had a placebo. Both groups also had two
chemotherapy drugs, carboplatin and paclitaxel. Both groups continued
with the drug or placebo alone, after chemotherapy had finished
(maintenance phase), until symptoms of tumour progression or side
effects showed.
Nexavar (sorafenib) attacks both the tumour cell and the blood vessels
that feed it. In studies before clinical trials, the drug showed
ability to target kinase proteins thought to be involved in cell growth
and development of blood supply, two essential cancer enablers. The
kinases involved include: Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3,
PDGFR-B, KIT, FLT-3 and RET.
Nexavar is approved for the treatment of liver cancer in over 30
countries and for the treatment of advanced kidney cancer in over 60
countries. It is being evaluated for use with many other cancers such
as breast cancer, metastatic melanoma, and as an adjuvant therapy for
kidney cancer and liver cancer.
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