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Study demonstrates that a drug called erlotinib (Tarceva)
increases survival in patients with advanced non-small cell lung cancer.
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An international clinical trial led by Canadian
researchers has demonstrated that a drug called erlotinib
increases survival in patients with advanced non-small cell
lung cancer who typically have no other treatment options.
The trial, funded by the Canadian Cancer Society and published in
tomorrow's issue of The New England Journal of Medicine, involved
731 patients at centres in North and South America, Europe, Israel,
New Zealand, Asia and South Africa. The patients had already
received at least one or two regimens of chemotherapy and were
randomly assigned to one of two groups: 488 patients received
erlotinib and 243 received a placebo. The researchers found that
treatment with erlotinib resulted in longer survival compared to the
placebo. Patients who received erlotinib survived an average of 6.7
months, while patients on placebo survived an average of 4.7 months
– a 42.5 per cent improvement. Of the patients receiving erlotinib,
31 per cent were alive after one year, compared to only 22 per cent
of patients receiving placebo. Unlike many chemotherapies, erlotinib
was generally well-tolerated and caused only minor side effects.
"This drug offers a new treatment option to patients at a time in
their disease when they have no other options," says Dr. Frances
Shepherd, the study's principal investigator, holder of the Scott
Taylor Chair in Lung Cancer Research and medical oncologist at
Princess Margaret Hospital, and professor of medicine at the
University of Toronto. "Not only does erlotinib help them live
longer, but it also improves their physical function, their quality
of life, and it improves their symptoms of cough, shortness of
breath and pain."
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Dr. Barbara Whylie, CEO of the Canadian Cancer Society, says,
"This is a welcome advance in the treatment of lung cancer, the most
common cause of cancer death in Canada. Canadian researchers
continue to be at the forefront of new advances in the fight against
this disease and we are committed to continuing to support their
outstanding efforts."
Also known commercially as Tarceva, erlotinib slows down tumour
growth by interfering with a specific cellular pathway that promotes
cell division. The drug interferes with epidermal growth factor
receptors (EGFR), which receive an ongoing signal for the cells to
divide, thus driving the cancer's growth. Erlotinib specifically
targets EGFR to prevent the tumour from growing. This is the first
drug of the EGFR inhibitors family demonstrated to improve survival.
In November 2004, the U.S. Food and Drug Administration approved
erlotinib for patients with advanced non-small cell lung cancer who
had received at least one regimen of chemotherapy.
In a companion study, also published in tomorrow's issue of The
New England Journal of Medicine, scientists led by Dr. Ming Tsao and
Dr. Frances Shepherd at Princess Margaret Hospital assessed tumour
biopsies from some of the patients on the trial. They looked for
gene mutations, gene copy number, and the expression of the
epidermal growth factor receptor protein in the cancer cells. Their
findings suggest that molecular testing is not necessary to identify
appropriate patients for treatment with erlotinib.
Lung cancer is one of the most common forms of cancer worldwide,
and it is the leading cause of death from cancer in North America.
Non-small cell lung cancer is the most common type of lung cancer,
accounting for almost 80 per cent of all cases. An estimated 22,200
Canadians will be diagnosed with lung cancer this year, and 19,000
will die of the disease.
The lung cancer clinical trial was coordinated by the National
Cancer Institute of Canada Clinical Trials Group, which is funded by
the Canadian Cancer Society and based at Queen's University in
Kingston, Ontario. It was also funded by OSI Pharmaceuticals Inc.
Princess Margaret Hospital and its research arm, Ontario Cancer
Institute, have achieved an international reputation as global
leaders in the fight against cancer. Princess Margaret Hospital is a
member of the University Health Network, which also includes Toronto
General Hospital and Toronto Western Hospital. All three are
teaching hospitals affiliated with the University of Toronto.
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The Canadian Cancer Society is a national community-based
organization of volunteers whose mission is to eradicate cancer and
to enhance the quality of life of people living with cancer.
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