DOI: 10.1097/01.COT.0000315639.66250.c5

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Issn Print: 0276-2234

Publication Date: 2003/01/10


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Docetaxel Approved for Initial Treatment of Advanced NSCLC

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Docetaxel has been approved by the FDA for use as first-line therapy for patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who have not received prior chemotherapy. The drug is marketed under the trade name Taxotere by Aventis.
With this FDA approval, Taxotere becomes the only agent indicated both for patients with newly diagnosed NSCLC, in combination with cisplatin, and for those with previously treated advanced NSCLC, as a single agent.
“The approval of Taxotere as a first-line treatment of advanced non-small cell lung cancer means that oncologists can now extend to newly diagnosed patients the benefits seen with this agent as second-line therapy,” Chandra P. Belani, MD, Professor of Medicine at the University of Pittsburgh School of Medicine and Co-director of the Lung Cancer Program at the University of Pittsburgh Cancer Institute, said in a news release. “In light of low survival rates among people with this disease, this approval means more patients can hope for longer survival.”
The new approval was based on a clinical trial with 1,218 patients, comparing the effect of docetaxel plus cisplatin or docetaxel plus carboplatin with a standard regimen of vinorelbine plus cisplatin. Patients in the docetaxel-plus-cisplatin group had a median survival time of 10.9 months vs 10.0 months for patients treated with vinorelbine plus cisplatin.
The overall response rates were 31.6% for docetaxel plus cisplatin vs 24.4% for vinorelbine plus cisplatin.
Additional study analysis, the news release noted, indicated that the benefits seen were maintained in patients who were 65 years of age and older. This is a key point, since approximately two thirds of all lung cancer patients are age 65 years or older.
Also applauding the approval was the Alliance for Lung Cancer Advocacy, Support and Education (ALCASE), which released a statement calling the approval “another step forward in the effort to improve standards of care and treatment for those fighting this devastating disease.”
Taxotere had previously been approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. About one of every three patients treated for NSCLC in the US today is treated with docetaxel-based therapy, according to Aventis.
The most common severe side effects associated with docetaxel are low white blood cell count, fatigue, fluid retention, and mouth sores.
The most common non-severe side effects included hair loss; neurosensory, cutaneous, and nail changes; and nausea and diarrhea—all generally reversible and manageable. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere is not appropriate treatment for patients with significant liver impairment or a low white blood cell count, the company reports, and patients age 65 or older may experience some side effects more frequently.
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