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Docetaxel Combination Shows Significant Survival Advantage Over Vinorelbine/Cisplatin Combination As First-Line Treatment For Advanced Lung Cancer

SAN FRANCISCO, May 12, 2001 — A chemotherapy regimen of docetaxel (Taxotere®) with cisplatin yields a significantly better overall survival rate (p=0.0469) than the combination of vinorelbine (Navelbine®) and cisplatin in patients with advanced non-small cell lung cancer (NSCLC) who have not undergone prior chemotherapy according to phase III trial data reported at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO).

The study, presented by Chandra P. Belani, M.D., professor of medicine, University of Pittsburgh School of Medicine and co-director, Lung Cancer Program, University of Pittsburgh Cancer Institute, showed that patients who were treated with docetaxel and cisplatin survived significantly longer than those who received combination therapy with vinorelbine and cisplatin, a standard regimen used to treat advanced NSCLC. The median survival for the docetaxel/cisplatin cohort was 10.9 months versus 10 months for the vinorelbine/cisplatin cohort. The one-and two-year survival rates were 46 percent and 20 percent versus 42 percent and 14 percent, respectively.

“While platinum-based chemotherapy is often viewed as a first-line therapy for patients with advanced non-small cell lung cancer, there is no established treatment standard for this population,” said Dr. Belani. “The improved survival associated with the docetaxel/cisplatin combination means that a superior treatment may be available for this vast group of patients who are not candidates for surgical resection.”

The trial included more than 1,200 men and women 18 years of age or older with pathologically confirmed, unresectable locally advanced and/or recurrent or metastatic NSCLC and a Karnofsky performance status of at least 70 percent. Recurrent disease was defined as evidence of tumor progression after surgical or radiation treatment. Patients who had undergone prior treatment for their lung cancer with a biologic response modifier or chemotherapy agent were ineligible.

The median age of the study population was 60 years, and most patients were men. Roughly 67 percent had stage IV disease, meaning the disease had spread to organs in addition to the lungs and nodes in the chest cavity. In about one-third of patients, disease had spread to at least three other organs.

Patients were randomized to one of three treatment groups. The first group received docetaxel, 75mg/m2, plus cisplatin 75mg/m2, and the treatment was repeated every 21 days. The second group was treated with the combination of docetaxel, 75 mg/m2, and carboplatin, AUC=6, and the treatment was repeated every 21 days. The third group received a combination of vinorelbine, 25 mg/m2/wk, and cisplatin 100mg/m2, and the treatment was repeated every 28 days.

Patients were treated until there was evidence of progressive disease or unacceptable adverse events or until six treatment cycles had been completed. Treatment response was assessed after every two treatment cycles.

The overall survival for patients treated with docetaxel and carboplatin was similar to patients treated with vinorelbine and cisplatin (p=0.710). Median survival was 9.1 months for the docetaxel/carboplatin regimen versus 10 months for the vinorelbine/cisplatin regimen. The one-and-two year survival rates were also similar between both arms; 37 percent and 16 percent for the docetaxel/carboplatin group versus 42 percent and 14 percent for the vinorelbine/cisplatin group, respectively.

All treatment arms were generally well tolerated. Less than 5 percent of patients experienced severe sensory neuropathy in both docetaxel treatment arms. Treatment related infection, febrile neutropenia and deaths were also similar between the groups. More patients in the vinorelbine /cisplatin group experienced severe nausea, vomiting and anemia; however, diarrhea was more common in patients treated with docetaxel/cisplatin.

The study was conducted at 135 sites in 28 countries.

Lung cancer is the leading cause of cancer-related deaths worldwide and is primarily due to cigarette smoking. Non-small cell lung cancer is the most common type of lung cancer. Most patients present with disease that cannot be cured surgically and depend on radiation therapy and/or systemic chemotherapy to improve their outcome.

Ranked 12th in NCI funding and the only NCI-designated comprehensive cancer center in western Pennsylvania, UPCI is widely recognized as a leader in translating laboratory findings into applications of potential clinical importance and for its commitment to developing new and effective approaches to cancer prevention, diagnosis, treatment and care.

For more information about UPCI, please access or call the UPCI Cancer Information and Referral Service toll-free at 1-800-237-4724.

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