Taxotere 'offers significant benefits' for cancer patients
Results of a phase III trial using Taxotere (docetaxel) injection concentrate when added to a standard therapy for nonresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) reported that the Taxotere-based regimen demonstrated superior overall survival rates, and patients also benefited from significantly improved progression-free survival and cancer response rates, as well as a lower rate of severe side effects compared with the standard therapy.
Results of a phase III trial using Taxotere (docetaxel) injection concentrate when added to a standard therapy for nonresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) reported that the Taxotere-based regimen demonstrated superior overall survival rates, and patients also benefited from significantly improved progression-free survival and cancer response rates, as well as a lower rate of severe side effects compared with the standard therapy.
The trial, conducted by the European Organization for Research and Treatment of Cancer (EORTC) Head and Neck Cooperative Group, involved 358 patients and demonstrated that patients receiving Taxotere plus cisplatin and 5-fluorouracil (5-FU) had significant prolongation of progression-free survival, the trial's primary endpoint, (12.7 months vs. 8.4 months) compared with those who received the standard treatment of cisplatin and 5-fluorouracil (5-FU). The Taxotere combination also resulted in significantly improved overall survival (18.6 months vs. 14.5 months) and significantly increased overall response rates (67.8% vs. 53.6% ), the trial's secondary endpoints.
'Head and neck cancer patients have very limited treatment options. The addition of Taxotere to this standard treatment regimen is very encouraging and may change the paradigm by which we treat this disease,' said Dr Jan Vermorken, EORTC's principal investigator. 'The trial findings provide new important information for oral surgeons, medical oncologists and radiation oncologists.'
Head and neck cancer is the seventh most frequently occurring cancer worldwide with an incidence rate of 390,000 cases annually. In the United States, it is estimated that more than 38,000 cases will occur in 2004.
'We are encouraged by today's results that suggest a benefit with Taxotere for patients with advanced head and neck cancer, a difficult to treat disease', said Dr Frank Douglas, executive vice president of drug innovation and approval, Aventis.
About Taxotere
Taxotere is a key growth driver for Aventis and is the foundation of the company's oncology franchise. Taxotere is indicated for treatment of metastatic breast cancer and non-small cell lung cancer, and is being studied extensively in clinical trials for safety and efficacy in early-stage breast and gastric cancers. Additional Taxotere submissions to regulatory authorities for gastric cancer are planned for the second half of the year and head & neck cancer is planned for 2005. In 2003, Taxotere generated worldwide sales of over Euro 1.3bn.