ROCKVILLE, Maryland—The FDA has approved Taxotere (docetaxel for injection, Sanofi-Aventis), in combination with cisplatin(Drug information on cisplatin) and fluorouracil(Drug information on fluorouracil) and administered prior to radiotherapy, for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN).
The agency granted marketing approval to the drug on the basis of phase III trial results showing patients treated with Taxotere and the two chemotherapeutic agents had a longer progressionfree survival and overall survival than those who received only the two cytotoxic drugs. The difference in both endpoints was statistically significant.
SCCHN, a group of related cancers, accounts for approximately 3% of all new cancers diagnosed in the United States, according to the FDA. These malignancies mostly develop in the cells lining the mucosal surfaces in the head and neck, including those of the mouth, nose, and throat.
“Survival rates for advanced head and neck cancer have historically been low,” noted Marshall Posner, MD, medical director of the Head and Neck Oncology Program at the Dana-Farber Cancer Institute. “This study has shown that induction therapy with a Taxotere, cisplatin, and 5-fluorouracil [TPF] regimen increases survival. With this approval, I hope to see TPF become the standard of care for induction therapy for patients with this type of cancer.”
The new indication for SCCHN is Taxotere’s seventh in the United States since the drug received its initial approval in 1996 as a treatment for breast cancer. Taxotere is a member of the taxoid family, and produces its antineoplastic effect by disrupting the network of microtubules that cells require for mitotic and interphase cellular functions.
Sanofi-Aventis submitted data from a multicenter, open-label, randomized phase III trial, designated EORTC 24971/ TAX323, which was conducted under the auspices of the European Organization for Research and Treatment of Cancer (EORTC).
Investigators enrolled 358 patients with previously untreated inoperable, locally advanced SCCHN who had a WHO performance status of 0 or 1. They randomized 177 participants to receive Taxotere 75 mg/m2 followed by cisplatin 75 mg/m2 on day 1, followed by fluorouracil 750 mg/m2/d as a continuous infusion on days 1 to 5 (TPF arm). They assigned another 181 patients to receive cisplatin 100 mg/m2 on day 1, followed by fluorouracil 1,000 mg/m2/d as a continuous infusion on days 1 to 5 (PF arm).