Docetaxel (Taxotere®) Before Radiation Extends Survival in Patients with Head and Neck Cancer
In a phase III study of patients with inoperable head and neck cancer, a multidrug chemotherapy regimen including the drug docetaxel (Taxotere®) that was given before radiation extended patients’ survival by about four months, with fewer side effects, compared to standard therapy.
American Society of Clinical Oncology annual meeting, New Orleans, June 5, 2004.
Head and neck cancers account for three percent of all cancers in the United States. Most of these cancers begin in squamous cells found in the lining of structures in the head and neck. Initial treatment options for most patients with head and neck cancer include surgery and/or radiation or, for patients with advanced tumors, chemotherapy combined with radiation.
Patients are sometimes given chemotherapy before other treatment, when it is thought that giving the drugs first may improve the effectiveness of the treatment that follows. This strategy is known as neoadjuvant chemotherapy. For patients with inoperable head and neck cancer, however, previous studies have not identified a neoadjuvant chemotherapy regimen that extended patients’ lives.
This study involved 358 patients with inoperable head and neck cancer whose tumors had spread to lymph nodes in the neck. Patients were randomly assigned to receive standard chemotherapy with the drugs cisplatin and 5-fluorouracil or the same chemotherapy plus docetaxel. After chemotherapy, both groups of patients also received standard radiation therapy.
The European Organization for Research and Treatment of Cancer conducted the study. The principal investigator was Jan B. Vermorken, M.D., Ph.D., of the University of Antwerp in Belgium. (See the protocol summary.)
After a median follow-up period of 32 months, patients treated with docetaxel survived for a median of 18.6 months, compared with 14.5 months for patients who received the standard platinum-based chemotherapy. In addition, patients in the docetaxel group lived for a median of 12.7 months before their disease progressed, compared with 8.4 months for standard-therapy patients. More patients in the docetaxel group than in the standard therapy group (67.8 percent vs. 53.6 percent) responded to treatment.
Fewer patients treated with docetaxel suffered side effects such as nausea, vomiting, and stomatitis (mouth sores). In addition, fewer patients in the docetaxel group died from adverse reactions to chemotherapy.
(Note: final results from this trial were subsequently published in the Oct. 25, 2007, New England Journal of Medicine; see the journal abstract.)
Previous randomized trials involving patients with advanced head and neck cancer have suggested that chemotherapy is most effective when administered concurrently with (at the same time as) radiation, notes Scott Saxman, M.D., of the National Cancer Institute’s Cancer Therapy Evaluation Program. Further study will be necessary, he says, to determine whether adding docetaxel concurrently with platinum-based chemotherapy and radiation is feasible and, perhaps, even more beneficial.