Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Head and Neck Cancer Home Page 2 NCI's gateway for information about head and neck cancer. Highlights from ASCO 2004 3 (Posted: 06/05/2004, Reviewed: 12/06/2005) - A collection of links to material summarizing some of the important clinical trial results announced at the 2004 annual meeting of the American Society of Clinical Oncology (ASCO).

Key Words

Head and neck cancer, docetaxel (Taxotere®), neoadjuvant chemotherapy. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ⁴.)

Summary

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.

Source

American Society of Clinical Oncology annual meeting, New Orleans, June 5, 2004.

Background

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.

The Study

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 ⁵.)

Results

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 ⁶.)

Comments

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.

Glossary Terms

A drug used together with other drugs to treat certain types of breast cancer, stomach cancer, prostate cancer, and certain types of head and neck cancer. It is also being studied in the treatment of other types of cancer. Docetaxel is a type of mitotic inhibitor. Also called Taxotere.

A statistics term. The middle value in a set of measurements.

Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.