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Summaries of Newsworthy Clinical Trial Results

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    Posted: 02/15/2006
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Chemotherapy During Radiation Treatment Improves Outcomes in Nasopharyngeal Cancer

Key Words

Nasopharyngeal cancer, head and neck cancer, cisplatin, chemoradiotherapy. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Researchers analyzed data from a number of international clinical trials and found that adding chemotherapy to the standard radiation treatment for nasopharyngeal cancer reduced the risk of death, and also of cancer recurrence. The modest but real benefit was evident primarily when the chemotherapy was given during the course of radiation therapy, rather than before or after.

Source

The International Journal of Radiation Oncology, Biology, Physics, January 1, 2006 (see the journal abstract).
(Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56)

Background

Nasopharyngeal cancer is a type of head and neck cancer, uncommon in the United States and Western Europe but very common in other areas of the world.

Cancer that has remained within the nasopharynx and lymph nodes in the neck (called “locally advanced”) is usually treated with radiation therapy, which is often effective. In 1998, a phase III trial conducted in the United States (called INT-0099) was stopped early when patients who were receiving a chemotherapy combination of cisplatin and 5-fluorouracil in addition to radiation therapy were about 30 percent more likely to survive compared to those receiving radiation therapy alone.

Most clinical trials of combination regimens in the treatment of nasopharyngeal cancer have been relatively small in size, so further information was needed to better define the role of this approach.

The Study

Researchers with the Meta-Analysis of Chemotherapy in Nasopharyngeal Cancer (MACH-NPC) study combined and re-evaluated data from randomized clinical trials that looked at the addition of chemotherapy to radiation therapy in the treatment of locally advanced nasopharyngeal cancer. (In a meta-analysis, researchers pool data from multiple, similar studies in order to look for statistically valid results that might not be apparent in any one study alone.)

The researchers found published results from 99 such clinical trials, but only eight were determined to be sufficiently comparable and reliable for inclusion in their final analysis. The eight trials, which included INT-0099, provided information from 1,753 patients. Researchers also added updated data from these trials, when such information was available. They looked at when the chemotherapy was given – before (induction), during (concomitant), or after (adjuvant) radiation; which drugs were given; and which stage of locally advanced disease the patients had.

The study’s senior author is Bertrand Baujat, M.D., from the Institut Gustave-Roussy in Villejuif, France.

Results

Overall, patients receiving chemotherapy were 18 percent less likely to have died after a median of six years compared to those treated with radiation alone. Sixty-two percent of those receiving the combination treatment were alive at five years compared to 56 percent of the radiation-alone group. Those receiving chemotherapy were also 24 percent less likely to have any progression of their cancer.

The cisplatin-based chemotherapy combinations were not identical across the studies, but the differences didn’t seem to matter. What did matter was timing: the advantage in overall survival was seen only when chemotherapy was given during radiation therapy; not before or after.

Comments

This study “succeeds in demonstrating the value of adding chemotherapy to radiation therapy,” said the National Cancer Institute’s Norman Coleman, M.D., head of the Radiation Research Program in the Division of Cancer Treatment and Diagnosis. The study authors were “very rigorous,” he said, in updating information and carefully trying to determine whether the timing of cisplatin-based chemotherapy is important.

While the authors included the INT-0099 trial in their analysis, “they were careful to also analyze the data without that strong result, and really did demonstrate this is the right general approach for locally advanced nasopharynx cancer,” he said.

Limitations

Coleman agrees with Baujat, the study’s lead author, who says the study proves there is a modest but significant benefit to chemotherapy when given at the same time as radiation therapy, but cautions that “the role of induction chemotherapy and adjuvant chemotherapy given alone, or added to concomitant chemotherapy is more questionable. Other improvements in outcome may come from the use of newer radiation therapy techniques and new combinations of agents.”

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