Combining two widely known anticancer drugs with radiation therapy
can dramatically improve the survival of patients with nasopharyngeal
carcinoma, a new clinical trial has shown. In most cases, physicians
now recommend only radiation therapy for such patients.
The new combined-modality treatment, which involved the use of
radiation plus cisplatin (Platinol) and fluorouracil, resulted
in a 3-year survival rate of 76%. This compared to a 3-year survival
rate of 45% for patients receiving radiation therapy alone.
"This is the first prospective, randomized clinical trial
for head and neck cancer in many years to demonstrate improved
survival through the use of a combined treatment regimen,"
said David E. Schuller, MD, director of Ohio State's Comprehensive
Cancer Center-Arthur G. James Cancer Hospital and Research Institute.
Study Stopped Early
The results of combining the two modalities were so strongly positive
that the study stopped adding new patients in December and all
trial participants were given the combination treatment. To ensure
the accuracy of the results, there was an additional 6-month follow-up
period during which the pronounced survival benefits were confirmed
through additional analysis.
The results of the study were announced at the 32nd Annual Meeting
of the American Society of Clinical Oncology in Philadelphia.
The study has greatest significance for Asia, North Africa, and
the Inuit population of the Canadian Yukon and Northwest Territories,
where rates of nasopharyngeal carcinoma are higher than in the
United States. Nasopharyngeal carcinoma is rare in the United
States, with an incidence of 1 per 100,000 in the general population
and 10 per 100,000 in the Chinese-American population. The highest
rates recorded by the International Agency for Cancer Research
are among the Chinese populations of Hong Kong and Singapore,
with 28.5 cases per 100,000 and 18 cases per 100,000, respectively.
The trial, which was coordinated by the Southwest Oncology Group
(SWOG), involved 150 patients with stage III or IV nasopharyngeal
carcinoma, 81 of whom received chemotherapy plus radiation and
69, radiation alone.
Nasopharyngeal carcinoma has an overall 5-year survival rate of
about 40%, a 10-year survival rate of 28%, and a 20-year survival
rate of about 12%. Treatment of patients with stage I and stage
II disease achieves management or cure in more than 75% of patients;
treatment of advanced disease by the traditional means of radiotherapy
alone has a success rate of only 20% to 50%.
Schuller, who also directs Ohio State's Head and Neck Oncology
Program, helped coordinate the study and chaired the Head and
Neck Intergroup committee that made the study a nationwide trial
in 1989. This committee included leaders in head and neck cancer
from all the major national cancer cooperative groups. Another
investigator at The James Cancer Center involved in the study
was Reinhard Gahbauer, MD, director of the Department of Medical
Oncology. The James was one of the accruing institutions for the
The study's principal investigator was Muhyi Al-Sarraf, MD, director
of Providence Cancer Center, Detroit, Michigan. The intergroup
trial also involved the Radiation Therapy Oncology Group (RTOG)
and the Eastern Cooperative Oncology Group (ECOG).