COLUMBUS, Ohio -- Combining two widely known anti-cancer 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 combination treatment, which involved the use of radiation plus the chemotherapy drugs cisplatin and 5-fluorouracil, resulted in a three-year survival rate of 76 percent. This compared to a three-year survival rate of 45 percent 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, M.D., director of Ohio State's Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Research Institute.
The results were so strongly positive for the new combined treatments 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 six-month follow-up period during which the survival data that revealed the pronounced survival benefits were confirmed through additional analysis.
The results of the study were announced in San Francisco May 20 at the 32nd Annual Meeting of the American Society of Clinical Oncology.
The study has greatest significance for Asia, North Africa, and the Inuit population of the Canadian Yukon and Northwest Territories, where the rates of nasopharyngeal carcinoma are higher than in the United States.
Nasopharyngeal carcinoma occurs primarily in tissues lining the space behind the nasal cavity and above the soft palate. The malignancy is rare in the U.S., 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 and IV nasopharyngeal carcinoma, 81 of which received CT-RT and 69 of which received RT alone.
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 leadership in head and neck cancer from all major national cancer cooperative groups. Another investigator at The James involved in the study was Reinhard Gahbauer, M.D., director of the Department of Medical Oncology. The James was one of the accruing institutions for the trial.
The study's principal investigator was Muhyi Al-Sarraf, M.D., 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).
Nasopharyngeal carcinoma has an overall five-year survival rate of about 40 percent, a 10-year survival rate of 28 percent, and a 20-year survival rate of about 12 percent. Treatment of patients with stage I and stage II disease achieves management or cure in more than 75 percent of patients; treatment of advanced disease by the traditional means of radiotherapy alone has a success rate of only 20 percent to 50 percent.