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(Drug information on cisplatin) (Platinol) and fluorouracil(Drug information on 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 trial.
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).