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The combination of chemotherapy and radiation therapy significantly improved the five-year overall survival of patients with Stage II nasopharyngeal carcinoma, according to a Phase III study published in the Journal of the National Cancer Institute.


Nasopharyngeal carcinoma is endemic in Southern China and Southeast Asia, where radiotherapy has been the primary treatment. Although the National Comprehensive Cancer Network recommends concurrent chemo-radiotherapy for Stage II disease, evidence regarding its efficacy is weak, a news release points out, and this has not been defined as a primary endpoint in Phase III trials.


To determine whether or not combined chemotherapy and radiotherapy confers survival benefit to such patients, Qui-Yan Chen, MD, PhD, of the Sun Yat-sen University Cancer Center in the People's Republic of China, and colleagues, conducted a Phase III trial of patients randomly assigned to receive either radiation therapy (114 patients) or combined chemotherapy and radiation (116 patients).


The results also showed that after a median follow-up of 60 months, 22.8% of patients in the radiation group had disease progression, compared with 11.2% in the concurrent therapy group. Five-year overall survival, progression-free survival, and distant metastasis-free survival were all statistically significantly higher in the concurrent therapy group compared with the group receiving radiation alone.


The authors conclude that based on the results of this trial, which they believe to be the first Phase III trial to compare the approaches, that the NCCN guidelines are reasonable. The team hypothesizes that early-stage disease may have a smaller distant tumor bulk, and thus the combined approach may be more effective in eradicating distant micro-metastases.


Although patients in the combined therapy group experienced more toxic side effects than patients who received only radiotherapy, the regimen was overall well tolerated when the chemotherapy drug dose was reduced. "In summary," the researchers said, "we think that the optimal choice for early-stage nasopharyngeal cancer is cisplatin, at a weekly dose of 30 mg/m2, for both an optimal chemotherapy effect to eradicate small distant tumors and to ensure NPC patient compliance."