CHEMORADIOTHERAPY VERSUS RADIOTHERAPY IN PATIENTS WITH ADVANCED NASOPHARYNGEAL CANCER - PHASE-III RANDOMIZED INTERGROUP STUDY-0099

Purpose: The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTO G), and Eastern Cooperative Oncology Group (ECOG). This randomised pha se III trial compared chemoradiotherapy versus radiotherapy alone in p atients with nasopharyngeal cancers. Materials and Methods: Radiothera py was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investig ational arm received chemotherapy with cisplatin 100 mg/m(2) on days 1 , 22, and 43 during radiotherapy; postradiotherapy, chemotherapy with cisplatin 80 mg/m(2) on day 1 and fluorouracil 1,000 mg/m(2)/d on days 1 to 4 was administered every 4 weeks for three courses. Patients wer e stratified by tumor stage, nodal stage, performance status, and hist ology. Results: Of 193 patients registered, 147 (69 radiotherapy and 7 8 chemoradiotherapy) were eligible for primary analysis for survival a nd toxicity. The median progression-free survival (PFS) time was 15 mo nths for eligible patients on the radiotherapy arm and was not reached for the chemo-radiotherapy group. The 3-year PFS rate was 24% versus 69%, respectively (P < .001). The median survival time was 34 months f or the radiotherapy group and not reached for the chemo-radiotherapy g roup, and the 3-year survival rate was 47% versus 78%, respectively(P = .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomis ed to radiotherapy was 46%, and for the chemoradiotherapy group was 76 % (P < .001). Conclusion: We conclude that chemoradiotherapy is superi or to radiotherapy alone for patients with advanced nasopharyngeal can cers with respect to PFS and overall survival. (C) 1998 by American So ciety of Clinical Oncology.