Journal of Clinical Oncology, Vol 16, 1310-1317, Copyright © 1998 by American Society of Clinical Oncology
Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099
M Al-Sarraf, M LeBlanc, PG Giri, KK Fu, J Cooper, T Vuong, AA Forastiere, G Adams, WA Sakr, DE Schuller and JF Ensley
Department of Medicine, Providence Cancer Center, Southfield, MI, USA.
PURPOSE: The Southwest Oncology Group (SWOG) coordinated an Intergroup
study with the participation of Radiation Therapy Oncology Group (RTOG),
and Eastern Cooperative Oncology Group (ECOG). This randomized phase III
trial compared chemoradiotherapy versus radiotherapy alone in patients with
nasopharyngeal cancers. MATERIALS AND METHODS: Radiotherapy 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 investigational arm
received chemotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 during
radiotherapy; postradiotherapy, chemotherapy with cisplatin 80 mg/m2 on day
1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4
weeks for three courses. Patients were stratified by tumor stage, nodal
stage, performance status, and histology. RESULTS: Of 193 patients
registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible
for primary analysis for survival and toxicity. The median progression-free
survival (PFS) time was 15 months 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 for the radiotherapy group and not reached for the
chemo- radiotherapy group, 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
randomized to radiotherapy was 46%, and for the chemoradiotherapy group was
76% (P < .001). CONCLUSION: We conclude that chemoradiotherapy is
superior to radiotherapy alone for patients with advanced nasopharyngeal
cancers with respect to PFS and overall survival.

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