A randomized controlled trial of concurrent UFT/Radiation and adjuvant chemotherapy for loco-regionally advanced non-metastatic Nasopharyngeal Carcinoma

Abstract

Background of the study: There have been many attempts tocombine chemotherapy (CT) and radiotherapy (RT) in treatment ofnasopharyngeal carcinoma (NPC), but improvement in tumor con-trol over standard RT was demonstrated only recently by theInternational Nasopharyngeal Carcinoma Study and the Head andNeck Intergroup. Methods and material: Patients with newly di-agnosed non-metastatic NPC with Ho’s stage T3, or N2-N3 dis-ease, or any lymph node „d4 cm were recruited. Patients were firstrandomized to receive UFT 200mg 3 times per day during wholecourse of RT or RT only, and they were also further randomizedto receive AC or no AC after RT. AC consisted of alternating PF (cisplatin 100mg/m2 D1 and 5-FU 1g/m2 D1-3) and VBM (vin-cristine 2mg, bleomycin 30mg and methotrexate 250mg/m2, all onD1) for total of 6 cycles. Thus, there were 4 treatment groups: a.RT alone, b. RT with concurrent UFT, c. RT and AC, d. RT withconcurrent UFT and then AC. For the analysis on efficacy ofconcurrent chemoradiation (i.e. no UFT vs. UFT), groups a and cwere compared with groups b and d. For the analysis on efficacyof AC (i.e. no AC vs. AC), groups a and b were compared withgroups c and d. Results: One hundred fifty-seven patients, atmedian follow up of 34 months, were included in this analysis.There was no significant difference in number of patients andprognostic factors between the groups. The 3 years failure-freesurvival (FFS) of the 4 groups were respectively 54.5%, 69.6%,51.1% and 73.3%. Patients on concurrent chemoradiation withUFT fared significantly better than patients on RT only (3 yearsFFS 71.4% vs. 52.9%, p ⫽ 0.019), but there was no significantdifference in 3 years overall survival (83.9% vs. 75.9%, p ⫽ 0.29).There was no significant difference in outcome for patients withand without AC (3 years FFS: 62.9% vs. 61.4%, p ⫽ 0.68).Conclusion: The results will be discussed.