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Preliminary report on a randomised controlled trial of concomitant UFT/radiation and adjuvant chemotherapy for loco-regionally advanced non-metastatic nasopharyngeal carcinoma

2001; Elsevier BV; Volume: 51; Issue: 3 Linguagem: Inglês

10.1016/s0360-3016(01)01900-9

1879-355X

Dora L.�W. Kwong, Jonathan S. T. Sham, G.K.H. Au,

Head and Neck Cancer Studies

Purpose: To study the efficacy of concomitant chemoradiation and adjuvant chemotherapy (AC) in improving outcome of loco-regionally advanced nasopharygngeal carcinoma (NPC). Materials and Methods: Patients with non-metastatic NPC in Ho's stage, T3 or N2, N3 or with any neck node with maximum diameter 4 cm or larger were recruited. A factorial design was used. Patients were first randomised to receive UFT 200mg 3 times a day during whole course of radiotherapy (RT) or RT alone and then further randomised to receive AC or no AC after RT. AC consisted of alternating PF (cisplatin 100mg/m2 D1 and 5FU 1g/m2 D1-3) and VBM (vincristine 2mg, bleomycin 30mg and methotrexate 250mg/m2, all on D1) for 6 courses. There were 4 treatment groups: 1. RT alone, 2. RT with concomitant UFT, 3. RT and AC, 4. RT and UFT and AC. For the analysis on efficacy of concomitant chemoradiation (no UFT vs UFT), group 1 and 3 were compared with group 2 and 4. For the analysis on efficacy of AC (no AC vs AC), group 1 and 2 were compared with group 3 and 4. Analysis was performed according to intention to treat. Results: 157 patients recruited from 5/1995 to 9/2000 were analysed. Median follow up was 34 months. Number of patients in group 1, 2, 3, 4 were 40, 35, 40 and 42 respectively. According to Ho's staging, 4, 136 and 17 patients had stage II, III and IV disease respectively. Restaging according to UICC 97 staging showed 48, 75 and 34 patients had stage II, III and IV disease respectively. There was no significant difference in stage distribution between the groups. 71.4% of patients received 66% or more of the prescribed dose of UFT and 71.9% of patients completed at least 4 courses of AC. 3 years loco-regional control rate for groups 1, 2, 3, 4 were 57.9%, 82.1%, 74.1%, 86.1% respectively and distant metastases free survival were 69.4%, 87.1%, 66.1%, 83.6% respectively. 3 years relapse free survival for the 4 groups were 54.5%, 69.6%, 51.1% and 73.3% respectively. Table 1 summarised the survival data comparing patients treated with and without UFT and with and without AC. The 3 years locoregional control rate, distant metastases free survival and relapse free survival were all significantly improved with use of concomitant RT and UFT. The overall survivals were not significantly different. Use of AC failed to improve outcome on all measures. Multivariate analysis confirmed use of UFT as significant prognostic factor for relapse free survival besides UICC N stage. Other factors such as T stage, age, sex and use of AC were not significant. Analysis with actual treatment showed similar results. Conclusion: Concomitant chemoradiation using UFT significantly improved relapse-free survival for patients with loco-regionally advanced NPC. This study confirms the positive results of chemoradiation for improving outcome of nasopharyngeal carcinoma and suggests that tumor cells radiation sensitisation is the major mechanism of action. The usefulness of adjuvant chemotherapy was not confirmed. Tabled 1No. of patientsTreatment3 years loco-regional control rate3 years distant metastases free survival3 years relapse free survival3 years overall survival80No UFT6667.652.975.977With UFT84.28571.483.9Log-rank test p value0.0170.0280.0190.2975No AC69.477.661.477.782With AC80.475.462.981.9Log-rank test p value0.160.830.680.7 Open table in a new tab