TY  - JOUR
PY  - 2010//
TI  - Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma
JO  - Journal of the National Cancer Institute
A1  - Lee, Anne W. M.
A1  - Tung, Stewart Y.
A1  - Chua, Daniel T. T.
A1  - Ngan, Roger K. C.
A1  - Chappell, Rick
A1  - Tung, Raymond
A1  - Siu, Lillian
A1  - Ng, W. T.
A1  - Sze, W. K.
A1  - Au, Gordon K. H.
A1  - Law, Stephen C. K.
A1  - O'Sullivan, Brian
A1  - Yau, T. K.
A1  - Leung, T. W.
A1  - Au, Joseph S. K.
A1  - Sze, W. M.
A1  - Choi, C. W.
A1  - Fung, K. K.
A1  - Lau, Joseph T.
A1  - Lau, W. H.
SP  - 1188
EP  - 1198
VL  - 102
IS  - 15
N2  - BACKGROUND: Current practice of adding concurrent-adjuvant chemotherapy to radiotherapy (CRT) for treating advanced nasopharyngeal carcinoma is based on the Intergroup-0099 Study published in 1998. However, the outcome for the radiotherapy-alone (RT) group in that trial was substantially poorer than those in other trials, and there were no data on late toxicities. Verification of the long-term therapeutic index of this regimen is needed.  METHODS: Patients with nonkeratinizing nasopharyngeal carcinoma staged T1-4N2-3M0 were randomly assigned to RT (176 patients) or to CRT (172 patients) using cisplatin (100 mg/m(2)) every 3 weeks for three cycles in concurrence with radiotherapy, followed by cisplatin (80 mg/m(2)) plus fluorouracil (1000 mg per m(2) per day for 4 days) every 4 weeks for three cycles. Primary endpoints included overall failure-free rate (FFR) (the time to first failure at any site) and progression-free survival. Secondary endpoints included overall survival, locoregional FFR, distant FFR, and acute and late toxicity rates. All statistical tests were two-sided.  RESULTS: The two treatment groups were well balanced in all patient characteristics, tumor factors, and radiotherapy parameters. Adding chemotherapy statistically significantly improved the 5-year FFR (CRT vs RT: 67% vs 55%; P =.014) and 5-year progression-free survival (CRT vs RT: 62% vs 53%; P =.035). Cumulative incidence of acute toxicity increased with chemotherapy by 30% (CRT vs RT: 83% vs 53%; P <.001), but the 5-year late toxicity rate did not increase statistically significantly (CRT vs RT: 30% vs 24%; P =.30). Deaths because of disease progression were reduced statistically significantly by 14% (CRT vs RT: 38% vs 24%; P =.008), but 5-year overall survival was similar (CRT vs RT: 68% vs 64%; P =.22; hazard ratio of CRT = 0.81, 95% confidence interval = 0.58 to 1.13) because deaths due to toxicity or incidental causes increased by 7% (CRT vs RT: 1.7% vs 0, and 8.1% vs 3.4%, respectively; P =.015).  CONCLUSIONS: Adding concurrent-adjuvant chemotherapy statistically significantly reduced failure and cancer-specific deaths when compared with radiotherapy alone. Although there was no statistically significant increase in major late toxicity, increase in noncancer deaths narrowed the resultant gain in overall survival.<p /> <p>Language: en</p>
LA  - en
SN  - 0027-8874
UR  - http://dx.doi.org/10.1093/jnci/djq258
ID  - ref1
ER  -