Preliminary results of a randomized study on therapeutic gain by concurrent chemotherapy for regionally-advanced nasopharyngeal carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group

被引:370
作者
Lee, AWM
Lau, WH
Tung, SY
Chua, DTT
Chappell, R
Xu, L
Siu, L
Sze, WM
Leung, TW
Sham, JST
Ngan, RKC
Law, SCK
Yau, TK
Au, JSK
O'Sullivan, B
Pang, ESY
O, SK
Au, GKH
Lau, JT
机构
[1] Pamela Youde Nethersole Eastern Hosp, Dept Clin Oncol, Queen Elizabeth Hosp, Tuen Mun Hosp, Chaiwan, Peoples R China
[2] Queen Mary Hosp, Hong Kong, Peoples R China
[3] Univ Wisconsin, Sch Med, Dept Biostat, Madison, WI USA
[4] Chinese Univ Hong Kong, Comprehens Canc Trials Unit, Sha Tin, Peoples R China
[5] Princess Margaret Hosp, Ontario Canc Inst, Toronto, ON M4X 1K9, Canada
关键词
D O I
10.1200/JCO.2004.00.7542
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose This randomized study compared the results achieved by concurrent chemoradiotherapy (CRT) versus radiotherapy (RT) alone for nasopharyngeal carcinoma (NPC) with advanced nodal disease. Patients and Methods Patients with nonkeratinizing/undifferentiated NPC staged T1-4N2-3MO were randomized to CRT or RT. Both arms were treated with the same RT technique and dose fractionation. The CRT patients were given cisplatin 100 mg/m(2) on days 1, 22, and 43, followed by cisplatin 80 mg/m(2) and fluorouracil 1,000 mg/m(2)/d for 96 hours starting on days 71, 99, and 127. Results From 1999 to January 2004, 348 eligible patients were randomly assigned; the median follow-up was 2.3 years. The two arms were well-balanced in all prognostic factors and RT parameters. The CRT arm achieved significantly higher failure-free survival (72% v 62% at 3-year, P =.027), mostly as a result of an improvement in locoregional control (92% v 82%, P =.005). However, distant control did not improve significantly (76% v 73%, P =.47), and the overall survival rates were almost identical (78% v 78%, P =.97). In addition, the CRT arm had significantly more acute toxicities (84% v 53%, P <.001) and late toxicities (28% v 13% at 3-year, P =.024). Conclusion Preliminary results confirmed that CRT could significantly improve tumor control, particularly at locoregional sites. However, there was significant increase in the risk of toxicities and no early gain in overall survival. Longer follow-up is needed to confirm the ultimate therapeutic ratio.
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页码:6966 / 6975
页数:10
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