A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients

doi:10.1016/S0360-3016(01)02781-X

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Title:	A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients
Authors:	Chi, Kwan-Hwa;張玉坤;Chang, Yue-cune;Guo, Wan-Yao;Leung, Mein-Jung;Shiau, Cheng-Yin;Chen, Sheng-Yu
Contributors:	淡江大學數學學系
Keywords:	Nasopharyngeal carcinoma;Adjuvant chemotherapy;Radiotherapy;Chemotherapy
Date:	2002-04
Issue Date:	2010-01-28 07:06:48 (UTC+8)
Publisher:	Elsevier
Abstract:	Full-size image (<1 K) To evaluate the role of adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma (NPC) patients, we conducted a randomized Phase III trial comparing radiotherapy (RT) followed by adjuvant chemotherapy to RT alone in patients with advanced NPC. Full-size image (<1 K) Between November 1994 and March 1999, 157 patients with Stage IV, M0 (UICC/AJCC, 1992) advanced NPC disease were randomized to receive standard radiotherapy, as follows: 35–40 fractions, 1.8–2.0 Gy/fraction/day, 5 days/week, to a total dose 70–72 Gy with or without 9 weekly cycles of 24-h infusional chemotherapy (20 mg/m2 cisplatin, 2,200 mg/m2 5-fluorouracil, and 120 mg/m2 leucovorin) after RT. Of 157 patients enrolled, 154 (77 radiotherapy, 77 combined therapy) were evaluable for survival and toxicity analysis. Full-size image (<1 K) With a median follow-up of 49.5 months, the 5-year overall survival and relapse-free survival rates were 60.5% vs. 54.5% (p = 0.5) and 49.5% vs. 54.4% (p = 0.38) for the radiotherapy-alone group and the combined radiotherapy and adjuvant chemotherapy group, respectively. The Cox regression showed that the hazard rates ratio of combined treatment to RT alone was 0.673 (p value = 0.232); the 95% confidence interval was 0.352 and 1.288, respectively. Patients who received combined treatment had a lower systemic relapse rate than radiotherapy-alone patients, according to relapse pattern analysis. The incidence of leukopenia (≥ Grade 3) occurred in 17 out of 819 (2.1%) cycles of weekly chemotherapy. No patient developed moderate to severe mucositis (≥ Grade 3). Full-size image (<1 K) We conclude that adjuvant chemotherapy after RT for patients with advanced NPC has no benefit for overall survival or relapse-free survival.
Relation:	International Journal of Radiation Oncology, Biology, Physics 52(5), pp.1238-1244
DOI:	10.1016/S0360-3016(01)02781-X
Appears in Collections:	[Graduate Institute & Department of Mathematics] Journal Article

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