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Progress report of a randomized trial comparing long‐term survival and late toxicity of concurrent chemoradiotherapy with adjuvant chemotherapy versus radiotherapy alone in patients with stage III to IVB nasopharyngeal carcinoma from endemic regions of China
Author(s) -
Chen Yong,
Sun Ying,
Liang ShaoBo,
Zong JingFeng,
Li WenFei,
Chen Mo,
Chen Lei,
Mao YanPing,
Tang LingLong,
Guo Ying,
Lin AiHua,
Liu MengZhong,
Ma Jun
Publication year - 2013
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.28049
Subject(s) - medicine , nasopharyngeal carcinoma , hazard ratio , radiation therapy , chemotherapy , chemoradiotherapy , surgery , gastroenterology , randomization , cisplatin , fluorouracil , survival rate , peripheral neuropathy , oncology , randomized controlled trial , confidence interval , diabetes mellitus , endocrinology
BACKGROUND The objective of this study was to evaluate the long‐term survival and late toxicities of concurrent‐adjuvant chemotherapy in patients with stage III through IVB nasopharyngeal carcinoma (NPC) from endemic regions of China. METHODS Patients with stage III to IVB NPC were assigned randomly to receive radiotherapy (RT) alone (the RT group) or RT plus concurrent adjuvant chemotherapy (the CRT group). CRT patients received concurrent cisplatin (40 mg/m 2 ) weekly during RT followed by cisplatin (80 mg/m 2 ) and fluorouracil (800 mg/m 2 daily for 5 days) every 4 weeks for 3 cycles. The primary endpoint was overall survival. RESULTS In total, 316 patients underwent randomization, with 158 to each group. At a median follow‐up of 70 months, the 5‐year overall survival rate was 72% for the CRT group and 62% for the RT group (hazard ratio, 0.69; 95% confidence interval, 0.48‐0.99; P = .043). Failure‐free survival was significantly higher in the CRT group ( P = .020). Most late toxicities were similar (33% vs 26%; P = .089), except for cranial neuropathy ( P = .042), peripheral neuropathy ( P = .041), and ear damage ( P = .048), which were significantly increased in the CRT group. CONCLUSIONS The addition of concurrent adjuvant chemotherapy to RT provides survival benefits to patients with stage III through IVB NPC in endemic regions of China, and it does not increase most late toxicities apart from cranial neuropathy, peripheral neuropathy, and ear damage. Cancer 2013;119:2230–2238. © 2013 American Cancer Society.