title: 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.
abstract: 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/m2) weekly during RT followed by cisplatin (80 mg/m2) 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.
authors.affiliation: State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Chen
authors.forename: Ying
authors.initials: Y
authors.lastname: Sun
authors.forename: Shao-Bo
authors.initials: SB
authors.lastname: Liang
authors.forename: Jing-Feng
authors.initials: JF
authors.lastname: Zong
authors.forename: Wen-Fei
authors.initials: WF
authors.lastname: Li
authors.forename: Mo
authors.initials: M
authors.lastname: Chen
authors.forename: Lei
authors.initials: L
authors.lastname: Chen
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Mao
authors.forename: Ling-Long
authors.initials: LL
authors.lastname: Tang
authors.forename: Ying
authors.initials: Y
authors.lastname: Guo
authors.forename: Ai-Hua
authors.initials: AH
authors.lastname: Lin
authors.forename: Meng-Zhong
authors.initials: MZ
authors.lastname: Liu
authors.forename: Jun
authors.initials: J
authors.lastname: Ma
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002277:Carcinoma; D059248:Chemoradiotherapy / Q000009:adverse effects*; D017024:Chemotherapy, Adjuvant; D002681:China; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003389:Cranial Nerve Diseases / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology* / Q000532:radiotherapy / Q000628:therapy*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002945:Cisplatin; D005472:Fluorouracil