title: Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma.
abstract: BACKGROUND
  Salvage treatment for locally recurrent nasopharyngeal carcinoma (NPC) is complicated and relatively limited. Radiotherapy, combined with effective concomitant chemotherapy, may improve clinical treatment outcomes. We conducted a phase II randomized controlled trial to evaluate the efficacy of intensity-modulated radiotherapy with concomitant weekly cisplatin on locally recurrent NPC.
  
  
  METHODS
  Between April 2002 and January 2008, 69 patients diagnosed with non-metastatic locally recurrent NPC were randomly assigned to either concomitant chemoradiotherapy group (n = 34) or radiotherapy alone group (n = 35). All patients received intensity-modulated radiotherapy. The radiotherapy dose for both groups was 60 Gy in 27 fractions for 37 days (range 23-53 days). The concomitant chemotherapy schedule was cisplatin 30 mg/m(2) by intravenous infusion weekly during radiotherapy.
  
  
  RESULTS
  The median follow-up period of all patients was 35 months (range 2-112 months). Between concomitant chemoradiotherapy and radiotherapy groups, there was only significant difference in the 3-year and 5-year overall survival (OS) rates (68.7% vs. 42.2%, P = 0.016 and 41.8% vs. 27.5%, P = 0.049, respectively). Subgroup analysis showed that concomitant chemoradiotherapy significantly improved the 5-year OS rate especially for patients in stage rT3-4 (33.0% vs. 13.2%, P = 0.009), stages III-IV (34.3% vs. 13.2%, P = 0.006), recurrence interval >30 months (49.0% vs. 20.6%, P = 0.017), and tumor volume >26 cm(3) (37.6% vs. 0%, P = 0.006).
  
  
  CONCLUSIONS
  Compared with radiotherapy alone, concomitant chemoradiotherapy can improve OS of the patients with locally recurrent NPC, especially those with advanced T category (rT3-4) and stage (III-IV) diseases, recurrence intervals >30 months, and tumor volume >26 cm(3).
authors.affiliation: Department of Radiation Oncology, Affiliated Cancer Hospital of Guangxi Medical University, Cancer Institute of Guangxi Zhuang Autonomous Region, Nanning, 530021, Guangxi, P. R. China. 386927552@qq.com.
authors.forename: Ying
authors.initials: Y
authors.lastname: Guan
authors.affiliation: Department of Radiotherapy Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510655, Guangdong, P. R. China. 7dolphin7@163.com.
authors.forename: Shuai
authors.initials: S
authors.lastname: Liu
authors.affiliation: Department of Radiotherapy Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medical, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, P. R. China. wanghany@sysucc.org.cn.
authors.forename: Han-Yu
authors.initials: HY
authors.lastname: Wang
authors.affiliation: Department of Clinical Trial, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medical, Guangzhou, 510060, Guangdong, P. R. China. guoying@sysucc.org.cn.
authors.forename: Ying
authors.initials: Y
authors.lastname: Guo
authors.affiliation: Department of Radiotherapy Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medical, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, P. R. China. xiaoww@sysucc.org.cn.
authors.forename: Wei-Wei
authors.initials: WW
authors.lastname: Xiao
authors.affiliation: Department of Radiotherapy Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medical, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, P. R. China. chenchuny@sysucc.org.cn.
authors.forename: Chun-Yan
authors.initials: CY
authors.lastname: Chen
authors.affiliation: Department of Radiotherapy Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medical, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, P. R. China. zhaochong@sysucc.org.cn.
authors.forename: Chong
authors.initials: C
authors.lastname: Zhao
authors.affiliation: Department of Radiotherapy Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medical, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, P. R. China. lutx@sysucc.org.cn.
authors.forename: Tai-Xiang
authors.initials: TX
authors.lastname: Lu
authors.affiliation: Department of Radiotherapy Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medical, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong, P. R. China. hanfeisysucc@163.com.
authors.forename: Fei
authors.initials: F
authors.lastname: Han
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D002277:Carcinoma; D002945:Cisplatin / Q000008:administration & dosage* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004307:Dose-Response Relationship, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D016879:Salvage Therapy; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D011838:Radiation-Sensitizing Agents; D002945:Cisplatin