title: [Concurrent chemotherapy with different dose regimens of cisplatin for nasopharyngeal carcinoma using intensity-modulated radiation therapy: a phase II prospective randomized controlled trial].
abstract: OBJECTIVE
  To explore the acute toxic effects and early curative efficacy of concurrent chemotherapy with different doses of cisplatin for Chinese nasopharyngeal carcinoma (NPC) patients using intensity-modulated radiation therapy (IMRT).
  
  
  METHODS
  Eighty-eight untreated stage II/III nasopharyngeal cancer patients receiving IMRT and concurrent cisplatin were randomized into two groups receiving different doses of cisplatin. The standard group (DDP 100 mg/m² q3w, n = 44) and the study group (DDP 80 mg/m² q3w, n = 44). The acute toxic effects and 3-month therapeutic efficacy (early curative efficacy) in patients of the two groups who completed treatment were compared and analyzed.
  
  
  RESULTS
  During the treatment, grade III-IV acute toxic effects were observed in more patients of the standard group compared with that in the study group (72.7% vs. 59.1%), but the difference was statistically not significant (P = 0.18). Significant difference was only seen in upper gastrointestinal reaction (P = 0.01) and anemia (P = 0.03) among the non-hematological and hematological adverse events. No significant differences in other adverse events were found between the two groups (P < 0.05). Three months after the completion of radiotherapy, 80 cases of the whole group achieved complete remission (CR) in the nasopharynx and neck MRI. In both the standard group and study group, 40 patients had CR and 4 patients had residual disease, respectively, showing a non-significant difference (P = 0.51) between the two groups.
  
  
  CONCLUSIONS
  During the IMRT course, patients received cisplatin 80 mg/m² q3w, experienced less grade III-IV acute toxic effects. Concurrent chemoradiotherapy with cisplatin 80 mg/m² q3w or 100 mg/m² q3w, demonstrate similar early curative efficacy in II/III stage NPC patients in endemic regions of China.
authors.affiliation: State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
authors.forename: Shuai
authors.initials: S
authors.lastname: Liu
authors.affiliation: State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Han
authors.affiliation: State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
authors.forename: Chunyan
authors.initials: C
authors.lastname: Chen
authors.affiliation: State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Zeng
authors.affiliation: State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
authors.forename: Xueming
authors.initials: X
authors.lastname: Sun
authors.affiliation: State Key Laboratory of Oncology in South China, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China. Email: lutx@sysucc.org.cn.
authors.forename: Taixiang
authors.initials: T
authors.lastname: Lu
mesh_terms: D000740:Anemia; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma; D059248:Chemoradiotherapy; D002681:China; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000628:therapy*; D009367:Neoplasm Staging; D011446:Prospective Studies; D050397:Radiotherapy, Intensity-Modulated; D012074:Remission Induction
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin