title: Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial.
abstract: OBJECTIVE
  Nasopharyngeal carcinoma (NPC) is highly sensitive to both radiotherapy (RT) and chemotherapy. This randomized phase III trial compared concurrent cisplatin-RT (CRT) with RT alone in patients with locoregionally advanced NPC.
  
  
  METHODS
  Patients with Ho's N2 or N3 stage or N1 stage with nodal size > or = 4 cm were randomized to receive cisplatin 40 mg/m(2) weekly up to 8 weeks concurrently with radical RT (CRT) or RT alone. The primary end point was progression-free survival (PFS).
  
  
  RESULTS
  Three hundred fifty eligible patients were randomized. Baseline patient characteristics were comparable in both arms. There were significantly more toxicities, including mucositis, myelosuppression, and weight loss in the CRT arm. There were no treatment-related deaths in the CRT arm, and one patient died during treatment in the RT-alone arm. At a median follow-up of 2.71 years, the 2-year PFS was 76% in the CRT arm and 69% in the RT-alone arm (P =.10) with a hazards ratio of 1.367 (95% confidence interval [CI], 0.93 to 2.00). The treatment effect had a significant covariate interaction with tumor stage, and a subgroup analysis demonstrated a highly significant difference in favor of the CRT arm in Ho's stage T3 (P =.0075) with a hazards ratio of 2.328 (95% CI, 1.26 to 4.28). For T3 stage, the time to first distant failure was statistically significantly different in favor of the CRT arm (P =.016).
  
  
  CONCLUSIONS
  Concurrent CRT is well tolerated in patients with advanced NPC in endemic areas. Although PFS was not significantly different between the concurrent CRT arm and the RT-alone arm in the overall comparison, PFS was significantly prolonged in patients with advanced tumor and node stages.
authors.affiliation: Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, N.T., Hong Kong.
authors.forename: A T C
authors.initials: AT
authors.lastname: Chan
authors.forename: P M L
authors.initials: PM
authors.lastname: Teo
authors.forename: R K
authors.initials: RK
authors.lastname: Ngan
authors.forename: T W
authors.initials: TW
authors.lastname: Leung
authors.forename: W H
authors.initials: WH
authors.lastname: Lau
authors.forename: B
authors.initials: B
authors.lastname: Zee
authors.forename: S F
authors.initials: SF
authors.lastname: Leung
authors.forename: F Y
authors.initials: FY
authors.lastname: Cheung
authors.forename: W
authors.initials: W
authors.lastname: Yeo
authors.forename: H H
authors.initials: HH
authors.lastname: Yiu
authors.forename: K H
authors.initials: KH
authors.lastname: Yu
authors.forename: K W
authors.initials: KW
authors.lastname: Chiu
authors.forename: D T
authors.initials: DT
authors.lastname: Chan
authors.forename: T
authors.initials: T
authors.lastname: Mok
authors.forename: K T
authors.initials: KT
authors.lastname: Yuen
authors.forename: F
authors.initials: F
authors.lastname: Mo
authors.forename: M
authors.initials: M
authors.lastname: Lai
authors.forename: W H
authors.initials: WH
authors.lastname: Kwan
authors.forename: P
authors.initials: P
authors.lastname: Choi
authors.forename: P J
authors.initials: PJ
authors.lastname: Johnson
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin