title: Efficacy and safety of concurrent chemoradiation with weekly cisplatin ± low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: a phase II-III clinical trial.
abstract: BACKGROUND
  This is the first study that aimed to determine the efficacy and safety of concurrent chemoradiation with weekly cisplatin ± celecoxib 100 mg twice daily in locally advanced undifferentiated nasopharyngeal carcinoma.
  
  
  METHODS
  Eligible patients had newly diagnosed locally advanced (T3-T4, and/or N2-N3, M0) undifferentiated nasopharyngeal carcinoma, no prior therapy, Karnofsky performance status ≥ 70, and normal organ function. The patients were assigned to receive 7 weeks concurrent chemoradiation (70 Gy) with weekly cisplatin 30 mg/m 2 with either celecoxib 100 mg twice daily, (study group, n = 26) or placebo (control group, n = 27) followed by adjuvant combined chemotherapy with cisplatin 70 mg/m 2 on day 1 plus 5-fluorouracil 750 mg/m 2 /d with 8-h infusion on days 1-3, 3-weekly for 3 cycles.
  
  
  RESULTS
  Overall clinical response rate was 100% in both groups. Complete and partial clinical response rates were 64% and 36% in the study group and 44% and 56% in the control group, respectively (P > 0.25). The addition of celecoxib to concurrent chemoradiation was associated with improved 2-year locoregional control rate from 84% to 100% (P = 0.039).
  
  
  CONCLUSIONS
  The addition of celecoxib 100 mg twice daily to concurrent chemoradiation improved 2-year locoregional control rate.
authors.affiliation: Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran. mohpanah@gmail.com
authors.forename: Mohammad
authors.initials: M
authors.lastname: Mohammadianpanah
authors.forename: Sasan
authors.initials: S
authors.lastname: Razmjou-Ghalaei
authors.forename: Amin
authors.initials: A
authors.lastname: Shafizad
authors.forename: Yaghoub
authors.initials: Y
authors.lastname: Ashouri-Taziani
authors.forename: Bijan
authors.initials: B
authors.lastname: Khademi
authors.forename: Niloofar
authors.initials: N
authors.lastname: Ahmadloo
authors.forename: Mansour
authors.initials: M
authors.lastname: Ansari
authors.forename: Shapour
authors.initials: S
authors.lastname: Omidvari
authors.forename: Ahmad
authors.initials: A
authors.lastname: Mosalaei
authors.forename: Mohammad Amin
authors.initials: MA
authors.lastname: Mosleh-Shirazi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002277:Carcinoma; D000068579:Celecoxib; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000473:pathology / Q000628:therapy*; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D002945:Cisplatin