title: Induction chemotherapy followed by concomitant radiotherapy and weekly cisplatin versus the same concomitant chemoradiotherapy in patients with nasopharyngeal carcinoma: a randomized phase II study conducted by the Hellenic Cooperative Oncology Group (HeCOG) with biomarker evaluation.
abstract: BACKGROUND
  Concomitant administration of radiation therapy (RT) and chemotherapy with cisplatin (CCRT) is considered standard treatment in patients with locally advanced nasopharyngeal cancer (LA-NPC). The role of induction chemotherapy (IC) when followed by CCRT in improving locoregional control remains controversial.
  
  
  METHODS
  Totally, 141 eligible patients with LA-NPC were randomized to either three cycles of IC with cisplatin 75 mg/m(2), epirubicin 75 mg/m(2) and paclitaxel (Taxol) 175 mg/m(2) (CEP) every 3 weeks followed by definitive RT (70 Gy) and concomitant weekly infusion of cisplatin 40 mg/m(2) (investigational arm, 72 patients) or to the same CCRT regimen alone (control arm, 69 patients).
  
  
  RESULTS
  Sixty-two patients (86%) received three cycles of IC. No difference between the arms was observed in the number of patients who completed RT (61 versus 64, P = 018). Overall and complete response rates were very similar in the two arms and so were 3-year progression-free and overall survival rates. Grade III or IV toxic effects from IC were infrequent, apart of alopecia. Mucositis, weight loss and leukopenia were the most prominent side-effects from CCRT.
  
  
  CONCLUSIONS
  IC with three cycles of CEP when followed by CCRT did not significantly improve response rates and/or survival compared with that of CCRT alone.
authors.affiliation: Department ofMedical Oncology Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece. fountzil@auth.gr
authors.forename: G
authors.initials: G
authors.lastname: Fountzilas
authors.forename: E
authors.initials: E
authors.lastname: Ciuleanu
authors.forename: M
authors.initials: M
authors.lastname: Bobos
authors.forename: A
authors.initials: A
authors.lastname: Kalogera-Fountzila
authors.forename: A G
authors.initials: AG
authors.lastname: Eleftheraki
authors.forename: G
authors.initials: G
authors.lastname: Karayannopoulou
authors.forename: T
authors.initials: T
authors.lastname: Zaramboukas
authors.forename: A
authors.initials: A
authors.lastname: Nikolaou
authors.forename: K
authors.initials: K
authors.lastname: Markou
authors.forename: L
authors.initials: L
authors.lastname: Resiga
authors.forename: D
authors.initials: D
authors.lastname: Dionysopoulos
authors.forename: E
authors.initials: E
authors.lastname: Samantas
authors.forename: H
authors.initials: H
authors.lastname: Athanassiou
authors.forename: D
authors.initials: D
authors.lastname: Misailidou
authors.forename: D
authors.initials: D
authors.lastname: Skarlos
authors.forename: T
authors.initials: T
authors.lastname: Ciuleanu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D002277:Carcinoma; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D053208:Kaplan-Meier Estimate; D019394:Ki-67 Antigen / Q000096:biosynthesis; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000532:radiotherapy*; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D016016:Proportional Hazards Models; D016159:Tumor Suppressor Protein p53 / Q000096:biosynthesis; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D019394:Ki-67 Antigen; D016159:Tumor Suppressor Protein p53; D015251:Epirubicin; D017239:Paclitaxel; D002945:Cisplatin