title: Concomitant boost radiotherapy with concurrent weekly cisplatin in advanced head and neck cancers: a phase II trial.
abstract: OBJECTIVE
  To determine the safety and efficacy of concomitant boost radiotherapy (CBRT) with concurrent cisplatin chemotherapy (CT) in advanced head and neck cancers.
  
  
  METHODS
  Between February 2000 and June 2001, 95 previously untreated patients of advanced head and neck cancers were treated with CBRT and concurrent cisplatin CT. CBRT consisted of: phase I--44 Gy/22fx/4.5 weeks, phase IIa--16 Gy/8fx/1.5 weeks and phase IIb--10 Gy/8fx (delivered as a second daily fraction after a gap of 6h along with phase IIa). CT (cisplatin 35 mg/m(2)) was administered weekly usually preceding CBRT by an hour.
  
  
  RESULTS
  The median follow-up was 39 months (range 8-50 months). CBRT compliance (70 Gy in 40-44 days) was seen in 66% (63/95). Six cycles of CT was delivered in 73% (69/95). Acute grade III/IV mucosal toxicity was seen in 79% and resulted, on average, in a total weight loss of 7.9 kg from a mean pretreatment weight of 51 kg. Nasogastric tube placements were required in 26% (25/95) for an average duration of 19.3 days. Grade III leucopenia was seen in 2%. Mortality during and within 30 days of treatment was seen in 14% (13/95). Crude incidence of late subcutaneous fibrosis (grade III) was 21% (12/57) and a case of mandibular necrosis and thyroid cartilage necrosis each were seen. Initial loco regional disease clearance was seen in 59% (56/95) and the Kaplan-Meier estimates of 3-year loco-regional control rate and overall survival were 25% (median 7 months, 95% C.I. 3-11) and 27% (median 12 months, 95% C.I. 8-16), respectively.
  
  
  CONCLUSIONS
  On present evidence, in the settings of a developing country, CBRT with concurrent cisplatin cannot be recommended as primary therapy in advanced head and neck cancers without formal comparison with other treatment modalities.
authors.affiliation: Department of Radiotherapy, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. shaleenkr@yahoo.com
authors.forename: Shaleen
authors.initials: S
authors.lastname: Kumar
authors.forename: Manish
authors.initials: M
authors.lastname: Pandey
authors.forename: Punita
authors.initials: P
authors.lastname: Lal
authors.forename: Neeraj
authors.initials: N
authors.lastname: Rastogi
authors.forename: K Joseph
authors.initials: KJ
authors.lastname: Maria Das
authors.forename: Kislay
authors.initials: K
authors.lastname: Dimri
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003906:Developing Countries; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D007194:India; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin