title: A phase 2 randomized study to compare short course palliative radiotherapy with short course concurrent palliative chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer.
abstract: BACKGROUND
  Treatment of unresectable HNSCC is not well defined and has a poor outcome. This study has been designed to address the unmet needs of such groups of patients with primary end points of (a) proportion of patients eligible for radical treatment in each arm (b) loco-regional disease control at 6months between two arms.
  
  
  METHODS
  Locally advanced and unresectable HNSCC patients (except Nasopharynx and Larynx) unfit for radical treatment were randomized to arm A [short course RT alone (4Gy/#/day for 5days)] or arm B [RT as arm A+concurrent cisplatin at 6mg/m(2)/day IV bolus for 5days]. Those with at least PR were taken for further RT to complete biological equivalent dose of 70Gy, in both the arms. In arm B, concurrent CDDP at a dose of 40mg/m(2)/week was administered.
  
  
  RESULTS
  114 patients (57 in each arm) were randomized but 111 were analyzable. 15 (27.27%) patients in arm A and 28 (50%) patients in arm B had ⩾PR (p=0.01) however patients taken for FRT were 14 (25.45%) and 26 (46.42%) in arms A and B respectively (p=0.02). Locoregional control i.e. (CR+PR) at 6months was 16.36% in arm A versus 32.14% in arm B (p=0.15). Median PFS (arm A - 3.2months, arm B - 6.2months; p=0.02) and OS (arm A - 5.9months, arm B - 10.1months; p=0.03) was significantly more in arm B. There was relative improvement in quality of life for most parameters in arm B.
  
  
  CONCLUSIONS
  Concurrent low dose CTRT can be an effective treatment modality in advanced and incurable HNSCC. However, a larger phase III trial is required.
authors: Department of Medical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India.
authors: Arvind
authors: A
authors: Kumar
authors: Department of Medical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India. Electronic address: atul1@hotmail.com.
authors: Atul
authors: A
authors: Sharma
authors: Department of Radiotherapy, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India.
authors: Bidhu Kalyan
authors: BK
authors: Mohanti
authors: Department of Otorhinolaryngology, All India Institute of Medical Sciences, New Delhi, India.
authors: Alok
authors: A
authors: Thakar
authors: Department of Surgical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India.
authors: Nootan Kumar
authors: NK
authors: Shukla
authors: Department of Radiology, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India.
authors: Sanjay P
authors: SP
authors: Thulkar
authors: Department of Otorhinolaryngology, All India Institute of Medical Sciences, New Delhi, India.
authors: Kapil
authors: K
authors: Sikka
authors: Department of Radiotherapy, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India.
authors: Suman
authors: S
authors: Bhasker
authors: Department of Otorhinolaryngology, All India Institute of Medical Sciences, New Delhi, India.
authors: Chirom Amit
authors: CA
authors: Singh
authors: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
authors: Sreenivas
authors: S
authors: Vishnubhatla
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000532:radiotherapy* / Q000628:therapy; D059248:Chemoradiotherapy / Q000379:methods; D002945:Cisplatin / Q000627:therapeutic use; D005260:Female; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010166:Palliative Care / Q000379:methods*; D011788:Quality of Life; D000077195:Squamous Cell Carcinoma of Head and Neck; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin
keywords: Advanced and incurable HNSCC; C15-PAL; CTRT; HN-35 questionnaire; Palliative; RT