title: Low-dose fractionated radiation with induction chemotherapy for locally advanced head and neck cancer: 5 year results of a prospective phase II trial.
abstract: OBJECTIVE
  This study aims to report the long-term outcomes of a novel treatment approach utilizing induction low-dose fractionated radiation therapy (LDFRT) and chemotherapy for locally advanced squamous cell carcinoma of head and neck (SCCHN).
  
  
  METHODS
  We prospectively enrolled 40 patients with locally advanced SCCHN (77 % stage IV) on a phase II clinical trial and treated with induction paclitaxel (225 mg/m2), carboplatin (AUC 6), and LDFRT (80 cGy BID on days 1 and 2) every 21 days for two cycles.
  
  
  RESULTS
  Forty patients enrolled; 39 were evaluable. The acute toxicity and response data have been previously reported; overall response rate (RR) was 82 %. After induction, definitive therapy was concurrent chemoradiation (CRT) in 51 %, XRT alone in 39 %, surgery in 5 %, and surgery and XRT in 5 %. The long-term outcomes are now reported with a median follow-up of 83 months. Locoregional control (LRC) is 80 % and distant control (DC) is 77 %. Five-year overall survival (OS), disease-specific survival, and progression-free survival (PFS) are 62 %, 66 %, and 58 %, respectively.
  
  
  CONCLUSIONS
  Induction chemotherapy with LDFRT has a high initial RR, comparable toxicity to two-drug induction regimens, but adds a third novel and effective agent, LDFRT. Five-year follow-up shows favorable outcomes compared to historical controls and excellent compliance with definitive therapy. This novel treatment approach is now planned for phase 3 trial evaluation.
authors.affiliation: Department of Radiation Medicine, University of Kentucky, Markey Cancer Center, Lexington, KY, USA.
authors.forename: John F
authors.initials: JF
authors.lastname: Gleason
authors.affiliation: Department of Radiation Medicine, University of Kentucky, Markey Cancer Center, Lexington, KY, USA.
authors.forename: Mahesh
authors.initials: M
authors.lastname: Kudrimoti
authors.affiliation: Division of Cancer Biostatistics, University of Kentucky, Markey Cancer Center, Lexington, KY, USA.
authors.forename: Emily M
authors.initials: EM
authors.lastname: Van Meter
authors.affiliation: King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Mohiuddin
authors.affiliation: Department of Radiation Oncology, University of Maryland, Baltimore, MD, USA.
authors.forename: William F
authors.initials: WF
authors.lastname: Regine
authors.affiliation: Department of Otolaryngology HNS, University of Kentucky, Markey Cancer Center, Lexington, KY, USA; Department of Surgery, University of Kentucky, Markey Cancer Center, Lexington, KY, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Valentino
authors.affiliation: Division of General Surgery, Department of Surgery, University of Kentucky, Markey Cancer Center, Lexington, KY, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Kenady
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Markey Cancer Center, cc445, 800 Rose Street, Lexington, KY 40536, USA.
authors.forename: Susanne M
authors.initials: SM
authors.lastname: Arnold
keywords: Chemotherapy; Induction; Low-dose; Radiation