title: Medical treatment of osteoradionecrosis of the mandible by PENTOCLO: preliminary results.
abstract: BACKGROUND
  Osteoradionecrosis (ORN) is a severe, generally irreversible complication of radiotherapy due to failure of healing. The pentoxifylline-tocopherol combination decreases the superficial fibrosis induced by radiotherapy. Potentiation by Clodronate (PENTOCLO) appears to be effective in ORN of the mandible. The objectives of this study were to evaluate the efficacy and safety of PENTOCLO to treat osteoradionecrosis of the mandible.
  
  
  METHODS
  Retrospective study of 27 patients with a mean age of 65±12 years, managed for ORN of the mandible secondary to irradiation for head and neck cancer, treated by the PENTOCLO protocol between January 2010 and March 2011. The primary endpoint was regression of exposed bone until complete healing. Assessment was both clinical (measurement of mucosal ulceration) and radiological (panoramic dental x-rays) before treatment, after antibiotic-corticosteroid combination therapy for one month (M1), and then after 3, 6, 12 months of PENTOCLO.
  
  
  RESULTS
  An improvement of mucosal ulceration was observed in 16/21 patients after 3 months and in 12/17 patients after 6 months of PENTOCLO. Healing was obtained in 16 patients. Median healing time was 82 days (range: 32-266), and was shorter after surgery and radiotherapy (49 days) and longer after chemoradiotherapy (169 days). Radiological healing was achieved later than clinical healing with improvement in 9 out of 20 patients at 3 months. The safety and efficacy of treatment were evaluated by intraoral clinical examination, and assessment of feeding, weight and analgesic consumption. No patient discontinued treatment because of adverse effects.
  
  
  CONCLUSIONS
  The PENTOCLO protocol achieved clinical and radiological regression of ORN with, in parallel, a reduction of the indications for major surgery. These preliminary results need to be confirmed by prospective studies comprising quality of life assessment.
authors.affiliation: Service ORL, CHU Côte-de-Nacre, avenue de la Côte-de-Nacre, 14033 Caen cedex 9, France. Electronic address: robard-l@chu-caen.fr.
authors.forename: L
authors.initials: L
authors.lastname: Robard
authors.affiliation: Service ORL, centre François-Baclesse, avenue Général-Harris, 14000 Caen, France.
authors.forename: M-Y
authors.initials: MY
authors.lastname: Louis
authors.affiliation: Service ORL, centre François-Baclesse, avenue Général-Harris, 14000 Caen, France.
authors.forename: D
authors.initials: D
authors.lastname: Blanchard
authors.affiliation: Service ORL, CHU Côte-de-Nacre, avenue de la Côte-de-Nacre, 14033 Caen cedex 9, France.
authors.forename: E
authors.initials: E
authors.lastname: Babin
authors.affiliation: Service oncologie-radiothérapie, hôpital Saint-Louis, AP-HP, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Delanian
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004002:Clodronic Acid / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008336:Mandibular Diseases / Q000188:drug therapy*; D008875:Middle Aged; D019226:Oral Ulcer / Q000188:drug therapy; D010025:Osteoradionecrosis / Q000188:drug therapy*; D010431:Pentoxifylline / Q000627:therapeutic use*; D011862:Radiography, Panoramic; D012189:Retrospective Studies; D024505:Tocopherols / Q000627:therapeutic use*; D014945:Wound Healing
chemical_list: D050071:Bone Density Conservation Agents; D004338:Drug Combinations; C559761:pentoxifylline-tocopherol-clodronate; D004002:Clodronic Acid; D024505:Tocopherols; D010431:Pentoxifylline
keywords: Osteoradionecrosis of the mandible; Pentoxifylline-tocopherol-clodronate; Radiotherapy