Major healing of refractory mandible osteoradionecrosis after treatment combining pentoxifylline and tocopherol: a phase II trial

Head Neck. 2005 Feb;27(2):114-23. doi: 10.1002/hed.20121.

Abstract

Background: Osteoradionecrosis (ORN) is a nonhealing wound of the bone that is difficult to manage. Is a treatment combining pentoxifylline (PTX) and tocopherol (vitamin E) boosted by clodronate effective in reversing this fibronecrotic process?

Methods: Eighteen consecutive patients previously irradiated for head and neck cancer had exteriorized mandible ORN. Length of exposed bone (L) was 13.4 +/- 8 mm, and the mean subjective objective medical management and analytic evaluation of injury (SOMA) score was 12.6 +/- 4.9. Between June 1995 and January 2002, all 18 were given a daily oral combination of 800 mg of PTX and 1000 IU of vitamin E for 6 to 24 months. In addition, the last eight patients who were the worst cases were given 1600 mg/day clodronate 5 days a week.

Results: The treatment was well tolerated. All patients improved at 6 months, with 84% mean L and 67% mean SOMA score reductions. Sixteen (89%) of 18 patients achieved complete recovery, 14 in 5 +/- 2.6 months. The remaining two patients exhibited a 75% response at 6 months.

Conclusion: PTX-vitamin E boosted by clodronate is an effective treatment of mandibular ORN that induces mucosal and bone healing in a median period of 6 months.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antimetabolites / administration & dosage
  • Antioxidants / administration & dosage*
  • Clodronic Acid / administration & dosage
  • Drug Therapy, Combination
  • Female
  • Head and Neck Neoplasms / radiotherapy
  • Humans
  • Male
  • Mandibular Diseases / diagnostic imaging
  • Mandibular Diseases / drug therapy*
  • Mandibular Diseases / etiology
  • Middle Aged
  • Osteoradionecrosis / diagnostic imaging
  • Osteoradionecrosis / drug therapy*
  • Osteoradionecrosis / etiology
  • Pentoxifylline / administration & dosage*
  • Radiation-Protective Agents / administration & dosage*
  • Radiography
  • Radiotherapy / adverse effects
  • Tocopherols / administration & dosage*
  • Wound Healing / drug effects

Substances

  • Antimetabolites
  • Antioxidants
  • Radiation-Protective Agents
  • Clodronic Acid
  • Tocopherols
  • Pentoxifylline