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


CONCLUSIONS
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.
Delanian
Sylvie
S
Service Oncologie-Radiothérapie, 1, ave Claude Vellefaux, 75010 Paris, France. sylvie.delanian@sls.ap-hop-paris.fr
Depondt
Joel
J
Lefaix
Jean-Louis
JL
D000328:Adult; D000368:Aged; D000963:Antimetabolites / Q000008:administration & dosage; D000975:Antioxidants / Q000008:administration & dosage*; D004002:Clodronic Acid / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008336:Mandibular Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D008875:Middle Aged; D010025:Osteoradionecrosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D010431:Pentoxifylline / Q000008:administration & dosage*; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D011859:Radiography; D011878:Radiotherapy / Q000009:adverse effects; D024505:Tocopherols / Q000008:administration & dosage*; D014945:Wound Healing / Q000187:drug effects
D000963:Antimetabolites; D000975:Antioxidants; D011837:Radiation-Protective Agents; D004002:Clodronic Acid; D024505:Tocopherols; D010431:Pentoxifylline