Abstract | PURPOSE: METHODS: 54 eligible patients previously irradiated for head and neck cancer (among 72 treated) a mean 5 years previously received exteriorized refractory mandibular ORN for 1.4 ± 1.8 years, mainly after local surgery and hyperbaric oxygen had been ineffective. The mean length of exposed bone (D) was 17 ± 8 mm as primary endpoint, and the mean Subjective, Objective, Management, and Analytic evaluation of injury ( SOMA) score was 16 ± 4. Between August 2000 and August 2008, all patients were given daily oral PENTOCLO: 800 mg pentoxifylline, 1,000 IU vitamin E, and 1,600 mg clodronate 5 days per week alternating with 20 mg prednisone and 1,000 mg ciprofloxacin 2 days per week. The duration of treatment was related to consolidated healing. RESULTS: Prolonged treatment (16 ± 9 months) was safe and well tolerated. All patients improved, with an exponential progressive--(f[t] = a.exp(-b.t)--and significant (p < 0.0001) reduction of exposed bone (D), respectively (months): D(2) -42%, D(4) -62%, D(6) -77%, D(12) -92%, and D(18) -96%, combined with iterative spontaneous sequestrectomies in 36 patients. All patients experienced complete recovery in a median of 9 months. Clinical improvement was measured in terms of discontinuation of analgesics, new fracture, closed skin fistulae, and delayed radiologic improvement: SOMA(6) -64%, SOMA(12) -89%, and SOMA(30) -96%. CONCLUSION: Long-term PENTOCLO treatment is effective, safe, and curative for refractory ORN and induces mucosal and bone healing with significant symptom improvement. These findings will need to be confirmed in a randomized trial.
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Authors | Sylvie Delanian, Cécile Chatel, Raphael Porcher, Joel Depondt, Jean-Louis Lefaix |
Journal | International journal of radiation oncology, biology, physics
(Int J Radiat Oncol Biol Phys)
Vol. 80
Issue 3
Pg. 832-9
(Jul 01 2011)
ISSN: 1879-355X [Electronic] United States |
PMID | 20638190
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Copyright | Copyright © 2011 Elsevier Inc. All rights reserved. |
Chemical References |
- Bone Density Conservation Agents
- Drug Combinations
- pentoxifylline-tocopherol-clodronate
- Clodronic Acid
- Ciprofloxacin
- Tocopherols
- Pentoxifylline
- Prednisone
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Bone Density Conservation Agents
(therapeutic use)
- Ciprofloxacin
(therapeutic use)
- Clodronic Acid
(therapeutic use)
- Drug Administration Schedule
- Drug Combinations
- Female
- Head and Neck Neoplasms
(radiotherapy)
- Humans
- Male
- Mandibular Diseases
(drug therapy)
- Middle Aged
- Osteoradionecrosis
(drug therapy)
- Pentoxifylline
(therapeutic use)
- Prednisone
(therapeutic use)
- Prognosis
- Tocopherols
(therapeutic use)
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