Delanian S, Chatel C, Porcher R, Depondt J, Lefaix JL, et al.
International journal of radiation oncology, biology, physics. Date of publication 2011 Jul 1;volume 80(3):832-9.
1. Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):832-9. doi:
10.1016/j.ijrobp.2010.03.029. Epub 2010 Jul 16.
Complete restoration of refractory mandibular osteoradionecrosis by prolonged
treatment with a pentoxifylline-tocopherol-clodronate combination (PENTOCLO): a
phase II trial.
Delanian S(1), Chatel C, Porcher R, Depondt J, Lefaix JL.
Author information:
(1)Service d'Oncologie-Radiothérapie, Hôpital Saint-Louis, APHP, Paris, France.
sylvie.delanian@sls.ap-hop-paris.fr
PURPOSE: Osteoradionecrosis (ORN) is a nonhealing wound of the bone that is
difficult to manage. Combined treatment with pentoxifylline and vitamin E
reduces radiation-induced fibrosis and ORN with a good prognosis. We previously
showed that the combination of pentoxifylline and vitamin E with clodronate
(PENTOCLO) is useful in healing sternocostal and some mandibular ORN. Is
PENTOCLO effective in ORN of poor prognosis?
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.
Copyright © 2011 Elsevier Inc. All rights reserved.
DOI: 10.1016/j.ijrobp.2010.03.029
PMID: 20638190 [Indexed for MEDLINE]
