Treatment of Soft-Tissue Necrosis of the Pyriform Sinus Using Pentoxyllifylline and Tocopherol.

Radiotherapy of the head and neck can often lead to complications and side effects, including osteoradionecrosis and soft tissue necrosis. One relatively well-established method of treating osteoradionecrosis includes the PENTOCLO protocol, which consists of Pentoxyllifylline, Tocopherol, and Clodronate. Despite its success in the treatment of osteoradionecrosis, the effectiveness of components of the PENTOCLO protocol in treating soft tissue necrosis of the head and neck is underexplored. This case study reviews the successful treatment of a pyriform sinus ulcer that developed after the use of radiotherapy in treating a T3N2b squamous cell carcinoma. The treatment plan used Pentoxyllifylline and Tocopherol, and omitted Clodronate, and can therefore be referred to as a PENTO protocol.

Osteoradionecrosis of the Midface and Mandible: Pathogenesis and Management.

Radiation therapy is an important and commonly used treatment modality for head and neck cancers. Osteoradionecrosis (ORN) is a potential debilitating complication of treatment, which most commonly affects the mandible. Management strategies are tailored to the severity of disease. Medical management including oral rinses, irrigations, antibiotics, and pharmacological treatments is viable for mild-to-moderate ORN. More severe disease is best addressed with a combination of medical management and surgical intervention aimed at aggressively removing devitalized tissue until bleeding bone is encountered and reconstructing the soft tissue and bone defect. Reconstruction with either regional vascularized flaps or vascularized osteocutaneous free flaps in case of larger full-thickness bone defects (greater than 6 cm) or anterior mandible (medial to mental foramen) is most appropriate. Maxillary ORN complications can present with a wide range of functional problems and facial disfigurement. Life-threatening and time-sensitive problems should be treated first, such as skull base bone coverage or correction of severe ectropion, to avoid blindness from exposure keratopathy. Then, less time-sensitive issues can be addressed next, such as nasal obstruction, velopharyngeal insufficiency, and chronic tearing. It may require a combination of specialists from different disciplines to address various issues that can arise from maxillary ORN.

Delayed septic radiation-induced calcinosis cutis long after cured anorectal cancer.

PURPOSE: Calcinosis cutis is an anecdotal local injury seen long after irradiation in cancer survivors. Our purpose was to shed light on this little studied and potentially serious ulceration. CASES: We report two cases of severe perineal-sacral infection with hard lesions, one decade after anorectal cancer irradiation. CT-scans showed extensive calcification and soft tissue inflammation, but previous radiation therapy was overlooked and the diagnosis was not made for several months after various tests, including biopsy. The two patients had different comorbidities and were managed by multidisciplinary collaboration between specialists. Surgery of the sacral ulcer was limited by the accessibility of non-irradiated tissues. In the absence of current guidelines, after radiopathological expertise, we used a "draining" procedure followed by antifibrotic pentoxifylline-tocopherol-clodronate treatment. CONCLUSION: Long after pelvic radiotherapy, symptomatic subcutaneous macrocalcification is suggestive of radiation-induced calcinosis. Prolonged antibiotic therapy followed by PENTOCLO treatment led to clinical improvement.

Long-term recurrences of jaw osteoradionecrosis after apparent healing with the PENTOCLO protocol.

Osteoradionecrosis of the jaws (ORNJ) is a late complication of head and neck irradiation estimated at around 3% of irradiated patients. The PENTO protocol (Pentoxyfilline and Tocopherol), with the eventual adjunction of Clodronate (PENTOCLO), showed interesting results even in advanced ORNJ. The current literature does not describe the long-term outcomes and particularly after the completion of the protocol. The PENTO or PENTOCLO protocol should be prescribed as a life-long treatment or the outcome should be monitored at least as long as the duration of the protocol after its end.

Is there a role for pentoxifylline and tocopherol in the management of advanced osteoradionecrosis of the jaws with pathological fractures? Case reports and review of the literature.

Osteoradionecrosis (ORN) is an infrequent but serious complication of radiotherapy, especially in the head and neck region. It is a slowly progressive condition, with management in the early stages focused on symptom control, and surgery usually reserved for advanced ORN. However, established ORN is difficult to treat. The role of hyperbaric oxygen therapy has recently been contested. The use of pentoxifylline in the management of ORN was first described by Delanian in 2004, but its benefits have not been replicated in other studies. In cases of advanced ORN with pathological fractures, many centres still advocate surgical resection and reconstruction. However, in this group of patients who often have multiple medical comorbidities, many of whom have previously undergone significant surgery, a resective plan is not always ideal. This paper presents two successful cases of bony union after the use of pentoxifylline and tocopherol to manage grade III ORN of the mandible. Both patients had pathological fractures and orocutaneous fistulas and were deemed unsuitable for surgery. The possible reasons for the success of pentoxifylline and tocopherol are discussed, and a review of the current literature evidence of similar cases is presented. Pentoxifylline and tocopherol should be considered for the management of advanced ORN where surgical management is not appropriate.

Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol± CLOdronate for the management of early osteoradionecrosis of the mandible.

INTRODUCTION: Osteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the mainstay of the early management of ORN. Literature about the efficacy of HBO is contentious. Recently, Oral and Maxillofacial surgical units in France and UK have trialled a combination of medications to treat ORN, also known as PENTOCLO (PENtoxifylline+TOcopherol±CLOdronate). This regime has shown promising results to date however randomised controlled trials in the area comparing HBO against PENTOCLO are lacking and there are no current trials registered in Europe, UK, Australia and the USA. The purpose of this pilot study is to generate a hypothesis that can be tested in large multi-centre controlled trials. METHODS AND ANALYSIS: For this pilot study we will recruit 16 patients who will be randomly allocated to one of either HBO or PENTOCLO. After a 4 week period of uniform 'pre-treatment' medication patients will be commenced on their allocated treatment. Standard follow-up examination, imaging and photographs will be taken and de-identified and then presented to two Oral and Maxillofacial surgeons for allocation of a Notani & Lyons classification score. Data for each patient will be tracked over the 18 months of treatment and follow-up. The results will then be analysed using descriptive statistics and all patients included in an intention to treat analysis. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the South Metropolitan Health Service HREC (PRN RGS0000001193). Data generated by conducting this study will be uploaded to an open access repository in a de-identified form. Results from this study will be disseminated at national and international conferences as well as peer reviewed medical publications. TRIAL REGISTRATION NUMBER: ACTRN12618001099213; Pre-results.

Successful treatment of grade III osteoradionecrosis with mandibular fracture with pentoxifylline, tocopherol and clodronate.

Osteoradionecrosis (ORN) is one of the most severe complications after head and neck radiotherapy. Once established, ORN is difficult to manage and is traditionally considered to be irreversible. Since the recent understanding of the pathophysiology of ORN is based on the concept of radiation-induced fibrosis, a new therapeutic medical regimen has been proposed comprising the combination of pentoxifylline, tocopherol and clodronate (PENTOCLO). A 55-year-old woman presented with grade III ORN with large intraoral bone exposure, a fracture of the left posterior horizontal branch and an orocutaneous fistula. Because she refused surgery, medical treatment with PENTOCLO was proposed. After 55months of treatment, there was complete mucosal coverage and complete consolidation of the fracture site around the orocutaneous fistula. PENTOCLO treatment can help some patients with grade III disease, as in this case. Further prospective randomized controlled trials are needed to confirm this result.

Pentoxifylline-tocopherol-clodronate combination: A novel treatment for osteoradionecrosis of the temporal bone.

BACKGROUND: Osteoradionecrosis (ORN) of the temporal bone is a complication of radiation therapy that is extremely challenging to manage. METHODS: We report the case of a patient treated at our institution and present a review of the literature. RESULTS: A 52-year-old woman presented with ORN of the temporal bone 20 years after radiation therapy for an ipsilateral parotid tumor. She failed conservative management, including serial debridements, oral and topical antibiotics/antifungals, and aural lavage. As an alternative to hyperbaric oxygen (HBO) and/or temporal bone resection, treatment with pentoxifylline-tocopherol-clodronate combination (PENTOCLO) was pursued and her condition improved dramatically. CONCLUSION: This is the first document use of PENTOCLO to treat ORN of the temporal bone. PENTOCLO may represent an effective nonsurgical management option for ORN of the temporal bone.