INLEIDING
Welkom
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INLEIDING Workshop
Osteonecrose van de kaak
Osteonecrosis of the jaw (ONJ)
Hoe kunnen we dit voorkomen en als het toch optreedt, hoe kunnen we het managen?
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INLEIDING Workshop
Osteonecrose van de kaak
• Complication of bisphosphonate and denosumab use1
Dit ga je echter niet zien
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1. Ruggiero SL, et al. AAOMS position statement 2014.
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INLEIDING Workshop
Osteonecrose van de kaak
• Cumulatieve incidentie van ONJ is laag (0.8−12%)1−4 – Risico groter bij patienten met bisfosfanaten IV en denosumab 120 mg SC Q4W dan patienten orale bisfosfanaten of denosumab 60 mg Q6M1,4
• Afhankelijk van risicofactoren1−3
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1. Gupta S, et al. Natl J Maxillofac Surg 2013;4:151−8; 2. O'Halloran M, et al. Aust Dent J 2014 [Epub ahead of print]; 3. Denosumab (XGEVA®) Summary of Product Characteristics, Amgen; 4. Denosumab (Prolia®) Summary of Product Characteristics, Amgen.
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INLEIDING Workshop
Osteonecrose van de kaak
• Risico factoren – Kaak/tand chirurgie – Kaak infectie – Onstekingen kaak/tanden – Orale comorbiditeit – Caries – Kaukasisch ras – Roken
Gupta S, et al. Natl J Maxillofac Surg 2013;4:151−8.
Ook niet oncologische risicofactoren
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INLEIDING Workshop
Osteonecrose van de kaak
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These non-specific findings, which characterize Stage 0, may occur in patients with a prior history of Stage 1, 2, or 3 disease who have healed and have no clinical evidence of exposed bone. Exposed and necrotic bone in patients who are asymptomatic and have no evidence of infection.
Stage 1 Exposed and necrotic bone in patients with pain and clinical evidence of infection. Stage 2 Exposed and necrotic bone in patients with pain, infection, and one or more of the following: Stage 3 • exposed necrotic bone extending beyond the region of alveolar bone, i.e., inferior border and ramus in the mandible, maxillary sinus and zygoma in the maxilla • pathologic fracture • extra-oral fistula • oral antral/oral nasal communication • osteolysis extending to the inferior border of the mandible or sinus floor •
Ruggiero SL, et al. J Oral Maxillofac Surg 2009;67:2–12.
INLEIDING Workshop
Osteonecrose van de kaak AAOMS ONJ staging
ONJ staging At risk
Stage 0
Stage 1 Stage 2
No treatment indicated Patient education Patients with no clinical evidence of necrotic bone, but present with
Stage 3
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non-specific symptoms or clinical and radiographic findings These non-specific findings, which characterize Stage 0, may occur in patients with a prior history of Stage 1, 2, or 3 disease who have healed and have no clinical evidence of exposed bone Exposed and necrotic bone in patients with pain and clinical evidence of infection Exposed and necrotic bone in patients with pain, infection, and one or more of the following Exposed necrotic bone extending beyond the region of alveolar bone, i.e., inferior border and ramus in the mandible, maxillary sinus and zygoma in the maxilla • pathologic fracture • extra-oral fistula • oral antral/oral nasal communication • osteolysis extending to the inferior border of the mandible or sinus floor
Ruggiero SL, et al. J Oral Maxillofac Surg 2009;67:2–12.
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* Exposed and necrotic bone extending beyond the region of alveolar bone resulting in pathologic fracture, extraoral fistula, oral antral/oral nasal communication, or osteolysis extending to the inferior border of the mandible or the sinus floor.
INLEIDING Workshop
Osteonecrose van de kaak AAOMS ONJ treatment strategies
ONJ staging At risk
Stage 0
Stage 1
Stage 2
Stage 3
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No treatment indicated Patient education Systemic management, including use of pain medication
and antibiotics Antibacterial mouth rinse Clinical follow-up on quarterly basis Patient education and review of indications for continued antiresorptive therapy Symptomatic treatment with oral antibiotics Oral antibacterial mouth rinse Pain control Superficial debridement to relieve soft tissue irritation Antibacterial mouth rinse Antibiotic therapy and pain control Surgical debridement/resection for longer term palliation of infection and pain
Ruggiero SL, et al. J Oral Maxillofac Surg 2009;67:2–12.
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* Exposed and necrotic bone extending beyond the region of alveolar bone resulting in pathologic fracture, extraoral fistula, oral antral/oral nasal communication, or osteolysis extending to the inferior border of the mandible or the sinus floor.
INLEIDING Workshop
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Osteonecrose van de kaak
1. Saad F, et al. Ann Oncol 2012;23:1341−7; 2. Denosumab (XGEVA®) Summary of Product Characteristics. Amgen.
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INLEIDING Workshop
Osteonecrose van de kaak
Results1 ONJ 1.6% − 1.3% zoledronic acid − 1.8% denosumab
Tooth extraction in 61.8% Treatment was conservative or required minor interventions in > 95% ONJ resolved in 36% − 29.7% for zoledronic acid − 40.4% for denosumab
Incidence of ONJ was higher with longer denosumab exposure2† − 1.1% during Year 1 − 3.7% during Year 2 − 4.6% per year thereafter •
1. Saad F, et al. Ann Oncol 2012;23:1341−7; 2. Denosumab (XGEVA®) Summary of Product Characteristics. Amgen.
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†Open-label extension
study in patients with breast or prostate cancer and bone metastases.
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INLEIDING Workshop
Osteonecrose van de kaak
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Minimaliseren risico op ONJ • Voor start bisfosfanaten of denosumab – Evaluatie mond via tandarts op bij tandprothese1−6 • Behandel active mond infecties, verwijderen plaatsen voor hoog risico op infectie4 – Niet starten met behandelen bij patienten die kaak chirurgie nodig hebben, of die niet hersteld zijn van orale chirurgie2,4 • Vraag aan patient of: – Ze zijn gecheckt door hun tandarts – Ze pijn hebben in de mond/kaak
1. Zoledronic acid (Zometa®) Summary of Product Characteristics, Novartis; 2. Denosumab (XGEVA®) Summary of Product Characteristics, Amgen; 3. Aapro M, et al. Oncologist 2010;15:1147−58; 4. Kyle RA, et al. J Clin Oncol 2007;25:2464−72; 5. Khan AA, et al. J Rheumatol 2008;35:1391−7; 6. Van Poznak CH, et al. J Clin Oncol 2011;29:1221−7.
INLEIDING Workshop
Osteonecrose van de kaak
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Patienten voorlichting mond hygiene • Bij gebruik bisfosfanaten of denosumab patienten worden geadviseerd: – Voortzetten mond hygiene1−6 • Tandenpoetsen minimaal 1 daags – Voorkom invasieve tand procedure1,2,4−6 – Routine check up door tandarts2 – Direct actie bij mond/tand pijn, zwelling, kleur, vieze smaak2 – Stoppen bisfosfanaten 3 maanden voor tandprocedures (low evidence prevention)5 • Let op cumulatieve dosis, duur van de behandeling •
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1. Zoledronic acid (Zometa®) Summary of Product Characteristics, Novartis; 2. Denosumab (XGEVA®) Summary of Product Characteristics, Amgen; 3. Aapro M, et al. Oncologist 2010;15:1147−58; 4. Kyle RA, et al. J Clin Oncol 2007;25:2464−72; 5. Khan AA, et al. J Rheumatol 2008;35:1391−7; 6. Van Poznak CH, et al. J Clin Oncol 2011;29:1221−7.
