Osteonecrosis of the jaw (ONJ)

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Anneleen Brander
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1 INLEIDING Welkom 1

2 2 Osteonecrosis of the jaw (ONJ) Hoe kunnen we dit voorkomen en als het toch optreedt, hoe kunnen we het managen?

3 3 Complication of bisphosphonate and denosumab use 1 Dit ga je echter niet zien 1. Ruggiero SL, et al. AAOMS position statement 2014.

4 4 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 Q6M 1,4 Afhankelijk van risicofactoren 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.

bisfosfanaten of denosumab 60 mg Q6M 1,4 Afhankelijk van risicofactoren 1 3 1. Gupta S, et al.

5 5 Risico factoren Kaak/tand chirurgie Kaak infectie Onstekingen kaak/tanden Orale comorbiditeit Caries Kaukasisch ras Roken Ook niet oncologische risicofactoren Gupta S, et al. Natl J Maxillofac Surg 2013;4:151 8.

Kaukasisch ras Roken Ook niet oncologische

6 6 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.

7 7 ONJ staging At risk Stage 0 Stage 1 Stage 2 Stage 3 No treatment indicated Patient education AAOMS ONJ staging Patients with no clinical evidence of necrotic bone, but present with 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. * 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.

$the following Exposed necrotic bone extending beyond the region of alveolar bone, i.e., inferior border and ramus in the mandible, maxillary sinus and zygoma in the maxilla pathologic fracture$

8 8 ONJ staging At risk Stage 0 Stage 1 Stage 2 Stage 3 AAOMS ONJ treatment strategies 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. * 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.

antibacterial mouth rinse Pain control Superficial debridement to relieve soft tissue irritation Antibacterial mouth rinse Antibiotic therapy and pain control Surgical debridement/resection for

9 9 1. Saad F, et al. Ann Oncol 2012;23:1341 7; 2. Denosumab (XGEVA ) Summary of Product Characteristics. Amgen.

10 Results 1 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.

10 10 Results 1 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 exposure 2 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. Open-label extension study in patients with breast or prostate cancer and bone metastases.

4% for denosumab Incidence of ONJ was higher with longer denosumab exposure 2 1.1% during Year 1 3.7% during Year 2 4.

11 Minimaliseren risico op ONJ 11 Voor start bisfosfanaten of denosumab Evaluatie mond via tandarts op bij tandprothese 1 6 Behandel active mond infecties, verwijderen plaatsen voor hoog risico op infectie 4 Niet starten met behandelen bij patienten die kaak chirurgie nodig hebben, of die niet hersteld zijn van orale chirurgie 2,4 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: ; 4. Kyle RA, et al. J Clin Oncol 2007;25: ; 5. Khan AA, et al. J Rheumatol 2008;35:1391 7; 6. Van Poznak CH, et al. J Clin Oncol 2011;29:

door hun tandarts Ze pijn hebben in de mond/kaak 1. Zoledronic acid (Zometa ) Summary of Product Characteristics, Novartis; 2.

12 12 Patienten voorlichting mond hygiene Bij gebruik bisfosfanaten of denosumab patienten worden geadviseerd: Voortzetten mond hygiene 1 6 Tandenpoetsen minimaal 1 daags Voorkom invasieve tand procedure 1,2,4 6 Routine check up door tandarts 2 Direct actie bij mond/tand pijn, zwelling, kleur, vieze smaak 2 Stoppen bisfosfanaten 3 maanden voor tandprocedures (low evidence prevention) 5 Let op cumulatieve dosis, duur van de behandeling 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: ; 4. Kyle RA, et al. J Clin Oncol 2007;25: ; 5. Khan AA, et al. J Rheumatol 2008;35:1391 7; 6. Van Poznak CH, et al. J Clin Oncol 2011;29:

5 Let op cumulatieve dosis, duur van de behandeling 1. Zoledronic acid (Zometa ) Summary of Product Characteristics, Novartis; 2.

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