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Bevacizumab (Avastin) Neus Spray voor Frequente Neusbloedingen bij ROW Proefbehandeling F.S. van der Meer, MD St Antonius hospital Nieuwegein,, The Netherlands.

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Presentatie over: "Bevacizumab (Avastin) Neus Spray voor Frequente Neusbloedingen bij ROW Proefbehandeling F.S. van der Meer, MD St Antonius hospital Nieuwegein,, The Netherlands."— Transcript van de presentatie:

1 Bevacizumab (Avastin) Neus Spray voor Frequente Neusbloedingen bij ROW Proefbehandeling F.S. van der Meer, MD St Antonius hospital Nieuwegein,, The Netherlands

2 | ROW en neusbloedingen (epistaxis) - > 90% terugkerende epistaxis - Frequent ijzer and bloedtransfusies - Verstoort dagelijkse leven en werk - Meeste behandelingen hebben tijdelijk effect of veel bijwerkingen -Laser, embolisation, surgery: Saunders -Estrogen (de pil), - Thalidomide

3 | Bevacizumab (Avastin) Eerder onderzoek: -Patienten met ROW hebben verhoogde spiegels van VEGF (oa Saddic et al, 2005) -Menselijk antilichaam -Bind aan en remt VEGF activiteit -Iremt vaatgroei

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5 | Eerdere Bevacizumab publicaties, lokale toepassing Davidson TM, Olitsky SE, Wei JL. Hereditary hemorrhagic telangiectasia/avastin Laryngoscope 2010: -Case report, male 45 yrs, HHT, recurrent epistaxis -Injection submucosal 100mg Bevacizumab <1 wk epistaxis stopped effect: 3-4 months -Nasal spray 10mg/ml, 2wk, total 50mg <1 wk epistaxis stopped effect 3-4 months -Nasal spray 25mg/ml, every 30min 1 spray till 25mg effect 2.5 months

6 | Eerdere Bevacizumab publicaties, lokale toepassing Karnezis TT, Davidson TM. Efficacy of intranasal Bevacizumab (Avastin) treatment in patients with hereditary hemorrhagic telangiectasia-associated epistaxis Laryngoscope 2011: -32 patients: 17 topical, spray, mg, 10 submucosal injection, 100mg (1  25mg), 5 topical spray and submucosal injection, 12/32 also KTP laser Follow-up: -ESS before treatment and 2-18 (mean 4.1) months after treatment Results: -ESS pre treatment 7.0, after treatment: 2.9 -( 17 topical: , 10 submucosal )

7 | Eerdere Bevacizumab publicaties, lokale toepassing Veiligheid Chen S 4th, Karnezis T, Davidson TM. Safety of intranasal Bevacizumab (avastin) treatment in patients with hereditary hemorrhagic telangiectasia-associated epistaxis. Laryngoscope 2010: 52 patients, treated with bevacizumab intranasally applied, some on mutiple occasions - Topical spray, mg Bevacizumab (26) KTP 0 - Submucosal injection, mg bevacizumab, (34), also KTP (30) Follow-up months after treatment: -5 septal perforation (all combined submucosal injection and KTP laser) -No other common or serious event

8 | Proefbehandeling Bevacizumab nasal spray -Solution 25mg/ml, dose 0.1ml (2.5mg) -Daily use: 2dd1 both sides (0.4ml=10mg) -Treatment duration: 1 week (70mg) -Inclusion of 8 HHT patients with recurrent epistaxis -All signed informed consent -Diary of epistaxis during 4 weeks before treatment and 4 weeks after treatment -Validated in previous studies -Hb, ferritin levels before and after treatment -Video of nasal mucosa before and after treatment -June and August 2011: -2 and 4 months after treatment evaluation -4 weeks diary, hb/iron/ferritine levels

9 | Pilot treatment Bevacizumab nasal spray -Solution 25mg/ml, dose 0.1ml (2.5mg) -Daily use: 2dd1 both sides (0.4ml=10mg) -Treatment duration: 1 week (70mg) -Inclusion of 8 HHT patients with recurrent epistaxis -All signed informed consent -Diary of epistaxis during 4 weeks before treatment and 4 weeks after treatment -Validated in previous studies -Hb, ferritin levels before and after treatment -Video of nasal mucosa before and after treatment -June and August 2011: -2 and 4 months after treatment evaluation -4 weeks diary, hb/iron/ferritine levels

10 | Pilot treatment Bevacizumab nasal spray -Solution 25mg/ml, dose 0.1ml (2.5mg) -Daily use: 2dd1 both sides (0.4ml=10mg) -Treatment duration: 1 week (70mg) -Inclusion of 8 HHT patients with recurrent epistaxis -All signed informed consent -Diary of epistaxis during 4 weeks before treatment and 4 weeks after treatment -Validated in previous studies -Hb, ferritin levels before and after treatment -Video of nasal mucosa before and after treatment -June and August 2011: -2 and 4 months after treatment evaluation -4 weeks diary, hb/iron/ferritine levels

11 | Pilot treatment Bevacizumab nasal spray -Solution 25mg/ml, dose 0.1ml (2.5mg) -Daily use: 2dd1 both sides (0.4ml=10mg) -Treatment duration: 1 week (70mg) -Inclusion of 8 HHT patients with recurrent epistaxis -All signed informed consent -Diary of epistaxis during 4 weeks before treatment and 4 weeks after treatment -Validated in previous studies -Hb, ferritin levels before and after treatment -Video of nasal mucosa before and after treatment -June and August 2011: -2 and 4 months after treatment evaluation -4 weeks diary, hb/iron/ferritine levels

12 | Inclusion Patients (8)Age (yrs)Sex (m/f)Type HHT Previous treatments Iron/bloodtran sfusions 168mHHT-1 Laser Argonlaser Iron and blood iv every 3wks 268fHHT-1 Laser Argonlaser Septumbutton Oral iron 368mHHT-1 Argonlaser Saunders Thalidomide stopped 2009 Sitaglyptine Oral iron 460fHHT-2 Argonlaser Saunders Estrogen Oral iron 568fHHT-2 Laser Embolisation Thalidomide stopped Iron iv every week 651fHHT-1 Embolisation Weekly visit ENT - 772mHHT-2 Saunders Argonlaser - 860mHHT-2 Laser Argonlaser septumbutton - Mean64.450% male50% HHT-1

13 | Results Freq epistaxis/day Duration of epistaxis min/day Severity of epistaxis Patients opinion of bleeding beforeafter diffbeforeafterdiffBeforeafterdiffDuring treatment After treatment =Shorter Heavy bleedingLess freq More bleeding Less freq less severe More bleeding= Severe bleeding Less severe, wholeday bleeding More bleedingLess Some bleedingLess More bleedingLess Median % -50% -52% -66% -65% +500% p / 0.065p Paired samples T-test

14 | Results Hb levelFerritin Patients opinion of bleeding patientsbeforeafterBeforeafterDuring treatmentAfter =shorter Heavy bleedingLess freq More bleeding Less freq en severe More bleeding= Severe bleeding, transfusion Less severe, wholeday bleeding More bleedingless Iron IV before last Hb/ferritin Some bleedingLess More bleedingLess Mean (21)

15 | Video before and after treatment No 4-5-8

16 | -Meer bloedneuzen tijdens gebruik neusspray(7) -Misselijkheid tijdens gebruik neusspray(1) -Moeheid(1) -Ernstige bloeding warvoor opname en bloedtransfusie (1) Ernstige bijwerkingen Bijwerkingen

17 | Conclusies Mening van de patiënt: -Tijdens de behandeling ervaarden 7/8 patienten meer bloedingen -Na behandeling ervaarden 6/8 patientsen minder of minder ernstige bloedneuzen Dagboek evaluatie: -Overall minder vaak en kortere duur bloedneuzen -Geen verschil in ernst bloedarmoede en ijzervoorraad -Geen relatie tussen behandelresultaat en mutatie HHT1 of HHT2

18 | Discussion Application of bevacizumab: -Competence/execution of spray -Spray type: lesions? -Dose of Bevacizumab -Previous reports: mg -This report 70mg -Follow up -Previous effects: after one week (case report), evaluation after 2-18 months -Extra follow-up planned after 2 and 4 months use -Adverse events: -Patient 5 stopped using thalidomide 5 weeks before treatment

19 | Bevacizumab Nasal Spray for Frequent Epistaxis in HHT, a pilot treatment Previous reports: positive effect Our treatment: -Some positive signs -Problems during application -More research needed -Study group size -Effective dose -Application -RCT -Long term effects NOSE: - Efficacy and safety

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