Ibrutinib, bij de eerstelijnsbehandeling van chronische lymfatische leukemie bij patiënten die geen del(17p) of TP53-mutatie hebben, voldoet alleen aan de stand van de wetenschap en praktijk bij patiënten bij wie toepassing van anti-CD20 gecontra-indiceerd is of meer nadelen biedt dan voordelen voor de patiënt.
5
Literatuur
1. Nederlandse Vereniging voor Hematologie. Chronische lymfatische leukemie. 2017. via http://www.hematologienederland.nl/chronisch-lymfatische-leukemie. 2. Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2015;26 Suppl 5:v78-v84.
3. HOVON. Richtlijn Chronische Lymfatische Leukemie. 2016. via http://www.hovon.nl/upload/Richtlijn-CLL-HOVON_07sep2016.pdf.
4. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International
Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute- Working Group 1996 guidelines. Blood 2008;111:5446-56.
5. Dighiero G, Hamblin TJ. Chronic lymphocytic leukaemia. Lancet 2008;371:1017- 29.
6. IKNL. Cijfers over kanker. 2016. via www.cijfersoverkanker.nl.
7. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a
randomised, open-label, phase 3 trial. Lancet 2010;376:1164-74.
8. Damle RN, Wasil T, Fais F, et al. Ig V gene mutation status and CD38 expression as novel prognostic indicators in chronic lymphocytic leukemia. Blood
1999;94:1840-7.
9. de G, V, Beckerman H, Lankhorst GJ, et al. How to measure comorbidity. a critical review of available methods. J Clin Epidemiol 2003;56:221-9.
10. Eichhorst B, Robak T, Montserrat E, et al. appendix 6: Chronic lymphocytic leukaemia: eUpdate published online September 2016
(http://www.esmo.org/Guidelines/Haematological-Malignancies). Ann Oncol 2016;27:v143-v144.
11. Hillmen P, Gribben JG, Follows GA, et al. Rituximab plus chlorambucil as first- line treatment for chronic lymphocytic leukemia: Final analysis of an open-label phase II study. J Clin Oncol 2014;32:1236-41.
12. EMA. SPC ibrutinib. 2016. via
http://www.ema.europa.eu/docs/nl_NL/document_library/EPAR_- _Product_Information/human/003791/WC500177775.pdf.
13. Zorginstituut Nederland. Beoordeling stand van de wetenschap en praktijk (geactualiseerde versie). 2015. via
https://www.zorginstituutnederland.nl/binaries/content/documents/zinl-
www/documenten/publicaties/rapporten-en-standpunten/2015/1501-beoordeling- stand-van-de-wetenschap-en-
praktijk/Beoordeling+stand+van+de+wetenschap+en+praktijk.pdf. 14. EMA. EPAR ibrutinib. 2016. via
DEFINITIEF | Farmacotherapeutisch rapport ibrutinib (Imbruvica®) bij de eerstelijnsbehandeling van chronische lymfatische leukemie bij patiënten die geen del(17p) of TP53-mutatie hebben | 25 april 2017
2017002154 Pagina 32 van 33
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Assessment_Report_-_Variation/human/003791/WC500208430.pdf. 15. EMA. EPAR obinutuzumab. 2014. via
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Public_assessment_report/human/002799/WC500171596.pdf. 16. EMA. EPAR ofatumumab. 2014. via
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Assessment_Report_-_Variation/human/001131/WC500170807.pdf.
17. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med 2015;373:2425-37.
18. Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med 2014;370:1101-10.
19. Goede V, Fischer K, Engelke A, et al. Obinutuzumab as frontline treatment of chronic lymphocytic leukemia: updated results of the CLL11 study. Leukemia 2015;29:1602-4.
20. Hillmen P, Robak T, Janssens A, et al. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet 2015;385:1873-83.
21. Foa R, Del G, I, Cuneo A, et al. Chlorambucil plus rituximab with or without maintenance rituximab as first-line treatment for elderly chronic lymphocytic leukemia patients. Am J Hematol 2014;89:480-6.
22. CBG. SPC chloorambucil. 2014. via http://db.cbg-meb.nl/IB- teksten/h00256.pdf.
23. EMA. SPC ofatumumab. 2016. 24. EMA. SPC obinutuzumab. 2016. via
http://www.ema.europa.eu/docs/nl_NL/document_library/EPAR_- _Product_Information/human/002799/WC500171594.pdf. 25. EMA. SPC rituximab. 2016. via
http://www.ema.europa.eu/docs/nl_NL/document_library/EPAR_- _Product_Information/human/000165/WC500025821.pdf.
26. Chanan-Khan A, Cramer P, Demirkan F, et al. Ibrutinib combined with
bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic
lymphoma (HELIOS): a randomised, double-blind, phase 3 study. Lancet Oncol 2016;17:200-11.
27. Else M, Wade R, Oscier D, et al. The long-term outcome of patients in the LRF CLL4 trial: the effect of salvage treatment and biological markers in those surviving 10 years. Br J Haematol 2016;172:228-37.
28. Hallek M, Kay NE, Osterborg A, et al. The HELIOS trial protocol: a phase III study of ibrutinib in combination with bendamustine and rituximab in
relapsed/refractory chronic lymphocytic leukemia. Future Oncol 2015;11:51-9. 29. De JJ, Sukbuntherng J, Skee D, et al. The effect of food on the pharmacokinetics of oral ibrutinib in healthy participants and patients with chronic lymphocytic
leukemia. Cancer Chemother Pharmacol 2015;75:907-16.
30. Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med 2014;371:213-23.
31. Langerbeins P, Bahlo J, Rhein C, et al. The CLL12 trial protocol: a placebo- controlled double-blind Phase III study of ibrutinib in the treatment of early-stage chronic lymphocytic leukemia patients with risk of early disease progression. Future Oncol 2015;11:1895-903.
32. Smith DD, Goldstein L, Cheng M, et al. Modeling absolute lymphocyte counts after treatment of chronic lymphocytic leukemia with ibrutinib. Ann Hematol 2015;94:249-56.
33. Lee HZ, Miller BW, Kwitkowski VE, et al. U.S. Food and drug administration approval: obinutuzumab in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia. Clin Cancer Res 2014;20:3902- 7.
34. Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol 2009;27:4378-84.
35. Gritti G, Reda G, Maura F, et al. Low dose alemtuzumab in patients with
fludarabine-refractory chronic lymphocytic leukemia. Leuk Lymphoma 2012;53:424- 9.
36. Marostica E, Sukbuntherng J, Loury D, et al. Population pharmacokinetic model of ibrutinib, a Bruton tyrosine kinase inhibitor, in patients with B cell malignancies. Cancer Chemother Pharmacol 2015;75:111-21.
37. de VR, Smit JW, Hellemans P, et al. Stable isotope-labelled intravenous microdose for absolute bioavailability and effect of grapefruit juice on ibrutinib in healthy adults. Br J Clin Pharmacol 2016;81:235-45.