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First annual report of the Austrian CML registry

Erster Jahresbericht des österreichischen CML-Registers

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Zusammenfassung

Unter der Schirmherrschaft der österreichischen Gesellschaft für Hämatologie und Onkologie (ÖGHO) wurde das österreichische CML-Register gegründet, um österreichweit Krankheitsverläufe, Behandlungen, Nebenwirkungen und Therapieansprechen insbesondere auch der nicht in klinischen Studien erfassten Patienten zu dokumentieren und so ein besseres Bild der real-life Situation zu erlauben. Dieser Bericht fasst die Register-Daten mit Stichtag des 20.3.2009 zusammen. Bis zu diesem Stichtag sind insgesamt 179 Patienten mit 1012 Follow-ups und einer medianen Beobachtungszeit von 20 Monaten im Register erfasst. Dabei verteilen sich die Patienten wie folgt auf die verschiedenen Krankheitsphasen: 151 Patienten in chronischer und 4 in akzelerierter Phase. Die Registerpatienten wurden großteils (n = 137) mit Tyrosinkinaseinhibitoren (TKI) behandelt, daneben wurden auch Chemotherapeutika und Stammzelltransplantationen eingesetzt. 14 Patienten wurden sequentiell mit TKI der ersten und zweiten Generation behandelt und 15 Patienten erhielten niemals einen TKI. Die kumulativen Inzidenzraten für ein komplettes hämatologisches Ansprechen nach 12 und 24 Monaten betrugen 91.6 % und 94.4 %. Zu denselben Zeitpunkten wurde eine kumulative Inzidenz einer kompletten zytogenetischen Remission mit 64 % und 80 % ermittelt. Das Gesamtüberleben zu 60 Monaten betrug 90 % während das progressionsfreie Überleben (orientiert an den ELN-failure Kriterien) nach 60 Monaten bei 58 % lag.

Summary

The Austrian chronic myeloid leukemia (CML) registry monitors individual disease courses, treatments applied, clinical outcome, and side effects of CML patients on a nationwide basis to provide data on the "real-life" situation and to complement the information and interpretation gained from the selected patient population observed in clinical trials. This report summarizes the Austrian CML registry data as of March 2009. A total of 179 patients have been registered with a median number of 1012 follow-up visits and median observation duration of 20 months. At diagnosis most patients (n = 163) were in chronic phase (early, late, and secondary), whereas only 4 were in advanced phase. A total of 137 patients were treated with tyrosine kinase inhibitors (TKIs), of which 14 received first and second generation TKIs sequentially. Other treatment modalities included chemotherapy or interferon and stem cell transplantation (SCT). Cumulative incidence rates for complete hematological responses (CHR) were 91.6% and 94.4% at 12 and 24 months, respectively, compared to cumulative incidence rates of complete cytogenetical response rates of 64% and 80% at these timepoints. A total of 5 patients progressed from chronic phase to accelerated (n = 3) and blastic phase (n = 2) while receiving imatinib standard dose. Estimated overall survival (OS) rate at 60 months was 90% and progression free survival (PFS) according to European Leukemia Net (ELN) failure definition was 58%.

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Schmidt, S., Wolf, D., Thaler, J. et al. First annual report of the Austrian CML registry. Wien Klin Wochenschr 122, 558–566 (2010). https://doi.org/10.1007/s00508-010-1450-x

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