Apalutamid bei Patienten mit einem Hochrisiko-M0CRPC: Daten der Zulassungsstudie SPARTAN und erste Erfahrungen aus einem Härtefallprogramm

Zusammenfassung

Das nicht-fernmetastasierte kastrationsresistente Prostatakarzinom (M0CRPC) ist mit einem erhöhten Progressions- und Mortalitätsrisiko verbunden, vor allem wenn eine schnelle Verdopplungszeit des Prostata-spezifischen Antigens (PSADT ≤ 10 Monate) vorliegt. Schreitet die Krankheit weiter voran und entsteht ein metastasiertes (m) CRPC, nehmen Progressions- und Mortalitätsrisiko weiter zu. Für die Therapie des Hochrisiko-M0CRPCs stehen die Androgenrezeptor-Inhibitoren Apalutamid, Darolutamid und Enzalutamid, jeweils in Kombination mit einer Androgendeprivationstherapie (ADT), zur Verfügung.

Die Ergebnisse der Zulassungsstudie SPARTAN zeigen, dass Apalutamid + ADT das metastasenfreie Überleben (MFS) und somit auch die Entstehung eines mCRPCs bei diesen Patienten hinauszögern kann. Vor Zulassung von Apalutamid in der Europäischen Union war der Wirkstoff im Rahmen eines internationalen Härtefallprogramms auch in Deutschland verfügbar. Insgesamt haben in Deutschland 109 Patienten aus 50 Zentren teilgenommen. Länger als 3 Monate wurden 45 Patienten, länger als 6 Monate 13 Patienten behandelt. Das Härtefallprogramm läuft in einigen Ländern weiter, weltweit wurden 556 Patienten aufgenommen.

Unsere Erfahrungen mit dieser Real-World-Population zeigten ein gutes PSA-Ansprechen, so wie es auch in der SPARTAN-Studie bei diesem explorativen Endpunkt gezeigt wurde. Auch hinsichtlich des Verträglichkeitsprofils konnten wir keine deutlichen Unterschiede zur Zulassungsstudie feststellen.

Apalutamid war in Kombination mit einer ADT auch in dieser Real-World-Patientenpopulation wirksam und konnte zu einem raschen PSA-Abfall führen. Dabei unterschied sich das Verträglichkeitsprofil nicht von dem in der SPARTAN-Studie.

Abstract

Non-metastatic castration-resistant prostate carcinoma (M0CRPC) is associated with an increased risk of progression and mortality, especially if the prostate-specific antigen doubling time is short (PSADT ≤ 10 months). The risk of progression and mortality increases even further if the disease progresses to the metastatic stage (mCRPC). The androgen receptor inhibitors apalutamide, darolutamide and enzalutamide, each in combination with androgen deprivation therapy (ADT), are available for the treatment of patients with high-risk M0CRPC.

Data from the pivotal SPARTAN study showed that apalutamide + ADT delayed metastasis-free survival (MFS) and thus also the development of mCRPC in these patients. Prior to the approval of apalutamide in the European Union, the active substance was available in Germany as part of an international compassionate use program. A total of 109 patients from 50 centres participated in Germany: 45 patients were treated for more than 3 months and 13 patients for more than 6 months. The compassionate use program continues in some countries; 556 patients have been enrolled worldwide.

In our experience, this real-world population showed a good PSA response, which was also shown for this exploratory endpoint in the SPARTAN study. We were also unable to identify any significant differences from the pivotal trial with regards to the tolerability profile.

Apalutamide in combination with ADT was also effective in this real-world population and led to a rapid decrease in PSA. The tolerability profile did not differ from that in the SPARTAN trial.

Schlüsselwörter

Prostatakarzinom - M0CRPC - Apalutamid - Härtefallprogramm - SPARTAN-Studie

Keywords

prostate cancer - M0CRPC - apalutamide - compassionate use program - SPARTAN trial

Publication History

Article published online:
23 February 2021

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