(Prostate Cancer) Custirsen Plus Cabazitaxel: ESMO 2016 AFFINITY Phase 3 Trial Results
Medical Supporter — Avis d’information
Cet article est une synthèse d’informations médicales internationales et ne constitue pas un avis médical ; il ne remplace pas le diagnostic ni le plan de traitement de votre médecin traitant. Les informations présentées sont compilées à partir de publications publiques et de déclarations officielles d’établissements médicaux japonais ; l’adéquation et les résultats de toute thérapie varient selon chaque patient et doivent être évalués individuellement par un médecin qualifié.
- October 26, 2016
- 1 min read
At ASCO 2010, J.S. De Bono of Royal Marsden NHS Foundation Trust published results demonstrating that cabazitaxel was effective in prostate cancer patients previously treated with docetaxel. This month at ESMO 2016, Karim Fizazi of Institut Gustave Roussy (France) presented Phase 3 clinical trial results for custirsen.
Custirsen (OGX-011) is a second-generation antisense oligonucleotide that blocks the anti-apoptotic mechanisms in cancer cells. Phase 2 clinical trial results comparing docetaxel alone versus docetaxel plus custirsen showed no significant difference in OS; however, subgroup analysis revealed better recovery outcomes with the combination. Based on this finding, a Phase 3 trial was initiated.
AFFINITY Phase 3 Trial Design:
A total of 635 subjects were enrolled. Eligibility required prior docetaxel treatment for castration-resistant prostate cancer. Patients were randomized to custirsen + cabazitaxel/prednisone versus cabazitaxel/prednisone alone.
- Custirsen arm: Cabazitaxel 25 mg/m² every 21 days + prednisone 10 mg daily + custirsen 640 mg (3 loading doses followed by weekly maintenance)
- Up to 10 treatment cycles in the absence of severe adverse events
Primary endpoints: overall OS and OS in poor-prognosis patients.
Poor-prognosis definition (2 of 5 criteria): Karnofsky PS ≤80%, liver metastases, Hb <12 g/dL, LDH ≥360 IU/L, PSA ≥150 ng/mL. Poor-prognosis patients: custirsen arm 61.5%, control arm 61.9%.
Results:
- Median OS (all patients): Custirsen arm 14.2 months vs. control arm 13.4 months
- No significant difference between arms
Safety:
No particular safety concerns. Grade 3+ adverse events: custirsen arm 76% vs. control arm 66%. Common adverse events included anemia, leukopenia, diarrhea, and back pain.
Conclusion: In previously docetaxel-treated, castration-resistant prostate cancer patients, the addition of custirsen to cabazitaxel did not provide additional therapeutic benefit.
Prostate Cancer | Custirsen | Cabazitaxel | ESMO 2016
-
Clinical Trial Medications
- (Lung Cancer) Phase II results for Topotecan and Topotecan + Berzosertib combination.
- (Lung Cancer) Efficacy of Enhertu in HER2-mutant non-small cell lung cancer (NSCLC).
- (Lung Cancer) Clinical outcomes of anti-B7-H3 antibody-drug conjugate DS-7300.
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Vous envisagez des soins au Japon ? Besoin d’informations et d’aide ?
Nous vous aidons à rassembler les informations nécessaires pour un déplacement médical au Japon, à contacter les établissements japonais et à organiser une consultation de second avis.La première consultation est gratuite ; un conseiller vous aide à clarifier les prochaines étapes.
Figure 1
Figure 2
Figure 3
Figure 4