• Traitements

  • Traitements systémiques : applications cliniques

  • Prostate

Phase II Randomized Study of Figitumumab plus Docetaxel and Docetaxel Alone with Crossover for Metastatic Castration-Resistant Prostate Cancer

Mené sur 204 patients atteints d'un cancer de la prostate résistant à la castration, cet essai de phase II évalue l'efficacité, du point de vue de la réponse du PSA, et la toxicité de l'ajout de figitumumab à un traitement combinant docétaxel et prednisone

Background: Figitumumab is a human IgG2 monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R), with antitumor activity in prostate cancer. This phase II trial randomized chemotherapy-naïve men with progressing castration-resistant prostate cancer to receive figitumumab every 3 weeks with docetaxel/prednisone (Arm A) or docetaxel/prednisone alone (Arm B1). At progression on Arm B1, patients could cross over to the combination (Arm B2). Methods: Prostate-specific antigen (PSA) response was the primary endpoint; response assessment on the two arms was non-comparative and tested separately; H0=0.45 vs. HA=0.60 (α=0.05; β=0.09) for Arm A; H0=0.05 vs. HA=0.20 (α=0.05, β=0.10) for Arm B2. A comparison of progression-free survival (PFS) on Arms A and B1 was planned. Results: 204 patients were randomized and 199 treated (Arm A: 97; Arm B1: 102); 37 patients crossed over to Arm B2 (median number of cycles started: Arm A=8; B1=8; B2=4). PSA responses occurred in 52% and 60% of Arms A and B1, respectively; the primary PSA response objective in Arm A was not met. Median PFS was 4.9 and 7.9 months, respectively (hazard ratio 1.44; 95% confidence interval [CI]: 1.06-1.96). PSA response rate was 28% in Arm B2. The figitumumab combination appeared more toxic, with more treatment-related grade 3/4 adverse events (75% vs. 56%), particularly hyperglycemia, diarrhea, and asthenia, as well as treatment-related serious adverse events (41% vs. 15%), and all-causality grade 5 adverse events (18% vs. 8%). Conclusion: IGF-1R targeting may merit further evaluation in this disease in selected populations, but combination with docetaxel is not recommended.

Clinical Cancer Research

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