Abstract
Aim:
To collect efficacy and safety data of enzalutamide after docetaxel, we retrospectively evaluated the Italian Named Patient Program results.
Patients & methods:
Two hundred and nine metastatic castration-resistant prostate cancer patients were enrolled. Median age was 73 years. Total 42.1% patients had pain, 14.4% had a performance status of two and 59.8% had a Gleason score ≥8. Total 31.1% had previously received ≥2 chemotherapies, 15.3 and 12% had been previously treated with abiraterone and cabazitaxel, respectively and 14.8% had received both.
Results:
Median progression-free survival and overall survival were 4.8 and 13.1 months, respectively. A prostate-specific antigen reduction ≥50% was observed in 49.1%. Total 32.7% abiraterone-pretreated patients achieved a biochemical response compared with 56% of abiraterone-naive patients.
Conclusion:
Enzalutamide was safe and well tolerated. Its antitumor activity in abiraterone-pretreated patients was limited.
Keywords:
efficacy; enzalutamide; prostate cancer; safety.
Publication types
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Clinical Trial, Phase III
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Androstenes / pharmacology
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Androstenes / therapeutic use
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Antineoplastic Combined Chemotherapy Protocols / pharmacology
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Benzamides
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Disease Progression
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Docetaxel / pharmacology
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Docetaxel / therapeutic use
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Drug Resistance, Neoplasm
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Humans
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Italy / epidemiology
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Kallikreins / blood
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Kaplan-Meier Estimate
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Male
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Middle Aged
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Nitriles
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Phenylthiohydantoin / analogs & derivatives*
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Phenylthiohydantoin / pharmacology
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Phenylthiohydantoin / therapeutic use
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Progression-Free Survival
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Prostate-Specific Antigen / blood
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Prostatic Neoplasms, Castration-Resistant / blood
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Prostatic Neoplasms, Castration-Resistant / drug therapy*
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Prostatic Neoplasms, Castration-Resistant / mortality
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Prostatic Neoplasms, Castration-Resistant / pathology
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Retrospective Studies
Substances
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Androstenes
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Benzamides
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Nitriles
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Docetaxel
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Phenylthiohydantoin
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enzalutamide
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KLK3 protein, human
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Kallikreins
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Prostate-Specific Antigen
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abiraterone