Urology · 2007
Phase II trial of gemcitabine, prednisone, and zoledronic acid in pretreated patients with hormone refractory prostate cancer.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Di Lorenzo Giuseppe, Autorino Riccardo, Giuliano Mario, Morelli Emilio, Giordano Antonio, Napodano Giorgio, Russo Aniello, Benincasa Giuseppe, D'Armiento Massimino, Altieri Vincenzo, De Placido Sabino
Аннотация
OBJECTIVES: To investigate the impact on biochemical and objective response and on pain improvement of gemcitabine, prednisone, and zoledronic acid in patients with hormone-refractory prostate cancer (HRPC), previously treated with docetaxel-based regimens.
METHODS: The patients were treated with gemcitabine 1000 mg/m2 every 14 days, prednisone 10 mg orally on days 1 to 7 and 14 to 21, and zoledronic acid every 4 weeks. Changes in prostate-specific antigen levels, tumor response, and toxicity were evaluated every month. The pain response, based on pain reduction and analgesic drug reduction, was assessed during therapy.
RESULTS: A total of 22 men (median age 65 years) were treated. Overall, 5 patients (23%) achieved a 50% or greater reduction in prostate-specific antigen level after two cycles; a partial response was observed in 1 (14%) of 7 patients with measurable disease, and 3 (43%) of 7 had stable disease. Of the 22 men, 23% had pain improvement. The most important hematologic toxicity was neutropenia (grade 3 in 18%).
CONCLUSIONS: The combination of gemcitabine, prednisone, and zoledronic acid appears to be associated with biochemical response, pain improvement, and good safety in pretreated patients with HRPC.
METHODS: The patients were treated with gemcitabine 1000 mg/m2 every 14 days, prednisone 10 mg orally on days 1 to 7 and 14 to 21, and zoledronic acid every 4 weeks. Changes in prostate-specific antigen levels, tumor response, and toxicity were evaluated every month. The pain response, based on pain reduction and analgesic drug reduction, was assessed during therapy.
RESULTS: A total of 22 men (median age 65 years) were treated. Overall, 5 patients (23%) achieved a 50% or greater reduction in prostate-specific antigen level after two cycles; a partial response was observed in 1 (14%) of 7 patients with measurable disease, and 3 (43%) of 7 had stable disease. Of the 22 men, 23% had pain improvement. The most important hematologic toxicity was neutropenia (grade 3 in 18%).
CONCLUSIONS: The combination of gemcitabine, prednisone, and zoledronic acid appears to be associated with biochemical response, pain improvement, and good safety in pretreated patients with HRPC.
Предметные рубрики MeSH
AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDiphosphonatesDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmFollow-Up StudiesHumansImidazolesMaleMiddle AgedNeoplasm InvasivenessNeoplasm StagingNeoplasms, Hormone-DependentPain MeasurementPalliative CarePrednisoneProbabilityProstate-Specific AntigenProstatic NeoplasmsRisk AssessmentSurvival RateTreatment OutcomeZoledronic AcidGemcitabine