A phase III multicenter, randomized, controlled study of combined androgen blockade with versus without zoledronic acid in prostate cancer patients with metastatic bone disease: results of the ZAPCA trial

Autor: Hideki Sakai, Toshiro Terachi, Tomomi Kamba, Mikio Sugimoto, Kiyohide Fujimoto, Yosuke Shimizu, Yusaku Okada, Takashi Kikuchi, Fuminori Sato, Jun Teishima, Shintaro Narita, Shunichi Namiki, Naoya Masumori, Shin Egawa, Toshiyuki Kamoto, Osamu Ogawa, Shinichiro Maruo, Takefumi Satoh, Hiroaki Kawanishi, Hideo Saito
Rok vydání: 2016
Předmět:
Male
0301 basic medicine
Oncology
medicine.medical_specialty
Time Factors
Bone disease
medicine.drug_class
Bone Neoplasms
Kaplan-Meier Estimate
Zoledronic Acid
Disease-Free Survival
law.invention
Androgen deprivation therapy
03 medical and health sciences
Prostate cancer
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Humans
Medicine
Treatment Failure
Aged
Proportional Hazards Models
Aged
80 and over
Diphosphonates
business.industry
Imidazoles
Prostatic Neoplasms
Bone metastasis
Androgen Antagonists
Hematology
General Medicine
Middle Aged
Prostate-Specific Antigen
Androgen
medicine.disease
Blockade
Survival Rate
030104 developmental biology
Zoledronic acid
030220 oncology & carcinogenesis
Surgery
business
Follow-Up Studies
medicine.drug
Zdroj: International Journal of Clinical Oncology. 22:166-173
ISSN: 1437-7772
1341-9625
Popis: To examine the antitumor activity of zoledronic acid (ZA) combined with androgen deprivation therapy (ADT) for men with treatment-naive prostate cancer and bone metastasis.We enrolled 227 men with treatment-naive prostate cancer and bone metastasis. Participants were randomly assigned (1:1 ratio) to receive combined androgen blockade alone (CAB group) or ZA with combined androgen blockade (CZ group). Time to treatment failure (TTTF), time to the first skeletal-related event (TTfSRE), and overall survival (OS) rates were estimated using the Kaplan-Meier method. Hazard ratios (HRs) were calculated using the Cox proportional hazards model. Median follow-up duration was 41.5 months.Median TTTFs were 12.4 and 9.7 months for the CZ and CAB groups, respectively (HR 0.75; 95 % CI 0.57-1.00; p = 0.051). For men with baseline prostate-specific antigen levels200 ng/mL, median TTTFs were 23.7 and 9.8 months for the CZ and CAB groups, respectively (HR 0.58; 95 % CI 0.35-0.93; p = 0.023). Median TTfSREs were 64.7 and 45.9 months for the CZ and CAB groups, respectively (HR 0.58; 95 % CI 0.38-0.88; p = 0.009). OS was similar between the groups.This study failed to demonstrate that combined use of ZA and ADT significantly prolonged TTTF in men with treatment-naive prostate cancer and bone metastasis. However, it generates a new hypothesis that the combined therapy could delay the development of castration resistance in a subgroup of patients with low baseline prostate-specific antigen values200 ng/mL. The treatment also significantly prolonged TTfSRE but did not affect OS.
Databáze: OpenAIRE
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