scholarly journals Comparison of Abiraterone and Combined Androgen Blockade Therapy for High-Risk Metastatic Hormone-Sensitive Prostate Cancer: A Propensity Score-Matched Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Naoki Matsumura ◽  
Kazutoshi Fujita ◽  
Mitsuhisa Nishimoto ◽  
Yutaka Yamamoto ◽  
Ken Kuwahara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factors ◽  
High Risk ◽  
Propensity Score ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Rank Test ◽  
Combined Androgen Blockade ◽  
Hormone Sensitive ◽  
Androgen Blockade

This study aimed to compare the effects of abiraterone acetate plus prednisone (AAP) with androgen deprivation therapy (ADT) with those of combined androgen blockade (CAB) therapy in patients with high-risk metastatic hormone-sensitive prostate cancer (mHSPC). This study retrospectively identified 163 patients with high-risk mHSPC at Kindai University and affiliated hospitals between January 2014 and December 2020. Kaplan-Meier analysis was used to summarize progression-free survival (PFS) and overall survival (OS). Multivariate Cox proportional hazard modeling was used to identify the prognostic factors in the overall cohort. Propensity score matching was used to adjust the clinical characteristics, and log-rank test was applied to these propensity score–matched cohorts. Seventy-four patients who received AAP with ADT and 89 patients who received CAB were included in this study. The median follow-up duration was 27 months (range, 2–89 months). The median PFS and OS were not reached by the AAP+ADT group and 15 and 79 months, respectively, in the CAB group. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score and AAP+ADT were significant prognostic factors for PFS, whereas ECOG PS score, visceral metastasis, and AAP+ADT were significant prognostic factors for OS. The 2-year PFS was 76.1% in the AAP+ADT group and 38.6% in the CAB group (P < 0.0001), and the 2-year OS was 90.2% in the AAP+ADT group and 84.8% in the CAB group (P = 0.015). In conclusion, AAP+ADT had better PFS and OS than CAB in patients with high-risk mHSPC.

scholarly journals Efficacy of Abiraterone Acetate For High-Risk Hormone-Naïve Metastatic Prostate Cancer: A Comparison With Combined Androgen Blockade Therapy With Bicalutamide And Androgen Deprivation Therapy Alone

2021 ◽  
Author(s):  
Kent Kanao ◽  
Takayuki Takahashi ◽  
Yuta Umezawa ◽  
Takashi Okabe ◽  
Gou Kaneko ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Androgen Deprivation Therapy ◽  
Treatment Efficacy ◽  
The Other ◽  
Propensity Score Matching Analysis ◽  
Combined Androgen Blockade ◽  
Androgen Blockade

Abstract Background: The treatment landscape for men with metastatic hormone-naïve prostate cancer (mHNPC) has dramatically changed with the approval of next-generation anti-androgen drugs. We compared the treatment efficacy of abiraterone with that of combined androgen blockade (CAB) therapy and androgen deprivation therapy (ADT) alone in men with high-risk mHNPC.Methods: In total, 146 Japanese men with high-risk mHNPC were retrospectively analyzed. As initial hormonal therapy, 30, 83, and 33 men were treated with ADT plus abiraterone (ABI group), ADT plus bicalutamide (CAB group), and ADT alone (ADT group), respectively. Treatment efficacy was compared using time to castration resistance (TTCR) and prostate-specific antigen (PSA) response among the groups. Propensity score matching analysis was also performed to adjust for baseline differences.Results: The median (95% confidence interval [CI]) TTCR in the ABI, CAB, and ADT groups were not reached, 10.7 (7.6–13.8) months and 11.0 (7.9–12.4) months, respectively, and it was significantly longer in the ABI group than in the other groups (p=0.0012, p=0.0008). In propensity score matching analysis, the median TTCR was also significantly longer in the ABI group than in the other groups (hazard ratio [HR], 0.47; 95% CI, 0.22–0.98; p=0.010; HR, 0.32; 95% CI, 0.12–0.85; p=0.004). The number of men who achieved PSA levels <0.2 ng/mL after propensity score matching were significantly higher in the ABI group than in the other groups.Conclusions: Our results provide important evidence regarding the superiority of abiraterone over CAB therapy and ADT alone for initial treatment for men with newly diagnosed mHNPC.

scholarly journals Prognostic Factors in Hormone-sensitive Prostate Cancer Patients Treated With Combined Androgen Blockade: A Consecutive 15-year Study at a Single Japanese Institute

In Vivo ◽  
2021 ◽  
Vol 35 (1) ◽  
pp. 373-384
Author(s):  
YOSHIYUKI MIYAZAWA ◽  
YOSHITAKA SEKINE ◽  
SEIJI ARAI ◽  
DAISUKE OKA ◽  
HIROSHI NAKAYAMA ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factors ◽  
Cancer Patients ◽  
Combined Androgen Blockade ◽  
Hormone Sensitive ◽  
Androgen Blockade

scholarly journals Combined Androgen Blockade in Localized Prostate Cancer Treated With Definitive Radiation Therapy

2019 ◽  
Vol 17 (12) ◽  
pp. 1497-1504
Author(s):  
Lucas K. Vitzthum ◽  
Chris Straka ◽  
Reith R. Sarkar ◽  
Rana McKay ◽  
J. Michael Randall ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
High Risk ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Short Term ◽  
Combined Androgen Blockade ◽  
Significant Difference ◽  
Androgen Blockade

Background: The addition of androgen deprivation therapy to radiation therapy (RT) improves survival in patients with intermediate- and high-risk prostate cancer (PCa), but it is not known whether combined androgen blockade (CAB) with a gonadotropin-releasing hormone agonist (GnRH-A) and a nonsteroidal antiandrogen improves survival over GnRH-A monotherapy. Methods: This study evaluated patients with intermediate- and high-risk PCa diagnosed in 2001 through 2015 who underwent RT with either GnRH-A alone or CAB using the Veterans Affairs Informatics and Computing Infrastructure. Associations between CAB and prostate cancer–specific mortality (PCSM) and overall survival (OS) were determined using multivariable regression with Fine-Gray and multivariable Cox proportional hazards models, respectively. For a positive control, the effect of long-term versus short-term GnRH-A therapy was tested. Results: The cohort included 8,423 men (GnRH-A, 4,529; CAB, 3,894) with a median follow-up of 5.9 years. There were 1,861 deaths, including 349 resulting from PCa. The unadjusted cumulative incidences of PCSM at 10 years were 5.9% and 6.9% for those receiving GnRH-A and CAB, respectively (P=.16). Compared with GnRH-A alone, CAB was not associated with a significant difference in covariate-adjusted PCSM (subdistribution hazard ratio [SHR], 1.05; 95% CI, 0.85–1.30) or OS (hazard ratio, 1.02; 95% CI, 0.93–1.12). For high-risk patients, long-term versus short-term GnRH-A therapy was associated with improved PCSM (SHR, 0.74; 95% CI, 0.57–0.95) and OS (SHR, 0.82; 95% CI, 0.73–0.93). Conclusions: In men receiving definitive RT for intermediate- or high-risk PCa, CAB was not associated with improved PCSM or OS compared with GnRH alone.

TALAPRO-2: Part 2 (P2) of the placebo-controlled phase 3 study of talazoparib (TALA) with enzalutamide (ENZA) in metastatic castration-resistant prostate cancer (mCRPC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS5092-TPS5092
Author(s):  
Neeraj Agarwal ◽  
Neal D. Shore ◽  
Curtis Dunshee ◽  
Lawrence Ivan Karsh ◽  
Beth Sullivan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Group Performance ◽  
Parp Inhibitor ◽  
Performance Status ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Metastatic Breast ◽  
Prior Treatment ◽  
Rank Test ◽  
Double Blind Study

TPS5092 Background: ENZA is approved to treat men with CRPC. TALA is a poly(ADP-ribose) polymerase (PARP) inhibitor that inhibits PARP1/PARP2 and traps PARP on DNA, preventing DNA damage repair (DDR), and causing cell death in BRCA1/2-mutated cells. TALA is approved in the US to treat germline BRCA1/2-mutated HER2- locally advanced/metastatic breast cancer. A combination of TALA with ENZA in mCRPC may improve clinical outcomes. TALAPRO-2 (NCT03395197) is a 2-part study to evaluate the efficacy, safety, pharmacokinetics and (patient) pt-reported outcomes of the combination treatment. The focus here is on P2 of TALAPRO-2. Methods: Approximately 860 pts are planned to be enrolled in P2 from multinational sites. Pts are aged ≥18 years, have asymptomatic/mildly symptomatic mCRPC, Eastern Cooperative Oncology Group performance status ≤1, no brain metastases, and have not received taxanes/novel hormonal therapy (NHT). P2 is a randomized double-blind study that will evaluate safety, efficacy, and pt-reported outcomes of TALA (0.5 mg QD) + ENZA (160 mg QD) vs placebo + ENZA (160 mg QD). Pts will be randomized to 1 of 2 treatment groups: TALA + ENZA, or matching placebo + ENZA. Randomization will be stratified by prior treatment with NHT for castration-sensitive prostate cancer (CSPC) or prior treatment with taxane-based chemotherapy for CSPC (yes/no) and DDR mutation status (deficient vs. nondeficient/unknown). The primary endpoint is radiographic progression-free survival (rPFS), defined as time to progression in soft tissue per RECIST v1.1 or in bone per PCWG3 criteria or death. The key secondary endpoint is overall survival (OS). Efficacy will be assessed by radiography every 8 weeks up to week 25 and every 8-12 weeks thereafter. The analyses of rPFS will be compared between TALA in combination with ENZA and placebo in combination with ENZA by using a 1-sided stratified log-rank test. OS will be evaluated separately in the all comers and the DDR-deficient populations. Pt recruitment is ongoing. Results: n/a. Conclusions: n/a. Clinical trial information: NCT03395197.

scholarly journals Prognostic Value of the LATITUDE and CHAARTED Risk Criteria for Predicting the Survival of Men with Bone Metastatic Hormone-Naïve Prostate Cancer Treated with Combined Androgen Blockade Therapy: Real-World Data from a Japanese Multi-Institutional Study

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Takashi Kawahara ◽  
Shuko Yoneyama ◽  
Yoshio Ohno ◽  
Junpei Iizuka ◽  
Yasunobu Hashimoto ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
High Volume ◽  
Low Risk ◽  
Free Survival ◽  
Combined Androgen Blockade ◽  
Number Of Patients ◽  
High Risk Disease ◽  
Low Volume ◽  
Androgen Blockade

Background. The CHAARTED and LATITUDE trials demonstrated a prolonged overall survival (OS) for metastatic hormone-naïve prostate cancer (mHNPC) patients who receive up-front docetaxel or abiraterone acetate. These studies used their own risk criteria: CHAARTED trial defines high- and low-volume diseases and LATITUDE trial targeting a high-risk disease. The present study explored whether or not the CHAARTED and LATITUDE criteria were useful for predicting the outcome in Japanese bone mHNPC patients, including elderly patients (≥70 years). Methods. A total of 532 mHNPC patients diagnosed from 2004 to 2014 in multithird referral cancer centers were enrolled in this study. All patients had bone metastasis and received combined androgen blockade treatment as an initial hormonal therapy. Results. The number of patients with CHAARTED low-volume and high-volume diseases was 178 (33.5%) and 354 (66.5%), respectively. On the contrary, the number of patients with LATITUDE low-risk and high-risk diseases was 157 (29.5%) and 375 (70.5%), respectively. A total of 307 (57.7%) patients were defined as having both CHAARTED high-volume and LATITUDE high-risk disease. The median castration-resistant prostate cancer- (CRPC-) free survival was 12.5 months for the CHAARTED high volume, 56.9 months for the CHAARTED low volume, 13.6 months for the LATITUDE high risk, and 37.3 months for the LATITUDE low risk, respectively. The OS was 50.1 months in patients with CHAARTED high-volume disease, 95.1 months in patients with CHAARTED low-volume disease, 54.0 months in patients with LATITUDE high-risk disease, and 92.7 months in patients with LATITUDE low-risk disease, respectively. This trend was also observed in elderly (≥70 years old) patients. Conclusions. The patients with CHAARTED high-volume disease or LATITUDE high-risk disease showed a shorter CRPC-free survival and a shorter OS than those in the CHAARTED low-volume disease group or in the LATITUDE low-risk group among Asian Japanese bone metastatic HNPC patients.

Prognostic factors for overall survival in patients with metastatic castration-resistant prostate cancer: Secondary analysis.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. e597-e597 ◽  
Author(s):  
Andrea Carolina Anampa-Guzman ◽  
Oliver Sulca-Huamani ◽  
Rushmely Perez-Mendez ◽  
Gloria Mendoza-Soto ◽  
Pamela Contreras Chavez ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Performance Status ◽  
Secondary Analysis ◽  
Rank Test ◽  
Poor Performance Status ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

e597 Background: The standard treatment for metastatic castration-resistant prostate cancer (MCRPC) is Docetaxel (DTX); however, it has serious adverse effects. It is necessary to know the prognostic factors for overall survival (OS) of patients with MCRPC treated with DTX. The aim of this study was to determine the prognostic factors for OS in patients with MCRPC treated with DTX. Methods: This study is a secondary analysis of the control arms of the clinical trials NTC00273338, NCT00519285 and NCT00988208. 1600 patients aged 18 years or older with MCPRC that received DTX and prednisone were included. Survival curves were estimated by Kaplan-Meier and comparison was done by log-rank test. Multivariate analysis for overall survival (OS) was performed with the Cox proportional hazard regression model. Results: The median OS time was 14.64 months. The 1-yr-OS and 2-yrs-OS were 86.2% and 28.6%, respectively. Patients with an ECOG score greater than 0 lived significantly less than the rest of patients (p = 0.00). The patients with an alkaline phosphate level (ALP) > 200 had significantly lower OS (p = 0.00). In the multivariate analysis, the factors that influenced OS were ECOG, ALP, HB, LDH and number of metastases. Conclusions: Poor performance status, high alkaline phosphatase level, low hemoglobin level, high LDH and more than 2 metastases were the main prognostic factors in patients with metastatic castration resistant prostate cancer. [Table: see text]

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