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 ◽  
...  

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]


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 231-231
Author(s):  
Vincenza Conteduca ◽  
Simon J. Crabb ◽  
Emanuela Scarpi ◽  
Catherine Hanna ◽  
Francesca Maines ◽  
...  

231 Background: Prostate specific antigen (PSA) decline by 50% from the baseline to 12 weeks (PSA50w12) is currently used to predict response to treatment and clinical outcome of patients with metastatic castration resistant prostate cancer (mCRPC). However, in clinical practice, PSA changes are monitored monthly in several centers. We evaluated the association between PSA changes at 4 weeks and clinical outcome. Methods: We retrospectively evaluated mCRPC patients treated with enzalutamide after docetaxel. Early PSA increase was defined as a PSA level at 4 weeks ≥ 20% (PSA+20w4) from baseline. Early PSA decline was defined as a PSA response at 4 weeks ≥ 30% (PSA30w4) and ≥ 50% (PSA50w4) from baseline.Progression-free survival (PFS), overall survival (OS) and their 95% Confidence Interval (95% CI) were evaluated by the Kaplan-Meier method and compared with the log-rank test. A multivariate analysis was performed including the following variables: PSA+20w4, PSA30w4, PSA50w4 and PSA50w12, baseline PSA, performance status, LDH values, sites of metastases, age. Results: We assessed 193 patients with median age of 73.1 years (range, 42.8 to 90.7). The median follow-up was 11.7 months. PSA+20w4 was associated with shorter PFS (median PFS 2.0 vs. 6.1 months; HR 4.03; 95% CI 2.62-6.19; p < 0.0001) and shorter OS (median OS 5.9 vs. 15.6 months; HR 3.48; 95% CI 2.12-5.69; p < 0.0001). At multivariate analysis, PSA+20w4 remained predictive of both PFS and OS [HR 4.03 (95% CI 0.2.62-6.19; p < 0.0001) and HR 3.48 (95% CI 2.12-5.69; p < 0.0001), respectively], whereas PSA30w4 and PSA50w4 predicted only PFS [HR 0.37 (95% CI 0.21-0.67; p = 0.0009) and HR 0.34 (95% CI 0.19-0.60; p = 0.0003), respectively]. No cases of PSA flare were reported. Conclusions: An early PSA increase, defined as a PSA level at 4 weeks ≥ 20% (PSA+20w4), could be useful to identify patients unlikely to benefit from enzalutamide. Larger studies are needed to confirm PSA+20W4 as an early and cheap biomarker of primary resistance to enzalutamide.



2019 ◽  
Vol 37 (5) ◽  
pp. 403-410 ◽  
Author(s):  
Susan Halabi ◽  
Sandipan Dutta ◽  
Catherine M. Tangen ◽  
Mark Rosenthal ◽  
Daniel P. Petrylak ◽  
...  

Purpose Several studies have reported that among patients with localized prostate cancer, black men have a shorter overall survival (OS) time than white men, but few data exist for men with advanced prostate cancer. The primary goal of this analysis was to compare the OS in black and white men with metastatic castration-resistant prostate cancer (mCRPC) who were treated in phase III clinical trials with docetaxel plus prednisone (DP) or a DP-containing regimen. Methods Individual participant data from 8,820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were combined. Race was based on self-report. The primary end point was OS. The Cox proportional hazards regression model was used to assess the prognostic importance of race (black v white) adjusted for established risk factors common across the trials (age, prostate-specific antigen, performance status, alkaline phosphatase, hemoglobin, and sites of metastases). Results Of 8,820 men, 7,528 (85%) were white, 500 (6%) were black, 424 (5%) were Asian, and 368 (4%) were of unknown race. Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men. Despite these differences, the median OS was 21.0 months (95% CI, 19.4 to 22.5 months) versus 21.2 months (95% CI, 20.8 to 21.7 months) in black and white men, respectively. The pooled multivariable hazard ratio of 0.81 (95% CI, 0.72 to 0.91) demonstrates that overall, black men have a statistically significant decreased risk of death compared with white men ( P < .001). Conclusion When adjusted for known prognostic factors, we observed a statistically significant increased OS in black versus white men with mCRPC who were enrolled in these clinical trials. The mechanism for these differences is not known.



2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 242-242 ◽  
Author(s):  
Gustavo Jankilevich ◽  
Luciana Gennari ◽  
Matias Salazar ◽  
Claudio Graziano ◽  
Eduardo Saravia ◽  
...  

242 Background: Tumor stage, Gleason score, PSA, Performance Status have been identified as important predictors of survival in prostate cancer. The Charlson Comorbidity Index (CCI) is a validated score used to stratify patients according to comorbidities. To evaluate the prognostic role of CCI in patients with CPRC. Methods: A retrospective study based on an analysis of medical records of 212 patients with CRPC treated at Durand Hospital between 2010-2015. The CCI was calculated for each patient and a correlation with overall survival was performed. Statistical analysis included univariate analysis and multivariate analysis (Cox regression). Patients were stratified according CCI ≤ 7.6 or ≥ 7.6. Survival analysis was performed using the Kaplan-Meier curve. Results: We analyzed records of 212 patients with prostate cancer, of which 59 were resistant to castration. Median age 69 years, the PFS with androgen blockade was 32.4 months. Patients with CPRC 54% perform chemotherapy as first-line treatment of castration resistance and 46% performed treatment of hormonal manipulation (Enzalutamide or Abiraterone Acetate). Median overall survival of patients with CCI < 7.6 was 75 months versus 62 months for those with CCI > 7.6 HR: 1.19 (1.03 to 1.36) p: 0.01. In multivariate analysis the ICC was an independent predictor of mortality in these patients HR: 1.23 (1.03 to 1.48) p: 0.02. (Table 1) CCI ≤ 7,6 was predictor to subsequent lines in CPRC setting. Gleason score, PS were independent predictors of survival. Conclusions: Based on our results we can consider the CCI as an independent predictor of survival in CPRC patients. CCI could be an useful tool useful to select patients in clinical trial and community settings. [Table: see text]



2018 ◽  
Vol 36 (18_suppl) ◽  
pp. LBA5005-LBA5005 ◽  
Author(s):  
Susan Halabi ◽  
Sandipan Dutta ◽  
Catherine M. Tangen ◽  
Mark Rosenthal ◽  
Daniel Peter Petrylak ◽  
...  

LBA5005 Background: Reports have suggested that African-American (AA) men with metastatic castration-resistant prostate cancer (mCRPC) have shorter overall survival (OS) than Caucasian (C) men. Prior reports have been limited by small sample size. The primary goal of this analysis was to compare OS in AA men to Caucasian men treated with docetaxel/prednisone or a docetaxel/prednisone containing regimen. Methods: Individual patient data from 8,871 mCRPC men randomized on nine phase III trials to docetaxel/prednisone (DP) or a DP containing regimen were combined. Race used in the analysis was based on self-report. The primary endpoint is OS, defined as the time between randomization and death or date of last follow-up if patients were alive. The proportional hazards model was used to assess the prognostic importance of race (AA vs. C) adjusting for established risk factors that were common across the trials (age, PSA, performance status, alkaline phosphatase, hemoglobin, and sites of metastases). Results: Of 8,871 patients, 7,528 (85%) were C, 500 (6%) were AA, 424 were Asian (5%) and 419 (4%) had race unspecified. The last two groups were deleted from the analysis leaving 8,452 pts. Median age was 69 years and 94% had performance status 0-1. Median hemoglobin, PSA and alkaline phosphatase were 12.9 g/dL, 86 ng/mL and 139 U/L, respectively. Pattern of metastatic spread were: 72% bone disease with or without lymph nodes, 9% lung disease, 9% liver disease and 7% lymph nodes only. Median OS were 21.0 (95% CI = 19.4-22.5) vs. 21.2 months (95% CI = 20.8-21.7) in AAs and C, respectively. In multivariable analysis adjusting for established risk factors, the pooled hazard ratio (HR) for AAs vs. Caucasians was 0.81 (95% CI = 0.72-0.92, p-value = 0.001) in all patients. Similar results were observed in 4,172 of patients who were treated with DP. Conclusions: We observed a statistically significant increased OS in AA vs. C men with mCRPC who were eligible to be enrolled on these clinical trials. Further understanding the biological variation by race in men with mCRPC treated with DP is warranted.



2021 ◽  
pp. 634-640
Author(s):  
Luigi Rossi ◽  
Giuseppe Cimino ◽  
Elisa Gozzi ◽  
Marsela Sinjari ◽  
Martina Brandi ◽  
...  

We report a case of an elderly patient with metastatic castration-resistant prostate cancer, initially treated with abiraterone acetate (1,000 mg/day) combined with LH-RH antagonist, prednisone (10 mg/day), and zoledronic acid to manage bone metastases. In consideration of his poor performance status, radiological and biochemical progression of the disease, we decided to switch abiraterone to enzalutamide (160 mg/day). Due to adverse events, we reduced enzalutamide to a dose of 80 mg/day. Currently, the disease is under control despite the use of a low dose of enzalutamide.



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