Prognostic model of event-free survival for patients with androgen independent prostate cancer

2003 ◽  
Vol 2 (6) ◽  
pp. 193
Author(s):  
M SHULMAN
Keyword(s):  
Prostate Cancer ◽  
Prognostic Model ◽  
Event Free Survival ◽  
Free Survival ◽  
Androgen Independent

scholarly journals Event-Free Survival, a Prostate-Specific Antigen–Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation

2020 ◽  
Vol 38 (26) ◽  
pp. 3032-3041 ◽  
Author(s):  
Wanling Xie ◽  
Meredith M. Regan ◽  
Marc Buyse ◽  
Susan Halabi ◽  
Philip W. Kantoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Event Free Survival ◽  
Free Survival ◽  
Patient Level ◽  
End Point

PURPOSE Recently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free survival (EFS), an earlier prostate-specific antigen (PSA)–based composite end point, may further expedite trial completion. METHODS EFS was defined as the time from random assignment to the date of first evidence of disease recurrence, including biochemical failure, local or regional recurrence, distant metastasis, or death from any cause, or was censored at the date of last PSA assessment. Individual patient data from trials within the Intermediate Clinical Endpoints in Cancer of the Prostate–ICECaP–database with evaluable PSA and disease follow-up data were analyzed. We evaluated the surrogacy of EFS for OS using a 2-stage meta-analytic validation model by determining the correlation of EFS with OS (patient level) and the correlation of treatment effects (hazard ratios [HRs]) on both EFS and OS (trial level). A clinically relevant surrogacy was defined a priori as an R2 ≥ 0.7. RESULTS Data for 10,350 patients were analyzed from 15 radiation therapy–based trials enrolled from 1987 to 2011 with a median follow-up of 10 years. At the patient level, the correlation of EFS with OS was 0.43 (95% CI, 0.42 to 0.44) as measured by Kendall’s tau from a copula model. At the trial level, the R2 was 0.35 (95% CI, 0.01 to 0.60) from the weighted linear regression of log(HR)-OS on log(HR)-EFS. CONCLUSION EFS is a weak surrogate for OS and is not suitable for use as an intermediate clinical end point to substitute for OS to accelerate phase III (neo)adjuvant trials of prostate cancer therapies for primary radiation therapy–based trials.

Skeletal related events (SREs) in metastatic androgen independent prostate cancer (AIPC) treated with docetaxel-based chemotherapy: Results from ASCENT

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4614-4614 ◽  
Author(s):  
J. S. Chan ◽  
C. W. Ryan ◽  
P. M. Venner ◽  
D. P. Petrylak ◽  
G. S. Chatta ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Cord Compression ◽  
Entire Group ◽  
Large Prospective Study ◽  
Free Survival ◽  
Skeletal Related Events ◽  
The Impact ◽  
Androgen Independent

4614 Background: Docetaxel prolongs survival in AIPC patients and zoledronic acid (ZA) reduces the incidence of SREs. The SRE incidence of patients treated with docetaxel-based chemotherapy has not previously been reported. Methods: ASCENT was a randomized clinical trial that compared weekly DN-101 (calcitriol, 45 μg p.o. on day 1) plus docetaxel (36 mg/m2 iv on day 2 for 3 weeks of a 4-week cycle) to placebo plus docetaxel in patients with chemotherapy-naïve metastatic AIPC. ZA use was not restricted. SRE-free survival was described for the entire group and then compared for patients randomly assigned to DN-101 or placebo and stratified by ZA use. Statistical comparisons were conducted using Cochran-Mantel-Haenszel for incidence and log-rank for SRE-free survival. Results: With a median follow-up of 18.3 months, 33% of subjects experienced at least one SRE and the overall median SRE-free survival was 13 (95% CI 10.5–14.3) months. The incidence of SRE by type was: radiation to bone (18.8%), fracture (10%), spinal cord compression (4%), surgery to bone (0.4%). Eighty-five (34%) patients received ZA. The study was not adequately powered to measure the impact of DN-101 or ZA on SRE endpoints. Exploratory analyses showed a trend for an increase in SRE-free survival (HR 0.78, p = 0.13) of DN-101-treated patients. SRE-free survival and incidence for subgroups were examined ( Table ). Conclusions: This is the first report of SRE incidence in a large, prospective study of docetaxel-based therapy. Improved therapies for reducing SREs in AIPC are needed because the risk of SREs remains high despite the use of modern chemotherapy and ZA. [Table: see text] [Table: see text]

scholarly journals Population-based 10-year event-free survival after radical prostatectomy for patients with prostate cancer in British Columbia

2015 ◽  
Vol 9 (11-12) ◽  
pp. 409 ◽  
Author(s):  
Michael Peacock ◽  
Jill Quirt ◽  
W James Morris ◽  
Alan So ◽  
Charmaine Kim Sing ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
British Columbia ◽  
Overall Survival ◽  
Radical Prostatectomy ◽  
Gleason Score ◽  
Population Based ◽  
Gleason Grade ◽  
Event Free Survival ◽  
Free Survival ◽  
Incident Cases

<p><strong>Introduction:</strong> We determined (1) the 10-year survival outcomes after radical treatment of prostate cancer and (2) the 10-year eventfree survival following radical prostatectomy (RP) at a populationlevel in British Columbia (BC), Canada.</p><p><strong>Methods:</strong> We identified all men with a new diagnosis of prostate cancer in BC between 1999 and 2000. Those treated with RP, external beam radiotherapy (EBRT) or brachytherapy (BT) were identified. Overall survival, and prostate cancer specific survival (PCSS) were calculated from diagnosis using the Kaplan-Meier method. For those men treated with RP, we calculated the 10-year event-free survival (freedom from salvage EBRT or androgen ablation, or death from prostate cancer). Reasons for initiating androgen therapy were unknown and may include symptomatic metastatic disease or asymptomatic biochemical recurrence. An important limitation was the absence of prostate-specific antigen data for staging or follow-up.</p><p><strong>Results:</strong> Among 6028 incident cases, RP was the curative-intent treatment within 1 year in 1360 (22.6%) patients, EBRT in 1367 (22.7%), and BT in 357 (5.9%). The 10-year PCSS was 98% for RP, 95% for EBRT and 98% for BT (log rank p &lt; 0.0001). The 10-year overall survival was 87%. The 10-year event-free survival for those treated with RP was 79% and varied with Gleason grade: 87%, 74%, and 52% for Gleason 2–6, 7, and 8-10, respectively (p &lt; 0.0001).</p><p><strong>Conclusions:</strong> This population-based study provides outcomes which can inform patient decision-making and provide a benchmark to which other therapies can be compared. Event-free rates for patients treated with RP vary with Gleason score. There is room for improvement in the outcomes of patients with high Gleason score treated with RP.</p>

Southwest Oncology Group S9921: Prolonged event-free survival in high-risk prostate cancer (PC) patients receiving adjuvant androgen deprivation

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5009-5009
Author(s):  
L. M. Glode ◽  
C. M. Tangen ◽  
M. H. Hussain ◽  
D. P. Wood ◽  
G. P. Swanson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Risk Group ◽  
Risk Groups ◽  
Stage Migration ◽  
Event Free Survival ◽  
Eligibility Criteria ◽  
Free Survival ◽  
High Risk Prostate Cancer ◽  
Psa Relapse

5009 Background: Patients with adverse pathologic risk factors after radical prostatectomy are at high risk for biochemical relapse and eventual death from disease. Adjuvant hormonal therapy with or without chemotherapy may prolong event free survival. Methods: SWOG 9921 randomized 859 eligible high risk PC patients to receive 2 years of adjuvant combined androgen blockade (CAB) (goserelin + bicalutamide) with (433) or without (426) chemotherapy (mitoxantrone + prednisone). The primary endpoint is survival. The DSMC has approved this analysis. PSA was to be assessed every 3 mo for 5 yrs and then every 6 mo for 10 more yrs. PSA relapse was defined as 3 consecutive measurements > 0.2 ng/ml. Death w/o relapse is censored. The CAB only eligible group is being reported (n=426). Risk groups based on eligibility criteria are as follows: Risk Group 1= positive margins or extraprostatic extension only with Gleason 7; elevated PSA (pre-op > 15 ng/ml), or had a pre-op PSA > 10 ng/ml and a biopsy Gleason 7(N=113); Risk Group 2 = seminal vesicle invasion or Gleason >/= 8, but no positive nodes (N=240), Risk Group 3 =positive nodes (N=69), 397 patients from both arms who completed 2 years of CAB were assessed for time to testosterone (T) recovery. T was assessed every 6 mo until it reached the institutional lower limit of normal. The median follow-up time from randomization is 3.8 years. Results: See Table . The estimated median time to T recovery (> 50ng/ml) is 11.7 mo from the end of CAB (95% CI 11.3, 11.9 months). The 6 and 18 mo recovery rates were 16% and 89%. Of 17 deaths (including ineligibles), 7 were from prostate cancer; 4 from other cancers, one cardiovascular disease, and 5 from miscellaneous causes. Conclusions: These data indicate a markedly low PSA relapse and death rates in high risk PC patients who received CAB. This likely is the result of stage migration, patient selection and/or the effects of CAB itself. [Table: see text] [Table: see text]

scholarly journals Event-Free Survival after 68Ga-PSMA-11 PET/CT in recurrent Hormone-Sensitive Prostate Cancer (HSPC) patients eligible for Salvage Therapy.

2021 ◽  
Author(s):  
Francesco Ceci ◽  
Guido Rovera ◽  
Giuseppe Carlo Iorio ◽  
Alessia Guarneri ◽  
Valeria Chiofalo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Salvage Therapy ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Event Free Survival ◽  
Free Survival ◽  
Kaplan Meier ◽  
Psma Pet ◽  
Hormone Sensitive

Abstract Background/AimProstate-Specific-Membrane-Antigen/Positron Emission Tomography (PSMA-PET) detects with high accuracy disease-recurrence, leading to changes in the management of biochemically-recurrent (BCR) prostate cancer (PCa). However, data regarding the oncological outcomes of patients who performed PSMA-PET are needed. The aim of this study was to evaluate the incidence of clinically-relevant events during follow-up in patients who performed PSMA-PET for BCR after radical treatment. Materials and Methodsthis analysis included consecutive, hormone-sensitive, hormone-free, recurrent PCa patients (HSPC) enrolled through a prospective study. All patients were eligible for salvage therapy, having at least 24 months of follow-up after PSMA-PET. The primary endpoint was the Event-Free Survival (EFS), defined as the time between the PSMA-PET and the date of event/last follow-up. The Kaplan-Meier method was used to estimate the EFS curves. EFS was also investigated by Cox proportional hazards regression. Events were defined as: death, radiological progression or PSA recurrence after therapy. ResultsOne-hundred and seventy-six (n=176) patients were analyzed (median PSA 0.62 [IQR:0.43–1.00] ng/mL; median follow-up of 35.4 [IQR:26.5-40.3] months). The EFS was 78.8% at one year, 65.2% (2-years), and 52.2% (3-years). Patients with clinically relevant events had a significantly higher median PSA (0.81 [IQR:0.53-1.28] vs 0.51 [IQR:0.36-0.80] ng/mL) and a lower PSAdt (5.4 [IQR:3.7-11.6] vs 12.7 [IQR:6.6-24.3] months) (p<0,001) compared to event-free patients. The Kaplan-Meier curves showed that PSA>0.5 ng/mL, PSAdt≤6 months and a positive PSMA-PET result were associated with a higher event rate (p<0.01). No significant differences of event rates were observed in patients who received changes in therapy management after PSMA-PET vs. patients who did not receive therapy changes. Finally, PSA> 0.5 ng/mL and PSAdt≤ 6months were statistically significant event-predictors in multi-variate model (p<0.001). ConclusionIn this cohort of HSPC patients prospectively enrolled, low PSA and long PSAdt were significant predictors of event. Furthermore, a lower incidence of events was observed also in patients having negative PSMA-PET, since longer EFS was significantly more probable in case of a negative scan.

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