Pain Predicts Overall Survival in Men With Metastatic Castration-Refractory Prostate Cancer

2008 ◽  
Vol 26 (15) ◽  
pp. 2544-2549 ◽  
Author(s):  
Susan Halabi ◽  
Nicholas J. Vogelzang ◽  
Alice B. Kornblith ◽  
San-San Ou ◽  
Philip W. Kantoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Group Performance ◽  
Opioid Analgesic ◽  
Objective Response ◽  
Pain Interference ◽  
Phase Iii ◽  
Risk Of Death ◽  
Pain Scores ◽  
The Impact

PurposePain from castration-refractory prostate cancer (CRPC) bone metastases is a common event. Although it is assumed that pain represents an adverse prognostic factor, this variable has not been extensively evaluated. The objective of this study was to determine whether men with CRPC who had higher pain interference scores at baseline had worse clinical outcomes compared with men who had lower pain scores.Patients and MethodsData from three randomized phase III multicenter trials conducted by the Cancer and Leukemia Group B from 1992 to 1998 were combined. Eligible patients had progressive CRPC adenocarcinoma of the prostate, an Eastern Cooperative Oncology Group performance status of 0 to 2, and adequate hematologic, renal, and hepatic functions. Seven items from the Brief Pain Inventory were used to assess the impact of pain on a range of daily activities and quality of life, each rated on a scale from 0 to 10.ResultsIn 599 men, the median pain interference scores was 17 (interquartile range, 4 to 34), and 38% of the men had opioid analgesic use at baseline. There was a statistically significant association between pain interference scores and risk of death. The median survival times were 17.6 months (95% CI, 16.1 to 19.1 months) and 10.2 months (95% CI, 8.6 to 11.3 months; P < .001) in men with low (< 17) and high (≥ 17) pain scores, respectively. Pain was inversely associated with likelihood of prostate-specific antigen decline, objective response, and time to bone progression.ConclusionThis analysis demonstrates that pain is a statistically significant predictor of overall survival in men with metastatic CRPC. These results need to be validated prospectively in future phase III trials.

scholarly journals Long-term overall survival and prognostic score predicting survival: the IMPACT study in precision medicine

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Apostolia-Maria Tsimberidou ◽  
David S. Hong ◽  
Jennifer J. Wheler ◽  
Gerald S. Falchook ◽  
Filip Janku ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Precision Medicine ◽  
Phase 1 ◽  
Prognostic Score ◽  
Objective Response ◽  
Molecular Profiling ◽  
Risk Of Death ◽  
Link Type ◽  
The Impact

Abstract Background In 2007, we initiated IMPACT, a precision medicine program for patients referred for participation in early-phase clinical trials. We assessed the correlation of factors, including genomically matched therapy, with overall survival (OS). Patients and methods We performed molecular profiling (Clinical Laboratory Improvement Amendments) (genes ≤ 182) for patients with lethal/refractory advanced cancers referred to the Phase 1 Clinical Trials Program. Matched therapy, if available, was selected on the basis of genomics. Clinical trials varied over time and included investigational drugs against various targets (single agents or combinations). Patients were followed up for up to 10 years. Results Of 3487 patients who underwent tumor molecular profiling, 1307 (37.5%) had ≥ 1 alteration and received therapy (matched, 711; unmatched, 596; median age, 57 years; 39% men). Most common tumors were gastrointestinal, gynecologic, breast, melanoma, and lung. Objective response rates were: matched 16.4%, unmatched 5.4% (p < .0001); objective response plus stable disease ≥ 6 months rates were: matched 35.3% and unmatched 20.3%, (p < .001). Respective median progression-free survival: 4.0 and 2.8 months (p < .0001); OS, 9.3 and 7.3 months; 3-year, 15% versus 7%; 10-year, 6% vs. 1% (p < .0001). Independent factors associated with shorter OS (multivariate analysis) were performance status > 1 (p < .001), liver metastases (p < .001), lactate dehydrogenase levels > upper limit of normal (p < .001), PI3K/AKT/mTOR pathway alterations (p < .001), and non-matched therapy (p < .001). The five independent factors predicting shorter OS were used to design a prognostic score. Conclusions Matched targeted therapy was an independent factor predicting longer OS. A score to predict an individual patient’s risk of death is proposed. Trial registration ClinicalTrials.gov, NCT00851032, date of registration February 25, 2009.

Association between radiographic response and overall survival in men with metastatic castration-resistant prostate cancer receiving chemotherapy.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 118-118
Author(s):  
G. Sonpavde ◽  
G. R. Pond ◽  
W. R. Berry ◽  
R. De Wit ◽  
M. A. Eisenberger ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Proportional Hazards ◽  
Objective Assessment ◽  
Objective Response ◽  
Cox Proportional Hazards ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Kaplan Meier

118 Background: In men with metastatic castration resistant prostate cancer (CRPC),the association of measurable tumor responses with overall survival (OS) is unknown. We retrospectively evaluated the TAX327 phase III trial to study this relationship. Methods: Eligible patients for this analysis included those with WHO-defined measurable metastatic disease randomized to receive either docetaxel or mitoxantrone. OS was estimated using the Kaplan-Meier method and the prognostic relationship of WHO-defined radiologic response with OS was performed using Cox proportional hazards regression. Landmark analyses evaluated survival from baseline and 2, 3, 4 and 6 months after baseline. Results: Four hundred and twelve patients enrolled on the TAX327 trial had measurable tumors. Thirty-seven patients exhibited a complete or partial objective response (CR/PR, 9.0%), 116 had stable disease (SD, 28.2%), 99 had progressive disease (PD,24%) and 160 (38.8%) did not have a post-baseline objective assessment. Partial responders demonstrated longer median OS (29.0 months) than patients with SD (22.1 months), or those with PD (10.8 months) or those who were not assessed (12.7 months). These results remained after landmark analysis. We found a significant association between ≥30% PSA declines and radiologic response, with ≥30% PSA declines occurring in all patients with CR/PR, 79.8% of patients with SD and 34.4% with PD. Radiologic response remained a significant but modest post-treatment prognostic factor for OS after adjusting for treatment, pain-response and ≥30% PSA-decline (p=0.009). Conclusions: In men with metastatic CRPC and measurable disease receiving chemotherapy, objective tumor response was prognostic for OS, and appears to complement PSA assessment. [Table: see text]

Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer postdocetaxel: Results from the phase III AFFIRM study.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. LBA1-LBA1 ◽  
Author(s):  
Howard I. Scher ◽  
Karim Fizazi ◽  
Fred Saad ◽  
Mary-Ellen Taplin ◽  
Cora N. Sternberg ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Androgen Receptor ◽  
Specific Antigen ◽  
Model Systems ◽  
Phase Iii ◽  
Receptor Signaling ◽  
Androgen Receptor Signaling ◽  
Risk Of Death ◽  
Psa Progression

LBA1 Background: MDV3100, a novel androgen receptor signaling inhibitor (ARSI), competitively inhibits binding of androgens to the androgen receptor (AR), inhibits AR nuclear translocation, and inhibits association of the AR with DNA (Tran et al, Science. 2009;324:787). MDV3100 was selected for development based on activity in prostate cancer model systems with overexpressed AR, and was active in a phase I-II trial enrolling pre- and post-chemotherapy treated patients with progressive castration resistant disease (CRPC) (Scher et al, Lancet. 2010;375:1437). The AFFIRM trial evaluated whether MDV3100 could prolong overall survival (OS) in men with CRPC who progressed following docetaxel-based chemotherapy. Methods: In this randomized, double-blind, placebo-controlled, multinational phase III study ( NCT00974311 ), patients who had received ≤ 2 regimens of docetaxel-based chemotherapy were randomized 2:1 to MDV3100 160 mg/day or placebo. Treatment with corticosteroids was allowed but not required. Patients were stratified by baseline ECOG performance status and mean brief pain inventory score. The primary endpoint was OS. Other efficacy endpoints included radiographic progression-free survival (PFS), time to first skeletal-related event, time to prostate-specific antigen (PSA) progression, and circulating tumor cell count conversion rate. Results: 1,199 patients were randomized between Sep 2009 and Nov 2010. Based on a planned interim analysis at 520 death events, the Independent Data Monitoring Committee (IDMC) recommended the study be unblinded and placebo patients offered MDV3100 due to a significant OS benefit (p<0.0001; hazard ratio 0.631). The estimated median OS was 18.4 months for MDV3100 treated compared to 13.6 months for placebo treated men, a median OS difference of 4.8 months. Data to be available include PFS, time to PSA progression, and safety. Conclusions: MDV3100, a novel ARSI, significantly improves OS in men with postdocetaxel-treated CRPC reducing the risk of death by 37% relative to placebo. The IDMC determined the risk:benefit of MDV3100 was favorable and recommended the phase III AFFIRM trial be unblinded.

scholarly journals Safety of image-guided radiotherapy in definitive radiotherapy for localized prostate cancer: a population-based analysis

2021 ◽  
Vol 94 (1121) ◽  
pp. 20200456
Author(s):  
Yao-Hung Kuo ◽  
Ji-An Liang ◽  
Guan-Heng Chen ◽  
Chia-Chin Li ◽  
Chun-Ru Chien
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Cancer Mortality ◽  
Phase Iii ◽  
Localized Prostate Cancer ◽  
Image Guided Radiotherapy ◽  
Definitive Radiotherapy ◽  
Image Guided ◽  
The Impact

Objectives: Image-guided radiotherapy (IGRT) is a recommended advanced radiation technique that is associated with fewer acute and chronic toxicities. However, one Phase III trial showed worse overall survival in the IGRT arm. The purpose of this observational study is to evaluate the impact of IGRT on overall survival. Methods: We used the Taiwan Cancer Registry Database to enroll cT1-4N0M0 prostate cancer patients who received definitive radiotherapy between 2011 and 2015. We used inverse probability treatment weighting (IPW) to construct balanced IGRT and non-IGRT groups. We compared the overall survival of those in the IGRT and non-IGRT groups. Supplementary analyses (SA) were performed with alternative covariates in propensity score (PS) models and PS approaches. The incidence rates of prostate cancer mortality (IPCM), other cancer mortality (IOCM), and cardiovascular mortality (ICVM) were also evaluated. Results: There were 360 patients in the IGRT arm and 476 patients in the non-IGRT arm. The median follow-up time was 50 months. The 5-year overall survival was 88% in the IGRT arm and 86% in the non-IGRT arm (adjusted hazard ratio [HR] of death = 0.93; 95% CI, 0.61–1.45; p = 0.77). The SA also showed no significant differences in the overall survival between those in the IGRT and non-IGRT arms. Both groups did not significantly differ in terms of IPCM, IOCM, and ICVM. Conclusions: The overall survival of localized prostate cancer patients who underwent IGRT was not inferior to those who did not. Advances in knowledge: We demonstrated that the overall survival for prostate cancer patients with IGRT was not worse than those who did not undergo IGRT; this important outcome comparison has not been previously examined in the general population.

Modified FOLFIRINOX versus S-1 as second-line chemotherapy in patients with gemcitabine-failed metastatic pancreatic cancer: A randomized phase III trial (MPACA-3).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4119-4119
Author(s):  
Se-Il Go ◽  
Sang-Cheol Lee ◽  
Woo Kyun Bae ◽  
Dae Young Zang ◽  
Hyun Woo Lee ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Group Performance ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line ◽  
Phase Iii Trial

4119 Background: Modified FOLFIRINOX (mFOLFIRINOX) consisting of 5-fluorouracil/leucovorin, irinotecan, and oxaliplatin has been assessed as second-line treatment of patients with advanced pancreatic cancer in retrospective and phase II studies. However, the result was not confirmed by randomized controlled trial. Methods: A randomized, open-label, phase III trial was conducted at 9 institutions in Korea. Patients with metastatic pancreatic adenocarcinoma (mPAC) and Eastern Cooperative Oncology Group performance status of 0-1 who failed to first-line gemcitabine-based chemotherapy were randomly assigned to receive mFOLFIRINOX or S-1. The primary endpoint was overall survival. Results: A total of 80 patients were enrolled from March 2017 to December 2019. The accrual of patients was early terminated due to clear difference of efficacy in the interim analysis and expectation of poor recruitment due to conflicting adjuvant regimens. Objective response and disease control rates were 15.4% vs. 2.4% ( p= 0.041) and 66.7% vs. 36.6% ( p= 0.007) in the mFOLFIRINOX and S-1 arms, respectively. The median progression-free survival was 5.2 and 2.2 months in the mFOLFIRINOX and S-1 arms, respectively ( p= 0.002). The median overall survival was 9.2 and 4.9 months in the mFOLFIRINOX and S-1 arms, respectively ( p= 0.048). The adjusted hazard ratio of the mFOLFIRINOX arm to the S-1 arm for overall survival was 0.402 (95% confidence interval 0.223-0.725, p= 0.002). All grade 3-4 adverse events occurred in 56.5% and 17.1% in the mFOLFIRINOX and S-1 arms, respectively ( p< 0.001). However, only one patient in each arm prematurely discontinued treatment due to toxicity and there was no treatment-related mortality in both arms. Minimally important differences in the health-related quality of life were not observed in both arms. Conclusions: mFOLFIRINOX as second-line treatment in mPAC patients failed to gemcitabine-based chemotherapy demonstrated a survival benefit versus S-1 alone with acceptable toxicities. Clinical trial information: KCT0003534.

Previous enzalutamide therapy and response to subsequent taxane therapy in metastatic castration-resistant prostate cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 227-227 ◽  
Author(s):  
Marco Gizzi ◽  
Giulia Baciarello ◽  
Aude Flechon ◽  
Philippe Beuzeboc ◽  
Antoine Angelergues ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Objective Response ◽  
Specific Antigen ◽  
Phase Iii ◽  
Cross Resistance ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Psa Response ◽  
Pretreated Patients ◽  
The Impact

227 Background: Cross-resistance between taxanes and androgen receptor axis targeted agents is a matter of debate in metastatic castration-resistant prostate cancer (mCRPC). Preclinical data about response to taxanes after prior enzalutamide suggest some level of cross-resistance (van Soest et al, Eur J Cancer 2013) though this was not confirmed in other models (Al Nakouzi N, Eur Urol 2014). The first objective of this study was to assess the impact of previous enzalutamide therapy on the efficacy of subsequent taxane-based chemotherapy. The second objective was to investigate the prognosis of patients when chemotherapy was initiated in enzalutamide-pretreated patients. Methods: Data from 96 enzalutamide- and placebo-treated patients enrolled in the Prevail phase III trial were retrospectively collected from 14 centers in France. Changes in prostate specific antigen (PSA) levels, progression free survival (PFS) and RECIST criteria v 1.1 were used to determine the activity of docetaxel (n=89) or cabazitaxel (n=7) treatment. The Halabi model was used to predict survival probabilities for the enzalutamide- or placebo-pretreated patients when chemotherapy was initiated (Halabi et al, J Clin Oncol 2014). Results: Overall, 96 patients were included in this analysis (58 in the placebo arm vs. 38 in enzalutamide arm). PSA response to taxanes (defined as a decline of ≥50% from baseline) was marginally lower in enzalutamide-vs. placebo-pretreated patients (34% vs. 53%, p=0.10). PSA response in enzalutamide-pretreated patients was not different from that observed with docetaxel given every 3 weeks in TAX 327 trial (Tannock et al, NEJM 2004) (45%, p=0.20, binomial test). Median PFS and objective response rates were similar between the two groups (4.8m vs 6.7 m;p=0.14 and 45% vs 43%;p=0.83 respectively). Halabi score was well-balanced between the two groups (p=0.30). Conclusions: Taxanes retain efficacy in enzalutamide-pretreated mCRPC. At the time of first-line taxane-based chemotherapy initiation, the prognosis of enzalutamide-treated patients according to the Halabi score was not different from that of enzalutamide-naïve patients.

PROfound: A randomized Phase III trial evaluating olaparib in patients with metastatic castration-resistant prostate cancer and a deleterious homologous recombination DNA repair aberration.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS5091-TPS5091 ◽  
Author(s):  
Johann S. De Bono ◽  
Maha Hussain ◽  
Antoine Thiery-Vuillemin ◽  
Joaquin Mateo ◽  
A. Oliver Sartor ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Homologous Recombination ◽  
Radiographic Progression ◽  
Response Rate ◽  
Objective Response ◽  
Abiraterone Acetate ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

TPS5091 Background: The median overall survival for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) is short. Available agents may offer limited therapeutic benefit, but no molecularly stratified treatment has yet been approved for this heterogeneous disease. A sizable percentage of pts with mCRPC has loss of function aberrations in genes involved in homologous recombination repair (HRR) in tumor tissue, such as BRCA1/2 and ATM. These aberrations can confer sensitivity to poly(ADP-ribose) polymerase (PARP) inhibition. A Phase II study indicated that the oral PARP inhibitor olaparib (Lynparza) had antitumor activity in 33% of mCRPC pts who had progressed after new hormonal agent (NHA) treatment and chemotherapy, with a strikingly higher composite response rate in pts with a deleterious HRR gene aberration (HRRa) (88%; 14/16) vs pts without a HRRa (6%; 2/33) (Mateo et al.2015). The PROfound study evaluates olaparib efficacy and safety versus physician’s choice of either abiraterone acetate or enzalutamide, in pts with mCRPC and a HRRa (NCT02987543). Methods: To be eligible for this multinational, open-label, Phase III study, mCRPC pts must have progressed on prior NHA treatment and have a tumor HRRa in one of 15 genes, as confirmed by an HRR Assay (Foundation Medicine, Inc.). Cohort A (n = 240 approx) includes pts with mutations in BRCA1, BRCA2 or ATM, while pts with a mutation in 12 other HRR genes will be assigned to Cohort B (n = 100 approx). Pts will be randomized (2:1) to olaparib tablets (300 mg orally bid) or physician’s choice of either enzalutamide (160 mg orally od) or abiraterone acetate (1000 mg orally od with 5 mg bid prednisone) and treatment continued until radiographic progression (as assessed by blinded independent central review) or lack of treatment tolerability. The primary endpoint of radiographic progression-free survival (rPFS) will be assessed in Cohort A using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria. Key secondary efficacy endpoints include confirmed objective response rate, time to pain progression, overall survival (all Cohort A) and rPFS (both cohorts combined). Clinical trial information: NCT02987543.

scholarly journals Meta-Analysis Evaluating the Impact of Site of Metastasis on Overall Survival in Men With Castration-Resistant Prostate Cancer

2016 ◽  
Vol 34 (14) ◽  
pp. 1652-1659 ◽  
Author(s):  
Susan Halabi ◽  
William Kevin Kelly ◽  
Hua Ma ◽  
Haojin Zhou ◽  
Nicole C. Solomon ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Liver Metastases ◽  
Lung Metastases ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Phase Iii Trials ◽  
The Impact ◽  
Sites Of Metastases

Purpose Reports have suggested that metastatic site is an important predictor of overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC), but these were based on a limited number of patients. We investigate the impact of site of metastases on OS of a substantial sample of men with mCRPC who received docetaxel chemotherapy in nine phase III trials. Patients and Methods Individual patient data from 8,820 men with mCRPC enrolled onto nine phase III trials were combined. Site of metastases was categorized as lymph node (LN) only, bone with or without LN (with no visceral metastases), any lung metastases (but no liver), and any liver metastases. Results Most patients had bone with or without LN metastases (72.8%), followed by visceral disease (20.8%) and LN-only disease (6.4%). Men with liver metastases had the worst median OS (13.5 months). Although men with lung metastases had better median OS (19.4 months) compared with men with liver metastases, they had significantly worse median survival duration than men with nonvisceral bone metastases (21.3 months). Men with LN-only disease had a median OS of 31.6 months. The pooled hazard ratios for death in men with lung metastases compared with men with bone with or without LN metastases and in men with any liver metastases compared with men with lung metastases were 1.14 (95% CI, 1.04 to 1.25; P = .007) and 1.52 (95% CI, 1.35 to 1.73; P < .0001), respectively. Conclusion Specific sites of metastases in men with mCRPC are associated with differential OS, with successive increased lethality for lung and liver metastases compared with bone and nonvisceral involvement. These data may help in treatment decisions, the design of future clinical trials, and understanding the variation in biology of different sites of metastases in men with mCRPC.

Association of metabolic syndrome with poorer prostate cancer and overall survival in men receiving androgen deprivation therapy (ADT) for biochemical relapse.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4555-4555
Author(s):  
Sarah Maria Rudman ◽  
Kathryn P. Gray ◽  
Julie Kasperzyk ◽  
Edward Giovannucci ◽  
Michael Pitt ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metabolic Syndrome ◽  
Overall Survival ◽  
African American ◽  
Type I ◽  
Biochemical Relapse ◽  
Risk Of Death ◽  
Increased Risk ◽  
The Impact

4555 Background: The metabolic syndrome (MS) has been implicated in the development of prostate cancer (PC). In our previous study of a Veterans’ Administration (VA) cohort, MS was associated with a shorter duration of PC control with ADT. We report the impact of MS on overall survival (OS) and PC specific death for a cohort of patients with biochemical relapse. Methods: 273 pts (64 VA pts and 209 pts from Health Professionals Follow up Study) treated with ADT for biochemical recurrence post radiation or prostatectomy for PC were included. The modified Adult Treatment Panel III criteria for MS was used to identify patients with MS status prior to the commencement of ADT. Cox models tested for association of MS status with OS or time to PC specific death. With 42% overall death rate, 31% MS prevalence, there was 90% power to detect HR= 1.81 (type I error rate =0.05). Results: 31% pts (84/273) had MS and 15% pts (40/273) died of PC. Median follow-up was 9.5 years. The median OS with and without MS was 7.4 and 11.2 years respectively. Patients with hypertension, being African American, having diabetes and age were associated with increased risk of death from any causes, while hypertension and being African American were also associated with increased risk of PC specific death. A multivariate Cox regression model adjusted for age at diagnosis, race, definitive local therapy (RT vs. RP), PSA at diagnosis and Gleason score revealed MS was associated with a significantly increased risk of death from any cause and PC specific death (Table). Conclusions: In men receiving ADT for biochemically recurrent androgen dependent PC, the presence of MS at the commencement of ADT is associated with an increased risk of death from any cause as well as prostate cancer specifically. [Table: see text]

Androgen deprivation therapy (ADT) for node postive prostate cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5061-5061 ◽  
Author(s):  
Y. Wong ◽  
S. Freedland ◽  
G. Hudes ◽  
N. Mitra ◽  
C. Montagnet ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Lymph Nodes ◽  
Propensity Scores ◽  
Regional Lymph Nodes ◽  
Risk Of Death ◽  
Medicare Data ◽  
Significant Difference ◽  
Definition Of ◽  
The Impact

5061 Background: The role of ADT for men with node positive prostate cancer following radical prostatectomy (RP) is unclear. One randomized trial has shown a survival advantage for men treated with immediate adjuvant (adj) ADT compared treatment at onset of clinical metastases. However, benefit of immediate therapy is less clear in the PSA era when ADT can initiated at the time of biochemical relapse. Methods: We used linked Surveillance, Epidemiology and End Results-Medicare Data to identify a cohort of men who underwent RP between 1991–1999 and were found to have positive regional lymph nodes. We searched Medicare claims to identify men with claims for ADT (hormonal therapy or orchiectomy) within 3 years of diagnosis. We excluded men who received ADT prior to RP. We classified men as receiving adj ADT if they received treatment within 120 days of RP and compared them to men who had not received adj ADT. We used propensity scores to balance potential confounders of receiving adj ADT (age, tumor characteristics, extent of nodal disease, demographics). We used Cox proportional hazard methods to estimate the impact of adj ADT on overall survival (OS) adjusting for propensity score. We conducted a sensitivity analysis using 90, 150, 180 and 365 days as the time limit for adj ADT. Results: 719 men were identified, of whom 190 received adjuvant ADT within 120 days of RP. There was no statistically significant difference in overall survival between the men who did or did not receive adj ADT (HR 0.96 95% CI 0.70–1.32) The results were similar for men who received ADT within 90 and 150 days. However, when the definition of adj ADT was moved to 180 days (HR 1.08 (0.80–1.47)) and 365 days (HR 1.24 (0.92–1.65)) the men receiving adj ADT had a slightly higher risk of death, suggesting some in the adj ADT groups using these later definitions may have received therapy as salvage therapy for progressive disease. Conclusions: This observational study suggests that in the PSA era when men can be started on ADT at the time of biochemical recurrence, overall survival may not be significantly compromised by deferring immediate ADT in men with positive lymph nodes following RP. Further clinical research is needed to better understand which patients are likely to benefit from immediate ADT, and which men can be spared the long term toxicities. [Table: see text]

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