Immediate or Deferred Androgen Deprivation for Patients With Prostate Cancer Not Suitable for Local Treatment With Curative Intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891

2006 ◽  
Vol 24 (12) ◽  
pp. 1868-1876 ◽  
Author(s):  
Urs E. Studer ◽  
Peter Whelan ◽  
Walter Albrecht ◽  
Jacques Casselman ◽  
Theo de Reijke ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Local Treatment ◽  
Androgen Deprivation ◽  
Cancer Specific Survival ◽  
Deferred Treatment ◽  
Symptomatic Disease ◽  
Androgen Ablation ◽  
Number Of Patients ◽  
Significant Difference

Purpose This study (EORTC 30891) attempted to demonstrate equivalent overall survival in patients with localized prostate cancer not suitable for local curative treatment treated with immediate or deferred androgen ablation. Patients and Methods We randomly assigned 985 patients with newly diagnosed prostate cancer T0-4 N0-2 M0 to receive androgen deprivation either immediately (n = 493) or on symptomatic disease progression or occurrence of serious complications (n = 492). Results Baseline characteristics were well balanced in the two groups. Median age was 73 years (range, 52 to 81). At a median follow-up of 7.8 years, 541 of 985 patients had died, mostly of prostate cancer (n = 193) or cardiovascular disease (n = 185). The overall survival hazard ratio was 1.25 (95% CI, 1.05 to 1.48; noninferiority P > .1) favoring immediate treatment, seemingly due to fewer deaths of nonprostatic cancer causes (P = .06). The time from randomization to progression of hormone refractory disease did not differ significantly, nor did prostate-cancer specific survival. The median time to the start of deferred treatment after study entry was 7 years. In this group 126 patients (25.6%) died without ever needing treatment (44% of the deaths in this arm). Conclusion Immediate androgen deprivation resulted in a modest but statistically significant increase in overall survival but no significant difference in prostate cancer mortality or symptom-free survival. This must be weighed on an individual basis against the adverse effects of life-long androgen deprivation, which may be avoided in a substantial number of patients with a deferred treatment policy.

Immediate Versus Deferred Hormonal Treatment for Patients With Prostate Cancer Who Are Not Suitable for Curative Local Treatment: Results of the Randomized Trial SAKK 08/88

2004 ◽  
Vol 22 (20) ◽  
pp. 4109-4118 ◽  
Author(s):  
Urs E. Studer ◽  
Dieter Hauri ◽  
Silvia Hanselmann ◽  
Dominique Chollet ◽  
Hans-Jürg Leisinger ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Statistical Power ◽  
Performance Status ◽  
Local Treatment ◽  
Specific Treatment ◽  
Hormonal Treatment ◽  
Deferred Treatment ◽  
Asymptomatic Patients ◽  
Number Of Patients

Purpose To determine if immediate hormonal therapy is advantageous compared with deferred treatment in newly diagnosed asymptomatic prostate cancer patients who, for any reason, were not candidates for curative local treatment. Patients and Methods Between February 1988 and February 1992, 197 patients with a median age of 76 years (range, 56 to 86 years) were randomly assigned to receive either immediate or deferred orchiectomy on symptomatic progression. The two groups did not differ significantly in clinical or laboratory parameters; 67% had T3-4 tumors and 20% had lymph node metastases. Patient accrual was stopped prematurely because of a similar competing trial. Therefore, observation time was prolonged to achieve the desired number of events and statistical power. Results Deferred orchiectomy was necessary in 58% of the patients. Median time to disease progression was 2.8 years less than for patients with immediate orchiectomy. However, overall pain-free time from random assignment to symptomatic progression after immediate or deferred orchiectomy, and performance status, were identical in both groups. Cancer-specific survival tended to be longer in the immediate group (P = .09) but there was no difference in overall survival between the two groups (P = .96). The median hemoglobin value decreased significantly after immediate orchiectomy (P < .001). Conclusion For elderly, asymptomatic patients not undergoing curative local treatment, we were unable to show any major advantage of immediate compared with deferred hormonal treatment regarding quality of life or overall survival in our limited number of patients. Disabling complications were prevented in the deferred-treatment arm by careful follow-up; 42% of these patients never required any tumor-specific treatment.

scholarly journals Seven-Month Prostate-Specific Antigen Is Prognostic in Metastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation With or Without Docetaxel

2018 ◽  
Vol 36 (4) ◽  
pp. 376-382 ◽  
Author(s):  
Lauren C. Harshman ◽  
Yu-Hui Chen ◽  
Glenn Liu ◽  
Michael A. Carducci ◽  
David Jarrard ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Prostate Specific Antigen ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Androgen Deprivation ◽  
Androgen Ablation ◽  
Hormone Sensitive ◽  
Low Volume

Purpose We evaluated the relationship between prostate-specific antigen (PSA) and overall survival in the context of a prospectively randomized clinical trial comparing androgen-deprivation therapy (ADT) plus docetaxel with ADT alone for initial metastatic hormone-sensitive prostate cancer. Methods We performed a landmark survival analysis at 7 months using the E3805 Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) database ( ClinicalTrials.gov identifier: NCT00309985). Inclusion required at least 7 months of follow-up and PSA levels at 7 months from ADT initiation. We used the prognostic classifiers identified in a previously reported trial (Southwest Oncology Group 9346) of PSA ≤ 0.2, > 0.2 to 4, and > 4 ng/mL. Results Seven hundred nineteen of 790 patients were eligible for this subanalysis; 358 were treated with ADT plus docetaxel, and 361 were treated with ADT alone. Median follow-up time was 23.1 months. On multivariable analysis, achieving a 7-month PSA ≤ 0.2 ng/mL was more likely with docetaxel, low-volume disease, prior local therapy, and lower baseline PSAs (all P ≤ .01). Across all patients, median overall survival was significantly longer if 7-month PSA reached ≤ 0.2 ng/mL compared with > 4 ng/mL (median survival, 60.4 v 22.2 months, respectively; P < .001). On multivariable analysis, 7-month PSA ≤ 0.2 and low volume disease were prognostic of longer overall survival (all P < 0.01). The addition of docetaxel increased the likelihood of achieving a PSA ≤ 0.2 ng/mL at 7 months (45.3% v 28.8% of patients on ADT alone). Patients on ADT alone who achieved a 7-month PSA ≤ 0.2 ng/mL had the best survival and were more likely to have low-volume disease (56.7%). Conclusion PSA ≤ 0.2 ng/mL at 7 months is prognostic for longer overall survival with ADT for metastatic hormone-sensitive prostate cancer irrespective of docetaxel administration. Adding docetaxel increased the likelihood of a lower PSA and improved survival.

Survival among colorectal cancer patients with a history of previous cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16146-e16146
Author(s):  
Sandi Pruitt ◽  
David E. Gerber ◽  
Hong Zhu ◽  
Daniel Heitjan ◽  
Bhumika Maddineni ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Cox Regression ◽  
Population Based ◽  
Competing Risk ◽  
Cancer Specific Survival ◽  
Risk Of Death ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Impact

e16146 Background: A growing number of patients with colorectal cancer (CRC) have survived a previous cancer. Although little is known about their prognosis, this population is frequently excluded from clinical trials. We examined the impact of previous cancer on overall and cancer-specific survival in a population-based cohort of patients diagnosed with incident CRC. Methods: We identified patients aged ≥66 years and diagnosed with CRC between 2005-2015 in linked SEER-Medicare data. For patients with and without previous cancer, we estimated overall survival using Cox regression and cause-specific survival using competing risk regression, separately by CRC stage, while adjusting for numerous covariates and competing risk of death from previous cancer, other causes, or the incident CRC. Results: Of 112,769 CRC patients diagnosed with incident CRC, 15,935 (14.1%) had a previous cancer – most commonly prostate (32.9%) or breast (19.4%) cancer, with many 7505 (47.1%) diagnosed ≤5 years of CRC. For all CRC stages except IV in which there was no significant difference in survival, patients with previous cancer had modestly worse overall survival (hazard ratios from fully adjusted models range from 1.11-1.28 across stages; see Table). This survival disadvantage was driven by deaths due to previous cancer and other causes. Notably, most patients with previous cancer had improved CRC-specific survival. Conclusions: CRC patients who have survived a previous cancer have generally worse overall survival but superior CRC-specific survival. This evidence should be considered concurrently with concerns about trial generalizability, low accrual, and heterogeneity of participants when determining exclusion criteria. [Table: see text]

Early Versus Delayed Androgen Deprivation for Prostate Cancer: New Fuel for an Old Debate

2005 ◽  
Vol 23 (32) ◽  
pp. 8225-8231 ◽  
Author(s):  
Charles J. Ryan ◽  
Eric J. Small
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
High Risk ◽  
Retrospective Analysis ◽  
Survival Benefit ◽  
Clinical Course ◽  
Local Therapy ◽  
Androgen Deprivation ◽  
Androgen Ablation ◽  
Overall Survival Benefit

The purpose of this review is to discuss the recent increase in data supporting the use of androgen ablation early in the clinical course for patients with nonmetastatic prostate cancer. We systematically reviewed recent publications that report on the use of androgen deprivation (AD) in nonmetastatic prostate cancer patients from the 2003 and 2004 procedings of the American Society of Clinical Oncology, the 2003 and 2004 procedings of the American Urological Association as well as published literature from 2003 to 2005. Five recently published mature randomized trials of AD plus local therapy were evaluated plus two large data sets on the use of AD for patients with serologic relapse after local therapy. Four mature randomized studies demonstrate an overall survival benefit to the use of AD in conjunction with definitive local therapy (three with radiation and one with surgery). One retrospective analysis suggests that AD administered early after serologic progression improves overall survival, and one retrospective analysis shows a reduction in metastasis-free survival but has not yet shown an overall survival benefit. For patients with nonmetastatic prostate cancer with high-risk features, as well as those for serologic relapse, the use of AD before the development of metastatic disease is supported by long-term outcomes from a series of clinical trials. Consideration of AD is therefore warranted early in the clinical course of high-risk patients.

Androgen deprivation therapy and statin therapy in prostate cancer patients.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 205-205
Author(s):  
Kin Chung Lai ◽  
Toiya Turknett ◽  
Parminder Singh
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Androgen Deprivation Therapy ◽  
Cox Regression ◽  
Androgen Deprivation ◽  
P Value ◽  
Primary Therapy ◽  
Significant Difference ◽  
Chi Squared ◽  
Statin Use

205 Background: Metastatic prostate cancer (mPC) is treated with androgen deprivation therapy( ADT). Duration of response to ADT predicts patient’s survival. It has been shown in observational studies that concurrent statin use may prolong response to ADT. Studies in mice have shown negative interactions. We wanted to examine the effect of this interaction in patients being followed at Mayo Clinic Arizona (MCA). Methods: We examined 441 patients with mPC, who received ADT and were treated at MCA from year 2011 to 2017. . Our study evaluated the time to progression (TTP) and overall survival(OS) for patients with mPC on ADT with or without concurrent statin use. Among the patients who were evaluated, there was a subset of 156 patients taking abiraterone (ABI). Characteristics were compared between statin users and nonusers using Chi squared test and Wilcoxon rank-sum tests. The primary outcome was TTP defined as the duration from ADT initiation to disease progression. The association between statin use and TTP was analyzed by multivariable Cox regression to estimate hazard ratios (HRs) and 95% Conference Interval (CI), and adjusted for Gleason score, primary therapy type, prior ADT, metastatic status, and PSA at ADT initiation. Results: There was no significant difference in TTP when comparing patients with statin to those without a statin. The HR for statin use vs no statin use is 1.049 with CI (0.838, 1.314) and p-value is 0.677. There was no significant difference in overall survival when comparing statin vs no statin use. The HR for statin use vs no statin use was 0.928(CI 0.642, 1.342) with p-value at 0.693. In the ABI population, there was no significant difference in TTP for patients with statin vs no statin. HR was 1.00 CI (0.725, 1.377) with p-value at 0.998. For overall survival, there was no significant difference with HR at 0.852 (CI 0.502, 1.446) with p-value at 0.553. Conclusions: Despite retrospective studies showing benefit of use of statin in men with prostate cancer, our study observed no difference in long term outcomes. Possible explanations could be smaller sample size, inability to verify data as medication intake was not verified directly. Also, patient’s compliance with medications could be a confounding variable.

Age-dependent overall survival benefit of androgen deprivation therapy for metastatic prostate cancer

2019 ◽  
Vol 25 (8) ◽  
pp. 1927-1932 ◽  
Author(s):  
Matthew J Keating ◽  
Lisa Giscombe ◽  
Toufic Tannous ◽  
Nishitha Reddy ◽  
Shiva Kumar R Mukkamalla ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Androgen Deprivation Therapy ◽  
Survival Benefit ◽  
Metastatic Prostate Cancer ◽  
Androgen Deprivation ◽  
National Cancer Database ◽  
Younger Patients ◽  
Significant Difference ◽  
Overall Survival Benefit

Background Androgen deprivation therapy (ADT) remains a standard of care in metastatic prostate cancer. Recent prospective trials have explored addition of chemotherapy to ADT. We retrospectively examined overall survival in metastatic prostate cancer patients treated with ADT, chemotherapy plus ADT (C + ADT), or observation from 2004 to 2010 using National Cancer Database data. Methods Using the National Cancer Database, 21,977 patients with metastatic prostate cancer diagnosed from 2004 to 2010 were identified. Multivariate logistic regression, Kaplan-Meier survival analysis and Cox proportional hazards regression modeling were implemented, with overall survival as the primary endpoint. Results Five-year overall survival was 13.6% in patients aged ≥ 75 years vs. 30.1% (age 65–74) and 34.5% (age 18–64). Subgroup analysis of age-based cohorts (<65 and ≥65 years) showed poor overall survival for C + ADT vs. ADT alone, both in younger (HR 1.35, 95% CI 1.21–1.50; p < 0.0001) as well as older (HR 1.21, 95% CI 1.08–1.34; p = 0.0006) populations. Younger patients had no significant difference in overall survival for observation vs. ADT (HR 0.99, 95% CI 0.92–1.08; p = 0.9121). Besides age, other factors impacting overall survival included race, rural/urban settings, comorbidity score, income, PSA and radiation. Discussion Younger patients had no significant difference in overall survival between observation or ADT. This implies a group of younger patients in whom ADT does not confer any overall survival benefit. Future clinical trials with genetic and biologic markers are needed to delineate which subgroups would not benefit from C + ADT or ADT alone. This is of utmost clinical importance given the negative impact of ADT on quality of life and comorbidities.

Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer

2021 ◽  
pp. 89-94
Author(s):  
Philipp Dahm
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Adverse Events ◽  
Randomized Trial ◽  
Median Time ◽  
Androgen Deprivation Therapy ◽  
Androgen Deprivation ◽  
Chemohormonal Therapy ◽  
Androgen Ablation ◽  
Hormone Sensitive

This chapter summarizes the findings of the landmark Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) trial conducted in men with metastatic, hormone-sensitive prostate cancer comparing docetaxel therapy plus systemic androgen-deprivation therapy to androgen-deprivation therapy alone. It demonstrated improved median overall survival and median time to progression in the chemotherapy arm at the price of some increased severe adverse events.

scholarly journals The efficacy of cytoreductive surgery for oligometastatic prostate cancer: a meta-analysis

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Bisheng Cheng ◽  
Shuchao Ye ◽  
Peiming Bai
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Endocrine Therapy ◽  
Cytoreductive Surgery ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Cancer Specific Survival ◽  
Free Survival ◽  
Oligometastatic Prostate Cancer ◽  
Significant Difference

Abstract Backgrounds At present, the application of tumor reduction surgery in oligometastatic prostate cancer has aroused extensive discussion among urologists, but clinicians have not reached a consensus on this issue. The purpose of this study was to evaluate the effect of cytoreductive surgery for patients with oligometastatic prostate cancer by meta-analysis. Methods All relevant studies were systematically searched through The Cochrane Library, PubMed, Web of Science, EMBASE, and China Biomedical Literature Database (CBM) up to December 2019. All the previous clinical studies on the comparison of long-term efficacy between the cytoreductive surgery group and the endocrine therapy group were included in the search. The included studies were analyzed using Stata ver.14.0. The research has been registered on PROSPERO website with the registration number of crd42021224316. The relevant registration information can be obtained from the website: https://www.crd.york.ac.uk/prospero. Results The case presentation is as follows: ten studies were identified that met the conclusion criteria. The total number of samples was 804; 449 patients underwent cytoreductive surgery, and 355 patients underwent endocrine therapy, and we conducted a meta-analysis of studies to compare the prognosis of endocrine therapy and cytoreductive surgery for treating prostate cancer. After all the studies were analyzed, we found that between cytoreductive surgery and endocrine therapy, a significant difference existed in overall survival (HR = 0.635, 95% CI 0.443–0.908, P = 0.013), cancer-specific survival (HR = 0.407, 95% CI 0.243–0.681, P = 0.001), and progression-free survival (HR = 0.489, 95% CI 0.315–0.758, P = 0.001), while there were no significant difference in progresses to castration-resistant prostate cancer (HR = 0.859, 95% CI 0.475–1.554, P = 0.616). Conclusion The cytoreductive surgery held advantages in overall survival, cancer-specific survival, and progression-free survival. Therefore, compared with endocrine therapy, cytoreductive surgery could be a more suitable approach in treating oligometastatic prostate cancer.

scholarly journals Next-generation androgen receptor inhibitors in non-metastatic castration-resistant prostate cancer

2020 ◽  
Vol 12 ◽  
pp. 175883592097813
Author(s):  
Pernelle Lavaud ◽  
Clément Dumont ◽  
Constance Thibault ◽  
Laurence Albiges ◽  
Giulia Baciarello ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Androgen Receptor ◽  
Androgen Deprivation Therapy ◽  
Androgen Deprivation ◽  
Next Generation ◽  
Castration Resistant Prostate Cancer ◽  
Free Survival ◽  
Castration Resistant ◽  
Recent Advances

Until recently, continuing androgen deprivation therapy (ADT) and closely monitoring patients until evolution towards metastatic castration-resistant prostate cancer (CRPC) were recommended in men with non-metastatic CRPC (nmCRPC). Because delaying the development of metastases and symptoms in these patients is a major issue, several trials have investigated next-generation androgen receptor (AR) axis inhibitors such as apalutamide, darolutamide, and enzalutamide in this setting. This review summarizes the recent advances in the management of nmCRPC, highlighting the favourable impact of next-generation AR inhibitors on metastases-free survival, overall survival and other clinically meaningful endpoints.

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