The impact of docetaxel (D) in an older population of patients with advanced prostate cancer (PC): A simulation study using TAX327 and SEER Medicare data

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16074-e16074
Author(s):  
E. Onukwugha ◽  
C. D. Mullins ◽  
N. Obeidat ◽  
B. Seal ◽  
A. Hussain

e16074 Background: The survival benefit of D in treatment of hormone refractory PC (HRPC) has been established in the TAX327 trial, but it is unclear how this benefit would translate in a heterogeneous population. This study sought to simulate the survival impact of D in a population of older pts with M1 PC on androgen deprivation therapy (ADT). Methods: A combination of TAX327 trial data and SEER-Medicare (SM) data were used. In pts age 69+ and randomized to D (every 3 weeks, D3P) or mitoxantrone (M), trial data showed a survival benefit for D. Accordingly, SM pts age 69+ diagnosed with M1 PC between 1994 and 2002 and receiving only ADT were selected. Graphical plots and statistical tests were used to find best-fitting parametric survival functions for D3P, M, and SM pts. The survival benefit for D was imposed on unadjusted and covariate-adjusted SM survival curves. The simulated benefit was assessed at 12 mos and 24 mos post-diagnosis of M1 PC in SM pts. Results: There were 326 TAX327 trial pts (D3P = 159, M = 167) used in the analysis. Median survival was 15.7 mos (12.6 - 19) in the M arm and 18.9 mos [17 - 21.8] in the D3P arm (p = 0.03). There were 3,515 SM pts, based on inclusion criteria. Median survival benefit of D was 3.2 mos based on Kaplan-Meier estimates and 2.4 mos using parametric curves in the TAX327 69+ group. Following covariate-adjustment in the SM sample, at 12 mos post-diagnosis, the median survival in mos was 61.7 (CI 36.3 - 87) in the ADT group and 62 (CI 37.6 - 87.1) in the simulated ADT+D group (i.e., 0.3 mos simulated benefit of D). A 0.8 mos simulated benefit was found if D was initiated 24 mos post diagnosis (in pts more likely to have HRPC). Conclusions: The survival benefit of docetaxel from the TAX327 trial is attenuated in a heterogeneous SEER-Medicare sample, and the simulated survival benefit is larger among patients who are more likely to have hormone refractory prostate cancer. [Table: see text]

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 244-244
Author(s):  
Aabra Ahmed ◽  
Timothy Dean Malouff ◽  
Ryan W Walters ◽  
Sydney Marsh ◽  
Peter T. Silberstein

244 Background: There is growing evidence of the impact of socioeconomic status on survival in cancer patients. To our knowledge, this is the largest study to examine demographics and the association between income and survival in patients with stage IV prostate cancer. Methods: Using the National Cancer Database, 50,639 patients diagnosed with stage IV prostate cancer between 2004-2011 were identified. Income was evaluated using the median income of the patient’s zip code. Between-income survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted p < .05 indicated statistical significance. Results: Survival differences were indicated between all income quartiles. Median survival was highest for patients in zip codes with a median income ≥ $63,000 and lowest for patients in zip codes with an income < $38,000 (46.1 months vs. 31.6 months, respectively; p < .001). As such, 41% of patients in zip codes with a median income ≥ $63,000 were alive five years following diagnosis, compared to 31% of patients in zip codes with median income < $38,000. Additionally, compared to patients in zip codes in which the median income was < $38,000, patients in zip codes with a median income ≥ $63,000 had a higher rate of zero comorbidities (81% vs. 76%), a greater percentage of patients living in an area where >93% people have a high school degree (58% vs 1%), and a lower proportion of African Americans (8% vs 41%). Conclusions: Compared to patients with a median income < $38,000, patients in zip codes with a median income > $63,000 had a median survival nearly 15 months longer, had 10% more patients alive after 5 years, and had fewer comorbidities. [Table: see text]


BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yechen Wu ◽  
Xi Chen ◽  
Duocheng Qian ◽  
Wei Wang ◽  
Yiping Zhang ◽  
...  

Abstract Background A history of prior cancer commonly results in exclusion from cancer clinical trials. However, whether a prior cancer history has an adversely impact on clinical outcomes for patients with advanced prostate cancer (APC) remains largely unknown. We therefore aimed to investigate the impact of prior cancer history on these patients. Methods We identified patients with advanced prostate cancer diagnosed from 2004 to 2010 in the Surveillance, Epidemiology, and End Results (SEER) database. Propensity score matching (PSM) was used to balance baseline characteristics. Kaplan–Meier method and the Cox proportional hazard model were utilized for survival analysis. Results A total of 19,772 eligible APC patients were included, of whom 887 (4.5 %) had a history of prior cancer. Urinary bladder (19 %), colon and cecum (16 %), melanoma of the skin (9 %) malignancies, and non-hodgkin lymphoma (9 %) were the most common types of prior cancer. Patients with a history of prior cancer had slightly inferior overall survival (OS) (AHR = 1.13; 95 % CI [1.02–1.26]; P = 0.017) as compared with that of patients without a prior cancer diagnosis. Subgroup analysis further indicated that a history of prior cancer didn’t adversely impact patients’ clinical outcomes, except in patients with a prior cancer diagnosed within 2 years, at advanced stage, or originating from specific sites, including bladder, colon and cecum, or lung and bronchus, or prior chronic lymphocytic leukemia. Conclusions A large proportion of APC patients with a prior cancer history had non-inferior survival to that of patients without a prior cancer diagnosis. These patients may be candidates for relevant cancer trials.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5156-5156
Author(s):  
M. Nakabayashi ◽  
O. Sartor ◽  
S. Jacobus ◽  
M. M. Regan ◽  
D. K. McKearn ◽  
...  

5156 Background: Effective treatment options for HRPC patients are limited. We evaluated efficacy of D/C-based chemotherapy as first- and second-line chemotherapy. Methods: We retrospectively identified all patients with HRPC treated with D/C-based chemotherapy at DFCI. Regimens either included estramustine (EDC) or not (DC). Patients treated with EDC received D 20–70 mg/m2 q1–4 weeks, E 140mg TID and C AUC 4–6 q 3–4 weeks. Patients treated with DC received D 50–70 mg/m2 and C AUC 4–5 q 3–4 weeks. PSA declines and measurable response were assessed per PSA Working Group and RECIST criteria, respectively. Time to event from chemotherapy initiation based on Kaplan-Meier method. Results: 58 patients were included: 27 patients received EDC, 35 received DC, and 4 received both regimens. Median age and PSA at initiation of chemotherapy was 58 years (range: 42–78) and 132.6 ng/ml (range: 0.3–5352.5), respectively. Table shows median duration of PSA response and TTP, by regimen. Most patients received EDC as first-line chemotherapy (89%). PSA declines ≥ 50% were observed in 24 patients (88.9%, 95% C.I. 71–98) and PSA declined in all 27 patients by a median of 81.3 % (range 33–100). Of 8 patients with measurable disease (MD), 2 had confirmed PR and 4 had SD. Median survival was 17.5 months (95% C.I. 12.0–24.5). 34 out of 35 patients received DC as ≥ 2nd line chemotherapy. PSA declines ≥ 50% were seen in 7 DC patients (20%, 95%C.I. 8–37) and PSA declined in 24 patients with a median of 37.7 % (range 2.0–100). Of 15 patients with MD at baseline, one had confirmed CR, one had PR, and 6 patients had SD. Median survival was 14.8 months (95% C.I. 9–19). The most common reversible grade 4 toxicity with either regimen was neutropenia (6.9%). Conclusions: D/C-based chemotherapy is well tolerated and active in HRPC. As first line chemotherapy, EDC demonstrated PSA declines ≥50% in 88.9% of patients. DC was active as ≥ 2nd-line chemotherapy with PSA declines ≥50% seen in 20%. [Table: see text] No significant financial relationships to disclose.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 439-439 ◽  
Author(s):  
Navid Hafez ◽  
Rong Wang ◽  
Michael E. Hurwitz ◽  
Xiaomei Ma ◽  
Daniel Peter Petrylak

439 Background: The male predilection of urothelial bladder cancer (UBC) as well as the expression of the androgen receptor in bladder tissue point to the role for androgens in UBC tumorigenesis. Animal studies demonstrate a potential role for androgen deprivation in diminishing UBC. More recently, two separate groups demonstrated decreased rates of both primary and recurrent UBC in prostate cancer patients previously receiving androgen deprivation therapy (ADT). Given the common use of radiation therapy (RT) in the treatment of localized prostate cancer, and previous data supporting the increased frequency of UBC in prostate cancer patients treated with RT, the interaction between ADT and RT in UBC remains an important consideration. Methods: Using the linked SEER-Medicare database, we investigated the interactions among ADT, RT and UBC by performing a retrospective cohort study of elderly (age 66-99) prostate cancer patients diagnosed between 1999-2011. Kaplan-Meier analysis and Cox proportional modeling were used to determine the risk of developing secondary bladder cancer after prostate cancer treatment (based on exposure to ADT, RT, both, or neither). All analyses were two-sided. Results: Of 121,927 patients with primary prostate cancer, 1,466 (1.20%) developed subsequent UBC with a median follow up of 5.08 years (range 0.003-12.00). Compared with patients never receiving ADT or RT (n = 43,809), the hazard ratios for the development of secondary bladder cancer in patients ever receiving ADT but no RT (n = 14,009), RT but no ADT (n = 16,672), or both ADT and RT (n = 17,465) were 0.76 (95% confidence interval [CI]: 0.63-0.91 ), 0.73 (95% CI: 0.64-0.83), and 0.69 (95% CI: 0.61-0.79), respectively. Conclusions: Both ADT and RT are independently associated with a reduced risk of secondary bladder cancers in prostate cancer patients. The finding of decreased UBC incidence in patients receiving RT was surprising, and in direct contradiction to previous studies of similar patient populations. Possible explanations include differences in cohort selection, changes in RT delivery, and differences in control groups.


Author(s):  
Sazan Rasul ◽  
Markus Hartenbach ◽  
Tim Wollenweber ◽  
Elisabeth Kretschmer-Chott ◽  
Bernhard Grubmüller ◽  
...  

Abstract Background and aims [177Lu]Lu-PSMA-617 radioligand therapy (PSMA-RLT) is a new therapy for patients with metastatic castration-resistant prostate cancer (mCRPC). However, identification of reliable prognostic factors is hampered by heterogeneous treatment regimens applied in previous studies. Hence, we sought clinical factors able to predict response and survival to PSMA-RLT in a homogenous group of patients, all receiving 7400 MBq every 4 weeks. Patients and methods Data of 61 patients (mean age 71.6 ± 6.9 years, median basal PSA 70.7 [range 1.0–4890 μg/L]), pretreated with abiraterone/enzalutamide (75.4%) and docetaxel/cabazitaxel (68.9%), received three cycles of PSMA-RLT (mean 7321 ± 592 MBq) at four weekly intervals and were analyzed retrospectively. General medical conditions and laboratory parameters of every patients were regularly assessed. Response to therapy was based on PSA levels 1 month after the 3rd cycle. Binary logistic regression test and Kaplan-Meier estimates were used to evaluate predictors and overall survival (OS). Results Forty-nine (80.3%) patients demonstrated a therapy response in terms of any PSA decline, while 21 (19.7%) patients showed increase or no changes in their PSA levels. Baseline hemoglobin (Hb) significantly predicted PSA reductions of ≥ 50% 4 weeks after receiving the 3rd PSMA-RLT (P = 0.01, 95% CI: 1.09–2.09) with an AUC of 0.68 (95% CI: 0.54–0.81). The levels of basal Hb and basal PSA were able to predict survival of patients, both P < 0.05 (relative risk 1.51 and 0.79, 95% CI: 1.09–2.09 and 0.43–1.46), respectively. In comparison to patients with reduced basal Hb, patients with normal basal Hb levels lived significantly longer (median survival not reached vs. 89 weeks, P = 0.016). Also, patients with basal PSA levels ≤ 650 μg/L had a significantly longer survival than patients with basal PSA levels > 650 μg/L (median survival not reached vs. 97 weeks, P = 0.031). Neither pretreatments with abiraterone/enzalutamide or docetaxel/cabazitaxel nor distribution of metastasis affected survival and rate of response to PSMA-RLT. Conclusion Basal Hb level is an independent predictor for therapy response and survival in patients receiving PSMA-RLT every 4 weeks. Both baseline PSA ≤ 650 μg/L and normal Hb levels were associated with longer survival.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4558-4558 ◽  
Author(s):  
A. M. Lin ◽  
J. E. Rosenberg ◽  
V. K. Weinberg ◽  
W. K. Kelly ◽  
M. D. Michaelson ◽  
...  

4558 Background: The clinical course of TR HRPC pts has not previously been evaluated in a large, prospective study. No standard treatment exists for this pt population, although MP is frequently used. Ix is an epothilone B analogue with activity against TR cell lines. Methods: Metastatic HRPC pts with disease progression during or within 60 days of stopping T chemotherapy were eligible. In a 2-arm, non-comparative randomized phase II study, pts were assigned to receive either: 1) M 14 mg/m2 IV q3wks and P 5 mg PO BID or 2) I × 35 mg/m2 IV q3wks. Crossover was allowed for progression or toxicity. The study’s primary endpoint was to detect a ≥ 50% PSA decline by Consensus Criteria in at least 25% of 2nd-line pts (H0 = 10%, α = 0.04, β = 0.18 for each arm). Pts were followed for survival. Results: Forty-one evaluable pts each were accrued to Ix and to MP. The median follow-up is 5.0 months (range: 0.3–19.5). The median number of cycles administered to each 2nd-line arm is 3 (range: Ix: 1–8, MP: 1–12). Median survival from protocol entry is 13.0 months with Ix and 12.5 months with MP. Confirmed 2nd-line post-therapy (rx) ≥50% PSA declines were observed in 17% of Ix pts (95% CI = 7–32) and 20% of MP pts (95% CI = 9–35). Of pts with measurable disease, partial responses were observed in 1/18 pts on 2nd-line Ix (6%; 95% CI = 0.1–27.3) and in 1/15 pts on 2nd-line MP (7%; 95% CI = 0.2–31.9). Median duration on 2nd-line Ix and MP was 2.2 months and 2.3 months, respectively. Crossover to 3rd-line rx occurred in 39% of Ix pts and 68% of MP pts. Confirmed 3rd-line post-rx ≥50% PSA declines were observed in 3/24 Ix pts and in 4/13 MP pts. The most common grade 3/4 toxicity associated with 2nd-line rx was neutropenia as previously reported (41% of Ix pts, 54% of MP pts). Conclusions: This prospective trial has characterized TR HRPC pts as having an observed median survival of approximately 1 year. This may be a useful reference for the screening of effective agents in the 2nd-line setting for TR HRPC. Both Ix and MP appear to have only modest activity as 2nd- and 3rd-line rx in this highly selected TR HRPC population. This study was supported by Bristol-Myers Squibb and the Prostate Cancer Foundation. No significant financial relationships to disclose.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14617-14617
Author(s):  
N. T. Rich ◽  
B. J. Smith ◽  
D. A. Vaena

14617 Background: Prior studies associated statin use with prevention and reduced progression of prostate cancer. (Platz et al, 96th AACR abst. 4374). However, the effects of statins in hormone refractory prostate cancer (HRPC) are unknown. We evaluated the impact of statins on survival of HRPC patients by comparing actual survival data with predicted survival using the Halabi nomogram (JCO 21:(7);1232). Methods: Using the Iowa City VA (ICVA) prescription database since 2001 along with chart review, we identified 28 consecutive patients who were prescribed statins when they had HRPC. Survival information, duration of statin use while HRPC, and Halabi nomogram variables were collected (Hb, PS, Alk Phos, Gleason, PSA). An LDH value of 90 U/L (low-normal at ICVA) was used for all patients, since LDH values were not available. Log-rank and and Cox regression analyses were performed. The outcome of interest was overall survival. Patients alive at last follow-up were censored. Statin use was treated as a time-dependent covariate in the regression analysis, and subject-specific predicted survival from the Halabi nomogram as another covariate. Results: 17 patients were alive and 11 had died. Median duration of follow-up for patients alive was 23 months. The observed vs. nomogram-predicted estimated median survivals were 36 vs. 17 months, respectively. Study patients significantly outlived their nomogram-predicted survival (p = 0.0004). Four patients had negative bone scans. 12 patients outlived their nomogram, 8 died before, and 8 were indeterminate (censored prior to their Halabi-predicted survival). Risk of death decreased with greater length of statin use (p = 0.02). When covariates for Halabi nomogram and statin use were both included in a multivariate regression model, neither was statistically significant, although similar point estimates for the relative risks were obtained. Conclusions: Statin use, and longer duration of use, significantly improved survival of HRPC patients in univariate analysis. The sample size limits the multivariate analysis. Evaluation of a time-dependent statin effect in HRPC could be considered in larger studies. No significant financial relationships to disclose.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8590-8590
Author(s):  
T. N. Kirk ◽  
M. A. Moyad

8590 Background: Over 50,000 men developed hormone refractory prostate cancer (HRPC) in 2005 (CancerMetrics 2005). The objective of this analysis is to understand patient attitudes towards advancing prostate cancer (PC) and treatment. Methods: Patients were recruited from NexCura’s database of users and links from PC websites: UsTOO, PCRI, PCF and PAACT. Board certified physicians who treat HRPC were recruited by J. Reckner & Assoc. Responses were collected via online survey and analyzed by TSC, a division of Yankelovich. Grant funding from Abbott. The scale was “agree”, strongly agree”, “disagree” or “strongly disagree.” Results: 409 HRPC patients (P), 236 caregivers (C), 100 urologists (U) and 104 oncologists (O) participated. 45% of patients have metastatic HRPC. Mean patient age was 65.7 and age at diagnosis was 60.2. Conclusions: Many patients and caregivers have difficulty with advancing PC. Respondents recognize the survival benefit associated with chemotherapy, but attitude on its impact on quality of life varies significantly. Disparity exists between patients, caregivers and physicians on the impact of treatment on quality of life. Additional education, enhanced dialogue and additional treatment options are needed for HRPC patients, caregivers and physicians. [Table: see text] [Table: see text]


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