Combination of statin/vitamin D and metastatic castration-resistant prostate cancer (mCRPC): A post-hoc analysis of two randomized clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6617-6617
Author(s):  
Guillermo de Velasco ◽  
David Lora ◽  
Alberto Carretero-Gonzalez ◽  
Maria Cruz Martin Soberón ◽  
Juan Manuel Manuel Sepulveda Sanchez ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Vitamin D ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Data Access ◽  
Phase Iii ◽  
Cox Regression Analysis ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
The Impact

6617 Background: Retrospective database studies have suggested that statins and vitamin D have a positive impact on prostate cancer survival and specifically in mCRPC patients (pt). Methods: We conducted a post-hoc analysis of individual pt data of mCRPC pts treated with abiraterone (AA) and/or Prednisone (P) on two randomized phase III clinical trials COU -AA-301 and COU-AA-302 to analyze the impact of statins and vitamin D in overall survival (OS). Statistical analyses were performed using the Kaplan Meier method and Independent predictors were investigated using Cox regression analysis. This study, carried out under YODA Project #2016-1136, used data obtained from the Yale University Open Data Access Project. Results: These two studies included 2280 patients (1340 treated with AA/P and 640 with P). Use of Statin + vitamin D was associated with a 38% reduction in mortality in the postdocetaxel setting and 32% in the predocetaxel setting in patients treated with abiraterone (Table 1 and 2). No significant reduction in the rate of skeletal-related events was seen in patients treated with vitamin D or statins. Conclusions: To our knowledge this is the first report suggesting the impact of vitamin D+statin in mCPRC treated with abiraterone. The potential benefits of vitamin D do not seem to be secondary to concomitant statin use in this population. Further studies are needed to confirm these results. [Table: see text][Table: see text]

Impact of statins on outcomes in patients (pts) with metastatic castration resistant prostate cancer (mCRPC): Post-hoc analysis of data from COU-AA-301 and COU-AA-302 trials.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 230-230
Author(s):  
Guillermo de Velasco ◽  
David Lora ◽  
David Lorente ◽  
Toni K. Choueiri ◽  
Christopher Sweeney ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Prognostic Factors ◽  
Randomized Clinical Trials ◽  
Cox Regression ◽  
Phase Iii ◽  
Interventional Treatment ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
The Impact ◽  
Statin Use

230 Background: Retrospective database studies have suggested that statins may have a positive impact on some mCRPC pts treated with prednisone (P)/abiraterone (AA) Methods: We conducted a post-hoc analysis of individual pt data of mCRPC pts treated with AA and/or P on randomized phase III clinical trials COU -AA-301 and COU-AA-302 to analyze the impact of statins on overall survival (OS). Statistical analyses were performed using the Kaplan Meier method and Cox regression adjusted for known prognostic factors. This study, was carried out under YODA Project #2016-1136 Results: 458 (41%) prechemotherapy pts and 348 (29%) postchemotherapy pts were statins users (Table). Improved OS was observed for mCPRC pts who were statins users in the postdocetaxel setting [HR: 0.82 (95% CI: 0.71 to 0.94); p = 0.006], and there was a trend towards a prolonged OS in the predocetaxel setting [HR: 0.89 (95% CI: 0.77 to 1.03); p = 0.13] adjusted by interventional treatment (AA and/or P). In the predocetaxel setting there were no significant differences in OS between the groups AA/P/non-statin users and placebo/P/statin users (p=0.3). In the multivariate analysis, patients randomized to AA/P who were statins users and presenting ECOG <2 had superior OS in the postdocetaxel setting. Similarly, age, ECOG and statin use were the strongest prognostic factors in the predocetaxel setting. Conclusions: In a post-hoc analysis of two prospective randomized clinical trials statin use was associated with superior OS in mCPRC pts treated with P or AA/P. Further studies are needed to confirm these results and guide use of statins as adjunct to P and A. [Table: see text]

25572 Impact of risankizumab on the duration of PASI90 achievement: A post hoc analysis of 4 phase III clinical trials

2021 ◽  
Vol 85 (3) ◽  
pp. AB62
Author(s):  
Mark G. Lebwohl ◽  
Ahmed M. Soliman ◽  
Hongbo Yang ◽  
Jessie Wang ◽  
Sarah H. Koenigsberg ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Post Hoc Analysis ◽  
Phase Iii Clinical Trials ◽  
Post Hoc

scholarly journals High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

2020 ◽  
Vol 08 (05) ◽  
pp. E628-E635
Author(s):  
Michael S. Epstein ◽  
Robert Benamouzig ◽  
Juha Halonen ◽  
Raf Bisschops
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Combined Treatment ◽  
Sulfate Solution ◽  
Lesion Detection ◽  
High Quality ◽  
Post Hoc Analysis ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Post Hoc

Abstract Background and study aims Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol (PEG) NER1006 versus 2 + 1 L PEG + ascorbate (2LPEG) or 1 + 2 L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0–4 (high-quality = HCS 3–4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29 % vs. 20 %; P < 0.001) and HCS 4 scores (20 % vs. 17 %; P = 0.007) versus 2LPEG/OSS. More polyps (678 versus 585) and adenomas (397 versus 331) were detected with NER1006 (N = 517) versus 2LPEG/OSS (N = 520). In all neoplasia-positive patients, with increasing minimal per-patient neoplasia multiplicity from 1 to 10, NER1006 numerically improved MPP (difference ± SE: 0.48 ± 0.24 to 3.89 ± 3.37) and MAP (0.47 ± 0.26 to 7.50 ± 9.00) versus 2LPEG/OSS. Conclusions Low-volume NER1006 enhances high-quality cleansing versus medium-volume 2LPEG or OSS, individually and when combined. NER1006 may consequently facilitate the detection of multiple neoplasia in patients.

scholarly journals Four-Factor Prothrombin Complex Concentrate Reduces Time to Procedure in Vitamin K Antagonist-Treated Patients Experiencing Gastrointestinal Bleeding: A Post Hoc Analysis of Two Randomized Controlled Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Majed A. Refaai ◽  
Truptesh H. Kothari ◽  
Shana Straub ◽  
Jacob Falcon ◽  
Ravi Sarode ◽  
...  
Keyword(s):  
Gastrointestinal Bleeding ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Invasive Procedure ◽  
Vitamin K Antagonist ◽  
Phase Iii ◽  
Two Phase ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
The Impact

Introduction. To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex®/Kcentra®]) versus plasma on “time to procedure” in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. Methods. A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure. Results. Analysis included 42 patients (plasma, n=20; 4F-PCC, n=22). Median (interquartile range) infusion time was significantly shorter for the 4F-PCC group than for the plasma group (16 [13, 26] min versus 210 [149, 393] min; P<0.0001). Median infusion volumes were significantly smaller (103 [80, 130] mL versus 870 [748, 1001] mL; P<0.0001) and median time from study treatment initiation to first procedure was significantly shorter in the 4F-PCC group than in the plasma group (17.5 [12.8, 22.8] versus 23.9 [18.5, 62.0] h; P=0.037). Conclusions. In this analysis of patients with acute/severe gastrointestinal bleeding requiring urgent VKA reversal prior to an invasive procedure, 4F-PCC (compared with plasma) was associated with smaller infusion volumes, shorter infusion times, and reduced time to procedure.

Effect of race on the safety and efficacy of pemetrexed (P) therapy in locally advanced and metastatic non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18082-18082
Author(s):  
D. F. Tai ◽  
P. Kulkarni ◽  
Y. Wang ◽  
J. Gill ◽  
C. Obasaju
Keyword(s):  
Clinical Trials ◽  
Cox Model ◽  
Single Agent ◽  
Locally Advanced ◽  
Phase Iii ◽  
Disease Stage ◽  
Safety And Efficacy ◽  
Post Hoc Analysis ◽  
Caucasian Patients ◽  
Post Hoc

18082 Background: P is a multitargeted antifolate active in NSCLC. While a number of clinical trials have evaluated P safety and efficacy in general patient populations, little is known of the possible impact of race on the utility of P therapy in NSCLC. The objective of this post-hoc analysis was to evaluate the effect of race on the safety and efficacy of P (single-agent or in combination) in patients with locally advanced and metastatic NSCLC. Methods: Data from 6 trials with at least 5% non-Caucasian patients were pooled for analyses. One Phase III trial evaluated P in a second-line setting. All other trials used P in Phase II first-line settings. Patients were given at least one dose of P (single-agent or in combination) at 600 mg/m2 (59 patients) or 500 mg/m2 (469 patients) every 21 days. Demographic, safety, and efficacy data were stratified broadly by race, to either Caucasian or non-Caucasian groups. Kaplan-Meier method was used to estimate median survival. The Cox model was used to calculate the hazard ratio (HR) for survival, adjusting for significant prognostic factors, including disease stage, performance status, gender, and line of treatment. Results: Results are summarized in the data table below. The adjusted HR for survival (non-Caucasian versus Caucasian) was 0.89 (p=0.365). Conclusions: In this post-hoc analysis of results from clinical trials using P therapy in NSCLC, race did not have a statistically significant impact on response rate, disease control rate, or survival. However, P therapy appeared to be better tolerated by non-Caucasian patients. [Table: see text] No significant financial relationships to disclose.

Impact of on-study corticosteroid use on efficacy and safety in the phase III AFFIRM study of enzalutamide (ENZA), an androgen receptor inhibitor.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 6-6 ◽  
Author(s):  
Howard I. Scher ◽  
Karim Fizazi ◽  
Fred Saad ◽  
Kim N. Chi ◽  
Mary-Ellen Taplin ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Post Hoc Analysis ◽  
Castration Resistant ◽  
Study Results ◽  
Psa Progression ◽  
Grade 3 ◽  
Post Hoc ◽  
The Impact

6 Background: ENZA increased median overall survival (OS) by 4.8 mo (P <0.001, HR 0.63) vs placebo (PBO) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) post-docetaxel in AFFIRM (HI Scher et al, NEJM 2012). Corticosteroids (CS) can activate AR signaling in nonclinical models (J Richards, Can Res 2012). In a multivariate model of AFFIRM data baseline CS use was associated with reduced OS (HI Scher et al. ESMO 2012 abstract 899PD). The impact of CS use during study treatment in AFFIRM was evaluated to test if concomitant CS use is also associated with inferior outcomes. Methods: Pts were randomized 2:1 to ENZA 160 mg/d or PBO. Pts were allowed but not required to take CS. OS was the primary endpoint. In a post-hoc analysis On-study CS use was defined as oral CS user for ≥ 1 day on study. Results: On study CS use was 48% in ENZA and 45% in PBO pts. Prognostic factors were slightly better in the no CS group compared to the CS group. Use of CS regardless of treatment was associated median OS of 11.5 mo (95% CI: 10.5, 13.0) for CS pts vs median OS NM (NM, NM) for no CS pts (HR=0.40; 95% CI: 0.33, 0.48). ENZA was consistently superior to PBO for OS, radiographic progression free survival (rPFS) and time to PSA progression (TTPP), regardless of CS use (Table). Pts on CS had higher rates of grade 3 - 4 adverse events (AE) compared to no CS pts: 63.3% vs 34.4% respectively. Conclusions: In this post-hoc analysis, on study CS use was associated with reduced OS and higher rates of grade 3 -4 AEs in mCRPC pts post-docetaxel. While CS pts had worse outcomes, ENZA was consistently superior to PBO regardless of on study CS use. The inferior outcomes in CS pts may be due to unmeasured confounders or the biologic properties of CS use itself. Clinical trial information: NCT00974311. [Table: see text]

scholarly journals Clinical response beyond the Systemic Lupus Erythematosus Responder Index: post-hoc analysis of the BLISS-SC study

2018 ◽  
Vol 5 (1) ◽  
pp. e000288 ◽  
Author(s):  
Ronald F van Vollenhoven ◽  
William Stohl ◽  
Richard A Furie ◽  
Norma Lynn Fox ◽  
James G Groark ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Activity Index ◽  
Phase Iii ◽  
Controlled Study ◽  
Systemic Lupus ◽  
Post Hoc Analysis ◽  
Post Hoc

ObjectiveThe Systemic Lupus Erythematosus (SLE) Responder Index (SRI), developed as a primary outcome measure for use in clinical trials, captures improvement in SLE disease activity without concomitant worsening in disease manifestations. This study investigated the relationships between the SRI and clinical/laboratory correlates of SRI response in patients with SLE.MethodsThis was a post-hoc analysis of the phase III, double-blind, placebo-controlled study of subcutaneous BeLimumab in Subjects with Systemic lupus erythematosus - SubCutaneous (BLISS-SC). Patients were randomised to weekly belimumab 200 mg subcutaneously or placebo, plus standard SLE therapy. Changes from baseline to week 52 in clinical and laboratory parameters were compared among SRI responders and non-responders, irrespective of the treatment received.ResultsSRI responders (n=475) had significantly better (p<0.0001) outcomes compared with non-responders (n=358), including (by definition) higher proportions achieving ≥4-point improvement in Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (100.0% vs 2.0%), no worsening in British Isles Lupus Assessment Group (BILAG; 0 new BILAG A or ≤1 new BILAG B score; 100.0 % vs 50.3%) and no worsening (<0.3-point increase) in Physician’s Global Assessment score (100.0% vs 49.7%). Among patients receiving >7.5  mg/day corticosteroids at baseline, significantly more SRI responders had reductions in prednisone dose to ≤7.5 mg/day than non-responders. SRI responders reported lower flare rates and improvements in serological markers and Functional Assessment of Chronic Illness Therapy-Fatigue score than non-responders.ConclusionSRI response is associated with improvements in clinical and laboratory measures, strengthening its value as a clinically meaningful primary endpoint in clinical trials.

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