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.

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 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.

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]

scholarly journals 935. Effect of Tesamorelin in People with HIV with and without Dorsocervical Fat: Post Hoc Analysis of Phase III Double Blind Placebo Control Trial

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S500-S501
Author(s):  
Farah Rahman ◽  
Marilyn de Chantal ◽  
Pedro Mesquita ◽  
Judith A Aberg
Keyword(s):  
Growth Hormone ◽  
Abdominal Fat ◽  
Fat Deposition ◽  
Phase Iii ◽  
Placebo Control ◽  
People Living With Hiv ◽  
Anthropometric Parameters ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract Background Lipohypertrophy is defined as excess fat deposition in abdominal defined as visceral adipose tissue (VAT) as well as in the dorsocervical region, breasts, trunk, and along with possible fat deposition in liver, muscle, myocardium and epicardium. Multiple factors have been described as contributing to lipohypertrophy in people living with HIV (PLWH), including patient characteristics, antiretroviral therapy (ART) and also impaired growth hormone (GH) secretion. Tesamorelin, a synthetic form of growth-hormone-releasing hormone (GHRH), is indicated for reduction of excess abdominal fat in PLWH with lipodystrophy Methods Post-hoc analysis was done on phase 3 randomized, double-blind, multicenter trials. Patients were eligible if between 18 and 65 years of age, had confirmed HIV infection, had evidence of excess abdominal fat accumulation and on stable ART regimen for 8 weeks or more. Participants were randomized to receive tesamorelin 2 mg daily or placebo daily for 26 weeks. Only tesamorelin responders, defined as patients with at least 8% decrease in VAT and who were adherent to the medication, were used for this analysis. Results are reported for patients with and without dorsocervical (DC) fat deposition. Results Demographic characteristics of responders at week 26 are shown according to presence or absence of DC fat (Table 1). At week 26, on average, the patients with DC fat deposition had higher BMI and waist circumference (WC) than the group without DC fat. Most patients in both groups had lipoatrophy. Metabolic and anthropometric parameters were measured at week 26 in patients with and without DC fat (Table 2). There was a decrease in VAT and also an improvement in their WC at week 26 in both groups. Table 1: Baseline Characteristics of Tesamorelin Responder Subjects at Week 26, by Dorsocervical Status Table 2: Change in Abdominal Adiposity, Insulin-Like Growth Factor-1 Levels, and Metabolic Parameters Between Baseline and Week 26 Among Tesamorelin Responders Conclusion This data demonstrates that tesamorelin is effective at reducing VAT in both patients with and without DC fat. The medication was well tolerated without significant changes to metabolic based measurements. Treatment of excessive VAT with tesamorelin has seemingly positive results in fat reduction in patients with or without DC fat deposition and our study contributes to the growing literature. Disclosures Marilyn de Chantal, PhD, Theratechnologies Inc (Employee) Pedro Mesquita, PhD, Theratechnologies, Inc. (Employee) Judith A. Aberg, MD, Theratechnology (Consultant)

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