scholarly journals Erenumab prevents the occurrence of migraine attacks and not just migraine days: Post-hoc analyses of a phase III study

Cephalalgia ◽  
2021 ◽  
pp. 033310242110103
Author(s):  
Hans-Christoph Diener ◽  
Messoud Ashina ◽  
Shannon Ritter ◽  
Gabriel Paiva Da Silva Lima ◽  
Soeren Rasmussen ◽  
...  
Keyword(s):  
Migraine Attack ◽  
Treatment Phase ◽  
Episodic Migraine ◽  
Trial Registration ◽  
Phase Iii ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Phase Iii Study ◽  
A Minor ◽  
Post Hoc

Background This post-hoc analysis was conducted to evaluate the effect of erenumab on monthly migraine days, monthly migraine attacks, and attack duration in patients with episodic migraine to investigate whether erenumab actually prevents the occurrence of migraine attacks and/or shortens them. Methods We conducted a post-hoc analysis of the data from the STRIVE study, in 955 patients with episodic migraine. Relative changes from baseline to mean over months 4, 5 and 6 of the double-blind treatment phase in monthly migraine days, monthly migraine attacks and mean migraine attack duration were assessed. Results Erenumab reduced monthly migraine days and monthly migraine attacks compared with placebo in a similar way. Erenumab had only a minor impact on shortening the duration of migraine attacks. Conclusion These post-hoc analyses demonstrate that the decrease in monthly migraine days by erenumab is mainly driven by a reduction in the frequency of monthly migraine attacks and to a much lesser extent by shortening the duration of migraine attacks. Trial registration: This study is registered at ClinicalTrials.gov (NCT02456740)

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)

scholarly journals Pain Progression at Initiation of Cabazitaxel in Metastatic Castration-Resistant Prostate Cancer (mCRPC): A Post Hoc Analysis of the PROSELICA Study

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1284
Author(s):  
Nicolas Delanoy ◽  
Debbie Robbrecht ◽  
Mario Eisenberger ◽  
Oliver Sartor ◽  
Ronald de Wit ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Radiological Progression ◽  
Post Hoc Analysis ◽  
Psa Response ◽  
Phase Iii Study ◽  
Psa Progression ◽  
Previously Treated ◽  
Post Hoc

Background: In the PROSELICA phase III trial (NCT01308580), cabazitaxel 20 mg/m2 (CABA20) was non-inferior to cabazitaxel 25 mg/m2 (CABA25) in mCRPC patients previously treated with docetaxel (DOC). The present post hoc analysis evaluates how the type of progression at randomization affected outcomes. Methods: Progression type at randomization was defined as follows: PSA progression only (PSA-p; no radiological progression (RADIO-p), no pain), RADIO-p (±PSA-p, no pain), or pain progression (PAIN-p, ±PSA-p, ±RADIO-p). Relationships between progression type and overall survival (OS), radiological progression-free survival (rPFS), and PSA response (confirmed PSA decrease ≥ 50%) were analyzed. Results: All randomized patients (n = 1200) had received prior DOC, and 25.7% had received prior abiraterone or enzalutamide. Progression type at randomization was evaluable in 1075 patients (PSA-p = 24.4%, RADIO-p = 20.8%, PAIN-p = 54.8%). Pain progression was associated with clinical and biological features of aggressive disease. Median OS from CABA initiation or date of mCRPC diagnosis, all arms combined, was shorter in the PAIN-p group than in the RADIO-p or the PSA-p groups (12.0 versus 16.8 and 18.4 months, respectively, p < 0.001). In multivariate analysis, all arms combined, PAIN-p was an independent predictor of poor OS (HR = 1.44, p < 0.001). PSA response, rPFS, and OS were numerically higher with CABA25 versus CABA20 in patients with PAIN-p. Conclusions: This post hoc analysis of the PROSELICA phase III study shows that pain progression at initiation of CABA in mCRPC patients previously treated with DOC is associated with a poor prognosis. Disease progression should be carefully monitored, even in the absence of PSA rise.

Understanding the Prognostic Value of Primary Tumor Location and KRAS in Metastatic Colorectal Cancer: A Post Hoc Analysis of the OPTIMOX3 DREAM Phase III Study

2020 ◽  
Vol 19 (3) ◽  
pp. 200-208.e1 ◽  
Author(s):  
Benoist Chibaudel ◽  
Thierry André ◽  
Christophe Tournigand ◽  
Christophe Louvet ◽  
Magdalena Benetkiewicz ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Primary Tumor ◽  
Prognostic Value ◽  
Tumor Location ◽  
Phase Iii ◽  
Primary Tumor Location ◽  
Post Hoc Analysis ◽  
Phase Iii Study ◽  
Post Hoc

Post hoc analysis of a phase III study to test the association between circulating methylated glutathione s transferase (mGSTP1) DNA levels and response to docetaxel (DTX) in metastatic castration resistant prostate cancer (mCRPC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5014-5014
Author(s):  
Kate Lynette Mahon ◽  
Wenjia Qu ◽  
Hui-Ming Lin ◽  
Calan Spielman ◽  
Daniel Cain ◽  
...  
Keyword(s):  
Cpg Island ◽  
Multivariable Analysis ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Serum Samples ◽  
Full Cohort ◽  
Post Hoc Analysis ◽  
Time Points ◽  
Phase Iii Study ◽  
Post Hoc

5014 Background: GSTP1 inactivation is associated with CpG island hypermethylation in > 99% prostate cancers. Detection of circulating mGSTP1 DNA predicts response to DTX and overall survival (OS) in phase I/II mCRPC cohorts. This post hoc analysis of a phase III study aims to test the association between circulating mGSTP1 DNA levels and outcomes. Methods: The phase III SYNERGY study tested DTX +/- custirsen as 1st line chemotherapy in mCRPC (n = 1022) with no OS benefit in the experimental arm. Serum samples were taken at baseline (BL) and preC3 of DTX +/- custirsen from 600 patients (pts) enrolled on the SYNERGY study. mGSTP1levels in free DNA were measured using a sensitive methylation specific PCR assay and correlated with PSA response, time to PSA progression (TTP) and OS. Results: On interim analysis of 300 pts, serum mGSTP1 was detectable at BL in 80% and preC3 in 44%. Undetectable preC3 mGSTP1 correlated with a ≥30% fall in PSA within 3m of starting DTX (p < 0.001). Detectable BL and preC3 mGSTP1 predicted shorter TTP after DTX (BL; HR 1.6 95%CI 1.1-2.3; p = 0.01 and preC3 HR 2.2 95%CI 1.6-2.9; p < 0.001). Detectable mGSTP1 at both time points predicted shorter OS (BL; median OS 18.4 vs 33.1m, HR 2.4 95%CI 1.6-3.7; p < 0.001 and preC3; median OS 13.9 vs 29m, HR 2.7 95%CI 2.0-3.6; p < 0.001). In those with detectable BL mGSTP1, 50% had undetectable preC3 mGSTP1 predicting > 30% fall in PSA within 3m (p < 0.001), improved TTP (HR 0.40 95%CI 0.29-0.57; p < 0.001) and improved OS (25.2 vs 13.9 m HR 0.38 95%CI 0.28-0.51; p < 0.001). On multivariable analysis including Hb, Karnofsky PS, LDH, PSA and visceral metastases, detectable preC3 mGSTP1 independently predicted shorter TTP (HR 1.9 95%CI 1.4-2.6; p < 0.001). Detectable mGSTP1at both time points independently predicted OS (BL; HR1.8 95%CI 1.2-2.8; p = 0.006 and preC3; HR 2.2 95%CI 1.6-3.0; p < 0.001). Results from the full cohort of 600 pts will be available for presentation at the meeting. Conclusions: This study should validate circulating mGSTP1 DNA as a marker of therapeutic benefit and prognosis in men with mCRPC receiving DTX and could be utilized for clinical management.

scholarly journals Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia

2021 ◽  
pp. 1-8
Author(s):  
Alexander V. Karaulov ◽  
Natalia I. Ilina ◽  
Natalia Shartanova ◽  
Aleksandr Maslakov ◽  
Luiz Lucio
Keyword(s):  
Allergic Rhinitis ◽  
Triamcinolone Acetonide ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Nasal Symptom ◽  
Phase Iii ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
To Receive

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease which affects &#x3e;24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. <b><i>Results:</i></b> Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were −7.78 (95% CI: −8.1701 to −7.3967; <i>p</i> &#x3c; 0.001) and −7.52 (−7.9053 to −7.1320; <i>p</i> &#x3c; 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. <b><i>Conclusions:</i></b> TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

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