A5052437831- Advanced Breast Cancer Therapies
- Cancer Treatment and Pharmacology
- HER2/EGFR in Cancer Research
- Neuroendocrine Tumor Research Advances
- Lung Cancer Research Studies
- Tuberous Sclerosis Complex Research
- PI3K/AKT/mTOR signaling in cancer
- Chronic Lymphocytic Leukemia Research
- Estrogen and related hormone effects
- Breast Cancer Treatment Studies
- Renal cell carcinoma treatment
- Cancer-related cognitive impairment studies
- Advanced Causal Inference Techniques
- Renal and related cancers
- Particle accelerators and beam dynamics
- Gyrotron and Vacuum Electronics Research
- Glaucoma and retinal disorders
- Cancer-related Molecular Pathways
- Polyomavirus and related diseases
- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Gestational Trophoblastic Disease Studies
- Genomics and Rare Diseases
- Fibroblast Growth Factor Research
- Antibiotic Use and Resistance
Sanofi (France)
2024
Novartis (France)
2016-2023
Novartis (Switzerland)
2019-2020
Viva Biotech (China)
2019
Massachusetts General Hospital
2018
Royal Marsden Hospital
2018
BC Cancer Agency
2018
Novartis (United States)
2017-2018
Yonsei University Health System
2017
Nagoya City University Hospital
2017
In the phase III RADIANT ‐4 study, everolimus improved median progression‐free survival ( PFS ) by 7.1 months in patients with advanced, progressive, well‐differentiated (grade 1 or grade 2), non‐functional lung gastrointestinal neuroendocrine tumors NET s) vs placebo (hazard ratio, 0.48; 95% confidence interval [ CI ], 0.35‐0.67; P < .00001). This exploratory analysis reports outcomes of subgroup s. ‐4, were randomized (2:1) to 10 mg/d placebo, both best supportive care. is a post hoc ,...
To examine patterns of prescribing oral antibiotics during pregnancy and to determine whether women were more or less likely receive specific types in than the years before after pregnancy. Finally, identify socio-demographic factors associated with antibiotic pregnancy.We identified 114 999 who gave live birth between 1992 2007 The Health Improvement Network (THIN) UK primary care database. Antibiotic was estimated for each calendar year 2007. Self-controlled case series (SCCS) methodology...
Cotargeting the mammalian target of rapamycin pathway and estrogen receptor may prevent or delay endocrine resistance in patients receiving first-line treatment for advanced breast cancer.To investigate combination everolimus plus therapy second-line settings postmenopausal women with receptor-positive, human epidermal growth 2-negative cancer.In multicenter, open-label, single-arm, phase 2 BOLERO-4 (Breast Cancer Trials Oral Everolimus) clinical trial, 245 were screened eligibility; 202...
A reduction in renal angiomyolipoma volume observed with everolimus (EVE) treatment patients tuberous sclerosis complex (TSC) has been postulated to translate clinical benefit by reducing the risk of hemorrhage and chronic failure.The long-term effects EVE on function (∼4 years treatment) were examined treated Phase 3 EXIST-1 EXIST-2 studies. Patients had TSC subependymal giant cell astrocytoma (SEGA), a definite diagnosis or sporadic lymphangioleiomyomatosis. was administered at 4.5...
Patients with tuberous sclerosis complex (TSC) often have multiple TSC-associated hamartomas, particularly in the brain and kidney. This was a post hoc analysis of pediatric patients being treated for subependymal giant cell astrocytomas (SEGAs) during phase 3, randomized, double-blind, placebo-controlled EXIST-1 trial. were initially randomly assigned to receive everolimus 4.5 mg/m2/day (target blood trough 5–15 mg/dl) or placebo could continue an open-label extension phase. Angiomyolipoma...
Abstract Background The BYLieve trial (NCT03056755) confirmed efficacy and safety of alpelisib with fulvestrant for hormone receptor–positive (HR+), human epidermal growth factor receptor-2–negative (HER2−), PIK3CA-mutated advanced breast cancer (ABC), after cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) an aromatase (AI) as immediate prior therapy. Further analyses were performed to compare from effectiveness standard treatment in the real-world setting. Materials Methods Patients who...
In the phase III SOLAR-1 trial (NCT02437318), PI3Kα-selective inhibitor and degrader alpelisib significantly improved median progression-free survival when added to fulvestrant in patients with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. We assessed health-related quality of life using patient-reported outcome measures these patients.In...
In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall (OS). Here, we present patient-reported outcomes from trial, including health-related quality life (HRQOL).Patients were randomized (2:1) to receive or placebo fulvestrant. Time definitive 10% deterioration (TTD) baseline in HRQOL (global health...
Abstract Background Tuberous sclerosis complex ( TSC ) is a genetic disorder associated with tumour growth in various organs, including the brain, kidneys, heart and skin. Cutaneous lesions are prevalent manifestations of , occurring up to 90% patients. Oral mammalian target rapamycin inhibitors, such as everolimus, believed be effective for treatment ‐associated because they act on underlying disease pathophysiology. Objective We evaluated long‐term effect oral everolimus skin secondary...
The TuberOus SClerosis registry to increase disease Awareness (TOSCA) Post-Authorization Safety Study (PASS) was a non-interventional, multicenter, safety substudy that assessed the long-term of everolimus in patients with tuberous sclerosis complex (TSC) receiving for its licensed indications European Union (EU). This also aimed address TSC-associated neuropsychiatric disorders (TAND), sexual development, and male infertility. Eligible were enrolled from 39 sites across 11 countries EU....
The current exploratory analysis was performed to evaluate the efficacy and safety of everolimus for treatment human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer in Asian subset patients BOLERO-1 trial.Postmenopausal women with HER2+ cancer, who had not received systemic therapy disease, were randomized 2:1 receive or placebo, plus trastuzumab paclitaxel. two primary end points investigator-assessed progression-free survival (PFS) full population hormone...
1040 Background: In the phase 3 SOLAR-1 study, ALP + fulvestrant (FUL) improved PFS in pts with HR+, HER2– ABC a PIK3CA mutation overall and small group of prior cyclin-dependent kinase 4/6 inhibitor (CDKi) use. We report interim data from BYLieve study PIK3CA-mutated CDKi exposure. Methods: is an ongoing, 2, open-label, non-comparative 300 mg QD ET men women whose disease progressed on/after ET. Pts are permitted ≤2 anticancer therapies ≤1 chemotherapy regimen for ABC. AI ( FUL cohort)...
TPS1107 Background: Endocrine therapy (ET) is the standard of care for treatment HR+, HER2– aBC. However, ET resistance occurs frequently due to dysregulation PI3K/AKT/mTOR pathway, specifically mutations in PIK3CA, gene encoding p110alpha subunit PI3K. In a phase 1 study, ALP, PI3Kα-specific inhibitor, combination with FUL has shown antitumor activity patients (pts) PIK3CA mutant, The ongoing 3 SOLAR-1 trial (NCT02437318) evaluating ALP + present BYLieve study aims assess efficacy and...
Maximal medical therapy (MMT) is the use of ≥3 classes topical anti-glaucoma agents to achieve maximal intraocular pressure (IOP) reduction while minimizing adverse effects and compliance challenges.To evaluate additive IOP-lowering effect twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) used adjunctively with once daily travoprost 0.004%/timolol 0.5% (TTFC) in patients open-angle glaucoma (OAG)/ocular hypertension (OHT).In this phase IV, double-masked study, on...
1010 Background: Initial first-line (1L) data from the phase 2 BOLERO-4 (NCT01698918) study of EVE + letrozole (LET) in postmenopausal patients (pts) with ER+, HER2− metastatic BC (MBC) or locally advanced (LABC) have been previously reported. Here, we present updated 1L progression-free survival (PFS) data, plus new describing second-line (2L) exemestane (EXE) pts disease progression after LET. Methods: Postmenopausal MBC LABC no prior therapy for received 10 mg/day LET 2.5 mg/day. After...
Objective The aim of the study was to assess impact systemic markers inflammation on outcomes in patients with neuroendocrine tumors (NETs) treated everolimus or placebo (as measured by baseline neutrophil-to-lymphocyte ratio [NLR] and lymphocyte-to-monocyte [LMR]). Methods Patient data (gastrointestinal, pancreatic, lung NETs) from 2 large phase 3 studies, RADIANT-3 (n = 410) RADIANT-4 302), were pooled analyzed. primary end point centrally assessed progression-free survival (PFS) as...
Rare disorders impact millions of children worldwide, and developing new medicines in this setting is associated with multiple challenges. In paper, we share a successful story how real-world data (RWD) were leveraged to accelerate evidence generation patient access life-changing therapy patients severe manifestations PIK3CA-related overgrowth spectrum who require systemic therapy. Despite all the existing regulatory guidelines considering (RWE), there limited precedent use framework support...
Background: Recently, everolimus was shown to improve median progression-free survival (PFS) by 7.1 months in patients with advanced, progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of lung or gastrointestinal (GI) tract compared placebo (HR, 0.48; 95% CI, 0.35–0.67; P <0.00001) the Phase III, RADIANT-4 study. This post hoc analysis evaluates impact prior therapies (somatostatin analogs [SSA], chemotherapy, and radiotherapy) on activity. Trial registration:...