Search results for "trials"

Ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma: extended 3.5-year follow up from a pooled analysis

2019

Investigator-initiated trials of targeted oncology agents: why independent research is at risk?

2010

Background: Drug development traditionally has relied upon the complementary contributions of clinicians and scientists at academic institutions and at pharmaceutical companies. Greater regulatory burdens, increased bureaucratic requirements, restricted reimbursement, and spiralling research and development costs are exerting pressure on the drug development pipeline. The result is a de-emphasis of exploratory research, particularly independent academic research, despite its proven value in identifying new drug targets and developing innovative cancer therapies. Design: An expert panel assembled by the Biotherapy Development Association-a nonprofit international forum for academic and indus…

391MO Impact of diabetes and metformin use on recurrence and outcome in early colon cancer (CC) patients: A pooled analysis of 3 adjuvant trials

2021

Evaluation of atezolizumab immunogenicity: Efficacy and safety (Part 2).

2022

Abstract Antibody therapeutics can be associated with unwanted immune responses resulting in the development of anti‐drug antibodies (ADA). Optimal methods to evaluate the potential effects of ADA on clinical outcomes in oncology are not well established. In this study, we assessed efficacy and safety, based on ADA status, in patients from over 10 clinical trials that evaluated the immune checkpoint inhibitor atezolizumab as a single agent or as combination therapy for several types of advanced cancers. ADA can only be observed post randomization, and imbalances in baseline prognostic factors can confound the interpretation of ADA impact. We applied methodology to account for the confoundin…

KRAS mutations and sensitivity to anti-EGFR monoclonal antibodies in metastatic colorectal carcinoma: an open issue.

2009

Background: Cetuximab and panitumumab, mAbs targeting EGFR, are registered for metastatic colorectal carcinoma (mCRC) patients whose tumors express EGFR as determined by immunohistochemistry. However, this method is not predictive of treatment efficacy. KRAS, the human homolog of the Kirsten rat sarcoma-2 virus oncogene, encodes a small G-protein that functions downstream of EGFR-induced signalling. Objective/Methods: To examine KRAS mutations as predictive factors of response to anti-EGFR mAbs using recently published data. Results/conclusions: Several retrospective studies show that efficacy of these mAbs is confined to patients with wild type KRAS and genotyping of tumors should be consi…

Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patient…

2020

<b><i>Background:</i></b> Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting. <b><i>Methods:</i></b> For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies). <b><i>Res…

Current questions for the treatment of advanced gastric cancer.

2013

Abstract Background Gastric cancer remains a major health problem worldwide. Treatment of advanced gastric cancer is controversial and there is no standard regimen for first- or second-line chemotherapy (CT). This review aims to give an overview of the hot topics concerning treatment, prognostic factors and new strategies in advanced gastric cancer. Material and methods Seven questions of special clinical interest have been formulated previously to the literature review. With the aim of answering each of these questions, a specific search of the relevant trials and meta-analyses published or communicated from 1990 to date was performed. Results Patients treated with CT have a survival benef…

CONVENTIONAL INTERNAL LIMITING MEMBRANE PEELING VERSUS INVERTED FLAP FOR SMALL-TO-MEDIUM IDIOPATHIC MACULAR HOLE

2022

Purpose: To compare conventional internal limiting membrane (ILM) peeling versus inverted flap technique in small-to-medium idiopathic macular hole. Methods: Eyes with ≤400 μ m idiopathic macular holes were randomized into the conventional ILM peeling group (25 eyes) and inverted flap group (25 eyes). A 12-month follow-up was considered. Macular sensitivity (MS) change detected with MP-1 microperimetry was the primary outcome. Secondary outcomes included best-corrected visual acuity change, closure rate, anatomical findings on optical coherence tomography such as U-shape foveal contour, restoration of external limiting membrane, and ellipsoid zone. Results: In both groups, MS improved throu…

Influence Of within-tree and environmental factors On fruit quality of cactus Pear (O. ficus-Indica)

2010

Introduction. Opuntia ficus-indica fruit quality was studied, in the main sites for cactus pear cultivation in Italy, with the ultimate goal of understanding the main sources of variability and increasing crop value. Materials and methods. A first study was carried out in 2006 on mature Opuntia ficus-indica trees, cvs. Gialla and Rossa, grown in ten commercial orchards located in the main sites for their cultivation in Italy. Trees were managed to produce an out-of-season crop in October, through the removal of the spring flush at bloom time, during the first week of June. Trees had a similar crop [(52 ± 10) kg of fruits•tree-1], and no more than six fruits were left on each of the fruiting…

Effects of a Home‐Based Physical Rehabilitation Program on Tibial Bone Structure, Density, and Strength After Hip Fracture: A Secondary Analysis of a…

2019

Abstract Weight‐bearing physical activity may decrease or prevent bone deterioration after hip fracture. This study investigated the effects of a home‐based physical rehabilitation program on tibial bone traits in older hip fracture patients. A population‐based clinical sample of men and women operated for hip fracture (mean age 80 years, 78% women) was randomly assigned into an intervention (n = 40) and a standard care control group (n = 41) on average 10 weeks postfracture. The intervention group participated in a 12‐month home‐based rehabilitation intervention, including evaluation and modification of environmental hazards, guidance for safe walking, nonpharmacological pain management, m…