Search results for " quality of life."
showing 10 items of 343 documents
Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists
2010
Abstract Background Overall survival (OS) is the gold standard for the demonstration of a clinical benefit in cancer trials. Replacement of OS by a surrogate endpoint allows to reduce trial duration. To date, few surrogate endpoints have been validated in digestive oncology. The aim of this study was to draw up an ordered list of potential surrogate endpoints for OS in digestive cancer trials, by way of a survey among clinicians and methodologists. Secondary objective was to obtain their opinion on surrogacy and quality of life (QoL). Methods In 2007 and 2008, self administered sequential questionnaires were sent to a panel of French clinicians and methodologists involved in the conduct of …
Long-Term Outcomes and Health-Related Quality of Life (HRQoL) By Response Status for Bortezomib, Melphalan, and Prednisone (VMP) ± Daratumumab (DARA)…
2020
Introduction: DARA is a human IgGκ monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action. In the phase 3 ALCYONE study (median follow-up of 40.1 months), DARA in combination with VMP (D-VMP) reduced the risk of disease progression or death by 58% versus VMP alone (median 36.4 vs 19.3 months; HR, 0.42; 95% CI, 0.34-0.51; P<0.0001) and demonstrated a significant overall survival (OS) benefit (median not reached in either group; HR, 0.60; 95% CI, 0.46-0.80; P=0.0003) for patients (pts) with transplant-ineligible newly diagnosed multiple myeloma (TIE NDMM). Here, we report the results of a subgroup analysis examining long-term efficacy outcome…
Phase I-II trial of gemcitabine-based first-line chemotherapies for small cell lung cancer in elderly patients with performance status 0-2: the G-STE…
2011
Introduction: Treatment of elderly patients with small cell lung cancer (SCLC) is based on scanty evidence. Methods: Patients with extensive SCLC, age >70 years, and performance status 0-2 were eligible for a study looking for optimal two-drug combination of gemcitabine (Gem) with vinorelbine (Vin), etoposide (Eto), cisplatin (Cis), or carboplatin (Car). Gemcitabine dose was the same (1000 mg/m2, days 1-8) in all combinations. A two-stage minimax flexible design for response was applied to GemVin combination (Vin 25 mg/m2, days 1-8). For GemCar, GemCis, GemEto, a phase I-II Bayesian design was applied, looking for the optimal dose of the partner drugs. Objective response rate ≥60% and un…
Quality of Life Analysis of TORCH, a Randomized Trial Testing First-Line Erlotinib Followed by Second-Line Cisplatin/Gemcitabine Chemotherapy in Adva…
2012
INTRODUCTION:: The TORCH (Tarceva or Chemotherapy) trial randomized patients with advanced non-small-cell lung cancer to first-line erlotinib followed by second-line cisplatin/gemcitabine versus. standard inverse sequence. The trial, designed to test noninferiority in overall survival, was stopped at interim analysis because of inferior survival in the experimental arm. Quality of life (QoL), a secondary outcome, is reported here. METHODS:: QoL was assessed at baseline and every 3 weeks during first-line, using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 and QLQ-lung cancer specific module (LC13). Mean changes from baseline within arms …
Quality of life after pulmonary stereotactic fractionated radiotherapy (SBRT): Results of the phase II STRIPE trial.
2019
Preserving health related quality of life (HRQOL) plays an important role in considering stereotactic body fractionated radiotherapy (SBRT). The prospective monocenter phase II STRIPE trial investigated long-term HRQOL after SBRT, efficacy and toxicity.Patients with ≤2 pulmonary lesions ≤5 cm were treated with 4DPET/CT-based SBRT (3 × 12.5 Gy or risk-adapted 5 × 7 Gy, to 60% isodose). Follow up (FU) was performed 2 and 7 weeks after SBRT, then 3-monthly for 2 years with assessment of response (primary endpoint: 2-year cumulative incidence of local progression (LP); secondary endpoints: local progression free survival (LPFS), overall survival (OS) and toxicity (CTCAE)). Impact of predefined …
Periodontitis as a risk factor for head and neck cancer
2020
Background Periodontitis may be associated with the development of head and neck cancer (HNC). A literature review was conducted to understand the possible association between them. Material and Methods Articles published in the PubMed database from January 1999 and May 2020 were retrieved. Limitations of the studies and biological mechanisms were discussed. Results A total of 4,232 articles were found. Of these, 13 were analyzed according to inclusion criteria. Most papers found some association between periodontitis and HNC, although differences in periodontal evaluation, sample size, study design and tumor sites were observed. Porphyromonas gingivalis appears to increase the chance of bo…
The Relevance of Online Social Relationships Among the Elderly: How Using the Web Could Enhance Quality of Life?
2020
This observational study analyzes the impact of Internet use on the quality of life and well-being of the elderly. Specifically, it seeks to understand and clarify the effects of Internet use on relationships in terms of self-esteem, life satisfaction, and Online and Offline Social Support in a sample of senior and elderly Italian people (over 60 years of age). A cohort of 271 elderly people (133 males and 138 females) aged between 60 and 94 years old participated in the study: 236 were Internet Users while the other 35 were Non-Internet Users. The results showed that the time elderly people spend online has a negative effect on their perception of Offline Social Support (Offline Emotional …
Oral health-related quality of life after dental treatment in patients with intellectual disability
2020
Background The influence of dental treatment on oral health-related quality of life (OHRQOL) has rarely been evaluated in patients with intellectual disability (ID) through validated questionnaires. The aim of this study was to estimate the changes on OHRQOL in patients with ID after the implementation of an institutional dental treatment program under general anesthesia using the Franciscan Hospital for Children Oral Health-Related Quality of Life questionnaire (FHCOHRQOL-Q). Material and Methods A prospective longitudinal study was conducted on 85 patients (mean age=24.85 years) classified according to DSM-V whose parents/caregivers completed the FHC-OHRQOL-Q. We analyzed the changes in t…
Non-specific oral and cutaneous manifestations of coronavirus disease 2019 in children
2020
Background Coronavirus Disease 2019 (COVID-19) seems to affect children only marginally, as a result, there is less knowledge of its manifestations in childhood. The purpose of this retrospective cross-sectional study was to investigate the oral and cutaneous manifestations in children affected by COVID-19. Material and Methods All the medical records of children with COVID-19 admitted to the Pediatric Clinic- ASST Spedali Civili of Brescia from March to April 2020 were reviewed. The following data were recorded: age, temperature, clinical presentation, oral mucosa lesions, taste alteration and cutaneous lesions. Results The medical records of twenty-seven pediatric patients (mean age 4,2 y…
Palliative Care Professionals’ Inner Life: Exploring the Mediating Role of Self-Compassion in the Prediction of Compassion Satisfaction, Compassion F…
2021
Context. Palliative care professionals are exposed to suffering on a daily basis. Working in such an environment frequently raises existential issues, psychological challenges, and emotional distress, that can detract from compassionate care. Identifying factors that help professionals cope with frequent exposure to issues related to mortality, such as compassion, could enhance palliative care providers’ and patients’ quality of life and wellbeing. Objectives. To improve our understanding of the factors associated with professionals’ inner life studying the role of self-compassion as a mediating variable between self-care and awareness and professionals’ quality of life, and quantifying the…