![]() | David F Cella |
Prominent publications by David F Cella
BACKGROUND: Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will ...
Known for Measurement Equivalence | Task Force | Reported Outcome | Report Recommendations | Ispor Epro |
BACKGROUND: In the ongoing phase 3, CheckMate 214 trial, nivolumab plus ipilimumab improved overall survival compared with sunitinib in patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma. We aimed to assess whether health-related quality of life (HRQoL) could be used to further describe the benefit-risk profile of nivolumab plus ipilimumab versus sunitinib.
METHODS: In the phase 3, randomised, controlled, CheckMate 214 trial, patients aged 18 ...
Known for Ipilimumab Sunitinib | Renal Cell | 3 Trial | Intermediate Poor Risk | Baseline Week |
PURPOSE: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non-small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide.
PATIENTS AND METHODS: The study was carried out by a ...
Known for Paclitaxel Cisplatin | Dose Levels | Quality Life | Cell Lung | Eastern Cooperative |
BACKGROUND: Renal-cell carcinoma is highly vascular, and proliferates primarily through dysregulation of the vascular endothelial growth factor (VEGF) pathway. We tested sunitinib and sorafenib, two oral anti-angiogenic agents that are effective in advanced renal-cell carcinoma, in patients with resected local disease at high risk for recurrence.
METHODS: In this double-blind, placebo-controlled, randomised, phase 3 trial, we enrolled patients at 226 study centres in the USA and Canada. ...
Known for Patients Sunitinib | 3 Trial | Sorafenib Placebo | Metastatic Renal | 4 Weeks |
OBJECTIVE: To develop a new measurement system, the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL), that can evaluate both general and caregiving-specific aspects of health-related quality of life (HRQOL) in caregivers of persons with traumatic brain injury (TBI).
DESIGN: New item pools were developed and refined using literature reviews, qualitative data from focus groups, and cognitive debriefing with caregivers of civilians and service members/veterans with TBI, as ...
Known for Service Members | Traumatic Brain Injury | Tbi Caregivers | Careqol Measurement | Healthrelated Quality |
BACKGROUND: In the AFFIRM trial of patients with metastatic castration-resistant prostate cancer after progression with docetaxel treatment, enzalutamide significantly increased overall survival compared with placebo. Here we present the prospectively defined analyses of some secondary endpoints, including occurrence of skeletal-related events, measures of pain control, and patient-reported health-related quality of life (HRQoL).
METHODS: In this phase 3, double-blind trial, patients ...
Known for Enzalutamide Placebo | Resistant Prostate | 95 P0·0001 | Affirm Trial | Time Deterioration |
BACKGROUND: In the phase 3 CheckMate 025 study, previously treated patients with advanced renal cell carcinoma who were randomly assigned to nivolumab had an overall survival benefit compared with those assigned to everolimus. We aimed to compare health-related quality of life (HRQoL) between treatment groups in this trial.
METHODS: CheckMate 025 was an open-label study done at 146 oncology centres in 24 countries. Patients were randomly assigned to treatment between Oct 22, 2012, and ...
Known for Nivolumab Everolimus | 3 Trial | Advanced Renal | Cell Carcinoma | Checkmate 025 |
OBJECTIVE: To describe health- and vision-targeted quality of life following treatment with iodine 125 brachytherapy vs enucleation for choroidal melanoma in a subgroup of patients who were treated and observed prospectively as part of a large randomized clinical trial.
MAIN OUTCOME MEASURES: Difficulty with driving, near vision activities, and activities using stereopsis or binocularity; anxiety; and depression.
PARTICIPANTS: Two hundred nine patients who enrolled in the Collaborative ...
Known for Quality Life | Melanoma Study | Brachytherapy Enucleation | Collaborative Ocular | 2 Years |
Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial
[ PUBLICATION ]
BACKGROUND: The treatment of advanced renal cell carcinoma has been revolutionised by targeted therapy with drugs that block angiogenesis. So far, no phase 3 randomised trials comparing the effectiveness of one targeted agent against another have been reported. We did a randomised phase 3 study comparing axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor (VEGF) receptors, with sorafenib, an approved VEGF receptor inhibitor, as second-line ...
Known for Sorafenib Axitinib | 3 Trial | Randomised Phase | Renal Cell | Comparative Effectiveness |
BackgroundThis study evaluated the cost-effectiveness of anastrozole versus generic tamoxifen for primary adjuvant treatment of postmenopausal women with hormone receptor-positive (HR+) early breast cancer (EBC), from a US healthcare perspective.MethodsA probabilistic Markov model was developed using the 5-year completed treatment analysis of the ATAC (‘Arimidex’, Tamoxifen Alone or in Combination) trial (ISRCTN 18233230) to project outcomes for anastrozole and tamoxifen to 25 years. ...
Known for Postmenopausal Women | Anastrozole Tamoxifen | Treatment Analysis | Early Breast Cancer | Markov Chains |
BACKGROUND: In the phase 3 TITAN study, the addition of apalutamide to androgen deprivation therapy (ADT) significantly improved the primary endpoints of overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer. We aimed to assess health-related quality of life (HRQOL) in TITAN, including pain and fatigue.
METHODS: In this randomised, placebo-controlled, double-blind, phase 3 study, patients with metastatic ...
Known for Prostate Cancer | Metastatic Castration | 3 Study | Apalutamide Treatment | Life Hrqol |
BACKGROUND: Data are limited regarding the use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors, such as veliparib, in combination with chemotherapy followed by maintenance as initial treatment in patients with high-grade serous ovarian carcinoma.
METHODS: In an international, phase 3, placebo-controlled trial, we assessed the efficacy of veliparib added to first-line induction chemotherapy with carboplatin and paclitaxel and continued as maintenance monotherapy in ...
Known for Maintenance Therapy | Brca1 Genes | Hazard Ratio | Carboplatin Paclitaxel | Mutation Ovarian |
BACKGROUND: Pazopanib and sunitinib provided a progression-free survival benefit, as compared with placebo or interferon, in previous phase 3 studies involving patients with metastatic renal-cell carcinoma. This phase 3, randomized trial compared the efficacy and safety of pazopanib and sunitinib as first-line therapy.
METHODS: We randomly assigned 1110 patients with clear-cell, metastatic renal-cell carcinoma, in a 1:1 ratio, to receive a continuous dose of pazopanib (800 mg once daily; ...
Known for Pazopanib Sunitinib | Cell Carcinoma | Efficacy Safety | Higher Incidence | Metastatic Renal |
BACKGROUND: In the SPARTAN trial, addition of apalutamide to androgen deprivation therapy, as compared with placebo plus androgen deprivation therapy, significantly improved metastasis-free survival in men with non-metastatic castration-resistant prostate cancer who were at high risk for development of metastases. We aimed to investigate the effects of apalutamide versus placebo added to androgen deprivation therapy on health-related quality of life (HRQOL).
METHODS: SPARTAN is a ...
Known for Resistant Prostate | Metastatic Castration | Life Hrqol | Patients Placebo | Androgen Deprivation Therapy |
Quality of Life of Postmenopausal Women in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial
[ PUBLICATION ]
PURPOSE: To determine the quality of life (QoL) of women participating in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial during the first 2 years of treatment.
PATIENTS AND METHODS: A total of 1,021 women were enrolled onto the QoL subprotocol. All had completed primary treatment (surgery +/- radiotherapy +/- chemotherapy) and were to receive 5 years of adjuvant treatment with anastrozole (n = 335), tamoxifen (n = 347), or a combination (n = 339) of ...
Known for Tamoxifen Patients | Treatment Anastrozole | Quality Life | Postmenopausal Women | Cancer Trial |
David F Cella: Influence Statistics
Concept | World rank |
---|---|
prognostic survival tool | #1 |
functioning persons tbi | #1 |
emotional functional | #1 |
drs subscale α | #1 |
clinical agendas | #1 |
facit | #1 |
facthep | #1 |
life hrpc | #1 |
colorectal fact | #1 |
cognitive functions older | #1 |
7 skin problems | #1 |
–based utility scores | #1 |
factor analysis techniques | #1 |
antia | #1 |
rdstscore | #1 |
cohort checkmate | #1 |
dutchflemish | #1 |
adults rp | #1 |
function reported | #1 |
fksi19 rccsi | #1 |
respondents valuation task | #1 |
5levels | #1 |
hcps avoidant coping | #1 |
cancer therapy general | #1 |
hrqol domain | #1 |
oakmethodswe | #1 |
linking fatigue | #1 |
clinically differences cids | #1 |
nfbsi16 | #1 |
hrqol patient | #1 |
paper pencil method | #1 |
parent proxy reports | #1 |
qol | #1 |
arthralgia severity prai | #1 |
ifnalpha2a 13cra | #1 |
depressive symptom prevalence | #1 |
gog ntx | #1 |
facittrans | #1 |
objective response chemotherapy | #1 |
gph4 gmh4 | #1 |
scores compared | #1 |
debulked ovarian cancer | #1 |
exploratory endpoint | #1 |
fact questionnaire | #1 |
qluc10d dimensions | #1 |
olaparib olaparib cediranib | #1 |
cbcl disruptive behavior | #1 |
tti ttsi | #1 |
life psychometrics quality | #1 |
neck scale facthn | #1 |
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Key People For Functional Assessment
David F Cella:Expert Impact
Concepts for whichDavid F Cellahas direct influence:Functional assessment, Quality life, Cancer therapy, Breast cancer, Life qol, Physical function.
David F Cella:KOL impact
Concepts related to the work of other authors for whichfor which David F Cella has influence:Breast cancer, Quality life, Chronic pain, Physical activity, Cell lung, Social support, Outcome measures.
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