The aim of the study was to report on the association of trial sponsors with intervention type, treatment intent, recruitment success and reasons to terminate cancer trials. The ClinicalTrials database was searched for interventional Phase 3 cancer trials (01/2006-05/2017). Noncancer studies and ongoing studies were excluded, permanently suspended studies were counted as terminated. Trials were stratified according to sponsors (industry/nonindustry), intervention type, setting (curative/palliative) and intent of intervention (curative/symptom-control/life-extending). We identified 345 terminated trials and 1137 completed studies as a control group. The frequency of premature termination did not differ significantly between sponsors. Time to termination was shorter but recruitment per month prior to termination was higher in industry-sponsored studies (7.0 vs 2.2 patients/month; P < .001). Drug interventions were more common in industry-sponsored, all other interventions in nonindustry-sponsored settings (P < .001). Life-extending palliative interventions occurred more frequently, symptom-control interventions in a curative setting less frequently in industry-sponsored trials (both P < .001). Intervention, setting and intent were not associated with termination in industry-sponsored trials. In nonindustry-sponsored trials, the frequency of drug interventions and life-extending (noncurative) interventions were increased in terminated trials (both P < .05); symptom-control interventions in curative settings occurred more frequently in completed studies. Industry-sponsored trials were more often terminated due to toxicity/inefficacy while lack of accrual occurred more frequently in nonindustry-sponsored trials (P < .01). Interventions, treatment setting/intent and reasons for termination differed between sponsor types. In nonindustry-sponsored trials, drug interventions and life-extending (noncurative) interventions were associated with premature termination and symptom-control interventions (curative setting) were associated with trial completion.
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http://dx.doi.org/10.1002/ijc.33342 | DOI Listing |
Cancer Treat Rev
January 2025
Department of Oncology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. Electronic address:
Importance: Endocrine treatments, such as Tamoxifen (TAM) and/or Aromatase inhibitors (AI), are the adjuvant therapy of choice for hormone-receptor positive breast cancer. These agents are associated with menopausal symptoms, adversely affecting drug compliance. Topical estrogen (TE) has been proposed for symptom management, given its' local application and presumed reduced bioavailability, however its oncological safety remains uncertain.
View Article and Find Full Text PDFJCO Oncol Pract
January 2025
Section of Hematology & Oncology, Department of Medicine, University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma City, OK.
Purpose: Older adults with cancer have unique needs, which likely influence surgical outcomes in the geriatric oncology population. We conducted a systematic review to describe the literature focused on perioperative supportive care interventions for older adults with cancer undergoing surgery.
Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we performed a comprehensive search using the Ovid MEDLINE, CINAHL, and Embase databases for literature published from January 2010 to October 2023.
JCO Precis Oncol
January 2025
Division of Hematology-Oncology, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA.
Purpose: Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) protein overexpression is an emerging biomarker in gastric cancer and gastroesophageal junction cancer (GC). We assessed FGFR2b protein overexpression prevalence in nearly 3,800 tumor samples as part of the prescreening process for a global phase III study in patients with newly diagnosed advanced or metastatic GC.
Methods: As of June 28, 2024, 3,782 tumor samples from prescreened patients from 37 countries for the phase III FORTITUDE-101 trial (ClinicalTrials.
JCO Precis Oncol
January 2025
Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Purpose: To investigate whether hormone receptor-positive, human epidermal growth factor receptor 2-low (HR+HER2-low) versus HR+HER2-zero early breast cancers have distinct genomic and clinical characteristics.
Methods: This study included HR+, HER2-negative early breast cancers from patients enrolled in the phase III, randomized BIG 1-98 and SOFT clinical trials that had undergone tumor genomic sequencing. Tumors were classified HR+HER2-low if they had a centrally reviewed HER2 immunohistochemistry (IHC) score of 1+ or 2+ with negative in situ hybridization and HR+HER2-zero if they had an HER2 IHC score of 0.
J Med Internet Res
January 2025
Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, US.
Background: Most cancer survivors have multiple cardiovascular risk factors, increasing their risk of poor cardiovascular and cancer outcomes. The Automated Heart-Health Assessment (AH-HA) tool is a novel electronic health record clinical decision support tool based on the American Heart Association's Life's Simple 7 cardiovascular health (CVH) metrics to promote CVH assessment and discussion in outpatient oncology. Before proceeding to future implementation trials, it is critical to establish the acceptability of the tool among providers and survivors.
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