Physicians have a moral responsibility to patients, they are trusted to place the needs and interests of patients ahead of their own, free of unwarranted outside influences on their decisions.The ...medical profession has not stood still in its efforts to eradicate meaningful COI.Finding the proper balance will not be easy, but it is essential for helping to ensure trust and integrity n the medical profession.
Cancer care’s sustainability is challenged by drug expenditures. In the absence of systemic change, innovation is needed to curtail drug costs. Interventional pharmacoeconomics (IVPE) utilizes ...clinical research to identify safe, efficacious, cost‐conscious dosing regimens to extract maximum value from expensive therapies. Strategies include de‐escalation of dosage, treatment duration and administration frequency, and substitution with therapeutic alternatives. In this review, we discuss how IVPE strategies have been successfully used and could be implemented going forward.
Summary Background Tamoxifen is standard adjuvant treatment for postmenopausal women with hormone-receptor-positive breast cancer. We assessed the benefit of adding chemotherapy to adjuvant tamoxifen ...and whether tamoxifen should be given concurrently or after chemotherapy. Methods We undertook a phase 3, parallel, randomised trial (SWOG-8814, INT-0100) in postmenopausal women with hormone-receptor-positive, node-positive breast cancer to test two major objectives: whether the primary outcome, disease-free survival, was longer with cyclophosphamide, doxorubicin, and fluorouracil (CAF) given every 4 weeks for six cycles plus 5 years of daily tamoxifen than with tamoxifen alone; and whether disease-free survival was longer with CAF followed by tamoxifen (CAF-T) than with CAF plus concurrent tamoxifen (CAFT). Overall survival and toxicity were predefined, important secondary outcomes for each objective. Patients in this open-label trial were randomly assigned by a computer algorithm in a 2:3:3 ratio (tamoxifen:CAF-T:CAFT) and analysis was by intention to treat of eligible patients. Groups were compared by stratified log-rank tests, followed by Cox regression analyses adjusted for significant prognostic factors. This trial is registered with ClinicalTrials.gov , number NCT00929591. Findings Of 1558 randomised women, 1477 (95%) were eligible for inclusion in the analysis. After a maximum of 13 years of follow-up (median 8·94 years), 637 women had a disease-free survival event (tamoxifen, 179 events in 361 patients; CAF-T, 216 events in 566 patients; CAFT, 242 events in 550 patients). For the first objective, therapy with the CAF plus tamoxifen groups combined (CAFT or CAF-T) was superior to tamoxifen alone for the primary endpoint of disease-free survival (adjusted Cox regression hazard ratio HR 0·76, 95% CI 0·64–0·91; p=0·002) but only marginally for the secondary endpoint of overall survival (HR 0·83, 0·68–1·01; p=0·057). For the second objective, the adjusted HRs favoured CAF-T over CAFT but did not reach significance for disease-free survival (HR 0·84, 0·70–1·01; p=0·061) or overall survival (HR 0·90, 0·73–1·10; p=0·30). Neutropenia, stomatitis, thromboembolism, congestive heart failure, and leukaemia were more frequent in the combined CAF plus tamoxifen groups than in the tamoxifen-alone group. Interpretation Chemotherapy with CAF plus tamoxifen given sequentially is more effective adjuvant therapy for postmenopausal patients with endocrine-responsive, node-positive breast cancer than is tamoxifen alone. However, it might be possible to identify some subgroups that do not benefit from anthracycline-based chemotherapy despite positive nodes. Funding National Cancer Institute (US National Institutes of Health).
Introduction by the Guest Editors Ratain, Mark J; Lichter, Allen S
The cancer journal (Sudbury, Mass.),
2020 Jul/Aug, 2020-7-00, 20200701, Letnik:
26, Številka:
4
Journal Article
The 2009 Institute of Medicine (IOM) report Conflict of Interest in Medical Research, Education, and Practice recognized the benefits that accrue when physicians and researchers collaborate with ...companies in the biomedical industry. Because the committee also recognized that certain financial ties can unduly influence professional judgment, it proposed a series of recommendations to help manage conflicts of interest (COIs). The core of those management strategies relies on the disclosure of relationships between individual researchers and the relevant companies. Here, Lichter and McKinney discuss harmonized and centralized COI disclosure.
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