The lancet oncology
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The lancet oncology · Nov 2016
Review21st century pharmacovigilance: efforts, roles, and responsibilities.
In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice. Pharmacovigilance identifies previously unrecognised adverse events or changes in the patterns of these effects, the quality and adequacy of drug supply, and should ensure effective communication with the public, health-care professionals, and patients about the optimum safety and effective use of medicines. In this paper, the first in a Series of three about drug safety in oncology, we discuss evolving challenges in the purview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines Agency with respect to pharmacovigilance efforts, with a special emphasis on oncology treatment.
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The lancet oncology · Nov 2016
ReviewAnalysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.
Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. ⋯ This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.
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With the advent of sentinel lymph node biopsy, surgical methods for accurately staging the axilla in patients with early-stage breast cancer have become progressively less extensive, with formal axillary lymph node dissection confined to a dwindling group of patients. Although details of methods for sentinel lymph node biopsy have yet to be standardised, this technique is now widely practised and accepted as standard of care worldwide. In the past 5 years, attention has focused on minimisation of surgical morbidity by restricting further axillary surgery or considering radiotherapy in patients with a small tumour burden in their sentinel nodes. ⋯ Indications for omission of completion axillary lymph node dissection in patients with two or fewer nodes containing macrometastases demand further clarification, together with the roles of preoperative imaging in defining axillary nodal burden, deselection of patients for sentinel lymph node biopsy, and provision of radiotherapy. Downstaging of biopsy-proven node-positive patients with neoadjuvant chemotherapy could safely permit sentinel lymph node biopsy alone when the index node has been successfully retrieved at surgery, while nodal deposits of any size continue to mandate completion axillary lymph node dissection. Developments in molecular imaging technologies and percutaneous biopsy techniques could potentially render sentinel lymph node biopsy redundant in the future.
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The lancet oncology · Oct 2016
ReviewInternational clinical practice guidelines including guidance for direct oral anticoagulants in the treatment and prophylaxis of venous thromboembolism in patients with cancer.
Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer. These patients are at an increased risk of developing VTE and are more likely to have a recurrence of VTE and bleeding while taking anticoagulants. Management of VTE in patients with cancer is a major therapeutic challenge and remains suboptimal worldwide. ⋯ The rapid global adoption of direct oral anticoagulants for management of VTE in patients with cancer is an emerging treatment trend that needs to be addressed based on the current level of evidence. In this Review, we provide an update of the ITAC-CME consensus recommendations based on a systematic review of the literature ranked according to the Grading of Recommendations Assessment, Development, and Evaluation scale. These guidelines aim to address in-hospital and outpatient cancer-associated VTE in specific subgroups of patients with cancer.
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The lancet oncology · Oct 2016
ReviewInternational clinical practice guidelines including guidance for direct oral anticoagulants in the treatment and prophylaxis of venous thromboembolism in patients with cancer.
Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer. These patients are at an increased risk of developing VTE and are more likely to have a recurrence of VTE and bleeding while taking anticoagulants. Management of VTE in patients with cancer is a major therapeutic challenge and remains suboptimal worldwide. ⋯ The rapid global adoption of direct oral anticoagulants for management of VTE in patients with cancer is an emerging treatment trend that needs to be addressed based on the current level of evidence. In this Review, we provide an update of the ITAC-CME consensus recommendations based on a systematic review of the literature ranked according to the Grading of Recommendations Assessment, Development, and Evaluation scale. These guidelines aim to address in-hospital and outpatient cancer-associated VTE in specific subgroups of patients with cancer.