Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe.

The pharmaceutical value chain, including clinical trials, pricing, access, and reimbursement, is designed for classical monotherapies. Although there has been a paradigm shift that increases the relevance of targeted combination therapies (TCTs), regulation and common practice have been slow to adapt. We explored access to 23 TCTs for advanced melanoma and lung cancer as reported by 19 specialists from 17 leading cancer institutions in nine European countries. We find heterogeneous patient access to TCTs between countries, differences in country-specific regulations, and differences in the clinical practice of melanoma and lung cancer. Regulation that is better tailored to the context of combinational therapies can increase equity in access across Europe and promote an evidence-based and authorized use of combinations.

Peri- and postoperative management of stage I-III Non Small Cell Lung Cancer: Which quality of care indicators are evidence-based?

Quality of care (QoC) has a central role in our health care system. The aim of this review is to present a set of evidence-based quality indicators for the surgical treatment and postoperative management of lung cancer. A search was performed through PubMed, Embase and the Cochrane library database, including English literature, published between 1980 and 2012. Search terms regarding 'lung neoplasms', 'surgical treatment' and 'quality of care' were used. Potential QoC indicators were divided into structure, process or outcome measures and a final selection was made based upon the level of evidence. High hospital volume and surgery performed by a thoracic surgeon, were identified as important structure indicators. Sleeve resection instead of pneumonectomy and the importance of treatment within a clinical care path setting were identified as evidence-based process indicators. A symptom-based follow-up regime was identified as a new QoC indicator. These indicators can be used for registration, benchmarking and ultimately quality improvement in lung cancer surgery.

Legal claims for malignant mesothelioma: dealing with all cases.

BACKGROUND: Apart of medical reasons, a definitive diagnosis of malignant mesothelioma may be required as a basis for a claim of financial compensation although a pathological source of conclusive evidence is missing. Clinical assessment of all available data is then the only option to come to a final conclusion. We evaluated the diagnostic work-up of a large cohort of Dutch patients who applied for financial compensation due to mesothelioma. We determined how often a pathological or clinical diagnosis can be made, and which factors are associated with making the final diagnosis malignant mesothelioma. METHODS: A flow diagram of the diagnostic work-up was constructed for patients that applied to the Dutch institute for asbestos victims between 2005 and 2008 (N=1498). Both pathological and clinical factors that may influence the diagnostic outcome were assessed. RESULTS: In 97 of the 1498 patients (6%) no pathologic diagnosis could be established because of an uncertain diagnosis (N=54), inadequate (N=22) or unavailable tumor samples (N=21). A final pathological diagnosis of malignant mesothelioma could most often be made when biopsy samples were available compared to those in whom only cytological material was available. In patients in who no conclusive diagnosis could be made, clinical assessment was performed. Eighty percent of patients (66/83) who were clinically assessed were considered to have mesothelioma. None of the clinical features analyzed were strongly associated with a confirmed diagnosis of malignant mesothelioma. DISCUSSION: Our study shows that only in a small number of the patients who applied no pathologic diagnosis could be obtained. Based on judgment of clinical experts in the majority of these cases a near to certain diagnosis could be made. Moreover, it is reasonable to obtain biopsy material from patients to increase the chance to obtain a confirmed diagnosis. Therefore, it is important to refer patients early for diagnostic procedures.