Background: The objective of this study was to describe the real-world treatment and overall survival (OS) of German patients with a diagnosis of advanced non-small cell lung cancer (aNSCLC), and to explore factors associated with the real-world mortality risk. Methods: This was a retrospective German claims data analysis of incident aNSCLC patients. Data were available from 01/01/2011 until 31/12/2016. Identification of eligible patients took place between 01/01/2012-31/12/2015, to allow for at least 1-year pre-index and follow-up periods. Inpatient and outpatient mutation test procedures after aNSCLC diagnosis were observed. Further, prescribed treatments and OS since first (incident) aNSCLC diagnosis and start of respective treatment lines were described both for all patients and presumed EGFR/ALK/ROS-1-positive patients. Factors associated with OS were analyzed in multivariable Cox regression analysis. Results: Overall, 1741 aNSCLC patients were observed (mean age: 66•97 years, female: 29•87%). The mutation test rate within this population was 26•31% (n = 458), 26•6% of these patients (n = 122) received a targeted treatment and were assumed to have a positive EGFR/ALK/ROS-1 test result. Most often prescribed treatments were pemetrexed monotherapy as 1 L (21•23% for all and 11•11% for mutation-positive patients) and erlotinib monotherapy as 2 L (25•83%/38•54%). Median OS since incident diagnosis was 351 days in all and 571 days in mutation-positive patients. In a multivariable Cox regression analysis, higher age, a stage IV disease, a higher number of chronic drugs in the pre-index period and no systemic therapy increased the risk of early death since first aNSCLC diagnosis. On the other hand, female gender and treatment with therapies other than chemotherapy were associated with a lower risk of early death. Conclusions: Despite the introduction of new treatments, the real-world survival prognosis for aNSCLC patients remains poor if measured based on an unselected real-world population of patients. Still, the majority of German aNSCLC patients do not receive a mutation test.
Malignant neoplasms of female genital organs (FGO) occupy the second place in structure of morbidity after breast cancer. Aim of the study is to estimate the annual costs of drug therapy in Moscow of patients with FGO. Methods: To estimate the annual costs of drug therapy in Moscow for patient with ICD C51-C58 we conducted retrospective cabinet analysis of drug utilization and drug cost. Main data source was regular database of reimbursed drug prescription of Moscow department of healthcare. We computed number of patients received each drug, number of prescriptions, mean cost of drugs per patient, total cost of drugs for all patients within 2018 year. Results: There was estimated that the most costly drug therapy of FGO is olaparib (42,0% of total costs of cancer treatment), then bevacizumab (18,2%), pacitaxel (8,0%), pazopanib (3,5%), trabectedin (2,5%), doxorubicin (2,3%), carboplatin (2,2%), docetaxel (2,2%) , epoetin beta (2,1%). Also we accessed the most prescribed drugs ondansetron (17,8%), carboplatin (13,1%), pacitaxel (12,8%), bevacizumab (11,0%), gemcitabine (5,2%), filgrastim (3,6%), cisplatin (3,3%), epoetin beta (3,3%), etoposide (2,7%). Conclusions: Analysis shows that the 5 most expensive cost of drug treatment for one patient have olaparib, trabectedin, pazopanib, doxorubicin and bevacizumab.
OBJECTIVES: Surrogate endpoints can support early access to novel therapies. In trial-level endpoint validation studies, the association between treatment effect e.g., the hazard ratio (HR) on both the surrogate and hard endpoint can be estimated. We aimed to review studies reporting an association between HRs of surrogate time-to-event endpoints and overall survival (OS) in advanced/metastatic cancers. METHODS: A systematic review was conducted using Medline and Embase. We included full reports assessing the association between HRs of surrogate time-to-event endpoints and OS in advanced/metastatic cancer indications. The following information was extracted: study characteristics, association measure, use of weighted analyses, logarithmic transformation of HRs, use of multivariate analysis, evaluation of crossover impact, use of IQWiG framework, estimating surrogate threshold effect (STE), and reported results and/or regression equations. RESULTS: Forty-five studies were included. Retrieved studies were conducted in 16 different cancer indications. Different methods were used to assess associations, including Spearman's/Pearson's correlation coefficient and linear regression analysis. Weighted analyses, logarithmic transformation of HRs and multivariate analysis were implemented in 35, 26 and 10 studies, respectively. Few studies assessed the crossover impact on the association (8 studies) and implemented IQWiG framework and STE assessment (11 studies and 3 studies, respectively). Detailed results are extracted, summarized and will be presented. CONCLUSIONS: There is inconsistency in conducting/reporting of trial-level endpoint validation studies in advanced/metastatic cancers. Future studies would benefit from building a structured data analysis checklist. Also, trial-level surrogacy was not assessed in all advanced/metastatic cancers and the strength of association varied across indications. The generalizability of results from one indication to another is limited.
OBJECTIVES: Surrogate endpoints can support early access to novel therapies. In trial-level endpoint validation studies, the association between treatment effect e.g., the hazard ratio (HR) on both the surrogate and hard endpoint can be estimated. We aimed to review studies reporting an association between HRs of surrogate time-to-event endpoints and overall survival (OS) in advanced/metastatic cancers. METHODS: A systematic review was conducted using Medline and Embase. We included full reports assessing the association between HRs of surrogate time-to-event endpoints and OS in advanced/metastatic cancer indications. The following information was extracted: study characteristics, association measure, use of weighted analyses, logarithmic transformation of HRs, use of multivariate analysis, evaluation of crossover impact, use of IQWiG framework, estimating surrogate threshold effect (STE), and reported results and/or regression equations. RESULTS: Forty-five studies were included. Retrieved studies were conducted in 16 different cancer indications. Different methods were used to assess associations, including Spearman's/Pearson's correlation coefficient and linear regression analysis. Weighted analyses, logarithmic transformation of HRs and multivariate analysis were implemented in 35, 26 and 10 studies, respectively. Few studies assessed the crossover impact on the association (8 studies) and implemented IQWiG framework and STE assessment (11 studies and 3 studies, respectively). Detailed results are extracted, summarized and will be presented. CONCLUSIONS: There is inconsistency in conducting/reporting of trial-level endpoint validation studies in advanced/metastatic cancers. Future studies would benefit from building a structured data analysis checklist. Also, trial-level surrogacy was not assessed in all advanced/metastatic cancers and the strength of association varied across indications. The generalizability of results from one indication to another is limited.
Immune-checkpoint inhibitors (ICI) are emerging as the standard of care for many cancers. However, HRQoL of patients treated with ICI in the real-world remain largely unknown. Social media is increasingly used by patients to express their views about their illness and treatment experience. The objective was to assess the conceptual similarity between cancer generic HRQoL measures and cancer patients' experience described in social media. Methods: Patient messages were retrieved from 19 different French social media sources between Jan-2011 and Aug-2018. Messages of interest were extracted using automatic processes and manual searches. Extracted messages were analysed by two independent reviewers. HRQoL statements were classified according to predefined HRQoL dimensions in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and FACT-G. Results: Overall, 137 ICI-treated patients posted HRQoL-related messages on social media. Cited dimensions of HRQoL were global health (115 patients), symptoms (76; mean: 2.1 per patient), emotion (49), role (22), physical functioning (13), professional situation (2) and cognitive state (2). Both the QLQ-C30 and FACT-G cover global health dimension expressed by patients in their messages. A total of 13 symptoms were identified from messages; the QLQ-C30 captured 5, whereas the FACT-G captured 3. Ten themes related to emotional functioning were identified, 2 were covered by the QLQ-C30 and 3 by the FACT-G. Seven themes were retrieved describing patients' role; the QLQ-C30 captured 5, whereas the FACT-G captured 3. In terms of physical functioning, 4 themes were identified; the QLQ-C30 captured all themes, whereas the FACT-G captured 1. Conclusions: Conceptual similarity between HRQoL themes from social media and the most commonly used generic HRQoL measures was generally suboptimal. Careful interpretation is required due to the relatively low sample size. A larger study on social media would be needed to assess correlation with tumor specific questionnaires of HRQoL.
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