Abstract:In recent years, the term “value-based healthcare” has been increasingly used in debates about costs and outcomes of health interventions in cancer care. This paper distinguishes 2 meanings of the term “value” and explores the relevance of both meanings of the word for assessing the “value” of cancer drugs. At the focus of the analysis are value judgments which form an integral part of the assessment of benefit of cancer drugs. The review concludes with a reflection on individual competences and systemic facto… Show more
“…About 21 million new cancers and 8.2 million cancer deaths worldwide are estimated until 2030 [2]. Surgery, radiotherapy, and chemotherapy are the most used approaches in the management and treatment of the disease [3]. Chemotherapy is commonly associated with the non-specific delivery of antineoplastic drugs capable of inhibiting mitosis, causing cell death and systemic toxicity.…”
Brazilian red propolis has been proposed as a new source of compounds with cytotoxic activity. Red propolis is a resinous material of vegetal origin, synthesized from the bees of the Appis mellifera family, with recognized biological properties. To obtain actives of low polarity and high cytotoxic profile from red propolis, in this work, we proposed a new solvent accelerated extraction method. A complete 23 factorial design was carried out to evaluate the influence of the independent variables or factors (e.g., temperature, number of cycles, and extraction time) on the dependent variable or response (i.e., yield of production). The extracts were analyzed by gas chromatography coupled with mass spectrometry for the identification of chemical compounds. Gas chromatography analysis revealed the presence of hydrocarbons, alcohols, ketones, ethers, and terpenes, such as lupeol, lupenone, and lupeol acetate, in most of the obtained extracts. To evaluate the cytotoxicity profile of the obtained bioactives, the 3-(4,5-dimethyl-2-thiazole)-2,5-diphenyl-2-H-tetrazolium bromide colorimetric assay was performed in different tumor cell lines (HCT116 and PC3). The results show that the extract obtained from 70 °C and one cycle of extraction of 10 min exhibited the highest cytotoxic activity against the tested cell lines. The highest yield, however, did not indicate the highest cytotoxic activity, but the optimal extraction conditions were indeed dependent on the temperature (i.e., 70 °C).
“…About 21 million new cancers and 8.2 million cancer deaths worldwide are estimated until 2030 [2]. Surgery, radiotherapy, and chemotherapy are the most used approaches in the management and treatment of the disease [3]. Chemotherapy is commonly associated with the non-specific delivery of antineoplastic drugs capable of inhibiting mitosis, causing cell death and systemic toxicity.…”
Brazilian red propolis has been proposed as a new source of compounds with cytotoxic activity. Red propolis is a resinous material of vegetal origin, synthesized from the bees of the Appis mellifera family, with recognized biological properties. To obtain actives of low polarity and high cytotoxic profile from red propolis, in this work, we proposed a new solvent accelerated extraction method. A complete 23 factorial design was carried out to evaluate the influence of the independent variables or factors (e.g., temperature, number of cycles, and extraction time) on the dependent variable or response (i.e., yield of production). The extracts were analyzed by gas chromatography coupled with mass spectrometry for the identification of chemical compounds. Gas chromatography analysis revealed the presence of hydrocarbons, alcohols, ketones, ethers, and terpenes, such as lupeol, lupenone, and lupeol acetate, in most of the obtained extracts. To evaluate the cytotoxicity profile of the obtained bioactives, the 3-(4,5-dimethyl-2-thiazole)-2,5-diphenyl-2-H-tetrazolium bromide colorimetric assay was performed in different tumor cell lines (HCT116 and PC3). The results show that the extract obtained from 70 °C and one cycle of extraction of 10 min exhibited the highest cytotoxic activity against the tested cell lines. The highest yield, however, did not indicate the highest cytotoxic activity, but the optimal extraction conditions were indeed dependent on the temperature (i.e., 70 °C).
“…a high chance of success, since in the former case an extremely high benefit may be expected in individual cases. The frameworks of the American Society of Clinical Oncology and the European Society for Medical Oncology concerning the benefit of diagnostic and treatment interventions and cancer drugs may provide a good evidence-based starting point regarding the respective decisions about prioritization (Cherny et al 2015 , 2017 ; Schildmann 2019 ; Schnipper et al 2012 ).…”
Purpose
Cancer care in Germany during the COVID-19 pandemic was affected by resource scarcity and the necessity to prioritize medical measures. This study explores ethical criteria for prioritization and their application in cancer practices from the perspective of German oncologists and other experts.
Methods
We conducted fourteen semi-structured interviews with German oncologists between February and July 2021 and fed findings of interviews and additional data on prioritizing cancer care into four structured group discussions, in January and February 2022, with 22 experts from medicine, nursing, law, ethics, health services research and health insurance. Interviews and group discussions were digitally recorded, transcribed verbatim and analyzed using qualitative content analysis.
Results
Narratives of the participants focus on “urgency” as most acceptable criterion for prioritization in cancer care. Patients who are considered curable and those with a high level of suffering, were given a high degree of “urgency.” However, further analysis indicates that the “urgency” criterion needs to be further distinguished according to at least three different dimensions: “urgency” to (1) prevent imminent harm to life, (2) prevent future harm to life and (3) alleviate suffering. In addition, “urgency” is modulated by the “success,” which can be reached by means of an intervention, and the “likelihood” of reaching that success.
Conclusion
Our analysis indicates that while “urgency” is a well-established criterion, its operationalization in the context of oncology is challenging. We argue that combined conceptual and clinical analyses are necessary for a sound application of the “urgency” criterion to prioritization in cancer care.
“…From a patient perspective, value may include more difficult-to-quantify interactions between clinically meaningful benefit, out-of-pocket healthcare costs, and effects on quality of life (QOL). 39 40 Effective anticancer treatments also benefit society as a whole by allowing patients to return to being productive contributors rather than having prolonged chronic illness ultimately resulting in death. An added facet of value that may be considered by investigators is the potential for a trial to provide informative data on biomarkers of response and resistance or for patient selection in order to maximize likelihood of success for future studies.…”
Section: Definition Of Value In Phase III Clinical Trialsmentioning
confidence: 99%
“…In evaluating the landscape of competing trials to assess unmet need, it is important to consider the magnitude and type of efficacy expected for an investigational combination. Additionally, patient-centered concepts of value 39 40 should be taken into account such as the potential for an investigational combination to offer disease control and even treatment-free remissions, with fewer detrimental impacts on QOL compared with the standard of care option or to reduce direct and indirect aspects of the financial burden of cancer care.…”
Section: Assessing Potential Value In Phase III Trialsmentioning
confidence: 99%
“…However, it must be emphasized that a positive result in phase III does not guarantee meaningful benefit to patients. 39 148 149 For example, statistical significance does not always correlate with clinical significance. Furthermore, for studies designed with PFS as the primary endpoint, successful prolongation of PFS is not always associated with prolonged survival, 42 nor does not necessarily improve QOL.…”
Section: Future Directions To Maximize Value In Phase III Immunothera...mentioning
The broad activity of agents blocking the programmed cell death protein 1 and its ligand (the PD-(L)1 axis) revolutionized oncology, offering long-term benefit to patients and even curative responses for tumors that were once associated with dismal prognosis. However, only a minority of patients experience durable clinical benefit with immune checkpoint inhibitor monotherapy in most disease settings. Spurred by preclinical and correlative studies to understand mechanisms of non-response to the PD-(L)1 antagonists and by combination studies in animal tumor models, many drug development programs were designed to combine anti-PD-(L)1 with a variety of approved and investigational chemotherapies, tumor-targeted therapies, antiangiogenic therapies, and other immunotherapies. Several immunotherapy combinations improved survival outcomes in a variety of indications including melanoma, lung, kidney, and liver cancer, among others. This immunotherapy renaissance, however, has led to many combinations being advanced to late-stage development without definitive predictive biomarkers, limited phase I and phase II data, or clinical trial designs that are not optimized for demonstrating the unique attributes of immune-related antitumor activity—for example, landmark progression-free survival and overall survival. The decision to activate a study at an individual site is investigator-driven, and generalized frameworks to evaluate the potential for phase III trials in immuno-oncology to yield positive data, particularly to increase the number of curative responses or otherwise advance the field have thus far been lacking. To assist in evaluating the potential value to patients and the immunotherapy field of phase III trials, the Society for Immunotherapy of Cancer (SITC) has developed a checklist for investigators, described in this manuscript. Although the checklist focuses on anti-PD-(L)1-based combinations, it may be applied to any regimen in which immune modulation is an important component of the antitumor effect.
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