bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sunitinib, sorafenib, temsirolimus, or bevacizumab in the treatment of metastatic renal cell carcinoma (RCC): A review of health economic evaluations
Authors: Norum J. , Nieder C. , Kondo M. 
Published: August 2020

e17539 Background: Renal cell carcinoma (RCC) is the most prevalent kidney cancer and the 5-year overall survival figure in metastatic disease (mRCC) is about 10%. New targeted drugs (sunitinib, sorafenib, bevacizumab, temsirolimus) have shown activity in the treatment of mRCC, but they are all associated with a significant burden of cost. Methods: To support decision makers in their allocation of resources, cost-effectiveness models are constructed to compare the costs and outcomes of anticancer therapy. The PubMed, ASCO abstracts, Google, and the Igaku Chuo Zasshi databases were searched in November 2008 with key terms: kidney, renal, cancer, cost, sunitinib, sorafenib, temsirolimus, and bevacizumab. Seven studies reporting data on cost-effectiveness were revealed. Three of them were published in full text versions. The countries of application were United Kingdom, Canada, United States, Finland, and Japan. An analytical checklist was applied to the seven economic evaluations. Results: The review reveals figures of cost per LYG or QALY in the range €22,648 to €203,692, depending on line setting and drug focused. The results were limited by short follow up periods and the consequently fact that premature data had to be implemented in the Markov models. When compared, sunitinib has the lowest cost-effectiveness figure. Second-line therapy dose not seem to offer valid incremental cost-effectiveness ratios (ICERs) below accepted cost-effectiveness thresholds. As long as cross-over to the experimental arm is allowed (based on improvement in progression free survival) overall survival data are difficult to interpret and the cost difference between the treatment and the control arm minimised. Conclusions: The review revealed ICERs with a wide range. Sunitinib has the lowest cost-effectiveness figure. Second-line therapy does not look cost-effective. [Table: see text]
An assessment of breast cancer survivorship awareness and educational needs among health care professionals
Authors: De Fusco P. , Chlebowski R. 
Published: August 2020

e17542 Background: Tremendous advances in detection and treatment have improved breast cancer survival rates. However, with nearly 22.4 million people worldwide living with cancer, optimal survivorship care has become a major focus of health care professionals (HCPs) and patient advocates. The Breast Cancer Survivorship Alliance (BCSA) is a group of HCPs and patient advocates dedicated to enhancing patient survivorship care and encouraging HCPs to look beyond the diagnosis and treatment of breast cancer. Methods: To identify educational needs in breast cancer survivorship, a 25-question survey was fielded at the 2007 San Antonio Breast Cancer Symposium. Electronic and print surveys were available at the Y-Me National Breast Cancer Organization and AstraZeneca booths. Results: Of the 516 respondents, 29% were from the United States, 63% were from the rest of the world, and 8% did not specify a location. A total of 73% were physicians, 7% were oncology nurses, nurse practitioners, or physician assistants, and 20% represented other aspects of breast cancer care (e.g., advocates and patients). The survey revealed a lack of consensus on the definition of cancer survivor, with only 26% of respondents selecting the definition established by the National Coalition for Cancer Survivorship (ie, from the moment of cancer diagnosis and for the balance of life). More than half (i.e., 51%) defined cancer survivor as a patient who has been disease-free for 5 years. Overall wellness promotion, adherence, and management of treatment-related side effects were ranked as the 3 most essential aspects of survivorship care. While most practices engage in posttreatment survivorship counseling, only 16% provide patients with an end-of-treatment summary or survivorship care plan. Most respondents indicated that their institution has a survivorship program in place (39%) or in development (30%). Conclusions: Although progress has been made in understanding and implementing survivorship care, additional education is needed to optimize care of breast cancer survivors. [Table: see text]
Current trend of breast cancer therapeutics from the U.S. clinical trial database
Authors: Kwok S. S. , Tsang J. 
Published: August 2020

e17546 Background: The standard of breast cancer care has been based on clinical trial results. With the International Committee of Medical Journal Editors (ICMJE) requiring all clinical trials registered in a public trial registry as a condition of publication, the US trials registry “ClinicalTrials.gov” has become a global registry of currently available clinical trials. We aim to explore the current clinical trials to study the trend of breast cancer therapeutics development based on analysis of a comprehensive breast cancer trial database. Methods: We performed a systematic review of all breast cancer therapeutic clinical trials. All data were captured from ClinicalTrials.gov for all “industry-sponsored” phase I-IV trials in October, 2007 including trials that were first registered between October 2005 and September 2007. Essential data was extracted by a tailor-made Statistical Analysis System Program developed by Professor JP Karlberg at the University of Hong Kong. The data included register identity, study phase, study compounds and recruitment status etc. Results: Altogether 443 clinical therapeutic interventional trials were identified and classified into 10 modes of action. The latest five mostly studied compounds accounted for 32.73% of all the therapeutic trials (n = 145). Lapatinib, a dual kinase inhibitor is studied most in 31 trials (9 monotherapy). Docetaxel, a mitotic inhibitor is studied in 27 trials (10 monotherapy) while letrozole, an aromatase inhibitor, currently used in adjuvant setting is tested in 18 out of a total 22 trials as monotherapy. Antimetabolites such as gemcitabine being involved in 24 trials (2 monotherapy) with capecitabine studied in 21 trials (11 monotherapy), were followed by bevacizumab, a VEGF monoclonal antibody which is currently studied in 20 trials, and tested as combinations in 75% of the related trials. Conclusions: According to the US trial registry, current most commonly tested compounds for breast cancer include lapatinib, followed by docetaxel, gemcitabine, letrozole, and capecitabine. There is increasing new therapeutics with combination strategy. This supports the trend of personalized medicine in the management of breast cancer which is a heterogeneous disease. No significant financial relationships to disclose.
Assessment of barriers to patient participation in clinical trials among oncology outpatients at a community teaching hospital in Toronto
Authors: Shamrakov L. , Sampson H. , Nyhof-Young J. , Rahim Y. 
Published: August 2020

e17547 Background: This study investigated barriers to patient participation in clinical trials (CTs). In particular, the effect of educational attainment on the understanding of, interest about, and past participation in CTs among cancer patients at a Toronto community teaching hospital was assessed. Methods: A survey was administered to cancer outpatients, containing Yes/No answers, and likert scales. Responses were analyzed quantitatively (SPSS). Results: 101 questionnaires were completed out of 112 administered (90% response rate). 76% of patients self-reported as knowledgeable about clinical trials. Patients education level correlated to their perceived knowledge of clinical trials: 37.5% of patients with a less than grade 9, 59.4% with a high school, and 90.2% with a university background identified themselves as knowing what CTs are. All patients scored poorly on details and held common misconceptions of CTs (e.g. knowing little about placebos and experimental drug testing). Overall, 27% of patients had been previously enrolled in CTs. Of the 34% of patients who had been previously approached, 79% had agreed to participate. The majority were willing to participate or unsure of participating in CTs. A minority stated they will never participate in a trial. Patients also identified concern about lack of hospital resources about CTs and a desire to have a doctor present when learning about CTs. Patients with less education identified a greater desire for a doctor's presence than those with more education. Conclusions: This study revealed lack of staff recruitment, low patient awareness, and lack of availability of trial facilities as potential barriers to participation. Targeted information to patients with different education levels may be appropriate, given variable knowledge about CTs. Education and counseling regarding placebos and experimental drugs should be targeted towards all patients to reduce barriers to patient participation, diminish myths, and increase understanding and interest. In response, this institution will design a brochure for all patients describing clinical trials, providing a glossary of terms, and offering a list of key resources in order to improve awareness and trial recruitment. No significant financial relationships to disclose.
A review of physician preparedness in response to a systemic crisis: The case of Eastern Regional Health Authority, Newfoundland, Canada, estrogen receptor (ER) breast cancer (BC) errors
Authors: Popadiuk C. 
Published: August 2020

e17551 Background: From March until October 2008, a Commission of Inquiry was held in St. John's, Canada, investigating systemic errors leading to incorrect ER results in BC patients. 386 ER negative BC samples tested between 1997 and 2005 were incorrect. Of 91 witnesses, 26 physicians testified about their roles in this “crisis.” Physicians have traditionally been trained to respond to individual clinical crises and acute traumatic situations. This study summarizes the physicians’ training and preparedness in response to a systemic organizational crisis. Methods: Inquiry exhibits, submissions, and transcripts of physician testimony were reviewed for evidence of education and experience in crisis management (CM) as applied to a complex organization. Education and experience with organizational health care crisis were tabulated and prevalent themes relevant for physicians summarized. Results: Evidence was reviewed from 5 oncologists, 17 pathologists, 1 health information analyst, and 3 senior physician leaders. 20 physicians held departmental or divisional leadership roles, one had an advanced degree in Public Health and one had direct experience in a complex private organization. 5 out of province expert consultants had direct experience with continuous quality control applied to large organizations. No physicians were formally trained in CM in terms of acute crisis response. Two prevailing concerns were expressed: 1) delayed and incomplete disclosure of information to patients and public, and 2) numerous preceding systems problems identified by physicians that did not translate into necessary systemic changes to prevent the crisis. Conclusions: The practice of CM recognizes the need to eliminate technological and human systems failure and to develop formal communication systems to avoid or to manage crisis situations. Large-scale organizational crisis management is an important concept for physicians to understand and actively participate in their professional roles. At present most physicians do not receive formal training in CM. No significant financial relationships to disclose.
A cost analysis of treatment with bevacizumab plus cisplatin and gemcitabine (BCG) versus cetuximab plus vinorelbine and cisplatin (CVC) in patients with advanced or recurrent non-small cell lung cancer (NSCLC) in Germany
Authors: Heigener D. F. , Wiesner C. , Aultman R. 
Published: August 2020

e17553 Background: Although new treatment options for advanced NSCLC can offer improved survival over standard treatment with chemotherapy (CT) they should also offer value for money. Bevacizumab (BEV), a humanized monoclonal antibody (MAb) directed against vascular endothelial growth factor when combined with CT increases overall survival (median 13.6 months in the AVAiL study) and progression-free survival (PFS) in patients with advanced NSCLC when compared with CT alone. Cetuximab (CTX), an IgG1 MAb which targets the epidermal growth factor receptor achieved a median survival time of 11.3 months when combined with CT in the FLEX study and marketing authorization is anticipated in 2009. The aim of this study was to compare the costs of treating NSCLC with BCG or CVC in Germany. Methods: A Markov model was used to compare drug and administration costs associated with treating advanced or recurrent NSCLC with either BCG or CVC. The model assumes patients move from non-progressive to progressed disease prior to death, according to transition probabilities derived from an indirect comparison of the efficacy of BCG and CVC in terms of PFS using data from the respective pivotal trials and appropriate indirect comparison methodology. Cost data were derived from local sources. Drug costs assumed CT was given for up to 6 cycles, that CTX was administered at an initial dose of 400 mg/m2 followed by 250 mg/m2 weekly until progression and that BEV was administered at 7.5 mg/kg until progression. The model estimated average drug and administration costs per patient treated with either BCG or CVC. Results: The mean total cost of BCG treatment was €4713 less per patient when compared with CVC (€28342 vs. €33055). The addition of BEV to CT was less costly than the addition of CTX to CT (€18796 vs. €29502) and the administration costs were also lower (€391 vs. €1179). Conclusions: Targeted therapy using BEV is less costly than CTX in Germany and thus, from a budget perspective, offers the best value for money strategy for improving outcomes in patients with advanced NSCLC. Furthermore, costs savings with BCG in Germany are likely to be increased when gemcitabine comes off-patent in 2009. [Table: see text]
Economic evaluation of sunitinib versus other new targeted therapies as first-line treatment of metastatic renal cell carcinoma (mRCC) in the United States
Authors: Benedict A. , Figlin R. A. , Charbonneau C. , Kreif N. , Hariharan S. , Négrier S. 
Published: August 2020

e17556 Background: RCC, the most prevalent kidney cancer, is a relatively rare malignancy that carries a poor prognosis. New targeted therapies, such as sunitinib, sorafenib, temsirolimus, and bevacizumab + interferon-alfa (IFN-α), are now available in the US for the treatment of mRCC. In the absence of head-to-head trials, the aim of this analysis was to assess the economic value of these therapies as first-line treatment of mRCC from a U.S. third-party payer perspective, using an indirect comparison based on reported survival data. Methods: An economic model was built to simulate progression-free and overall survival based on each treatment's hazard ratio against IFN-α as reported from phase II and III clinical trials. Clinical model parameters were also derived from these trials and complemented with clinical experts’ opinions. Costs of drugs, routine follow-up, treatment-related adverse events, disease progression, and best supportive care of terminally-ill patients were included in the model. Results, expressed as life-years (LY), progression-free LY (PFLY), and quality adjusted LY (QALY) gained, treatment costs (applied in 2008 USD), and incremental cost-effectiveness ratios (ICER), were obtained through probabilistic analysis over a 10-year time horizon. Since the phase III clinical trial of temsirolimus included the MSKCC (modified) poor risk group patients only, two separate evaluations were carried out: (1) comparison of sunitinib, sorafenib, and bevacizumab + IFN-α in all patients and (2) a similar comparison of sunitinib and temsirolimus in the poor-risk group patients only. Results: In the first comparison model, sunitinib was both more effective (with gains of 0.52 and 0.19 PFLY, and 0.17 and 0.03 QALY) and less costly (by $13,675 and $84,260) than sorafenib and bevacizumab + IFN-α, respectively, over 10 years. Similarly, sunitinib was both more effective (with gains of 0.12 PFLY and 0.07 QALY) and less costly (saving $9,605 over ten years) than temsirolimus in patients in the poor risk group. Conclusions: These model results suggest that sunitinib is a cost-effective alternative to sorafenib, bevacizumab + IFN-α, and temsirolimus as a first-line treatment of mRCC. [Table: see text]
Variables in the correct subclassification of non-small cell lung cancer (NSCLC)
Authors: Mishra A. , Farghaly H. , Rabinowits G. , Kloecker G. H. 
Published: August 2020

e17561 Background: Targeting specific cancer growth pathways has become standard in treating NSCLC. Distinguishing subclasses of NSCLC is therefore increasingly important. However, 20–30% of cases in major clinical trials are categorized as “not otherwise specified” (NOS), similar to our cancer registry at the University of Louisville hospital. This study examines clinical and pathological variables that may affect the probability to accurately specify NSCLC histology. Methods: 147 cases of NSCLC after 2004 were randomly selected and reviewed. The variables examined included time of diagnosis, amount of tissue at diagnosis, use of immuno-histochemistry (IHC), and eligibility for systemic therapy. NOS was defined as unclassified histology, including poorly differentiated carcinoma. Results: NSCLC was confirmed by cytomorphology in all but one case. 69 cases were adeno ca (47%), 45 squamous (31%), 2 large cell (1%), 31 NOS (21%), with the percentage of NOS being constant over the years. The patient's eligibility for systemic therapy was not associated with any particular histology. Only 3/31 (10%) cases of NOS had surgical specimens, whereas 36/116 (31%) with specified histology had surgical specimens (p<0.05). 47 % of adeno ca, 24% of squamous ca, and 41% of NOS cases had IHC. Of all specimens only 39% had IHC performed. Conclusions: Cytomorphology alone is not able to subclassify all cases of NSCLC in FNA specimens. Our study found a significant association between adequate tissue quantity and correct subclassification of NSCLC. IHC helps to subclassify NSCLC, but was not done in most cases. Lack of sufficient tissue is a major reason for absent IHC's and failure to subclassify NSCLC. To retrieve genomic and proteomic information from tissue and target therapy correctly, it becomes important to do core needle biopsies whenever possible. Pathology assistance at time of biopsy to assure adequacy of the sample is another practical measure to decrease the proportion of cases with NOS. [Table: see text] No significant financial relationships to disclose.
Interim results of a survey to evaluate use and interest in autologous and allogeneic bone marrow transplant as a treatment option among patients
Authors: Van Hoef M. 
Published: August 2020

e17569 Background: A survey was placed on websites inviting patients to provide an opinion about bone marrow transplant as treatment option for their disease. Herein an interim analysis of results is presented. Methods: A survey was developed requesting general information about the responder, the disease, and the experience with and interest in autologous and allogeneic donor transplants as treatment option for disease. The survey was placed on sites in the Netherlands and Belgium (cancer fora and website) and was initially announced in a few magazins. Results: Several cancer fora in the Netherlands initially rejected the survey; in Belgium no restrictions were encountered. At the interim analysis 81 Dutch and 2 English speaking responders have started the survey. 60 Dutch and 1 English speaking responder completed the survey as of December 1, 2008. Of Dutch responders 60.5% accessed the survey from the website, 79.9% were women, 56% were patient. Among responders 18.7% responded related to leukemia, and the remaining to other diseases among which myeloma (10.7%), lymphoma (13.3%) and breast cancer (19.4%). The majority had been diagnosed in 2006 and 2007. The majority of responders had not been treated with autologous or allogeneic transplants (for both 87%), however 43.8% informed to know what and autologous transplant is and 55.2% knew what an allogeneic transplant is. About 25% of responders of either type had spoken about transplant with a doctor and about 35% of responders of either type thought that BMT is a treatment option for their disease. 76% of responders were aware that people can be a bone marrow donor. Conclusions: 20 questions were asked and answered; 75% of responders completed the survey. Interim results gave among others insight in knowledge, treatment. and discussion of transplant as treatment option with doctors. An update and further details will be presented. No significant financial relationships to disclose.
Allocation of high demand, scarce medical technology: Lessons for proton radiotherapy
Authors: Rakszawski K. , Bekelman J. E. 
Published: August 2020

e17570 Background: Proton radiotherapy is a scarce therapeutic resource. To inform policy development on the allocation of proton radiotherapy, we performed a systematic review to investigate the use of high demand, scarce medical technology in three settings: 1) proton radiotherapy; 2) liver transplantation; and 3) intensive care units (ICUs). Methods: Studies were identified by searching MEDLINE (from 1990 to 2008) and references of articles, letters, commentaries, and editorials. We included English-language quantitative and qualitative studies, commentaries and policy papers addressing the methods and effects of resource allocation. A total of 2,304 citations were screened, 197 potentially eligible full articles were retrieved on a basis of abstract review, and 34 studies met our inclusion criteria (1 related to proton radiotherapy, 10 related to liver transplantation, and 23 related to ICUs). Data was extracted from each of the 34 studies into tabular displays, drawing from the balance sheet model for integrating and interpreting multiple types of evidence. Results: A single case report addressed the allocation of proton radiotherapy. Within the liver transplantation setting, the Model for End-Stage Liver Disease (MELD) system utilizes a priority scale based on objective indicators of disease severity. One study showed that use of the MELD system increased transplants among patients with greater disease severity and reduced transplant wait times. Within the ICU system, formal admission guidelines have been developed by committees with input from multiple stakeholders. However, one survey showed that while the majority of hospitals have formal guidelines, only 25% use these guidelines in routine clinical practice. Conclusions: Evidence to inform policy development on the allocation of proton radiotherapy is sparse. The substantial potential benefits and costs of proton radiotherapy underscore the need for an objective, transparent system for proton radiotherapy allocation. [Table: see text]