bluuebunny/crossref_metadata_2025_split huggingface dataset:
A retrospective exploratory study of the variability of radiologists’ measurements in a selected subgroup of subjects enrolled in a clinical trial
Authors: Ford R. W. , Ford R. R. , Zhou K. 
Published: March 2020

6523 A retrospective exploratory study of the variability of radiologists’ measurements in a selected subgroup of subjects enrolled in a clinical trial Background: Independent centralized review of imaging studies is an established means of validating data used in support of corporate ‘go-no go‘ decisions, regulatory approval, and post marketing claims. Despite best efforts at standardizing this process using the Response Evaluation Criteria in Solid Tumors (RECIST), there will be inherent differences in radiologic measurements. To define a concise value for the variation between a specific set of radiologists, the following study was performed. Methods: An experienced radiologist and a research intern reviewed digital Computerized Tomographic (CT) scans from 31 subjects to identify 150 primary and metastatic tumors. Tumors were categorized into 4 categories. [Category (Cat.) 1 - Defined Edge/Radially Symmetric, Cat. 2 - Defined Edge/Irregular Shape, Cat. 3 - Blurred Edge/Radially Symmetric, Cat. 4 - Blurred Edge/Irregular Shape] Fifteen radiologists independently measured each tumor. Mixed effects models controlling for different tumors were used to assess the variance. Results Overall, the between reader variations accounted for 4.15% percent of total errors for the length. The respective between reader and the random errors are 0.32 (95% CI: 0.14, 0.77) and 7.51 (95%CI: 7.08, 8.01). The data shows that the variances are smallest for category 1 tumors (total error: 1.45) and largest for category 4 tumors (total error: 20.79). The total error for categories 2 and 3 are listed in Table 1 below. Conclusions The (low reader error) / (total error) verifies that the radiologists were only responsible for a small portion of the total error, and suggests these 15 radiologists measuring a tumor will be comparable to one of these radiologists measuring the tumor many times. No significant financial relationships to disclose. [Table: see text]
Screening cancer patients for clinical trial eligibility: A randomized study
Authors: Wright J. , Whelan T. , Julian J. , Simunovic M. , Levine M. 
Published: March 2020

6529 Background: The overall proportion of cancer patients enrolled into clinical trials is undesirably low. Research suggests many aspects of the recruitment process can be improved. The present study was undertaken to evaluate the benefit of identifying potentially eligible (PE) clinical trial patients for physicians. Methods: Consenting physicians were randomized to 26 weeks of screening support or not, and were then crossed-over to the other strategy for a second 26-week time period. A computer program reviewed new patient consultations to identify PE clinical trial patients. Physicians receiving support were provided with written individualized details of patient eligibility for trials prior to their medical consultation. The primary outcome of interest was the difference, by physician, in the number of patients who were approached for consent to enter a clinical trial. Results: Thirty-six physicians participated in the 52-week study. 5051 consultations were screened in a blinded fashion, 2,376 when physicians had support and 2,675 when they did not. 939 of 2,376 (39.5%) consultations were identified as involving PE patients when physicians were receiving support, and 1,061 of 2,675 (39.7%) when without. The primary outcome of the study, by physician, did not demonstrate a statistically significant improvement, with 4.1 patients per physician without vs. 4.7 patients with screening support (p>0.05). Secondary analysis demonstrated that the overall proportion of patients approached with the clinical trial option increased from 149/2,675 (5.6%) to 169/2,376 (7.1%) with screening support (Chi-square, p=0.024) and that the number of patients that entered a clinical trial also increased from 60/2,675 (2.2%) to 83/2,376 (3.5%) (Chi-square, p=0.007). Conclusions: This study suggests that individualized patient screening for clinical trial eligibility may be useful to improve the numbers of patients approached to consider clinical trials. The number of new patients that entered clinical trials remained low, and ongoing research to facilitate improvements is required. No significant financial relationships to disclose.
Expanding participation to non-group members in phase III cooperative group treatment trials
Authors: Denicoff A. M. , Hopkins J. R. , Riordan S. E. , Adler J. M. , Marinucci D. M. , Geisen K. , Lambersky R. , Catalano R. B. , Mooney M. M. , Abrams J. S. 
Published: March 2020

6533 Background: The NCI initiated the Cancer Trials Support Unit (CTSU) Independent Clinical Research Site (CICRS) Program at the ASCO Annual meeting in 2002. Building upon the CTSU's initial aim to expand participation of any NCI-sponsored Cooperative Group (Group) phase 3 trial to all Group and Community Clinical Oncology Program (CCOP) members, the CICRS initiative has enabled unaffiliated sites to enroll patients in a wide variety of Group trials. Methods: Interested oncology practices submitted applications that were reviewed by a committee, including external reviewers, to select the most qualified sites. They had to meet standards similar to those for Group members and were assessed for the quality of investigator credentials and site preparedness. Sites were required to demonstrate functioning IRBs, pharmacy facilities, and data management standard operating procedures to ensure a high level of clinical trials practice. A CTSU research nurse mentor was added to address challenges faced by the sites. Sites were required to enroll at least 5 patients per year to remain active participants. Results: Via the CTSU, a trial menu of over 60 Group phase 3 studies, and selected phase 2 trials, were made available to CICRS participants. Active CICRS sites are distributed over 19 states and 6 of the 7 highest accruers are in population areas with less than 300,000 persons. Participating sites were surveyed in January 2006 to better understand barriers to clinical trials enrollment and 68% percent reported the main barriers were dedicated staff, time, adequate IRB and financial support for research. Conclusions: Obstacles for participation in the CICRS program have been defined and strategies to overcome them are being implemented. Results of these efforts will be updated, including provision of survey results, updated accrual, audit results and a review of successful enrollment strategies. No significant financial relationships to disclose. [Table: see text]
The use of telemedicine to care for cancer patients at remote sites
Authors: Taylor M. , Khoo K. , Saltman D. , Bouttell E. , Porter M. 
Published: March 2020

6538 Background: At the BC Cancer Agency -CSI we are challenged to provide systemic cancer care to a population of 720,000 widely dispersed over 250,000 square kilometers. Video-link technology (VT) has been used at our centre since April 2004 to help provide distant care and prevent patient and physician travel. Methods: Patients gave consent for the use of VT. We prospectively collected data on patient and physician experiences as part of on-going quality assurance. We retrospectively collected the clinical data on these patients. Results: We performed 104 encounters on 100 patients between April 2, 2004 and October 4, 2006. Patient characteristics: female 62%, male 38%, average age was 66 years with a range of 28 –83. Extent of cancer was 67% curable, 31% advanced and 7% unknown. Visit type and cancer sites are shown below. Patients rated this experience very highly and the vast majority would repeat the experience rather than travel or wait several weeks to see the doctor in person. Physicians were not as satisfied as the patients; and both groups expressed a concern about the need for physical exam. In those having a consult, 54% had an exam within 60 days, and in none of these patients were the treatment recommendations changed. The majority (57%) of those consult patients that didn’t have an exam had either Stage 0 or I breast cancer or Stage II or III colorectal cancer; and it seems unlikely that physical exam would have changed management in these patients. Conclusions: We were able to deliver cancer care at distant sites with VT and patients found the experience very acceptable. There may not be a need for repeat physical exam in these patients, who had previously been examined by other physicians, prior to referral. No significant financial relationships to disclose. [Table: see text]
Chemotherapy (CT) dose adjustment for obese or elderly patients: How often does it occur, and should it? Results of an Australian survey
Authors: Field K. M. , Kosmider S. , Jefford M. , Jennens R. , Michael M. , Green M. , Gibbs P. 
Published: March 2020

6539 Background: Determining the optimal starting dose of chemotherapy (CT) for an individual patient (pt) presents a considerable challenge and is generally empirical. While body surface area (BSA)-based dosing has major limitations, it is standard practice worldwide. It may perform particularly poorly in certain scenarios, including the obese or elderly pt, representing an increasing area of clinical practice. We sought to determine the range of approaches employed by medical oncologists Australia-wide when administering CT to these pts. Methods: A questionnaire was developed by a panel of oncologists and mailed to all members of the Medical Oncology Group of Australia. The survey was designed to document the methods of calculating CT doses, with an emphasis on the parameters utilised and also factors considered in a variety of settings, including obese and elderly pts. Results: Evaluable responses were obtained from 181 of 315 medical oncologists and fellows (RR 57.5%). BSA-based dosing was reported as standard practice by 176 (97.2%). In the adjuvant disease setting, 23 (12.7%) use ideal rather than actual body weight (BW), or whichever is less, when prescribing CT. 14.5% (n=25) defined ideal BW as a body mass index (BMI) of 27, while 41% chose BMI 20–25 as ideal. When treating the obese pt (BMI>30), only 6.2% of respondents routinely use actual BW. Of the remainder, 69.5% either routinely cap the dose at 2m2 or use ideal BW, and 16.4% cap at a maximum dose or at a different BSA. In underweight (BMI<18.5) pts conversely, 95% (n=171) routinely use BSA based on actual BW. 41 respondents (22.7%) routinely dose reduce in the fit elderly population. Conclusions: Many current methods of BSA-based CT dosing demonstrated in this survey are not supported by the available literature. There is strong evidence from adjuvant studies in breast and bowel cancer that actual BSA is desirable; we clearly demonstrate that a substantial number of Australian patients, especially the obese, are being under-dosed, potentially leading to inferior outcomes. Until alternative methods to BSA-based CT dosing are available, education regarding the appropriateness of routine dose adjustments in specific circumstances is urgently required. No significant financial relationships to disclose.
Medication safety in cancer clinical trials: An analysis of medication error reports at a comprehensive cancer center
Authors: Kane M. P. , Fessele K. , Gordilis-Perez J. , Schwartz S. , Lisi S. , Nishioka J. , Vamos D. , Tan A. , Cunningham R. , Goodin S. 
Published: March 2020

6547 Background: Although medication errors comprise 10–25% of all medical errors, little is known concerning the occurrence or types of medication errors occurring while treating patients on a clinical trial. Therefore, we retrospectively reviewed the medication errors reported in patients enrolled on clinical trials at our center. Methods: As part of a multidisciplinary continuous quality improvement project, from January 2003 through December 2006, we collected voluntary reports of medication errors in adult and pediatric patients on clinical trials involving both oral and intravenous chemotherapy. All reports were classified prospectively regarding clinical trial involvement, severity category (A to I) per the National Coordination Council on Medical Error Reporting and Prevention, type, cause, and where in the medication use process the error occurred. Results: There were 163 reports involving patients treated on clinical trials. The most common errors were those corrected prior to reaching the patient in 68% of events (Category A&B), while 31% reached the patient but did not result in harm (Category C&D), with 1% resulting in temporary patient harm (Category E&F). The most common type of errors were prescribing (66%), improper dose (42%), and omission errors (9%). Not following an institutional procedure or the protocol was the primary cause for these errors (39%), followed by the written order (30%), and poor communication involving both the healthcare team and the patient (26%). The processes where the errors initiated were in prescribing 47%, administration 10%, dispensing 6%, and monitoring 5%. Conclusion: Medication errors do occur in clinical trials, however the majority of these are corrected prior to reaching the patient or do not result in harm. Not following an institutional procedure or the protocol was the most common cause of error. This is most likely due to the protocol procedures differing from existing standards of care. Protocol-specific education through the Centralized Education and Training Service, a shared resource within our cancer center, addresses this issue enhancing the quality and safety of clinical trials through the education and training of healthcare professionals. No significant financial relationships to disclose.
Cost containment in oncology: A single-centre model for drug waste reduction
Authors: Aita M. , Aprile G. , Follador A. , Mansutti M. , Marini L. , Mattioni L. , Tosolini M. , Fasola G. 
Published: March 2020

6557 Background: To control costs while maintaining or improving the quality of patient care is challenging for physicians and health care managers. The problem has become critical in oncology, due to the increasing number of cancer cases and the recent availability of new drugs, with a dramatic rise in health care expenditure. Here we report the experience of our Medical Oncology Department, where centralization of chemotherapy (CT) manufacturing and development of a computerized physician order-entry (CPOE) system allowed an effective planning of CT services with a substantial waste minimization and a significant cost saving. Methods: Starting January 2005 we collected data about drug demand, real consuming and resulting wastes and quantified the economic value of drug leftovers. Finally, based on a web literature search and a survey among other Cancer Services, an internal protocol for waste limitation was developed. Main adopted measures were: 1) a rational, per pathology distribution of CT sessions over the week, allowing waste recovery while respecting drug stability; 2) the use of multi-dose vials, that maintain microbial and chemical stability for up to 28 days; 3) a reasonable dose rounding, to fit with available vial sizes/leftovers; 4) the selection of the most convenient vial size when more options are available. Results: The baseline analysis focused on 29 drugs over a 1-year period. Considering their price per milligram and the amount of wastes, we found that 74% of the expense was attributable to six compounds only (cetuximab, docetaxel, gemcitabine, oxaliplatin, pemetrexed and trastuzumab) and that the economic loss due to their waste equaled 4.5% of the annual drug expenditure. Following the application of the above listed measures, the monetary loss due to unused drugs showed an impressive 45% reduction throughout 2006. Conclusions: Our experience may represent an accessible model in addressing the issue of cost rising in oncology. A critical evaluation and planning of CT daily workload, provided by CPOE, and a multidisciplinary effort to pursue specific waste reduction strategies produce a relevant cost saving. No significant financial relationships to disclose.
Cost-effectiveness of primary prophylaxis (PP) with colony-simulating factor (CSF) when compared with secondary prophylaxis (SP) in elderly patients with diffuse aggressive lymphoma undergoing curative chemotherapy
Authors: Chan K. K. , Imrie K. R. , Alibhai S. M. 
Published: March 2020

6558 Background: The 2006 ASCO guideline recommends PP with CSF for elderly patients with diffuse aggressive lymphoma, partially based on previous cost-minimization analyses showing that CSF saved costs when compared with no CSF by reducing hospitalization from febrile neutropenia (FN) when the risk of FN was > 20%. However, these studies examined only one cycle of chemotherapy and did not account for costs of CSF in subsequent cycles, did not consider SP, and did not consider patients’ preferences. Methods: We conducted a cost-utility analysis to compare PP with SP in this setting using a Markov model for a time horizon of 8 cycles of chemotherapy with a government payer perspective. Costs were adjusted to 2006 $CAD. Ontario health economic data were used. The cost of hospitalization for FN was obtained from Ontario Case Costing Initiative. Data for efficacies of CSF, probabilities and utilities were obtained from published literature. Sensitivity analyses were conducted using a threshold of $100,000/QALY. Results: The base case costs for PP and SP were $22,077 and $17,641. The QALYs of PP and SP were 0.254 and 0.248. The incremental cost effectiveness ratio of PP to SP was $739,999/QALY. One-way sensitivity analyses showed that in order for PP to be cost-effective, the cost of hospitalization per episode of FN had to be > $31,138 (i.e. 2.5 times > base case), the cost of CSF per cycle had to be < $896 (base case = $1,960), the risk of FN in the 1st cycle had to be > 48% (base case = 24%), or the relative risk reduction of FN with CSF had to be > 97% (base case = 41%). Our result was robust to all other cost, probability and utility variables. First order microsimulation showed that < 17% of simulations were cost-effective. Conclusions: PP is not cost-effective when compared with SP for this population under most assumptions. PP only becomes attractive in places where the cost of hospitalization for FN is much more than that of Ontario, or the cost of CSF is under $896 per cycle. The costs of CSF and hospitalization in all cycles (instead of just one cycle) should be accounted for in any economic evaluation of CSF. Current guidelines recommending PP in this population should be revisited. No significant financial relationships to disclose.
Barriers to cancer clinical trials (CCT) participation: “We have met the enemy and he is us.”
Authors: Comis R. L. , Colaizzi D. D. , Miller J. D. 
Published: March 2020

6567 Background: A web based survey of attitudes and awareness of cancer survivors (Ca. surv) towards CCT was performed from 3–4, 2005. The survey was developed jointly by the Coalition of Cancer Cooperative Groups and Michigan State University (MSU) and executed by MSU and Knowledge Networks (KN). Methods: Ca surv. were obtained from a panel of 40,000 adults through KN based on a US household probablility sample who agree to weekly surveys in exchange for a free MSN box and ISP service. 2,029 panel members reported a cancer diagnosis (dx); 1,788/2,029 (88%) agreed to participate. Results: About 10% of Ca surv. are aware of CCT opportunities at the time of dx. 73% become aware through a physician (ASCO 2006: 6061). Ca surv. were asked to rank the most trusted sources of health care information from a list of 23 categories on a 0 (least) to 10 (most) scale. Physicians scored the highest (8.6) followed by information from the NCI (8.4) and reports from societies of cancer physicians/researchers (8.3). Although not significantly different from each other, all were significantly different from the other 20 sources (p<.05). CCT aware Ca surv. were asked whether the physician discouraged, was neutral or encouraged participation or made a little, moderate or great deal of effort to educate them and find a CCT. Enrollment (%) was directly related (p< 0.01) to the perceived physician involvement as follows: Encouragement: discouraged (0); neutral (16); encouraged (84); Educate: little (22); moderate (41%); great deal (64%); Find trial: little (23); moderate (39); great deal (82%). Of the 90% of Ca surv. who were not aware of CCT, 65% indicated that they would be somewhat or very receptive to enrollment if they had been made aware of an opportunity. Conclusion: Ca surv. are not CCT averse a priori. The physician is the most trusted, primary source of awareness and influence in decisions concerning CCT. Although there are myriad reported barriers to CCT participation, increased CCT participation hinges upon physician commitment and communication; conversely, a lack thereof may be the greatest barrier to increased CCT participation. No significant financial relationships to disclose.
A review of 565 phase II trial abstracts from ASCO 2005: Design characteristics of contemporary trials evaluating cytotoxic versus non-cytotoxic regimens
Authors: Elser C. , Pond G. , Chen E. , Siu L. 
Published: March 2020

6569 Background: New phase II trial designs have been proposed to accommodate the non-cytotoxic nature of molecularly targeted agents. In particular, the use of alternative endpoints and controls has been suggested. The objectives of this survey are to review the designs of contemporary phase II trials, to compare trials of cytotoxic versus non-cytotoxic regimens, and to identify predictors of acceptance for presentation. Methods: Abstracts of phase II trials of systemic anticancer therapy published in the 2005 ASCO Proceedings were hand searched. The trial context, type of intervention, trial design, endpoints, and completeness of reporting were assessed. Results: Our search yielded 565 abstracts: 72% were multi-center, 44% North American, 25% clearly identified as industry-sponsored, the median number of patients was 44 (range 8–346). Only 83% explicitly reported the study phase, 29% the primary endpoint, 11% the number of stages, and 5% the statistical design. For design properties, 16% used multiple arms and 6% used enrichment. Of trials reporting the primary endpoint, 48% used radiological or marker response and 22% time-to-event endpoints. The median number of endpoints was 4 (range 1–8). Non- cytotoxic regimens, which included targeted agents, hormone- or immunotherapy, constituted 22% of the trials reviewed, purely cytotoxic regimens 60%, the remaining 18% contained combinations of both. Trials of non-cytotoxic and combination regimens were more likely to report the primary endpoint (p=0.02), use time-to-event endpoints (p=0.006), have multiple arms, use enrichment, be conducted in North America, be industry-sponsored, and be accepted for oral or poster presentation (all p<0.001). Other predictors of publication type in multivariate analysis were multi-centricity, higher number of patients, industry involvement, and being conducted in North America (all p<0.05). Conclusions: Design properties of contemporary phase II trials of non-cytotoxic agents differ from trials of cytotoxic chemotherapy, and are more likely to be accepted for presentation at ASCO. Proposed new trial designs start to be more widely adopted. Most abstracts incompletely report design properties. No significant financial relationships to disclose.