bluuebunny/crossref_metadata_2025_split huggingface dataset:
Source of funding, conflict of interest (COI), and the interpretation of cancer clinical trials
Authors: Riechelmann R. P. , Dounaevskaia V. , Taback N. , O′Carroll A. , Krzyzanowska M. K. 
Published: March 2020

6530 Background: Concern exists that industry sponsorship and financial relationships between investigators and drug companies may bias clinical cancer research. Our objective was to determine whether funding or authors' COI are associated with interpreting cancer clinical trials in more positive light. Methods: We reviewed phase II and randomized clinical trials (RCT) of anticancer and supportive care drugs published in 5 clinical cancer journals in a one-year period. We collected information on study design, source of funding, COI disclosure and results of primary endpoints (EP). Each concluding statement in the articles′s abstracts were independently rated by two reviewers (blinded to other study information) with respect to level of enthusiasm for the experimental agent using a 5-point scale ( Table 1 ). Summary statistics and logistic regression were used to describe the results. Results: 213 articles met inclusion criteria: 124 phase II and 89 RCT. Approximately 40% were funded by industry, at least one COI was declared in 35% of articles. Among 130/213 (61%) articles with clearly positive conclusions, the proportion of articles with highly positive conclusions was 61% in articles that declared COI vs. 40% in articles with no COI (p=0.017, CMH, adjusted for study result). In a stepwise logistic regression with journal, funding, study type, study result, and COI only COI remained significant (OR=2.4, 95%CI 1.2–5.0, P=0.017). While all articles with a negative conclusion had a negative primary EP, 21 articles with clearly positive conclusions had a negative primary EP. The most common reasons for such finding were: positive secondary EP (6 studies), experimental agent had better toxicity profile (5), non-statistically significant difference in favour of experimental agent (4). Conclusion: COI is associated with highly positive conclusions that use superlatives to promote the experimental arm No significant financial relationships to disclose. [Table: see text]
The quality of phase I trial (P1T) abstracts submitted to ASCO meetings
Authors: Strevel E. L. , Chau N. , Pond G. R. , Murgo A. J. , Ivy S. P. , Siu L. L. 
Published: March 2020

6532 Background: Conference abstracts of P1T communicate important information of anticancer drug development. Our objectives were to determine elements considered by experts as essential for good P1T abstract reporting, to assess the quality of P1T abstracts submitted to ASCO meetings, and to propose guidelines for future reporting. Methods: Elements important for P1T abstract reporting were determined by a survey of experts in developmental therapeutics, and a scoring system for abstract quality was generated. All P1T abstracts published in ASCO Proceedings from 2002–2006 were reviewed, and a quality score was assigned. Results: An electronic survey was sent twice to 69 experts, with a response rate of 39% (27/69). Characteristics of the 27 experts were: average age = 48; male = 74%, USA:Europe:Canada = 78%:15%:7%; 89% had 10+ years experience in drug development; 93% from academic institutions versus 7% from governmental agencies; 56% currently involved in clinical research versus 44% in translational research. Experts were asked to rate each of 37 elements using a five-point Like rt scale, and elements with average expert ratings over 3.75 were included in the final quality score calculations. A total of 920 P1T abstracts over 5 years were reviewed. A positive and linear association was observed between average expert rating of the elements and proportion of P1T abstracts that included those elements (Spearman correlation coefficient, ρ=0.65). The median quality score for all 920 abstracts was 65% (range 26%–95%, SD 12.6%). Deficiencies existed in abstract reporting; for instance, dose-limiting toxicity was described in only 63% of abstracts, while recommended dose or maximum tolerated dose was reported in only 38%. A significant association between year of presentation was found (ρ=0.36, P<0.001), with later years possessing better quality scores. The quality score was also statistically significant as a predictor of type of presentation (odds ratio 0.20, 95% CI 0.08–0.54, P=0.002), with oral presentations having the highest scores. Conclusion: The quality of P1T abstract reporting at ASCO has improved over time, although there is room for optimization. The quality of P1T abstract reporting may be enhanced using guidelines derived from our expert consensus. No significant financial relationships to disclose.
To determine the cost-effectiveness of pemetrexed (PEM) compared to current standards of care in 2nd-line advanced non-small cell lung cancer (NSCLC) from the UK National Health Service (NHS) perspective
Authors: Bhalla S. , Hibbert C. , Watkins J. , Beard S. , Cetty M. , Arellano J. 
Published: March 2020

6540 Objective: To assess the clinical and cost-effectiveness of pemetrexed (PEM) compared with current standards of care (SOC) in 2nd-line advanced NSCLC from a UK perspective. The SOC selected for the evaluation were: (i) docetaxel (DOC) as it is the standard active therapy in the UK and is recommended by the National Institute for Health and Clinical Excellence (NICE) and (ii) best supportive care (BSC) as the majority patients in the UK who fail 1st-line therapy do not receive further chemotherapy. Methods: The analytic technique used was a cost-utility analysis (CUA) in the form of a Markov model. Utilities were generated from 100 members of the general public, considering tumor response status and toxicity, in accordance with the standard NICE appraisal methodology. Clinical inputs were derived from a pooled analysis phase III clinical trial data. Costs were taken from the British National Formulary and UK national databases. The incremental cost-effectiveness ratios (ICERs) are presented for both life-years gained (LYG) and quality-adjusted life- years (QALY) gained. Conclusions: The incremental cost per LY and cost per QALY for pemetrexed in 2nd-line NSCLC are below £20,000, compared to docetaxel and BSC. Based on its survival and toxicity benefits PEM is a cost-effective option in within the UK. No significant financial relationships to disclose. [Table: see text]
Evaluation of number of target lesions to analyze in time to progression by RECIST
Authors: Gonen M. , Schwartz L. , Ford R. 
Published: March 2020

6549 Background: RECIST criteria were designed to evaluated tumor shrinkage and response to therapy by measurement of multiple target lesions, evaluation of non target and new lesions. There is considerable controversy surrounding the optimal number of lesions to assess response, with RECIST requiring the measurement of up to 10 target lesions. These guidelines were set up to evaluate the endpoint of best overall response. Increasingly, time to progression has become an important endpoint in oncology trials. We evaluated the optimal number of lesions to measure to accurately and reproducibly assess time to progression. Methods: We evaluated target lesions metastases in 105 patients enrolled on a Phase III clinical trial. All patients underwent CT at baseline and standard follow up scans until progression. Target lesions were measured unidimensionally and response was assessed according to RECIST by 2 independent Radiologists. A total of 519 target lesions were assessed. Response was calculated according to the rules of target lesions (up to 10) by RECIST, utilizing the 2 largest lesions and randomly selecting 2 target lesions. Results: Using the 2 largest lesions, time to progression was concordant in 83% of cases. The 2 Radiologists determined the two same largest lesions in 89% of cases. Since the determination of the largest or the same target lesions is not always possible or performed, a random selection of 2 target lesions demonstrated a 76% concordance in the time to progression. Conclusions: Measurement of time to progression may have a greater degree of variability than measurement of best overall response and therefore measurement of minimal selected lesions will lead to a great variability in response assessment. No significant financial relationships to disclose.
Sociodemographic factors influencing Breslow thickness at diagnosis for patients with melanoma
Authors: Stitzenberg K. B. , Thomas N. E. , Berwick M. , Anton-Culver H. , Mujumdar U. J. , Millikan R. C. 
Published: March 2020

6552 Background: In previous work, we demonstrated that Breslow thickness at diagnosis is significantly related to distance to provider for patients with melanoma in North Carolina (NC). Expanding the study population to include patients in New Jersey (NJ) and southern California (CA), we hypothesize that distance to provider is an effective measure of access to melanoma care regardless of geographic region. Methods: An IRB-approved secondary data analysis was performed of all incident cases of invasive cutaneous melanoma in 2000 from 3 population-based ascertainment areas (CA, NC, NJ). Patients and providers were geocoded to street address; Euclidian distances between patients and providers were calculated. The outcome variable, Breslow thickness at diagnosis, was logged for analysis. Simple and multiple linear regression were used to test associations between Breslow thickness and multiple sociodemographic factors. Results: Of 1,408 eligible cases, 16% were excluded for missing Breslow data. Median Breslow thickness was 0.6 mm (range 0.01–30.0 mm). Median distance to provider was 7 miles (range 0–372 miles). There was no significant difference in Breslow between the 3 geographic regions. Males had on average 15.5% thicker tumors than females, p=0.009. Patients 51–80 years old had 15.3% thicker tumors than patients =50, p=0.015, and those >80 had 64.3% thicker tumors than patients =50, p<0.001. For all patients, Breslow thickness increased only 2% for each 10 mile increase in distance, p=0.047. However, when limited to patients from rural areas, each 10 mile increase in distance corresponded to an 8% increase in Breslow, p<0.001. Meanwhile, Breslow was not associated with any area-based measures of rurality or provider supply. Each 1% increase in poverty rate corresponded to a 1% increase in Breslow, p=0.036. Conclusion: Breslow thickness at diagnosis is strongly correlated with distance to provider, especially for patients from rural areas. Distance to provider is a better measure of access to melanoma care than area-based measures of rurality. No significant financial relationships to disclose.
Racial differences in the perception of lung cancer: Data from the 2005 Health Information National Trends Survey (HINTS)
Authors: Lathan C. S. , Okechukwu C. , Drake B. F. , Bennett G. 
Published: March 2020

6556 Background: Black men have the highest rates of lung cancer incidence and mortality in the US, and yet continue to obtain treatment at lower rates than White patients. Racial differences in the perception of lung cancer in the population could contribute to racial disparities in seeking timely treatment. Methods: Data are from the 2005 HINTS survey. Sample design was random digit dialing of listed telephone exchanges in US. Complete interviews were conducted on 5491 adults, of which 1872 respondents were assigned to receive questions pertaining to lung cancer. All analyses were conducted on this subset of respondents. SAS callable SUDAAN was used to calculate χ2 tests and perform logistic regression analyses to model racial differences in perceptions of lung cancer. All estimates were weighted to be nationally representative of US population; jack knife weighting method was used for parameter estimation. Results: Black and White patients shared many of the same beliefs about lung cancer mortality, and etiology. African Americans were more likely than Whites to agree that its hard to follow recommendations about preventing lung cancer (OR 2.05 1.19–3.53 95% CI), to avoid evaluation for lung cancer due to fear of having the disease (OR 3.32 1.84–5.98 95% CI), and to believe that patients with lung cancer would have pain or other symptoms before diagnosis (OR 2.20 1.27–3.79 95% CI). Conclusions: African Americans are more likely to hold beliefs about lung cancer that could interfere with prevention and treatment of lung cancer. No significant financial relationships to disclose. [Table: see text]
An automated practice-based intervention for case management of abnormal mammograms
Authors: Eberl M. M. , Fox C. H. , Broffman G. , Pomerantz J. , Serghany J. , Reinhardt M. , Watroba N. , Edge S. B. 
Published: March 2020

6563 Background: Failure to obtain follow-up (f/u) of abnormal mammograms may delay cancer diagnosis and impact outcome; studies show up to 20% of women do not get recommended f/u. Our group previously established that administrative claims linked to medical records accurately identify care for management of abnormal mammograms. We are testing a case management system linking claims data to mammogram information to assist physicians in assuring appropriate f/u for abnormal mammograms. Methods: Electronic medical records in a staff model practice affiliated with a single payer are scanned to identify the BI-RADS code for all mammograms. The practice performs about 8,000 mammograms with about 500 abnormal mammograms annually. Physicians are notified of each abnormal mammogram and provided with a standardized care pathway for management. For each BI-RADS 0, 3, 4 or 5 mammogram, claims are searched for f/u breast procedures (imaging, biopsy, surgery). If recommended f/u (additional imaging for BI-RADS 0, biopsy by 2 months for BI-RADS 4 and 5, f/u imaging by 8 months for BI-RADS 3) is not observed, the ordering physician is alerted. Results: From 01/01/2001 to 12/31/2003, we observed that among women eligible for f/u, 189 (16%) did not receive BI-RADS recommended f/u care. In the prospective intervention from 1/1/06 - 6/30/06, 166 BI-RADS 0, 21 BI-RADS 4, and 3 BI-RADS 5 mammograms had 98.2%, 76.2%, and 100% appropriate f/u, respectively. From the alerts, all but one patient who refused biopsy received appropriate care. Conclusions: A practice intervention utilizing BI- RADS data linked to claims accurately identified missed f/u in a time frame when appropriate care can be delivered. This practice-based intervention has potential to improve the management of other cancers and chronic diseases. This intervention is being expanded on a community wide level. No significant financial relationships to disclose.
Breast cancer diagnosis and treatment in a safety net setting: Differences between insured and uninsured patients
Authors: Farrell N. J. , Bradley C. J. , Schickle L. M. 
Published: March 2020

6566 Background: Despite the safety net system and many other means of providing free or low cost care to women with breast cancer, disparities in health outcomes between uninsured and insured women with breast cancer exist. In this study, we evaluate the role of health insurance on breast cancer treatments at a large safety net hospital system. Methods: From the patient population at the Massey Cancer Center at Virginia Commonwealth University Health Care System (a large regional safety net provider), we selected women ages 21 to 64 diagnosed with breast cancer between January 1999 and March 2006 (n=1,381). We used billing records to identify health insurance status of these patients. First, we compared the stage of disease and tumor size at diagnosis for women with and without insurance. Next, we compared the number of days between diagnosis and surgery and the number of days between surgery and chemotherapy initiation. Finally, we estimated the number of days it took these groups of women to complete a common adjuvant chemotherapy regimen of doxorubicin plus cyclophosphamide (AC) or doxorubicin plus cyclophosphamide followed by paclitaxel (ACT). Results: Our analysis shows that women without insurance were more likely to have more advanced cancers and correspondingly larger tumors. Uninsured women experienced considerable delays from the date of diagnosis to surgery and from surgery to chemotherapy initiation compared with insured women (21.5 and 22 days longer, respectively). Uninsured women also took significantly longer to complete adjuvant chemotherapy regimens relative to insured women (4 and 26 days for AC and ACT, respectively). Conclusions: To understand the disparities that exist in breast cancer outcomes among women with and without health insurance, we must understand the different experiences these groups of women have with treatment. In this study, uninsured women had more advanced cancers, and experienced considerable delays receiving and completing treatment relative to insured women. Our study demonstrates the value of health insurance in the timely provision of health care even in a safety net setting where care is guaranteed. No significant financial relationships to disclose.
Costs of administration of intravenous (IV) therapies in early versus late stage breast cancer in a US population
Authors: Kruse G. B. , Amonkar M. M. , Skonieczny D. , Smith G. L. 
Published: March 2020

6588 Background: There are significant costs associated with IV administration of cancer drugs ranging from adverse events associated with the administration to the need for specialized equipment, supplies and personnel time. This study utilized a novel provider-payer contract database to compare the cost components of providing IV therapy to women with early and late stage breast cancer. Methods: Women diagnosed with breast cancer (ICD-9 code 174) between 01/01/2003 and 05/31/2006 and receiving IV monotherapy were identified from an administrative claims database of >60 multi-specialty medical practices/clinics (additional ICD-9 codes 196–198 used to identify late stage breast cancer). Costs were estimated on a per IV administration visit basis using the allowable amount for a claim which closely represents the actual amount paid to providers. Published literature was used to categorize the various billable cost components. Results: 1,393 early and 828 late stage breast cancer patients receiving any of 11 IV breast cancer drugs were identified. The costs breakdown by category for all drugs and for the 2 most commonly used drugs, per IV administration visit, is presented in the table . Conclusions: Costs associated with administration of IV therapies and other visit-related services constituted more than 36% of total costs for early stage and 41% of total costs for late stage breast cancer patients. These costs represent a significant cost burden to payers. Maximization of valuable resources could be effected by increased use of effective oral therapies for treatment of breast cancer. [Table: see text] [Table: see text]
Measuring clinically significant chemotherapy-related toxicities using Medicare claims from CALGB breast and lung cancer trial participants
Authors: Lamont E. B. , Herndon J. E. , Weeks J. C. , Henderson I. C. , Lilenbaum R. , Schilsky R. L. , Christakis N. A. 
Published: March 2020

6595 Background: Because the elderly are numerically underrepresented in cancer clinical trials, the benefits and toxicities of cancer therapies in the general population of elderly patients is not known. Nevertheless, clinicians need such information. A solution may be found in analyses of observational data. Specific Aim: We performed a criterion validation study to determine the accuracy with which observational Medicare claims data measure clinically significant chemotherapy-related toxicities in elderly Medicare beneficiaries with cancer. Methods: We created a cohort of 175 elderly clinical trial patients treated on two Cancer and Leukemia Group B (CALGB) trials (i.e., 9,344 adjuvant breast and 9,730 advanced lung cancer trials) and merged participants’ CALGB data with their Centers for Medicare and Medicaid Services (CMS) data. From CALGB data, we identified all grade III/IV toxicities with a frequency of ≥3%. We reviewed diagnostic and procedure codes from CMS coding manuals, developed initial algorithms to measure the toxicities and then finalized the algorithms after empiric review of individual patients’ actual CMS codes incurred during the observation period (i.e., date of first trial treatment through 90 days following last trial treatment). We compared results of each of our CMS toxicity algorithms to gold-standard of CALGB grade III/IV toxicity information in order to calculate the CMS algorithms’ test characteristics. Results: The following 15 grade III /IV chemotherapy-related toxicities occurred in ≥3% of the 175 patients: white blood cell, hemoglobin, platelets, anorexia, nausea, vomiting, diarrhea, stomatitis, sensory neuropathy, motor neuropathy, motor or sensory neuropathy, dyspnea, hyperglycemia, infection, and malaise. Of these, only the CMS-based algorithm measuring ‘grade III/IV vomiting‘ had a sensitivity, specificity, and area under the ROC of ≥ 80%. Conclusions: The results of this preliminary study suggest that CMS claims data may be of only limited value in measuring clinically significant chemotherapy- related toxicities in elderly Medicare beneficiaries with cancer. Future research will focus on confirming these findings in a larger and more diverse patient sample. No significant financial relationships to disclose.
Outcomes for hematologic malignancies in the Nurses’ Health Study (NHS) as compared to the Surveillance, Epidemiology, and End Results (SEER) program
Authors: Abel G. A. , Bertrand K. A. , Earle C. C. , Laden F. 
Published: March 2020

6599 Background: Health literacy, often defined as the degree to which an individual can obtain and understand information needed to make appropriate health decisions, may lead to a decreased incidence and improved mortality for some cancers by promoting risk factor modification and adherence to treatment. As a result, nurses, who presumably possess a higher level of health literacy and access to care than the general population, might be expected to manifest a lower incidence of and better survival for the hematologic malignancies. Methods: We assessed the incidence, all-cause, and cause-specific mortality for Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL), multiple myeloma (MM) and chronic lymphocytic leukemia (CLL) in the NHS, an ongoing cohort study of 121,700 female registered nurses aged 30–55 years at entry who have been followed for 30 years. We compared these outcomes to those in the SEER program of the National Cancer Institute, matching for age and race. Results: In over 2.5 million person-years, the incidence of HD in the NHS was the same as in SEER. The incidence of NHL, CLL and MM was slightly increased. All-cause mortality was better in the NHS when compared to SEER for HD (HR= 0.62, 95% CI: [0.38, 1.0]) and NHL (HR= 0.81, 95% CI: [0.71, 0.91]). There were no differences in cause-specific mortality, except for MM, which was worse in the NHS (HR= 1.27, 95% CI: [1.07, 1.52]). Conclusion: The incidence of hematologic malignancy is not reduced in nurses, possibly because preventable risk factors for these cancers have yet to be elucidated. To the contrary, the slight increase in incidence for NHL, MM and CLL may be due to higher levels of overall health vigilance and/or occupational exposures. The fact that cancer-related mortality is similar for nurses as compared to age and race-matched SEER controls casts doubt on the roles of health literacy and access to care in improving survival for these disorders. No significant financial relationships to disclose. [Table: see text]