bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient and surgeon correlates of shared decision making for surgical breast cancer treatment
Authors: Hawley S. , Lantz P. , Salem B. , Fagerlin A. , Janz N. , Morrow M. , Hofer T. , Deapen D. , Liu L. , Schwartz K. , Katz S. J. 
Published: March 2020

6031 Background: The choice of surgical breast cancer treatment represents an opportunity for shared decision making (SDM), since both mastectomy and breast conserving surgery are viable options. Yet women vary in their desire for involvement in this decision. Correlates of SDM and/or the level of involvement in breast cancer surgical treatment decision-making are not known. Methods: Breast cancer patients of Detroit and Los Angeles SEER registries were mailed a questionnaire shortly after diagnosis in 2002 (N = 1,800, RR: 77%). Their responses were merged with a surgeon survey (N = 456, RR: 80%) for a dataset of 1,547 patients of 318 surgeons. Surgical treatment decision making was categorized into: 1) surgeon-based; 2) shared; or 3) patient-based. The concordance between a woman’s self-reported actual and desired decisional involvement was categorized as having more, less, or the right amount of involvement. Decision making and concordance were each analyzed as three-level dependent variables using multinomial logistic regression controlling for clustering within surgeons. Independent variables included patient clinical, treatment and demographic factors, surgeon demographic and practice-related factors, and a measure of surgeon-patient communication. Results: 37% of women reported the surgery decision was shared, 25% that it was surgeon-based, and 38% that it was patient-based. Two-thirds experienced the right amount of involvement, while 13% had less and 19% had more. Compared to women who reported a shared decision, those with surgeon-based decision were significantly (p < 0.05) more likely to have male surgeons, and those reporting a patient-based decision were more likely to have received mastectomy vs. breast conserving surgery. Women who were less involved in the surgery decision than they wanted were younger and had less education, while those with more involvement (vs. the right amount) more often had male surgeons. Patient-surgeon communication was associated with decisional involvement. Conclusions: Correlates of SDM and decisional involvement relating to surgical breast cancer treatment differ. Determining patients’ desired role in decision making may as important as achieving a shared decision for evaluating perceived quality of care. No significant financial relationships to disclose.
Use of health administrative databases in the analysis of waiting times and costs for the diagnosis of non-small cell lung cancer (NSCLC)
Authors: Cheung W. Y. , Butler J. , Kliewer E. , Demers A. , Musto G. , Navaratnam S. 
Published: March 2020

6042 Background: Knowledge of waiting times and costs involved in diagnosis will help to define more effective diagnostic services. The use of administrative databases for such health services research provides a large, population-based cohort and permits an accurate calculation of costs. Methods: Patients diagnosed with NSCLC in Manitoba, Canada from 1996 to 2000 were identified by the cancer registry. Information on diagnostic and staging tests, timeline of investigations, physician visits, hospital admissions, and outcomes were obtained from detailed chart review for 472 patients and from the Manitoba Health Administrative Databases for 2,862 patients. Tariff codes for physician services were used to calculate costs. Results: An excellent correlation was observed (range 83.3 to 99.2%) between the chart review and the administrative databases with regards to timelines of imaging studies, physician services, and procedures. However, charts considerably underreported certain services. For instance, only 58% of chest x-rays performed were captured by chart review. Therefore, costs were analyzed using the administrative databases. Waiting times from chest x-ray to chest CT scan and from CT scan to definitive histologic diagnosis were a median of 8 (range 1–25) and 18 (range 3–42) days respectively by administrative databases, and 10 (range 1–31) and 18 (range 6–36) days respectively by chart review. At least 25% of 2862 patients waited more than 55 days from initial suspicion on chest x-ray to arrive at a final diagnosis. The mean cost to reach a lung cancer diagnosis was $7,578 but analysis indicates that there were large variations in costs among patients. The majority of expenses was accounted by hospital admissions and repeated primary care physician visits, while shorter waiting times to diagnosis corresponded with relatively less costs. Conclusions: Since there is an excellent correlation between chart review and administrative databases, the latter can be used in the future for large cohort studies instead of expensive, laborious chart reviews. Despite clinical suspicion, 25% of patients wait more than 8 weeks for a final diagnosis. A centralized diagnostic service may reduce waiting times and costs for diagnosis. No significant financial relationships to disclose.
Is it cost-effective to add erlotinib to gemcitabine in advanced pancreatic cancer?
Authors: Grubbs S. S. , Grusenmeyer P. A. , Petrelli N. J. , Gralla R. J. 
Published: March 2020

6048 Background: Single agent gemcitabine has been considered the standard of care in advanced pancreatic cancer since 1996. A recent 569 patient randomized trial comparing gemcitabine alone with gemcitabine + erlotinib as first line therapy found a small but statistically significant difference in survival (6.0 vs 6.4 months, respectively, p = .028). The impact on survival may be small, but with nearly 33,000 new cases of pancreatic cancer per year, the impact on health care costs with the use of the combined regimen may be large. Using the known survival data and costs, we analyzed the incremental cost-effectiveness of adding erlotinib. Methods: Costs for a six month course of gemcitabine were developed using Medicare reimbursement from the January, 2006 CMS Drug Payment Table and Physician Fee Schedule assuming no change in infusion reimbursement. Since erlotinib is not approved as a Medicare Part B drug, costs were developed from wholesale and retail sources. Drug dosing and schedules were based on the clinical trial protocol leading to approval. Incremental cost effectiveness of adding erlotinib was calculated. Results: Six month course of gemcitabine alone costs $23,493. The addition of erlotinib increases cost by $12,156 wholesale or $16,613 retail. Given an increase of 0.4 months in median survival over gemcitabine alone, the addition of erlotinib costs $364,680 per year of life gained (YLG) wholesale and $498,379/YLG retail. Sensitivity analyses were conducted assuming shorter therapy of 4 and 5 months. In order to be cost effective even at the $100,000/YLG level, six months of erlotinib would have to be reduced to 20% of the current retail cost (lowered to $18.52 per tablet.) Conclusions: Adding erlotinib to gemcitabine does not approach cost effectiveness at even the highest year per life gained parameters. Such impacts on health care costs, especially for very small gains, become more pressing as all health care costs continue to increase. [Table: see text] [Table: see text]
Prostate-cancer (CaP) screening decision aid for black men designed to enhance shared decision-making
Authors: Gilligan T. D. , Kennedy M. W. , Olson E. , Gerberick A. , Wilson-Glover A. , Allen J. D. 
Published: March 2020

6059 Background: The high CaP incidence and mortality of black men combined with their relatively low rate of CaP screening and their elevated risk of presenting with advanced disease has led to their being identified as a high-priority group for screening. The benefit of screening, however, is uncertain. Most guidelines recommend that men make an individualized screening decision in consultation with their doctor. Motivating and preparing men to actively participate in this difficult decision remains a challenge. This is particularly relevant regarding black Americans given their historical alienation from the health care system. Methods: A CaP screening decision aid designed to promote shared decision-making was tested in 5 small group sessions of black men at community sites in Boston. The decision aid was preceded by a brief didactic presentation on CaP screening. The decision aid included a graphical depiction of all potential major outcomes that may follow a decision for or against screening. Vignettes about the decision-making and outcomes of hypothetical men with different life circumstances and priorities were presented to enhance values clarification by the participants. Endpoints measured before and after the intervention included self efficacy (SE)[Decision Self Efficacy Scale], decisional conflict (DC) [Decisional Conflict Scale], desire for autonomy (DFA) [Control Preferences Scale], and prostate cancer knowledge (PCK) [Prostate Cancer Knowledge and Prostate Cancer Screening Knowledge scales]. Pre- and post-intervention scores were compared using a Wilcoxon Matched-Pairs Signed Rank test. Results: 64 men were accrued over 4 months during 2005. Significant changes were seen in all measures. Average scores improved 16% on SE (p<.001) and 17% on DC (p<.004). DFA increased, with the proportion of men wanting to play a dominant role in health care decisions rising from 62% to 81% (p<.001). PCK more than doubled on both scales (p<.001). Focus groups held after the intervention reinforced these findings. Conclusions: Men were better informed, felt better prepared to actively participate in CaP screening decisions, and wanted to play a stronger role in decisions about their health care following exposure to our decision aid. No significant financial relationships to disclose.
Axillary lymph node nanometastases are prognostic factors for metastatic relapse in breast cancer patients
Authors: Alberti S. , Querzoli P. , Pedriali M. , Rinaldi R. , Biganzoli E. , Boracchi P. , Piantelli M. , Iacobelli S. , Marubini E. , Nenci I. 
Published: March 2020

610 Background: Early breast cancer presents with a remarkable and largely unaccounted for heterogeneity of outcomes. Undetected, microscopic lymph node tumor deposits may account for a significant fraction of this prognostic diversity. Thus, we systematically evaluated the presence of lymph node tumor cell deposits <0.2 mm in diameter [pN0(i+), nanometastases], and analysed their prognostic impact. Methods: Seven hundred and two single institution, consecutive patients with 8 years of median follow-up were studied. To maximize the chances of detecting micro and nanometastases, whole-axilla dissections were analysed. pN0 cases were systematically reevaluated by step sectioning and anti-cytokeratin immunohistochemical analysis of 6676 corresponding dissected lymph nodes. The risk of first adverse events and of distant relapse of bona fide pN0 patients was compared with that of pN0(i+), pN1mi and pN1 cases. Crude cumulative incidence (CCI) curves were used to estimate the cumulative probability of occurrence of adverse events. CCI curves were compared by the Gray’s test. A proportional sub distribution hazard (SDH) regression model was utilized to assess the difference among CCI curves of pN0(i+) versus pN0(i-), and of pN1mi versus pN0(i+). Competing risks were accounted for and regression models were adjusted for established breast cancer prognostic factors, i.e. grading, pathological T stage and age. Proportional SDH assumptions were checked using Schoenfeld-type residuals. Results: A pN0(i+) status was shown to be a strong risk factor for event-free survival (P<0.0005) and for metastatic relapse in both univariate and multivariate analyses accounting for competing risks and adjusted for grading, pathological T stage and age. Conclusions: Our findings demonstrate that nanometastases are an important risk factor in breast cancer. These results support the inclusion of procedures for nanometastasis detection in TNM pathological staging. No significant financial relationships to disclose.
Use of placebo in cancer medicine: The experience of a National Clinical Trials organization
Authors: Pater J. L. , Parulekar W. 
Published: March 2020

6104 Background: The use of placebos in cancer clinical trials requires careful evaluation. Factors that must be considered include the impact of placebo on endpoint measurement, the efficacy of placebo relative to standard of care treatment, patient altruism/acceptance of a non-active intervention and the resulting increase in complexity of study conduct with respect to randomization, drug supply, data management, analysis and the unblinding process. Methods: We reviewed the experience of the National Cancer Institute of Canada Clinical Trials Group with the use of placebo in the randomized phase III setting from 1982–2005. Results: Since 1982, 34 studies were identified that utilized a placebo as part of study design. Data is presented below according to the type of study and date of study activation. The numbers in brackets represent those studies in which placebo was used alone in the control arm. Supportive care studies were the most common type of study employing a placebo as part of study design and constituted almost 50% of our Group’s experience. Therapeutic studies involving placebo were conducted in multiple sites including breast (4), lung (6), myeloma (1), melanoma (1), ovary (1) and pancreas (1). Conclusion: Phase III studies involving a placebo constitute an important part of our clinical trial activity and cross the spectrum of supportive care, therapeutic and prevention trials. The use of placebo in cancer studies may increase due to the relative ease of blinding in studies that evaluate targeted, oral therapies with minimal toxicities as well as the need for unbiased assessment of increasingly used endpoints such as time to progression. [Table: see text] No significant financial relationships to disclose.
A cost-effectiveness analysis of surveillance, radiotherapy, and carboplatin in the management of stage I testicular seminoma
Authors: Patrice S. J. , Patrice J. R. , Steinberg J. S. , Zietman A. L. , Smith M. R. , Hayman J. A. 
Published: March 2020

6108 Background: Alternative post-orchiectomy management strategies for patients with Stage I Testicular Seminoma (TS) have different costs, recurrence risks, and toxicities. This study compares the cost-effectiveness (CE) of surveillance (SVL), dogleg radiotherapy (DLRT), para-aortic radiotherapy (PART), or one cycle of Carboplatin (CARB) from a societal perspective. Methods: Using TreeAge software, a decision tree with embedded Markov process models was constructed to simulate the natural history of Stage I TS from orchiectomy until death for hypothetical cohorts of 35 year-old men. Recurrence risks, established follow-up guidelines, utilities, direct and indirect costs, and excess mortality and costs attributable to late second cancers were modeled. CE and incremental CE (ICER) ratios were calculated per life-year (LY) and quality-adjusted life year (QALY) using a 3% discount rate; one- and two- way sensitivity analyses were performed. Results: The base case results are shown in the Table . SVL is CE when both recurrence risk is decreased 50% and follow-up costs are reduced 65%. PART is CE when follow-up and indirect costs are reduced 29% while PART second cancer relative risk (RR) is reduced to 1.8. CARB is CE when follow-up and indirect costs are reduced 41%, or the PART relapse risk function is increased 41% while DLRT costs are increased 87%. The model was insensitive to changes in utilities. Conclusions: Despite an assumed increased second cancer risk, DLRT is CE. This is due to the routine use of intensive follow-up for the alternative strategies and the high cost of salvage treatment. PART may become CE if a decrease in second cancer RR is observed without increases in recurrences. SVL should be reserved for those with favorable prognostic factors who can be followed less intensely. At a reasonable willingness-to-pay ceiling CARB is optimal, however, the small differences in effectiveness between the strategies may support decision-making based on costs. [Table: see text] No significant financial relationships to disclose.
Dose intensity comparison of African-American and white patients in NSABP breast treatment trials of postoperative doxorubicin and cyclophosphamide
Authors: Wilson J. W. , Thomas C. R. , Mamounas E. P. , Raich P. C. , Lagrange A. , Wolmark N. 
Published: March 2020

6111 Background: It has been proposed that ethnic neutropenia in African-American (AA) breast cancer patients leads to lower chemotherapy dose intensity (DI) compared to white (W) patients and hence to increased mortality from the disease [Hershman 2003]. Thomas et al. [2005] confirmed that AA patients in NSABP breast treatment trials had lower WBC and ANC than W counterparts and found that the total amount of chemotherapy received was no different in AA and W patients. The aim of the present study was to extend previous work to determine whether postop doxorubicin (A) and cyclophosphamide (C) DIs (as opposed to total doses) were lower in AA pts enrolled in NSABP breast cancer adjuvant treatment trials. Methods: Pooled data from AA and white (W) pts enrolled in NSABP trials B-15, B-16, B-18 (postop pts only), B-22, B-23, and B-25 (N=10,678 total: 1,040 AA pts and 9,638 W pts) were analyzed. Outcome measures were 1) total A received as a % of the total dose projected on the basis of BSA divided by total days of chemotherapy and 2) corresponding % of C divided by total days of chemotherapy. These quantities were compared in AA and W pts using ANOVA with adjustment for protocol, BMI, G-CSF use, C regimen (600mg/m2 ×4, 1200mg/m2 ×2, 1200mg/m2 ×2, 2400mg/m2 ×2, 2400mg/m2 ×4), and significant pairwise interactions among these variables. Results: After adjustment for the above-listed factors, AA was not a significant predictor of dose intensity for either A or C (p = 0.24 for both comparisons). Conclusions: This retrospective exploratory analysis suggests that despite lower baseline WBC and ANC, AA pts enrolled in these NSABP trials did not receive substantially lower A and C DI than did W pts. Recommending identical dose regimens for AA and W patients in AC-based breast treatment trials is thus most likely clinically reasonable. No significant financial relationships to disclose.
Risk of cardiac (CD) and pulmonary (PD) death after post-operative radiotherapy (PORT) for non-small cell lung cancer (NSCLC): Analysis of the Surveillance, Epidemiology, and End-Results (SEER) program
Authors: Lally B. E. , Detterbeck F. C. , Thomas C. R. , Machtay M. , Miller A. A. , Oaks T. E. , Petty W. J. , Robbins M. E. , Blackstock A. W. 
Published: March 2020

6122 Background: Since radiation treatment planning and delivery techniques have evolved over time, we investigated if the risk of CD and PD after PORT for NSCLC has decreased. Methods: We selected postoperative patients with non-metastatic NSCLC diagnosed in 1980–1995 from the SEER data. To account for peri-operative mortality, patients with survival less than 6 months were excluded. Variables analyzed included age, gender, laterality, disease stage, SEER geographic region, ethnicity/race, and histology. CD and PD were calculated at 10 years and compared for patients diagnosed during 1980–83, 1984–88, 1989–91, and 1992–95. Cox proportional hazards models (CPHM) were used to calculate the hazard of CD and PD. Results: This analysis included 29,093 patients treated with observation (OB) and 8334 patients who received PORT. For the patients treated with OB, the 10 yr mortality rates for CD/PD were 17%/2%, 15%/3%, 15%/3%, and 14%/<0.1% for years of diagnosis of 1980–83, 1984–88, 1989–91, and 1992–95, respectively. For the patients who were treated with PORT, the 10 yr mortality rates for CD/PD were 21%/3%, 21%/4%, 15%/4%, and 14%/<0.1% for years of diagnosis of 1980–83, 1984–88, 1989–91, and 1992–95, respectively. CPHM showed the hazard of CD for patients treated with OB to be significantly decreasing; 1980–83 (HR=1.412; CI=1.257–1.585; p<0.0001), 1984–88 (HR=1.260; CI=1.124–1.413; p<0.0001), 1989–91 (HR=1.180; CI=1.054–1.321; p=0.0042), and 1992–95 (HR=1.00; Ref.). CPHM showed the hazard of CD for patients who received PORT to be significantly decreasing; 1980–83 (HR=1.568; CI=1.222–2.011; p=0.0004), 1984–88 (HR=1.435; CI=1.125–1.830; p=0.0036), 1989–91 (HR=0.992; CI=0.767–1.282; p=0.9504), and 1992–95 (HR=1.00; Ref.). Although PD showed a similar decreasing trend relative to year of diagnosis, CPHM did not demonstrate this to be statistically significant. Conclusions: There was a greater reduction in the CD rate in the PORT group compared to the OB group. While there appeared to be a trend in the reduction of PD, the results were not significant which may be secondary to too few events occurring. No significant financial relationships to disclose.
A case-control study evaluating differences in resource utilization between diabetic and non-diabetic cancer patients undergoing chemotherapy
Authors: Robertson M. D. , George T. J. , Chang M. , Richardson L. C. 
Published: March 2020

6126 Background: Patients with diabetes mellitus (DM) and cancer have been noted to have worse overall and disease-free survival compared to those without DM. However, there is a paucity of data addressing why diabetic cancer patients have worse outcomes. We performed a retrospective case-control study to evaluate cancer patients undergoing chemotherapy comparing persons with and without DM to evaluate differences in resource utilization and mortality. Methods: Using chart review and tumor registry data from January 2001 through December 2003, we identified DM patients 18 years or older, treated with chemotherapy at the Gainesville Veterans Administration Medical Center (GVAMC) for lung, colon, or head and neck cancer. Non-diabetic (Non-DM) controls were matched for age, cancer type and stage. A comorbidity score was calculated based on a previously validated measurement scale, Adult Comorbidity Evaluation 27 (ACE-27). The primary outcome measure was the number of inpatient hospital days in the first year after diagnosis. Secondary outcome measures included the total number of outpatient visits, emergency room (ER) visits, infusion room visits for chemotherapy, blood transfusions, home health consults, telephone calls, and mortality. Results: A total of 42 DM cases and 42 non-DM controls were identified who had undergone similar treatments with radiation and surgery. The DM patients had higher comorbidity ACE 27 scores when corrected for the cancer being treated, median 3.0 versus 2.0, p < 0.005. The table summarizes the results. Mortality was the same (15) for both the DM and non-DM patients at one year. Conclusions: Cancer patients with DM undergoing chemotherapy have significantly more comorbidities and utilize more outpatient visits compared to non-DM. However, all other measures of resource utilization and mortality appear similar. Further studies to identify causes of increased utilization should be done. [Table: see text] No significant financial relationships to disclose.