bluuebunny/crossref_metadata_2025 huggingface dataset:
Oncologists' and primary care providers' awareness of late effects of cancer treatment: Implications for survivorship care.
Authors: Nekhlyudov Larissa , Aziz Noreen , Lerro Catherine C. , Virgo Katherine S.
Published: March 2020

6008

Background: There is a growing population of cancer survivors, many of whom may experience late or long-term effects (LEs) of treatment. The goal of our study was to describe and compare primary care providers’ (PCP) and oncologists’ awareness of LEs. Methods: The Survey of Physician Attitudes Regarding the Care of Cancer Survivors was completed by a nationally representative sample of 1,072 PCPs and 1,130 oncologists (cooperation rate 65%). Respondents were asked to report for each of four standard chemotherapy drugs used to treat breast or colorectal cancer the five LEs they had observed and/or had seen reported in the literature. We described and compared the physicians’ responses and, using separate multinomial logistic regression models, determined predictors of their ability to identify the main LEs for all agents, adjusting for physician demographics and practice characteristics. Results: Almost all (95.3%) oncologists identified cardiac dysfunction as a LE of doxorubicin (Adriamycin), and peripheral neuropathy as LEs of both taxol (97.3%) and oxaliplatin (96.6%); while these LEs were identified by only 55.1%, 21.8% and 21.8% of PCPs, respectively. Most oncologists identified premature menopause (71.4%) and secondary malignancies (62.0%) as LEs of cytoxan, compared with only 14.8% and 17.2% of PCPs. Main LEs for all four chemotherapy drugs were identified by 65% (n=741) of oncologists and only 6% (n=60) of PCPs. In adjusted models, oncologists were more likely to identify the main LEs for all chemotherapy drugs if they spent 51-90% (OR 1.87, 95% CI 1.21-2.88) or >90% (OR 1.82, 95% CI 1.08-3.08) of their time on patient care, and less likely if they were not board certified (OR 0.58, 95% CI 0.37-0.89). African American PCPs were less likely to identify the main LEs for all chemotherapy drugs (OR 0.19, 95% CI 0.08-0.45). Conclusions: Oncologists often identified the main LEs of cancer drugs while PCPs did not. While not surprising, these findings emphasize that in the transition of patients from oncology to primary care settings, PCPs should be informed about the LEs of cancer treatment so that they may be better prepared to recognize and address these among survivors in their post-treatment care.
Impact of adjuvant trastuzumab-based chemotherapy in T1ab node-negative HER2 overexpressing breast carcinomas.
Authors: Frenel Jean-Sebastien , Rodrigues Manuel Jorge , Peron Julien , Yann-Alexandre Vano , Wassermann Johanna , Debled Marc , Picaud Francois , Albiges Laurence , Vincent-Salomon Anne , Cottu Paul H.
Published: March 2020

601

Background: HER2 overexpression has been recognized as a pejorative prognostic factor in node negative T1ab (T1abN0) breast tumors. Randomized clinical trials have shown benefit of adjuvant trastuzumab-based chemotherapy (ATBC) for node-positive and/or greater than 1 cm (T1c or more) HER2+ breast carcinomas. There are no prospective efficacy data of ATBC in T1abN0 HER2+ tumors. Methods: We retrospectively evaluated 276 cases of T1ab node-negative HER2+ breast tumors in 8 French Comprehensive Cancer Centers. We assessed clinical, therapeutic features and outcome. We estimated the probability of disease-free survival (DFS), analyzed associations of ATBC, patient and tumor characteristics with DFS and prognosis factors using the log-rank test, multivariate analysis with logistic regression and Cox’s proportional hazards model. Results: Out of the 276 T1abN0 cases, 129 (47%) received ATBC (ATBC+) and 123 (45%) were not treated by either trastuzumab or chemotherapy (ATBC-). Of these 252 ATBC+ or ATBC- patients, decision of ATBC was associated with date of diagnosis (before or after ASCO 2005 Annual Meeting when interim results from three trastuzumab adjuvant trials were reported) and with poor prognosis features: negative hormone receptors (HR-) status, Elston-Ellis high grade, tumor size > 5 mm and age. With a median follow-up of 44 months 16 recurrences were observed (13 in the ATBC- group, 2 in the ATBC+ and 1 with adjuvant chemotherapy alone). Nine recurrences were distant metastases. A survival benefit in ATBC+ was observed with a 99% 40-months DFS versus 93% for ATBC- (logrank p-test = 0.018). In an exploratory analysis, two factors were significantly associated with worst prognosis for ATBC- that were not observed for ATBC+ : HR- status (98% 40-months DFS for ATBC+ patients versus 84% for ATBC- patients; logrank p-test = 0.0003) and presence of lymphovascular invasion (100% 40-months DFS for ATBC+ versus 73% in ATBC- cases; logrank p-test = 0.003). Conclusions: In our seriesATBC is associated with a significant reduction of risk of recurrence of T1abN0 HER2+ tumors. A clear DFS benefit of ATBC was observed in HR- tumors and/or in presence of lymphovascular invasion.
Do insurance status and neighborhood characteristics explain why minorities underutilize NCI cancer centers?
Authors: Huang Lyen C. , Ma Yifei , Ngo Justine V , Rhoads Kim F
Published: March 2020

6010

Background: National Cancer-Institute (NCI) designated cancer centers provide some of the highest quality cancer care in the US, in part due to the availability of cutting edge technologies and access to cancer clinical trials. Racial/ethnic minorities suffer from persistent disparities in cancer outcomes, and these groups are typically under-represented in clinical trials. This may be due in part to under-utilization of NCI centers by these groups. Methods: A unique dataset linking the California Cancer Registry with California patient discharge abstracts was used to identify patients undergoing resection for a primary diagnosis of colorectal cancer (CRC) (1996-2006). Travel distance to treatment hospital was determined using GIS software. Chi-square analysis correlated patient demographics, clinical characteristics, insurance status, and neighborhood socioeconomics with NCI center use. Multivariable regression models were constructed to predict the likelihood of using an NCI center. Results: 95,994 CRC patients were identified. Median travel distance for care was <5 miles. Only 12,659 (13%) lived within a 5 mile radius of an NCI center; and of those, fewer than 10% used the center for CRC care (n=1130). Black (OR 0.83 95%CI 0.72-0.95) and Hispanic (OR 0.72 95%CI 0.65-0.81) patients were less likely than white patients to use NCI centers. Neighborhood socioeconomics, but not insurance status, were significantly correlated with NCI under-utilization. Asian populations were more likely to use NCI centers than white patients (OR 1.40 95%CI 1.28-1.54). Conclusions: Black and Hispanic patients are less likely to use nearby NCI hospitals for CRC care. Outreach efforts in communities with low socioeconomic status and educational attainment may increase use of NCI centers, improve CRC outcomes, and increase minority enrollment in clinical trials.
Adjuvant chemotherapy (AC) initiation and early discontinuation in elderly patients (EPs) with stage III colon cancer (CC).
Authors: Ko Jenny J , Kennecke Hagen F. , Lim Howard John , Gill Sharlene , Woods Ryan , Speers Caroline , Cheung Winson Y.
Published: March 2020

6014

Background: Research suggests that EPs with cancer are commonly undertreated, but the precise reasons for this observation are unclear. Our aims were to 1) evaluate the impact of advanced age on AC use (none vs capecitabine vs FOLFOX) for stage III CC, 2) determine the specific reasons for selecting and discontinuing a particular regimen, and 3) examine if the effect of AC on outcomes is modified by age. Methods: Patients diagnosed with stage III CC from 2006 to 2008 and referred to any 1 of 5 cancer centers in British Columbia, Canada were identified. Descriptive statistics were used to summarize treatment patterns in young patients (YPs) aged <70 vs EPs aged >/=70 years. Logistic regression was used to evaluate the association between AC and cancer-specific survival (CSS) in YPs and EPs. Results: We identified 810 patients: 51% men, 52% YPs and 48% EPs, and 74% received AC in the entire cohort. When compared to YPs, EPs had worse ECOG and more comorbidities (both p<0.01). EPs were less likely than YPs to receive AC (57 vs 91%, p<0.01). Frequent reasons for no treatment included age, comorbidities and perceived minimal benefit from AC. Among those treated with AC, EPs were less likely to receive FOLFOX (32 vs 74%, p<0.01) in favor of capecitabine due to patient preference, age and comorbidities. Once started on AC, EPs had similar rates of early treatment discontinuation as YPs (70 vs 62%, p=0.08). Reasons for early discontinuation were comparable between EPs and YPs (Table). Receipt of either FOLFOX or capecitabine was correlated with improved CSS, compared to surgery alone. Age did not modify CSS, irrespective of AC choice (interaction p for capecitabine and age=0.26; interaction p for FOLFOX and age=0.40). Conclusions: EPs with stage III CC frequently received either no adjuvant treatment or capecitabine monotherapy due to advanced age and comorbidities. The treatment effect of AC on CSS is similar across age groups, with comparable side effects and rates of discontinuation between EPs and YPs. AC should not be withheld from CC patients based on advanced age alone. [Table: see text]
Do patients with advanced-stage non-small cell lung cancer (AS NSCLC) live longer if managed within a clinical trial setting?
Authors: Abu Hejleh Taher , Chrischilles Elizabeth A. , Halfdanarson Thorvardur Ragnar , Pendergast Jane F , Jiang Dingfeng , Smith Carmen J. , Porter Aaron T. , Wallace Robert B ,   Cancer Care Outcomes Research and Surveillance Consortium (CanCORS)
Published: March 2020

6034

Background: Treatment outcomes of AS NSCLC (stages IIIB and IV) are poor. There is an argument that participation in a clinical trial (CT) may confer survival benefit, probably, through enhancing quality of care. In this study, we explore the survival outcomes and perceived care quality for AS NSCLC patients (pts) treated within vs outside a CT. Methods: Data were obtained from surveys of newly diagnosed AS NSCLC pts studied by the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS), a large cohort of pts across the United States. Pts who did not complete the baseline survey were excluded as this was associated with worse performance status (PS). Baseline characteristics according to CT participation were determined. Association between CT enrollment and survival was explored utilizing univariate and multivariate survival analysis after adjusting for age, comorbidities and self-reported PS. Results: Of 815 AS NSCLC pts, 56 (7%) were enrolled on a CT. Chemotherapy trials comprised 67% of all trials. Of the 815 pts, 697 (86%) died. Median survival for pts within vs outside a CT was 62 vs 64 months. Neither age, comorbidities nor recalled PS differed significantly between pts within vs outside a CT (P=0.2085, 0.5818 and 0.1678 respectively). On the multivariate survival model, CT enrollment did not correlate with longer survival (P=0.8811) and only presence of comorbidities was associated with worse survival (P=0.0021). Comparing pts according to CT enrollment, there was no significant difference in symptom management, receiving hospice care (P=0.606), death location (P=0.2018), or following pts’ wishes (P=0.8321). However, perception of the overall cancer care quality was greater among CT enrollees (P=0.0171). Conclusions: Management of AS NSCLC pts within a CT setting conveyed a perception of superior care that did not translate into survival benefit after adjusting for differences in age, comorbidities, and self-reported PS. These findings suggest that providing cancer care within a CT should not imply a survival benefit when counseling AS NSCLC pts about entering CTs.
Association of increases in quality of care with the NCI Community Cancer Center Program (NCCCP) pilot.
Authors: Halpern Michael T. , Spain Pamela , Holden Debra J. , Stewart Andrew , McNamara Erica J. , Gay E. Greer , Clauser Steven B. , Prabhu Das Irene
Published: March 2020

6046

Background: The NCCCP pilot is an initiative designed to enhance research and improve cancer care at community hospitals. As part of a multi-method evaluation of this pilot, we assessed changes in quality of care among the 16 pilot NCCCP hospitals over time (before vs. after program initiation) and in comparison to a group of 25 similar hospitals that did not participate in the NCCCP. Methods: We compared changes in 5 NQF-approved quality of care measures (3 for breast cancer, 2 for colon cancer) from 2006/07 (before NCCCP initiation) vs. 2008/09/10 (post-initiation) for NCCCP and comparison group hospitals. Data were collected from all study hospitals using the Commission on Cancer’s Rapid Quality Reporting System, which allowed near real-time tracking of quality of care process measures. Results: Analyses included 18,608 breast cancer and 7,031 colon cancer patients. Patient-level concordance rates for all 5 quality of care measures increased significantly among both NCCCP and comparison group hospitals. The change (from baseline to post-NCCCP) in quality of care among NCCCP hospitals was significantly greater than the change among comparison group hospitals for two measures: radiation therapy following breast conserving surgery (RT-BCS) and hormonal therapy for women with hormone receptor positive breast cancer (HT). For the RT-BCS measure, NCCCP patients from underserved populations also experienced significantly greater changes in concordance than did corresponding populations from comparison group hospitals. In multivariate regression analyses controlling for patient characteristics, the change for the HT measure among NCCCP hospitals was significantly greater than that among comparison group hospitals. Conclusions: While both NCCCP and comparison group hospitals showed improved quality of care, participation in the NCCCP was associated with significantly greater improvements for a subset of measures. Including a separate comparison hospital group was critical for assessing changes associated with NCCCP participation while controlling for broader U.S. trends in improved quality of care. Future work will examine how hospital networks may have facilitated improvements in quality of care.
Geographic and network analysis of oncology trials: Portfolio assessment of ClinicalTrials.gov.
Authors: Cheng Steven Kunyuan , Hirsch Bradford Richard , Califf Robert M , Tasneem Asba , Schulman Kevin A. , Abernethy Amy Pickar , Dilts David M.
Published: March 2020

6047

Background: Increasing complexity and specificity of cancer trials (CT) necessitates collaboration across the CT network to optimize research efforts. The relationship among CT sites and networks provide unique insights into improving coordination and accrual. Methods: 5971 interventional CTs registered between 2007 and 2010 were aggregated by trial and location. CTs in the Aggregate Analysis dataset from ClinicalTrials.gov (AACT) were identified using MeSH terms. The distribution of mid-phase (MP)(phase I/II,II) and late-phase (LP)(PII/III,PIII) CTs for the ten most represented cancer types by number of sites was assessed using network graph theory and geographic analysis comparing distribution of trials across metropolitan statistical areas. Results: 66,566 CT sites were identified across the sample, 59.6% were in the United States (MP: 50.2%; LP: 42.9%). Geographical availability of CTs and local cancer incidence rates were highly correlated (0.797, p≤ 0.001) but varied depending upon disease type. Network density (the degree of dyadic interconnections between sites studying similar cancer types) showed overall that MP trials were less dense with sparser interconnections among sites than LP trials. Network density of LP trials was higher for cancer types that had poorer correlation between geographic distribution of incidence and enrolling sites (-0.777, p=0.008). MP trials did not show a similar trend. Conclusions: The relationship between the distribution of CT and site location can be envisaged through geographic and network analysis of CT registry data. LP high-density networks should strive to diversify trial locations to better meet regional incidence rates. [Table: see text]
How do social factors explain outcomes in non-small cell lung cancer among Hispanics/Latinos in California?
Authors: Patel Manali I. , Chang Ellen T. , Gomez Scarlett Lin , Schupp Clayton , Wakelee Heather A.
Published: March 2020

6050

Background: Hispanics in the United States have a lower age-adjusted incidence and mortality rate from non-small cell lung cancer compared with non-Hispanic whites. Previous studies have demonstrated the influence of nativity on survival among Hispanic patients but no studies have evaluated the interplay of nativity, clinical factors, social factors, and neighborhood factors on survival among Hispanic patients with non-small cell lung cancer. Methods: All Hispanic patients with non-small cell lung cancer between the years of 1988-2008 were identified in the California Cancer Registry (CCR). Kaplan Meier curves depict survival by nativity status among Hispanics with non-small cell lung cancer. Cox proportional hazard models estimate the hazard of mortality by race with adjustment for individual covariates (age, gender, marital status), clinical factors (histologic grade, surgery, radiation, and chemotherapy), and social and neighborhood factors (neighborhood and ethnic enclave status). Results: A total of 4,062 Hispanic patients with non small cell lung cancer were included. Overall, there was a 7% decreased risk of disease-specific mortality for foreign-born patients as compared with US-born patients (HR 0.93, p=0.08, 95% CI 0.87-1.00) although not-statistically significant. Adjustment for individual patient factors and clinical factors conferred a statistically significant 16% decreased risk of disease-specific mortality compared with US-born patients (HR 0.84, p<0.0001, 95% CI 0.78-0.91). Adjustment for socioeconomic status and neighborhood socioeconomic and ethnic enclave status did not explain the differences in survival (HR 0.84, p <0.001, 95% CI 0.78-0.91). Conclusions: Overall, foreign-born Hispanics with non-small cell lung cancer have a decreased risk of disease-specific mortality compared with US-born Hispanics with non-small cell lung cancer but social factors do not explain this survival advantage. Further investigation is needed to understand the drivers of the survival advantage outcomes in foreign-born populations.
Examining patient choices for metastatic breast cancer drugs.
Authors: Smith Mary Lou , White Carol B , Railey Elda , Storniolo Anna Maria , Sledge George W.
Published: March 2020

6053

Background: Patients with metastatic breast cancer face difficult drug decisions. Our previous research (ASCO Proc 2011, abstr 6044) focused on general benefit and toxicity showed that conjoint analysis (CA) allows patients to express preferences; our current research quantifies patient preference for specific drug profiles (capecitabine and paclitaxel). Methods: Research Advocacy Network and CBWhite conducted research using CA for DOD Center of Excellence for Individualization of Therapy in Breast Cancer. An online survey was sent by four breast cancer organizations (N=641). Questions elicited views on trade-offs between benefit and type/severity/duration of toxicity. CA questions present pairs of hypothetical treatments and ask respondents their preferred alternative; a follow-up question asks whether the person would take the treatment if it were the only option available. Analysis of response patterns allows study of treatment preferences for combinations of benefit and described toxicity. Results: See table. Preferences show much greater attention to benefit than to toxicity. When CA is used to examine impact of biomarkers, focus on benefit continues. Paclitaxel profile (IV) set with moderate PN lasting 1 year post treatment: with 33% benefit LH, 6% of respondents change treatment decision if biomarker predicts 27% vs 60% toxicity likelihood; with 27% toxicity LH, 22% of respondents change treatment decision if biomarker predicts 20% vs 50% benefit likelihood. Conclusions: For patients with metastatic disease, CA shows much greater attention to benefit than toxicity, and high likelihood to take treatment with at least 30% chance of benefit for any toxicity tested here. These results suggest biomarkers (for the profiled drugs) predicting benefit are more likely to be used to affect patient treatment decisions than biomarkers for toxicity. [Table: see text]
Health care costs associated with venous thromboembolism in select high-risk ambulatory solid tumor patients in the United States.
Authors: Khorana Alok A. , Dalal Mehul , Lin Jay , Connolly Gregory Clayton
Published: March 2020

6059

Background: Venous thromboembolism (VTE) is an increasingly common complication of cancer and its treatment, including chemotherapy. VTE has significant clinical consequences, including mortality. However, contemporary data on the healthcare costs of cancer-associated VTE are limited. We examined the real-world economic burden of VTE in ambulatory patients initiating chemotherapy for select common high-risk solid tumors. Methods: Healthcare claims data (2004-2009) from the IMS/PharMetrics Patient-Centric database were collected for propensity score-matched adult cancer (lung, colorectal, pancreas, stomach, bladder and ovary) patients with VTE (n=912) and without VTE (n=2,736) after initiating chemotherapy. Healthcare resource utilization (inpatient, outpatient medical, and outpatient prescription drug claims) and costs were compared between the two cohorts during 12 months’ follow-up after the index VTE event. Incremental costs of VTE were adjusted for demographic and clinical covariates. Results: Cancer patients with VTE had ~3-times as many all-cause hospitalizations (mean 1.38 vs. 0.55 per patient) and days in hospital (10.2 vs. 3.4 per patient), and more outpatient claims (331 vs. 206 per patient) than matched cancer patients without VTE (all P<0.0001). Cancer patients with VTE incurred significantly higher overall (all-cause) inpatient costs (mean $21,299 vs. $7,459 per patient), outpatient costs (mean $53,660 vs. $34,232 per patient) and total healthcare costs (mean $74,959 vs. $41,691 per patient) than cancer patients without VTE (all P<0.0001). Total VTE-related healthcare costs were (mean) $9,247 per VTE patient over 12 months. Adjusted incremental all-cause healthcare costs of VTE were (mean) $30,538 per patient across the selected tumors, ranging from $11,946 per patient for gastric cancer to $38,983 per patient for pancreatic cancer. Conclusions: VTE results in significant inpatient and outpatient resource utilization, and increased all-cause (in addition to VTE-related) healthcare costs. Measures to prevent outpatient cancer-associated VTE may reduce healthcare utilization and costs in high-risk cancer patients.
Use and spending on antineoplastic therapy (AT) in the Medicare population and the role of supplemental coverage.
Authors: Davidoff Amy J. , Shaffer Thomas , Zuckerman Ilene H. , Pandya Naimish B. , Stuart Bruce C. , Erten Mujde Z. , Shoemaker J. Samantha , Bryant-Comstock Lynda , Shenolikar Rahul
Published: March 2020

6060

Background: Oral antineoplastic agents (OAA) represent a growing sector of cancer therapy. Prior studies of older adult cancer patients (pts) examined use of infused/ injected chemotherapy (IICT) covered by Medicare Part B. We examined trends in IICT and OAA use, and the effect of supplemental coverage on AT use and spending. Methods: We used Medicare Current Beneficiary Survey data (1997-2007). Newly diagnosed cancer pts were selected using ICD-9CM codes. IICT use was identified from Part B claims; OAAs were identified from self reported prescription medication events. Supplemental coverage and pt characteristics were assessed from administrative records and self-report. Total spending summed payments from all sources during the cancer diagnosis and subsequent year. Logistic regression examined factors associated with use of any and type of AT; Generalized Linear Models estimated factors associated with spending. Results: Of 1,836 newly diagnosed cancer pts 559 (31%) received AT; 395 (21%) used IICT and 253 (15%) used OAAs. Spending per user was $7,544(AT), $9,892 (IICT), and $1,535 (OAA). Supplemental coverage was associated with increased odds of AT use compared to no supplemental coverage (see Table). Cancer site and age were key predictors of spending among users. OAA spending increased during 2006-7 relative to 2004-5. Conclusions: AT use in Medicare beneficiaries is sensitive to the presence but not type of supplemental coverage. OAAs were used by a relatively large proportion of cancer pts receiving AT, although spending was less than for IICT during this largely pre-Part D period. With the growing number of relatively new OAAs, and more in the pipeline, monitoring the role of supplemental coverage, and particularly the role of Part D on access and spending is a critical area for ongoing research. [Table: see text]
Patient-related predictors of poor-quality pain care in advanced lung cancer patients.
Authors: Lennes Inga Tolin , Temel Jennifer S. , Gallagher Emily R. , Greer Joseph A. , Pirl William F.
Published: March 2020

6062

Background: Unrelieved pain remains a major problem for all patients, including those with cancer, despite national standards for pain management. Screening and addressing pain is an integral part of oncology visits and an ASCO QOPI indicator of quality oncology care. The goal of this study was to assess associations between patient-related factors, particularly patient distress, and meeting ASCO quality metrics for appropriate management of pain in patients with advanced lung cancers. Identification of patient related factors could lead to targeted quality improvement efforts. Methods: From 8/07 to 9/10, we recruited consecutive new patients in a multidisciplinary thoracic oncology clinic to participate in a research database for which patients completed self-report instruments for distress, depression (PHQ-9) and anxiety (GAD-7), at their first oncology visit. We then performed a QOPI chart audit for patients with advanced lung cancer who received care at our institution. A composite measure of appropriate pain management was calculated. Components of the composite measure included 1) documentation of pain assessment, and 2) for patients with moderate-severe pain (≥4 on 10 point scale) plan of care documentation. Results: 253 patients completed baseline assessments and had follow up. Pain was assessed in 252 (99%) patients. Over a third (88/253) of newly diagnosed advanced lung cancer patients had at least moderate pain on their first visit to the medical oncologist. Almost half of patients with moderate-severe pain were depressed (40/88). Of the patients with moderate-severe pain, 54/88 (63%) had a plan of care related to pain documented in the oncologist’s note. In total, 219 (87%) patients received appropriate pain assessment and care. In a multivariate model including age, sex, histology, ECOG PS, provider, depression, and anxiety, only depression independently predicted inadequate pain care. Depressed patients were 3 times more likely to receive poor quality pain care (OR 2.75, 95% CI 1.04-7.25, p=0.04). Conclusions: At initial oncology visit, pain is present in over a third of patients with advanced lung cancer. Depression is highly co-morbid with pain and appears to be a risk factor for inadequate pain care.
Impact of county-level surgical specialist density on breast (BrCa) and lung cancer (LuCa) mortality.
Authors: Karpov Andrei , Cheung Winson Y.
Published: March 2020

6064

Background: Variations in distribution of the surgical workforce may result in differential access to cancer screening and treatment. Our aim was to explore the relationship between county-level surgical specialist density and BrCa and LuCa mortality. Methods: Using data from Area Resource File, US Census and National Cancer Institute, regression models that controlled for cancer incidence, county demographics and socioeconomic factors were constructed to examine the association among a) general surgeon (GS) and radiation oncologist (RO) density with BrCa mortality and b) thoracic surgeon (ThS) and RO density with LuCa mortality. Plastic (PS) and transplant surgeons (TrS) were used as surgical controls as they were not expected to correlate significantly with BrCa or LuCa mortality. Results: A total of 1,557 and 2,044 US counties were analyzed for BrCa and LuCa, respectively: mean incidences were 119 and 75 and death rates were 25 and 59 per 100,000 people, respectively, for BrCa and LuCa. Mean specialist densities were 7.72 (GS), 0.80 (RO), and 0.97 (PS) [for BrCa counties] and 0.55 (ThS), 0.55 (RO), and 0.01 (TrS) [for LuCa counties] per 100,000. When compared to counties with no surgical specialist, those with at least one GS and RO for BrCa and at least one ThS and RO for LuCa were associated with decreased mortality (Table). Increasing the density of GS and RO beyond 9 and 1 per 100,000 did not result in significant reductions in BrCa mortality. Likewise, increasing the density of ThS and RO to above 1 each per 100,000 failed to yield further improvements in LuCa mortality. Counties with more elderly residents also correlated with worse BrCa and LuCa outcomes. Conclusions: The presence of specific surgical specialists is associated with lower BrCa and LuCa mortality. There appears to be a threshold at which point further increase in their density do not contribute to continued improvements in outcomes. Distributing the surgical workforce across all counties will offer population-based improvements in BrCa and LuCa mortality. [Table: see text]
Elevated pretreatment serum activin A and progression-free and overall survival in trastuzumab-treated metastatic breast cancer.
Authors: Lipton Allan , Zubritsky Lindsey , Leitzel Kim , Ali Suhail M. , Koestler Wolfgang , Fuchs Eva-Maria , Costa Luis , Knight Robert D. , Laadem Abderrahmane , Sherman Matthew L.
Published: March 2020

607

Background: About half of HER2-positive metastatic breast cancer patients will respond tofirst-line trastuzumab-containing therapy, but most will progress within a year. Trastuzumab resistance remains a vexing clinical problem, and better predictive and prognostic biomarkers are needed. Activin A is a TGF-B superfamily member and regulates cell proliferation, apoptosis, differentiation, and immune response. Methods: Serum activin A was measured using ELISA (R&D Systems, Minneapolis, MN) in 60 metastatic breast cancer patients before starting first-line trastuzumab-containing therapy. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method and Cox modeling with both continuous and dichotomous (median) serum activin A analyses. Results: Pretreatment serum activin A levels averaged 2376 pg/ml, and had a median of 629 pg/ml and 25th and 75th quartile values of 406 and 1791 pg/ml, respectively. Patients who were hormone receptor negative had significantly higher activin A levels (median 1287 vs 450 pg/ml, p=0.002). Higher serum activin A was significant on a continuous basis for predicting reduced PFS to first-line trastuzumab-containing therapy (p<0.003), and for predicting shorter OS (p<0.0001). When analyzed using a dichotomous (median) cutpoint, the elevated serum activin A cohort had a significantly reduced PFS (HR 2.79, p <0. 002) (median 6.6 mo vs. 31.1 mo) and OS (HR 5.24, p <0.0001) (median 19.6 mo vs. median not reached). In multivariate analysis for PFS with other covariates (age, line of therapy, CA 15-3, and hormone receptor status), activin A was the only significant covariate (p=0.021). In multivariate analysis for OS, activin A (p=0.002) and CA 15-3 (p=0.03) remained significant as prognostic factors. Conclusions: Elevated pretreatment serum activin A predicts reduced PFS and overall survival in metastatic breast cancer patients treated with first-line trastuzumab-containing therapy. Activin A deserves further study as an adverse biomarker, and to select patients most likely to respond to activin A-targeted therapy.
Disparities in the treatment and outcomes of lung cancer among HIV-infected people in Texas.
Authors: Suneja Gita , Shiels Meredith S. , Melville Sharon K. , Williams Melanie A. , Rengan Ramesh , Engels Eric A.
Published: March 2020

6070

Background: HIV-infected (HIV+) people are at elevated risk for lung cancer and have higher mortality following lung cancer diagnosis than uninfected (HIV-) individuals. The disparity in survival is partly due to advanced stage at diagnosis, but it is unclear whether HIV+ people with lung cancer are less likely to receive cancer treatment, which could worsen survival. Methods: We included adults ≥ 18 years of age with lung cancer reported to the Texas cancer registry (N=156,930). HIV status was determined by linkage with the enhanced Texas HIV/AIDS Reporting System. We compared HIV+ and HIV- lung cancer cases with respect to demographic and clinical characteristics. For non-small cell lung cancer (NSCLC) cases, we identified predictors of cancer treatment (surgery, radiation, and chemotherapy) using logistic regression. We used Cox regression to evaluate the effects of HIV and treatment on lung cancer-specific mortality. Results: Compared with HIV- lung cancer cases (N=156,593), HIV+ lung cancer cases (N=337) were more likely to be young, non-Hispanic black, male, and to have distant stage disease (53.7% vs. 44.4%). HIV+ cases were less likely to receive cancer treatment than HIV- cases (60.3% vs. 77.5%; odds ratio 0.39, 95%CI 0.30-0.52 after adjustment for diagnosis year, age, sex, race, stage, and histologic subtype). In Cox models adjusted for these variables, both HIV infection (hazard ratio [HR] 1.34, 95%CI 1.15-1.56) and lack of cancer treatment (HR 1.69, 95%CI 1.66-1.72) were associated with higher lung cancer-specific mortality. After adjustment for cancer treatment, the association between HIV and lung cancer mortality was attenuated (HR 1.25, 95%CI 1.06-1.47). The association between HIV and lung cancer-specific mortality was stronger among untreated lung cancer cases (HR 1.32, 95%CI 1.01-1.72) than treated cases (adjusted HR 1.16, 95%CI 0.94-1.43; p-interaction=0.34). Conclusions: In this population-based study, HIV+ people with NSCLC were less likely to be treated for lung cancer than their HIV- counterparts. This lack of treatment may be partly responsible for higher cancer-related mortality in HIV+ cases. Further investigation is needed to understand disparities in cancer treatment for HIV+ people.
Beyond the performance rate: Understanding differences in treatment status using the Rapid Quality Reporting System (RQRS).
Authors: McNamara Erica J. , Stewart Andrew , Gay E. Greer , Banasiak James , Eremin Dmitry , Harman Dennis , Flores Rafael , Edge Stephen B.
Published: March 2020

6088

Background: RQRS is a cancer registry based tool for rapid case ascertainment and real-time care tracking using 5 National Quality Forum approved quality measures for breast (BC) and colon cancer (CC) and 1 American Society of Clinical Oncology, National Comprehensive Cancer Network and Commission on Cancer (CoC) endorsed rectal cancer (RC) measure. RQRS was introduced in 2009 for testing at selected CoC accredited programs. The purpose of this study was to evaluate the proportion of cases with treatment administered for 4 measures where care is concordant with treatment either “administered” or “considered but not administered” (CNA). Methods: Case information on 19,631 breast, colon and rectal cancer patients diagnosed from 2009 – 2010 submitted by 64 RQRS participating sites were reviewed for 4 measures: (1) hormone therapy within 1 year of diagnosis (dx) for AJCC T1c, N0M0, or stage II or II; hormone receptor positive BC (HT), (2) multi-agent chemotherapy within 4 months of dx; age < 70; hormone receptor negative BC (MAC), (3) adjuvant chemotherapy within 4 months of dx; age <80; AJCC Stage III CC (ACT), and (4) radiation therapy within 6 months of dx; age <80; AJCC T4N0M0 or stage III patients receiving surgical resection for RC (AdjRT). Treatment status was defined as concordant (administered or CNA) or non-concordant (NC – not part of planned first course therapy or received after required time frame). Patient demographics and Charlson-Deyo (CD) co-morbidity scores were compared by concordance status using Chi-square tests. Results: The aggregate concordance rate was 83.3%. Among these 889 (5.4%) were CNA. Co-morbidity score was > 0 for 15% of cases. Patients age > 70, with Medicare insurance, CD score > 0 were significantly more likely to be CNA compared to completed or NC. Patient choice was the most common reason for CNA (64%). Conclusions: Among patients treated at RQRS test sites for which RQRS measures applied and care was concordant, only 5% were CNA. Patients over age 70 or with CD > 0 were more likely to have treatment CNA. Inclusion of CNA as concordant care has a minor impact on concordance rates and provides cancer programs with important information for targeting care review and quality improvement programs.
Health-related quality of life assessment in EORTC cancer clinical trials.
Authors: Zikos Efstathios , Coens Corneel , Ediebah Divine Ewane , Quinten Chantal , Greimel Eva , Flechtner Henning , Taphoorn Martin J. B. , Reijneveld Jaap , Koller Michael , Bottomley Andrew
Published: March 2020

6090

Background: Over the last three decades health-related quality of life (HRQOL) has become an important part of the randomised controlled trials (RCTs) conducted by the European Organisation for Research and Treatment of Cancer (EORTC). This review aims to undertake a descriptive database evaluation of all the HRQOL studies conducted in EORTC since 1980. Methods: The EORTC protocol database (n=785) was reviewed, restricting the search to between 1980 and 2011 (n=735). We investigated the number of HRQOL studies conducted in EORTC trials, the RCTs’ status and the use of HRQOL tools since 1980. Results: 157 protocols with HRQOL assessment were identified involving 70,903 patients. 73 studies ended as defined in the protocol; 27 studies closed early due to poor accrual; 17 are at the final analysis of the primary end point stage; 14 studies are still open to recruitment; 11 are closed to patient entry; and 15 new RCTs are pending activation with HRQOL. The majority of phase III (n=135) and phase II/III (n=9) RCTs have HRQOL as secondary endpoint. EORTC also conducted a number of large scale field studies (n=11), where HRQOL was the primary endpoint. During the early period of 1980 to 1989 HRQOL was assessed in 12 EORTC RCTs by using a small number of HRQOL items, but from 1990 to 2000, HRQOL was assessed in 97 RCTs using more comprehensive HRQOL tools. Between 2001 and 2011 the number of RCTs with HRQOL was 48. The EORTC clinical groups with the most RCTs containing HRQOL were Radiation Oncology (n=22), Genito-Urinary (n=20), Gynaecological (n=16), Breast Cancer (n=16), Lung (n=13), Gastrointestinal, (n=13) and Brain (n=10). The EORTC HRQOL tools were used in 90% of the trials, with other validated tools being used when required. Conclusions: Our review of EORTC RCTs has shown how patient perspective has been constantly considered of major importance in oncology during the last three decades. The inclusion of patient perspective in drug development shows that a more comprehensive HRQOL assessment has taken place over time as better instruments have become available. As the positive value of patient perspective grows to clinicians, regulatory bodies and industry, we expect that EORTC will continue its support by including HRQOL endpoints where appropriate.
Relationship between Oncotype DX testing and the use of chemotherapy in high-risk patients (pts).
Authors: Wong Winston , Cooper Joseph , Richardson Steve , Feinberg Bruce A.
Published: March 2020

6098

Background: CareFirst BlueCross BlueShield (CFBCBS) insurance network partnered with Cardinal Health Specialty Solutions (CHSS) to develop a cancer care pathway for network physicians in 2008. The program included a recommendation for molecular diagnostic testing with the Oncotype DX assay for pts with early-stage estrogen receptor-positive breast cancer. Based on NCCN guidelines, the pathway suggested adjuvant chemotherapy for all pts with Oncotype DX Recurrence Scores (RS) in the high-risk category. We aimed to determine the RS risk distribution among pts who received Oncotype DX testing and assess the patterns of care that followed. Methods: Using data from CFBCBS, CHSS proprietary claims software, and Genomic Health, we retrospectively identified a cohort of women with breast cancer who were treated on the CFBCBS clinical care pathways program from 8/2008 to 6/2011 and received Oncotype DX testing. We determined the number of pts with a RS value in the low- (RS <18), intermediate- (RS 18-30), and high-risk (RS ≥31) groups along with the number of pts who subsequently received chemotherapy in each category. Results: Of 1174 women who received Oncotype DX testing, 53% of pts were in the low-, 35% in intermediate-, and 12% in the high-risk groups. Five percent of low-, 41% of intermediate-, and 74% percent of pts in the high-risk category were treated with chemotherapy. Twenty-six percent of pts in the high-risk group did not receive chemotherapy. Conclusions: The proportionate use of chemotherapy in the low and intermediate risk groups was as expected based on adjuvant chemotherapy guidelines; however, the underuse of chemotherapy in 26% of high-risk pts was an unexpected finding. Further study is needed to determine: (1) why physicians avoided chemotherapy in 26% of high-risk pts; (2) the overall number of appropriate pts who underwent Oncotype DX testing; and, (3) the tumor characteristics that may have driven the underutilization of chemotherapy in the high-risk population.
Long-term central venous catheter use among cancer patients in administrative claims data.
Authors: Lipitz Snyderman Allison Nicole , Sepkowitz Kent , Elkin Elena B. , Pinheiro Laura C , Son Crystal , Bach Peter
Published: March 2020

6101

Background: This study’s objective was to examine administrative claims data’s capacity to serve as a surveillance tool for long-term catheter use and related bloodstream infections among cancer patients. Population-based estimates and efforts to track catheter use and infections for this group are limited. As such, we sought to explore catheter use documentation using a cohort of colorectal cancer patients. Methods: We performed a retrospective analysis using the population-based SEER-Medicare dataset for patients 66 years or older diagnosed with colorectal cancer in 2005-2007 (n = 54,870). Insertions and removals of long-term central venous catheters (i.e., tunneled, ports/pumps, peripherally inserted central catheter [PICCs]) were identified by billing codes within 2 years of diagnosis. Factors associated with catheter use were identified in multivariable logistic regression analysis. Results: Findings were consistent with clinical expectations. A total of 11,775 patients (21%) had at least one documented long-term catheter insertion within 2 years of diagnosis, 19% within 6 months. Of those with catheters, approximately 25% had more than one insertion. Sixty-eight percent had at least one port/pump, 8% at least one tunneled catheter, and 33% at least one PICC. Seventy-four percent of catheterized patients had IV chemotherapy. Of patients stages I, II, III, and IV, 10%, 18%, 37%, and 39% had catheters, respectively. Adjusted for other factors, patients with catheters were significantly more likely to be younger, female, black (vs. white), and have comorbidities (vs. none documented in year prior to diagnosis), compared to patients without catheters. By the end of the study, 34% of patients with ports/pumps had documented removal and 42% died (for patients with tunneled catheters, 28% and 52%, respectively). Conclusions: Findings support the use of claims data to capture long-term catheter use in cancer patients, providing a foundation for exploration of its capacity to capture infections. Given extensive documented catheter use (21%), infections may be a significant problem. Claims data may offer a low-burden method for surveillance and study, aiding the development of targeted initiatives.
Assessing the clinical significance of real-time quality of life data in cancer patients treated with radiation therapy.
Authors: Halyard Michele Y. , Tan Angelina D. , Atherton Pamela J. , Wong William , Schild Steven E. , Vora Sujay A. , Ashman Jonathon , Callister Matthew , Ciafone Denise , Zimmerman Pamela , Phillips Paula , Mortarotti Joan , Kruse Janice , Luna Hermenigilda , Olson Jillian , Burris Patricia , Young Brian , Dueck Amylou C. , Sloan Jeff A.
Published: March 2020

6108

Background: This pilot study evaluated whether providing clinicians with patient(pt) QOL results and symptom management pathways linked to QOL domains at the time of clinical appointment would result in improvement in QOL and treatment (tx) satisfaction. The objective was to obtain preliminary effect size estimates and logistical evidence for design of a larger, definitive trial. Methods: Oncology pts receiving 5-7 weeks of radiotherapy (RT) electronically completed QOL assessments (LASA) at baseline and biweekly prior to seeing clinicians. Was It Worth It (WIWI) and Interpersonal Patient-Provider Relationship (IPPRS) were measured at tx end. Pt endpoints (pro-rated primary endpoint LASA area under the curve (AUC), LASA changes from baseline, and WIWI responses) and clinician endpoints (IPPRS) were compared between the control group (Phase 1: no QOL feedback) and the intervention group (Phase 2: QOL feedback) via Wilcoxon, Chi-square and Fisher Exact tests. There was 80% power to detect a 10 point difference in average AUC. Results: 148 pts enrolled (79 Phase 1, 69 Phase 2) from 11/28/2008 to 09/20/2011 (sites GI (27%), Lung (22%) and Head and Neck (52%)). 68% received RT and chemo. There were consistently moderate effect sizes observed but no statistically significant differences in any AUC nor end of tx change from baseline scores. 20% fewer pts in phase 2 reported clinical deficits in overall QOL (pain). In pts receiving 7 weeks of RT, end of tx average overall QOL, mental well-being (WB), physical WB and pain severity were significantly better in Phase 2 pts. WIWI results showed 76% found participation worthwhile, 95% would participate again, and 92% would recommend the study to others. No differences between groups were found in communication between clinicians and pts (IPPRS). Conclusions: Preliminary estimates indicate potentially clinically significant improvements of moderate effect size in mental and physical WB and pain severity when clinicians received QOL real time with symptom management pathways. Further study is warranted in larger trial setting.