bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of early palliative care on health care costs in patients with metastatic NSCLC.
Authors: Greer Joseph A. , McMahon Pamela M , Tramontano Angela , Gallagher Emily R. , Pirl William F. , Jackson Vicki A. , Temel Jennifer S. 
Published: March 2020

6004 Background: Introducing palliative care soon after diagnosis for patients with metastatic non-small cell lung cancer (NSCLC) leads to improvements in quality of life, mood, end-of-life care, and possibly survival. We sought to investigate whether early palliative care is also associated with health care cost savings. Methods: This secondary analysis is based on a randomized controlled trial of 151 patients with newly-diagnosed, metastatic NSCLC presenting to an outpatient clinic at a tertiary cancer center between 6/2006 and 7/2009. Participants received either early palliative care integrated with standard oncology care or standard oncology care alone. We queried participants’ electronic health records as well as our institution’s billing database to collect data on frequency and costs of outpatient clinic visits, inpatient hospitalizations, chemotherapy administration, and hospice services. The primary outcome was the difference in average resource use costs during the final month of life between groups. Results: By 18-month follow up, 133 (88.1%) participants had died, and 125 (82.8%) had available data for this analysis. Participants in the early palliative care group had a mean cost savings of $2,282 (median=$2,432) per patient in total health care expenditures during the final month of life compared to the standard care group. The difference was primarily accounted for by lower costs for inpatient visits (mean saving per patient=$3,110) and chemotherapy administration (mean saving per patient=$640). Although expenditures for outpatient clinic visits were similar between groups, the costs for hospice services were greater for the early palliative care group because of the longer lengths of stay in hospice care (mean cost per patient=$1,125). Conclusions: Early palliative care for individuals diagnosed with metastatic NSCLC not only improves multiple patient outcomes but also may be associated with lower hospital resource use costs, primarily through decreased inpatient visits and chemotherapy administration at the end of life.
Who gets a referral to oncologists and subsequent treatments for stages III and IV non-small cell lung cancer (NSCLC)?
Authors: Goulart Bernardo Haddock Lobo , Fedorenko Catherine R. , Mummy David G , Blough David K , Koepl Lisel , Satram-Hoang Sacha , Reyes Carolina M. , Ramsey Scott David 
Published: March 2020

6007 Background: We identified the physicians initially involved in the management of stages III and IV NSCLC, and explored associations of patient and their initial physician factors with referrals to oncologists and subsequent receipt of guideline-based therapies (GBTs) endorsed by the National Comprehensive Cancer Network. Methods: Using a retrospective cohort design, we identified patients with a new diagnosis of stages III and IV NSCLC from 01/01/2000 to 12/31/2005 included in the Surveillance, Epidemiology, and End Results-Medicare database. After collecting patient sociodemographic, tumor, and treatment data, we linked Unique Physician Identifier Numbers (UPINs) from Medicare claims to the American Medical Association Masterfile database to identify the initial physicians and subsequent referrals to cancer specialists, defined as surgeons, radiation oncologists and oncologists. We used logistic regression to explore associations between: 1) patient and initial physician independent variables with referrals to oncologists; 2) referrals to different combinations of cancer specialists with receipt of stage-specific GBTs, adjusted for confounders. The follow-up period was 12 months or up to 12/31/2006. Results: For 28,977 patients, mean age was 75 years, 53% were male, 83% were white, 51% had stage IV, 37% initially saw an internal medicine doctor, 84% saw at least an oncologist, 31% saw all 3 types of cancer specialists, and 44% received GBTs. Younger age, white race, stage IV, higher income, lower co-morbidity index, initial physicians other than family practice doctors, and referral to pulmonologists were associated with higher likelihood of referral to oncologists (P<0.01 for all factors). Compared to those who saw only an oncologist, those who saw only a surgeon and/or a radiation specialist were less likely to receive GBTs (OR=0.3; 95%CI=0.3-0.4). Among patients who had no referrals or who saw specialties other than oncology, 14% received GBTs. Conclusions: Seeing an oncologist is a critical step in the standard treatment of advanced NSCLC. Yet, race, income, and the type of initial physician may constitute barriers of access to oncologists, which can result in substandard care.
An assessment of the collective efforts of clinical trials to provide evidence-based practice guidelines in cancer care.
Authors: Lloyd Shane , Buscariollo Daniela L. , Gross Cary P. , Makarov Danil V. , Yu James B. 
Published: March 2020

6019 Background: It is unclear how many of the recommendations in the National Comprehensive Cancer Network (NCCN) guidelines are based Category 1 (C1: “high level evidence”), or whether current cancer research efforts are focusing on the knowledge gap between guidelines and supporting evidence. We defined the knowledge gap as the percent of NCCN recommendations based on lower levels of evidence, and assessed the relation between the knowledge gap and cancer research efforts in terms of clinical trial enrollment. Methods: We examined the active, phase 3 randomized controlled trials (RCTs) listed on clinicaltrials.gov for the 17 most prevalent solid tumors. We used the NCCN guidelines to tally the percentage of C1 recommendations. We used the Pearson coefficient and linear regression to examine whether enrollment in active phase 3 RCTs is associated with 1) the knowledge gap and 2) measures of burden to society including prevalence, incidence, person years life lost (PYLL) and disability adjusted life years (DALY). Results: We identified 834 treatment recommendations for the 17 included cancer types. Overall, 15% of the NCCN recommendations were rated as C1, varying from 40% for hepatobiliary to 0% for endometrial cancer. There was no association between RCT enrollment and the proportion of C1 recommendations in univariate or multivariate analyses. RCT enrollment positively correlated with measures of burden to society including prevalence (p-value < 0.001), incidence (p-value 0.001), and DALY (p-value 0.038). Breast and prostate cancers have a large amount of RCT enrollment per PYLL and a relatively small knowledge gap. Melanoma, ovarian, and endometrial cancers have a moderate amount of RCT enrollment per PYLL and a relatively large knowledge gap. Lung, esophagus, bladder and CNS cancers have a low amount of RCT enrollment per PYLL and a moderate to large knowledge gap. Conclusions: RCT enrollment is not correlated to the knowledge gap. Current planned enrollment in RCTs is partially predicted by burden to society, with the strongest correlation to incidence and prevalence. Most recommendations in the NCCN guidelines are not based on C1 evidence.
Results of a cluster randomized trial to evaluate a nursing lead supportive care intervention in newly diagnosed breast and colorectal cancer patients.
Authors: Sussman Jonathan , Howell Doris , Bainbridge Daryl , Brazil Kevin , Schiff Susan , Whelan Timothy Joseph , Wiernekowski Jennifer 
Published: March 2020

6035 Background: Patient transitions during the early phases of cancer care from initial diagnosis through oncology consultation are often poorly coordinated resulting in unmet need, poor continuity, and resultant distress. It has been proposed that better coordination of care during this period would improve the care experience from the patient’s perspective. We designed a randomized trial to test a community based nursing lead coordination of care intervention in newly diagnosed breast and colorectal cancer patients. Methods: Cluster randomized control trial in 193 newly diagnosed breast and colorectal cancer patients enrolled through surgical practices within 7 days of cancer surgery in Toronto, Canada. Surgical practices were randomized between a standardized nursing intervention and a control group involving usual care practices. The intervention consisted of a standardized in person supportive care assessment with ongoing supportive care by telephone or in person that included linkage to community services using protocol specified guidelines according to identified needs. The primary outcomes measured at 8 weeks were validated patient reported outcomes (PROs) of 1) unmet need (SCNS) and 2) continuity of care (CCCQI). Secondary outcomes included 1) quality of life (EORTC QLQ-C30), 2) health resource utilization, and 3) level of uncertainty with care trajectory (MUIS) at 8 weeks. Results: 121 breast and 72 colorectal patients were randomized through 28 surgical practices. The intervention group had a median of 6 nursing contacts over the study period. There were no differences between groups on PROs of unmet need, continuity of care, quality of life, or uncertainty. Health service utilization did not differ between groups. Conclusions: A specialized oncology nursing intervention early in the care trajectory did not result in improved supportive care outcomes for patients. [Table: see text]
Which women with breast cancer do, and do not, undergo receptor status testing? A population-based study.
Authors: Sharp Linda , De Camargo Cancela Marianna , Comber Harry 
Published: March 2020

6036 Background: Receptor status is a determinant of breast cancer (BC) treatment and prognosis. Clinical practice guidelines advise that all women diagnosed with BC may undergo estrogen (ER), progesterone (ER) and human epidermal growth factor 2 (HER2) receptor tests. We conducted a population-based study to investigate what proportions of women undergo testing and predictors of test receipt. Methods: Incident BCs (ICD10 C50) diagnosed 2006-2008 were identified from the National Cancer Registry Ireland. Receptor tests were identified from registration records augmented by review of selected medical records. For each of the three receptors separately, logistic regression was used to identify which socio-demographic (age, marital status, smoking status, area of residence, and deprivation category) and clinical factors (grade, tumour size (T), nodal status (N), distant metastasis (M)) were associated with undergoing testing. Adjusted odds ratios (OR) and 95% confidence intervals were computed. Results: 7619 BCs were included. 7% were not tested for any of the receptors. 73% were tested for all three. Considering each receptor separately, 90% had an ER test, 86% a HER2 test and 80% a PR test. Women with T4 tumours were less likely to have ER and HER2 tests, and more likely to have a PR test, than women with T1 tumours. After adjustment for clinical variables, age was not a significant predictor for ER and HER2 testing, while older women (≥70) were more likely than younger women to have a PR test. For all three tests, non-married women were significantly less likely to be tested (ER: OR=0.65, 95%CI 0.52-0.8; PR: OR=0.81, 95%CI 0.7-,0.93; HER2: OR=0.72, 95%CI 0.62-0.85) and current smokers more likely (ER: OR=1.55, 95%CI 1.14-2.1: PR: OR=1.38, 95%CI 1.15-1.66; HER2: OR=1.25, 95%CI 1.01-1.55). Area of residence at diagnosis was a significant predictor of having each test, although the geographical patterns varied. Conclusions: More than one-quarter of women with BC do not have one or more of the receptor tests. After adjusting for clinical variables, socio-demographic factors were significant predictors of test receipt. In the interests of equity, the reasons underlying these associations should be further investigated.
Somatic mutation spectrum of non-small cell lung cancers (NSCLCs) from African Americans (AAs).
Authors: Lammers Philip Edward , Matthews-Smith Velmalia , Yun Ya-Lin , Pan Yumei , Zaja-Milatovic Snjezana , Sullivan Amy , Eisenberg Rosana , Gonzalez Adriana , Shyr Yu , Wolff Steven N. , Schwartz Ann G. , Pao William , Carbone David Paul 
Published: March 2020

6038 Background: In the AA population, previous studies have presented conflicting data on the frequency of EGFR mutations (Reinersman JTO 2011;Leidner JCO 2009), while frequencies of other gene mutations and translocations, including anaplastic lymphoma kinase (ALK), have not been described. Methods: 161 archival FFPE tumor specimens from self reported AA patients with any stage NSCLC from 1997-2010 were collected from 3 sites in Tennessee (132 samples) and one site in Michigan (29 samples). Samples were evaluated for known recurrent driver mutations in EGFR, KRAS, BRAF, NRAS, AKT1, PI3KCA, PTEN, HER-2, MEK1 by standard SNaPshot/sizing assays, and translocations in ALK by FISH. Clinical data was collected on 119 patients. Chi-square was used to compare the frequency of mutations in subgroups and Kaplan-Meier and log rank were used to calculate and compare PFS between groups. Results: 5.0% of tumors had EGFR mutations, 14.9% had KRAS mutations, 0.6% had a BRAF, AKT1, PI3KCA, or HER2 mutation, and 0% had NRAS, PTEN, or MEK1 mutations. Of 35 ‘pan-negative’ non-squamous specimens, 0 had ALK translocations. PFS was the same in those with and without KRAS mutation (p=0.74) and showed a trend towards improvement in those with EGFR mutation (p=0.08). The frequency of EGFR mutations was higher in samples from Detroit versus those from Tennessee (17% vs 2.3%, p<0.01), as was the frequency of adenocarcinoma (62% vs 44%, p<0.05). The frequency of EGFR mutations in never smokers was higher in the samples from Detroit versus Tennessee (83% vs 7.1%, p<0.01). Conclusions: In the largest tumor mutational profiling study of NSCLC from AAs to date, EGFR mutations occurred less frequently than would be expected from a North American population. We noted a regional difference, with fewer EGFR mutations in Tennessee than in Michigan, a finding that may have been the result of more adenocarcinoma samples from Michigan. The rates of other mutations and translocations including ALK were low. While lung cancer tumors should continue to undergo routine molecular testing to prioritize therapy, future comprehensive genotyping efforts should focus on identifying novel driver mutations in this population. Funding: 5RC1CA162260 R01CA060691 R01CA87895.
Lapatinib in HER2+ early breast cancer: Quality of life analysis.
Authors: Boyle Frances , Smith Ian Edward , O'Shaughnessy Joyce , Ejlertsen Bent , Kaufmann Manfred , Buzdar Aman , Fumoleau Pierre , Gradishar William John , Martin Miguel , Moy Beverly , Piccart-Gebhart Martine J. , Pritchard Kathleen I. , Lindquist Deborah , Amonkar Mayur , Huang Yingjie , Williams Lisa Simone , Wang Qing , Finkelstein Dianne M , Goss Paul Edward 
Published: March 2020

604 Background: TEACH, a randomized, double-blind, multi-center, phase III study evaluated the efficacy and safety of 12 months lapatinib (N=1571) versus placebo (N=1576) in women with HER2+ EBC. Patients receiving lapatinib more often reported treatment-related AEs (87% vs 47%) in the Intent-to-treat (ITT) population. The comparison of recurrence-free survival was not significant (p=.053). This analysis focuses on QOL in the ITT. Methods: Participants on TEACH completed the Short Form-36 version 2 (SF-36v2) at baseline and every 6 mo. for 24 mo. SF-36v2 captures physical, social, mental, emotional domains of patient perceptions; summary scores of physical and mental components are derived from domain scores using norm based scoring method. Changes in the domain and summary scores were compared between two groups using ANCOVAs. Missing post-baseline data were imputed using the last observation carried forward method. A clinically relevant change in scores was defined as a 3-5 point change. Results: For randomised patients who completed the SF-36, QOL scores decreased relative to baseline for all domains and summary scores across all assessments and treatment arms, however the decreases were small and not clinically meaningful. There were no statistically significant (p< 0.05) or clinically meaningful differences between arms for the summary scores relative to baseline (Table). Conclusions: In HER2 positive EBC one year treatment with lapatinib is associated with a significant increase in AEs but it does not have a significant detrimental impact on QOL when compared to placebo. [Table: see text]
Effectiveness of a screening intervention to identify clinical-trial-eligible patients.
Authors: Chen Leo , Grant Janice , Kennecke Hagen F. 
Published: March 2020

6069 Background: Advancements in cancer therapy require clinical trials, but only 3% of all cancer patients (CP) participate in trials causing many studies to be delayed or fail to complete. Literature indicates that accrual to clinical trials is primarily driven by MD related factors. The objective of this study was to evaluate whether the screening and identification of potentially eligible patients (PEP) for specific clinical trials would lead to an increased rate of accrual (RA). Methods: During a 4 month period, the charts of CP attending the outpatient clinics of 12 MDs were reviewed to determine eligibility for 21 phase II-IV trials for CP with BR, GI, GU, GY, or LG cancer. Trials were included if they had been open for ≥ 4 months and would remain open ≥ 8 months from the start of the intervention. A screening coordinator with minimal clinical background reviewed the electronic record of new and followup CP to determine eligibility according to protocol specified criteria. PEP were identified for medical oncologist by attaching notices to CP charts. Participating MDs were surveyed regarding the helpfulness and accuracy of the forms. A negative-binomial regression model was used to compare RA and find 95% CI for relative rates. Results: Between May 1 to August 31, 2011 a total of 2,098 charts were screened for eligibility for 21 trials, and 120 PEP were identified. Of these, 15 were randomized to the referred study, 4 to a different study, and 4 CP were offered but declined the referred study. Four month RA for included trials were 61 before, 73 during and 51 after the intervention. Relative rates adjusted for MD bookings were 0.85 (95% CI: 0.67, 1.06, p = 0.15) before and 0.70 (95% CI: 0.54, 0.90, p < 0.005) after, relative to during the intervention. 33 completed questionnaires were received: 22 (67%) were helpful and 23 (70%) were accurate. Screening required a 1.0 Full Time Equivalent position during the period of the intervention. Conclusions: Manual screening of patient records to determine clinical trial eligibility is labor intensive and increases enrolment to specific clinical trials. Notifications were deemed mostly helpful and accurate by oncologists. Screening interventions should be considered to improve clinical trial accrual.
Colorectal cancer survivors' needs and preferences for survivorship information.
Authors: Salz Talya , McCabe Mary S. , Blinder Victoria Susana , Elkin Elena B. , Kemeny Margaret , Saltz Leonard , Temple Larissa K. F. , Oeffinger Kevin C. 
Published: March 2020

6073 Background: We assessed colorectal cancer (CRC) survivors’ needs and preferences for information to guide development of a survivorship care plan. Methods: We conducted a survey of survivors treated for stage I-III CRC at two hospitals in New York City. Participants completed treatment 6-24 months before the interview and had not received a survivorship care plan. We evaluated whether survivors knew their basic treatment history, whether they understood ongoing risks, and their preferences for receiving survivorship information. Results: 175 CRC survivors completed the survey between June 2010 and November 2011. Survivors generally remembered basic information about their diagnosis and treatment: 88% accurately reported the location of their cancer; 95-100% accurately reported whether they had surgery, chemotherapy, or radiation; and 90-95% correctly reported the completion date (within 6 months) for each treatment. Survivors knew less about the risks of local and distant recurrences (69% and 77% correct, respectively) and of getting another CRC compared to unaffected individuals (40% correct). More than three quarters of participants received information about their cancer, their treatment history, ongoing oncology visits, and testing to be done by the oncologist (77-86% across categories). Across these categories of information, 93-99% of those who received information found it useful. Most survivors did not receive information about symptoms to report to their doctors, returning to work, financial issues, or legal issues (59-95% across categories); but those who received this information found it useful (67%-100% across categories). Conclusions: Even without receiving survivorship care plans, CRC survivors generally understood their cancer diagnosis and treatment. However, many lacked knowledge of ongoing risks, prevention, and nonmedical survivorship issues. Most survivors found the survivorship information they received useful. The greatest benefit of survivorship care plans to survivors may not be summarizing past care as much as helping survivors understand their risks and plan for the future.
Characterizing fatigue associated with sunitinib (SU) in patients (pts) with metastatic renal cell carcinoma (mRCC).
Authors: Cella David , Davis Mellar P. , Bushmakin Andrew G. , Cappelleri Joseph C , Hahn Elizabeth A , Korytowsky Beata , Bhattacharyya Helen , Sandin Rickard , Beaumont Jennifer L , Matczak Ewa , Motzer Robert John 
Published: March 2020

6092 Background: Fatigue is common in cancer pts and associated with use of tyrosine kinase inhibitors (TKIs) such as SU. Limited data exist on the time pattern of fatigue with TKI therapy. Methods: Data from treatment-naïve mRCC pts in SU arms of two clinical trials were analyzed retrospectively. Study 1; 375 pts were randomized to SU 50 mg/d on a 4 weeks-on-2-weeks-off schedule (Schedule 4/2), for up to 30 cycles. Study 2; pts were randomized to SU 50 mg/d Schedule 4/2 (Group 1; n=146) or 37.5 mg/d continuous daily dosing (CDD; Group 2; n=146). In both trials, fatigue was measured with the question to pts: “I feel fatigued” over the past week (5-point rating scale, not at all-very much), and with the provider-rated Common Terminology Criteria for Adverse Events (CTCAE). In addition to descriptive profiles, Study 1 used two modeling approaches; repeated measures model (M1), with time as a categorical predictor; and random intercept-slope model (M2), with time as a continuous predictor. Study 2 calculated mean absolute values of within-cycle rate of change (from one assessment to the next) through the first 6 treatment cycles. Results: In Study 1, representing fatigue across cycles, M1 showed that the initial increase in patient-reported fatigue was worst during Cycle 1; mean values at all subsequent cycles were numerically better. For CTCAE fatigue, M1 showed that all but one of the pair-wise comparisons of the cycle means were not significantly different. M2 showed that the overall trend for patient-reported fatigue and CTCAE fatigue was not statistically different from zero. In Study 2, the mean absolute rate of change for fatigue during 6 treatment cycles was greater for Group 1 (4/2) compared to Group 2 (CDD): 0.042 vs. 0.032, respectively; P=0.003, t-test. Conclusions: In Study 1, pts reported notable fatigue in Cycle 1, which improved or stabilized, thereafter. In Study 2, Schedule 4/2 was associated with more within-cycle fluctuation in fatigue. These findings illustrate how SU-associated fatigue occurs early in therapy and continues with more within-cycle fluctuation associated with 4/2 dosing. This may help patient-clinician communications and interventions that support maintaining effective therapy.