bluuebunny/crossref_metadata_2025 huggingface dataset:
Factors associated with chemotherapy receipt and intensity for stage IV colorectal cancer (CRC): A multihealth system, population-based study
Authors: Zafar Y. , Grambow S. C. , Abbott D. H. , Malin J. L. , Zullig L. L. , Kolimaga J. T. , Provenzale D. T.
Published: August 2020

6519

Background: Little is known about chemotherapy practice patterns for patients with stage IV CRC. Methods: Cancer Outcomes Research & Surveillance Consortium (CanCORS) is a prospective cohort study including patients with incident CRC sampled from a set of defined populations and health systems. Eligible patients for this analysis (n = 742) had stage IV CRC and abstracted medical record data, including stage, chemotherapy, comorbidity (measured by the Adult Comorbidity Evaluation 27 index), and sociodemographic data. Logistic regression models were used to evaluate factors associated with chemotherapy receipt and intensity. Results: A majority of patients were male (62%) and white (62%). 27% were ≥75 years old, and 14% had severe comorbidity. 34% had private insurance, 32% had public insurance (including Medicare/Medicaid), 18% were Veterans Affairs patients, 4% had no insurance, and 13% were missing insurance information. Overall, 77% received chemotherapy, and 57% received >1 line of therapy. Patients were less likely to receive chemotherapy if they were older (65–74 vs. <55 years = adjusted odds ratio [OR] 0.14, 95%CI 0.06–0.33, p < 0.001; ≥75 vs. <55 years = OR 0.04, 95%CI 0.02–0.64, p < 0.001), or had severe comorbidity (OR 0.38; 95%CI 0.23–0.64; p < 0.001). When treated, patients ≥75 years were more likely to receive capecitabine vs. 5-fluorouracil (5-FU) (p < 0.001), less likely to receive >1 line of therapy (p < 0.001), and less likely to receive oxaliplatin or irinotecan combination therapy vs. a single-agent fluorouracil (p < 0.001). Although only 4% were uninsured, lack of insurance did not appear to be a factor in receipt of chemotherapy. Patients with public vs. private insurance were more likely to receive chemotherapy (OR 2.58; 95%CI 1.49–4.47; p < 0.001) but were less likely to receive combination therapy versus a single-agent 5-FU (p = 0.02). Conclusions: The elderly are less likely to receive standard therapy. While patients with public insurance are more likely to receive chemotherapy, they are less likely to receive recommended first-line combination regimens. Future research should investigate how insurance coverage and demographics influence physician and patient preferences for advanced CRC treatment.

No significant financial relationships to disclose.
Accuracy and comprehensiveness of pathology reportage after lung cancer resection
Authors: Farooq A. , Osarogiagbon R. U. , Allen J. W. , O'Brien T. F. , Spencer D. , Berry A.
Published: August 2020

6523

Background: Decisions about prognosis, adjuvant chemo/radiation therapy and clinical trial eligibility require careful examination of the surgical resection specimen. In January 2004, the College of American Pathologists (CAP) and the American College of Surgeons Committee on Cancer mandated reportage of specific items after resection of lung cancer. The extent of compliance is unknown. Methods: We examined final pathology reports for all lung cancer resections in the Memphis Metropolitan Area from January 2004 to December 2007. End-points were the percentage of reports with each CAP item and the 6 most vital determinants of post-operative management and accuracy of TNM staging. Chi-square test was used for year to year comparisons. Results: Table 1 shows frequency of reportage of CAP items. Of those with reported pT stage, it was accurate in 242 of 263 (92.02%) identified as T1; 193 of 208 (92.79%) T2; 21 of 24 (87.5%) T3; 11 of 11 (100%) T4. The most common T-staging error, understaging of satellite nodules (T4), occurred in 12 of 21 (57%) mis-staged as T1, 11 of 15 (73%) T2, 3 of 3 (100%) T3. Overall, 62.6% of reports accurately identified pT-stage. Of those with reported pN-stage, 351 of 352 (99.7%) accurately identified N0; 69 of 81 (85.2%) accurately identified N1, 12 of 81 (14.81%) N1 designations were actually N2; 27 of 27 (100%) N2 designations were accurate; 31 of 34 (91.2%) identified as Nx (no lymph nodes in the specimen) were accurate, 3 (8.8%) were truly N0. Overall, 64.08% of reports accurately identified pN-stage. 4 of 503 identified as pMx (0.8%) had pM1. There was no change in proportion of incomplete and/or inaccurate pathology reports over the 4 years of analysis. Conclusions: Pathology evaluation of lung cancer resection specimens is frequently incomplete or inaccurate, potentially impairing clinical decision-making. Satellite nodules are often understaged. Simple corrective interventions such as enforcement of mandatory institutional utilization of the CAP checklist and AJCC staging manual need to be investigated.

[Table: see text]

[Table: see text]
Patient and health system disparities in timeliness of treatment for individuals with colorectal cancer (CRC)
Authors: Halpern M. T. , Holden D. J.
Published: August 2020

6540

Background: Timely initiation of treatment following cancer diagnosis can improve morbidity, quality of life, and survival. We used SEER-Medicare data for individuals diagnosed with CRC to explore disparities in the timeliness of initial cancer therapy. Methods: Medicare patients diagnosed with CRC in 2000–2001 while living in SEER regions were identified. Only patients who received cancer treatment (surgery, radiation therapy, or chemotherapy), were diagnosed at age 66 or later, and were enrolled in Medicare at least one year post-diagnosis were included. Multivariate logistic regression analysis was used to evaluate the impact of patient sociodemographic, clinical, community, and health system factors on receipt of timely care, defined as treatment initiation within the 95th percentile of waiting time for all CRC patient (two months). Results: Black and Hispanic CRC patients were significantly more likely to experience delays in treatment than were White patients. Males and patients from areas with more non-English speakers were also more likely to experience delays. Among earlier stage patients who received surgery, those treated at physician offices (10.2%) were significantly more likely to experience delays than were those treated at hospitals (as inpatients or outpatients). Among patients with distant stage disease, those initially treated as hospital inpatients were significantly less likely to experience delays than were those treated as hospital outpatients or in physician offices. For these patients, initial treatment with chemotherapy or radiation therapy was associated with significantly greater likelihood of delays compared to patients initially receiving surgery. Conclusions: Controlling for other factors, significant disparities in timeliness of care were observed for racial/ethnic minority patients, males, and those from non-English speaking areas. Treatment site and modality also affected timeliness of care. While more research is needed, programs should target these at-risk populations for education and follow-up after diagnosis.

No significant financial relationships to disclose.
Risk factors for severe cancer chemotherapy toxicity in the outpatient setting: Results of a nested case control study using a novel patient cohort
Authors: Jacobson J. O. , Brozovic S. , Stahl J. E. , Papi M. , Stankiewicz R.
Published: August 2020

6545

Background: Risk factors for severe cancer chemotherapy-related toxicity (resulting in hospitalization and/or death) in the adult outpatient setting are largely unknown. Between 2003–2006, we identified all chemotherapy patients from a single hospital-affiliated outpatient cancer center who required admission to the hospital, and using a structured process that included monthly peer review meetings, we determined which admissions were due to chemotherapy toxicity. Among 2,082 patients who received chemotherapy, 185 required at least one admission. In this study we describe the development of a prediction model for severe chemotherapy-related toxicity. Methods: We undertook a nested case control study by randomly selecting 98 patients admitted to the hospital within 30 days of their last chemotherapy administration and 173 controls. We selected 33 clinical and demographic variables that we hypothesized might predict severe toxicity, and used standard descriptive, univariate and regression methods to characterize the data and develop a prediction model. Results: We were able to identify the following variables that predicted for severe chemotherapy toxicity: increasing age; increasing Charlson Comorbidity index (CCI); treatment with a prior chemotherapy regimen; prior admission for chemotherapy toxicity; decreasing hemoglobin and absolute neutrophil count (ANC) and increasing creatinine, and albumin. Independent variables that did not predict for increased risk for severe toxicity included the following: performance status; chemotherapy intent (curative, adjuvant or palliative); full dose versus reduced dose for cycle I; cisplatin-based chemotherapy; median income (by postal codes). Using logistic regression we created a parsimonious model (ROC AUC of 0.69) that included four clinical independent variables: CCI; prior chemotherapy regimen; ANC; and albumin. Conclusions: This analysis may permit the development of a predictive model which will include CCI, prior chemotherapy regimen, ANC, and albumin to help identify patients prior to the initiation of chemotherapy who are risk for severe toxicity.

No significant financial relationships to disclose.
Clinical trial metrics: Protocol performance and resource utilization from 14 cancer centers
Authors: Durivage H. J. , Bridges K. D.
Published: August 2020

6557

Background: Observations at the authors’ institutions and by Dilts et al (JCO 2008, abstr 6534) indicate a high percentage of industry (IND)- and cooperative group (CG)-sponsored therapeutic clinical trials (TCTs) with minimal enrollment. We observed most of the enrollment from a small proportion of the TCTs. To determine if this data was representative of other cancer centers (CCs) we examined accrual to IND- and CG-sponsored adult TCTs from 14 CCs. Methods: Accrual data to IND- and CG-sponsored TCTs was obtained from 14 U.S. CCs. Data for the 3-year period from 2005 through 2007 was analyzed. Pediatric TCTs were excluded. Results: Of 2,685 TCTs, 1455 (54.2%) did not accrue any patients (pts). Only 713 (26.6%) TCTs enrolled > 2 pts and these TCTs provided 88.8% of the total enrollment. Resource utilization: We estimate > 230,000 hours (median: 3,773 hours per CC per year) were devoted to study start up and regulatory maintenance for the 1,455 TCTs that did not accrue any pts (Guidance Document for Implementing Effective Cancer Clinical Trials, www.c-changetogether.org/pubs/default.asp). Conclusions: Approximately 90% of the accrual to IND and CG TCTs is from 26% of these TCTs. Significant resources are used on TCTs that do not contribute significantly to overall accrual. Effective rules governing selection of IND and CG TCTs for activation are needed. Effective rules will enable centers to re-direct valuable resources to useful activities without adverse effect on overall enrollment.

[Table: see text]

No significant financial relationships to disclose.
Impact of patient navigation on breast cancer outcomes
Authors: Haideri N. A. , Moormeier J.
Published: August 2020

6572

Background: Disparities between U.S. population groups in cancer incidence, treatment and outcome have been well documented. There is little information available about effective means of eliminating these differences utilizing patient navigator programs. Through the evaluation of the processes and outcomes of breast cancer care at a safety net hospital, this study attempts to better define, the impact of a patient navigation program. Methods: This was a retrospective case series analysis. Navigator program was established in January 2000. Eligible women with a diagnosis of breast cancer between January 1, 1997 and December 31, 1999, were included in the standard management (SM) group. Women with breast cancer diagnosed between January 1, 2000 and December 31, 2003, were included in the Patient Navigator (PN) group. The time interval from symptom presentation or abnormal mammogram to first access to treatment which includes surgery, chemotherapy or radiation was obtained. Statistical data was analyzed using SPSS software. Results: Three hundred and thirty five women were diagnosed between January 1, 1997 and December 31, 2003. Thirteen patients were ineligible leaving a final study population of 322 women; 103 women in the SM group, and 219 women in the PN group. The time interval from initial presentation to the date of definitive therapy was shorter during the period of time when PN was available with a median time to first treatment was 9 days shorter (42 days in SM group compared to 33 days in PN group). The stage of cancer at the time of presentation and treatment was not different between the two groups. One potential impact of PN program was dramatic increase in proportion of insured patients. Overall survival was not influenced by the PN program. Conclusions: The PN program at this safety net hospital did not influence the stage of presentation or the overall survival of women with breast cancer. There was a modest decrease in the time between initial presentation and definitive therapy. The utility of navigator programs is likely to vary with each institution and the program should be modified to respond to the unique needs of the patients being served.

No significant financial relationships to disclose.
Is survival improving in stage IV non-small cell lung cancer?
Authors: Birnbaum A. E. , Ng T. , O'Connor B. , Plette A. , Berz D.
Published: August 2020

6577

Background: Non small cell lung cancer (NSCLC) represents the number one cause of cancer mortality in the United States. Over several decades clinical research has focused on the development of new, more active chemotherapeutic drugs to improve survival. Over the time period from 1994 to 2003 six drugs have been approved for the treatment of metastatic NSCLC. We are presenting a population based analysis of the survival in patients with metastatic NSCLC in the US from 1981–1990, 1991–1997 and 1998–2003. We also provide a pharmaco-economic view of this observation. Methods: We analyzed the SEER (Surveillance, Epidemiology, and End Results) program database for cancer specific survival rates in stage IV NSCLC patients who were diagnosed between 1980 and 2003 in the SEER catchment geographic areas. The primary exposure of interest was the year of diagnosis. Results: We identified 52,086 eligible patients in total. 8,950, 21,111 and 18,712 patients were diagnosed 1981 to1990, 1991 to 1997 and 1998 to 2003 respectively. The cox proportional hazard ratios were 0.97 (95% CI 0.94–0.99) and 0.85 (0.83–0.88) for the time periods 1991 to 1997 and 1998 to 2003, respectively, using the time period from 1981 to1990 as reference. This subtle increase in survival was strictly paralleled by increasing costs for the medical care of this patient population. Conclusions: The survival of stage IV NSCLC patients seems to be mildly improving, what is paralleled by increasing cost for the care of those patients.

[Table: see text]

No significant financial relationships to disclose.
Prospective evaluation of patient perceptions and willingness to undergo pharmacodynamic and pharmacokinetic tests in early phase oncology trials
Authors: Smith J. , Benjamin M. , Yim J. H. , James R. L. , Ramanathan R. K. , Anthony S. P. , Borad M. , Bay R. C. , Piper B. F. , Tibes R.
Published: August 2020

6587

Background: Increasing numbers of clinical trials include optional or mandatory pharmaco-dynamic and -kinetic assays. Since little is known about patients’ (pts) perceived willingness to undergo specific tests and the number of tests pts would tolerate on a single trial, this study was conducted. Secondary purposes included correlating test number and type with demographics, prior test experience, coverage, and inconvenience. Methods: Exploratory correlative study using a multi-item self-report questionnaire to measure pts willingness (0–10 scale, 0 = not willing, 10 = very willing) to undergo imaging (e.g., MRI, ECHO), invasive (e.g., tumor, skin biopsies [bx]) and less invasive tests (e.g., blood, urine). 61 pts (22 female, 39 male) with advanced malignancies participating in phase I or II trials at one institution were enrolled from June 2008-December 2008. Descriptive and non-parametric statistics were used. Results: Statistically significant (p < 0.01) inverse relationships were found between the number of imaging studies (e.g., CT, ECHO), tests required (e.g., tumor, skin bx, blood draws) and pts reported willingness to undergo these tests. Pts were least willing to undergo tumor bx (median 5.5, interquartile range [IQR] 3.5–10), skin bx (6.8, 3.1–10), and unexpectedly MRIs (8, 4–10) (all p < 0.01). Surprisingly, inconvenience and prior negative experiences for the more invasive tests (e.g., skin bx) did not negatively affect willingness to undergo these tests in the future as opposed to most imaging studies. College-educated were more willing to undergo tests than non-college educated. Few pts were unwilling to undergo tests/procedures at all, if mandatory for enrollment. Conclusions: Results provide improved understanding of pts willingness to undergo trial requirements and suggest that adequate explanation (e.g., MRI) and test rationale may affect willingness to undergo tests. Findings can be used to improve study design and consent procedures to minimize patient discomfort and inconvenience. The overall willingness of advanced stage cancer pts to undergo study specific tests/procedures is high.

No significant financial relationships to disclose.
Medical error prevention: The role of oncological nursing
Authors: Kohen N. , Morgenfeld E. , Ernesto G. , Negro A. , Muiño M. , Juarez D. , Aguirre S. , Santillan D. , Rivarola E. , Gercovich F. G.
Published: August 2020

6591

Background: The medical care of oncological patients is a multidisciplinary task. The nurse is a key member of the team. The aim of this study is to analyze the incidence rate and the type of intravenous chemotherapy prescription errors detected by the nurses in the the ambulatory setting at the IOHM in a 3 months period. Methods: The intravenous chemotherapy treatments (tx) prescribed by the IOHM's staff (14 oncologists and 4 onco-hematologists) between Aug 1, 2008 and Nov 1, 2008, were analyzed. A database was prospectively built with the following variables: attending physician, diagnosis, treatment cycle, drug, dosage, time of perfusion, type of error detected, and potential harm from it. Frequency tables were established for the type of error. The correlation between the rate of errors by prescribing physician and his expertise, weekly hours of work at the institution, number of patients under his care and number of consults were also studied. Results: A total of 5,015 tx administered to 2,492 pt were evaluated (mean of 2.1 tx per pt, range 1–5). The most common cancer diagnoses were breast (20%), colon (16%), lung (10%), and lymphoma (7%). Forty-five medical prescription errors before administration of treatment were found. There were no errors found in the preparation and administration of treatment. Of the 45 errors detected, 18 were related to drug selection (in 2 cases the error could lead to serious complications). Twenty seven errors were related to a dosage mistake (3 cases with serious potential harm). The frequency of medical errors between the attending physicians did not differ statistically (Fisher Exact Test 0.082) and due to the low error rate, none of the other variables could be properly studied. Conclusions: 1. Specialized nursing is a key element in the safety of the patient and the prevention of malpractice, 2. The rate of errors in this population is 0.9% (45 errors out of 5,015) and the rate of potentially serious harm to the patient is 1/1000 tx.; 3) All errors were corrected before drug administration.

No significant financial relationships to disclose.
Factors associated with willingness to participate in an acupuncture clinical trial for arthralgia among breast cancer patients
Authors: Desai K. , DeMichele A. , Bruner D. , Vapiwala N. , Hughes Halbert C. , Stricker C. , Mao J. J.
Published: August 2020

6596

Background: Many breast cancer patients use complementary and alternative medicine (CAM), which warrant rigorous evaluation of the safety and efficacy of these therapies. As with conventional cancer treatment studies, researchers face challenges in accruing patients to CAM trials. This study aims to identify the factors associated with willingness to participate (WTP) in a trial evaluating use of acupuncture for arthralgia among breast cancer patients. Methods: We conducted a cross-sectional survey study among outpatient postmenopausal breast cancer patients who were receiving aromatase inhibitors. Self-reported WTP in an acupuncture trial was used as the main outcome variable. Expectation towards acupuncture efficacy was measured using a previously validated Acupuncture Expectancy Scale. Multivariate logistic regression was used to identify factors associated with WTP. Results: 300 patients participated (92% response rate), with a mean age of 61 ± 10 years, 252 (84%) White, and 38 (13%) Black. Of the participants, 148 (49.8%) reported WTP in an acupuncture trial should they be offered an opportunity for such research. In a multivariate model, higher likelihood of WTP was associated with having a college education, adjusted odds ratio (95% confidence interval), 3.78 (1.83–7.81); having previous radiation therapy 2.02 (1.13–3.62); and current experience of arthralgia 2.36 (1.11–4.98). Positive expectancy of acupuncture outcome was also associated with greater likelihood of WTP 1.20 (1.12–1.28). Age and race were not predictors of WTP in the multivariate model. Conclusions: Almost half of the outpatient breast cancer patients expressed WTP in an acupuncture clinical trial for arthralgia. Higher education, previous radiation therapy, current experience of arthralgia, and positive expectancy related to acupuncture may affect breast cancer patients’ willingness to participate in an acupuncture trial for arthralgia.

No significant financial relationships to disclose.
Voluntary submission of biological specimens from cancer clinical trials: An update of the Eastern Cooperative Oncology Group experience
Authors: Jenab-Wolcott J. , Catalano P. J. , Fillingham B. , Ferriere M. , O'Dwyer P. J. , Giantonio B. J.
Published: August 2020

6597

Background: Recent advances in cancer therapy underscore the need to acquire biological specimens from participants in well-conducted clinical trials. The Eastern Cooperative Oncology Group (ECOG) has previously reported a high rate of assent to the banking of biological specimens from participants in ECOG led trials. Methods: Since November 2000, ECOG trials include the Intergroup Specimen Banking Committee (ISBC) consent form governing biological specimen use. Data collected at patient registration regarding assent to specimen submission for correlative projects and/or banking are maintained in a data-base at the ECOG Coordinating Center. These data include participant responses to all questions contained in the consent from, and can be associated with study specific information and demographic data. Results: From November 2000 to August 2008, 30,695 participants were accrued from both academic centers and community based practices to ECOG led trials that included a voluntary request for biological specimens for correlative research, banking, or both. Overall, of the 30,496 participants presented with a request for specimen banking, 88.0% agreed to do so. Variance in assent rates for banking was noted by disease type. Permission to bank specimens was provided by 93.8% of leukemia patients (pts), 93.5% of breast cancer pts, and 91% of gastrointestinal cancer pts, whereas 75.7% of thoracic cancer pts, 75.0% multiple myeloma pts, and 63% of pts on prevention trials agreed. Data from 12,605 participants presented with a protocol-specified correlative project consent form are currently being analyzed. Interactions based on disease type, age, gender, type of institution and phase of study will be evaluated for biological specimen acquisition for banking and correlative use. Conclusions: Overall, a high rate of assent is demonstrated for biological specimen acquisition for banking purposes from participants in ECOG led clinical trials. Differences in assent rates for banking are suggested based on disease types. Further study to better define associations for suboptimal participation and reasons for refusal are planned.

No significant financial relationships to disclose.
Oncology nurses’ views of oncologists’ prognosis-related communication (PRC)
Authors: Helft P. R. , Terry C. , Chamness A. R. , Uhrich M. M.
Published: August 2020

6602

Background: PRC is critical to care, treatment, and decision-making for advanced cancer patients (ACP). Deficits in oncologists’ (MDs) PRC have previously been identified. The role oncology nurses (RNs) play in PRC and their views and experiences of PRC among MDs with whom they work is unknown. Methods: Mail survey of a random sample of Oncology Nursing Society members with at least one year of experience working with cancer patients (pts). Questionnaire was sent to 1338 members of ONS. 394 completed surveys were returned. Overall RR was 29.4%. Significance, if noted, implies p<0.001. Results: Respondent demographics: median age 49.2, 96.6% female, 88.5% Caucasian, median years (yrs) as an RN 18, median yrs working with cancer patients 12, 69.1% had a BSN or ASN, 34.1% inpt RNs, 38.6% outpt RNs. 46% of RNs always/often cared for ACPs who did not appear to understand their prognosis, and 58.6% of RNs always/often encountered questions that suggested pts wanted more prognosis related information (PRI). 26.1% disagreed that the MDs they worked with were skilled at PRC. 72% agreed that MD discomfort with giving bad news is a major barrier to helping pts understand their prognosis. 54.9% of RNs always/often/sometimes felt pressured not to provide pts PRI because they did not want to contradict what MDs had said. 25.1% of RNs felt that MDs rarely or never kept them informed about their PRC with pts (frequency positively associated with yrs as an RN, yrs working with cancer pts, education level). RNs with at least an MSN were more likely to report that MDs more frequently kept them informed about their PRC. 30.2% of RNs felt that MDs rarely or never addressed end of life issues early in the course of their illness. 32.8% of RNs agreed that, when pts did not appear to understand their prognosis, it was because MDs had not discussed it fully (positively associated with working in an inpt setting). 42.6% of RNs were rarely or never present when PRI was discussed (negatively associated with working in an outpt setting and amount of formal education regarding PRC). Conclusions: Oncology RNs identify several deficits in MDs’ PRC with ACPs, including provision of information early in the course of illness, gaps in sharing content of PRC with RNs, and communicative aspects of team-based pt care.

No significant financial relationships to disclose.
Employment status among low-income Caucasian and Latina breast cancer survivors
Authors: Blinder V. S. , Patil S. , Diamant A. , Thind A. , Maly R.
Published: August 2020

6612

Background: Return to work (RTW) after breast cancer is associated with treatment recovery and quality of life. Prior research has found an 80% RTW rate in primarily Caucasian breast cancer survivors; however, little is known about the trajectory of RTW among Latinas. Qualitative research suggests that RTW is a major concern for Latinas. This study compares the rate of RTW between Latinas and Caucasians and investigates the role of job type in RTW. Methods: This is a prospective, longitudinal study of low-income, underserved breast cancer survivors who spoke English or Spanish, did not have metastatic disease, and were enrolled in the Medi-Cal Breast and Cervical Cancer Treatment Program. We interviewed survivors at 6 mos., 18 mos., and 3 yrs. after diagnosis to assess changes in employment status. The impact of independent variables including ethnicity, employment at diagnosis, job type, age, health status, and education was assessed using chi-square tests. Results: 666 survivors completed surveys at both 6 mos. and 3 yrs; 65% were Latina. The median age was 49 and 54 yrs. for Latinas and Caucasians, respectively (p < 0.001). 45% of Latinas had less than a high-school education compared to 3% of Caucasians (p < 0.001). The majority of Latinas worked in 3 job types: personal care-provider (23%), housekeeper (22%), and manufacturing (13%). Caucasians had greater job diversity, including clerical (15%), personal care-provider (13%), food preparer/server (12%), and sales (10%). At diagnosis, 51% of Latinas and 59% of Caucasians were employed (p = 0.07), and among these, Latinas were less likely to be working at 6 and 18 mos. than Caucasians (27% vs. 47% at 6 mos., p = 0.002 and 45% vs. 59% at 18 mos., p = 0.026). This difference dissipated by yr. 3 (53% of Latinas vs. 58% of Caucasians, p = 0.41). Job type at diagnosis was associated with RTW. Conclusions: Employed low-income Latinas and Caucasians appear to follow different RTW trajectories after breast cancer, with fewer Latinas working at 6 and 18 mos. Differences exist in job type between these populations; Caucasians have greater variation in job type and a trend toward greater likelihood of changing job type after breast cancer. This may reflect limitations in career choice among low-income Latinas and may be related to their protracted RTW trajectory.

No significant financial relationships to disclose.
Challenges for retrospective cohort studies: A profile of patients who refuse participation or are lost to follow-up
Authors: Patel R. , Kurian S. , Sun C. , Francisco L. , Wong L. , Sharp J. , Armenian S. , Forman S. , Bhatia S.
Published: August 2020

6615

Background: As hematopoietic cell transplantation (HCT) has increasingly become a curative option for many diseases, studying long-term complications has assumed critical importance. A major issue in conducting scientifically rigorous long-term follow up studies with large cohorts is the ability to track patients, and obtain informed consents. High participation rates are critical to avoid selection bias and ensure generalizability. Methods: A mass consenting process was implemented to obtain informed consents from 1056 City of Hope HCT patients transplanted during 1976–2006 who were one+ year survivors and alive in June 2007. This process involved mailing consent forms followed by phone calls. Patients were classified as consented, refused, or lost-to-follow-up (LTFU). Sociodemographic and clinical characteristics indicative of higher risks for refusal or LTFU were identified. Results: Study patients comprised 58% males, and 53% Caucasians. Median age at HCT was 34 years (0.6–73); median age at study initiation was 47 years (6–81); and median time from HCT to study initiation was 10 years (1–30). Primary diagnoses included acute/chronic leukemia (43%), Hodgkin/non-Hodgkin lymphoma (36%), multiple myeloma (9%), and other miscellaneous diagnoses (12%). Fifty percent received allogeneic HCT. At the end of the process, 46% consented, 17% refused, and 37% were LTFU. Compared to consented patients, males, Asians, and younger patients were more likely to refuse consent. Patients LTFU were more likely to have lower SES, a longer time since HCT, in addition to being males, Asians and younger at HCT (Table). Conclusions: This study demonstrates the critical need for maintaining up-to-date contact information on patients after HCT in order to obtain valid long-term follow-up data. It also describes the characteristics of the sub-population that are more likely to refuse or be LTFU, information necessary for planning targeted interventions in long-term follow-up initiatives.

[Table: see text]

No significant financial relationships to disclose.
Real-time quality assessment of cancer care through information technology instruments incorporated into routine clinical practice
Authors: Galligioni E. , Forti S. , Berloffa F. , Caffo O. , Ferro A. , Eccher C. , Caldara A. , Murgia V. , Soini B.
Published: August 2020

6620

Background: Information technology may provide complete and timely data, to monitor process-based and outcomes measurements, which are crucial for health care improvement. Since June 2000, we have developed an Electronic Oncological Patient Record (EOPR), which is routinely used in our Department, providing a powerful link between computer-based technology and clinical practice (Ann. Oncol. 2008). Recently EOPR was implemented with a Clinical Instrument Panel (OncoQual) which enables oncologists to explore clinical data and perform real-time process and outcome measurements, by applying a flexible module to formulate complex population queries. Methods: To evaluate the performance of OncoQual in our pts, we chose as quality indicator, the adherence to ASCO recommendations on adjuvant endocrine therapy (ET), in hormone receptor positive (HR+) breast cancer (BC) pts. In particular, we assessed pts treated from 2000 to 2004 for Tamoxifen (TAM) and pts treated from 2006 to 2007 for Aromatase Inhibitors (AIs). Furthermore TAM results were compared with the adjuvant treatments modalities of 77 italian centres, reported from a cooperative group (NORA) for the same period. Results: The results are shown in the table. Patients characteristics and Tam use in our series, were similar to those of the NORA group, while TAM use decreased and AIs increased in the 2006–07 series, as expected. It took few hours to collect and analyzed our series, which can be easily updated and adapted to different requirements. Conclusions: Our experience shows the feasibility of incorporating real-time process-based measurements into daily practice, to provide self assessment for continuous quality of care monitoring and improving.

[Table: see text]

No significant financial relationships to disclose.
Do ACE-I protect against the development of doxorubicin cardiac toxicity?
Authors: Blaes A. , Peterson B. A. , Yee D. , Virnig B.
Published: August 2020

6623

Background: Doxorubicin (DOX), an anthracycline, has been associated with irreversible cardiotoxicity. Recently, newer agents such as angiotensin converting enzyme (ACE-I) inhibitors have been used in small trials to prevent cardiac toxicity in patients receiving DOX. This retrospective study analyzes whether ACE-I and other medications are protective in the development of DOX cardiomyopathy. Methods: Patients receiving DOX chemotherapy at the University of Minnesota Cancer Center who had two or more multigated blood pool imaging (MUGA) scan or echocardiograms performed were identified and reviewed. Patients who had at least a 10% drop in their ejection fraction (EF) to below the lower limits of normal (50%) or had an absolute decrease in EF of 15% or greater were identified and compared with those that did not have a decline in EF. Patient variables and the use of concurrent medications were compared between these two groups using logistic regression. Results: 350 patients received DOX chemotherapy between November 2004 and 2007. Of 142 patients who had two or more MUGA scans performed during the course of their therapy, 22 (15%) had a significant drop in EF. Median age was 52 years old (range 7–88). 85 (60%) were female. Cancer diagnosis was breast (n = 26), lymphoma (n = 92), and other (n = 25). The median baseline EF of all patients was similar (62% versus 63%). A stepwise variable selection retained two predictors significant at alpha = 0.1 in a logistic regression model: Age and ACE-I (p = 0.0252 and p = 0.0940, respectively). Adjusting for Age, the odds ratio for ACE-I is 0.267, suggesting that ACE-I has a protective effect, as it reduces the probability of a drop in EF. Cumulative DOX dose, obesity, hypertension, and history of tobacco use did not appear to be associated with a decline in ejection fraction. The use of beta-blockers, aspirin or statins did not appear to be associated with a decline in ejection fraction. Conclusions: DOX chemotherapy has been associated with the development of cardiomyopathies. While this is an observational study that is limited by its retrospective nature, the study supports our hypothesis that the use of ACE-I is possibly protective when given with DOX chemotherapy and warrants further investigation.

No significant financial relationships to disclose.
Evaluating risk of hospitalization with G-CSF use in real-world oncology practice
Authors: Tan H. , Tomic K. , Daniel G. , Hurley D. , Barron R.
Published: August 2020

6626

Background: Limited published data exist on how granulocyte colony-stimulating factor (G-CSF) treatment patterns affect risk of neutropenia-related hospitalizations. This study examines prophylactic vs. delayed use of G-CSF and compares the effectiveness of prophylaxis with filgrastim (FIL) vs. pegfilgrastim (PEG). Methods: A retrospective analysis of administrative claims from U.S. commercial health plans identified adult patients with non-Hodgkin's lymphoma, breast, or lung cancer, treated with chemotherapy between July 2004 and January 2008. For these patients, the first course of chemotherapy and each unique cycle with use of G-CSF (FIL or PEG) was identified and designated ‘prophylaxis’ if used within the first 5 days of each cycle, or ‘delayed', if after day 5. The risk of neutropenia-related hospitalization was then evaluated on a cycle basis. A generalized estimating equation (GEE) was used to adjust for baseline demographics and clinical characteristics. Results: Among 5,571 patient-cycles identified: 87.4% were prophylactic and 12.6% were delayed G-CSF. PEG use was primarily prophylactic (93.6%) in contrast to use of FIL which was delayed in 62.5% of patient-cycles. The rate of neutropenic hospitalization was 1.2% for prophylaxis (n=59) and 3.7% for delayed G-CSF (n=26) (P < 0.001). Among prophylactic patient-cycles, the neutropenic hospitalization rate was lower with PEG than FIL (1.1% (n=51) vs. 3.5% (n=8), p = 0.001). Multivariate analyses using GEE model showed consistent trends (Table). Conclusions: Prophylactic G-CSF use was associated with lower neutropenic hospitalization risk than delayed use. Among prophylactic use in real-world oncology practice, PEG was associated with about a two-thirds lower risk of neutropenic hospitalization compared with FIL.

[Table: see text]

[Table: see text]
MicroRNA 181a (miR-181a) expression as a prognosticator in cytogenetically normal acute myeloid leukemia (CN AML)
Authors: Schwind S. , Marcucci G. , Maharry K. , Radmacher M. D. , Whitman S. P. , Paschka P. , Mrózek K. , Kolitz J. E. , Larson R. A. , Bloomfield C. D.
Published: August 2020

7001

Background: We showed recently that CEBPA mutations (mut) in CN AML are associated with better outcome and a unique microRNA expression profile, including miR-181a upregulation. Here we tested if miR-181a expression can predict outcome independently. Methods: We analyzed 187 de novo CN AML adult patients (pts) aged <60 years (y; median 45) similarly treated on CALGB 9621 and 19808. Of these, 122 had molecular high risk [FLT3-ITD or NPM1 wild type (wt)] and 65 low risk (no FLT3-ITD, NPM1 mut) CN AML. FLT3, NPM1, CEBPA, MLL, and WT1 mutations, and ERG and BAALC expression were analyzed centrally. miR-181a expression was measured in pretherapy marrow using OSUCCC v3.0 arrays. The mean of 2 miR-181a probe log intensities was used as a continuous variable for analyses. Results: Higher miR-181a levels (miR-181a↑) were associated with CEBPA mut, NPM1 wt, no FLT3-TKD, lower ERG expression, higher %FAB M1/M2, lower WBC and age, higher blood blasts, and lower % gum hypertrophy. miR-181a↑ tended to associate with more complete remissions (CRs; p = .07) and significantly associated with longer disease-free (DFS; p = .05) and overall (OS; p = .01) survival (median follow-up 6.5 y for pts alive). A stronger prognostic impact of miR-181a was observed in the molecular high risk group, where miR-181a↑ predicted more CRs (p = .03), and longer DFS (p = .0002) and OS (p = .0001). In multivariable analyses of the molecular high risk group, miR-181a↑independently predicted CR, and longer DFS and OS (Table). For descriptive purposes, we dichotomized pts at the median miR-181a expression value. For high v low miR-181a expressers, CR rates were 84% vs 72% and 5 y DFS and OS rates 43% vs 18% and 48% vs 19%, respectively. Conclusions: miR-181a expression is a prognostic marker in CN AML, mainly in the molecular high risk group, where it predicts outcome independently of other variables including CEBPA mutations. As miR-181a↑ confer better treatment response, novel approaches increasing miR-181a levels might benefit not only CN but also other AML pts.

[Table: see text]

No significant financial relationships to disclose.
Dasatinib dose-optimization study in chronic phase chronic myeloid leukemia (CML-CP): Three-year follow-up with dasatinib 100 mg once daily and landmark analysis of cytogenetic response and progression-free survival (PFS)
Authors: Stone R. M. , Kim D. W. , Kantarjian H. M. , Rousselot P. , Hochhaus A. , Dorlhiac-Llacer P. E. , Milone J. , Matloub Y. , Lambert A. , Shah N. P.
Published: August 2020

7007

Background: The recommended dosing regimen of dasatinib for CML-CP is now 100 mg once daily (QD) (previously 70 mg twice daily [BID]), based upon a phase III dose-optimization study (CA180–034) that enrolled patients (pts) with CML-CP with resistance, intolerance, or suboptimal response to imatinib. While therapeutic milestones have been established for pts with CML-CP treated with imatinib, they have not been well established for pts treated with second-line TKIs. Methods: Pts were randomized using a 2 × 2 factorial design to one of four treatment arms: 100 mg QD (n = 167), 70 mg BID (n = 168), 140 mg QD (n = 167), or 50 mg BID (n = 168). Details of study design and endpoints have been described previously. Results: After a minimum of 24 months of follow-up, the 24-month PFS rate with 100 mg QD was 80% (vs. 75%-76% in other arms) and the overall survival rate was 91% (vs. 88%-94%). In all arms, high response rates were achieved in pts with or without a baseline BCR-ABL mutation. Dasatinib 100 mg QD was well tolerated and rates of key side effects showed only a minimal increment from 12 to 24 months. Among the four treatment arms, significant differences were observed in rates of drug-related pleural effusion (all grades: p = 0.049) and cytopenia (p = 0.003 for grade 3/4 thrombocytopenia), with lowest rates observed for 100 mg QD. Dasatinib 100 mg QD treatment resulted in the lowest rates of treatment interruption, reduction, and discontinuation. In addition to providing 36-month follow-up, the likelihood of achieving long-term endpoints based on cytogenetic status at 6, 12, and/or 18 months will be presented. Conclusions: Dasatinib 100 mg once daily remains the optimal dosing schedule for pts with CML-CP. The landmark analyses to be presented should provide useful information to clinicians treating imatinib-resistant, -suboptimally responding, or -intolerant CML-CP pts with dasatinib 100 mg once daily based on cytogenetic response at key intervals.

[Table: see text]
Efficacy of a novel schedule of decitabine in previously untreated AML, age 60 or older
Authors: Blum W. G. , Klisovic R. , Liu S. , Kefauver C. , Grever M. R. , Schaaf L. , Chan K. , Byrd J. C. , Villalona-Calero M. , Marcucci G.
Published: August 2020

7010

Background: We established an optimal daily dose of decitabine in AML at 20mg/m2/day based on re-expression of epigenetically silenced genes, with promising clinical activity seen in poor risk older patients (pts) (Blum, J Clin Oncol. 2007). Methods: We designed a phase II study of decitabine for untreated AML pts of age≥60 who were not candidates for intensive chemotherapy (or who refused it). PS was ECOG <3. All pts received induction with decitabine at 20mg/m2 IV on days 1–10 of 4 week cycles. Pts with persistent AML at the end of a cycle received a repeat of the 10 day course, but responding pts received maintenance with abbreviated courses of 3–5 days depending on degree and duration of neutropenia. Results: 33 pts had median age of 74 years (range, 60–83). 15 pts had either secondary or t-AML. Median WBC count was 2400/μL (range, 400–58,800/μL) with marrow blasts of 44% (range, 21–92%). 13 pts had complex karyotype (≥3 abnormalities); 13 had normal karyotype; one pt had t(8;21). 31/33 pts had at least 2 poor-risk factors of age ≥70, antecedent hematologic disorder, unfavorable karyotype, or ECOG 2, and 28/33 had HCT-CI scores of ≥2. 42% of pts achieved CR (14/33). 58% achieved either CR or CRi (19/33). CR occurred in all subsets of disease and cytogenetic risk groups. CR durations to date are 2–14+ months. Median time from initial response to relapse for 6 pts who relapsed after CR was 6.5 months. Median OS has not been reached; median f/u of 19 surviving pts is 8 months. The median number of cycles received to date is 5 (range, 1–10). 9 of 14 pts who achieved CR required only a single 10 day course before initial response was achieved (CR, N = 2; CRi, N = 7). For pts who had CRi as initial response, the median number of additional cycles to achievement of full CR was 1 (range, 1–3). Death within 8 weeks of any cause occurred in 15% of pts (due to infection in each case). Though non-hematologic toxicities were infrequent, infection and/or febrile neutropenia were common (in 24/33 pts). Correlative studies are ongoing. Conclusions: Decitabine in this novel schedule of induction with outcome-adapted modification of maintenance therapy was highly active in this poor risk cohort. Survival results warrant comparison with intensive therapy for pts eligible to receive it. (supported by NO1-CM62207, K23 CA120708–01, RO1CA102031)

[Table: see text]