bluuebunny/crossref_metadata_2025 huggingface dataset:
Non-clinical factors associated with intentionally reduced breast cancer chemotherapy doses
Authors: Culakova E. , Griggs J. J. , Sorbero M. E. , Wolff D. A. , Poniewierski M. S. , Lyman G. H.
Published: March 2020

6020

Background: Breast cancer survival and case-fatality rates are lower in women of lower socioeconomic status (SES) compared to those of higher SES. Disparities in the quality of chemotherapy may contribute to poorer outcomes among women of lower SES. The purpose of this study was to investigate the relation between SES (as measured by both individual and area-level characteristics) and the use of intentionally reduced breast cancer adjuvant chemotherapy doses. Methods: The cohort consisted of 764 breast cancer patients treated with a standard adjuvant chemotherapy regimen for stages I, II, or III enrolled in an IRB approved prospective registry. Information was collected on patient, disease, and treatment characteristics, including chemotherapy doses. Zip code level data on median household income (MHI), and proportions of residents with a high school (HS) or college degree were obtained from the US 2000 Census. Doses for cycle 1 of chemotherapy < 85% of standard were considered to be reduced. Multivariate logistic regression analysis was performed to identify factors associated with the use of reduced first cycle doses. Results: In bivariate analysis, body mass index (BMI) (P=.003), education (P=.002), and region (P < .001) were associated with the use of reduced doses. Race was borderline significant (P=.056). Reduced doses were more commonly administered to patients who lived in zip codes with lower MHI (P < .001), lower education (P=.006), and higher levels of poverty (P < .001). Age, stage, comorbidity, hormone receptor status, insurance, occupation, employment and marital status were not associated with use of reduced doses. In multivariate analysis without practice effects, high BMI (P < .001), education less than HS (P=.009), and geographic region (P < .001) were independently associated with reduced doses. The effect of BMI (P < .001) stayed significant after adjustment for practice site, but education (P=.082) and geographic region (P=.127) became less so. Conclusions: Non-clinical factors, such as educational attainment and area level income, are associated with intentionally reduced doses of adjuvant chemotherapy. Interventions directed at improving quality of chemotherapy may improve breast cancer outcomes in patients of lower SES.

No significant financial relationships to disclose.
Adequacy of follow-up after an abnormal fecal occult blood test (FOBT) result
Authors: Richardson L. C. , Berkowitz Z.
Published: March 2020

6035

Background: Annual fecal occult blood testing (FOBT) is the only colon cancer screening shown to reduce colon cancer incidence and mortality in randomized controlled trials. The true benefits of screening are only realized when total colon examination (TCE) is performed as follow-up to an abnormal screening result. Methods: We used the 2000 National Health Interview Survey (NHIS) Cancer Control Supplement, a nationally representative sample of households, to examine follow-up after abnormal FOBT and the content of this follow-up. Persons who reported undergoing an FOBT were the population of interest. Reasons for FOBT, results of test, and follow-up after an abnormal FOBT were examined. Inadequate follow-up after a positive FOBT included no follow-up or another FOBT. TCE was defined as sigmoidoscopy with double contrast barium enema (DCBE) or colonoscopy. We used SUDAAN to obtain population estimates. Results: We included 4,908 respondents who indicated they had undergone FOBT (79.8% as part of the routine physical examination, 14.7% for a specific problem, 2.0% as follow-up of a previous abnormal test/screening examine, 1.4% family history). Overall, 5.7% of respondents reported an abnormal test, varying by reason for test (3.5% for screening and 16.9% for those who had FOBT done for a specific problem). For those reporting an abnormal FOBT during screening, 62.9% had some follow-up diagnostic procedures. Fifty-three percent reported having a TCE as defined above. Forty-seven percent either had no further evaluation, another FOBT or incomplete colon examination with sigmoidoscopy alone, and DCBE only or a surgical evaluation. Those who had FOBT completed for a specific problem had more surgical evaluations (18.4%) and fewer TCEs (44.3%). Conclusions: Among a nationally-representative sample of adults who reported FOBT as a screening test for colorectal cancer, close to 63% had some type of follow-up. Only 53% of those with a positive screening FOBT had a TCE. These results suggest that the full potential of CRC screening is not being realized, and point to the need to improve follow-up of abnormal FOBT results.

No significant financial relationships to disclose.
Time from diagnosis to treatment initiation in advanced non-small cell lung cancer (NSCLC): Time trends and racial differences
Authors: Martins R. , Blough D. , Ramsey S.
Published: March 2020

6037

Background: Historical survival evaluation of clinical trials for advanced NSCLC suggests that median survival improved by 0.4 months over a 22 year period. Survival in clinical trails is evaluated from treatment initiation and not from diagnosis. If treatment is initiated earlier over time, this may create a lead-time effect on survival analysis and thus may explain the apparent discrepancy between trial findings and outcomes in the community. Objective: Investigate if, over time, there has been a shortening of the time between the diagnosis of NSCLC and the initiation of chemotherapy. Methods: We evaluated patients with NSCLC stages IIIB and IV between 01/01/1994 and 12/31/1999. Date of diagnosis was obtained from Surveillance, Epidemiology, and End Results (SEER). Treatment data was obtained from Medicare claims and is restricted to patients above age 65. Differences were compared using analysis of variance (ANOVA). Results: A total of 11,995 patients were identified. Patient’s characteristics: median age 74 years; 57% of patients were males; racial distribution: white (82.4%), black (9.4%), Asian (3.2%), Hispanics (1.2%), others (3.8%); stage distribution: IIIB (38%), IV (62%). Chemotherapy was given to 3,377 (28%) patients. There was an increase in chemotherapy utilization over time: 10% in 1994 to 35% in 1999. Over time there was a shortening from diagnosis to chemotherapy initiation from 1.6 months in 1994 to 1.3 months in 1999 (p = 0.0004). Among those receiving chemotherapy, median survival from diagnosis did not change over this time period. Black patients had a longer time between diagnosis and treatment initiation: 1.7 months vs. 1.4 months (p < 0.01). Conclusions: Over time, there has been a shortening of the time between diagnosis and chemotherapy initiation. This difference, although small, seems to account for much of the apparent historical survival benefit observed. This finding puts additional limitation on the historical comparisons of survival between trials. Racial differences may help explain, in part, observed differences in outcome.

No significant financial relationships to disclose.
Compliance and persistency with imatinib
Authors: Feng W. , Henk H. , Thomas S. , Baladi J. , Hatfield A. , Goldberg G. A. , Cortes J.
Published: March 2020

6038

Background: Imatinib is an oral therapy with efficacy in chronic myelogenous leukemia (CML) and gastrointestinal stromal tumors (GIST). Optimal dosing and adherence to treatment is critical to achieve the best clinical outcomes. This study examined compliance and persistency with imatinib and identified the clinical and patient characteristics related to compliance. Methods: Claims data from a US health plan were used to identify imatinib-treated patients from 6/1/01–3/31/04 who had continuous pharmacy and medical benefits in the 3 months prior and 12 months following initiation of imatinib therapy, and a diagnosis of CML or GIST (ICD-9-CM 205.1, 205.10, or 205.11 for CML; 159.0, 159.8, or 159.9 for GIST). Compliance was defined by medication possession ratio (MPR = total days supply of imatinib in the first year divided by 365). Persistency was defined as failure to refill imatinib within 30 days from the run-out date of the prior prescription. Multivariate analyses were used to identify key factors associated with compliance. Results: Total 878 imatinib-treated patients were identified of whom 413 had at least 15 months’ continuous eligibility. Sixty-nine percent (n = 286) were diagnosed with CML, 8% (n = 34) with GIST, and 23% (n = 93) with neither. Results are presented for CML and GIST patients. The average age was 51 and 58% were males. The average starting daily dose was 424 mg, with 80% (n = 255) initiating on 400 mg daily. The mean MPR was 76%. Overall, 28% patients discontinued imatinib for at least 30 consecutive days during the 1-year follow up period. Multivariate analyses indicated MPR improved with age until age 51 and then deteriorated (p < 0.001) but at a diminishing rate, decreased as the number of medications increased (p < 0.001), and was lower in women (p = 0.005) and patients with more cancer complications (p < 0.001). In addition, women were more likely to discontinue than men (OR = 2.08; p = 0.003). Conclusions: Compliance to imatinib was about 75% with 30% of patients interrupting therapy for at least 30 consecutive days in the first year. It has been found that interruption of imatinib therapy may lead to rapid tumor progression in GIST (PASCO05 Le Cesne #9031). Not having patients take the correct doses on a regular basis may lead to sub therapeutical clinical outcomes.

[Table: see text]
Who are the users of publicly reported cancer treatment wait times (WT)?
Authors: Evans W. K. , Green E. , Whitton A. , Fitch M. , Holowaty E. , Jadad A. , Golden B. , Soman D. , Gutierrez E.
Published: March 2020

6043

Background: Greater participation by patients in health care decision-making and public concerns about WT led Cancer Care Ontario (CCO) to post radiation WT by cancer type and treatment centre on its website http://www.cancercare.on.ca anticipating patients and referring physicians (MDs) would use WT information to access facilities with shorter waits. The availability of more radiation treatment facilities in Southern Ontario provides patients and MDs with more options for location of treatment. Methods: The usefulness of this approach was evaluated by an on-line survey, patient focus groups, physician interviews and usability lab testing. Results: 1,043 on-line surveys were completed by patients/family members (35%), media (24%) and others, including health professionals (HP) and administrators (AD). HP found the information useful and clear but patients were less satisfied, wanting information on the effect of WT on their illness. 45 individuals (40 treated patients, 5 family) participated in 8 geographically dispersed focus groups. Facilitator-led conversations were recorded, transcribed verbatim and content grouped in themes by 4 researchers. Most patients were unaware of the CCO WT information. Patients indicated that MDs should have and use WT information and determine speed of access to care based on urgency of condition. Patients would accept MD advice to travel to a more distant treatment facility but patients questioned why WT existed and why health care system not managed more efficiently. 15 MD phone interviews indicated MDs were distrustful of WT data, did not use the web data for referral, preferring usual practice patterns. MDs were reluctant to share WT information with patients for fear of creating unnecessary anxiety. AD found data useful as a stimulus for performance improvement. Usability lab testing uncovered numerous user preferences for redesign of the site, including its content. Conclusions: Current Ontario patients and MDs are not ‘consumers’ of WT information but AD see value in this information for system improvement. As society increasingly uses the internet as an information resource, future patients and MDs will likely utilize WT information in the decision-making for location of care. Supported by Cancer Care Ontario and grant 03110 from the Change Foundation.

No significant financial relationships to disclose.
Recommended healthcare among elderly cancer survivors
Authors: McBean A. M. , Yu X. , Virnig B. A.
Published: March 2020

6045

Background: Earle and colleagues (2003, 2004) have published conflicting information regarding recommended services among cancer survivors: breast cancer survivors had higher rates than persons without cancer (2003); and colorectal cancer survivors had lower rates (2004). We examined the use of preventive services and recommended diabetes care in 1999–2002 among elderly Medicare beneficiaries who were long-term survivors of 5 different types of cancer: bladder, breast, colorectal, prostate and uterine. Methods: Retrospective cohort analysis using the linked SEER/Medicare database of beneficiaries living in the SEER areas of the NCI who survived 5 years after bladder, breast, colorectal, prostate or uterine cancer diagnosis and a 5% random sample of beneficiaries with no cancer history residing these areas. We compared the rates of influenza vaccination and breast cancer screening, as well as diabetes care services: hemoglobin A1c (HbA1c) testing, eye examination, and lipid testing. Crude and multivariate adjusted rates were calculated and compared. Results: In 1999 through 2002, depending on the cancer type and year, cancer survivors were between 20 and 50% more likely to receive influenza vaccine or mammograms than persons who never had cancer (women with breast cancer excluded). Among those cancer survivors with diabetes, the rates of annual HbA1c testing or eye examination were 1 to 16% greater in all years than among those without cancer, p < 0.05, when adjusted for age-group, gender (if needed), and race. Differences in the serum lipid level determination rates were even smaller or not significant (p ≥ 0.05) between the cancer survivors and controls. Interestingly, depending on the cancer type, the rates of influenza vaccination and mammography were up to 30% higher among cancer survivors with diabetes than in survivors who did not have diabetes. Multivariate models that included other sociodemographic variables, comorbities and other relevant covariates confirmed these findings. Conclusions: Elderly persons who have survived cancer were generally more likely to receive preventive and other recommended services compared with those without cancer. The presence of another chronic disease such as diabetes, may enhance the use of preventive services.

No significant financial relationships to disclose.
Use of experimental therapy outside of clinical trials among U.S. oncologists
Authors: Peppercorn J. , Joffe S. , Burstein H. J. , Winer E.
Published: March 2020

6047

Background: Investigational cancer therapies being tested in clinical trials may be available outside of trials, or “off-protocol” (OPRx). There are no published data on either the frequency of OPRx or the attitudes of physicians towards OPRx. Methods: In spring 2005, we surveyed a random sample of American medical oncologists chosen from the ASCO directory regarding their attitudes and practices surrounding OPRx. We evaluated the correlation between demographic factors, attitudes, use of OPRx, and response to hypothetical cases. All statistical tests were two-sided. Results: 146 of 471 (31%) oncologists responded. 93% reported ever discussing OPRx and 81% ever prescribing OPRx. 66% reported prescribing OPRx ≥ once/year and 12% ≥ once/month. 68% reported denying requests for OPRx ≥ once/year and 6% ≥ once/month. Academic oncologists were simultaneously more likely than community oncologists to have ever provided OPRx (89% v. 75%, p = 0.06 by Fisher’s exact test), to discuss OPRx ≥ 1 month (45% v. 12%, p = .003), and to deny requests for OPRx ≥ 1 month (15% v. 2%, p = 0.02). While 61% of oncologists believe that patients should be discouraged from OPRx, only 31% felt it should not be available. 53% felt that patients considering trial enrollment should be informed if OPRx is available, whereas 34% disagreed. 26% felt that patients considering enrollment have a right to OPRx, whereas 56% disagreed. Neither practice setting nor other demographic factors predicted attitudes towards OPRx. For hypothetical cases, there was little consensus regarding when to prescribe OPRx. For example, prior to the release of data from recent trials, 41% reported that they would prescribe adjuvant trastuzumab OPRx at a patient’s request. Factors correlating with willingness to provide OPRx included non-academic practice setting (p = 0.04), > 15 years in practice (p = 0.08), belief that non-trial care and trial care are equivalent (p = 0.01) and belief that patients have a right to OPRx (p = 0.004). Conclusion: American oncologists commonly discuss and provide OPRx. Attitudes towards and utilization of OPRx vary substantially in the oncology community. Further discussion of OPRx and guideline development appear warranted.

No significant financial relationships to disclose.
Impact of patient and physician factors on oncologists’ recommendations for adjuvant chemotherapy in stage III colon cancer
Authors: Krzyzanowska M. K. , Regan M. M. , Powell M. , Earle C. C. , Weeks J. C.
Published: March 2020

6051

Background: Population-based studies indicate that elderly patients with colon cancer are less likely to receive adjuvant therapy (tx). Lack of tx may reflect patient preference, appropriate consideration of comorbid illness, or physician bias. Methods: To study physician preference for tx of elderly patients with colon cancer, a vignette-based survey was developed then mailed to a nationally representative sample of 1,000 oncologists. Patient age (61/72/83 yrs), comorbidity level (none/mild/severe CHF with symptoms on minimal exertion) and preference were varied across 8 vignettes. Physician preference for recommending tx was measured using a 7-pt Likert scale; mixed effects linear regression was used to evaluate the results. Results: 485 oncologists returned the survey (RR = 49%); 363 that had seen patients with colon cancer during the previous year were included in further analyses. Median age of the respondents was 52 (range 30–77), 73 (20%) were women. Median time since graduation from medical school was 25 yrs (range 5–53); 17% were employed in academic centers, 8% in HMOs and the remainder in the community. Patient age and comorbid illness interacted to significantly influence physician recommendations. Among patients with mild comorbidity, physician preference for tx of an 83 yr old patient was 1.1 lower than for a 72 yr old (3.8 vs 4.9 on a 7-pt Likert scale) and 1.7 lower than for a 61 yr old (each p<0.0001). This age effect was similar among patients with no comorbidity (p=0.30), with physicians’ preferences consistently higher by about 1.5 than for patients with mild comorbidity (p<0.0001). Among patients with severe comorbidity, preference for tx of an 83 yr old was only 0.9 lower than for a 61 yr old patient (p<0.0001), whereas the decrease was 2.6 for a 61 yr old with severe vs mild comorbidity. Patient preference against tx resulted in 0.3 (p<.0001) decrease in physicians’ recommendations for tx. Among physician factors, only type of employment was associated with tx recommendations with a 0.3 decrease in preference for tx (p=0.0014) among academic oncologists. Conclusions: Patient rather than physician factors have the greatest effect on oncologists’ preferences for adjuvant tx with age and severe comorbidity having the strongest effect.

No significant financial relationships to disclose.
Barriers for accrual to clinical trials in adult patients (pts) with thoracic malignancies
Authors: Baggstrom M. Q. , Gilstrap E. , Skelton A. , Viswanathan A. , Morgensztern D. , Nations P. A. , Foersterling D. , Govindan R.
Published: March 2020

6058

Background: Despite recent advances in the treatment of pts with thoracic malignancies, the outcome continues to be poor. Only about 3% of all adult oncology pts enroll in clinical trials compared to approximately 50% of pediatric pts. The proportion of adult pts enrolled in clinical trials is low, even in tertiary cancer centers. It is critical to understand the barriers for accrual to clinical trials. Methods: We reviewed the outpatient charts of all pts with thoracic malignancies (non-small cell lung cancer [NSCLC], small cell lung cancer, and esophageal cancer) referred to the thoracic medical oncology group at our institution from 11/1/2004 to 10/31/2005. Available and appropriate clinical trials are presented to the pts routinely and reasons for non-enrollment are documented. We collected information on histology, stage, performance status (PS) and co-morbid conditions. Appropriate studies at the time of initial consultation were noted from database. Results: Of 284 consecutive patient charts reviewed, 13 pts (4.6%) did not require therapy, 6 pts (2.1%) were deemed to have a non-thoracic primary on review, and 15 pts (5.3%) had already initiated therapy at the time of consultation. Of the remaining 250 evaluable pts, 88 pts (35.2%) were not enrolled because of lack of available appropriate clinical trials at the time of initial consultation. The most common categories were adjuvant therapy for early stage NSCLC and advanced esophageal cancer. Twenty-one pts (8.4%) enrolled onto a clinical trial. The most common reasons for not participating in a clinical trial include: ineligibility due to PS (28 pts, 11.2%), geographic issues (23 pts, 9.2%), patient refusal (16 pts, 6.4%) and co-morbid conditions (9 pts, 3.6%). Ten pts (4.0%) were lost to follow up. Conclusions: 1. Lack of appropriate and available clinical trials and poor PS are the two most common reasons for lack of patient enrollment in clinical trials at our institution. 2. It is critical to develop innovative clinical trials for pts with advanced esophageal cancer, adjuvant therapy in early stage NSCLC, and poor PS. 3. More work is needed to understand patient perception about clinical trials.

[Table: see text]
The relationship between cancer patient treatment decision-making roles and quality of life (QOL)
Authors: Atherton P. J. , Smith T. , Huntington J. , Huschka M. , Sloan J. A.
Published: March 2020

6075

Background: Failing to meet patient expectations for participating in treatment decisions impacts satisfaction with care, but it is unknown whether this translates into QOL deficits. As part of a larger survey of cancer survivors conducted by the American Cancer Society (ACS), data were gathered on the role patients in Minnesota preferred and the role actually experienced during the treatment decision-making process. Methods: Patients who were diagnosed with one of the ten most common cancers in 2000 completed a survey containing the Profile of Mood States (POMS), the SF-36, and the Control Preferences Scale (CPS). Fisher’s exact tests compared role preference distributions across demographic categories. Two-sample t-tests compared the POMS and SF-36 scores between patients whose preferred role preference was concordant with the role experienced and those with discordant preferred and actual roles. Results: 33% of the 599 consenting patients preferred an active role in treatment decision-making, 52% preferred a collaborative role, and 13% preferred a passive role. The actual roles experienced were 33% active, 50% collaborative, 17% passive. Over 88% of patients had concordant preferred and actual roles. Patients with concordant roles had higher SF-36 physical scores (45 vs 40, p=0.004), higher vitality (50 vs 42, p=0.005), less fatigue (70.2 vs 60.1, p=0.001), better concentration (84 vs 79, p=0.008) and better overall mood (77 vs 73, p=0.006). Role preference differed across gender (p=0.0002) in that more women preferred a collaborative role than men (57.8% vs 45.5%) and fewer women preferred a passive role (9% vs 17.3%). Patients under age 50 experienced more active roles in treatment decisions than those aged 50+ (p=0.04). Patients reporting an active actual role had higher SF-36 physical scores (p=0.005) and higher POMS vigor subscale scores (p=0.04). There were no differences in QOL scores for preferred roles. Conclusions: Patients who experienced discordance between their preferred role and their experience reported substantial QOL deficits in both physical and emotional domains. Oncologists can improve patient satisfaction with care and QOL by meeting patient expectations with respect to the amount of input they have in making treatment decisions.

No significant financial relationships to disclose.
Cancer patients’ reported illness and treatment related concerns, perception of availability and use of available information: The influence of socio-demographics
Authors: Jean-Pierre P. , Roscoe J. A. , Morrow G. R. , Hofman M. , Fiscella K. , Griggs J. , Carroll J. , Figueroa-Moseley C. , Mattar B. I. , Wade J. L.
Published: March 2020

6077

Backgrounds: Studies that examine the roles of socio-demographics in illness perception and healthcare communication among cancer patients are relatively absent. Methods: This sample included 973 (904 whites, 69 non-whites) patients undergoing treatment for cancer at 20 geographically separate sites. Concerns over understanding the diagnosis and treatment plan were assessed on a 5-point-scale (“1=no concern” to “5=a great deal of concern”). Patients were also asked if: a) whether or not information was available to them, b) if yes, did they used it or not, and c) would more information have been helpful. χ2-analyses and ANCOVAs, were conducted to examine group differences in education, occupation, and concern over understanding the diagnosis and treatment plan. Logistic regressions were conducted to assess the independent association of race to patients’ beliefs that additional information would have been helpful. Results: χ2 analyses showed no significant difference between whites and non-whites in education and occupation (Ps > .05). Subsequent ANCOVAs showed significant group differences in concerns over understanding the diagnosis (F(1, 967) = 9.13, p = 0.003) and treatment plan (F(1, 967) = 7.95, p = 0.01), after adjusting for education, occupation, age, and gender. Additionally, χ2 showed significant group differences in beliefs that more information would have been helpful (p < .05). More non-whites (70.3%) than whites (53.1%) indicated that additional information would have been helpful to understanding the diagnosis. Similarly, more non-whites (69.4%) than whites (53.4%) indicated that additional information would have been helpful to understanding the treatment plan. Subsequent logistic regressions confirmed that race independently predicted patients’ indications that more information would have been helpful to understanding the diagnosis (OR = 1.96, 95%CI = 1.12, 3.42) and treatment plan (OR = 1.84, 95%CI = 1.05, 3.22). Conclusion: The findings underscore the need for oncology professionals to consider and integrate information about socio-demographics in their intervention and communication with racial/ethnic minority patients. Supported by NHI PHS-grant U10-CA37420

No significant financial relationships to disclose.
What do adjuvant and metastatic breast cancer patients (BC) expect from their doctors? Final results of a german survey in 617 patients:
Authors: Oskay-Oezcelik G. , Lehmacher W. , Mirz R. , Christ H. , Kaufmann M. , Bamberg M. , Werner L. , Wallwiener D. , Overkamp F. , Hindenburg H. J. , Sehouli J.
Published: March 2020

6085

Background: An increasing number of breast cancer patients in western countries are accessing the Internet for medical information. The following study was condcuted to explore the information needs and preferences with special focus on doctor-patient communication. Methods: A questionnaire was developed and validated in a phase-I study and was than administered to breast cancer patients both via internet (online) or via a print-version consisting of 62 questions. Results: A total of 617 patients were interviewed, 552 by online version (online group) and 65 by printed questionnaire (print group). The median age of the online group was 47 years (21–85), for the print group 53 years (40–92). 65% of the patients were treated with the intention of cure, 35% of the patients had a metastatic disease. The median time of consultation communicating the information “You have breast cancer”, was 15 minutes (0–300). The most effective and “patient-relevant source of information and explanations of treatment options was the consultation with their physician (84%). When asked to suggest areas for improvement, most frequent answers were: more alternative therapies should be offered by physician (54%); physicians should have more time for explanations (51%); cooperation between involved physicians should be optimized (39%). Most relevant questions for patients are: “Do I receive the adequate treatment?” (89%); “How many patients with my disease does my physician treat?” (46%); “Can I be enrolled into a trial?” (46%). An independent second opinion centre was desired by 94% of the patients, but only 20% know such an institution. Conclusions: This study underlines the need to give patients with breast cancer all details on treatment options and cancer managements.

No significant financial relationships to disclose.
The influence of radiation therapy on survival among Medicaid-enrolled breast cancer patients treated with breast conserving surgery
Authors: Foley K. L. , Camacho F. , Levine E. A. , Kimmick G. , Balkrishnan R. , Anderson R.
Published: March 2020

609

Background: A growing body of evidence indicates that breast cancer patients treated with breast conserving surgery (BCS) without radiotherapy (RT) have a greater risk of cancer recurrence and mortality compared to those receiving BCS plus RT. Most of the research to date has not included or accounted for women with lower socioeconomic status. Methods: Using cancer registry, Medicaid claims, and Social Security death index data, we evaluated receipt of RT and mean 6-year overall and cancer-specific survival among Medicaid-enrolled breast cancer patients treated with BCS (n=230). Logistic regression was used to assess predictors of RT. The Kaplan-Meier method was used to determine survival by RT status and a multivariate Cox proportional hazards regression model was used to evaluate the role of RT on overall and cause-specific survival while controlling for demographic, clinical, and comorbid factors. Results: 65% of women received RT. Overall, 82% of the sample survived the 5–6 year study period, with death rates of 16% compared to 51% among those who did and did not receive RT, respectively (p<.001). Among the 24 individuals who died from cancer, 8 (33.3%) received radiation and 16 (66.7%) had not. After controlling for demographics, clinical factors, and comorbidity, use of RT was associated with a statistically significant decrease in all-cause mortality (hazard ratio = 0.42, 95% CI 0.21–0.85) and cancer-specific mortality (hazard ratio = 0.22, 95% CI −0.09–0.57). Conclusions: We found under-use of radiation following BCS in this Medicaid-enrolled population of breast cancer patients. Furthermore, omission of RT was associated with a greater than two-fold increased risk of death and almost a five-fold increase in cancer-specific death. Measures to improve RT use among poor women receiving BCS need to be implemented.

No significant financial relationships to disclose.
Gemcitabine-related thrombocytosis: Does it increase the risk of thrombosis?
Authors: Ahmed S. , Shahid R. K. , Sami A. , Yadav S. , Ahmad I. , Mirchandani D. , Popkin D. , Haider K.
Published: March 2020

6091

Background: Gemcitabine is an antimetabolite agent that has demonstrated activity in various solid and hematological malignancies. Although thrombocytopenia is a known side effect, gemcitabine-related thrombocytosis has been uncommonly reported. Chemotherapy increases the risk of thrombo-embolism in patients with cancer. The study aimed to identify the incidence of gemcitabine-related thrombocytosis and to determine whether it has been associated with an increased risk of thrombo-embolism. Methods: Medical records of 175 consecutive adults patients with a malignant disease who received gemcitabine at Saskatoon Cancer Center were reviewed. Patients with history of prior thrombo-embolism or with baseline thrombocytosis were excluded. Fisher’s Exact test was done for statistical analysis. Results: 149 eligible patients with median age of 62 (26–83) and M:F of 1.01:1 were identified. 141 (95%) patients had advanced malignancy and 61 (41%) had received prior chemotherapy. 106 (71%) patients received combination of chemotherapy and 95% of those patients received gemcitabine in combination with a platinum compound. Median number of cycle was 3 (1–8). Median platelets count prior to commencement of gemcitabine was 285 × 109 (44–449). 83 (56%) patients experienced thrombocytopenia whereas 69 (46%) patients experienced thrombocytosis within 3 weeks of treatment with gemcitabine. Median post-gemcitabine platelet count in patients with thrombocytosis was 622 × 109 (457–1385). 15 (10%) patients experienced thrombocytosis with each cycle of gemcitabine. Median duration of thrombocytosis was 2 weeks (0.5−5). 13 (9%) of 149 patients experienced a vascular event (venous, n=9; arterial, n=4) within 6 weeks of treatment with gemcitabine. Median platelet count prior to the vascular event was 268 × 109 (79–669). All except one patient had advanced malignancy and 85% had received combination of chemotherapy. 5 of 69 (7%) patients with thrombocytosis experienced a vascular event compared with 8 of 80 (10%) patients without thrombocytosis (p=0.77). Conclusions: Gemcitabine has been associated with an increased incidence of thrombocytosis. However gemcitabine-related thrombocytosis is a transient phenomenon and has not been associated with an increased risk of a vascular event.

No significant financial relationships to disclose.
Utility of the SEER-Medicare data to identify medical androgen deprivation therapy
Authors: Oleynick J. U. , Albertsen P. C. , Barry M. M. , Walker-Corkery E. M. , Yao S. , Lu-Yao G. L.
Published: March 2020

6113

Background: Researchers are increasingly using SEER-Medicare data to measure the use of various cancer therapies. However, the validity and completeness of Medicare data as a source of information for identifying medical androgen deprivation has not been established. In this study, we compared the classification of ADT use based on SEER-Medicare linked data and medical record review. Methods: Among patients who were included in the Prostate Cancer Outcomes Study (PCOS) aged 65 or older and have Medicare part A and B coverage as their primary health insurance, their use of medical androgen deprivation therapy (ADT) identified from the SEER-Medicare data was compared with the results of medical record review. The linkage of the datasets was accomplished by using encrypted IDs. Two algorithms were evaluated. Algorithm A defines ADT use liberally, if at least one of the following HCPCS codes is present: J1950, J9202, J9217, J9218, or J9219. Algorithm B, developed by the authors to identify consistent androgen deprivation, defines ADT only if there is evidence of treatment lasting for 3 months or longer, indicated by either the 12-month treatment J9219 or at least 3 months of treatment with J9202 or J9217. Results: For the 673 patients eligible for this validation study, algorithm A has a sensitivity of 92.5% and a specificity of 85.2% in identifying medical ADT compared to medical record review (see table ), while algorithm B has a sensitivity of 81.8% and a specificity of 88.9% ( Table 1 ). When the study was further restricted to patients with Medicare insurance only (N=142), both algorithms improved: 96.2% sensitivity and 85.6% specificity for algorithm A, and 88.5% sensitivity and 91.1% specificity for algorithm B. Conclusions: Both algorithms have reasonable sensitivity and specificity. Medicare claims can be used to track ADT use for the treatment of prostate cancer in the Medicare population.

[Table: see text]

No significant financial relationships to disclose.
What is the probability that new cancer treatments are better than standard treatments?
Authors: Djulbegovic B. , Kumar A. , Soares H. P.
Published: March 2020

6120

Background: How often new treatments tested in phase III randomized controlled trials (RCT) are superior to standard treatments is not known. To accurately answer this question three factors have to be considered: publication rate, quality of trials and the choice of the adequate comparator intervention. Methods: All consecutive RCTs conducted by 6 National Cancer Institute sponsored cooperative groups from 1955 to 2000 were reviewed. Data on primary outcomes from published and unpublished trials were analyzed. The results were assessed for the possible effects of bias, random error and choice of comparator intervention. Results: We abstracted data from 444 trials, involving 566 comparisons, enrolling more than 150,000 patients. Hazard ratio (HR) for overall survival favored experimental treatments 0.96 [99%CI (0.94, 0.98), p<0.0001]. Treatment related mortality (TRM) was worse with innovative treatments (HR 1.45 [99%CI (1.24, 1.69)], p<0.0001). In absolute difference this amounts to <0.4% in survival and 0.38% in TRM. Although the distribution of successes was on average similar between experimental and standard treatments, we found that one in 14 trials lead to discovery of a treatment that improved survival by 50%. The findings were not affected by publication bias, methodological quality, treatment type, disease, or comparator. Conclusions: In clinical trials of new cancer drugs, experimental treatments in cancer which have progressed to testing in RCTs are, on average, as likely to be inferior as to be superior to standard treatments. Individual treatments may be more or less successful but this cannot be predicted and can only be known after a trial is conducted. This pattern of treatment success is not accidental, but is directly related to moral principle for conduct of clinical trials known as equipoise or uncertainty principle (BMJ2005;331:1295). Such uncertainty makes it easier for patients to decide whether to participate in such trials, and for researchers to justify the clinical trial system, which has led to advances in treatment of cancer.

No significant financial relationships to disclose.
Molecular signatures generated with RNA Isolated from formalin-fixed paraffin-embedded tumor specimens differentiate metastatic and non-metastatic primary breast cancer
Authors: Tanaka K. , Shimizu D. , Kuramochi H. , Cooc J. , Williams M. , Li R. , Chen P. , Danenberg K. D. , Danenberg P. V. , Lenz H. J.
Published: March 2020

614

Background: Breast cancer can be either non-metastatic (locally-advanced) or metastatic, with the latter giving rise to a considerably worse prognosis. Because tissue from patients is generally available only as FFPE specimens, we investigated whether distinct molecular “signatures” could be obtained for these breast cancer types using RNA isolated from archival FFPE specimen blocks in gene expression arrays. Methods: FFPE specimens were available from 15 non-metastatic tumors and 12 primary tumors along with their matching metastases. Up to 5 10-micron sections of each were microdissected to isolate areas of tumor tissue. RNA was extracted using a proprietary procedure of Response Genetics, Inc. and was then amplified and labeled. The resulting cRNA was hybridized to the U133 plus 2.0 GeneChip. An unsupervised PCA analysis of the samples resulted in the first principal component separating 2 distinct groups which consisted of the non-metastatic and metastatic tumors. A differentially expressed gene list between metastatic and non-metastatic CRC was determined. These data were also analyzed for differential canonical pathways using Ingenuity Pathway Analysis. Results: Hierarchical clustering analysis segregated locallyadvanced primary tumors and metastatic primary tumors intotwo clusters with distinct gene signatures. A T-test with unequal variance assumption identified 1595 differentially expressed probe sets with FDR (false discovery rate) = 0.005 (p=0.00015). However, comparison of primary tumors with their liver metastases using a paired T-test showed only 18 differentially expressed probe sets at FDR=0.05 and 1019 genes with significance p value ≤ 0.005. Pathway analysis showed significant deregulation of FGF signaling, G2/M DNA damage cell cycle checkpoint, IL-2, IL-4 and EGF signaling between locally advanced and metastatic primary tumors. Conclusion. We have demonstrated the feasibility of identifying metastatic and non-metastatic tumors by microarray analysis using FFPE breast cancer tissue. This result is currently being validated in a separate larger cohort of patients.

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Optimizing the design and distribution of clinical trial information via handheld devices
Authors: Monaco V. , Arnold A. M. , Simon B. , McCarty K. S. , Jacobs S. A.
Published: March 2020

6145

Background: The timely identification of available clinical trials by an oncologist for a patient represents a critical initial step in the research process. The challenges in supporting this step are threefold: (1) Large cancer centers may have more than 200 active clinical trials; (2) The accrual status of any particular clinical trial can change frequently; (3) Oncologists have limited time in their schedule to seek out clinical trial information. We hypothesized that delivering up-to-date clinical trial information directly to a handheld device would address the combination of these three challenges, and we utilized an iterative design process to refine the format and organization of this information. Methods: Web pages containing clinical trial information and optimized for a handheld display were created using an existing database and standard web development software. AvantGo software was utilized for transferring these web pages to handheld devices upon synchronization. Feedback on the initial design was obtained from four oncologists based in our community network locations. Two subsequent designs were developed based on both this feedback and encountered technical constraints. Results: Four major design changes emerged during our iterative design process. These changes included: (1) The organization of trial information based on network location; (2) The improvement of trial disease categories; (3) The shortening of trial titles; and (4) The inclusion of descriptive trial summaries for all trials. Conclusions: A demonstration of the handheld clinical trial information that is available to over 60 oncologists in our extended network will be provided. The merits of this approach as well as the lessons learned from our design process should be considered by other cancer centers seeking new methods for the distribution of clinical trial information.

No significant financial relationships to disclose.
Circulating endothelial progenitor cells correlate to stage in patients with invasive breast cancer
Authors: Naik R. , Jin D. , Chuang E. , Gold E. , Tousimis E. , Christos P. , De Dalmas T. , Donovan D. , Rafii S. , Vahdat L.
Published: March 2020

616

Background: Tumor growth and metastasis is dependent on neo-angiogenesis. Both pre-existing and circulating vascular cells have been shown to contribute to the assembly of tumor neo-vessels in specific tumors. Mobilization of endothelial progenitor cells (EPCs) from the bone marrow constitutes a crucial step in the formation of de novo blood vessels, and levels of peripheral blood EPCs have been shown to be increased in certain malignant states. However, the role of circulating EPCs in breast cancer is largely unknown. Methods: We recruited twenty-five patients with biopsy-proven invasive breast cancer (BC) at Weill Cornell Breast Center to participate in a pilot study investigating the correlation of circulating EPCs to extent of disease and initiation of chemotherapy. For each patient, a baseline sample was drawn before systemic treatment, and for seventeen of those patients, a second sample was taken after the first round of chemotherapy. Levels of peripheral blood EPCs, as defined by co-expression of CD133 and VEGFR2, were quantified by flow cytometry. Results: BC patients with stage III & IV disease had statistically higher levels of circulating EPCs than did patients with stage I & II disease (median=165,000 EPCs/5×106MNCs vs. median=6,920 EPCs/5x106MNCs, respectively, p < 0.0001 by Wilcoxon rank-sum test). In addition, in late-stage patients, levels of EPCs demonstrated a statistically significant drop after initiation of chemotherapy (median=162,500 EPCs/5x106MNCs [pre] vs. median=117,500 EPCs/5x106MNCs [post], p = 0.01 by Wilcoxon signed-rank test). Conclusion: These results suggest that circulating EPCs may serve as a potential tumor biomarker in breast cancer and that EPCs may represent a plausible target for future therapeutic intervention. Supported in part by the Mentored Medical Student in Clinical Research Program (General Clinical Research Center/National Institutes of Health Grant M01RR00047), Madeline & Stephen Anbinder Clinical Scholar Award, and Anne Moore Breast Cancer Research Fund

No significant financial relationships to disclose.
Simultaneous, quantitative detection of multiple biomarkers in human breast cancers using multicolor nanoparticles
Authors: Al-Hajj A. H. , Yezhelyev M. V. , Liu T. , O’Regan R. M.
Published: March 2020

619

Background: Conventional methods of detecting breast cancer biomarkers are hampered by a lack of adequate quantification and/or an inability to detect multiple targets on small quantities of tissue. We have previously demonstrated that estrogen receptor (ER), progesterone receptor (PR) and HER2/neu (HER2) can be detected and quantified simultaneously using antibodies (Abs) directly conjugated to nanoparticles, called quantum dots (QDs), on single breast cancer sections (ASCO 2005). We have expanded our assay to use multicolored QDs conjugated directly to Abs (QD-Abs) to detect and quantify simultaneously ER, PR, and HER2, along with 3 putative biomarkers, epidermal growth factor receptor (EGFR), mammalian target of Rapamycin (mTOR), and insulin-like growth factor receptor (IGFR), in breast cancer cell lines and human breast cancers. Methods: We used multicolored QDs directly conjugated to primary Abs to detect the 6 proteins in breast cancer cell lines (MCF-7, BT474, MDA-231) and single sections of human breast cancers. The 6 proteins were quantified using spectral separation microscopy, and compared to Western blotting. Results: We detected all 6 proteins simultaneously using QD-Abs in breast cancer cell lines and breast tumors. Using hyper-spectral imaging and wavelength-resolved spectroscopy, we separated all 6 fluorescent signals, and quantified the expression of each protein detected using QD-Abs. Quantification of the biomarkers showed good correlation with Western blotting. Conclusions: These results are proof of principle that 6 proteins can be simultaneously quantified using QD-Abs in single breast cancer sections. The use of multiplex QDs offers a novel method of determining the proteome of an individual breast cancer on single breast cancer sections. With the expanding use of targeted therapies in breast cancer, the ability to detect multiple proteins on small breast cancer specimens using QD-Abs, could allow not only the accurate selection of therapy, but a unique method of determining the activity of specific targeted agents.

No significant financial relationships to disclose.