bluuebunny/crossref_metadata_2025 huggingface dataset:
When using patient-reported outcomes in clinical practice, the measure matters: Results from an RCT.
Authors: Snyder Claire Frances , Herman Joseph M. , Blackford Amanda L. , Carducci Michael Anthony , Wu Albert W.
Published: March 2020

6519

Background: Patient-reported outcomes (PRO) assess patients' perspectives on the impact of diseases and treatments. There is increasing interest in having patients complete PRO questionnaires and using the data clinically to identify and address patients' issues. There are many different PRO questionnaires, and this study investigated whether one PRO is more appropriate than others for clinical use. Methods: This controlled trial randomly assigned patients to complete 1 of 3 PRO questionnaires: six domains from the Patient Reported Outcomes Measurement Information System (PROMIS), the EORTC QLQ-C30, or the Supportive Care Needs Survey-Short Form (SCNS). Breast or prostate cancer patients, >=21 years old, undergoing treatment, with oncologist visits at least monthly were eligible. Patients completed their assigned PRO questionnaire via computer either in the clinic or via the web prior to their clinic visits for the duration of active treatment. The results were provided to their clinicians for use during visits. After treatment ended, patients completed a 13-item feedback form to assess the impact of the questionnaire on their care (e.g., easy to complete, promoted communication, improved care quality). We hypothesized that there would be no difference in the proportion of patients who strongly agreed/agreed to all 13 items in the feedback form by questionnaire arm. Results: Of 294 eligible patients approached, 224(76%) enrolled (mean age 66, 78% white, 28% breast, 72% prostate). Of these, 181 patients (81%) responded to the feedback form, with 116 patients (52%) completing all 13 items. Of the 116 patients with complete data, subjects in the QLQ-C30 arm were most likely to strongly agree/agree to all items (82%), followed by PROMIS (62%), and SCNS (56%) [p=.05]. Among the 181 patients with at least partial data, the proportions strongly agreeing/agreeing to all items were 74% for QLQ-C30, 61% for PROMIS, and 52% for SCNS [p=.03]. Conclusions: In a randomized trial comparing the benefits of PROs applied in clinical practice, we found significant differences among the 3 PRO questionnaires. Future applications of PROs for patient care should select the most appropriate PRO measures for the purpose and setting.
Does biomarker information impact patients’ preferences for therapy?
Authors: Partridge Ann H. , Sepucha Karen , O'Neill Anne , Miller Kathy , Baker Emily , Dang Chau T. , Northfelt Donald W. , Sledge George W. , Schneider Bryan P.
Published: March 2020

6527

Background: Biomarker information can risk stratify patients based on potential for benefits/toxicity from therapy. Ideally, a biomarker will identify those who benefit with limited toxicity. However, the impact of biomarkers is unclear when indicting individuals with greatest benefit are also at increased risk for toxicity. Methods: We surveyed participants at 18 month follow-up in the Decision-Making/Quality of Life (DM-QOL) component of ECOG5103, a RCT where patients were randomized to receive adjuvant chemotherapy for breast cancer with either placebo or bevacizumab (in 2 schedules). We asked patients for the preferred treatment in two hypothetical scenarios: 1) preference for chemo A or chemo A + B without biomarker information; 2) preference for chemo A or chemo A+B when participants tested positive for a “B-receptor” which increased both the benefit and toxicity of chemo A+B. McNemar’s test was used to examine changes in preferences. Results: 439 patients completed both scenarios on 18-month survey. The Table shows the treatment preferences in each scenario. The positive biomarker information in scenario 2 led 60/439 (14%) participants to switch their preference. The main reason for treatment preference in scenario 2 was greater benefits of chemo A+B (64%), the lower risks with chemo A (20%) and positive biomarker (10%). Among participants who changed preference, those randomized to receive bevacizumab were more likely to switch to chemo A in scenario 2. Conclusions: Information about a positive biomarker, indicating increased benefit and increased risk from additional chemo, did not significantly change participants’ preferred treatment. All participants were involved in a large placebo controlled double blind trial and the majority (70%) preferred the most aggressive course of treatment in both scenarios. Whether patients not enrolled in the trial would be more sensitive to the increased risk information is unclear. [Table: see text]
Racial/ethnic differences in end-of-life (EoL) treatment preferences: The role of religious beliefs about care.
Authors: Balboni Tracy A. , Maciejewski Paul K , Balboni Michael J. , Enzinger Andrea Catherine , Paulk M. Elizabeth , Munoz Francisco , Rivera Lorna , Mutchler Jan , Finlay Esme , Marr Lisa , McCorkle Ruth , Temel Jennifer S. , Weeks Jane C. , Vanderweele Tyler J. , Prigerson Holly Gwen
Published: March 2020

6529

Background: Racial/ethnic minorities and patients who turn to religion to cope receive more aggressive EOL care. Beliefs underlying these associations are unknown. Methods: Coping with Cancer is an ongoing, multi-site, NCI-funded study examining factors influencing racial/ethnic EoL disparities. From 11/2010-10/2012, 133 advanced cancer patients underwent baseline interviews, including 7 items assessing religious beliefs about EoL care (RBEC). Univariate analyses assessed racial/ethnic differences in RBEC and EoL treatment preferences. Multivariable analyses (MVA) modeled mean RBEC score as a function of race/ethnicity, controlling for confounders, and assessed the relationship of race/ethnicity and RBEC to treatment preferences. Results: Religious beliefs about EoL care are common and more often held by racial/ethnic minorities (Table); racial/ethnic differences persisted in MVA (p<.0001). Black patients were more likely than Whites to prefer aggressive EOL care (OR=5.03, p=.02), whereas Latino’s EOL preferences did not differ from Whites (p=.87). In MVA including race and RBEC score, Black race was not related to EOL care preferences (OR 1.61, p=0.55), whereas greater RBEC score was associated with greater preference for aggressive care (OR 2.48, p=0.003). Conclusions: Religious beliefs about EoL care are common and significantly more so among racial/ethnic minorities. Preliminary data suggest these beliefs mediate the relationship between race/ethnicity and EoL treatment preferences. [Table: see text]
Perceptions regarding prostate cancer (CaP) treatment options: Results from the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).
Authors: Chen Ronald C. , Nielsen Matthew Edward , Reeve Bryce B. , Hendrix Laura H. , Agans Robert P , Hoffmeyer Anna , Usinger Deborah , Strigo Tara , Jackman Anne , Godley Paul Alphonso
Published: March 2020

6530

Background: NC ProCESS is a population-based cohort of early (non-metastatic) CaP patients followed prospectively from diagnosis. Methods: Patients were identified through Rapid Case Ascertainment of the NC Cancer Registry from all NC counties in 2010-12. Phone survey assessed perceptions regarding treatment options and priorities in treatment selection. Results: 937 (59% of all eligible) completed this survey. Median age was 65; 72% were Caucasian. At time of survey, ~13 weeks from diagnosis, 98% had discussed options with a urologist, 49% with primary care, and 41% radiation oncologist. Many patients had concerns about potential effects of surgery and radiation on ability to perform daily activities, recovery time, and burden to family (Table). Open prostatectomy (ORP) and external beam radiation (RT) were deemed most likely to affect urinary and sexual function; fewer reported concern with robotic prostatectomy (RALP). Only 32% reported hormonal therapy would affect sexual function. Most reported surgery (especially RALP) had the best chance for cure, while 59% worried about recurrence with RT. In almost all questions, patients who consulted only with a urologist had significantly different perceptions about treatment options than those who also consulted with a radiation oncologist. In choosing treatment, 61% reported that cure was the highest priority, and 28% indicated preserving quality of life. Conclusions: Modern CaP patients often have misconceptions about treatment options inconsistent with published evidence, which are partially mitigated by multidisciplinary consultation. Most indicated cure as the highest priority, and surgery offers the best chance of cure. [Table: see text]
Use and impact of chemotherapy-free intervals in metastatic colorectal cancer in routine practice.
Authors: Kay Amin , Yun Lingsong , Taback Nathan , Krzyzanowska Monika K.
Published: March 2020

6535

Background: Several randomized trials have shown that chemotherapy-free intervals (CFIs) may reduce toxicity without compromising survival in patients with metastatic colorectal cancer (mCRC) treated with non-curative intent. However, uptake and outcomes of this approach in routine practice are unknown. We performed a population-based study of the patterns of use of CFIs and their impact on survival and toxicity among patients treated with first-line intravenous (IV) chemotherapy in Ontario, Canada. Methods: The Ontario Cancer Registry was linked with several other administrative databases to identify patients with colorectal cancer who started first-line IV chemotherapy between 2007-2009. A patient was considered to have had a CFI if more than 56 days elapsed between two chemotherapy billing claims. Survival of patients who had at least one CFI was compared to those who did not using Cox regression stratified by duration of treatment and adjusted for age, sex and Charlson comorbidity score. Analysis was performed separately for each type of first line treatment: Irinotecan (IRI), Irinotecan plus Bevacizumab (IR+B), and Oxaliplatin (OX). Toxicity was estimated by calculating the rate of emergency department visits and hospitalizations (adjusted for time on treatment) between those who did and did not have chemo breaks. Results: Between 2007-2009, 1,989 patients started first-line chemotherapy for mCRC in Ontario (22.6% IRI, 47.9% IRI+B, 29.5% OX). 489 (24.6%) had at least one CFI (14.9% IRI, 33.2% IRI+B, 18.1% OX). The median duration of first line treatment was 205 days (IQR 107-366 days). The median duration of the first CFI was 127 days (IQR 90-234 days). In multivariate models stratified by duration of treatment, CFIs did not have a negative effect on survival in either of the 3 treatment groups (HR: 0.62 IRI, 0.90 IRI+B, 0.51 O). Toxicity was lower in patients who had at least one CFI (12.6 vs 16.8 ER visits or admissions per person-month, p=0.036). Conclusions: Chemo-free intervals are used in routine practice in Ontario, and are associated with lower toxicity, without any apparent evidence of negative impact on survival.
Cost-effectiveness of everolimus plus exemestane in post-menopausal hormone receptor positive metastatic breast cancer.
Authors: Zeichner Simon B. , Avancha Kiran Kumar Venkata Raja , Lopes Gilberto , Gluck Stefan , Montero Alberto J.
Published: March 2020

6548

Background: Everolimus in combination with exemestane is approved for the treatment of postmenopausal women with hormone-receptor (HR) positive, HER2-negative metastatic breast cancer (MBC). The BOLERO-2, a randomized phase 3 trial, demonstrated a significantly improved progression free survival (PFS) with everolimus plus exemestane compared to exemestane alone in patients previously treated with non-steroidal aromatase inhibitors. In order to better inform U.S. policymakers, this study aimed to assess the cost-effectiveness, from a payer perspective, of everolimus in combination with exemestane. Methods: We created decision analytical and Markov models using published data from the BOLERO-2 trial. Utilities were derived from available literature. Costs were obtained from the Center for Medicare Services drug payment table and physician fee schedule and were represented in 2012 U.S. dollars. The quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER) were calculated. One way and probabilistic sensitivity analyses were performed. Results: Everolimus added 0.42 years of progression-free survival (PFS) by central radiographic assessment with an incremental cost of $33,103, an overall cost of $62,751.54 per year of PFS gained, and an ICER of $79,376/QALY. By local assessment, everolimus added 0.29 years PFS years with an incremental cost of $31,873, an overall cost of $83,222 per year of PFS gained, and an ICER of $108,131/QALY. The results of the model were robust in sensitivity analyses. The primary drivers in this model were found to be: PFS duration, progression free probability on therapy, and overall everolimus cost. Conclusions: Everolimus plus exemestane appears to be cost-effective in the treatment of metastatic breast cancer. Based on efficacy and value, this newly approved combination should be considered to be a viable option in treating patients with HR+/HER2- MBC upon progression on non-steroidal aromatase inhibitors.
Simulating the cost-effectiveness of lung cancer screening by low-dose CT scan in Canada.
Authors: Goffin John R. , Flanagan William M , Miller Anthony , Liu Fei Fei , Cressman Sonya , Fitzgerald Natalie , Fung Sharon , Wolfson Michael , Evans William K.
Published: March 2020

6550

Background: The National Lung Screening Trial (NLST) demonstrated that low-dose CT screening diminishes the risk of death among smokers. A cost-effectiveness analysis was undertaken in the context of the Canadian publically funded healthcare system. Methods: Microsimulation of CT screening was undertaken using the Cancer Risk Management Model, which incorporates demographic data, cancer risk factors, cancer registry data, diagnostic and treatment algorithms and health utilities. Simulations were performed at the individual level for a cohort incepted during the period 2012-2032. The criteria for the screen-eligible population, CT scan test characteristics, and screened cohort outcomes were derived from NLST and Canadian data. The baseline screening scenario was annual CT screening for ≥30 pack-year smokers, age 55 to 74. Simulation assumed 60% of the eligible population participates by 10 years, 70% adhere to the screening regimen, and smoking cessation rates are unchanged. One-way sensitivity analyses were performed. Costs and life-years lived were discounted at 3% annually. Results: Compared to no screening, annual screening results in incremental system costs of $2.97 billion (Cdn), 149,000 life-years saved (LYS) or 55,000 quality-adjusted life-years saved (QALYS), an incremental cost-effectiveness ratio (ICER) of $19,900/LYS, and $53,700/QALYS. With participation rates from 40% to 80%, ICER /QALYS remained within the range of $53,700 to $58,200. Increases in screening adherence from 50% through 90% increased the ICER /QALY from $50,400 to $58,800. Higher rates of smoking cessation led to improvements in ICER /QALY (150% of background cessation rate of 3.2-5.3%, $47,000; 200%, $41,500; 300%, $32,900). A system of biennial screening had a net cost of $1.81 billion, resulting in an ICER of $19,600 /LYS, and $54,800 /QALYS. Conclusions: Screening for lung cancer with low-dose CT scans could be cost-effective, but requires substantial system costs. The smoking cessation rate greatly impacts the ICER and a cessation program should be considered if screening is implemented. Compared to annual screening, biennial screening costs less and produces a similar ICER. Further analyses will be detailed.
NCIC CTG MAP.3: Symptoms and quality of life (QoL) among racial/ethnic minority women taking the aromatase inhibitor (AI) exemestane (EXE) for breast cancer risk reduction.
Authors: Moy Beverly , Tu Dongsheng , Richardson Harriet , Maunsell Elizabeth , Goss Paul E.
Published: March 2020

6557

Background: Racial/ethnic minority postmenopausal women reported fewer side effects than whites on the aromatase inhibitor (AI) letrozole in MA.17. We present symptoms and QoL according to race and ethnicity in women taking EXE for BC prevention in MAP.3. Methods: Adjusted proportions ever experiencing symptoms or reporting worsened SF-36 domains (change scores from baseline decreased by ≥ -5 points) among racial minorities (M) and whites (W), and Hispanics (H) and non-Hispanics (non-H), were compared using logistic regression models adjusting for age, body mass index (BMI), country, marital status, education level and employment status. Results: Of 2285 women randomized to EXE, 2231 (97.6%) women had race information: 129 M (6.1%) and 2102 W (93.9%).Compared to W, M were significantly older, had higher BMI, had lower Gail scores, received more drugs for cardiovascular diseases, and were more likely to live in the United States.M women experienced fewer sweats (12% vs. 22%; p = 0.005) and less vaginal dryness (8% vs. 16%; p=0.03). No significant difference between W and M was seen in the proportion with worsened QoL on any SF-36 domain. Ethnicity was known for 2198 women on EXE (96.2%): 241 H (11.0%) and 1957 non-H (89%). The following were less frequent among H women: hot flashes (21% vs. 42%; p<0.0001); fatigue (14% vs. 24%; p=0.01); sweats (5% vs. 24%; p<0.0001); insomnia (6% vs. 11%; p=0.001); heartburn (5% vs. 16%; p=0.001); nausea (3% vs. 7%; p=0.02); arthritis (5% vs. 12%; p=0.02); depression (7% vs. 11%; p=0.005); back pain (2% vs. 10%; p=0.002); cough (4% vs. 11%; p=0.02); and vaginal dryness (4% vs. 17%; p<0.0001). Fewer H women reported worsening in SF-36 bodily pain (60 vs. 66%; p=0.02) but more reported worsening in SF-36 mental health (59% vs. 48%; p=0.02). Conclusions: Consistent with MA.17 findings, racial/ethnic minorities experienced fewer adverse events on AI. H women had less bodily pain but reported worsening mental health. These differences may be important for minority women contemplating EXE for BC prevention. Genotypic variations and pharmocogenomics that might account for these differences merit investigation.
Quality of reporting of phase II trials in oncology in highly ranked oncology journals.
Authors: Grellety Thomas , Petit-Monéger Aurelie , Diallo Abou , Mathoulin-Pelissier Simone , Italiano Antoine
Published: March 2020

6582

Background: Phase II trials represent an essential step in the development of anti-cancer drugs. The aim of this study was to assess the quality of their reporting in highly-ranked oncology journals, to investigate predictive factors of quality and to develop better reporting guidelines for authors. Methods: We reviewed the tables of contents of 8 peer-reviewed oncology journals published between January 2011 and December 2011 and with a 2011 impact factor (IF) >4: Br J Cancer, Eur J Cancer, Oncologist, J Clin Oncol, Lancet Oncol, JNCI, Clin Cancer Res and Ann Oncol. Two reviewers assessed the quality of each report by using a 44-point overall quality score (OQS; range, 0 to 44 points) inspired from the revised Consolidated Standards of Reporting Trials statement. Primary endpoint definition, justification of sample size and definition of the evaluable population for each endpoint, were assessed separately because of their crucial methodological importance using a 3-point key methodological score (KMS; range, 0 to 3). Exploratory analyses were used to identify predictive factors associated with the different scores. Results: 156 articles were included. Agreement between the reviewers for each item was good (kappa coefficient range: 0.62-1). The median OQS was 28 (range: 9-35). OQS sub-score analysis showed that reporting of statistical methods was particularly low with a mean of 2.5 (6 items). The median KMS was 2 (range 0-3). Primary endpoint definition, justification of sample size and definition of the evaluable population were reported only in 107 (68.6%), 121 (77.6%), and 52 (33.3%) cases, respectively. On multivariate analysis, reporting of clinicaltrial.gov registration was associated with improved OQS, OR = 3.2 (95CI, 1.5 to 7.1). No predictive factor for KMS were identified. Conclusions: Phases II trials reporting is still poor even in journals with strict editorial policies. This may lead to biased interpretation of phase II trial results. We have developed a checklist for use by authors, reviewers, and editors to improve reporting of these studies. As well as using a checklist during the preparation of their manuscript, we recommend that authors provide reviewers and readers with the last version of the study’s protocol.
Identification of knowledge translation opportunities in the treatment of locally advanced breast cancer: Results of a national survey of physicians.
Authors: Rajmohan Yanchini , Leonard Robyn , Hogeveen Sophie , Ebrahim Jalal , Han Dolly , Wong Audrey , Boileau Jean-Francois , Gandhi Sonal , Lee Justin , Dinniwell Robert Edward , Brackstone Muriel , Simmons Christine E.
Published: March 2020

6585

Background: Locally advanced breast cancer (LABC) accounts for only 10% of all breast cancers. While several guidelines and consensus statements exist, whether the current practice reflects these guidelines is unclear. We sought to survey the oncologists in Canada to assess current practice patterns and identify areas of targeted knowledge translation interventions (KTIs) in the treatment of LABC. Methods: 426 Canadian oncologists were surveyed with a 29 item survey-tool. They were subdivided into LABC experts (n=83) and non-experts (n=343). Physicians were removed from the survey if they identified that they were not involved in the treatment of breast cancer. The survey included demographic information as well as questions as to the current practice patterns utilized in the pathway of care for LABC patients. Level of discordance was calculated between the expert and non-expert responses using a z test. Results: 139 responses were obtained (48% response rate) from the non-experts and 51 responses were obtained from the experts (61% response rate). Areas of discordance in expert and non-expert survey included: frequency of clinical assessment during neoadjuvant therapy, methods for clinical assessment, radiographic re-evaluation post therapy, and assessment of receptor status (see Table). Conclusions: Several areas have been identified as targets for KTIs that may help to improve the quality and consistency of care of patients with LABC in Canada and may also have implications for improvements in resource utilization. [Table: see text]
Incidence of venous thromboembolism in patients with hematologic malignancies related to upper extremity peripherally inserted central venous catheters.
Authors: Giever Thomas A. , Richter Emily L. , Broge Kristine M. , Foy Patrick C. , Blust Linda S. , Palmer Jeanne M. , Fenske Timothy S. , Rilling William S. , Hari Parameswaran , Atallah Ehab L.
Published: March 2020

6586

Background: Central venous catheters (CVCs) are an integral part of management in patients with hematological malignancies (HMs). CVCs are not without risk however, including DVT which adds significant morbidity. Peripherally inserted central venous catheters (PICCs) via the brachiocephalic veins were the most common CVCs utilized at the Medical College of Wisconsin for patients with HMs. Recent evidence has indicated an increased risk of DVT in patients with PICCs. Methods: We retrospectively reviewed patients admitted to our institution from 2009-2011 with a HM and a CVC placed based upon CPT codes. A chart review was performed and those with a radiologic-confirmed DVT were identified. Results: From 2009-2011, 487 patients with HMs had 1091 CVCs placed. Diagnoses included lymphoproliferative disorders (35.8%), acute leukemia excluding APL (23.8%), APL (1.6%), plasma cell dyscrasias (34.6%), MDS (1.7%), CML (1.6%), and other diagnoses (0.7%). Of the CVCs placed 51% were in patients undergoing stem cell transplantation (HCT) and 49% were placed in non-HCT patients. A total of 91 DVTs were documented and confirmed. DVTs occurred in 85 of 728 PICCs (11.7%), 3 of 104 implanted ports (2.9%), 3 of 249 tunneled CVCs (1.2%), and 0 of 10 other CVCs. DVT rates were similar between HCT (47 of 556, 8.4%) and non-HCT (44 of 535, 8.2%) patients. The highest number of DVTs were associated with plasma cell dyscrasias (29 of 378, 7.7%) followed by lymphoproliferative disorders (28 of 391, 7.2%), acute leukemia (26 of 260, 10%), APL (3 of 18, 16.6%), MDS (3 of 19, 15.8%), and CML (2 of 17, 11.7%). Two DVTs occurred in the setting of warfarin therapy, 5 while on prophylactic and 9 while on therapeutic LMWH. The mean duration from line placement to DVT was 21 days (range 1-169). Using standard chi-squared evaluation, PICC lines were significantly more likely to be associated with DVTs than tunneled or implanted CVCs (p<0.0001). Conclusions: Brachiocephalic PICC-lines are associated with a high incidence of DVT in patients with HMs compared to other CVCs. We have currently changed our practice to utilizing a tunneled internal jugular PICCs for central venous access.
Analysis of health-related quality of life during neoadjuvant endocrine therapy with letrozole in postmenopausal breast cancer patients: N-SAS BC06 trial.
Authors: Ohtani Shoichiro , Taira Naruto , Kihara Kiyohiro , Hasegawa Yoshie , Sakai Takehiko , Iwase Takuji , Masuda Norikazu , Fujisawa Tomomi , Yanagita Yasuhiro , Ohsumi Shozo , Higaki Kenji , Yamaguchi Takuhiro , Iwata Hiroji
Published: March 2020

6588

Background: The impact of neoadjuvant endocrine therapy (NET) on health-related QOL (HRQOL) has not been clarified yet. N-SAS BC 06 is a multicenter study in postmenopausal patients with hormone-sensitive primary breast cancer, two-staged (preoperative and postoperative) enrollment, and intervention. It includes a randomized controlled study of patients responding to NET, which is designed to compare chemotherapy followed by endocrine therapy, with endocrine therapy alone, as postoperative adjuvant therapy. The primary endpoint is DFS, and the secondary endpoints include adverse events, HRQOL and health economic evaluation. This report presents the planned analysis of HRQOL during 6 months of NET. Methods: The target sample size was 850 patients of whom the first 500 enrolled patients were included in HRQOL evaluation. Subjects were assessed at enrollment, and at 1 and 4 months after starting NET, using FACT-G (General), B (Breast), ES (Endocrine Symptoms) and HADS (Hospital Anxiety and Depression Scale). Results: Mean age was 63 years, mean BMI was 23.9. Results of clinical efficacy were as follows: CR: 2%; PR: 44.3%; SD: 48%; and PD: 5.7%. The questionnaire response rates at enrollment, and at 1 and 4 months were 93%, 90% and 82%, respectively, quite a high response rate. The mean scores at enrollment, and at 1 and 4 months were as follows: FACT-G: 82.9; 83.4; 82.7, FACT-B TOI (Trail outcome index): 68.3; 69.5; 68.9; ES subscale: 61.2; 60.1; 59.7 and HADS score: 10.4; 8.9; 8.8 respectively. There were no significant changes in the FACT-G or B-TOI over time, while the social domain score, ES subscale, decreased significantly (worse social well-being and ES). In the ES analysis by item, symptoms such as hot flash showed a greater decrease. HADS scores deceased significantly (improved anxiety and depression), and emotional domain scores increased significantly (better emotional well-being) at 1 month and 4 months after NET. Conclusions: NET had no impact on the overall HRQOL scores, but the anxiety and depression observed at enrollment had improved by 1 month after therapy. To our best knowledge, this is the first report of HRQOL during NET. Clinical trial information: 000001090.
Hepatitis B reactivation in HBsAg-/cAb+ patients receiving rituximab: A meta-analysis.
Authors: Mozessohn Lee , Chan Kelvin K. , Feld Jordan J. , Hicks Lisa K
Published: March 2020

6592

Background: Patients with hepatitis B virus (HBV) who are HBsAg+ are recognized to be at risk of HBV reactivation if rituximab is administered in the absence of antiviral treatment. Recently, it has been reported that patients with so-called “resolved HBV infection”(HBsAg-/cAb+) may also be at risk; however, the degree of risk is not known. Methods: We performed a systematic review of the English and Chinese language literature in Medline (1996 to July week 2 2012) and Embase (1996 to 2012 week 29) using the MeSH terms “lymphoma” and “hepatitis B”. Eligible studies were limited to those reporting primary data on HBV reactivation rates in HBsAg-/cAb+ patients receiving rituximab. We excluded case series with less than 5 patients. Pooled estimates were calculated for HBV reactivation and the impact of HBsAb status on HBV reactivation rate was explored. Results: Data from 445 patients in 12 studies were included. Using a standardized definition of HBV reactivation, (ALT >3 x upper limit of normal AND either an increase in HBV DNA from baseline OR HBsAg seroreversion), the pooled estimate for the risk of HBV reactivation in HBsAg-/cAb+ patients was 5.4% (I2 = 63%, P = 0.009). Significant heterogeneity was apparent. Exploratory analyses suggested that patients were less likely to reactivate if they were HBsAb+ (OR = 0.32; 95% CI 0.12-0.85, P = 0.0285). Conclusions: Our meta-analysis confirms that there is a measurable risk of HBV reactivation in HBsAg-/cAb+ patients exposed to rituximab HBsAb+ patients may be at lower risk than those who are HBsAb-. However, heterogeneity in the risk estimates limits their generalizability. Large prospective studies are needed to clarify the risk of HBV reactivation in HBsAg-/cAb+ patients and to inform decisions about best practice.
Effect on patient care of repeat pathologic review for breast cancer.
Authors: Shaw Andrew Cota , Sanoff Hanna Kelly , Smolkin Mark E
Published: March 2020

6599

Background: Many cancer centers routinely re-review outside pathologic specimens. We hypothesized re-review rarely changes patient treatment plans. Methods: Of 1495 patients seen at the University of Virginia with a diagnosis of breast cancer from 2006-2011, the 276 cases with both internal and outside pathology reports comprised the study cohort. Interobserver agreement (kappa coefficient, K) between internal and outside diagnoses were calculated for histopathology, lymph node, margin, ER/PR, and HER2 status. We then evaluated if the change would result in a change in therapy or surveillance per the National Comprehensive Cancer Network (NCCN) guidelines. The effect of region and teaching affiliation of outside institutions was explored. Results: For the 276 cases with re-reviewed pathology at UVA there was absolute agreement for ER/PR and surgical margins, and excellent agreement for lymph node, K= 0.93, and histopathology, K=0.93. Agreement was good for HER2, K=0.83. 3 cases were changed from HER2 positive to negative (2) or intermediate (1). Of 9 changes in histopathology, 2 had a major upgrade: 1 ADH to DCIS; 1 DCIS to carcinoma. 3 had a major downgrade: 2 from DCIS to ADH; 1 from carcinoma to DCIS. 2 cases changed from ALH to LCIS. Lymph node status was changed from positive to negative in one out of 31 reviewed cases. Treatment plan would have changed for all 13, 4.7% of all patients. Changes were made almost exclusively (11/13) if referred from a hospital with no or minor teaching affiliation, including all major histopathology changes and changes in lymph node and HER2 status. Conclusions: Interobserver agreement for breast pathology between pathologists at an NCI designated cancer center and outside institutions was good. However, 4.7% of women had discordant results that would lead to a change in their care. Changes were most common for noninvasive carcinoma and benign atypia. In order to best utilize resources, referral centers may want to consider limiting re-review to the pathology from centers with high risk for discordance.
Continuing to work while receiving cancer treatment: A financial or a symbolic issue?
Authors: Ganem Gerard , Naman Herve L. , Dohollou Nadine , Facchini Thomas , Coscas Yvan , Antoine Eric-Charles , Lortholary Alain , Catala Stephanie , Jacquot Stephane , Lhomel Christine , Eisinger François
Published: March 2020

6603

Background: As improved cure rates lead to longer life expectancy, occupational concerns during and after cancer treatment become important. The advent of new drugs with fewer side effects will increase the profile of this issue. We carried out a field survey to explore the question. Methods: We questioned 97 oncologists, and a subgroup of 216 patients treated for breast cancer who were working at the time of diagnosis and who wanted to continue to do so during at least part of the treatment period. Results: Data Collected from Patients: In total, 208 patients (96%) were satisfied or very satisfied with their jobs. Only 68 (31%) were able to achieve the goal of working without interruption while being treated (physicians estimated that figure at only 11%). For the remaining women, who did stop working (69%), the median number of days off work was 59. Data Collected from Physicians: A total of 87 physicians (89%) stated that having information regarding working conditions is very important when counseling patients about whether they could continue to work. Comparison of the answers given by patients and physicians: 36% of physicians thought that the initiative in addressing the work/job issue was taken primarily by themselves, while 53% felt it came from the patient. The patient perspective was different: 61% of patients thought they took the initiative themselves and only 13% of them thought the physician took the lead. The main reason behind the desire to continue working is thought by 56% of physicians to be “Financial gain”; while for patients it is “To feel the same” (42%). A total of 90 (92%) physicians feared that those patients continuing to work would face at least one type of medical difficulty; only 143 (66%) patients shared this fear. Lastly, although 94% of the physicians have access to psychological or psychiatric support workers at the health care center, only 62% have access to a social worker. Conclusions: Of the patients who really wanted to work while being treated for breast cancer, only 31% could achieve that goal without any interruption. There is also a difference of perception regarding patient motivation, with physicians believing that the reasons are mainly financial while the patients see it as more of a symbolic issue.
Shared decision making in radiation oncology: Implications for patient satisfaction.
Authors: Shabason Jacob Ezra , Mao Jun J , Frankel Eitan S. , Vapiwala Neha
Published: March 2020

6610

Background: Shared decision making (SDM) has been linked to healthcare quality outcomes, including patient satisfaction. However, the importance of SDM has not been evaluated in radiation oncology. This study aims to determine the association between patient-perceived SDM and patient satisfaction during radiation therapy (RT). We also explore patient desire for and perception of control during RT and its relationship to patient satisfaction. Methods: We conducted a cross-sectional survey of 305 patients undergoing RT at an urban academic cancer center. Patients self-reported measures of satisfaction and control during the last week of RT. SDM was measured using a 3-item validated instrument. The relationships between SDM, control over treatment decisions, and satisfaction were evaluated using chi-2 analyses. Results: The 305 participants had a mean age of 59.8 (range 18-87) and were 47.5% female. Ethnicities included white (75.7%), black (19.7%), Asian (2.6%), and Hispanic (0.7%). Tumor types represented were breast (19.7%), prostate (17.7%), head and neck (18%), gastrointestinal (15.1%), lung (13.4%), and other cancers (16.1%). Ninety (31.3%) patients reported experiencing SDM and 227 (76.2%) reported feeling very satisfied with their treatments. There were no significant differences in these outcomes based on demographic or clinical characteristics. Patients who experienced SDM were more likely to be satisfied with the care provided by their radiation oncologist (84.4% vs. 71.4%, p <0.02). Furthermore, the perception of having control in treatment decisions was associated with increased satisfaction regardless of whether the patient preferred control or not (Table). Conclusions: These findings emphasize the value of SDM in radiation oncology. Regardless of a patient's desire for control, it is important for physicians to engage patients in the decision making process. Both physician- and patient-targeted interventions may aid in improving SDM and, in turn, overall satisfaction among radiation oncology patients. [Table: see text]
A retrospective cohort study of inpatient chemotherapy utilization in hospitalized advanced lung cancer patients in the United States.
Authors: Kang Hyunseok , Kim Sungjin , Chen Zhengjia , El-Rayes Bassel F. , Brandes Johann Christoph , Saba Nabil F. , Khuri Fadlo Raja , Ramalingam Suresh S. , Owonikoko Taofeek Kunle
Published: March 2020

6611

Background: The administration of chemotherapy to patients with limited performance status and within 6 weeks of death is considered an indicator of poor quality care. We assessed predictors of inpatient chemotherapy use and the risk of death in hospitalized lung cancer patients treated with chemotherapy in the US. Methods: Data were obtained from all US states that contributed to the Nationwide Inpatient Sample (NIS) by Agency for Health Care Research and Quality (AHRQ) in 2006 and 2010. Lung cancer diagnoses and inpatient chemotherapy were identified using Clinical Classification Software (CCS) code which is based on ICD9 and CPT codes. Univariate and multivariate analyses were performed to compare patients based on chemotherapy administration using ANOVA, chi-square test, and logistic regression. Initial analysis in the 2006 NIS data was validated in the 2010 NIS data. Results: 24,025 and 24,323 eligible hospitalized lung cancer patients including 1,005 (4.2 %) and 869 (3.6 %) patients treated with chemotherapy were identified in 2006 and 2010 respectively. Female gender, radiation use, urban location and longer length of stay (LOS) were significantly associated with receipt of chemotherapy. Chemotherapy administration was associated with prolonged hospital stay (14.1 ± 9.8 vs. 8.8 ± 8.1 days, p<.001) and increased odds of death in unadjusted analyses. Adjusted analysis showed significant increased odds of death in chemotherapy-treated patients with metastatic disease (vs. no metastasis); poor performance status indicated by severe loss of function (vs. minor/moderate loss of function) and increased LOS (Table). Conclusions: Inpatient administration of chemotherapy to hospitalized US lung cancer patients is associated with higher mortality and can be explained by treatment given to patients with high co-morbidity and disease burden. [Table: see text]
Desire for and use of genetic testing in a population-based sample of breast cancer patients.
Authors: Hawley Sarah T. , Hamilton Ann S. , Graff John , Katz Steven J. , Jagsi Reshma
Published: March 2020

6615

Background: Prior research suggests that receipt of genetic testing to assess risk of disease in patients or their families is not limited to those who meet high-risk criteria (i.e., diagnosed at young age &/or with strong family history). There is little research from large population-based samples describing patterns and correlates of genetic testing receipt or reasons why patients undergo testing. Methods: We surveyed 2290 women newly diagnosed with breast cancer reported to the Detroit & Los Angeles SEER registries from 6/05-2/07. We merged these data to SEER and re-surveyed them again approximately 4 years later (n=1536). The primary outcomes were patient reports of a strong desire for genetic testing, participation in a discussion about genetic testing, and receipt of genetic testing. We also evaluated patient reports of reasons for getting tested. We compared dependent and independent factors using chi-square tests and used logistic regression to evaluate correlates of each outcome. Results: One third (33.9%) reported a strong desire to be tested, of whom 54% discussed testing with a health professional, & 46% were tested. A strong desire to be tested was associated with younger age (F=32.03, P<0.001), minority race (F=62.5, P<0.001), family history of breast &/or ovarian cancer (F=18.5, P<0.001) and worry about recurrence (OR: 1.8; 95% CI: 1.3-2.6). Overall, 19.3% were tested. Test receipt was significantly associated with younger age (F=26.8, P<0.001), higher education (OR: 1.8; 95% CI:1.13-2.71), and family history (F=25.1, P<0.001). Of those tested, reasons included: physician recommendation (61.8%), wanting more information about one’s own health (51.8%), wanting more information for family (54.2%), and family desire (13.6%). 7.8% of those not tested indicated it was because of the expense. Conclusions: Many women have a strong desire for genetic testing after diagnosis of breast cancer but often do not discuss testing with professionals. Desire for testing was correlated with pertinent clinical factors but also non-clinical factors such as minority race and worry about recurrence. Results suggest the continued need to address patient desire for testing and selection of appropriate patients for testing.
Predictors of early mortality and validation of novel prognostic models in Asian patients on phase I trials (PIT): A single-center experience.
Authors: Ahmad Aziah , Ong Whee Sze , Lim Wan-Teck , Tai Wai Meng David , Lim Cindy , Tan Eng-Huat , Choo Su Pin , Tan Daniel Shao-Weng
Published: March 2020

6618

Background: Despite the growing number of clinical trials conducted in Asia and the unique pt demographic and molecular profile of endemic cancers, there is still lacking of studies examining the outcomes of pts on PIT. We examined the characteristics and outcomes of pts enrolled in phase I trials in National Cancer Center Singapore (NCCS). Methods: We reviewed 296 pts enrolled in PIT from 2004-2012 to identify factors that predicted for 90-day mortality and OS. Logistic regression model and Cox proportional hazard model assessed factors associated with 90DM and OS, respectively. The discriminative ability of the RMH prognostic score (LDH, no of met sites, albumin) and the final multivariate Cox model derived in Asian pts was evaluated using Harrell’s concordance index (c-index), and that for the logistic model was based on area under ROC curve (AUC). Internal validation was performed based on simulated data via bootstrapping. Results: Median age 60 (23-85), M:F (65/35%). The commonest cancer type thoracic (56%), GI (24%), head and neck (12%). 57% pt had comorbidities, commonest diabetes (16.6%) and hepatitis B (11.1%). Median no of lines of treatment 2. 20% of pts had known mut status. 15% pts survived less than 90 days from start of trial. Median OS was 9.6 m (95CI 7.8-11.2 m). Based on the RMH prognostic model, pts with score of 0 to 1 had a superior OS (median OS = 12.9 m) compared to those with score of 2 to 3 (OS = 5.7 m) (p < 0.001). The c-index for the RMH prognostic score was 0.64. On univariate analysis, alb<35,LDH>ULN, ≥3 met sites, low BMI, ECOG>0, Na<135,plt>440, Hb<12 and ≥3 lines of chemo were negative prognostic factors. On multivariate analysis, reduced model selection techniques identified alb<35, LDH>ULN, ≥3 met sites, and ≥ 3 prior lines of chemo as independent negative predictors of OS with a bias-corrected of 0.69. For 90DM, we developed a risk normogram based on ECOG, WBC, Na and Hb as continuous predictors with bias-corrected AUC 0.78. Conclusions: We have developed a novel NCCS normogram to predict for 90DM for PIT. The RMH prognostic score can be improved upon with the addition of number of prior lines of chemotherapy, underscoring the importance of early access to phase I trials.
Concordance between abstracts, virtual meeting (VM) presentations, and final publication of phase III clinical trials presented at the Annual Meeting of the American Society of Clinical Oncology.
Authors: Khanna Suneil Kumar , Boyko Matthew John , Heng Daniel Yick Chin , Vickers Michael M. , Tam Vincent Channing
Published: March 2020

6622

Background: Phase III clinical trial results described in abstracts in the ASCO Annual Meeting Proceedings often differ from final results seen in publication. We hypothesize that the abstracts may act only as place holders, while the results presented at the ASCO Annual Meeting are more highly concordant with the final publication. Methods: A retrospective review of all abstracts submitted to the ASCO Annual Meeting in 2005 to 2007 was conducted. Inclusion Criteria: randomized, prospective phase III clinical trials of greater than 200 patients with at least one quantitative primary endpoint such as OS or PFS. For each abstract, we viewed the VM presentation and searched Pubmed and Medline for the corresponding publications. Data regarding the clinical trials was extracted from all three sources and statistical comparisons were made. Results: A total of 7,900 abstracts were screened from the ASCO 2005 and 2007 Annual Meetings, of which 124 met the inclusion criteria. An additional 43 studies were excluded due to absence of either a VM presentation or publication. The majority (96%) of these trials were presented as either an oral presentation or poster discussion. Key comparisons of the concordance between the abstract or VM presentation and the final publication are shown in the Table below. Conclusions: While the statistical significance of the primary endpoint and conclusions from all three sources are very similar, the results reported in VM presentations at ASCO Annual Meetings are a better representation of the final publication compared to the abstract. When relying on clinical trial results from these meetings to change clinical practice, physicians should refer to the VM presentation rather than the abstract. [Table: see text]
The use of routine surveillance imaging scans in women with early breast cancer (EBC) treated in Ontario, Canada.
Authors: Enright Katherine , Ghannam Mohammed , Yun Lingsong , Taback Nathan , Booth Christopher M. , Trudeau Maureen E. , Krzyzanowska Monika K.
Published: March 2020

6628

Background: Over use of routine surveillance imaging to detect recurrence in women with EBC was recently identified as one of the top five opportunities to improve the quality of cancer care by the American Society of Clinical Oncology. We undertook a population level assessment of the current practice of surveillance imaging in EBC women treated in Ontario Canada. Methods: Incident early breast cancer patients diagnosed 01/07 – 12/09 in Ontario, Canada were identified from the Ontario Cancer Registry. Patient records were linked deterministically to provincial health care databases to provide comprehensive medical follow-up. Basic (chest x-ray, abdominal x-ray and abdominal ultrasound) and advanced (computed tomography [CT] or bone scans) surveillance imaging scans completed during the first and second year of follow-up care (starting 6 months after surgery or upon completion of adjuvant chemotherapy) were identified. Logistic regression models were used to identify covariates associated with advanced surveillance imaging. Results: 16,981 EBC patients were included in the analysis of which 7,907(46.6%) received chemotherapy. In the first year of follow up care, 8,311 (48.9%) had at least 1 basic imaging test, while 4,916 (29.0%) had advanced imaging. This fell to 45.7% (basic) and 25.1% (advanced) in the second year of follow-up. Bone scans were the most common advanced imaging test (14.5%), followed by CT thorax (10.8%). On multivariable analysis age, stage, the use of chemotherapy and comorbidity were associated with increased use of advanced surveillance imaging (Table). Significant geographic variation was also demonstrated. Conclusions: Surveillance imaging was common in the first two years of follow-up for EBC patients. While appropriate for symptom driven investigation, attention should be paid to the routine use of surveillance imaging in EBC women during follow-up care. [Table: see text]