bluuebunny/crossref_metadata_2025_split huggingface dataset:
Identification of risk factors in mammographically occult contralateral breast carcinoma detected by magnetic resonance imaging (MRI)
Authors: Bernard J. R. , Vallow L. A. , Packianathan S. , Feigel D. G. , DePeri E. R. , Buskirk S. J. , Perez E. A. 
Published: March 2020

614 Background: An analysis of preoperative bilateral breast MRI at our institution suggests that approximately 1/3 of patients with newly diagnosed breast cancer may have a mammographically occult, but MRI-evident, contralateral breast abnormality. A number of these patients will have pathologic confirmation of carcinoma in the contralateral breast. Identification of risk factors to predict which patients are at high risk for having a mammographically occult contralateral carcinoma was performed. Methods: MRI results of 401 women with newly diagnosed breast carcinoma who underwent MRI were reviewed (overall group; OG). Patients with a contralateral abnormality identified only by MRI were analyzed to determine the incidence of contralateral carcinoma. In addition, the following risk factors were evaluated: Age at diagnosis, menopausal status, tumor size, nodal status, ipsilateral tumor histology, tumor grade, hormone receptor status, Her-2/neu receptor status, and whether the patient had a palpable vs. mammographically detected abnormality. Results: Pathologically confirmed contralateral carcinoma (CC) was found in 13 patients (3.2%). Similar percentages of patients in both groups (OG and CC) were noted in regard to tumor size, histology, grade, nodal status, Her-2/neu receptor status, and method of detection (palpable vs. mammographic). However, median patient age was 71 (CC) vs. 62(OG); 92% (12/13) were postmenopausal (CC) compared to 75% (OG); and 100% were ER positive (CC) vs. 81% percent (OG). Conclusions: Older, postmenopausal women who have ER + tumors may have a higher likelihood of having synchronous, contralateral, mammographically occult, MRI-detected breast carcinoma. Preoperative MRI may be beneficial in patients with similar risk factors; however, further follow up and additional experience is needed for confirmation of these findings. No significant financial relationships to disclose.
Comparing study of positron emission tomography and ultrasonography in the detection of axillary lymph node metastasis in patients with early stage breast cancer
Authors: Song B. , Bae J. , Kim J. , Jeon H. , Jung S. 
Published: March 2020

616 Background: The current status of axillary lymph node is the most important prognostic factor in breast cancer. Axillary lymph node dissection (ALND) is currently the standard option for assessment of axillary lymph nodes. Positron emission tomography - computerized tomography (PET-CT) imaging and breast sonography are a noninvasive imaging modality that can detect malignant lymph node. The purpose of this study was to evaluate the clinical usefulness of axillary lymph node staging by means of PET-CT imaging compare with breast sonography in breast cancer. Methods: This study involves 129 breast cancer patients and clinically negative axillary node. All patients had whole body PET-CT imaging and breast sonography before SLN biopsy. After SLN biopsy, all patients underwent complete ALND. Axillary lymph nodes were evaluated by standard hematoxylin and eosin staining techniques, while sentinel nodes were further examined for micrometastatic disease. The findings of PET-CT imaging and breast sonography of 129 patients were compared with pathologic findings after operation. Diagnostic accuracy was evaluated applying ROC curve areas. Results: The sensitivity of PET-CT imaging was 60.0%; specificity and accuracy were 83.6% and 73.4%, respectively. The sensitivity, specificity and accuracy of breast sonography were 61.8%, 89.0%, and 77.3% respectively. The SUVs of axillary lymph node ranged from 0.0 to 7.01. Analysis using ROC curves revealed the area under each curve which indicated a diagnostic accuracy. For involvement of axillary lymph node, PET-CT imaging had the area under the curve of 0.735, breast sonography one of 0.769. Conclusions: Axillary lymph node staging using PET-CT imaging is inferior to the breast sonography in early stage of breast cancer patients. Our study reveals the value of PET-CT imaging is not good compare to the breast sonography in the detection of axillary lymph nodes metastasis in patients with early breast cancer. No significant financial relationships to disclose.
Improvement in oncology practice performance through voluntary participation in the Quality Oncology Practice Initiative (QOPI)
Authors: Jacobson J. O. , Neuss M. N. , McNiff K. , Kadlubek P. , Thacker L. R. , Eisenberg P. D. , Simone J. V. 
Published: March 2020

6505 Background: QOPI became available to all ASCO physicians in 2006 as a voluntary office-based quality improvement project. QOPI assesses practice performance for a series of evidence- and consensus-based process measures, relying on practices to do structured chart reviews and submit data via a secure web-based portal. Methods: This analysis focused on the 71 practices that participated in both the March and September 2006 data collections. Of the 33 measures common to both collections, 14 were chosen for analysis based on adequate sample size and variation from the mean. Four additional measures relating to antineoplastic therapy administration were also analyzed. Results: : 87 practices abstracted 9,324 charts in March and 113 practices abstracted 14,292 charts in September. Among the 71 practices participating in both data collections, statistically significant improvement was seen in 9 of 18 measures (mean change 2.0%, median 1.9%, range -10.1 to 8.2%) from March to September. Improvement was most marked among practices originally performing in the bottom quartile (mean change 11.8%, median 10.2%, range -10.1 to 24.7%). Table 1 shows the magnitude of change for selected measures of the lowest performing practices compared to all others. Improvement was not assessable in 4 measures where performance was uniformly very high in the first data collection (these included all measures of appropriate antineoplastic treatment). Conclusions: Participation in QOPI is associated with improved performance in self-reported process measures, with the greatest improvement demonstrated in initially low-performing practices. (The late Dr. Christopher Desch was integral to the preparation of this report and the success of QOPI.) No significant financial relationships to disclose. [Table: see text]
When the goal is not cure: A randomized trial of a patient decision aid in advanced colorectal cancer
Authors: Leighl N. B. , Shepherd H. , Butow P. , Clarke S. J. , McJannett M. , Beale P. , Wilcken N. , Moore M. J. , Chen E. X. , Tattersall M. H. , Goldstein D. 
Published: March 2020

6509 Background: With improvements in treatment and supportive care, decisions in advanced cancer are increasingly complex. To facilitate decision-making, we developed a decision aid (DA) for patients considering first-line chemotherapy for incurable colorectal cancer, reviewing treatment options, prognostic information and toxicities. We examined its impact on patient understanding, consultation and decision- making satisfaction, anxiety, decisional conflict, quality of life, information preferences, and treatment decisions made. Methods: 207 newly diagnosed advanced colorectal cancer patients at 5 cancer centers in Australia and Canada were randomized to receive either a standard medical oncology consultation, or the same plus the DA, (take-home booklet with audio-recording, selected review by oncologist). Results: 100 were randomized to the control arm, 107 to receive the DA. Sample characteristics: median age 62 years, 58% male, 89% PS 0/1, 36% prior adjuvant chemotherapy. Patients in the DA arm demonstrated a greater increase in understanding of prognosis, options, benefits and toxicities (+19% vs +5.6%, p 0.001), with higher overall understanding (72% vs 60%, p<0.0001). Decision and consultation satisfaction, decisional conflict and quality of life were similar between groups. Anxiety, measured serially over 4–6 weeks, was similar and decreased over time. Most arrived at a decision during the first consultation; 80% chose chemotherapy, 7.5% supportive care alone, 10.5% a wait and watch strategy, with no differences between arms. 87% wanted as much information as possible, 82% wished to share decision-making with the physician, and only 15% felt the doctor alone should make the decision. More patients who received the decision aid felt they received all possible details about therapy, (72% vs 63%). 90% felt the decision was shared in part between physician and patient. Conclusion: This first randomized trial of a decision aid in advanced cancer patients shows that its use in advanced colorectal cancer improved patient understanding of prognosis, treatment options, risks and benefits without increasing anxiety. Decision aids can improve informed consent and decision-making, and can be tested through randomized trials even in the setting of advanced cancer. No significant financial relationships to disclose.
A tool for assessing adverse events in phase I/II oncology clinical trials
Authors: Coombes M. , Mukherjee S. , Kowaleski B. , Levine M. , Cosby J. , Arnold A. 
Published: March 2020

6518 Background: RECIST and NCI's Common Terminology Criteria are accepted systems that have standardized the reporting of oncology clinical trial outcomes. A standard system for attributing causality to Serious Adverse Events (SAEs) is lacking which can impact drug development and patient safety. The objectives of this study were to: 1) understand the clinical reasoning behind causality assessment during phase I/II oncology clinical trials; and, 2) use this information to develop a causality assessment tool for oncology. Methods: In-depth interviews were conducted with oncologists and trial coordinators at 6 Canadian academic cancer centres. Five main conceptual categories were explored: clinical reasoning; information resources; tools; challenges and concerns; and education. Interviews were recorded and transcribed verbatim. Individual interview content analysis was followed by thematic analysis across the interview set. A new causality assessment tool was developed based upon the qualitative findings and an analysis of existing generic tools. Results: Thirty-two interviews were conducted between May and August 2006 (65% participation). Half of participants were female, 66% were oncologists and 42% had more than 10 years of clinical trial experience. Data showed that participants use a common strategy to assess causality: they gather information, eliminate alternative explanations, and consider the study drug as the cause of the SAE. Over half cited the quality of information resources as a major factor contributing to uncertainty when assessing causality. Participants expressed the need for a standardized approach to causality assessment in oncology clinical trials. The tool developed in this study guides users to consider 5 statements related to potential alternative etiologies and 4 related to other factors that support a drug-SAE connection. The user is asked for their overall impression using a continuous probability rating scale. Conclusions: Attributing causality to SAEs is complex and uncertain. Clinicians describe using a logical system of reasoning, but have encountered barriers which must be addressed. We have developed and are validating a new tool to assist cancer clinicians in providing higher quality safety data about new cancer drugs early in development. [Table: see text]
Bisphosphonate use and osteonecrosis of the jaw: Pharmacovigilance and reporting of this serious adverse event from the Research on Adverse Drug Events and Reports (RADAR) project
Authors: Edwards B. J. , Gounder M. , McKoy J. , Raisch D. , Farrugia M. , Cesar M. , Marx R. , Ruggiero S. , Dimopoulos M. , Bennett C. 
Published: March 2020

6519 Background: Two years after zoledronate, received FDA approval, four dental professionals treated 107 cases of osteonecrosis of the jaw (ONJ). We review the timeline and source for initial recognition of ONJ and the comprehensiveness of dissemination of information on this adverse drug event. Methods: Data sources included primary case series from dental professionals; published case reports, clinical trials, and cases reported to the manufacturers or the FDA. Exposure adjusted incidence rates estimates were derived from manufacturer sponsored and investigator initiated review of claims data from large cancer centers. Safety notifications were disseminated by the manufacturers, regulatory authorities, and academic investigators. Results: Between 2001 and 2003, 107 patients with ONJ received care from dental professionals. In late 2003, and 2004 peer-reviewed case series were published. By 2006, safety databases maintained by the FDA, the manufacturer, and the RADAR project included information on 2,270, 1,178, and 368 cases of ONJ, respectively. In 2004 and 2005, incidence estimates of 0.8 and 22 ONJ cases per 1,000 person-years of intravenous bisphosphonate therapy were reported by the manufacturer and academic investigators. From 2003 to 2006, safety information from manufacturers, national regulatory authorities, case series, and clinical guidelines were disseminated. Conclusions: Recognition and reporting of ONJ occurred two years after FDA approval of zoledronate, dissemination of safety information occurred in the third year, and publications were disseminated from year three to year five. The life-cycle for identification and information dissemination for this serious adverse drug reaction was short and comprehensive. [Table: see text] [Table: see text]
New IRB guidelines: Will cancer patient safety improve?
Authors: Angelotta C. , Dorr D. , West D. , Burdon R. , Lagman J. , Workman D. , Hurdle J. , Belknap S. , Bennett C. L. 
Published: March 2020

6520 Background: Beginning in the 1990s, drug companies increasingly sent reports of all serious adverse events (AEs) to any Institutional Review Board (IRB) overseeing a trial using the agent involved, whether or not the same study was underway at that IRB site and regardless of the likelihood of a causal link between the event and agent. This led to a flood of AE reports and a small signal-to-noise ratio. Recent federal draft guidance emphasizes that regulations require investigators to notify IRBs only when there are “unanticipated problems involving risks to subjects or others. Consequently, many IRBs relaxed their reporting requirements, focusing only on unanticipated events. The objective of this study is to estimate how adoption of the new guidance affects IRB workload and patient safety. Methods: We reviewed AEs reported since 2004 to the IRB at Oregon Health & Science University for eight oncology drugs: bevacizumab, gefitinib, imatinib mesylate, oxaliplatin, bortezomib, sorafenib, sunitinib, and cetuximab. We defined unanticipated AE as any AE not included in the patient consent forms. Results: Forty-seven studies were reviewed with 885 unique AEs reported for the eight drugs. Of these, 494 were unanticipated, meaning the event was not described in the consent form. Thus, the IRB workload would decrease by 44% under the new guidance. Twenty-six AEs led to actual consent form changes, suggesting these signal events represented serious, related, but previously unknown toxicities of the study drug. This led to a signal-to-noise ratio improvement from 3% to 5.3%. For imatinib mesylate, the signal-to-noise ratio improved from 4.1% (14 signals out of 339 reports) to 7.8% (14 signals out of 179 reports), the largest improvement of the drugs studied. Conclusions: These results suggest that adoption of the new guidance may improve signal detection capabilities of local IRBs while decreasing workload. More empirical evidence is needed to ensure patient safety. Enhanced pharmacovigilance practices at the IRB level should lead to improved detection of serious AEs during clinical trials - before the drug is approved and widely available to veterans. In addition, improving the signal-to-noise ratio should allow IRBs to improve the welfare of cancer research subjects. [Table: see text]
Patient-centered validation of 11 symptom indices to evaluate response to chemotherapy for advanced cancer
Authors: Rosenbloom S. K. , Beaumont J. , Diaz P. , Yount S. E. , Abernethy A. P. , Jacobsen P. B. , Paul D. , Syrjala K. , Von Roenn J. H. , Cella D. 
Published: March 2020

6524 Background: Symptom burden in advanced disease has relevance both for clinical practice and in evaluating the efficacy of new chemotherapeutic agents. This study aimed to identify patients’ highest priority symptoms for 11 advanced cancers, compare priority ratings with those obtained from clinicians, and construct brief symptom indices based on their combined input. Methods: 534 patients with advanced bladder, brain, breast, colorectal, head/neck, hepatobiliary/pancreatic, kidney, lung, lymphoma, ovarian or prostate cancer from a subset of National Comprehensive Cancer Network (NCCN) member institutions and 4 Cancer Health Alliance of Metropolitan Chicago organizations completed a survey of priority symptoms and concerns and a disease-specific FACT QOL measure. 112 physicians at NCCN institutions completed a rating of whether symptoms and concerns were considered disease- or treatment-related. Symptoms endorsed more often than chance probability were retained. Expert clinician and patient ratings were equally weighted in item selection. Responses to symptom index items drawn from the QOL questionnaires allowed for validation analyses. Results: Items comprising 2 to 3 subscales (up to 20 items in length) were retained for each of the 11 disease-specific symptom indices. Content-determined subscales consisted of symptoms and concerns that were 1) exclusively or predominantly disease-related symptoms (DRS); 2) exclusively or predominantly treatment side effects (TSE); and 3) descriptive of general function or well-being (F/WB). For example, the NCCN/FACT Breast Cancer Symptom Index (FBSI) contains 17 items: 8 DRS, 4 TSE and 5 F/WB. Data on 14 of 17 FBSI items showed good internal consistency (a=.89). Correlations between FBSI and FACT-B scores were high for physical well-being, functional well-being and breast cancer subscales (r = 0.83, 0.77, and 0.61 respectively). Correlation with emotional well-being subscale was 0.55. FBSI scores differed across PSR groups in the appropriate direction (p<0.0001). Conclusions: NCCN/FACT disease-specific questionnaires have been transformed into brief, patient-centered symptom indices that can be used as stand-alone measures in oncology research and practice. No significant financial relationships to disclose.
A study of informed consent (IC), age, and cognitive function (CF) among advanced cancer patients (acp) in phase I trials
Authors: Hlubocky F. J. , Larson E. , Sachs G. , Daugherty C. K. 
Published: March 2020

6548 Background: Ethical concerns exist about acps’ ability to provide adequate informed consent (IC) for phase I trials. While cognitive impairment (CI) among acp is well-recognized due to multiple factors, e.g., previous effects of chemotherapy, age, psychological status, the prevalence of CI among acp in phase I trials has never been described. Methods: Acp CF was assessed using a neuropsychological battery of instruments: Hopkins Verbal Learning (HVLT); Verbal Fluency; Mini-Cognitive Assessment; Trail-making (Parts A& B); Boston Naming (short); WAIS subtests (Comprehension and Digit Span). Acp underwent semi-structured interviews to evaluate elements of IC, and completed the FACT-COG and the Hospital Anxiety and Depression Scale (HADS). Results: To date, a total of 34 acp enrolling in Phase I trials have been studied. Median age: 63y (range: 38–81y); 77% male; 77% Caucasian; 67% > HS education. Regarding IC understanding: Only 20% of responding acp correctly identified the purpose of Phase I trials; all subjects could recall risks of side effects, correctly stated they could refuse trial participation, and stated they could withdraw at anytime; 53% believed the trial was their only option. Older acp (>age 55y) were less likely to correctly describe the research purpose of the trial (29% v. 71% p=0.02). Older acp had measurable deficits in CF: Boston Naming (14±0.9 v.15±0.3, p=0.09); HVLT Total Recall (14±2 v.26±6, p<0.00) and Discrimination Index (7.5±3 v.11±1, p=0.03); Digit Span-Backwards (4±2 v.7±2, p<0.00); Trail-making B (244±64 v.188±51, p=0.04). While there were no differences in perceived CI (95±18 v.101±19, p=0.5) or impact on quality of life (25±7 v. 27±5, p=0.5), both groups had scores well below prior reported means. Older acp tended to report depressive symptoms more than younger acp (8±2 v.6±1, p=0.07). Conclusions: Our data suggest that CF may play a role in acp understanding of IC for clinical trials, especially among the elderly. Further research is needed, given ethical concerns regarding elderly acp in clinical trials of experimental agents who may have CI. No significant financial relationships to disclose.
Determining knowledge transfer gaps in the life cycle of evidence for chemotherapy in non-small cell lung cancer (NSCLC) through cumulative meta-analysis
Authors: Reaume M. N. , Nurbhai M. , McGowan J. , O'Rourke K. , Moja P. L. , Evans W. K. , Graham I. D. , Grimshaw J. M. 
Published: March 2020

6555 Background: The uptake of research findings into practice is often delayed (Antman et al. JAMA 1992). We investigated the relative role of evidence in determining clinical recommendations and practice for NSCLC. Novel chemotherapy agents (NCA) approved for use in Canada between 1992 and 2002 were eligible. Methods: We conducted a systematic review of evidence for vinorelbine (V), paclitaxel (P) and gemcitabine (G) in combination with a platinum agent for the treatment of advanced NSCLC. Primary endpoint of efficacy was median survival. For each included randomized controlled trial (RCT), the publications dates of abstracts and journal articles were considered. At each time point when new data was available, a new meta-analysis using the Follman methodology was performed. Bibliometric analyses were performed to identify key milestones for each drug (e.g. Health Canada Notice of Compliance, provincial drug funding, and clinical recommendations). Results: 3,399 references were obtained for NCA in advanced NSCLC. Eligibility review identified 20 references for V representing 6 RCTs (1994–2002), 16 for P representing 4 RCTs (1997–2000), and 10 for G representing 7 RCTs (1998–2003). All drugs trended towards median survival benefit throughout the time of analysis. However, over time the estimated effect for V became weaker, remained stable for P and became stronger for G. The 1997 ASCO guideline recommended V and P as standard therapy; G was only cited as a promising investigational agent. By 2003, the ASCO guideline recommended G as a standard. Only V received Ontario provincial funding in 1997, while G and P received funding in 2002 and 2003 respectively. Conclusions: This study demonstrates the relatively small pool of RCT evidence for NCAs. These three commonly used NCAs demonstrate different patterns of evolution of evidence. For advanced NSCLC, the time gap between evidence and clinical recommendations is short. Caution should be used for generating recommendations using early results, when the evidence base is not stable, which may either over or underestimate true effectiveness. No significant financial relationships to disclose.