bluuebunny/crossref_metadata_2025_split huggingface dataset:
Recurrence score and clinicopathologic characteristics of TAILORx participants by race and ethnicity.
Authors: Sparano Joseph A. , Gray Robert J , Zujewski Jo Anne , Whelan Timothy Joseph , Albain Kathy S. , Hayes Daniel , Geyer Charles E , Dees Elizabeth Claire , Perez Edith A. , Keane Maccon M. , Vallejos Sologuren Carlos , Goggins Timothy F , Mayer Ingrid A. , Brufsky Adam , Toppmeyer Deborah L , Kaklamani Virginia G , Atkins James N , Berenberg Jeffrey L , Sledge George W. 
Published: February 2017

36 Background: Black race is associated with worse outcomes in localized breast cancer. We evaluated the characteristics of patients enrolled in the Trial Assigning Individualized Options for Treatment (TAILORx) by race and ethnicity. Methods: The analysis included 10,071 evaluable patients with Recurrence Score (RS) data. Eligibility criteria included: (1) T1-2, N0 disease, (2) estrogen receptor (ER) and/or progesterone receptor (PR) positive disease that was also HER2/neu negative, (3) age 75 years or younger and medically appropriate for adjuvant systemic chemotherapy. Results: The study population included 8,501 whites (84%), 722 blacks (7%), 423 Asians (4%), and the remainder other/unknown race. With regard to ethnicity, 7,916 were nonHispanic (79%), 919 were Hispanic (9%), and 1,236 were of unreported ethnicity (12%). There was no significant difference in RS distribution (p = 0.14), median RS (17 vs. 17), and mean RS (19.6 vs. 18.4) in blacks compared with nonblacks. There was likewise no difference in Hispanic vs. nonHispanic ethnicity for RS distribution (p = 0.53), median RS (17 vs. 17), and mean RS (18.6 vs. 18.4). Blacks were significantly more likely to be younger (39% vs. 30% < 50 years), have larger tumors (37% vs. 31% > 2 cm), poor histologic grade (25% vs. 17%), and PR-negative disease (14% vs. 10%) (Chi square test p < 0.05). Hispanic women were also significantly younger (39% vs. 30% < 50 years), and demonstrated marginal but statistically significant differences in tumor size (65% vs. 69% > 2 cm), histologic grade (20% vs. 18% poor), and PR expression (12% vs. 10% negative) (Chi square test < 0.05). In 974 patients with information on body mass index (BMI), there was no correlation between BMI and RS (r = -0.04). BMI was higher for blacks than whites (medians 31.6 vs. 28.9, p = 0.02, Wilcoxon test), but not in Hispanics. Conclusions: In patients selected for participation in TAILORx there were no significant differences in RS by race, ethnicity, and BMI. Black and Hispanic patients were significantly younger, and blacks had tumors that were larger and more likely to be associated with poor grade. Clinical trial information: NCT00310180.
A NSQIP analysis of 30-day complications after bilateral versus unilateral mastectomy with immediate reconstruction.
Authors: Silva Amanda Kathryn , Lapin Brittany , Yao Katharine , Song David H. , Sisco Mark 
Published: February 2017

62 Background: Women with breast cancer are increasingly electing to undergo contralateral prophylactic mastectomy (CPM) despite questionable survival benefit and limited data on added risks. This study seeks to assess differences in perioperative complications between those who have bilateral mastectomy with reconstruction (BM/R) and unilateral mastectomy with reconstruction (UM/R). Methods: The American College of Surgeons National Surgery Quality Improvement Program Participant Use Files (2005-2012) were used to identify women with breast cancer undergoing UM/R or BM/R. 30-day complications after implant-based or autologous reconstruction were compared between UM/R and BM/R groups. Linear and logistic regression models were used to adjust for differences in age, obesity, smoking, diabetes, and hypertension between groups. Results: 18,229 patients were identified, of whom 6,502 (35.7%) underwent BM/R. Most patients underwent implant-based reconstruction (88.6% of BM/R and 79.4% of UM/R). Among patients with implant-based reconstruction, BM/R was associated with higher rates of implant loss (adjusted odds ratio [aOR] 1.55, p=0.02), transfusion (aOR 2.20, p<0.001), and reoperation (aOR 1.14, p=0.05) than was UM/R. Patients who had BM/R with autologous reconstruction were more likely to require transfusion (aOR 2.34, p<0.001) than those who had UM/R. BM/R was associated with a greater length of hospital stay (LOS) than was UM/R for implant and autologous reconstruction groups (aOR [for LOS ≥ 2 days] 2.22 and 2.25, respectively, p<0.001). There were no significant differences in rates of medical complications, surgical site infection, or wound disruption between UM/R and BM/R groups for either type of reconstruction. Conclusions: Women who undergo implant-based BM/R have a greater risk of implant loss and reoperation then those who undergo UM/R. Those who have BM/R are also more likely to require a transfusion and have a longer hospital stay, regardless of reconstruction type. Women considering CPM with reconstruction should be educated about these increased risks.
Predictors of performing response monitoring in patients with chronic-phase chronic myeloid leukemia (CP-CML) in a prospective observational study (SIMPLICITY).
Authors: Goldberg Stuart L. , Cortes Jorge E. , Gambacorti-Passerini Carlo , Khoury Hanna Jean , Mauro Michael J. , Paquette Ronald , Simonsson Bengt , Foreman Aimee , Rasouliyan Lawrence , Mohamed Hesham , Subar Milayna , Zyczynski Teresa Maria 
Published: February 2017

116 Background: Previous SIMPLICITY data (ASCO 2014) have shown, in CP-CML patients (pts) with at least 12 months (mths) follow-up, monitoring for cytogenetic response (CyR) and molecular response (MR) differs from NCCN/ ELN recommendations and shows regional and practice-type variation. Few data describe predictors of monitoring. Methods: SIMPLICITY is an ongoing observational study of CP-CML pts receiving first-line (1L) imatinib (IM), dasatinib (DAS) or nilotinib (NIL) in the United States (US) and Europe (Eu); its primary objective is to understand tyrosine kinase inhibitor (TKI) management patterns in clinical practice (NCT01244750). Frequency of testing for CyR, by FISH or karyotype, and MR, by PCR, were analyzed in 3, 6 and 12 mth increments from TKI start. Stepwise multivariable logistic regression was performed to assess predictors of monitoring (including: age, sex at birth, region, practice type, 1L TKI, ECOG performance status, still on 1L TKI). Results: 1,083 pts (US: 66%; Eu: 34%) were enrolled prospectively through 1Apr2014, receiving IM (n=415), DAS (n=343) or NIL (n=325). 1,050, 985 and 862 pts were followed for at least 3, 6 and 12 mths, respectively. Of these, 15%, 34% and 49% were tested for CyR, and 27%, 65% and 83% were tested for MR, between 0–3 mths, 0–6 mths and 0–12 mths. By 3 mths, 33% had either CyR and/or MR testing and 88% of pts underwent testing by 12 mths. None of the candidate predictors distinguished between pts who were monitored vs. those that were not by 3 mths after start of 1L TKI. Pts <65 years (yrs) at start of 1L TKI (odds ratio [OR]=1.41) and those in Eu vs. US (OR=1.45) were more likely to be monitored by 6 mths. By 12 mths, pts <65 yrs (OR=2.27), those no longer on 1L TKI (OR=1.96), and those seen in academic centers (OR=1.59) were more likely to be monitored (all p<.05). A comparison of monitoring patterns with ELN/NCCN recommendations will also be presented. Conclusions: Two-thirds of pts were not monitored for CyR or MR within 3 mths of TKI start.Although there were no predictors of monitoring for CyR or MR by 3 mths, age <65 yrs at initiation of 1L TKI was a consistent predictor of monitoring by 6 and 12 mths. Clinical trial information: NCT01244750.
Modeling and improving chemotherapy patient flow.
Authors: Lennes Inga Tolin , Zenteno Langle Ana Cecelia , Duk Michael , Levy Carlis Avital , Bloom Mara , Souza Elizabeth , Levi Retsef , Ryan David P. 
Published: February 2017

175 Background: Chemotherapy administration scheduling is dependent on infusion room hours of operation, availability of oncologist, capacity for treatment, pharmacy hood time, nursing and pharmacy staffing, and physical space limitations. In 2013, the main infusion center at MGH Cancer Center had 45% room/chair utilization reported by the Ambulatory Patient Tracking System and 33% exam room utilization in the clinics. However our infusion center experienced extremely high volume during peak hours, 10am to 2pm, but was underutilized before 10am and after 2pm, making it difficult to add on additional patients. Methods: In November 2013, MGH Cancer Center began collaboration with MIT Operations Management experts to ultimately improve patient flow through the Cancer Center by flattening the bottleneck at peak hours of operation and improving utilization of the infusion area and clinics. In phase I of the project, data was reviewed and refined. Key role groups of schedulers, prescribers, pharmacists and infusion nurses were shadowed by collaborators to gain insight into complex scheduling practices. A multidisciplinary working group met weekly to discuss the progress and suggest areas for further investigation. In phase II, optimization models testing the impact of alternative scheduling practices, physical space changes and alternative clinic configurations will be created. Finally, in phase III, change implementation and measurement will take place. Results: Process flow maps of patient movement through the cancer center were created. Patient tracking data was manipulated to understand key operational metrics. Several insights include an overall same-day chemotherapy cancellation rate of 10.7%, with the majority of cancellations from thoracic, GI and GU disease centers. Our mean scheduled infusion treatment length was 2.13 hours and 25% of appointments booked into infusion are not linked with a same-day clinic appointment. Conclusions: Understanding and refining incomplete or problematic data was a key part of understanding the issues contributing to the middle of the day bottleneck in the infusion area. Future work on this project will include optimization modeling and change implementation.
Enhancing the delivery of take-home cancer therapies in Ontario.
Authors: Rae Erin , Chan Amanda , Yeung Lyndee , Gavura Scott , Arias Jessica , Kukreti Vishal , Kaizer Leonard 
Published: February 2017

46 Background: The delivery of systemic cancer therapy has expanded from primarily intravenous (IV) treatment, delivered in cancer centres, to include significant use of take-home cancer therapies (THCT) (e.g., oral medications). An industry pipeline survey suggests half of new cancer drugs are expect to be THCT. While IV treatments administered in hospitals are publicly funded for Ontario residents, public funding of THCT is dependent on age, socioeconomic status, and other factors. The delivery of these therapies may also take place outside the cancer centre. While the lack of universal funding is cited as a significant barrier to access, the growing use of THCT has introduced other system delivery questions. Cancer Care Ontario recently hosted a “Think Tank” to inform public policy recommendations for system change to enhance the delivery of THCT in the province. Methods: The day was highly interactive with health professionals and patient participants, and was structured around a case study of a patient receiving both IV and THCT. Approaches taken with THCT in other Canadian provinces were examined. Participants used a multi-dimensional framework (safety and quality; reimbursement and distribution; data and information) to develop recommendations across pre-defined “checkpoints” in the patient’s treatment journey. Pre-assigned groupings of participants with common professional/patient backgrounds developed recommendations that were subsequently prioritized by reassigned multidisciplinary groups. Results: Over 80 stakeholders developed and prioritized more than 180 recommendations. Major themes included education, technology levers, and drug access model reform. This advice will inform system planning and next steps in defining opportunities for system change. The majority of participants (84%) felt the event broadened their understanding of THCT delivery issues. Conclusions: The strategic design of the “Think Tank” facilitated the development of robust recommendations for improving the delivery and reimbursement of THCT. These recommendations, along with the lessons learned from other provinces, will provide the foundation for potential policy and system changes to enhance the quality of THCT delivery in Ontario.
Evaluation of nausea control with NEPA, a novel oral combination antiemetic.
Authors: Bosnjak Snezana , Schwartzberg Lee Steven , Rizzi Giada , Borroni Maria Elisa 
Published: February 2017

169 Background: The introduction of NK1 receptor antagonists (RAs) improved the control of chemotherapy-induced nausea and vomiting. However, prevention of nausea, particularly in the delayed phase remains suboptimal, with no consistent superiority seen with the addition of aprepitant over 5-HT3 RAs + dexamethasone (DEX). NEPA, a fixed-dose oral combination of the new NK1RA, netupitant (NETU 300 mg) plus palonosetron (PALO 0.50 mg) targets two main antiemetic pathways with a convenient single dose. NEPA has shown superior complete response rates (no vomiting and no rescue use) compared with PALO in pivotal trials. This analysis summarizes the nausea control seen with NEPA in all 3 pivotal trials in the clinical development program. Methods: Patients in 3 randomized, double-blind trials received a single dose of NEPA + DEX prior to a variety of either highly emetogenic (HEC) (Studies 1 and 3) or moderately emetogenic (MEC) (Studies 2 and 3) chemotherapeutic agents. Patients receiving HEC also received additional DEX on Days 2–4. Nausea was measured daily with a 100 mm visual analog scale (VAS). The proportion of patients with no significant nausea (VAS <25 mm) were summarized (Table). Results: In Studies 1 and 2, NEPA was significantly more effective in controlling delayed and overall nausea compared with PALO (Table). The greatest nausea control with NEPA was seen in the non-AC MEC and HEC settings. Conclusions: This summary suggests that NEPA + DEX improves control of nausea during the delayed and overall periods following chemotherapy. High levels of nausea control were seen and were most noteworthy in patients receiving HEC or non-AC MEC. Clinical trial information: NCT01339260; NCT01376297. [Table: see text]
Developing a decision support tool for responding to patients’ reported levels of information needs, family anxiety, depression, and breathlessness.
Authors: Vliet Liesbeth van , Harding Richard , Bausewein Claudia , Payne Sheila , Higginson Irene J. ,   EUROIMPACT
Published: February 2017

173 Background: Routine clinical use of Patient Reported Outcome Measures (PROMs) such as the Palliative Care Outcome Scale (POS) may be prevented by a lack of guidance on how to respond to reported symptoms. When using POS in clinical care, clinicians encounter the most difficulties with responding to information needs, depression and family anxiety while breathlessness remains a difficult to treat symptom. We aimed to create a Decision Support Tool (DST) on how to respond to different levels of these patient-reported symptoms. Methods: A systematic search for guidelines and systematic reviews on these topics was conducted (in Pubmed, Cochrane and York DARE databases, Googlescholar, NICE, National Guideline Clearinghouse, Canadian Medical Association, Google.com). In a two-round online Delphi study purposefully sampled international experts (clinicians, researchers, patient representatives) judged the appropriateness (1-9 scale + do not know option) of drafted recommendations for each POS answer category (0-4) and provided qualitative remarks. Recommendations with a median of 7-9 and <30% of scores between 1-3 and 7-9 were included in the DST. Quality was assessed using an adapted GRADE approach. Results: Twenty-five out of 38 (66%) experts participated in round 1, 23 out of 37 (62%) in round 2. Higher POS scores were related to more included recommendations. The DST consists of both a manual and flow-charts of included recommendations for each topic. Overall, psychosocial interventions were recommended for lower levels of depression and breathlessness than drug interventions (e.g., goal-setting/coping versus morphine for breathlessness). Good communication and emotional support were recommended for low family anxiety levels, but a social needs assessment only for higher levels. For information needs recommendations were least discriminative; almost all recommendations (e.g., assess patients’ understanding of information, show empathy) seemed always relevant. Conclusions: The developed DST can assist clinical responses to patient-reported symptoms in palliative care. Future work is needed to test the effect of using the DST on patients’ outcomes.
Preliminary results from a phase I study of substance P-saporin in terminal cancer patients with intractable pain.
Authors: Frankel Arthur E. , Nymeyer Hugh , Lappi Douglas A. , Higgins Denise , Ahn Chul , Noe Carl 
Published: February 2017

191 Background: For 10-15% of cancer patients, pain cannot be controlled using existing therapies (Zech et al., Pain, 63, 65-76, 1995). SP-SAP is the first targeted toxin to undergo phase I testing for pain. SP-SAP (Wiley and Lappi, Neurosci Lett, 230, 97-100, 1997) covalently linkes substance P (SP), a neuromodulator that binds to NK1 receptors on laminae I and X of the dorsal horn, and saporin (SAP), a ribosomal toxin that ablates cells that express NK1 and endocytose the toxin. Intrathecal injections of SP-SAP in rats reduce chemically or thermally induced pain, thermal hyperalgesia, and mechanical allodynia, with no signs of motor, sensory, or behavioral dysfunction (Mantyh et al., Science, 278, 275-9, 1997; Nichols et al., Science, 286, 1558-61, 1999; Suzuki et al., Nature Neurosci, 5, 139-26, 2002; Vierck et al., Neurosci, 199, 223-32, 2003). In canines, intrathecal injections into the lumbar region – 45 mcg for 10-15 kg (Allen et al., Toxicol Sci, 91, 286-98, 2006) or 15 mcg for 8-12 kg (Wiese et al., Anesthesiol, 119, 1163-77, 2013) – produce no neurological, behavioral, or histological deficits. A double-blinded RCT of SP-SAP for the treatment of bone pain in canines (Brown and Agnello, Anesthesiol, 199, 1178-85, 2013) showed that a single injection of 60 mcg (above 30 kg) or 40 mcg (below 30 kg) significantly reduced pain as measured by time to owner unblinding (p=0.002) or number of canines unblended (p=0.001). Methods: A single intrathecal injection of SP-SAP is made at the L5-S1 interspace of cancer patients with intractable sub-umbilical pain. Single subject cohorts are at doses of 1, 2, 4, 8, 16, 32, 64, and 90 mcg. Primary outcomes are assessed by pain survey (VAS “bothersome pain”, VAS “pain intensity”, ODI, EQ-5D, and BDI) and medication use log. Patients are monitored for toxicity, neurological and cardiac abnormalities, and SP-SAP antibodies for 6 months. Results: This report presents the results from the first three subjects of the phase I study. No evidence of toxicity or neurological or cardiac abnormalities were found. No clear evidence for pain reduction was observed. Conclusions: At existing doses (< 4 mcg), SP-SAP appears safe for human use. The study is continuing with dose escalation. Clinical trial information: NCT02036281.
Reducing patient suffering and preventing readmissions via supportive care screening: The James Cancer Hospital supportive-care screening model.
Authors: Wells-Di Gregorio Sharla , Zaleta Alexandra , Porensky Emily , Graham Lisa , McDowell Kelly , Snapp Janet 
Published: February 2017

33 Background: Hospital admissions create physical, financial and emotional stress for oncology patients. Hospital avoidable readmissions are considered a marker of poorer quality patient care. To reduce readmissions, cancer hospitals must understand modifiable readmission risk factors AND establish screening systems to triage at-risk patients to outpatient palliative/supportive care services. The James Cancer Hospital is in Phase II development of a model to reduce patient suffering and readmission via the James Supportive Care Screening (JSCS), a 48-item validated clinical-research instrument. Methods: In 2013, the James Cancer Hospital began implementation of Supportive Care Screening to meet Standard 3.2 (Psychosocial Distress Screening) of the Commission on Cancer. The JSCS asks patients to rate distress in six palliative care domains including emotional concerns, physical symptoms, social/practical problems, spiritual problems, cognitive concerns, and healthcare decision-making/communication issues. Between January 2011 and December 2013, one-thousand and one patients completed the JSCS in the Outpatient Palliative Care clinic. During this period, 57 patients had at least one readmission. Hierarchical linear regression was used to predict the number of future readmissions with JSCS subscales as independent variables. Results: The overall model predicting readmissions was significant, F(7,959) = 37.074, p<.001. Time to readmission, physical symptoms, emotional concerns, spiritual concerns, and social concerns were significant predictors of patient readmission. We are currently examining palliative care outcomes in these domains and have found that outpatient palliative care significantly reduces suffering related to physical and emotional distress. Conclusions: Supportive care screening, can serve to reduce oncology readmissions and prevent patient suffering in six key palliative domains. During Phase II of the James Supportive Care Screening Model, we have identified several problem areas targeted to reduce readmissions and improve patient self-reported outcomes.
Impact and timing of palliative care referral.
Authors: Blackhall Leslie J , Read Paul W , Stukenborg George , Barclay Margaret , Dillon Patrick M , James Harrison , Barclay Joshua 
Published: February 2017

50 Background: Recent studies suggest that early integration of palliative care services into the care of patients with advanced cancer can improve end of life care. Unfortunately, there are insufficient resources for all advanced cancer to see palliative care from time of diagnosis. This 2012 CMS innovation award is attempting to improve identification of cancer patients in need of palliative care. Methods: In Year 1 of this award, increased staffing was added to existing palliative care resources to improve access. Patients were referred at discretion of their oncologist. A control group consisting of patients with similar diagnoses not referred to palliative care was identified including those without any contact with palliative care, and those who only saw palliative care in the hospitalization prior to death. Data regarding hospitalization in the last month of life, and hospice utilization was obtained. Results: Median time between referral to palliative care clinic and death was 72.5 days (mean 112). See table below. Conclusions: These data suggest patients referred to palliative care clinic within 3 months of death had benefits similar referral at time of diagnosis. However, many patients were never referred or referred only at the very end of life. The next phases of this award will utilize patient-reported outcome data to better identify those who need palliative care. Although most palliative care services are hospital-based, in this study, in-patient consultation only was too late to provide much benefit for these patients. Re-focusing scarce palliative care resources to the out-patient setting may have greater impact on patient care. [Table: see text]