bluuebunny/crossref_metadata_2025_split huggingface dataset:
Opportunities for improvement (OFI) in guideline concordance (GLC) at National Comprehensive Cancer Network (NCCN) member institutions (MI).
Authors: Lyle Jennifer , Vandergrift Jonathan L. , Kulig Kimary ,   NCCN OFI Working Group
Published: February 2017

172 Background: The NCCN is implementing a performance improvement initiative using breast cancer (BC) practice data from NCCN MIs to improve institutional delivery of GLC and identify tailored opportunities for improving efficiency and quality of care delivered. Methods: This initiative includes evaluation of baseline GLC, review of non-concordant (NC) cases, design of tailored institutional interventions, and post-intervention evaluation of GLC and reasons for NC. BC patients presenting from July 2007 to March 2009 at 11 NCCN MIs were included in the baseline review. Six Category 1 GLC and 3 ASCO/NCCN quality measures evaluating adjuvant chemotherapy (CTX), endocrine therapy (ET), and radiation (XRT) were reviewed. GLC was assessed using the NCCN Outcomes database. Results: Aggregate GLC across all measures was 90% (MI range 66% to 100%). Review of NC cases was used to develop tailored OFI interventions. Three MIs are focusing on clinical practice improvement via provider education and feedback and integration of electronic medical record flags for treatment consideration. Nine MIs are working on improving access and reducing time-to-treatment lags. Currently, half of MIs are implementing and half are evaluating OFI interventions. Conclusions: This program supports data-driven QI efforts at MIs with the goal of improving efficiency and quality of care delivered to patients at participating sites, as well as serving as a model for data-driven quality improvement programs. [Table: see text]
Impacts of toxicity on patient treatment choices for metastatic breast cancer.
Authors: White Carol B. , Smith Mary Lou , Abidoye Oyewale O. , Lalla Deepa 
Published: February 2017

18 Background: Most patients with metastatic breast cancer (MBC) are treated with chemotherapy and/or targeted therapy with varying toxicity profiles. Experience with adverse events (AE) may vary and factor into subsequent treatment decisions. As newer agents and combinations become available, it becomes increasingly important to understand which AEs impact treatment decisions. Methods: The objective was to assess patient experience with AEs and preferences for future treatments. Following focus groups and pretests, an online survey was released by breast cancer organizations to recruit patients with MBC. The survey assessed the impact of experiences on future treatment choices and measured preferences via conjoint analysis (CA). Results: A total of 551 respondents completed the online survey. Among the AEs studied to assess their impact on either treatment stops or breaks, neutropenia topped the list, particularly for a required break. Fatigue, hand and foot syndrome, diarrhea, joint pain and peripheral neuropathy (PN) were high for chosen stops. Five AEs (fatigue, alopecia, diarrhea, PN, neutropenia) were studied extensively. Almost all respondents report experiencing fatigue, ~80% experienced alopecia, and ~66% each of the other 3 AEs. For each AE, the majority of respondents reported their prior experience would not impact a future decision involving the same AE; about 1/3 report they’d be more likely to take a treatment with the same AE; 8% to 18% would be less likely to take a treatment with the same AE. CA was also used to assess influence of the 5 AEs on future decisions. Within the tested ranges of likelihood, severity and duration, alopecia had the highest impact; PN, diarrhea, and neutropenia were in the middle; and fatigue was lowest. Further analysis is ongoing and final results will include differences in patient subgroups. Conclusions: This information informs priorities for development of new therapies allowing additional attention on AEs that matter most to patients. In addition, these results may generate discussion and consideration of patient preferences in conversations about care and treatment selection.
Radiotherapy protocol deviations and clinical outcomes: A meta-analysis of cooperative group clinical trials.
Authors: Ohri Nitin , Shen Xinglei , Dicker Adam , Doyle Laura , Harrison Amy , Showalter Timothy Norman 
Published: February 2017

181 Background: Several reports have linked noncompliance with radiotherapy (RT) protocol guidelines with inferior clinical outcomes. Here we perform a meta-analysis of prospective cooperative group trials to determine the impact of RT quality assurance (QA) deviations on disease control and overall survival (OS). Methods: We searched MEDLINE and the Cochrane Central Register of Controlled Trials for multi-institutional trials that reported clinical outcomes in relation to RT quality assurance (QA) results. Hazard ratios (HRs) describing the impact of RT protocol noncompliance on outcomes were extracted directly from the original studies or calculated from survival curves. Analyses were performed to assess the impact of RT QA deviations on OS and secondary outcomes (local/locoregional control, event-free survival, relapse), which were grouped together. Pooled estimates were obtained using the inverse variance method. A random effects model was used in cases of significant effect heterogeneity (p<0.10 using Q test). Results: Eight studies met all inclusion criteria and were incorporated into this analysis. Four were pediatric trials (POG 8346, SFOP.TC 94, POG 9031, SIOP/UKCC PNET-3), and four studied adult patients (RTOG 73-01, SWOG 7628, TROG 02.02, RTOG 97-04). Six of these trials reported the impact of RT QA deviations on overall survival, and six described the effects of RT QA deviations on secondary endpoints. The frequency of RT QA deviations ranged from 8% to 71% (median: 40%). Using a random effects model, RT deviations were associated with a significant decrease in OS (HR = 1.74, 95% CI: 1.28 to 2.35, p<0.001). A similar effect was seen for secondary endpoints (HR = 1.79, 95% CI: 1.15 to 2.78, p=0.009). No evidence of publication bias was detected using the Egger test (p=0.361 for OS, p=0.468 for secondary endpoints). Conclusions: In clinical trials, RT protocol deviations are associated with increased risk of treatment failure and overall mortality. The magnitude of these effects demonstrates that RT QA results should be considered in the interpretation of clinical trial results. More importantly, the delivery of high-quality RT is critical for the successful treatment of cancer patients.
National evaluation of the VA’s quality of supportive care.
Authors: Walling Anne M. , Tisnado Diana M. , Malin Jennifer , Asch Steven M , Pantoja Philip , Ettner Susan , Dy Sydney Morss , Lorenz Karl A. 
Published: February 2017

218 Background: Although known to provide more efficient end-of-life cancer care, the quality of VA’s end of life cancer care is unknown. We used Cancer Quality ASSIST to evaluate supportive care comprehensively in a national sample. Methods: We measured ASSIST QIs addressing symptoms, communication, treatment toxicities, and complications among 719 Veterans with a 2008 registry diagnosis of stage IV colorectal (37%), pancreatic (30%), or lung cancer (33%). We abstracted records from diagnosis for 3 years or until death among eligible Veterans (lived >= 30 days following diagnosis with >= 1 VA hospitalization or >=2 VA outpatient visits). We determined patient-level overall and individual QI scores (%delivered/appropriate care) and confirmed reliability on a 5% sample, retaining 39 of 42 QIs. Results: Most Veterans were older (mean 66 years) male (97%), and white (68%) with 20% African American, and 3% Hispanic. 85% had >=1 hospitalization and 93% died. Overall, subjects received 48% of recommended care. The average Veteran triggered 13 QIs, and scores ranged from 0-98% (pain 0-96%; dyspnea 11-98%, depression 36-79%, fatigue 4-80%, nausea/vomiting 41-87%, treatment toxicities 13-70%, care planning 18-86%). Notable gaps in care were identified. Inpatient pain screening was common (96%) but lacking for outpatients (58%). With opioids, bowel prophylaxis occurred for only 52% of outpatients and 70% of inpatients. Few patients had timely dyspnea evaluation (16%) or treatment (11%). Outpatient assessment of fatigue occurred for 32%. 24% of patients who received chemotherapy high risk for diarrhea were offered appropriate anti-diarrheals. Only 19% of Veterans had goals of care addressed in the month after a diagnosis of advanced cancer, and 63% of patients had timely discussion of goals following ICU admission. Most decedents (86%) were referred to palliative care or hospice before death. Single vs. multiple fraction radiotherapy should have been considered in 28 Veterans with bone metastasis, but none were offered it. Conclusions: These patient and family-centered supportive care gaps reflect important HRQOL impacts and targets for quality improvement in a system known for excellence in chronic disease care.
Integration of survivorship care in community oncology practice.
Authors: O’Brien Michele Renee , Ness Kimberly , Arlen Aimee , Schwartz Rowena , Foster Jackie , Sborov Mark D. 
Published: February 2017

33 Background: Each of the 12 million cancer survivors in the United States has unique needs, giving oncology providers the opportunity to address survivorship issues and optimize care. Minnesota Oncology, a community oncology practice, has implemented a survivorship program that evaluates patient specific issues through a series of clinic visits guided by results from the Functional Assessment of Chronic Illness Therapy (FACIT) quality of life assessment tool. Methods: Survivorship care is initiated at diagnosis. After determining the treatment plan, a one hour survivorship visit with a midlevel provider is dedicated to patient concerns and quality of life. Additionally, visits are scheduled at the time of treatment completion and 3-6 months later. The frequency and focus of visits is determined by the patient. Patients complete the FACIT assessment on an electronic tablet in the clinic, immediately prior to scheduled visits. This tool addresses physical, social, emotional and functional well-being, and takes 5-7 minutes to complete. A report of patient specific information is generated for providers to guide each visit, and ultimately to coordinate additional referrals for care. Patient satisfaction is measured at each visit and via a follow up survey. Results: A total of 152 patients (168 visits) have taken the FACIT survey from January 1 – June 30, 2012. Average FACIT general raw scores at baseline, treatment conclusion and 3-6 months following completion were 77.6 (n=121), 76.9 (n=37) and 82.3 (n=10), respectively. Median patient age was 59 (range 22-84). Breast cancer (n = 44) was the most common diagnosis seen and initial visit disease status was: stage I (n = 28), II (n = 37), III (n = 43), IV (n = 36). As a result of the surveys and/or clinic visits referrals to social work, dietician, rehab and counseling have occurred. Conclusions: Attention to survivorship issues is essential to provide comprehensive care to those affected by cancer. Early intervention should consider disease state along with patient specific factors. Following a standard method for addressing survivorship issues allows for cancer care referral coordination. Benefits of adopting a survivorship program include improvement in quality of care and patient satisfaction.
Moving prevention of central line associated bloodstream infection efforts beyond the hospital walls: A multicenter pediatric hematology/oncology collaborative.
Authors: Billett Amy , Gaur Aditya H. , Werner Eric J. , Winkle Cindi , Hord Jeffery D. , Brown Richard , Bundy David , Miller Marlene R. ,   Children’s Hospital Association Quality Transformation Network
Published: February 2017

86 Background: Elimination of central-line (CL) associated blood stream infections (BSI) (CLABSI) in the inpatient setting has been a focus for many healthcare organizations. Little is known about the rate of CLABSI in the ambulatory setting or the optimal improvement strategies. We systematically expanded CLABSI prevention efforts for children with underlying pediatric hematology/oncology (PHO) disease from inpatient to ambulatory settings and describe the related process (definitions, improvement change packages, compliance assessment) and outcome measures (CLABSI and other BSI rates). Methods: The evidence-based CL care and maintenance bundles developed for the Children’s Hospital Association Quality Transformation Network PHO inpatient multisite collaborative were adapted for the ambulatory setting. Teams self-reported compliance with bundle elements (daily goals, line entry/dressing/ port needle/ tubing change processes) and submitted total CL days for the PHO cohort in their care. National Healthcare Safety Network (NHSN) defined CLABSI, secondary BSI (as per NHSN definitions), and single positive blood cultures (SPBC) (currently not captured by NHSN) were tracked. All process and outcome measures were collected using an online data entry system. Results: Prospective data collection and ambulatory bundle implementation began in Nov. 2011; to date 24 of 36 hospitals participating in the inpatient PHO CLABSI prevention collaborative have successfully implemented the ambulatory component to their program. As of May 2012, accrued data from the ambulatory setting exists for 214 ambulatory CLABSI, 30 secondary BSI, and 72 SPBC in patients with 719,637 CL in situ (not CL accessed) line days. To date self-reported compliance with bundle elements is > 80%. Conclusions: We demonstrate a successful multisite expansion of CLABSI prevention efforts to the ambulatory setting in PHO patients. Given the limitations of the current NHSN CLABSI definitions in the PHO population and the goal to reduce all BSI, not just CLABSI, we also propose tracking of secondary BSI and SPBC and discuss how this contextual information can be helpful.
Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The phase III DECISION trial.
Authors: Brose Marcia S. , Nutting Christopher , Jarzab Barbara , Elisei Rossella , Siena Salvatore , Bastholt Lars , de la Fouchardiere Christelle , Pacini Furio , Paschke Ralf , Shong Young Kee , Sherman Steven I. , Smit Johannes WA , Chung John Woojune , Siedentop Harald , Molnar Istvan , Schlumberger Martin 
Published: February 2017

4 Background: Sorafenib, an orally active inhibitor of VEGFR1-3 and Raf kinases, has shown promising clinical activity in single-arm phase II studies in radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). The double-blind, randomized, multicenter phase III DECISION trial examined sorafenib efficacy and safety vs placebo in patients with progressive RAI-refractory DTC. Methods: Patients with locally advanced/metastatic RAI-refractory DTC who progressed in the preceding 14 months were randomized 1:1 to sorafenib 400 mg bid po or placebo. Placebo patients were allowed to receive sorafenib open-label upon progression. The primary endpoint was progression-free survival (PFS) assessed every 8 wks by independent radiologic review using modified RECIST 1.0 and analyzed by stratified log-rank statistics at α = 0.01 (one-sided). Secondary endpoints included overall survival (OS), response rate (RR; complete + partial response [PR]), and safety. Results: A total of 417 patients were randomized (207 to sorafenib and 210 to placebo); median age 63 yr, 52% female. Tumor histology by independent assessment was 57% papillary, 25% follicular, and 10% poorly differentiated. 96% of patients had metastatic disease; the most common target lesions were lung (71%), lymph node (40%), and bone (14%). The primary endpoint was met: median PFS 10.8 months (sorafenib) vs 5.8 months (placebo); HR 0.58, 95% CI 0.45–0.75, p<0.0001. Median OS has not been reached in either arm; 70% of placebo patients started open-label sorafenib. RR (all PRs) in the sorafenib vs placebo arms was 12.2% and 0.5% (p<0.0001) and stable disease ≥ 6 months was 42% and 33%, respectively. The most common any-grade treatment-emergent adverse events in the sorafenib arm included hand–foot skin reaction, diarrhea, alopecia, rash/desquamation, fatigue, weight loss and hypertension. One death in each arm was attributed to study drug. Conclusions: Sorafenib significantly improved PFS compared with placebo in patients with progressive RAI-refractory DTC. Tolerability was consistent with the known sorafenib safety profile. Clinical trial information: NCT00895674.
MAP plus maintenance pegylated interferon α-2b (MAPIfn) versus MAP alone in patients with resectable high-grade osteosarcoma and good histologic response to preoperative MAP: First results of the EURAMOS-1 “good response” randomization.
Authors: Bielack Stefan S. , Smeland Sigbjorn , Whelan Jeremy , Marina Neyssa , Hook Jane , Jovic Gordana , Krailo Mark D. , Butterfass-Bahloul Trude , Kühne Thomas , Eriksson Mikael , Teot Lisa A. , Gelderblom Hans , Kager Leo , Sundby Hall Kirsten , Gorlick Richard Greg , Randall R. Lor , Hogendoorn Pancras C. W. , Calaminus Gabriele , Sydes Matthew Robert , Bernstein Mark L. 
Published: February 2017

LBA10504 Background: EURAMOS-1 (NCT00134030) is an international randomized controlled trial investigating treatment optimization in osteosarcoma on the basis of histologic response to preoperative chemotherapy (CT). In patients (pts) with “good response” (GR; <10% viable tumor at surgery) to induction CT, efficacy of maintenance therapy with pegylated interferon α-2b (Ifn) was investigated. Methods: Pts ≤40yrs with resectable localized or primary metastatic high-grade extremity or axial osteosarcoma were eligible for registration at diagnosis. Eligibility for randomization included: [a] receipt of two cycles pre-op methotrexate, doxorubicin, cisplatin (MAP); [b] complete macroscopic resection of primary tumor; and [c] no disease progression. GR pts were randomized (1:1) after surgery to four cycles MAP +/-Ifn. Ifn (0.5-1.0 μg/kg/wk) was given after CT until 2yr post registration. Primary endpoint: event free survival (EFS); secondary: overall survival, toxicity. The trial design sought improved 3yr EFS from 70% to 80% (80% power, 2-sided alpha 5%). The final analysis was planned after 147 EFS events. Results: 2,260 pts were registered (Apr 05 to Jun 11) from 17 countries (326 sites) making it the largest trial in this rare cancer. GR was reported in 1,034 pts and 715 consented to randomization (358 MAP, 357 MAPIfn) with baseline characteristics balanced by arm: median age 14yr, 59% male, 79% localized disease. 271/357 (76%) pts started Ifn; main reason for not starting was treatment refusal, 66/86. By Feb 13 234/271 had stopped Ifn. Median duration of Ifn if started was 455 days; grade 3+ toxicity during Ifn reported by 81pts (30%). Median follow-up is 3.1yr with 174 EFS events reported: 93 MAP, 81 MAPIfn. Hazard ratio for EFS from adjusted Cox model was 0.82 (95% CI 0.61-1.11; p=0.201) in favor of MAPIfn. Conclusions: With current follow-up, EFS for MAPIfn is not statistically superior to MAP alone in pts with high-grade osteosarcoma and good response to pre-op MAP. One-quarter of pts did not start Ifn, which may have influenced this finding. Further follow-up for events and survival continues. Clinical trial information: NCT00134030.
Lapatinib in combination with capecitabine plus oxaliplatin (CapeOx) in HER2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma (AC): The TRIO-013/LOGiC Trial.
Authors: Hecht J. Randolph , Bang Yung-Jue , Qin Shukui , Chung Hyun-Chul , Xu Jian-Ming , Park Joon Oh , Jeziorski Krzysztof , Shparyk Yaroslav , Hoff Paulo M. , Sobrero Alberto F. , Salman Pamela , Li Jin , Protsenko Svetlana , Buyse Marc E. , Afenjar Karen , Kaneko Tomomi , Kemner Allison , Santillana Sergio , Press Michael F. , Slamon Dennis J. 
Published: February 2017

LBA4001 Background: HER2 amplification is common in upper GI tract (UGIT) adenocarcinomas and inhibition improves clinical outcomes. Lapatinib ditosylate (L), a dual anti EGFR and anti HER2 tyrosine kinase inhibitor with preclinical activity against these cancers, was investigated in a phase III, randomized, double blind trial evaluating efficacy and safety in combination with CapeOx as first-line treatment of advanced or metastatic HER2+ UGIT ACs. Methods: Subjects had measurable and/or non-measurable disease with overexpression or amplification of HER2 (IHC2+ and FISH amplified, or IHC 3+, or FISH, CISH, or SISH amplified). HER2 status was reviewed by the central lab. Subjects were randomized 1:1 to CapeOx q3w (oxaliplatin 130mg/m2 day 1; capecitabine 850mg/m2/BID days 1 – 14), and daily L (1250mg) (CapeOx+L) or placebo (CapeOx+P). The primary efficacy population (PEP) comprised all subjects whose tumors were centrally confirmed to be FISH amplified. The primary endpoint was overall survival (OS) of the PEP. Secondary endpoints included progression free survival (PFS), overall response rate (ORR) and safety. Results: 545 pts were randomized and 487 had HER2+ centrally confirmed. The primary endpoint was not reached with a hazard ratio (HR) for OS of CapeOx+L compared to CapeOx+P of 0.91 (95% CI 0.73, 1.12, p=0.35); median 12.2 vs. 10.5 months, respectively. HR for uncensored PFS was 0.86 (95% CI 0.71 - 1.04, p=0.10); median 6.0 vs. 5.4 months. The analysis of PFS censored by the time of subsequent anticancer therapy as per protocol showed a HR of 0.82 (95% CI 0.68, 1.00, p=0.04). ORR was 53% in the CapeOx+L arm and 40% in the CapeOx+P arm. Pre-specified subgroup analyses showed significant improvements in OS in Asian pts (HR= 0.68) and those under 60 years (HR=0.69). There was no association between IHC and OS. Toxicity profiles were similar except for increased overall diarrhea, and skin toxicity and grade 3+ diarrhea (12 vs 3%) with CapeOx+L. Conclusions: The addition of L to CapeOx did not reach its primary endpoint, though certain subgroups showed improvement. Further clinical and molecular analyses will be presented. Clinical trial information: NCT00680901.