bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of intervention on quality measures of symptom management in the Michigan Oncology Quality Consortium (MOQC).
Authors: Smerage Jeffrey B. , Abstoss Katie , Severson Jane , Muir J. Cameron , Martin Claudia Jane , DeHority Kevin G. , Blayney Douglas W. 
Published: February 2017

70 Background: Michigan oncology practice groups that participated in MOQC [JOP 5(6):281, 2009] used the Quality Oncology Practice Initiative (QOPI) tool. Adherence to processes of disease specific care was high, but poor in domains associated with palliative care. These measures did not change over time [Health Affairs. 31(4):718, 2012]. These findings prompted us to test interventions to improve quality in palliative care domains. Methods: MOQC created a process, based on the IHI Framework for Spread, to assist oncology practice groups in establishing their own primary Palliative Care services, including the implementation of Edmonton Symptom Management Scale. 8 practice groups formed teams of local change agents to participate in the Palliative Care Demonstration (PC Demo) project. The teams participated in 3 in-person and 4 online learning sessions over 8 months, led by palliative care and quality experts. Teams were provided tools, training materials, and necessary support to implement the improvements and measure their success. The learning network facilitated the sharing of best practices and lessons learned throughout the process. The teams presented their results broadly to other MOQC participants at project conclusion. Results: Success was measured using palliative care-focused ASCO QOPI results. PC Demo sites consecutively improved their scores in many of the QOPI measures, and their rate of improvement from Fall 2011 to Spring 2012 was greater than that of their peers. Conclusions: We observed that collecting and distributing data in our consortium was insufficient to improve palliative oncology care. Providing practice groups with the appropriate infrastructure improved their capacity and capability to make the necessary changes to improve performance. [Table: see text]
A Web-based decision support platform to reduce non-evidence-based treatment of non-small cell lung cancer.
Authors: Grund Stephen H. , Forastiere Arlene A. , Flood William A. , Whyler Elaine , Kozlovski Vlad , Wong Yu-Ning 
Published: February 2017

71 Background: Published reports indicate 30% to 40% of oncology treatments deviate from evidence-based standards. Little is known about the extent of deviation from guidelines in lung cancer. Methods: eviti is a web-based decision support platform that incorporates all recognized guidelines (ASCO, NCI, NCCN, ASTRO, and others) and supporting literature. An automated precertification code is issued if planned treatment is evidence-based and meets payer language. Variances may be discussed in a peer-to-peer (P2P) with staff oncologists. We analyzed all treatment plans submitted for patients with stage I to IV NSCLC between 1/1/2011 and 5/10/2012 to understand reasons for non-compliance with practice guidelines. There were seven payers with a total of 650,000 covered lives encompassing 43 states. Results: 561 treatment plans were submitted. 241 (43%) received an automatic code, and another 256 (46%) were given preauthorization codes after submission of medical records. 117 treatment plans required a P2P. 26% of cases that required a P2P resulted in a change to evidence based treatment (31 cases or 5% of total cases submitted). 64 (11%) did not meet evidence-based standards and did not receive a code for pre-certification. The most common deviations were: 1. Non-evidence-based therapeutic regimen 59% (38 cases); 2. Use of supportive drugs not consistent with guidelines 23% (15 cases); 3. Non-evidence-based variation in dose and/or schedule of chemotherapy 6% (4 cases). In 7 cases the payer declined payment despite recommendation for coverage. 139 submitted treatment plans were for second line or greater and 88 were for third line or greater. Conclusions: After review for medically justified deviations and peer to peer discussions, decision support for automated pre-certification based on adherence to evidence-based standards reduced non-standard treatment plans from 30 to 11%. A Web-based, point-of-care decision-support that connects payers and providers can reduce unwarranted deviation from evidence-based standards, reducing variability and improving quality. Any such tool should promote compliance with evidence-based cancer care but allow flexibility for medically justified variances.
Developing a comprehensive smoking cessation program in patients with lung cancer: The role of social smoking environments.
Authors: Eng Lawson , Su Jie , Qiu Xin , Palepu Prakruthi R. , Hon Henrique , Fadhel Ehab , Harland Luke , La Delfa Anthony , Habbous Steven , Kashigar Aidin , Cuffe Sinead , Leighl Natasha B. , Pierre Andrew , Selby Peter , Goldstein David P. , Liu Geoffrey , Xu Wei 
Published: February 2017

75 Background: Smoking during cancer treatment negatively impacts outcome, survival, and quality of life. Social smoking environments (SSEs) (i.e., smoking in household, peers, and spouse) influence cessation rates in non-cancer patients, but are understudied in cancer patients. Methods: Lung cancer patients, recruited from Princess Margaret Hospital (2006-2012) were given baseline and follow-up questionnaires (median of 2 years apart) evaluating changes in smoking habits and SSEs. Multivariate logistic regression and Cox-proportional hazard models evaluated the association of socio-demographics, clinicopathological and SSE factors with smoking cessation and time to quitting, respectively. Results: 721 patients completed both questionnaires. Of the 261 current smokers at diagnosis, 180 (69%) had quit by follow-up. Among 318 ex-smokers, 5 re-started smoking after diagnosis. All of the 140 never smokers remained non-smoking. Home smoke exposure (OR=9.4; 95% CI: 3.4-26.2; p=2.0 x 10E-5), spousal smoking (OR=4.7, 95% CI:1.7-12.6; p=3.0 x 10E-3) and peer smoking (OR=2.6; 95% CI:1.1-6.1; p=0.03) were each associated with reduced cessation, adjusted for a base multivariate model that included education and past history of depression. Individuals with no SSE factors had a much higher chance of quitting smoking when compared to patients with multiple areas of SSEs (0 vs. 3, OR=16.4; 95% CI: 4.1-66.7; p=7.3 x 10E-5). Similar results were seen when using time-to-quitting as the outcome (0 vs 3, OR=4.4, 95% CI=1.4-14.1, p=0.01). Time to quitting analysis found that 60% of patients with at least one SSE who did quit, did so within 6 months of diagnosis. Subgroup analysis revealed similar associations in early- and late-stage patient groups. Conclusions: SSE is a key factor in smoking cessation, where household smoke exposures reduces the chance of quitting up to 9-fold. SSEs should be a key consideration when developing smoking cessation programs in lung cancer patients, as part of quality improvement strategies. Approaches incorporating household members or spouses into the smoking cessation intervention, around the time of diagnosis, should be researched further. GL and WX are co-senior authors.
Utilizing network quality committees to improve reporting and adherence to evidence-based clinical pathways.
Authors: Patt Debra A. , Hoverman J. Russell , Lindsey Gay , Jastrzembski Deedra , Taniguchi Cynthia , Turnwald Brian , Espirito Janet L. , Garey Jody S. ,   on behalf of the Texas Oncology Quality Committees
Published: February 2017

76 Background: In an era of evidence based medicine, several different evidence based pathways for cancer treatment exist. Few, however, contain decision support, are implemented into an electronic health record (EHR) or have demonstrated their effectiveness to provide value-based care. Providing systems to make a Pathways program operational and improve adherence supports a culture of value-based care. Methods: Physician designed evidence based pathways for a large network of community oncologists was rolled out over a statewide practice. A team of pharmacists and data managers designed a program to support implementation of this pathways initiative. Physician-led quality committees were created at the practice level to troubleshoot and characterize the process of making adherence operational and improving upon other quality metrics, variance reporting, and patient satisfaction. Treatments were charted in the EHR and available for reporting. Documentation of rationale for off-pathway exceptions was also captured. Assessable data, adherence, and exception documentation were measured prior to the onset of the committees and again with follow-up for 1 year after initiation of the committees from March 2011 through February 2012. Results: Within this large practice of 342 physicians, there were 39 quality committees created. During this time assessable data, adherence, and justification of exceptions to evidence-based pathways changed. At the beginning of the time period, assessable data was 84% and improved to 90% after a year. Adherence to pathways was 60% and improved to 68% over the same time interval. Exception documentation also improved from 14% to 25%. Conclusions: Formalizing an internal physician-driven operational procedure to improve upon quality can increase the reporting and adherence to physician created evidence-based pathways across a network of community oncologists and moves to change a culture of value-based excellence within community oncology practices. Continuous and internally driven adherence to value-based metrics improve compliance over time. Internal systems such as these are essential to make evidence-based pathways operational.
Development of a collaborative improvement network by a state affiliate of the American Society of Clinical Oncology.
Authors: Hertler Andrew Allan , Hammond Denis Brin , Larmon Steven S. , Openshaw Thomas H. , Thomas Christian , Weisberg Tracey ,   Northern New England Clinical Oncology Society (NNECOS)
Published: February 2017

79 Background: Participation in the Quality Oncology Practice Initiative (QOPI) by members of the Northern New England Oncology Society (NNECOS) has been historically low (two practices consistently participating). A survey of members identified a lack of resources (time, personnel, financial) as the principal obstacles. In alignment with NNECOS’ mission “To assure the availability of and access to high quality oncology care in our region,” NNECOS sought to determine if it could establish a Collaborative Improvement Network (CIN) in which 1) experienced practices mentor inexperienced practices in QOPI, and 2) practices benchmark results against each other, sharing best practices. Methods: Six practices from the NNECOS member states of Maine, New Hampshire, and Vermont agreed to join the CIN and participate in the fall 2010 and spring 2011 QOPI data collection. Meetings were held following each QOPI data collection and blinded results were compared. High achievers on individual metrics shared their processes/tools with all the participants in the CIN. Results: To develop consistency in data collection, a joint training program for abstractors was developed. There was rapid agreement to eliminate the blinding of results, allowing candid discussions about the barriers to success and strategies for overcoming those barriers. The following tools that successful practices had used were shared: a “one page chemotherapy treatment summary,” chemotherapy consent forms, an oral chemotherapy procedure, and a “chair-side smoking cessation program.” Interventions piloted included a “hardwired chemotherapy treatment summary” and a “hardwired intervention for emotional distress.” Improvement was seen in “plan of care for severe pain” (72% to 85%), “signed consent for chemotherapy” (59% to 81%), and “infertility risk discussions” (14% to 35%). The CIN continues to operate, with 8 of the 17 practices in the three states participating. It is currently engaged in a project to implement specific performance improvement processes for end-of-life care. Conclusions: We have shown that it is possible for an ASCO State Affiliate to sponsor and develop a CIN.
Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: A phase III randomized trial of the Gynecologic Oncology Group.
Authors: Tewari Krishnansu Sujata , Sill Michael , Long Harry J. , Ramondetta Lois M. , Landrum Lisa Michelle , Oaknin Ana , Reid Thomas J , Leitao Mario M. , Michael Helen E , Monk Bradley J. 
Published: February 2017

3 Background: Vascular endothelial growth factor (VEGF) promotes angiogenesis, a mediator of disease progression in cervical cancer. Bevacizumab (B), a humanized anti-VEGF monoclonal antibody, has shown single-agent activity in pretreated recurrent disease. We aimed to evaluate B in chemotherapy (CTX)-naive recurrent/persistent/metastatic cervical cancer. Methods: Using a 2x2 factorial design, patients were randomly assigned to CTX with or without B 15 mg/kg. The CTX regimens included cisplatin 50 mg/m2 plus paclitaxel 135-175 mg/m2 and topotecan 0.75 mg/m2 d1-3 plus paclitaxel 175 mg/m2d1. Cycles were repeated every 21 days until disease progression, unacceptable toxicity, or complete response. Overall survival (OS) was the primary endpoint with a reduction in the hazard of death by 30% using anti-VEGF therapy considered important (90% power, 1-sided alpha=2.5%). Final analysis was planned when 346 deaths were observed. Results: 452 patients were accrued from 4/6/09 to 1/3/12. The scheduled interim analysis occurred after 174 patients had died and showed that the topotecan-paclitaxel backbone was not superior to the cisplatin-paclitaxel backbone. A second interim analysis was conducted after 271 deaths. A total of 225 patients received CTX alone and 227 patients received CTX plus B. The randomized treatment groups were similar with regard to age, histology, performance status, previous platinum as a radiosensitizer, and recurrence, persistence, or advanced disease. The B-to-no-B hazard ratio (HR) of death was 0.71 (97.6% CI 0.54-0.95; 1-sided p=0.0035). Median survival was 17 m (CTX plus B) and 13.3 m (CTX alone). The RR were 48% (CTX plus B) and 36% (CTX alone) (p=0.0078). Treatment with B was associated with more grade 3-4 bleeding (5 vs 1%) thrombosis/embolism (9 vs 2%), and GI fistula (3 vs 0%). Conclusions: For the first time a targeted agent significantly improved OS in gynecologic cancer. The second interim analysis crossed the boundary for efficacy, warranting early release of this information. The nearly 4-month increase in median OS with the addition of B to CTX in women with recurrent cervical cancer is considered to be clinically significant. Clinical trial information: NCT00803062.
Inherited mutations in breast cancer genes in African American breast cancer patients revealed by targeted genomic capture and next-generation sequencing.
Authors: Churpek Jane E. , Walsh Tom , Zheng Yonglan , Casadei Silvia , Thornton Anne M. , Lee Ming K. , Churpek Matthew , Huo Dezheng , Zvosec Cecilia , Liu Fang , Niu Qun , Zhang Jing , Fackenthal James , King Mary-Claire , Olopade Olufunmilayo I. 
Published: February 2017

CRA1501 Background: African American (AA) women are disproportionately affected by early-onset and triple-negative breast cancer (TNBC). One explanation for these disparities may be a higher frequency of inherited mutations among AA women in genes in DNA repair pathways, including BRCA1 and BRCA2. Using targeted genomic capture and next generation sequencing (NGS), we screened DNA from AA women with breast cancer for mutations in all 18 known breast cancer genes. Methods: A total of 249 unrelated AA women with breast cancer were ascertained through the Cancer Risk Clinic at The University of Chicago. Genomic DNA was extracted from peripheral blood and 3 micrograms were used for targeted capture and sequencing. Average read depth across the 1.4 MB targeted region was 320-fold. Sequence reads were aligned and all classes of variants identified: point mutations, small insertions and deletions, and large genomic rearrangements. Only unambiguously damaging mutations were called: stops, complete genomic deletions, and missenses demonstrated experimentally to cause loss of protein function. Variants were validated by PCR or Taqman analysis. Results: Fifty-six of 249 subjects (22%) carried at least one loss-of-function mutation, distributed among BRCA1 (n=26), BRCA2 (n=20), CHEK2 (n=3), PALB2 (n=3), ATM (n=5), and PTEN (n=1). The majority of mutations were unique. Damaging mutations were carried by 30% of patients with TNBC, 27% of patients diagnosed at age ≤45, 49% with a second breast primary, and 30% with a family history of either breast or ovarian cancer in any close relative. Conclusions: We present the first comprehensive screen of all known breast cancer susceptibility genes among AA women using NGS. Mutation carrier frequencies are >25% for major subsets of patients defined by tumor or host characteristics. These high carrier frequencies suggest the importance of screening for mutations in all breast cancer genes in all AA breast cancer patients diagnosed at a young age, with a family history, or with TNBC as a way to identify at-risk family members for life-saving interventions.
A randomized study of ganetespib, a heat shock protein 90 inhibitor, in combination with docetaxel versus docetaxel alone for second-line therapy of lung adenocarcinoma (GALAXY-1).
Authors: Ramalingam Suresh S. , Goss Glenwood D. , Andric Zoran Gojko , Bondarenko Igor , Zaric Bojan , Ceric Timur , Poddubskaya Elena Vladimir , Ciuleanu Tudor-Eliade , Spicer James F. , Felip Enriqueta , Hirsh Vera , Manegold Christian , Rosell Rafael , Khuri Fadlo Raja , Vukovic Vojislav M. , Teofilovici Florentina , El-Hariry Iman , Guo Wei , Bahcall Safi R. , Fennell Dean 
Published: February 2017

CRA8007 Background: Heat shock protein 90 chaperone function is critical for the biological effects of several oncoproteins. Ganetespib (G) is a highly potent 2nd-generation Hsp90 inhibitor with a favorable safety profile and single-agent clinical activity. Methods: Based on synergistic preclinical interactions between docetaxel (D) and G, we conducted a randomized (1:1), international open-label study of D with or without G. Patients with advanced lung adenocarcinoma, one prior systemic therapy, and ECOG PS 0/1 were included. D was given at 75 mg/m2 on day 1 of a three-week cycle. In the experimental arm, D was given on day 1 and G at 150 mg/m2 on days 1 and 15. The co-primary endpoints were PFS in patients with elevated LDH (eLDH) levels, or tumors harboring KRAS mutations. Key secondary endpoints were OS and PFS in all adenocarcinoma patients. Target enrollment was 240 adenocarcinoma, 120 eLDH, and 80 mKRAS patients. Statistical tests are 1-sided. Results: Enrollment of 255 adenocarcinoma patients completed in November 2012; results are reported for this population. Patient characteristics were balanced (median age 60 years, males ~60%, PS 0 ~40% and never-smoker ~25%). For D+G vs. D the median number of cycles delivered was 5 vs. 4; the grade 3/4 adverse events were neutropenia 38% vs. 37%; fatigue 4% vs. 3%; anemia 7% vs. 6%; diarrhea 3% vs. 0; fever with neutropenia 8% vs. 2%. At the time of abstract submission OS HR was 0.69 (90% CI 0.48 to 0.99, p=0.093), the PFS HR was 0.70 (90% CI 0.53 to 0.94, p=0.012), and the ORR was 15% vs 11%, favoring D+G. For patients that were enrolled >6 months after diagnosis of advanced NSCLC (N=175; 69%), a prespecified stratification factor, the OS HR was 0.41 (90% CI 0.25 to 0.67, p=0.0009), the PFS HR was 0.47 (90% CI 0.32 to 0.69, p=0.0005), and the ORR was 16% vs 12%. Updated results for both populations above, as well as for the eLDH and mKRAS subsets, will be presented. Conclusions: D+G demonstrated improvement in OS, PFS, and ORR over D alone for second-line therapy of lung adenocarcinoma. A phase III study in second-line advanced adenocarcinoma patients (> 6 months from diagnosis) is ongoing (GALAXY-2). Clinical trial information: NCT01348126.
Survival and long-term follow-up of safety and response in patients (pts) with advanced melanoma (MEL) in a phase I trial of nivolumab (anti-PD-1; BMS-936558; ONO-4538).
Authors: Sznol Mario , Kluger Harriet M. , Hodi F. Stephen , McDermott David F. , Carvajal Richard D. , Lawrence Donald P. , Topalian Suzanne Louise , Atkins Michael B. , Powderly John D. , Sharfman William Howard , Puzanov Igor , Smith David C. , Wigginton Jon M. , Kollia Georgia , Gupta Ashok Kumar , Sosman Jeffrey Alan 
Published: February 2017

CRA9006^ Background: The monoclonal antibody nivolumab blocks PD-1, an inhibitory immune checkpoint receptor expressed by activated T cells. Pts with previously treated MEL or other tumors received nivolumab IV Q2W during dose escalation and/or cohort expansion in a phase I trial (Topalian et al., NEJM 2012;366:2443). Methods: Pts received ≤12 cycles (4 doses/cycle) of treatment until discontinuation criteria were met. Cohorts of MEL pts were expanded at 0.1, 0.3, 1, 3, and 10 mg/kg. We report overall survival data and long-term safety and response data from the MEL pts treated on this study. Results: 107 MEL pts received nivolumab as of July 2012. 103/107 pts (97%) were ECOG PS ≤1 and approximately 25% received ≥3 prior therapies. Median OS was 16.8 months across doses and 20.3 months at the 3 mg/kg dose selected for phase III trials. 44% and 40% of pts were alive at 2 and 3 yrs (Table). ORs were observed at all doses (highest at 3 mg/kg) (Table). Of 29 responders who initiated treatment ≥1 year prior to data analysis, 16 had responses lasting ≥1 year. Drug-related AEs (any grade) occurred in 82% of pts, with Gr 3-4 drug-related AEs in 21% of pts; the most common included lymphopenia (3%), fatigue, and increased lipase (2%). Gr 3-4 drug-related diarrhea (2%), endocrine disorders (2%), and hepatitis (1%) was observed. No Gr ≥3 drug-related pneumonitis was observed in the MEL cohort. Conclusions: In this large cohort of pretreated MEL pts, nivolumab produced durable OS and responses with an acceptable safety profile. OS compares favorably with historical data. Data updated as of Feb 2013 will be reported. Phase III registration trials have been initiated. Clinical trial information: NCT00730639. [Table: see text]