bluuebunny/crossref_metadata_2025_split huggingface dataset:
The CAIRO4 study: The role of surgery of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastases of colorectal cancer—A randomized phase III study of the Dutch Colorectal Cancer Group (DCCG).
Authors: de Wilt Johannes H.W. , Verhoef Cornelis , Punt Cornelis J. A. , 't Lam-Boer Jorine HW , Yilmaz Mette , Mol Linda , Koopman Miriam 
Published: February 2017

TPS782 Background: There is no consensus regarding resection of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastatic colorectal cancer. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour in later stages of the disease. Retrospective studies also show a potential survival benefit for patients undergoing resection. However, surgery can cause severe morbidity and mortality in this patient group. We hereby propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival. Methods: The CAIRO4 study is a multicentre, randomized, phase III study of the Dutch Colorectal Cancer Group (DCCG). Patients with synchronous unresectable metastases of colorectal cancer and few or absent symptoms of the primary tumour are randomized 1:1 between systemic therapy only, and resection of the primary tumour followed by systemic therapy. Patients will be stratified according to location of the primary tumour (colon versus rectum), WHO performance status (0-1 versus 2), hospital of inclusion, serum LDH (normal versus abnormal) and number of metastatic sites (single versus multiple). To demonstrate a survival benefit of 6 months in the experimental arm, a total of 218 events are needed (80% power, significance lever 0.05). Accounting for accrual time and follow-up, we need a total of 360 patients (180 patients per arm). Systemic therapy will consist of fluoropyrimidine-based chemotherapy in combination with bevacizumab. The primary objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour. Secondary endpoints include progression free survival, surgical morbidity, quality of life and the number of patients requiring resection of the primary tumour in the control arm. Accrual has started in September 2012. As of January 2015, 64 centres in the Netherlands and Denmark are participating in the CAIRO4 study. Clinical trial information: NCT01606098.
Phase II study of ADXS11-001 in patients with persistent/recurrent, locoregional or metastatic squamous cell carcinoma of the anorectal canal.
Authors: Fakih Marwan , O'Neil Bert H. , Chiorean E. Gabriela , Hochster Howard S. , Chan Emily , Mauro David J. , Eng Cathy 
Published: February 2017

TPS786 Background: ADXS11-001 is a live attenuated Listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy bioengineered to secrete an antigen-adjuvant fusion protein (fused to HPV16 E7) that has demonstrated promising single-agent activity in human papilloma virus-driven cancers (e.g., head and neck, cervical) and promising clinical activity in combination with chemoradiation in high-risk squamous cell carcinoma (SCC) of the anorectal canal. This study will assess the efficacy and safety of ADXS11-001 monotherapy in patients with persistent/recurrent, locoregional or metastatic anorectal SCC. Methods: Phase 2, multicenter, open-label, 2-stage trial (NCT02399813). Eligible patients (female or male; ≥ 18 years) will have histologically confirmed, measurable (defined by Response Evaluation Criteria In Solid Tumors [RECIST] 1.1) anorectal SCC, previously have received ≥ 1 line of therapy for metastatic/locally advanced disease, Eastern Cooperative Oncology Group performance status of 0 or 1 with adequate organ function. Patients will receive intravenous ADXS11-001 (1×109 colony-forming units) every 3 weeks during a 9-week treatment cycle for ≤ 2 years or until a discontinuation criterion is met (eg documented progression, unacceptable adverse events [AEs], noncompliance with study procedures or treatments). Tumor assessments will occur every 9 weeks. AEs will be monitored throughout the study and will be graded according to the National Cancer Institute-Common Toxicity Criteria version 4.0. The study will be conducted in a 2-stage design. Stage 1 will evaluate the safety and efficacy of ADXS11-001 in 31 patients. If the efficacy from Stage 1 has a response rate (RR) ≥ 10% by RECIST 1.1 or 6-month progression free survival (PFS) ≥ 25%, enrollment will proceed to Stage 2 with the addition of another 24 evaluable patients. RR and PFS will be described for the overall population. The end of the study will be defined as 1 year after the last patient has been enrolled. To date, enrollment has begun at 1 study site. Clinical trial information: NCT02399813.
KEYNOTE-164: Phase II study of pembrolizumab (MK-3475) for patients with previously treated, microsatellite instability-high advanced colorectal carcinoma.
Authors: Le Dung T. , Yoshino Takayuki , Jäger Dirk , Andre Thierry , Bendell Johanna C. , Wang Ruixue , Kang SoonMo Peter , Koshiji Minori , Diaz Luis A. 
Published: February 2017

TPS787 Background: A subset of advanced colorectal cancers (CRC) is characterized by mismatch repair (MMR) deficiency leading to a microsatellite instability-high (MSI-H) phenotype, which is characterized by a high mutational burden and lymphocytic infiltrates. Pembrolizumab is a monoclonal anti–PD-1 antibody designed to block the interaction between PD-1 and its ligands PD-L1 and PD-L2. In the phase II KEYNOTE-016 study, pembrolizumab provided an ORR of 62% in patients (pts) with progressive MMR-deficient metastatic CRC vs 0% in pts with MMR-proficient CRC. The multicenter, phase II KEYNOTE-164 trial (NCT02460198) will evaluate the efficacy and safety of pembrolizumab in pts with previously treated, advanced MSI-H CRC. Methods: Key eligibility criteria include age ≥ 18 y; advanced CRC; MSI-H phenotype evidenced by ≥ 2 allelic shifts using a PCR-based assay or lack of expression of ≥ 1 MMR protein (MLH1, MSH2, MSH6, PMS2) by IHC; prior treatment with a fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and, if KRAS and NRAS wild type, cetuximab or panitumumab; ECOG PS 0-1; no active autoimmune disease or brain metastases; and no prior anticancer therapy within 2 wk of study treatment. Pembrolizumab 200 mg Q3W will be administered for 35 cycles or until disease progression, unacceptable toxicity, pt withdrawal, or investigator decision. Clinically stable pts with RECIST-defined progression may continue pembrolizumab until a scan performed ≥ 4 wk later confirms progression. Pts who complete all 35 cycles or who discontinue pembrolizumab following a complete response and experience progression may be eligible for 1 y of pembrolizumab retreatment. Response will be evaluated every 9 wk per RECIST v1.1 by central review and per RECIST adapted for immunotherapy response patterns. AEs will be assessed throughout treatment and for 30 d thereafter (up to 90 d for serious AEs) and graded per NCI CTCAE v4.0. Pts will be followed for survival every 2 mo. ORR per RECIST v1.1 by central review is the primary end point; secondary end points include PFS, OS, disease control rate, and duration of response. Enrollment is ongoing and will continue until ~60 pts have enrolled. Clinical trial information: NCT02460198.
The benefits of clinical pathways (CP) for radiation oncology in a large cancer care network.
Authors: Heron Dwight Earl , Beriwal Sushil , Benson Hans , Lorinc Zach , Barry Amanda , Lokay Kathleen 
Published: February 2017

148 Background: UPMC CancerCenter and the University of Pittsburgh Cancer Institute (UPMC) created a radiation oncology CP program (now incorporated separately as Via Pathways) in 2003 to standardize care at 19 radiation sites. The program exists to ensure consistency and rapid adoption of best evidence-based care in a large, integrated NCI-designated comprehensive cancer center. Methods: The web-based CP portal integrates with electronic medical records to provide point-of-care patient-specific decision support. CP content is developed and maintained by committees of oncologists culled from the network. Meetings occur semi-annually to review and update treatment recommendations for the nearly 95% of cancers covered. Evidence is evaluated hierarchically on efficacy, toxicity, then cost. When the committee modifies CP content, the software is updated within 35 days and new recommendations are available to the 38 network providers. Through analysis of the utilization data, leaders can monitor adherence to the CP recommendations and research practice patterns at an unprecedented level of granularity. Results: Since data collection in the portal began in 2009, UPMC has captured over 48,000 visits and adhered to CP recommendations 96% of the time. Off-pathway decisions were approved prior to treatment by a designated peer review radiation oncologist at UPMC. Reasons for going off pathway and the alternative approach to care were recorded. Efforts to increase efficiencies and trial accruals have been successful due in large part to access to such a vast and comprehensive database. Conclusions: CP are an integral part of standardizing to high-value care across large networks and geographic regions. The committee process, rapid electronic deployment, and easy access to evidence reviews have garnered high physician buy-in and consistent adherence to CP recommendations. Other benefits of the program include: a transition from volume to value care models; facilitation of onboarding new physicians, residency trainees, and fellows; providing transparency through peer review, a committee process, and evidence reviews. CP are now used by more than 1000 physicians across the US in a variety of academic and community settings.
Toward quality peer review: Outcomes of peer review across provincial radiation oncology programs.
Authors: Rouette Julie , O'Donnell Jennifer , Foxcroft Sophie , Hart Margaret , Gutierrez Eric , Reddeman Lindsay Elizabeth , Mitera Gunita , Warde Padraig Richard , Brundage Michael Donald ,   on behalf of the Pan-Canadian Peer Review Initiative Steering Committee and the Cancer Care Ontario Radiation Treatment Program
Published: February 2017

205 Background: Review of treatment plans by a second radiation oncologist is an important quality indicator in radiation oncology. Peer review (PR) can improve quality of care in individual patients by detecting clinical and planning issues and recommending plan changes. This study reports the frequency and nature of these changes across all 14 radiation oncology programs (ROPs) in Ontario, Canada. Methods: We identified all peer-reviewed curative treatment plans delivered in Ontario within a 3-month study period between Dec 2013-Nov 2014 using Cancer Care Ontario’s Activity Level Reporting System, where data on treatment intent and date, disease site treated, PR status, timing of PR, and nature of recommended changes were available. Results: There was considerable variation in the proportion of plans peer-reviewed across ROPs (70.2%, range: 40.8-99.2%). Over the study period, 5,561 curative treatment plans were peer-reviewed and 3.3% had changes recommended. Of those, 21.0% had major clinical and re-planning implications. Recommended changes most often involved minor (63.1%) vs major (36.9%) re-planning implications. Highest proportions of changes were recommended for the treatment of the esophagus, uterus, upper limb, cervix, lower limb, H&N, bilateral lung, right supraclavicular nodes, rectum, and spine (5.0%-7.0%). Plans involving the left breast had slightly more changes recommended (3.0% [95%CI:2.0%-4.5%]) vs right breast (2.4% [95%CI:1.5%-3.8%]). Recommendations were more frequently made when PR was conducted pre-radiotherapy (3.8%) vs during (1.4%-2.8%; p = 0.005), however the nature and implementation of changes were not statistically associated with the timing of PR (p = 0.91; p = 0.23, respectively). Proportion of recommended changes to treatment plans was not statistically associated with ROP patient volume (p = 0.08), proportion of plans peer-reviewed (p = 0.36) or academic status (p = 0.75). Conclusions: Significant variation exists in the proportion of recommended changes across all disease sites and ROPs. PR seems effective in detecting treatment plans with important clinical and planning issues; strategies should be developed to optimize its conduct in radiation oncology.
Evaluation of resource utilization using time-derived, activity-based costing (TDABC) to result in more effective processes and cost reduction.
Authors: Soliman Pamela T. , Garcia Elizabeth A. , Lang Kai E. , Villanueva Valerie , Westin Shannon Neville , Fleming Nicole D. , Feeley Thomas W. , Lu Karen H. , Meyer Larissa 
Published: February 2017

22 Background: Current changes in health care economics have led to a focus on value-based health care. TDABC is a systematic method to assess personnel utilization and the associated cost in the delivery of medical care. Based on baseline process maps and cost estimates in our outpatient center, cancer surveillance visits (CSV) were identified as inefficient, lengthy and high cost. The purpose of this study was to determine if reallocation of personnel was feasible, resulted in decrease cost and better value care. Methods: In 2014, a multidisciplinary team developed process maps for each visit type in the outpatient center. Maps included each step of clinical care from registration to check out and the personnel associated with that care. Total personnel costs were based on the estimated time spent with each patient and the average salary of the care provider. In 9/2014, we instituted an advanced practice provider (APP) independent practice initiative where CSV were done by either faculty or APP, no longer both. Billing codes were used to determine the % of CSV seen by APPs only. Patient and staff satisfaction were assessed pre- and post-implementation with validated measures. Results: At baseline, the estimated patient time and personnel cost for a CSV was 98 min and $380.79. The estimated patient time and personnel cost for an APP only CSV was 53 min and $132.60.; resulting in a potential savings of $249/CSV. Prior to 9/14 less than 21% were seen by APP’s only. After implementation of the initiative, the number of APP only visits increased each quarter to Q1 27%, Q2 38%, Q3 40% and Q4 41%. The estimated cost savings based on 4000 CSV/year was $354,000. Patient satisfaction remained the same (Press-Ganey). APP and physician engagement/satisfaction increased by 30% (Gallup Employee Survey). Conclusions: Evaluation of our outpatient clinic using TDABC allowed us to identify low efficiency, high cost processes. After implementation of a new process, patient wait times and personnel costs were significantly reduced resulting in better value care and improved provider satisfaction.
Improving transitions of care through implementation of a standardized handoff at a comprehensive cancer center.
Authors: Bodurka Diane C. , Ait Aiss Mohamed , Phu Helene P , Day Lakeisha R , Abraham Varkey , Chen Karen , Rodrigo Mejia , Razvi Shehla , Gonzalez Carmen E. , Brito-Dellan Norman , Banala Srinivas , Rubio David , Vaughan-Adams Nicole , Ruiz Debra S , Jens Tan , Levenback Charles F. , Frumovitz Michael M. , Zand Behrouz , Escalante Carmelita P. 
Published: February 2017

242 Background: Communication failures cause two-thirds of sentinel events in hospitals. These adverse occurrences are often both fatal and preventable. Consequently, improving the quality of handoffs has been identified by multiple accreditation constituents as a top priority patient safety goal. This project was part of an institutional initiative to standardize handoffs among physicians, trainees, and midlevel providers. Methods: Four subgroups were identified as pilot areas: Gynecologic Oncology (Gyn Onc) fellows to nocturnalists, Surgical Oncology fellows, Pediatric Oncology residents and fellows, and Emergency Center attending staff to inpatient hospitalists. This abstract focuses on the Gyn Onc and Pediatric Oncology services. All teams used a PDSA cycle (Plan, Do, Study, Act) to conduct its pilot study. A gap analysis, root cause analysis, and process mapping were performed in each area to identify specific handoff issues. A validated standardized handoff tool, I-PASS (Illness severity, Patient summary, Action list, Situational awareness and contingency planning, and Synthesis by receiver), was selected. Of note, “Illness severity” highlights patients identified at higher risk for complications and denotes their status as “watcher” or “unstable.” Interventions included I-PASS skills training and utilization of the I-PASS mnemonic. Each service developed a standardized definition to identify patients classified as “watchers.” Medical errors, ICU transfers, and provider satisfaction were assessed pre- and post-intervention. Results: Results from 40 handoff surveys showed communication errors dropped by 10% (16.49 vs 14.93). Minor harm as result of a problematic handoff decreased by 45% (2.55 vs 1.39), with a 55% reduction in ICU transfers. There was an overall increase in handoff satisfaction using I-PASS and 100% standardization of handoffs across the Gyn Onc and Pediatric Oncology units. Conclusions: Implementation of I-PASS, a validated standardized handoff was associated with reductions in medical errors and improvement in communication. Our institution is moving toward implementing I-PASS across all units to increase the safety and quality of patient care.
Safer transitions of care at a major cancer center: The emergency center to hospitalist experience.
Authors: Banala Srinivas , Gonzalez Carmen E. , Brito-Dellan Norman , Rubio David , Ait Aiss Mohamed , Rice Terry , Chen Karen , Bodurka Diane C. , Escalante Carmelita P. 
Published: February 2017

247 Background: Failures in communication lead to serious medical errors particularly during transitions of care. A standardized handoff of patients requiring admission to the inpatient setting between the Emergency Center (EC) and the Hospitalist Inpatient Service (HIS) at a comprehensive cancer center was lacking during this vulnerable time. Methods: A quality pilot study using Plan, Do, Study, Act methodology was conducted. First, root cause analysis and process mapping of the current state was performed to identify pitfalls of the handoff process between the EC and the Hospitalist Service. Second, a validated standardized handoff tool, “I-PASS” (Illness severity, Patient summary, Action list, Situational awareness and contingency planning, and Synthesis by receiver) was selected and then transformed to DE-PASS, where D stands for Decisive problem requiring admission and E for Evaluation, to suit the EC workflow. The DE-PASS identified patients at higher risk for complications as urgent and emergent in the evaluation section and required a verbal communication in addition to an email using DE-PASS format. Third, we measured pre versus post intervention impact metrics. ICU transfers and Rescue Team calls within 24 hours were obtained from 822 patients. Time interval between EC admission physician order and HIS order was analyzed in a population of 174 randomly selected patients. Provider satisfaction with handoffs was surveyed. Results: The DE-PASS utilization ranged from 75% to 100% by the end of the pilot. The data analysis revealed a 60% reduction in the number of ICU transfers and a 64% reduction of Rescue Team calls post intervention. There was an 18% reduction in the interval time for an inpatient order in the medical record. EC Physicians satisfaction with DE-PASS increased by 10% and the Hospitalists increased by 40%. Conclusions: Implementation of the standardized handoff tool DE-PASS led to improved communication between two clinical services of a major cancer center. Patients’ safety improved by designation of risk stratification and reducing the time to evaluate unstable patients by the receiving HIS. Physician’s satisfaction with the handoff process increased.
Impact of precancer multimorbidity clusters on survival and functional outcomes after cancer in older patients.
Authors: Kenzik Kelly , Richman Joshua , Kent Erin E. , Pisu Maria , Bhatia Smita 
Published: February 2017

291 Background: While multimorbidity clustering is a significant problem in older adults, the impact of clusters present prior to cancer on post-diagnosis survival and function is unknown. We used SEER-Medicare Health Outcomes Survey data for 4583 cancer patients to address this research gap. Methods: Patients with prostate (1741), breast (BC: 1345), colorectal (CRC: 904) and lung (593) cancer with pre- and post-diagnosis survey data were included. Surveys assessed comorbidity and activities of daily living (ADLs). Previously defined multimorbidity clusters were cardiovascular disease (CVD), skeletal, metabolic, pulmonary + major depressive disorder (MDD), and gastrointestinal (GI) + MDD. Cox regression models estimated hazard ratios (HR) for death after cancer diagnosis. Among those without pre-cancer ADL impairment, modified Poisson regression models estimated relative risk (RR) for developing post-cancer functional impairment (ADL ≤ 4). Models controlled for age, race, education, poverty level, stage, and treatment (radiation, surgery). Results: Median age at cancer diagnosis was 74y (65-103). Post-diagnosis mortality: After 6y median follow-up, mortality was 30%; 5y survival was 74%.Prostate, BC and CRC patients with pre-diagnosis CVD clusters were at increased risk of death compared to those without CVD cluster (HR 1.9, 2.0, 1.7, respectively, p < 0.05). Compared to those without the cluster, prostate and BC patients with metabolic cluster were at increased risk (HR 1.7, 1.9, respectively, p < 0.05) and prostate cancer patients with pulmonary conditions + MDD or GI + MDD (HR 1.9, 2.1, respectively, p < 0.05) were at increased risk. Post-diagnosis functional impairment: Prevalence of moderate functional impairment at a median of 1y after cancer diagnosis was 31%. Prostate, lung, and CRC survivors with GI + MDD had a significant RR of developing impairment (RR 1.8, 1.8, and 1.7, p < 0.001). For BC patients, those with skeletal cluster had a 2.1 RR (p < 0.001). Conclusions: Specific multimorbidity clusters prior to cancer are associated with post-cancer mortality and ADL impairment and identify at-risk groups where interventions can be instituted to decrease morbidity and mortality.