bluuebunny/crossref_metadata_2025 huggingface dataset:
Race-based socioeconomic and treatment disparities in adolescent and young adults with stage II-III rectal cancer.
Authors: Lee David Y , Teng Annabelle , Pedersen Rose C , Tavangari Farees R , Attaluri Vikram , McLemore Elisabeth C , Stern Stacey , Bilchik Anton J. , Goldfarb Melanie R
Published: February 2017

714

Background: Stage II-III rectal cancer (CA) requires a multidisciplinary approach to optimize outcomes. This study explores whether treatment disparities account for racial differences in outcomes of AYA (ages 15-39) patients. Methods: AYAs with clinical stage II-III rectal CA were identified in the National Cancer Database. Demographic, clinical, and pathologic features predictive of receipt of adjuvant and surgical therapies were examined as well as factors associated with overall survival (OS). Results: Most of the 3,295 patients were white (72.0%), male (57.5%) and free of comorbidities (93.8%). Income, education levels, and rates of health insurance coverage were higher for whites than for blacks or Hispanics. Clinical stage was balanced by race, but more blacks and Hispanics did not receive radiation (24.5% and 27.1%, respectively, vs 16.5% for whites), surgery (22.4% and 15.3%, vs 12.3%), or chemotherapy (21.5% and 24.1%, vs 16.7%; p < 0.05). Additionally, the average number of days before treatment was 34.0 for blacks and 33.3 for Hispanics, versus 27.5 for whites (p < 0.05). Multivariate analysis showed that receipt of neoadjuvant chemoradiation was less likely when patients were black (OR 0.7, 95%CI 0.5-0.9, p = 0.014), Hispanic (OR 0.6, 95%CI 0.4-0.9, p = 0.012), female (OR 0.8, 95% CI 0.63-0.94, p = 0.011), without insurance (OR 0.5, 95%CI 0.36-0.69, p < 0.001), or treated at a community cancer center (OR 0.5, 95%CI 0.36- 0.74, p < 0.05). Race significantly influenced treatment, regardless of disease stage. Although 5-year OS was lower (p < 0.05) in blacks (59.8±3.3%) and Hispanics (65.9±3.5%) compared to whites (74.9±1.1%), race did not impact mortality on Cox regression. Instead, mortality was associated with male sex (HR 1.5, 95%CI 1.1-2.0, p = 0.009), nodal positivity (HR 2.6, 95%CI 1.9-3.6, p < 0.001), nonsurgical therapy (HR 7.1, 95%CI 2.8-18.2, p < 0.001), no chemotherapy (HR 1.9, 95%CI 1.03-3.6, p = 0.04), poorly differentiated histology (HR 3.0, 95%CI 1.3-6.5, p = 0.007), and no insurance (HR 1.7, 95%CI 1.1-2.7, p = 0.022). Conclusions: Race-based socioeconomic and treatment disparities may contribute to survival differences among AYAs with rectal cancer.
Palliative radiotherapy and chemotherapy instead of surgery in symptomatic rectal cancer with synchronous unresectable metastases: Final overall survival analysis of phase II study.
Authors: Wyrwicz Lucjan , Tyc-Szczepaniak Dobromila , Mydlowska Magdalena , Pietrzak Lucyna , Rutkowski Andrzej , Bujko Krzysztof , Michalski Wojciech , Olszyna-Serementa Marta , Palucki Jakub
Published: February 2017

726

Background: A palliative surgery and chemotherapy is the standard of care in stage IV rectal cancer patients with pelvic symptoms. Recently we published primary results of the single-arm phase II study on combination of short-course radiation (5x5 Gy) with an oxaliplatin-based chemotherapy started after one-week rest (NCT01157806). The study met its primary end-point with only 17.5% (95% CI 13% to 22%) of patients (pts) who needed stoma throughout the observation and 67% (95% CI 58% to 76%) of pts having significant resolution of pelvic symptoms. Here we provide the long-term follow up data after median 60 months of observation. Methods: 40 consecutive patients with symptomatic rectal cancer with unresectable distant metastases were enrolled from September 2009 to February 2011. The time of treatment failure on chemotherapy (TTF3) was measured from the start of radiation to disease progression on fluoropiridine, oxaliplatin and irinotecan. All eligible patients were assessed for KRAS/NRAS status. Due to limitations in access to targeted agents none of patients were treated with anti-angiogenic agents and anti-EGFR treatment was restricted to third line. Results: Total 40 pts were assessed for pelvic symptoms, chemotherapy response and overall survival. In the group of patients with survival reaching over 2 years we have not observed any additional local complications which were treated surgically. The patients with total symptoms’ resolution after one month had significantly longer time-to-treatment failure (TTF3) than non-responders (median 22.5 vs 5 months, p < 0.05), while patients with minor local response had intermediate TTF3. The subgroup of patients who experienced clinical complete response of rectal tumor had a median TTF3 and overall survival reaching median 40 months. Conclusions: In the palliative setting short-course radiotherapy and early chemotherapy allowed for acceptable and durable local control. Metastatic rectal cancer patients with early symptomatic response of primary tumor had significantly better prognosis. Clinical trial information: NCT01157806.
Observational cohort study of first-line bevacizumab with oxaliplatin or irinotecan and fluoropyrimidines in metastatic colorectal cancer: HGCSG0802—Analysis of early tumor shrinkage (ETS).
Authors: Yuki Satoshi , Nakatsumi Hiroshi , Sawada Kentaro , Kato Takashi , Meguro Takashi , Nakamura Michio , Iwanaga Ichiro , Ehira Nobuyuki , Sonoda Norikazu , Kudo Mineo , Kato Kanji , Sogabe Susumu , Amano Toraji , Ono Kota , Sakamoto Keita , Miyamoto Noriyuki , Kudo Kohsuke , Sakamoto Naoya , Sakata Yuh , Komatsu Yoshito
Published: February 2017

753

Background: It was reported that early tumor shrinkage (ETS) was associated with better overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC) receiving first line chemotherapy. We investigated association of ETS with progression-free survival (PFS) and OS in pts with mCRC treated with first-line bevacizumab (BV)-based chemotherapy (HGCSG0802). Methods: The objective of HGCSG0802 was to evaluate PFS, OS, response rate (RR), safety and so on. The key eligibility criteria were evaluable lesions, older than 20 years old, ECOG PS 0-2. This analysis evaluated the association of ETS at 8 weeks from the start of chemotherapy with pts characteristics, PFS and OS. To identify factors associated with ETS, if there were clinical variables with p < 0.2 in univariate analysis, we planned a multivariate analysis using the logistic regression model. To identify predictive and prognostic factors, a multivariate analysis was performed using Cox proportional hazard model with backward elimination for variables with p < 0.2 in univariate analysis. Results: Of 108 pts (the full analysis set), 99 pts were evaluable for ETS. Sixty-eight pts (68.7%) had ETS ≥20%. The pts characteristics between ETS ≥20% (ETS) and <20% (Non-ETS) were well balanced. In univariate analysis to identify factors associated with ETS, there were no clinical variables with p < 0.2. The median PFS and OS were 7.3/18.3 months in Non-ETS versus 10.0/25.2 months in ETS (HR 0.529; p=0.006 and HR 0.627; p=0.107). In multivariate analysis for PFS and OS, although there was no significant difference between ETS and Non-ETS for OS (HR 0.709; p=0.186), there was significant difference for PFS (HR 0.524; p=0.006). Conclusions: ETS was observed in 68.7% (68/99) and non-ETS in 31.3% (31/99) of patients with metastatic colorectal cancer received bevacizumab combined first line chemotherapy. In univariate analysis, it could not identify any factors associated with ETS. In the results of multivariate analysis, ETS showed an independent predictive impact, but not prognostic impact. Clinical trial information: UMIN000018935.
Pembrolizumab (MK-3475) for recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma: Multicohort phase II KEYNOTE-059 study.
Authors: Fuchs Charles S. , Denker Andrew E. , Tabernero Josep , Van Cutsem Eric , Ohtsu Atsushi , Lam Baohoang , Koshiji Minori , Bang Yung-Jue
Published: February 2017

TPS184

Background: Pembrolizumab (pembro) is a humanized monoclonal antibody that targets the PD-1 receptor and prevents it from interacting with its ligands, PD-L1 and PD-L2. In the phase I KEYNOTE-012 trial, pembro showed an acceptable safety profile and promising antitumor activity in patients (pts) with PD-L1+ metastatic gastric cancer. The multicohort, phase II KEYNOTE-059 (NCT02335411) trial was designed to further evaluate pembro as monotherapy or in combination with 5-fluorouracil (5-FU) and cisplatin in pts with advanced gastric cancer. Methods: Patients ≥ 18 y who have relapsed or metastatic gastric or GEJ adenocarcinoma, ECOG PS 0-1, no active autoimmune disease or brain metastases, and no prior chemotherapy within 2 wk of the first dose of pembro are eligible. PD-L1 expression status will be determined by IHC using the 22C3 antibody (Merck). In cohort 1 (C1), up to 180 pts with any PD-L1 status whose disease progressed on ≥ 2 prior chemotherapy regimens, including a fluoropyrimidine and platinum doublet and, if HER2+, trastuzumab, will receive pembro 200 mg Q3W. In cohort 2 (C2), ~12 Asian and ~6 non-Asian, treatment-naive, HER2– pts of any PD-L1 status will receive pembro 200 mg Q3W + infusional 5-FU or capecitabine and 6 cycles of cisplatin. In cohort 3 (C3), ~25 treatment-naive pts with HER2–/PD-L1+ tumors will receive pembro 200 mg Q3W. Treatment may continue for up to 24 mo or until progression, intolerable toxicity, or investigator decision. Response will be assessed at wk 9 and every 6 wk thereafter per RECIST v1.1 and RECIST v1.1 adapted for immunotherapy response patterns. Treatment may be discontinued for eligible pts who have a CR. Eligible pts may continue treatment beyond initial RECIST-defined progression. AEs will be collected throughout the study and for 30 d thereafter (90 d for serious AEs) and graded per NCI CTCAE v4.0. The primary efficacy end point for C1 and C3 is ORR per RECIST v1.1 by central review; the primary end point for C2 is safety and tolerability of the combination. Secondary end points include PFS, OS, DCR, and duration of response. Enrollment in KEYNOTE-059 is ongoing and will continue until up to 223 pts are enrolled across all cohorts. Clinical trial information: NCT02335411.
A multicenter phase II study of istiratumab (MM-141) plus nab-paclitaxel (A) and gemcitabine (G) in metastatic pancreatic cancer (MPC).
Authors: Ko Andrew H. , Murray James , Horgan Kerry E , Dauer Julia , Curley Michael , Baum Jason , Louis Chrystal Ursula , Lugovskoy Alexey
Published: February 2017

TPS481

Background: Despite recent advances in the treatment of MPC, overall prognosis for patients remains poor. This may be attributed in part to the ability of pancreatic tumors to co-opt growth factor signaling pathways to counteract the activity of chemotherapy. We previously demonstrated that IGF-1 and heregulin, the ligands for IGF-1R and ErbB3, respectively, can decrease the cytotoxic activity of A/G (JCO 33 2015 s3 a289). Additionally, co-expression of IGF-1R and ErbB3 is known to be associated with poor survival prognosis in MPC patients (JCO 33 2015 s3 a295). Istiratumab, a fully human bispecific antibody directed at IGF-1R and ErbB3, produced significant tumor regression, including durable complete responses, when combined with A/G in preclinical models of pancreatic cancer, and has been shown to be safe and tolerable in a Phase 1 study (JCO 33 2015 s3 a384). On these bases, the current Phase 2 study was developed to evaluate istiratumab plus A/G in pts with MPC. Methods: Eligible patients have biopsy-confirmed MPC, ECOG PS 0-1, no prior therapy for advanced disease, and elevated serum levels of free IGF-1 (estimated to be ~40% of all screened patients). The study design includes two parts: Part 1 (n = 12) is an open-label assessment of the safety, tolerability, and pharmacokinetics (PK) of a fixed dose of istiratumab (2.8 grams IV q 2 weeks) in combination with A/G; in Part 2 (n = 146), pts are randomized 1:1 to receive A/G plus either istiratumab or placebo. The primary objective of Part 2 is to compare progression free survival (PFS) between the two treatment arms in two distinct cohorts: a) patients with high free serum IGF-1 levels (i.e., the entire study cohort), and b) patients with both high free serum IGF-1 levels and positive expression of heregulin in tumor tissue. Additional objectives include safety, overall survival, PK and immunogenicity analyses of istiratumab, and correlative analyses of pre-defined biomarkers and their potential correlation with study outcomes. The study is designed with 80% power to detect a hazard ratio of 0.63 in favor of the experimental arm (8 vs 5 months) at a one-sided significance level of 0.05. The study has been open to enrollment as of September 2015. Clinical trial information: NCT02399137.
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.
Changing patterns of care for locally advanced non-small cell lung cancer (NSCLC): Implications for quality initiatives.
Authors: Hall Matthew David , Gabriel Peter Edward , Guo Wensheng , Upasani Sandhya , van der Pas Marjorie , Schultheiss Timothy E. , Goldwein Joel W. , Christodouleas John Paul
Published: February 2017

302

Background: Our purpose was to assess the utilization of dose escalated radiotherapy (RT) in Stage III NSCLC patients in the United States from 2004-2013, a period when no Level 1 evidence on dose escalation was published. Methods: Data on all NSCLC patients treated with RT were extracted from the National Oncology Data Alliance (NODA), a pooled database of cancer registries from >150 US hospitals. The NODA contains the same data submitted to state cancer registries and SEER, but also contains RT dose fields that are manually verified by trained staff. Search algorithms to identify patients with complete RT dose data and who met the RTOG 0617 eligibility criteria were developed and validated by manual chart review at two institutions. The search algorithm positive predictive values for RT dose and RTOG 0617 eligibility were 97% and 91%, respectively. The primary endpoint was utilization of dose escalated RT, defined as >70 Gy. Multivariate logistic regression (MVA) was used to measure the association of treatment year with dose escalated RT use in two predefined periods straddling the early closure of RTOG 0617 on 6/17/2011: Period 1 2004-2010 and Period 2 2010-2013. To address potential limitations in generalizability, we repeated the same analysis in the National Cancer Database (NCDB). Results: The percentage of patients treated with >70 Gy increased monotonically from 22% in 2004 to 37% in 2010 and then declined to 20% in 2012. On MVA, increasing utilization of doses >70 Gy was observed during Period 1 (p<0.001) followed by decreasing use during Period 2 (p=0.002), after adjusting for the effects of other significant patient and hospital level variables. A similar utilization pattern was observed in the NCDB. After adjusting for age and comorbidities, significant changes in the mean RT dose prescribed compared to the 3-year moving average could have been detected in 2008 and 2012, if dose had been prospectively monitored in the NODA. Conclusions: Our study suggests that US radiation oncologists increasingly utilized RT doses >70 Gy in Stage III NSCLC patients treated from 2004-2010 followed by a decline after 2010. RT dose may be an important standardization metric in national quality initiatives.
The Dutch Upper GI Cancer Audit: 2011-2014.
Authors: Busweiler Linde A.D. , Wijnhoven Bas P.L. , van Berge Henegouwen Mark I. , Henneman Daniel , Wouters Michel W.J.M. , van Hillegersberg Richard , van Sandick Johanna W. ,   Dutch Upper GI Cancer Audit group
Published: February 2017

309

Background: In 2011, the Dutch Upper GI Cancer Audit (DUCA) group started with a nationwide registration of all patients who underwent surgery for esophageal or gastric cancer. The aim of this study was to describe the initiation and implementation of the DUCA and to provide an overview of the results. Methods: The DUCA is part of the Dutch Institute for Clinical Auditing. It provides (surgical) teams with reliable, weekly updated, benchmarked information on process and (casemix-adjusted) outcome measures. A web-based registration was designed, based on a set of predefined quality measures. Results: Between 2011 and 2014, a total of 4672 patients with esophageal or gastric cancer was registered in the DUCA. Case ascertainment has approached 100% for patients registered in 2014. The percentage of patients with esophageal cancer starting treatment within 5 weeks after diagnosis significantly increased over time (33 to 41%) and the percentage of patients with a minimum of 15 lymph nodes in the resected specimen significantly increased for both esophageal cancer (50 to 73%) and gastric cancer (48 to 74%). Postoperative mortality decreased for patients with gastric cancer (8.0% in 2011 to 4.0% in 2014; p = 0.020) and remained stable (around 4%) for patients with esophageal cancer. Conclusions: Nationwide implementation of the DUCA has been successful. Results give a valuable insight in the quality of the surgical care for patients with esophageal or gastric cancer and show a positive trend for various process and outcome measures.
Financial risk-sharing agreements: Using options to make marginal benefits cost effective.
Authors: Conter Henry Jacob
Published: February 2017

41

Background: New cancer treatments have become increasingly costly. Although new drugs may be sufficiently cost-efficiency for a primary indication (i1) to receive funding, subsequent indications (ia) may not prove cost-effective. A financial risk-sharing agreement to increase access is proposed. A potential 2012 real-world implementation in Canada for pazopanib use in metastatic renal cell carcinoma (mRCC) as i1, and soft-tissue sarcoma (STS) as ia is presented. Methods: The market value of an indication can be approximated by its net-present-value (NPV) of expected cash flows. If the incremental cost-effectiveness ratio (ICER) for ia is expected to be greater than willingness-to-pay (WTP), the payer then has an incentive to enter into a risk-sharing agreement. A binomial option pricing model is employed to compute the price of the call option to contract such an agreement. The probability of being eligible for ia is extracted from the pan-Canadian Oncology Drug Review (pCODR), a national drug funding advisory body. Correspondence with industry was performed to identify additional ia. Cost, effectiveness, the ICER, discount rates, and drug revenues are calculated using inputs from pCODR, the Bank of Canada, Statistics Canada, and pazopanib’s relevant clinical data at the time of its submission for i1. Results: Of the 47 drugs eligible for i1, 46% are eligible for an ia(Wilson interval 33%-60%). For pazopanib in mRCC, at a mean price of $164/day and an ICER of $0-$57,309, the expected NPV was computed to be $338M. In STS, based on its clinical data at the time, at the same price, the ICER was expected to be > $100,000, with an NPV of $37M. The price of the call option is $17M. Alternatively, the price of pazopanib could be adjusted to $172/day in mRCC, keeping its ICER below WTP, with an agreement that if efficacious, the drug would be provided by the company gratis for STS patients. Conclusions: In a reality where high drug costs are limiting access for vulnerable patients, risk sharing agreements using financial instruments offer an opportunity to re-deploy health technology assessment to expand drug access. For a price increase of $8 per day in i1, Canadian STS patients could have had access to an effective treatment instead of nothing.
Early discussion of advance directives for patients with newly diagnosed cancer.
Authors: Jang Sekwon , Sundaram Suvarna , Finlay Andrea , Romanova Natalia , Knopp Laura , Pierattini Chiara , Fuentes Jenny , Hidalgo Emily , Daye Marian , Kokon Megan , Gustavson Christina , Radomsky Pamela , Buras Josefina , DeSimone Jennifer , Venna Suraj S. , Deeken John F. , Trump Donald L.
Published: February 2017

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Background: Although advance care planning and the completion of advance directives (ADs) are important methods to prevent unwanted aggressive care once patients have lost their decision-making capacity, only a minority of patients have ADs at the time of cancer diagnosis. Methods: We established a new multidisciplinary outpatient clinic to provide comprehensive care to patients with newly diagnosed cancer at the Inova Dwight and Martha Schar Cancer Institute in Northern Virginia. Improvement in advance care planning was chosen as one of the first quality improvement initiatives for 2015. We started the first PDSA cycle after creating the team, establishing the problem and goal statement, and reviewing the process map. We had three measures including: 1. Inquiring whether the patient has advance directives or not at the time of scheduling their first appointment, 2. Provide written information about advance directives at the patient’s first visit, 3. Obtain advance directives by the third office visit. The goal for each measure was 90%, 90%, and 50% by the end of 2015. Results: Between May-June 2015, 65 patients were evaluable. Baseline rates were 26%, 2%, and 12%, respectively for measures 1, 2, and 3. In July 2015, we convened a staff meeting to review each staff’s role in the process of advance care planning. The new patient schedulers had training and created a telephone script to effectively communicate advance directives information with patients. The front desk staff included written information about advance care planning in the new patient information folders. Clinical staff were asked to address any questions or concerns that patients have and to encourage patients to complete the ADs by next visit. After this intervention, the rates increased to 100%, 44%, and 33%, respectively for measures 1, 2, and 3 in August and September, 2015 (n = 45). Conclusions: Early discussion about the ADs for newly diagnosed cancer patients at our outpatient clinic showed improvement in the rate of completed ADs by a third office visit.
Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study
Authors: Janelsins Michelle C. , Heckler Charles E. , Peppone Luke J. , Kamen Charles , Mustian Karen M. , Mohile Supriya G. , Magnuson Allison , Kleckner Ian R. , Guido Joseph J. , Young Kelley L. , Conlin Alison K. , Weiselberg Lora R. , Mitchell Jerry W. , Ambrosone Christine A. , Ahles Tim A. , Morrow Gary R.
Published: February 2017

Purpose

Cancer-related cognitive impairment is an important problem for patients with breast cancer, yet its trajectory is not fully understood. Some previous cancer-related cognitive impairment research is limited by heterogeneous populations, small samples, lack of prechemotherapy and longitudinal assessments, use of normative data, and lack of generalizability. We addressed these limitations in a large prospective, longitudinal, nationwide study.

Patients and Methods

Patients with breast cancer from community oncology clinics and age-matched noncancer controls completed the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at prechemotherapy and postchemotherapy and at a 6-month follow-up as an a priori exploratory aim. Longitudinal models compared FACT-Cog scores between patients and controls at the three assessments and adjusted for age, education, race, menopausal status, and baseline reading ability, anxiety, and depressive symptoms. A minimal clinically important difference cutoff determined percentages of impairment over time.

Results

Of patients, 581 patients with breast cancer (mean age, 53 years; 48% anthracycline-based regimens) and 364 controls (mean age, 53 years) were assessed. Patients reported significantly greater cognitive difficulties on the FACT-Cog total score and four subscales from prechemotherapy to postchemotherapy compared with controls as well as from prechemotherapy to 6-month follow-up (all P < .001). Increased baseline anxiety, depression, and decreased cognitive reserve were significantly associated with lower FACT-Cog total scores. Treatment regimen, hormone, or radiation therapy was not significantly associated with FACT-Cog total scores in patients from postchemotherapy to 6-month follow-up. Patients were more likely to report a clinically significant decline in self-reported cognitive function than were controls from prechemotherapy to postchemotherapy (45.2% v 10.4%) and from prechemotherapy to 6-month follow-up (36.5% v 13.6%).

Conclusion

Patients with breast cancer who were treated in community oncology clinics report substantially more cognitive difficulties up to 6 months after treatment with chemotherapy than do age-matched noncancer controls.