bluuebunny/crossref_metadata_2025 huggingface dataset:
NISCAHN: A phase II, multicenter nonrandomized trial aiming at evaluating nivolumab (N) in two cohorts of patients (pts) with recurrent/metastatic (R/M) salivary gland carcinoma of the head and neck (SGCHN), on behalf of the Unicancer Head & Neck Group.
Authors: Fayette Jerome , Even Caroline , Digue Laurence , Geoffrois Lionnel , Rolland Frederic , Cupissol Didier , Guigay Joel , Le Tourneau Christophe , Dillies Anne-Francoise , Zanetta Sylvie , Bozec Lemoal Laurence , Borel Christian , Guyennon Aurélie , Couchon-Thaunat Sophie , Costes Valerie , Jallut Isabelle , Delaye Jessy , Lardy-Cleaud Audrey , Chabaud Sylvie
Published: May 2019

6083

Background: SGCHN are rare tumors including adenoid cystic carcinoma (ACC) and non-ACC, with no standard systemic treatment for R/M pts. We evaluated N monotherapy in R/M SGCHN pts. Methods: R/M SGCHN pts (ACC or non-ACC) not eligible to local treatment and with centrally confirmed RECIST 1.1 disease progression over the last 6 months were enrolled and received N 3 mg/kg IV, every 2 weeks for a maximum of 12 months (mo). Possibility was given to re-start N in case of progression during the 2-year follow-up phase. Primary endpoint was 6-mo non-progression Rate (NPR6m) as per RECIST 1.1. Secondary endpoints included ORR, PFS, OS, and safety. Considering that N would be uninteresting if NPR6m ≤ 20% and promising if ≥ 40% and using a Fleming’s single-stage design (α: 5% unilateral, power: 90%), at least 14 successes/42 evaluable pts were required for each cohort to be positive. Results: 46 ACC and 52 Non-ACC pts (median age 61 yrs (range 29-81), 43.9% female, 55.1% PS1 and 2.0% PS2) were enrolled and received at least one dose of N. Median treatment duration was 5.5 mo (ACC) and 3.3 (Non-ACC). Median FU was 10.8 mo (ACC) and 8.3 mo (Non-ACC). 95 patients were evaluable for the primary endpoint. NPR6m was 15/45 pts (33.3%, 90%CI :21.8;46.6) and 7/50 pts (14.0%, 90%CI:6.8;24.7) for ACC and non-ACC pts respectively. 4 (8.7%) partial responses (PR) and 26 (56.5%) stable diseases (SD) were observed in ACC cohort while 2 (3.8%) PR and 22 (42.3%) SD were observed in non-ACC. Median PFS was 4.9 mo (95%CI = 3.4;5.6) in ACC pts and 1.8 mo (95%CI = 1.7;3.5) in non-ACC pts. The most common related adverse events (AE) ( > 10% by cohort) were asthenia, hyperthyroidism, diarrhea, rash, pruritus and hypothyroidism. 7/98 pts (7.1%) presented at least one related AE Grade 3-4 (mainly hepatic) and 9 pts (9.2%) prematurely discontinued Nivolumab due to toxicity. Conclusions: Limited efficacy was observed with N in R/M SGCHN pts. N in combination might be of interest and deserves exploration in ACC pts. Clinical trial information: NCT03132038.
Development and validation of a prediction-score model for distant metastases in major salivary gland carcinoma.
Authors: Lukovic Jelena , Alfaraj Fatima , Mierzwa Michelle Lynn , Nader Marta Gustavo , Xu Wei , Su Jie , Ynoe de Moraes Fabio , Huang Shao Hui , Bratman Scott Victor , O'Sullivan Brian , Kim John , Ringash Jolie , Waldron John , de Almeida John R. , Goldstein David Paul , Rosko Andrew , Spector Mathew E , Kowalski Luiz Paulo , Hope Andrew , Hosni Ali
Published: May 2019

6085

Background: We developed and validated a prediction-score for distant metastases (DM) in major salivary gland carcinoma (SGC). Methods: Patients with SGC treated with curative-intent surgery +/- postoperative radiation therapy (PORT) at 4 tertiary cancer centers were divided into discovery (institution A&B) and validation (institution C&D) cohorts. Multivariable analysis using competing risk regression was used to identify predictors of DM in the discovery cohort and create a prediction score. The optimal score cut-off for high vs low-DM risk was determined using a minimal p-value approach. The results were subsequently evaluated in the validation cohort. The cumulative incidence and Kaplan-Meier methods were used to analyze DM and overall survival (OS), respectively. Results: Overall, 1035 patients were included (Table). In the discovery cohort, DM predictors (risk score coefficient) were: positive margin (0.6), pT3-4 (0.7), pN+ (0.7), lymphovascular invasion (LVI; 0.8), and high risk histology* (1.2). High DM-risk SGC was defined by sum of coefficients greater than 2. In the discovery cohort, the 5-year cumulative incidence of DM for high vs low risk SGC was 50% vs 8%; p < 0.01; these results were similar in the validation cohort (44% vs 4% at 5 years; p < 0.01). In the combined cohorts, this model predicted distant-only failure (40% vs 6%, p < 0.01) and late ( > 2yr post surgery) DM (22% vs 4%; p < 0.01). Patients with high DM-risk SGC had an increased incidence of DM in the subgroup receiving PORT (46% vs 8%; p < 0.01) or concurrent chemotherapy (71% vs 34%; p < 0.01). The 5-yr OS for high vs low risk SGC was 48% vs 92% (p < 0.01). Conclusions: This validated prediction score model may be used to identify SGC patients at increased risk for DM and select those who may benefit from prospective evaluation of treatment intensification and/or surveillance strategies. Baseline characteristics. [Table: see text]
Comparison of normal saline versus heparin flush solutions for maintaining patency of central venous catheter in cancer patients.
Authors: Pai Amy , Ferrajoli Alessandra , Cheng Lee , Huynh Tam , Rodriguez Maria Alma
Published: May 2019

6501

Background: Published guidelines recommend normal saline (NS) flushes for maintaining patency of central venous catheters (CVCs) in cancer patients. The practice at a large oncology ambulatory facility was modified to use NS flushes instead of heparin for CVC maintenance (centrally inserted catheters and peripherally inserted central catheters, excluding implanted ports). The number of catheter occlusion events, pre- and post-implementation, was utilized to determine the effectiveness and safety of this practice change. Methods: Retrospective data of patients aged 18 years and older who presented to the ambulatory centers were collected from the electronic health record (EHR). The number of alteplase instillations was used as a surrogate measure for occlusion events. Ambulatory line-days, defined as patients arriving for an appointment and with either an active CVC or a CVC placement, was the denominator. The numerator was the number of ambulatory line-days with a catheter line and alteplase dose(s) given. The pre-intervention CVC maintenance period using heparin flushes was March 2016 - April 2017. The post-intervention CVC maintenance period using NS flushes was May 2017 - September 2018. Results: 95,089 line-days and 4,452 unique patients were analyzed pre-intervention and compared to 115,194 line-days and 5,575 unique patients post-intervention. The baseline incidence rate of occlusion was 0.91%, compared to the post-intervention incidence rate was 2.67% ( p < 0.01). The increase started immediately within the first month of the practice change (2.26%) and continued throughout the post-implementation observation time. Conclusions: In an ambulatory oncology-practice setting with a high volume of CVC utilization, an increase in line occlusions rate was observed after implementing the practice change of flushing CVCs from heparin to NS. This raises concerns regarding safety and additional burdens to patients and caregivers, and additional analyses are ongoing to evaluate the further impact of this evaluation.
Significance of examined lymph node number in accurate staging and long-term survival in resected stage I-II pancreatic cancer: More is better? A large international population-based cohort study.
Authors: Huang Lei , Jansen Lina , Balavarca Yesilda , van der Geest Lydia , Lemmens Valery , Groot Koerkamp Bas , van Santvoort Hjalmar , Grützmann Robert , Besselink Marc G. , Schrotz-King Petra , Brenner Hermann
Published: May 2019

6503

Background: Examined lymph node (ELN) number is an important quality metric in cancer care. This large international cohort study aimed to investigate the associations of ELN number with accurate staging and long-term survival in pancreatic cancer (PaC) and to robustly determine the minimal and optimal ELN thresholds. Methods: Population-based data on patients with stage I-II PaC resected in 2003-2015 from the US Surveillance, Epidemiology, and End Results (SEER)-18 Program and Netherlands National Cancer Registry (NCR) were analyzed. Associations of ELN number with stage migration and survival were evaluated using multivariable-adjusted logistic and Cox regression models, respectively. The series of odds ratios (ORs) for stage migration and hazard ratios (HRs) for survival with more ELNs were fitted using a LOWESS smoother, and structural breakpoints were determined by Chow test. Results: Overall 18,303 patients were analyzed. With increasing ELN number, both cohorts exhibited significant proportional increases from node-negative to node-positive disease (ORSEER-18= 1.05, 95% CI = 1.04-1.05; ORNCR= 1.10, 95% CI = 1.08-1.12) and serial improvements in survival (HRSEER-18= 0.98, 95% CI = 0.98-0.99; HRNCR= 0.98, 95% CI = 0.97-0.99) per additional ELN after controlling for confounders. Associations for stage migration and survival remained significant in most stratifications by patient, tumor, and treatment factors. Cut-point analyses suggested a minimal threshold ELN number of 12 and an optimal number of 19, which were validated both internally in the derivative US cohort and externally in the Dutch cohort with the ability to well discriminate different probabilities of both survival and stage migration. Conclusions: In stage I-II PaC, more ELNs are associated with more precise nodal staging, which might largely explain the survival association. Our results robustly conclude 12 ELNs as the minimal and suggest 19 ELNs as the optimal cut-points, for evaluating quality of lymph node examination and possibly for stratifying postoperative prognosis. Our findings provide important references for defining population-based quality metrics in PaC care.
A process to reduce hospital admissions in the OCM population through focused intervention of super-utilizers.
Authors: Perry Manuel , Rudy-Tomczak Katie , Lalanne Joanne , Whalen Allison , Shah Shannon , Hines Scott
Published: May 2019

6505

Background: A small number of patients (super-utilizers) are responsible for much of the cost in healthcare. In several studies, 5% of patients are responsible for 50% of the cost. Healthcare hot-spotting is the strategic use of data to deliver enhanced resources to selected super-utilizers in an effort to improve the quality of care and to reduce costs. Methods: Patients enrolled in the Oncology Care Model (OCM) who were scheduled to receive cytotoxic, targeted therapy or immunotherapy beginning in the fall of 2017 were screened by nurse practitioners prior to initiating treatment in an effort to identify super-utilizers. Risk factors included high risk disease (stem cell transplant, myelodysplastic syndrome, acute leukemia, stage IV disease), significant co-morbidities (CHF, COPD, renal failure, Insulin Dependent Diabetes , presence of a gastrostomy tube), or an admission to the hospital in the past 6 months. Such patients were provided with enhanced services which included twice weekly outreach by a nurse practitioner between 8am and 10am for a telephonic evaluation of their health status. If the patient was found to have either a new problem that required intervention or a worsening chronic problem, then a same-day appointment was made with the nurse practitioner, oncologist, primary care provider or appropriate specialist. Results: Inpatient admissions decreased from 21.3 per 100 OCM beneficiaries to 18.7 per 100 OCM beneficiaries representing a 12.2% decrease. Inpatient costs were reduced from $979 per beneficiary per month (PBPM) to $885 PBPM representing a decrease of $94 PBPM (9.6% decrease). Conclusions: Targeting oncology super-utilizers based on the nature of their diagnosis, co-morbidities, or history of a recent hospital admission and offering telephonic evaluation reduced hospitalizations and decreased cost resulting in a savings of nearly $600,000 per year for our OCM cohort of 600 beneficiaries. [Table: see text]
The financial impact of physician practice patterns: An analysis of as-needed filgrastim versus prophylactic pegfilgrastim in patients with prostate cancer receiving docetaxel.
Authors: Barrett Christine , Park Seon Jo , Gaertner Kelly , Mao Shifeng
Published: May 2019

6506

Background: Docetaxel improves survival in metastatic prostate cancer. Patients receiving docetaxel are at an intermediate risk of febrile neutropenia (FN). Granulocyte-colony stimulating factor (G-CSF) reduces the incidence of neutropenia and infection. There is no consensus among physicians on G-CSF use with docetaxel in prostate cancer, and physician preference may significantly impact healthcare costs. The purpose of this study is to assess physician practice patterns by comparing efficacy and cost of as-needed filgrastim (ANF) to prophylactic pegfilgrastim (PPF) for neutropenia in patients with prostate cancer receiving docetaxel. Methods: This retrospective cohort study included patients with prostate cancer that received standard docetaxel and G-CSF, either ANF or PPF, from February 2016 to October 2018 at our institution. In the ANF arm, patients with an ANC less than 1000 cells/µL on day 8 of the cycle received filgrastim. In the PPF arm, patients received pegfilgrastim on day 2 for primary prophylaxis. Patient characteristics, chemotherapy dose intensity, delays, and reductions, and incidence of FN were collected. Results: Of the 65 patients included in this study, 32 received ANF and 33 received PPF. Patients in the ANF arm received an average of 6.0 cycles versus 4.8 cycles in the PPF arm (p = 0.013). The completion rate of planned cycles differed, with 93.8% completion in the ANF arm versus 66.7% in the PPF arm (p = 0.001). Average total drug exposure per patient was greater in the ANF arm than the PPF arm (437.5 mg/m2 versus 343.4 mg/m2; p = 0.007). In both groups, there was no significant difference in dose delays or reductions, or incidence of FN. However, there was a significant difference in cost, with an average of $740.26 per cycle per patient for filgrastim, versus $7327.72 per cycle per patient for pegfilgrastim, based on current average wholesale price. Conclusions: In our study, use of ANF was safe, and did not impact planned dose, intensity, or duration when compared to PPF. In addition, the administration of ANF was associated with significant cost savings. Analysis of G-CSF use in patients with prostate cancer receiving docetaxel at our institution has identified an opportunity for substantial healthcare cost savings.
Impact of a same-day breast biopsy program on disparities in time to biopsy.
Authors: Seidler Matthew , Dontchos Brian Nicholas , Mercaldo Sarah , Miles Randy C. , Narayan Anand , Lehman Constance Dobbins
Published: May 2019

6508

Background: While screening rates have improved among minorities, racial/ethnic disparities in diagnosis and treatment persist. Many steps in the diagnostic pathway can delay tissue diagnosis, and in usual practice breast biopsies are performed days to weeks after biopsy recommendation. The purpose of this study was to identify if racial/ethnic disparities exist in time from biopsy recommendation to biopsy, and if a same-day biopsy program (biopsy on the same day as the recommendation) eliminates these disparities. Methods: After IRB approval, we identified all diagnostic mammogram and ultrasound exams leading to biopsy pre- (September 2016-March 2017) and post- (September 2017-March 2018) implementation of our same-day biopsy program. We compared the distribution of age, race, language, insurance type, days to biopsy and proportion of same-day biopsies in pre- vs. post-implementation groups using the Wilcoxon test (for continuous variables) and the Pearson’s chi-squared test (for categorical variables). Multivariable linear and logistic models were estimated in pre and post periods to assess if days from biopsy recommendation to biopsy (linear) and having a same-day biopsy (logistic) were associated with age, race, language, and insurance type. Results: 663 and 482 patients underwent biopsy during pre- and post-implementation, respectively. Age, race, language, and insurance type were similar between time periods. For all patients, the same-day biopsy program decreased mean time from diagnostic examination to biopsy from 8 (IQR: 4-13) to 0 (IQR: 0-4) days (p < 0.001). During the pre time period, non-white patients and having government insurance were significantly associated with longer days to biopsy (non-white aCoef: 2.30 (95% CI: 0.58-4.03); insurance aCoef: 1.67 (95% CI: 0.02-3.32); p < 0.05), and increasing age and having government insurance were significantly associated with decreased odds of having a same-day biopsy (age aOR: 0.97 (95% CI 0.95-0.99); insurance aOR: 0.35 (95% CI 0.14-0.88); p < 0.05), after adjustment. During the post time period there was no evidence of these disparities. Conclusions: A same-day biopsy program eliminated racial/ethnic disparities in time from breast biopsy recommendation to biopsy.
The use of optimal evidence-based chemotherapy (chemo) regimens in physician offices versus hospital outpatient facilities.
Authors: Fisch Michael Jordan , Liu Ying , NGUYEN ANN , Barron John , Fishman Ezra , Sylwestrzak Gosia
Published: May 2019

6514

Background: The proportion of infused chemo administered in hospital outpatient facilities (HOF) increased from 6% in 2004 to 43% in 2014. The average annual cost for patients receiving chemo was significantly higher in HOFs than in physician offices (POs). One option to explore differences in the quality of care between these two settings is to examine the use of chemo regimens, which, based on their efficacy, toxicity, and costs, have been designated as “on-pathway.” This study compared on-pathway rates among patients receiving infused chemo administered in POs vs. those in HOFs. Methods: Using administrative claims data, we identified 61,496 breast, lung, or colorectal cancer patients receiving chemo from 2013 to 2018. Chemo regimens were considered “on-pathway” when they were on payer's program list of optimal regimens when administered. Generalized linear models examined the association between site of service and on-pathway prescribing rates, and costs of care. Models adjusted for age, sex, year, rural status, cancer type and setting, and comorbidities, with fixed effects for providers. Results: Percentage of infused chemo administered in HOFs increased from 44.2% in 2013 to 54.7% in 2018. After adjustment, on-pathway prescribing rate did not differ significantly between HOFs and POs (50.1%, 95% CI: 48.6%-51.5% vs. 49.8%, 95%CI: 48.3%-51.3%, p = 0.65). 6-month chemo cost ($56,885, 95% CI: $54,364-$59,524 vs $32,240, 95% CI: $30,929-$33,605, p < 0.001) and 6-month medical cost ($114,280, 95% CI: $110,716-$117,960 vs $79,455, 95% CI: $77,089-$81,893, p < 0.001) were significantly higher in HOFs vs. POs. Conclusions: Quality of care as measured by use of optimal chemo regimens was similar in hospital and office setting. Cost continues to be significantly higher in hospital setting. These findings provide a strong basis for site-neutral reimbursement policies.
Randomized trial of text messaging (TM) to reduce early discontinuation of aromatase inhibitor (AI) therapy in women with breast cancer: SWOG S1105.
Authors: Hershman Dawn L. , Unger Joseph M. , Grace Hillyer , Moseley Anna , Arnold Kathryn B , Dakhil Shaker R. , Esparaz Benjamin , Kuan Ming C. , Graham Mark , Lackowski Douglas M , Edenfield William Jeffery , Dayao Zoneddy Ruiz , Gralow Julie , Ramsey Scott , Neugut Alfred I.
Published: May 2019

6516

Background: Non-adherence to AI’s for breast cancer is common and increases risk of recurrence. Text messaging (TM) has been shown to increase adherence to medications for chronic conditions. We conducted a multicenter randomized trial to evaluate if TM reminders improve AI adherence. Methods: Patients taking an AI for ≥30 days and having ≥36 mos of planned therapy were eligible. Patients were randomly assigned 1:1 to receive either TM or NO-TM twice a week for 36 mos. Randomization was stratified by length of time on prior AI therapy ( < 12 (64%) vs. 12-24 mos (36%)) and AI class (anastrozole, letrozole, exemestane). Content themes of the 36 TMs focused on overcoming barriers to adherence. Patients were assessed for discontinuation of AIs every 3 mos for 36 mos. The primary outcome was time to non-adherence, where non-adherence was defined as urine AI metabolite assay results satisfying the following: < 10 [units], undetectable, or no submitted specimen. A stratified Log-rank test was conducted. Multiple sensitivity analyses were performed using Cox regression. Results: In total, 724 patients were registered between May, 2012 and September, 2013, among whom 696 (338/360 (93.9%) on TM and 338/364 (92.9%) on NO-TM) were eligible and adherent at baseline. Observed (time-independent) adherence at 36 mos was 55.4% for TM and 55.4% for NO-TM. The primary analysis showed no difference in time-to-adherence failure between patients on the TM and NO-TM arms (HR = 0.89, 95% CI:0.76,1.05 p = .18). An analysis of negative urine tests alone resulted in similar non-significant results. With missed appointments not counted as failures, time to self-reported discontinuation (89.6% vs. 89.7%; HR = 1.17, 95% CI:0.69-1.98, p = .57) and site reported discontinuation (78.1% vs. 81.1%; HR = 1.31, 95% CI:0.86-2.01, p = .21) were also similar between the 2 groups. Conclusions: As the first large long-term randomized trial of an intervention directed at improving AI adherence, we found high rates of AI discontinuation. Bi-weekly text reminders did not improve adherence to AIs compared to usual care. Improving long—term adherence will likely require sustained behavioral interventions and support. Clinical trial information: NCT01515800.
Impact of Electronically Accessible Pathways (EAPathways) on clinical trial enrollment at a large multisite cancer center.
Authors: Villadolid Jeryl Jean , Jandrisevits Elizabeth , Moore Donald , Patel Jai Narendra , Mileham Kathryn Finch , Kim Edward S.
Published: May 2019

6517

Background: Clinical pathways streamline evidence-based treatment decisions and provide consistent, high-quality, value-based care. A high-quality clinical pathway should enhance screening and access to clinical trials. Our healthcare system utilizes EAPathways to allow providers to select treatment regimens vetted by section experts, inquire about clinical trials, and refer to relevant programs (e.g. palliative medicine) or testing (e.g. genomics) at a main cancer center and 22 regional sites. With over 400 clinical trials, our goal is to provide access regardless of where a patient lives or receives treatment. We aim to explore the impact of EAPathways on clinical trial enrollment at our healthcare system. Methods: This study is a retrospective review to compare clinical trial inquiries through EAPathways and clinical trial enrollment using Oncore between 1/1/2017 and 7/31/2018. The primary outcome is the success rate reported as the total number of inquiries that resulted in clinical trial enrollment. Other outcomes include a comparison of inquiries and enrollments for hematology and solid tumor oncology, cancer treatment and non-treatment (e.g. specimen collection), and our main cancer center and regional sites. The number of and reason for opting out of treatments or trials was also analyzed. Results: A total of 29.1% (740/2539) of clinical trial inquiries through EAPathways resulted in clinical trial enrollment. Success rates for the following settings were reported: 39.5% (223/564) in hematology, 26.2% (517/1975) in solid tumor oncology, 27.0% (594/2203) in treatment trials, and 43.5% (146/336) in non-treatment clinical trials. Sixty-three percent of enrollments were at our main cancer center compared to regional sites. A total of 39.7% (3356/8453) of patients were enrolled into an opt-out pathway due to reasons such as performance status, organ dysfunction, or hospice. Conclusions: Clinical pathways can provide access to clinical trial enrollment in multiple settings. These baseline metrics will help assess process improvement needs to increase clinical trial enrollment success rates and address reasons for opt-out.
The financial impact of fractionation scheme and treatment planning method for rectal cancer in the United States.
Authors: Moore Assaf , Den Robert Benjamin , Gordon Noa , Sarfaty Michal , Kundel Yulia , Brenner Baruch , Goldstein Daniel A.
Published: May 2019

6518

Background: Preoperative long-course chemoradiotherapy (CRT) and short-course radiotherapy (SCR) for locally advanced rectal cancer (LARC) were found to have equivalent outcomes in three randomized trials. SCR may have lower acute toxicity and the down-staging following CRT is more well-established. At present, SCR is frequently used in Europe but has not been widely adopted in the United States (US). It is standard to deliver radiotherapy by 3D planning, while the use of Intensity-modulated radiotherapy (IMRT) is controversial. In recent years there has been an increasing focus on understanding the cost and value of cancer care. In this study we aimed to assess the economic impact of fractionation scheme and treatment planning method for payers in the US. Methods: We performed a population-based analysis of the total cost of radiotherapy for LARC in the US annually. The national annual target population of patients was calculated using the Surveillance, Epidemiology, and End Results (SEER) database. Treatment costs for various fractionation schemes were based on billing codes and 2018 pricing by Medicare's Hospital Outpatient Prospective Payment System (OPPS). The cost of chemotherapy was based on the Payment Allowance Limits for Medicare Part B Drugs by Centers for Medicare and Medicaid Services (CMS). Results: We estimate that 12,945 patients with LARC are treated with radiotherapy annually in the US. The cost of CRT with 3-D or IMRT is US$ 15,881.76 and US$ 23,744.82 per patient, respectively. With 3-D SCR the cost is US$ 5,457 per patient. The use of SCR would lead to 64-77% annual savings of US$ 125,701,387 - US$ 236,727,934 in the US compared with 3-D and IMRT based CRT, respectively. IMRT based planning increases the total cost of CRT by 49% and if adopted widely would lead to an excess cost of US$ 101,787,312 annually. Conclusions: SCR may have the potential to save in the region of US$ 0.12-0.23 billion annually in the US, likely without impacting outcomes. Lack of evidence showing benefit with costly IMRT should limit its use to clinical trials. SCR may also lead to lower personal financial toxicity. It would be reasonable for public and private payers to consider which type of radiation is most suited to reimbursement.
Comparative effectiveness of proton therapy versus photon therapy as part of concurrent chemoradiotherapy for locally advanced cancer.
Authors: Baumann Brian Christopher , Mitra Nandita , Harton Joanna , Xiao Ying , Wojcieszynski Andrzej , Gabriel Peter Edward , Zhong Haoyu , Geng Huaizhi , Doucette Abigail , Wei Jenny J. , O'Dwyer Peter J. , Bekelman Justin E. , Metz James M.
Published: May 2019

6521

Background: Concurrent chemo-radiotherapy is standard-of-care curative treatment for many cancers, but is associated with substantial morbidity. Proton therapy may increase the tolerability or effectiveness of concurrent chemo-radiotherapy by reducing radiation to normal tissues. Methods: We conducted a comparative effectiveness study of adult non-metastatic cancer patients treated with curative intent with proton chemo-radiotherapy vs. photon chemo-radiotherapy from 2011-2016 at the University of Pennsylvania. Re-irradiation and disease sites treated with photon-only therapy were excluded. Data on adverse events and survival was gathered prospectively. Primary endpoint was 90-day adverse events associated with unplanned hospitalizations (CTCAEv4 grade ≥3 adverse events). Secondary endpoints included decline in ECOG performance status during treatment, 90-day grade ≥2 adverse events, disease-free survival (DFS) and overall survival (OS). Modified Poisson regression models with inverse propensity score weighting were fit for both outcomes. Propensity scores were estimated using an ensemble machine-learning approach. Results: 1,483 patients were included (391 proton/1,092 photon). Proton patients were significantly older (median 66 vs. 61), had less favorable Charlson-Deyo comorbidity scores (median 3.0 vs. 2.0), and had lower integral radiation dose to tissues outside the target (p < 0.05 for all). Baseline toxicity and performance status were similar (p > 0.05). In propensity score weighted-analyses, proton chemo-radiotherapy was associated with significantly lower relative risk (RR) of 90-day grade ≥3 adverse events [11.5%(95%CI 8.3-14.7%) for protons; 27.6%(95%CI 24.9-30.2%) for photons; RR 0.31, 95%CI 0.15-0.66, p < 0.01]; 90-day grade ≥2 adverse events (RR 0.78, 95%CI 0.65-0.93, p < 0.01); and decline in performance status during treatment (RR 0.51, 95%CI 0.37-0.71, p < 0.01). There was no difference in DFS or OS. Conclusions: In adults with locally advanced cancer, proton chemo-radiotherapy was associated with significantly reduced acute adverse events causing unplanned hospitalizations with similar disease-free and overall survival.
Improving time to initiation of bone modifying agents in patients with newly diagnosed multiple myeloma.
Authors: Rosko Nathaniel , Lee Sarah , Samaras Christy Joy , Mejia Alex V. , Anwer Faiz , Faiman Beth , Mathur Saveta , Hamilton Kimberly , Reed Janice , Karam Mary Ann , Valent Jason Neil
Published: May 2019

6528

Background: Current ASCO and IMWG guidelines recommend that all patients (pts) on active anti-myeloma therapy receive concurrent supportive care treatment with a bone modifying agent (BMA) to decrease the risk of skeletal related events (SRE). Unfortunately, recent data shows only 51% of Medicare pts with myeloma received a BMA within 90 days of first chemotherapy. We implemented a quality improvement project to identify the average time to BMA initiation at all Cleveland Clinic affiliated sites, with the primary goal to improve time to initiation of BMA in newly diagnosed multiple myeloma (NDMM) pts by 4 weeks at Cleveland Clinic Main Campus (MC). Methods: Barriers with BMA initiation were identified using quality improvement tools developed at the ASCO Quality Training Program. The first PDSA cycle was implemented between September 2018 – January 2019 with an emphasis on education. This included review of updated guidelines, literature review of risks and toxicities associated with BMAs, and strategies for choosing BMA based on pt factors. Baseline data on time to start BMA and data to evaluate impact of PDSA intervention was completed via chart review. Results: 161 NDMM pts were evaluated between 2015 to 2018 at all sites. The average time difference between the start of anti-myeloma therapy and the start date of a BMA in NDMM pts was 10.5 weeks. Subset analysis based on whether pts were treated at MC vs affiliate sites was 10.6 weeks vs 9.1 weeks, respectively. During the first PDSA cycle, 14 NDMM pts were treated at MC. 86% (12/14) pts were treated with a BMA. The average time between cycle 1 day 1 of first line treatment and first dose BMA was 4.3 weeks (range 4-12 weeks). Conclusions: With increased physician education and awareness of internal baseline data, we achieved our initial goal and observed a significant improvement in time to initiation of BMA from 10.5 weeks to 4.3 weeks. Obstacles regarding effective communication with patients on the benefit of BMAs as well as need for dental clearance were barriers identified early on. We plan to incorporate BMA guidelines in our institutional care path with the goal to decrease time to initiation at all affiliated practices. Further mechanisms to ensure reinforcement of BMA initiation in NDMM patients is warranted to maintain therapeutic benefit.
Evaluation of a risk-based approach to follow-up care for breast cancer survivors: From oncology specialist to primary care provider (PCP).
Authors: Keenan Kathleen , Dunne Megan
Published: May 2019

6529

Background: The number of cancer survivors in the Unites States is expected to exceed 18 million by the year 2020. Predicted care demands coupled with an anticipated shortage of oncologists have led to alternate follow up care models and providers. This nurse practitioner- (NP) led survivorship team was charged with developing a risk-based discharge plan for the > 8,000 breast cancer survivors in our survivorship clinic at this NCI-designated cancer center. Methods: In collaboration with breast oncologists and surgeons, a risk-based strategy to identify and transition eligible survivors to their PCPs was developed. Low risk was determined by: stage, absent disease and significant late-effects, and time since diagnosis. Interventions: Evidence supporting the willingness, availability and expectations of PCPs to provide follow-up care to cancer survivors was reviewed. Criteria for eligibility were developed; patient and PCP educational documents were created. Continued breast cancer screening at our center was offered with results sent directly to PCP. Outreach educational programs were provided to local PCP groups to build relationships and provide breast specific follow up recommendations. To promote communication and collaboration between NP and PCP prior to and at the time of transition, clinic notes were shared after each survivorship visit. A comprehensive transition note including detailed follow-up recommendations was provided at the time of transition. Patients were assured of rapid return to the oncology provider in the event of recurrence or cancer related issue. Results: 5080 patients were offered transition, with 3642 accepting. Mitigating factors and facilitators to transition for both patients and PCP will be discussed and educational strategies to overcome barriers will be described. Conclusions: Transition of breast cancer survivors’ care to PCPs is successful approximately 56% of the time. Key factors include seamless communication among providers and early discussions with patients to set expectations and normalize the transition early in the care pathway.
The effects of immunotherapy and novel therapies on medical oncology work load in a Canadian province.
Authors: Ramjeesingh Ravi , Colwell Bruce , Rayson Daniel
Published: May 2019

6532

Background: Both novel targeted therapies and immunotherapies have dramatically changed the landscape in a number of disease sites with previously limited treatment options. This has resulted in an impact on clinical workload for oncologists with subspecialty practices in the areas of non-small cell lung, (NSCLC), melanoma (M), and genitourinary (GU) cancer. Our aim was to investigate the shift in workload amongst these practices as compared to other disease sites within a single academic cancer center in Nova Scotia (NS), Canada. Methods: The NS Cancer Center is the academic cancer center for the province of NS providing consultative and ongoing care for approximately 72% of provincial patients. We manually quantified appointment visits (new consultation, treatment and follow up visits) as well as telephone toxicity and chart checks booked from February 1 to April 30 across a 3-year interval (2016, 2017, and 2018) and then extrapolated this data to derive full year estimates. Disease sites most impacted by therapies that have changed treatment landscape (NSCLC, M and GU) were compared with the Breast and Gastrointestinal disease sites. Results: Clinical workload increased across all domains over the 3 year period but the majority of the increase is attributed to the 3 disease sites (Table). Conclusions: Medical oncology workloads are increasing over time and novel treatments (including immunotherapy) in disease sites with previously limited options likely account for a significant portion of that increase. New patient consultation metrics, taken in isolation, do not reflect current trends in medical oncology workload. Hiring practices, space allocation and use of physician extenders must take into account these shifting workload dynamics to mitigate physician burnout and potential impacts on quality and timeliness of care. [Table: see text]
Proactive, multidisciplinary approach to supportive medicine: Improving health outcomes and care utilization.
Authors: Worster Brooke , Csik Valerie P , Minetola Jared , Garber Gregory D. , Petok Alison , Yocavitch Liana , Lama Jasmine Tenpa , Gandhi Krupa , Lu-Yao Grace L.
Published: May 2019

6537

Background: Evidence suggests that cancer patients who receive palliative care early in their disease have improved quality of life, decreased emergency department (ED) visits, and less aggressive end-of-life care. In 2017, the Sidney Kimmel Cancer Center at Jefferson established the Neu Center for Supportive Medicine and Cancer Survivorship (NCSMCS) as a model for integrated care in the outpatient setting for all cancer patients. A multidisciplinary team consisting of palliative care physicians, social work, psychology, and navigation conducts biopsychosocial screening and initiates a personalized care plan for each patient to clarify treatment goals and offer assistance. Objectives: To use biopsychosocial screening at specified time points to identify needs and evaluate the impact of supportive care as part of standardized oncology care regardless of stage. Methods: This assessment utilized Oncology Care Model (OCM) data for Jefferson Medicare patients between 7/1/16 to 7/31/18. Incidence of ED admits ED/Observation and admissions were evaluated as well as ICU utilization and advanced care planning. Poisson regression was used to generate incidence rate ratios (IRR) and 95% confidence intervals (CI) to facilitate the comparison of post- vs. pre- incidence rates of hospitalization. Results: The post-intervention hospital admissions decreased by 31% in NCSMCS (IRR 0.69; 95% CI 0.48-0.98) and by 10% in Non-NCSMCS (IRR 0.90; 0.84-0.96) and advanced care plans were more likely to be on file for NCSMCS (9.0% vs. 4.9%). The intensive care unit (ICU) admissions were decreased by 17% among Non-NCSMCS (IRR 0.83; 95% CI 0.74-0.93). The utilization rates for ED admissions were not statistically different among both the groups. Conclusions: The preliminary data is promising and impact will be monitored as the intervention is expanded. Reducing admissions has benefits from both a cost savings as well as quality of life perspective. Future analyses will consider the impact of the intervention on a patient’s quality of life.
Safety and outcomes of a cancer patient urgent care clinic.
Authors: Bevins Jack S , Fullington Hannah , Froehlich Thomas W. , Hobbs Stephanie , Halm Ethan , Lee Simon Craddock , Hong Arthur
Published: May 2019

6542

Background: Several cancer centers describe cancer-patient dedicated urgent care clinic (UCC) that address commonly anticipated complaints of adults with cancer. UCC may be capable of preventing some ED visits, but little is known of the safety and outcomes for patients after a UCC visit. Methods: We identified UCC visits made by adults at our comprehensive cancer center between 2013-2016 and compared the cohort to patients who did not visit the UCC. We linked patients to tumor registry data and their electronic health record from the UCC visit, then tracked ED visits, inpatient and intensive care unit (ICU) admissions occurring within 24 hours of the UCC visit. Results: Between 2013-2016, 551 patients generated 772 UCC visits, compared to 17,496 who did not visit. UCC users had significantly (p<0.001) more advanced-stage cancer than non-UCC users (37.3% vs 18.9%), but there were no significant differences in mean age, race/ethnicity, or death within 180 days of diagnosis. The most common chief complaints accounted for nearly half of all UCC visits: (17.4%), URI symptoms/fever (12.6%), nausea/vomiting/diarrhea (7.8%), and fatigue/weakness (7.6%). After 10.0% of UCC visits, patients had an ED visit, while 12.3% were admitted to the hospital; only 5 UCC visits (0.7%) had an associated ICU stay. Most patients (75.7%) only had a single UCC visit, but patients who visited the UCC more often tended to have higher rates of ED visits and hospitalizations within 24 hours (Table). The mean time from UCC arrival to ED arrival was 3.0 hours, and 6.5 hours from UCC arrival to inpatient arrival. Conclusions: The majority of patients seen in UCC did not require ED or inpatient hospitalization. Patients with subsequent ED or inpatient visits had minimal delays in care. Findings suggest that triaging cancer patients for commonly anticipated complaints to a UCC does not result in high rates of mis-triaging or major delays in care. Patients with ED, Inpatient, or ICU visit after UCC, stratified by UCC visits per patient (2013-2016). [Table: see text]
Validation of an oncology-specific instrument to measure cancer patients’ perception of care coordination.
Authors: Okado Izumi , Cassel Kevin , Pagano Ian , Fukaya Erin , Kelleher Timothy , Hewitt Tracey , Holcombe Randall F.
Published: May 2019

6543

Background: According to the IOM, effective coordination of care (CC) is a critical component of high-quality cancer care; however, lack of a reliable and validated measure limits our current understanding of cancer care coordination. We examined psychometric properties and utility of a Care Coordination Instrument (CCI), a survey developed to assess cancer patients’ perceptions of care coordination. Methods: The 29-item CCI was administered to 200 patients receiving active treatment for cancer at private oncology practices and hospital-based facilities from Oct. 2018 to Jan. 2019. The CCI includes subscales that evaluate CC in 3 domains (Communication, Navigation, Operational) across 4 areas of CC (patient-physician; between health providers; during inpatient-to-ambulatory care transitions; during transitions across different phases of care). All items were rated on a 4-point Likert scale. Results: Psychometric analyses of the CCI demonstrated that it has good internal consistency reliability (α = .917) and the three-factor solution was an acceptable fit (CFI = .853, SRMR = .065). Overall, cancer types (leukemia, myeloma) and having an identified patient navigator significantly predicted higher patients’ ratings of CC ( p < .05). Similar trends were found for Communication and Operation subscale scores ( p < .05). Having an identified navigator predicted higher Navigation scores ( p < .05). Marginally significant differences were found for practice setting, with patients receiving care in hospital-based facilities reporting better CC ( p = .085). Item-level analyses revealed significant differences in specific aspects of CC (e.g., physician-patient communication) across cancer type, presence/absence of a patient navigator, and practice setting. Conclusions: The results demonstrate that the CCI is a reliable and valid instrument for measuring cancer patients’ perceptions of care coordination. Perception of CC correlated with the presence of a navigator, underlying cancer type and (trending) practice setting. Use of this instrument may reveal important information about cancer care coordination and may identify areas of targets for improvement in patient-centered cancer care delivery.
Nurse Navigators telephone and web application follow-up intervention for patients treated with oral anticancer medication: an optimization of oncologists' medical time.
Authors: Ferrua Marie , YATIM FATIMA , Fourcade Aude , Lacaze Marilène Guillet , Mir Olivier , Minvielle Etienne
Published: May 2019

6544

Background: Many interventions to improve safety and quality of oral anti-cancer medication have occurred the past few years. Frequently, these systems involve Nurse Navigators (NN) but rather limited data is actually available describing their activities and quantifying which intervention could have been performed without an oncologist's expertise. This is a major issue in optimizing the workload of oncologists statewide. Methods: The study was conducted at Gustave Roussy (Villejuif, France) as part of an assessment program of an intervention combining NN and mobile app dedicated to patients receiving oral cancer medication (cytotoxic, targeted therapies). A coding grid was developed to classify the NNs' activities from the intervention reports. NN interventions consist in regular follow-up calls and requests from patients and their relatives (via phone calls or mobile app). NN interventions recorded over a 24-month period were all encoded by two researchers. Results: 2395 interventions were analyzed concerning 236 patients, 1880 of which were regular follow-ups, and 515 patient requests. The majority of contacts were carried by phone conversation (94%). 52% of the interventions were followed-up upon by at least one additional action by the NN (n = 1250). In 25% (n = 318) of the interventions, the oncologist's expertise was required mainly because of the presence or aggravation of symptoms and/or toxicities or concerning oncological treatment (therapeutic protocol, biological assessment). 75% (n = 932) of the interventions have been processed successfully by NN by themselves. The principal actions carried out by the NN were: A. Contact or provide referral to a health professional or institution 24%, B. Advice to the patient 43%, C. Management of medical documents and appointments 6%; D. Administrative management 2%. Conclusions: Patients' needs for oral cancer drugs are mainly related to advice, information and coordination of the care pathway. In the majority of interventions, the NNs were able to manage these situations by themselves, which could optimize the workload of oncologists.
The diagnosis and outcomes when the outpatients receiving chemotherapy visited the emergency room: A tertiary referral center retrospective study of 734 cases.
Authors: Ogata Takatsugu , Satake Hironaga , Ogata Misato , Yasui Hisateru
Published: May 2019

6552

Background: Today, the chemotherapy is performed in outpatient, but there is no research on the safety. This study aimed to determine the safety of outpatients receiving chemotherapy and the points to note when they visit the emergency room. Methods: We retrospectively collected data from July 2011 to October 2018 in tertiary referral center of outpatients receiving chemotherapy when they visited the ER within 3 months from the administration of chemotherapy. Results: Seven hundred and thirty-four cases (345 patients) were enrolled (median age, 71 years; male 410, female 324). The median days of the patients visiting the ER was 16 days after the administration of chemotherapy. The tumor types were gastrointestinal (226 cases), urological (199 cases), respiratory (112 cases), and the other (197 cases). The cytotoxic agents, antibody, or hormonal agents were 530 cases, 150 cases, or 173 cases, respectively. The median body temperature and systolic blood pressure were 36.8 °C and 130 mmHg, respectively. The median estimated glomerular filtration rate was 68. The cases of emergent admission were 256 cases. The tumor-associated disease was 184 cases and the chemotherapy-associated disease was 105 cases. The most frequent chemotherapy-associated disease was febrile neutropenia (FN) (35 cases). The admission of tumor-associated disease or chemotherapy-associated were 94 cases or 41 cases, respectively (p = 0.273). Conclusions: The outpatients receiving chemotherapy visited the emergency room because of the tumor-associated symptoms rather than chemotherapy-associated symptoms. It was safe that the chemotherapy is performed in outpatient. FN was the most frequent chemotherapy-associated disease. It is important to be careful that not only chemotherapy-associated symptoms but also tumor-associated symptoms when the outpatients receiving chemotherapy visited the ER.