bluuebunny/crossref_metadata_2025_split huggingface dataset:
Concurrent and sequential chemoradiation therapy are associated with improved survival among unresected stage III non-small cell lung cancer patients in the United States.
Authors: Zheng Zhiyuan , Rengan Ramesh , Zhao Jingxuan , Sineshaw Helmneh M. , Chun Stephen G. , Han Xuesong , Yong Candice , Seal Brian S. , Makari Doris , Simone Charles B. 
Published: May 2020

7043 Background: Concurrent chemoradiation therapy (cCRT) has been shown to improve survival outcomes among inoperable stage III non-small cell lung cancer (NSCLC) patients compared to sequential CRT (sCRT) and single-modality therapy in clinical trials. However, many “real world” patients do not receive CRT, and less is known about the survival benefits of concurrent CRT vs other treatment modalities in pragmatic, non-clinical trial settings. Methods: We used the National Cancer Database (2004-2011) to identify unresected stage III NSCLC patients (ages 18-79 years) with Charlson comorbidity score ≤1 and 5-year follow up through the end of 2016. cCRT was defined as the initiations of chemotherapy (CT) and radiation therapy (RT) that were ≤14 days (n = 30,290) apart, whereas sCRT was defined as > 14 days apart (total n = 10,596). The remaining three treatment groups included CT only (n = 11,216), RT only (n = 7,772), and neither CT/RT during first course treatment (n = 10,694). Cox proportional hazard model was used to examine the 5-year survival by treatment modalities, controlling for patient demographics, comorbidity score, health insurance, facility type, area-level social deprivation index (SDI, a composite measure for area-level socio-economic status), driving time to the treatment facility, diagnosis year, and region. Adjusted hazard ratios (HR), and medium survivals were generated by treatment modalities. Results: Among 70,568 unresected stage III NSCLC patients, 61,487 (87.1%) patients died within the 5-year follow-up period. In adjusted analyses, cCRT and sCRT had similar survival (median survivals: 15.3 months), whereas other treatment modalities were associated with worse survival compared to cCRT: CT only (median survival: 10.8 months; HR [95%CI]: 1.46 [1.43-1.50]), RT only (median survival: 6.7 months; HR [95%CI]: 1.93[1.88-1.99]), and no treatment (median survival: 3.2 months; HR [95%CI]: 2.64 [2.58-2.71]), all p < 0.001. Higher comorbidity score (Charlson score 1 vs 0, HR [95%CI]: 1.18 [1.16-1.21]), non-private insurance (Medicaid: 1.16 [1.12-1.20]; Medicare: 1.10 [1.08-1.13]; uninsured: 1.21 [1.16-1.26]) were all associated with worse survival (all p < 0.001). Conclusions: Concurrent CRT and sequential CRT have similar survival outcomes among unresected stage III NSCLC patients with minimum comorbidities, however, single modality and no therapy are associated with much poorer survival among “real world” patients, and should be avoided unless clinically appropriate.
Prior authorization process improvement for pain medications in an oncology unit: Timely initiation of test claim request form.
Authors: Varghese Susy , Amaram-Davila Jaya Sheela , George Marina C. 
Published: May 2020

7050 Background: Oncology patients with extensive metastatic disease and advanced-stage cancer frequently require controlled medications for pain managements. Insurers require Prior Authorization (PA) for high-cost specialty medications including: Hydromorphone, Oxycodone, Oxymorphone, Fentanyl, Nucynta, Lyrica and Lidocaine patch. Failure to obtain PA may delay patient hospital discharge and attainment of discharge medications, increase patient medication costs, increase hospital readmissions and emergency visits, and exacerbate clinical complications. In order to avoid delays, providers must submit a Claim Request (CR) to initiate the PA process. PA usually takes 48-72 hours after the CR is submitted; therefore, timely CR submission in anticipation of discharge is imperative. Baseline rates for initiating CR in a timely manner was 15%. A quality improvement project was conducted to increase provider-initiated CRs for prescribed pain medications requiring PA and to demonstrate a sustainable process, anchored by development of new policy. Methods: The project revised the provider-initiated CR process by implementing the following interventions: The Electronic Medical Record (EHR) was modified to create a ‘quick link’ to facilitate CR form submissions. The link was made available to providers via their dashboard for easy access to the CR form.The medication reconciliation process was revised to require nurses to send reminders to providers for any of the seven discharge medications requiring CR submission for PA. A new component was incorporated into the discharge planning process by discussing PA and CR during interdisciplinary rounds. Providers and nurses were educated about the revised process. Results: Rates for timely CR submission were collected from the EHR biweekly for 3 months post-intervention. Post-intervention, 77% of timely CR claims increased from baseline of 15% to 87%. Due to the timely initiation of CR, some medications were deemed not to require PA, and the percentage of PA requirement reduced from 95% to 55%. In addition, up to 16% of patients had money refunded as a result of timely CR submission. Conclusions: The new process was effective for ensuring an efficient and effective process for patients who require high-cost controlled medications for pain management, reducing waste and providing a quality experience for the patient. As a result of the project, the new process has become policy and is now being used on other units in the institution for additional medications that requires CR and PA.
Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention.
Authors: Wallner Lauren P. , Abrahamse Paul , Radhakrishnan Archana , An Lawrence C. , Griggs Jennifer J. , Schott Anne F. , Ayanian John , Sales Anne , Katz Steven J. , Hawley Sarah T. 
Published: May 2020

7056 Background: The delivery of team-based survivorship care after primary cancer treatment remains challenging, in part due to a lack of effective interventions. We developed a multi-level intervention for breast cancer patients and their primary care and medical oncology providers to improve the delivery of team-based survivorship care called ConnectedCancerCare (CCC). CCC includes a patient-facing, personalized mobile website, and tailored feedback letters to providers. Methods: We conducted a pilot randomized controlled trial in a breast oncology clinic to establish the feasibility and acceptability of CCC. Women within one year of completing primary treatment for stages 0-II breast cancer were randomized to CCC (intervention) or a static online survivorship care plan (control). Participants completed online surveys at baseline and 3 months, ascertaining their knowledge about PCP roles in their survivorship care, their communication with their PCP about team-based care, and whether they scheduled a follow-up visit with their PCP. Multiple measures of acceptability were collected among women in the intervention arm (n = 28). Qualitative interviews were conducted at the completion of the study with 5 PCPs, 6 oncology providers, and 10 intervention patients to identify barriers and facilitators to implementing CCC. Results: Among 160 eligible women invited to participate, 66 women completed the baseline survey and were randomized (41% participation rate), and 54 completed the 3-month follow-up survey (83% response rate). Women in the intervention arm found the content of the CCC website to be highly acceptable, with 82% reporting it was easy to use, and 86% reporting they would recommend it to other patients. A greater proportion of women randomized to CCC (vs. control) reported scheduling a PCP follow-up visit (64% vs. 42%) and communicating with their PCP about provider roles (67% vs. 18%). Women in the CCC arm also reported higher mean knowledge scores regarding team-based cancer care (3.7 vs. 3.4). Providers noted challenges to implementing CCC, including integration into electronic medical records, and supporting sustained engagement with CCC over time. Conclusions: Our findings suggest deploying CCC in medical oncology practices is feasible, and the intervention content is acceptable among breast cancer patients. CCC shows promise for improving understanding and communication about provider roles in survivorship care, and facilitating patients to follow up with their PCP early in the survivorship period. Clinical trial information: NCT03618017 .
Real-world outcomes of immune-related adverse events in 2,125 patients managed with immunotherapy: A United Kingdom multicenter series.
Authors: Olsson-Brown Anna Claire , Baxter Mark , Dobeson Caroline , Feeney Laura , Lee Rebecca , Maynard Alec , Mirza Shagufta , Mughal Sohail , Parikh Shefali , Rodgers Lisa Jane , Salawu Abdulazeez , Shotton Rohan , Tinsley Nadina , Zhao Sizheng Steven , Jones Christopher ,   The UK National Oncology Trainee Collaboration for Healthcare Research (NOTCH)
Published: May 2020

7065 Background: Immune-related adverse events (irAE) are a recognised complication of immune checkpoint inhibitor (ICI) therapy. Previous characterisation of irAEs has been limited to clinical trial or registry populations and small case series. Here we present a multi-centre, granular, real-world analysis of the prevalence and outcomes of irAEs experienced by patients managed within a single comprehensive public health service. Methods: A multi-centre retrospective analysis of 2125 consecutive patients treated with ICIs was undertaken across 12 centres. All patients were managed within the UK National Health Service outside of a trial setting between June 2016 and September 2018. Patients received either ICI monotherapy (MT) or combination therapy (CT). Data were collected using a standardised, pre-piloted, collection tool. IrAEs ≥ grade 2 or endocrinopathies of any grade were considered clinically significant and recorded as per the Common Terminology Criteria for Adverse Events (V5) (CTCAE). Descriptive statistics were employed using Stata v15 (College Station, TX). Results: Patients received αPD-1 (1757; 82%), combination αPD-1/αCTLA-4 (285, 13%), αCTLA-4 (51; 2%) and αPD-L1 (31; 1%) immunotherapy for malignant melanoma (961), non-small cell lung cancer (788) or renal cell carcinoma (335). The median age was 66 (MT) and 57 (CT). Clinically significant irAEs occurred in 732 (34%) individuals; 28% (524) on MT and 73% (208) on CT. Colitis (206,10%), thyroiditis (194, 9%), hepatitis (142, 7%) and dermatitis (126, 6%) were most commonly observed. Grade 1 endocrinopathies occurred in 20% (173) of cases. Grade 2 irAEs occurred in 43% (359), grade 3 31% (269) and grade 4 6% (51). The were 3 (0.4%) cases of grade 5 irAE; pneumonitis (2) and hepatitis, all following αPD-1 MT. 93% (680) required corticosteroids with 64% (490) requiring systemic corticosteroids and 11% (80) steroid sparing immunosuppression. 16% (336) of patients had pre-existing autoimmune disease of whom 40% (136) experienced irAEs. IrAEs led to admission in 42% (308) of cases, accounting for 2996 bed days. Length of stay was 7 days (1-67; IQR 4-13). Higher dependency care was required in 0.7% (15) of cases. Colitis (35%, 107) and hepatitis (25%, 77) accounted for the most admissions. Pneumonitis accounted for 3% (66) of irAEs but 12% of admissions. Conclusions: One third of patients experienced a clinically-significant irAE resulting in significant morbidity and admission burden highlighting the need for effective management strategies to optimise patient outcomes.
A randomized controlled trial (RCT) testing a mobile application (app) to identify cancer treatment-related financial assistance.
Authors: Tarnasky Aaron , Tran George Nhat , Nicolla Jonathan , Friedman Fred Andrew Paul , Wolf Steven , Troy Jesse D , Sung Anthony Derek , Shah Kanan , Oury Jakob , Thompson Jillian C , Gagosian Ben , Pollak Kathryn I. , Manners Ian , Zafar Yousuf 
Published: May 2020

7073 Background: Insured cancer patients face high treatment-related, out-of-pocket costs. While philanthropic- and pharmaceutical-sponsored financial assistance programs exist, patients are often unaware of them. We developed “Bridge”, a patient-facing app that identified financial assistance programs for which a patient might be eligible based on treatment, disease, insurance, and financial characteristics. We hypothesized that patients in the Bridge study arm would be more likely than controls to apply for and receive financial assistance. Methods: We enrolled patients at a single institution from January 2018-March 2019. Patients were receiving treatment for any cancer, had a life expectancy of ≥6 months, and self-reported out-of-pocket costs. We randomized patients 1:1 to intervention (Bridge) vs. control (financial assistance educational websites). We assessed subjective financial distress with the validated COST measure. Outcomes included application for and receipt of financial assistance. Data on outcomes was collected from the medical record, institutional pharmacy database, and Bridge. We compared patient characteristics between study arms using chi-square and Mann-Whitney-Wilcoxon tests. We used an unadjusted logistic regression model to compare differences in outcomes. Results: We randomized 200 patients and found no significant differences between arms in baseline characteristics (Table). At 6 months from enrollment, patients in the Bridge arm were more likely than controls to apply for financial assistance [35% Bridge vs. 10% control, OR 3.53, 95%CI 1.69-7.34, p < 0.01]. Bridge patients were also more likely than controls to receive financial assistance (30% Bridge vs. 9% control, OR 3.39, 95%CI 1.78-6.46, p < 0.01). Conclusions: Among patients with treatment-related out-of-pocket costs, those who interacted with a financial assistance app were significantly more likely to apply for and receive treatment-related financial assistance. [Table: see text]
Health plan expenditures young adults with newly-diagnosed Hodgkin lymphoma (HL) by care at NCI-designated comprehensive cancer centers (CCC) vs. other treatment sites (non-CCC).
Authors: Wolfson Julie Anna , Bhatia Smita , Ginsberg Jill P. , Becker Laura , Bernstein David , Henk Henry J. , Lyman Gary H. , Nathan Paul C. , Puccetti Diane , Wilkes Jennifer J , Winestone Lena , Kenzik Kelly 
Published: May 2020

7081 Background: Patients diagnosed with HL between 22-39y have worse outcomes than younger patients (≤21y); we previously reported that treatment at a CCC mitigates these disparities [Wolfson, Leukemia 2017]. While there is general consensus that CCC care is expensive, expenditures for managing young adults with HL in CCC vs. non-CCC are not known. Methods: Cancer-related expenditures were examined in HL patients diagnosed between 2001-2014 at age 22-39y and treated at CCC and non-CCC sites using commercial insurance claims data (OptumLabs Data Warehouse). Multivariable generalized linear models with log link modeled average monthly health plan paid expenditures, adjusting for sociodemographics, stage, adverse events, pre-existing comorbidities, and diagnostic era. Results: Of the 1501 HL patients, 33% (n = 489) were treated at a CCC. Patients treated at CCC vs. non-CCC did not differ with respect to race, sex, income, diagnostic era or comorbidities (p≥0.3). Mean duration of enrollment was longer in CCC than non-CCC (25 vs. 23 mos; p < 0.001) patients. During the first year after HL diagnosis, total average monthly expenditures were higher in CCC ($9,111) than non-CCC ($7,834, p = 0.001), including those related to inpatient (CCC: $1,790 vs. non-CCC: $1,011; p = 0.001) and outpatient (CCC: $6,971 vs. non-CCC: $6,487; p = 0.001) expenditures. The higher CCC expenditures were associated with higher monthly rates of inpatient admissions (IRR = 1.3, p = 0.001) and outpatient visits (IRR = 1.1, p = 0.02) at CCC. Rates of chemotherapy-related inpatient admissions were higher (IRR = 2.3, p = 0.001) in CCC than non-CCC patients, while outpatient chemotherapy visit rates were lower (IRR = 0.9, p = 0.001) in CCC. During Years 2-3, total average monthly expenditures were higher in CCC ($19,259) than non-CCC ($4,145, p = 0.002) patients. Outpatient expenditures were higher in CCC ($10,164) vs. non-CCC ($2,901, p = 0.001), with higher monthly outpatient visit rates (IRR = 1.7, p = 0.001) at CCC. Conclusions: Inpatient and outpatient cancer-related expenditures in young adults with HL were higher at CCC than non-CCCs. Higher outpatient expenditures at CCC were associated with only higher monthly visit rates. Higher inpatient expenditures were in the setting of higher admission rates, including those related to chemotherapy. Additional work is necessary to understand whether these higher expenditures at CCC are related to supportive care and/or differences in facility structure and billing practices.
Cost-effectiveness analysis of stereotactic ablative radiotherapy in patients with oligometastatic cancer.
Authors: Kumar Abhishek , Straka Christopher Andrew , Vitzthum Lucas , Cherry Daniel R , Courtney Patrick T , Riviere Paul , Murphy James Don 
Published: May 2020

7085 Background: The SABR-COMET randomized clinical trial found that stereotactic ablative radiotherapy (SABR) improved outcomes among cancer patients with oligometastatic disease. Yet, the cost of SABR along with the large number of patients with oligometastatic disease raises the important question of value. This study sought to evaluate the cost-effectiveness of SABR compared to standard therapy among cancer patients with oligometastatic disease. Methods: We constructed a Markov model to simulate treatment with stereotactic ablative radiotherapy or standard therapy among patients with oligometastatic cancers. The model derived transition probabilities from clinical trial data to estimate risks of toxicity, disease progression and survival. Healthcare costs and health utilities were estimated from the literature. Cost-effectiveness was estimated with an incremental cost-effectiveness ratio (ICER) defined as dollars per quality-adjusted life year (QALY), with an ICER less than $100,000/QALY considered cost-effective. One-way and probabilistic sensitivity analyses were used to examine model uncertainty. Results: The addition of SABR increased total costs by $54,279 and improved effectiveness by 1.20 QALYs compared with standard therapy, leading to an ICER of $45,162/QALY. The model was sensitive to assumptions about tumor progression, though the model was not sensitive to assumptions about survival or cost of treatment. The cost of SABR would need to increase approximately six-fold from $12,241 to $78,151 before SABR becomes cost-ineffective. Probabilistic sensitivity analyses demonstrated that SABR was the cost-effective treatment option 97.2% of the time. Conclusions: The addition of SABR increased costs and improved quality adjusted survival, overall leading to a cost-effective treatment strategy for patients with oligometastatic cancer.
Phase Ib/II study of the IDH1-mutant inhibitor ivosidenib with the BCL2 inhibitor venetoclax +/- azacitidine in IDH1-mutated hematologic malignancies.
Authors: Lachowiez Curtis Andrew , Borthakur Gautam , Loghavi Sanam , Zeng Zhihong , Kadia Tapan M. , Masarova Lucia , Takahashi Koichi , Tippett George Dono , Naqvi Kiran , Bose Prithviraj , Jabbour Elias , Ravandi Farhad , Daver Naval Guastad , Garcia-Manero Guillermo , Stoilova Bilyana , Vyas Paresh , Kantarjian Hagop M. , Konopleva Marina , Dinardo Courtney Denton 
Published: May 2020

7500 Background: Mutations in the isocitrate dehydrogenase-1 gene ( IDH1) result in myeloid differentiation arrest and accumulation of the oncometabolite 2-hydroxyglutarate (2-HG), promoting leukemogenesis. We report a primary safety and efficacy analysis of the IDH1 inhibitor ivosidenib (IVO; 500 mg PO daily D15-continous) combined with venetoclax (VEN; D1-14 per 28-day cycle), with and without azacitidine (AZA; 75mg/m2 D1-7). Methods: Eligible patients age ≥18 with IDH1 mutated myeloid malignancies (high-risk MDS and AML) enrolled into one of three successive cohorts (Cohort 1: IVO+VEN 400 mg, Cohort 2: IVO+VEN 800 mg, Cohort 3: IVO+VEN 400 mg+AZA). Primary endpoints include safety and tolerability and overall response rate (ORR) by revised IWG criteria. Key secondary endpoints include survival endpoints and PK correlates. Results: 19 patients (median age 68) enrolled, 17 with AML: 9 relapsed/refractory AML (R/R; median 1 prior line of therapy), 5 treatment naïve AML, and 3 HMA-failure MDS with secondary AML. Two patients had high-risk MDS. ELN risk was favorable, intermediate, and adverse risk in 37%, 15%, and 47%. Co-mutations included NPM1 (37%), chromatin-spliceosome (32%), methylation (16%), and RAS pathway (21%). Adverse events of special interest included IDH differentiation syndrome (n=4, grade > 3 in 1) and tumor lysis syndrome (TLS; n=2), including one grade 3 TLS event in a NPM1+ patient (successfully managed without hemodialysis). In evaluable patients (n=18), composite complete remission (CRc: CR+CRi+CRh) rates were 78% overall (treatment naive: 100%, R/R: 75%), and 67%, 100%, and 67% by cohort (median time to best response: 2 months). 7 (50%) patients achieving CRc were also MRD negative by flow cytometry. 1 patient had HI without CR/CRi and 1 had a MLFS. 9 (50%) patients remain on study, 3 (17%) proceeded to SCT in CR, 2 were non-responders, and 5 (22%) experienced progressive disease following CRc occurring after a median of 3 months. After a median follow up of 3.5 months, median OS was not reached in treatment naïve patients, and 9.7 months in R/R patients. Conclusions: IVO+VEN +AZA therapy is well tolerated and highly effective for patients with IDH1 mutated AML. Follow up and accrual is ongoing to better define duration and biomarkers of response. Clinical trial information: NCT03471260 . [Table: see text]
Development and validation of a pediatric disease risk index for allogeneic hematopoietic cell transplantation.
Authors: Qayed Muna , Kitko Carrie L , Ahn Kwang Woo , Johnson Mariam H , Schultz Kirk R. , Smith Angela R. , Yanik Gregory A , Eapen Mary 
Published: May 2020

7503 Background: Characteristics such as disease, disease status and cytogenetic abnormalities impact relapse and survival after transplantation for acute myeloid (AML) and acute lymphoblastic (ALL) leukemia. In adults, these attributes were used to derive the disease risk index for survival. Thus, the current analysis sought to develop and validate a pediatric disease risk index (p-DRI). Methods: Eligible were patients aged <18 years with AML (n=1135) and ALL (n=1228) transplanted between 2008 and 2017 in the United States. Separate analyses were performed for AML and ALL. Patients were randomly assigned (1:1) to a training and validation cohort. Cox proportional hazards model with stepwise selection was used to select significant variables (2-sided p<0.05). The primary outcome was leukemia-free survival (LFS; relapse or death were events). Based on the magnitude of log(HR), a weighted score was assigned to each characteristic that met the level of significance and risk groups were created. Results: Four risk groups were identified for AML and three risk groups for ALL (Table). The 5-year probabilities of LFS for AML were 81% (68-91), 56% (51-61), 44% (39-49) and 21% (15-28) for good, intermediate, high and very high-risk groups, respectively. The 5-year probabilities of LFS for ALL were 68% (63-72), 50% (45-54) and 15% (3-34) for good, intermediate, high risk groups, respectively. Conclusions: This validated p-DRI successfully stratified children with AML and ALL for prognostication undergoing allogeneic transplantation. [Table: see text]