bluuebunny/crossref_metadata_2025_split huggingface dataset:
Analysis of hydration and antiemetics policies in preventing cisplatin-related gastrointestinal and renal toxicities in low-risk human papillomavirus positive-oropharyngeal cancer (HPV+OPC) patients undergoing chemoradiation in De-ESCALaTE trial.
Authors: Kong Anthony Hee , Mistry Pankaj , Evans Mererid , Hartley Andrew G. J. , Fulton-Lieuw Tessa , Jones David , Dalby Matthew , Gray Alastair , Foran Bernadette , Sen Mehmet , O'Toole Lorcan , Al-Booz H , Dyker Karen , Moleron Mancebo Rafael , Whittaker Stephen , Brennan Sinead Maire , Cook Audrey , Griffin Matthew , Dunn Janet , Mehanna Hisham Mohamed ,   De-ESCALaTE HPV Trial Group
Published: May 2019

6076 Background: The De-ESCALaTE trial confirmed the superiority of cisplatin over cetuximab in combination with radiotherapy for the treatment of low risk human papillomavirus positive oropharyngeal cancer (HPV+OPC). The most common serious adverse events (SAEs) for cisplatin were due to vomiting and nausea, in contrast with oral mucositis and vomiting for concurrent cetuximab. In this study, we examined the efficacy of different hydration and anti-emetic policies in preventing cisplatin-related gastrointestinal and renal toxicities as well as related SAEs in the cisplatin arm of the De-ESCALaTE trial. Methods: This was a post-hoc pre-specified analysis of data collected within the De-ESCALaTE trial including pre-hydration, diuretics, the amount of intravenous (IV) fluids before, during and after chemotherapy, whether oral fluid hydration was advised and type of antiemetic regimen prescribed, if any, after chemotherapy administration, including if a triple antiemetic regimen with a NK1 receptor antagonist, steroids and a serotonin 5-HT3 antagonist was given before and after chemotherapy. The primary outcome was number of SAEs per patient; secondary outcome was number per patient of cisplatin-induced severe toxicity events of interest: nausea, vomiting, dehydration or renal toxicity. Results: 166 (mean age 57 yrs; 132 m, 34 f) patients received cisplatin. Hydration and anti-emetics policies for cisplatin treatment are significantly correlated with the rate of SAEs and acute severe nausea, vomiting, dehydration or renal toxicities. Using stepwise backwards multivariable ordinal logistic regression in the presence of baseline characteristics, use of a triple anti-emetics regimen (OR 0.41,p = 0.032) and 2.5 to 3L IV fluids given before and during cisplatin chemotherapy (OR 0.161, p = 0.009) as well as oral fluids advised post chemotherapy (OR 0.365, p = 0.03) were associated with a significantly lower incidence of SAEs and severe toxicities of interest. We will also present data on relative cost-effectiveness of the different regimens. Conclusions: Based on our results, we recommend the use of a triple anti-emetic regimen, adequate hydration of 2.5-3L before and during chemotherapy as well as advising patients to take oral fluids advised to reduce cisplatin toxicities related to nausea, vomiting, dehydration and/or renal injury. Clinical trial information: ISRCTN33522080.
Genomic landscape of FNAs positive for medullary thyroid cancer (MTC) and potential impact on systemic therapy.
Authors: Wirth Lori J. , Waguespack Steven G. , Busaidy Naifa Lamki , Hu Mimi I-Nan , Grubbs Elizabeth Gardner , Weitzman Steven P , Zafereo Mark , Babiarz Joshua , Hao Yangyang , Huang Jing , Kennedy Giulia , Walsh P. Sean , Kloos Richard 
Published: May 2019

6087 Background: Systemic therapies targeting specific genomic alterations in advanced MTC are available or under investigation. The Afirma Genomic Sequencing Classifier (GSC) uses RNA sequencing to assess FNA specimens from cytologically indeterminate thyroid nodules, which are also tested for specific molecular aberrations associated with thyroid cancer via a suite of highly accurate malignancy classifiers. This suite can be applied independently to Bethesda V/VI nodules. The Afirma Xpression Atlas (XA) is an additional test that can be combined with Afirma GSC to report nucleotide variants and fusions across 511 cancer-associated genes. Here we report the prevalence and genomic landscape of MTC classifier positive (MTC+) FNA samples. Methods: All Afirma GSC and malignancy classifier tests run in the Veracyte Clinical Laboratory between July 2017 and January 2019 were deidentified and examined for MTC+ cases. Afirma XA was run on all such cases, and all variants and fusions were tabulated. Results: Examination of 29,895 FNAs revealed 90 MTC cases. Of 22,793 Bethesda III cases, 32 (0.14%) were MTC+. Of 5,491 Bethesda IV cases, 33 (0.60%) were MTC+. Provider-ordered testing was done on an additional 16 and 9 MTC cases from Bethesda V and VI nodules, respectively. 58% of all MTC+ samples harbored a RET variant (+/- others), 9% contained a KRAS variant (+/- others), 6% included an HRAS variant, 1% had a BRAF fusion, 1% demonstrated other fusions, and 26% held no variant/fusion. Conclusions: In our cohort, Afirma XA identified a variant or fusion in 74% of MTC+ FNAs. Currently approved or investigational therapies exist for cancers with RET, BRAF and HRAS alterations, suggesting that 64% of our series might be eligible for treatment based on genomic information from FNA. In advanced MTC, noninvasive FNA sample collection at the time of diagnosis may ultimately impact on targeted therapy selection, with the option to repeat FNA testing should the disease progress. Future studies may investigate how finding a genomic alteration by FNA can inform the management of MTC and, in the case of progressive disease, improve our understanding of the mechanisms of disease progression and drug resistance.
Longitudinal toxicity analysis with novel summary metrics of lenalidomide maintenance in follicular lymphoma in ECOG-ACRIN 2408.
Authors: Thanarajasingam Gita , Dueck Amylou C. , Novotny Paul J , Habermann Thomas Matthew , Advani Ranjana H. , Gascoyne Randy D. , Witzig Thomas E. , Quon Andrew , Ranheim Erik , Kahl Brad S. , Evens Andrew M. , Hong Fangxin 
Published: May 2019

6511 Background: Conventional adverse event (AE) analysis (ToxC) focuses on incidence of grade (gr) 3+ toxicities, and fails to capture AE time profile. Novel metrics that reflect chronic low gr and overall AE burden are needed. We applied the Toxicity over Time (ToxT) approach to ECOG-ACRIN 2408 to depict time-dependent toxicity of lenalidomide (L) with rituximab maintenance (MR) in follicular lymphoma (FL), and we developed a novel summary metric of symptomatic AE burden, the maximum gr over time (MGOT). Methods: In E2408, high risk FL patients (pts) were randomized (1:2:2) to: A) bendamustine-rituxumab (BR) x 6 then MR x 2 years (yrs) vs B) BR-bortezomib x 6 then MR x 2 yrs vs C) BR x 6 then MR x 2 yrs + L x 1 yr (MRL). Analysis included 3 laboratory and 5 symptomatic AEs of highest incidence during maintenance on arms A and C. Treatment-related AEs of any gr were analyzed by ToxC and ToxT. Repeated measures, time-to-event (TTE) and area under the curve (AUC) analyses capture trends over time in ToxT. MGOT combines the 5 symptomatic AEs. Results: 104 randomized pts (30 MR, 74 MRL) were included. For the laboratory AEs, by ToxC, neutropenia incidence was significantly higher in MRL (84%) than MR (47%, p < .001). ToxT additionally shows neutropenia does not worsen over time (10/14/20% gr 1/2/3+ at c1, 6/21/12% gr 1/2/3+ at c12). For the symptomatic AEs, ToxC indicates 2% gr 3+ GI AEs. However, gr 1-2 GI AEs are more common on MRL (59%) than MR (26%, p < .001). ToxT AUC captures a higher burden of GI AEs over time on MRL(2.8) vs MR(1.4, p = .002). TTE depicts sooner GI AE onset in MRL (10% vs 0% gr 2+ GI by day 50, p = 0.03). Bar charts of incidence and grade by cycle illustrate this improves over time (34/7/4% gr 1/2/3+ at c1, 13/0/0% gr 1/2/3+ at c12). ToxT MGOT analyses demonstrate earlier time to gr 2+ symptomatic AE on MRL vs MR (63% vs 31% by day 50, p < .001) and suggest that overall AE burden over time is higher for patients on MRL(AUC 18.2) than MR(11.8, p < .001). Conclusions: ToxT depicts AE time profile and can guide AE interventions. Summary metrics suggest that symptomatic AEs occur earlier and their burden over time is higher on MRL. We are implementing ToxT in patient-reported AE data to better characterize pt tolerability.
Population-based cohort of prostate cancer patients on active surveillance (AS): guideline adherence, conversion to treatment and decisional regret.
Authors: Peterson Sabrina , Basak Ramsankar , Moon Dominic Himchan , Liang Claire , Basak Ram S , Walden Sarah , Katz Aaron J , Chen Ronald C. 
Published: May 2019

6512 Background: AS is recommended for early-stage prostate cancer, for which over-treatment has been widely described. In published studies from large academic institutions and/or controlled clinical trials, where patients are monitored rigorously, AS is safe and results in low rates of cancer-specific mortality. However, active surveillance in the community setting has not been previously examined. Methods: In collaboration with the North Carolina state cancer registry, 346 men with newly-diagnosed low- or intermediate-risk prostate cancer throughout the state from 2011–13 who pursued active surveillance were enrolled in an observational cohort; medical records and patient-reported outcomes (validated measures of prostate cancer anxiety [MAX-PC] and Clark’s prostate cancer decision regret) were collected prospectively. Guideline-adherent monitoring during active surveillance was assessed using contemporary NCCN guidelines: PSA testing every 3–6 months and prostate biopsy within 18 months of initial diagnosis. Results: 58% of patients received adequate PSA testing and 45% prostate biopsy; overall, 32% of patients received guideline-adherent monitoring. Urology follow-up in Year 1 was 97% but dropped to 67% in Year 2. Within the first 2 years, 16% of patients converted to treatment. Multivariable analysis showed MAX-PC scores (OR 1.8, p = 0.008) and younger age were significantly associated with conversion; no other sociodemographic (race, education, marital status, rural/urban) or diagnostic variable (risk group) was associated. At 2 years, 94% expressed no regret. Conclusions: In a non-controlled setting of patients pursuing AS in the community, adherence to guideline-recommended monitoring was only 32%. Few patients expressed decisional regret. Conversion to treatment was likely driven by patient anxiety but not disease-related factors. While there are continued efforts to increase AS uptake, these results highlight the importance of behavioral interventions during active surveillance to reduce anxiety and improve monitoring adherence. Whether AS in non-controlled settings is safe and effective requires further study.
Integrating psychosocial care into routine cancer care: A stepped-wedge design cluster randomized controlled trial (SWD-RCT) to evaluate effectiveness of the HuCare Quality Improvement Strategy (HQIS) on health-related quality of life (HRQoL).
Authors: Passalacqua Rodolfo , Iezzi Elisa , Annunziata Maria Antonietta , Verusio Claudio , Pinto Carmine , Airoldi Mario , Aragona Marcello , Caputo Francesca , Cinieri Saverio , Giordani Paolo , Gori Stefania , Mattioli Rodolfo , Novello Silvia , Pazzola Antonio , Procopio Giuseppe , Russo Antonio , Sacco Cosimo , Sarobba Giuseppina , Zerilli Filippo , Caminiti Caterina ,   AIOM Italian Association of Medical Oncology
Published: May 2019

6515 Background: Cancer patients (pts) often do not receive evidence-based psychosocial care. We evaluate the effects of an implementation strategy we previously demonstrated feasible, which includes communication skill training for all physicians and nurses; four support visits at the centers by an improvement team to assist staff in identifying obstacles, finding solutions, and strengthening motivation; screening for distress and social needs; individualized pts' education with a referring nurse; use of a question prompt list. Methods: Multicenter incomplete SWD-RCT with 3 clusters of 5 centers each. Consecutive outpatients requiring medical treatment and diagnosed in the previous 2 months were eligible. Primary endpoint: difference of at least one of the 2 domains of HRQoL emotional or social functions, at 3 months from baseline, in pts of the centers that implemented the HQIS vs standard of care (SoC). Secondary endpoints include: patient mood, long-term effect, overall HRQoL. Analyses were performed using a beta-binomial regression model. Results: 762 pts were enrolled. At baseline, 41% showed high anxiety (HADS-A>7), and 88% had at least one psychosocial need. 299 health professionals attended 3-day courses (84% of all clinical staff). 647 pts (85%) were available for analysis. The 315 pts who received HQIS exhibited better quality of life for the emotional domain than those assigned to SOC (OR=1.115, p=0.016). Pts who showed the greatest improvement were the older (OR=1.003, p=0.035), had lower anxiety basal levels (OR=0.853, p<0.001), and social needs were met (OR=1.182, p<0.001). The difference was not significant for the social domain (OR=0.955, p=0.353). The HQIS’s long-term effect was confirmed for the emotional domain at 12 months. No effect on mood (HADS-D) and overall HRQoL was observed. Conclusions: To our knowledge this is the first RCT demonstrating the effectiveness of a psychosocial care implementation strategy on cancer patients’ emotional well-being. Clinical trial information: NCT03008993.
Trends in financial relationships between industry and individual medical oncologists in the United States from 2014 to 2017: A cohort study.
Authors: Marshall Deborah Catherine , Tarras Elizabeth Stieglitz , Rosenzweig Kenneth , Korenstein Deborah , Chimonas Susan 
Published: May 2019

6520 Background: Industry-physician financial relationships in medical oncology are common and introduce conflicts of interest. The Open Payments (OP) program collects and discloses data on industry payments to physicians, in part to discourage inappropriate relationships. However, the effect of OP on how oncologists engage with industry is unknown. Our aim was to evaluate trends in physician-level payments to test whether the implementation of OP has resulted in fewer physicians engaging with industry and has shifted the nature of interactions towards those considered more appropriate. Methods: We performed a retrospective cohort study of US medical oncologists in 2014 from the National Plan and Provider Enumeration System. OP data for general (non-research) payments between 2014-2017 were matched to physician to evaluate receipt of payments over time. We calculated the percentage of physicians receiving payments, annual value and number of payments, and average annual trends over time, including by nature of payment. Results: From 2014-2017, medical oncologists received 1.4 million industry payments totaling $330.6 million. The absolute number of medical oncologists receiving payments decreased 4% on average annually ( P= .006), and proportionally from 67.2% to 59.6% overall. The value and number of payments have not significantly changed. The value and number of payments increased for accredited/certified CME (+821% and +209% annually) and decreased for non-accredited/certified CME (-18% and -25% annually). The value and number of food/beverage payments remained the same. The value and number of royalty/licensing payments increased. Conclusions: Fewer oncologists are receiving payments, but spending has not decreased suggesting that physicians are less likely to engage and industry is more selective. Increased payments for accredited CME suggest that less appropriate speaker’s fees are being avoided. Food/beverage payments are not decreasing, thus these interactions may not be recognized as problematic. Increasing royalty/licensing payments require ongoing scrutiny. Changes in physician payments since the inception of OP highlight the importance of transparency in policymaking.
Previsit breast cancer educational microlearning videos: Impact on patient satisfaction and engagement.
Authors: Hurley Rachel M , Wyatt Kirk , Johnson Rachel F , O'Brien Michael W , Zenz Wendy J , Anderson Stacy R , Brugger Cheryl A , Ruddy Kathryn Jean , Boughey Judy Caroline , Pruthi Sandhya 
Published: May 2019

6526 Background: Most patients diagnosed with breast cancer turn to the Internet to learn about their diagnosis; however, information online is often generic, challenging to navigate, and not expert-curated. To facilitate patient education and engagement in our breast clinic, we piloted the implementation of pre-visit education via brief microlearning videos organized within an online platform. Methods: Seventeen videos of 2-4 minute duration were developed by multidisciplinary content experts. Videos covered a variety of educational topics relevant to breast cancer, including treatment options. Patients received a link via email to create an account, which provided access to the platform. Aggregate viewing data and optional patient surveys (online after viewing 3 videos and at the clinical appointment) were used to assess opt-in rates, engagement, and satisfaction. Results: Between September 2018 and January 2019, 57.4% (240/418) of women with biopsy proven breast cancer who were sent an email invitation registered on the platform. On average, patients watched 11 of the 17 videos, with 93.7% of users (225/240) viewing at least one. Overall, 85% (168/198) of women recommend the microlearning format for patient education. The most-viewed video topics included types of breast cancer, breast abnormality and biopsy, understanding biopsy results, tumor markers, and staging. Seventy-eight percent (154/198) of women reported that they planned to share the videos with family or caregivers, and 67% (133/198) felt that the educational content increased their satisfaction with their overall experience. Barriers to video access were emails marked as junk, not having an email address, and difficulties with videos loading. Conclusions: The majority of patients participating in this pilot registered on the platform and watched pre-visit microlearning educational videos. These expert-curated videos contributed to high levels of satisfaction and engagement. Strategies to overcome barriers to access will be developed to expand the reach of this new valuable component of breast cancer care.
Growth factor use and rate of neutropenic complications in breast cancer patients treated with dose-dense paclitaxel: A 5-year experience from a safety net hospital.
Authors: Halawi Racha , Patel Kavi , Tobias Ethan , Syed Samira K. , Unni Nisha , Li Hsiao Ching , Sadeghi Navid 
Published: May 2019

6527 Background: The NCCN guidelines recommend growth factor (G-CSF) support to reduce the risk of febrile neutropenia and maintain dose density in patients receiving dose dense chemotherapy. We retrospectively reviewed growth factor utilization with dose dense paclitaxel (ddT) in breast cancer patients treated at our institution. Methods: Electronic medical records of patients treated at Parkland Health and Hospital System between 2012-2017 for breast cancer with dose dense adriamycin and cyclophosphamide (ddAC) followed by ddT were reviewed. Data on patient characteristics as well as G-CSF use and neutropenic complications were collected. Results: Two-hundred sixty eight patients received a total of 1019 cycles of ddT. Only one physician in the practice routinely prescribed G-CSF after ddT. The majority of ddT cycles were administered without G-CSF support (781 vs 238 cycles). There were no episodes of neutropenic fever in either group. The rate of grade 3/4 neutropenia was 2.1 % with G-CSF support (all grade 3), and 2.7% without G-CSF support (85% grade 3), p = 0.61. Treatment delays were longer in patients who did not receive G-CSF support, but this difference was not statistically significant (mean of 4 vs 2.2 days, p = 0.07). The number of cycles needed to treat to prevent 1 episode of grade 3/4 neutropenia was 167. Based on Medicare average sales price (ASP) for pegfilgrastim, routine use of G-CSF in our patient population would have added over $3.6M to the cost of care over the study period. Conclusions: Our results show a similarly low rate of neutropenic complications in patients receiving dose dense paclitaxel with or without G-CSF support. Therefore routine use of G-CSF with this regimen is not warranted. Judicious use of expensive medications such as G-CSF would reduce the cost of care and financial toxicity to patients, and promote high value care.
Delay in receipt of newly prescribed oral anticancer drugs.
Authors: O'Neil Daniel , Accordino Melissa Kate , Wright Jason Dennis , Law Cynthia , Nitta Suzuka , Buono Donna , Abbott Maura , Ustoyev Yelena , Cole Ellen , Hu Jianhua , Neugut Alfred I. , Hur Chin , Patel Khilna , Hershman Dawn L. 
Published: May 2019

6541 Background: Oral anticancer drug (OACD) prescriptions require coordination between clinicians, payers, specialty pharmacies, and financial assistance (FA) groups, which may delay patient receipt of the drug. Factors associated with delay in receipt of OACDs are unknown. Methods: We prospectively collected data on all new OACD prescriptions (RXs) from the medical oncology practice at the Herbert Irving Comprehensive Cancer Center from 1/1/2018 to 12/1/2018. We collected patient demographic, insurance and clinical information; date of prescription; date of drug delivery; and staff interactions with payers and FA groups. Federal Drug Association (FDA) labels and Micromedex were reviewed for initial drug approval dates, approved indications and average wholesale price. We used multivariable linear and logistic regression to determine factors associated with number of days from prescription to receipt of OACD. Results: During the study period 510 OACD RXs were evaluated. Of these, 84 (16%) were never filled. The most common OACDs were capecitabine (90, 18%), abiraterone (45, 9%), palbociclib (35, 7%) and osimertinib (28, 6%). Of 426 filled RXs, the median time from prescription to receipt was 8 days (IQR 5-13), with 193 RXs (46%) received in ≤7 days, 145 (34%) in 8-14 days and 65 (15%) in 14-28 days, and 23 (5%) at > 28 days. Linear regression showed time to receipt of OACD (log transformed) was associated with having commercial primary insurance (p = 0.02), pursing FA (p = < 0.001), RX of a drug approved by the FDA < 2 years earlier (p = 0.008), drugs without an approved indication for the primary tumor (p = 0.03) and estimated drug cost (p = 0.002). The other included covariates, patient age and prior authorization, were not associated with time to receipt. Logistic regression comparing receipt at ≤14 versus > 14 days found association with FA (OR 3.17; 95%CI 1.78-5.65), FDA approval within 2 years (OR 3.52; 95%CI 1.31-9.45) and off-label use (OR 2.30; 95%CI 1.18-4.50). Conclusions: Over 20% of new OACDs were received 14 days or longer from the date of RX. Financial and insurance related factors; and more expensive and recently approved drugs were associated with longer delays in receipt of therapy. Policy changes to improve the timeliness of OACD access are needed.