bluuebunny/crossref_metadata_2025 huggingface dataset:
Racial disparities in outcome among head and neck cancer patients in the United States: An analysis using SEER-Medicare linked database.
Authors: Suzuki Ikumi , Cullen Kevin J. , Mehra Ranee , Bentzen Søren , Goloubeva Olga G.
Published: May 2019

6051

Background: Despite overall decline in cancer mortality, African Americans suffer from higher mortality in most cancer types including cancers of the head and neck. These differences likely result from a complex interplay of clinical and non-clinical factors. We aim to estimate disparities in overall survival across racial groups in HNSCC in the United States. Methods: This study used SEER-Medicare linked database. We identified all patients aged 66 years or older diagnosed with HNSCC as their first cancer from 1992 to 2011. We excluded those in HMO, diagnosed by death certificate or autopsy, non-SCC, unknown race, and missing month and/or year of diagnosis. Further exclusions included metastatic disease, salivary gland cancers, receiving no treatment in the first 180 days, and unknown stage. Analytic data set included oropharynx, oral cavity, nasopharynx, hypopharynx, and larynx. Primary treatment was defined as any treatment modality received within 180 days after diagnosis. Overall survival (OS) parameters were estimated across ethnic groups by the Cox regression model stratified by site and stage of cancer at diagnosis, adjusted for clinical and demographic characteristics, and propensity score weighted. Results: Our study population included 15, 547 patients. Median OS was 3.5 years (95% CI: 3.4-3.7) across all ethnic groups. African Americans (AA) had inferior outcome with median OS of 2.0 years (95% CI: 1.9-2.3) compared to 3.7 years (95% CI: 3.6-3.8) for Caucasian Americans (CA) (p < 0.0001). This difference was seen despite AA patients receiving comparable treatments and presenting at similar stage of disease, except for cancers of the oral cavity where AA were more likely to present with advanced disease (67% versus 47%; P < 0.001). The difference was most pronounced in the oropharynx where median OS was 1.9 years (95% CI: 1.7-2.1) for AA and 3.8 years (95% CI: 3.5-4.1) in CA (P < 0.0001). AA also had consistently worse OS over time from 1992 to 2011. This study clearly demonstrated AA have inferior outcomes despite similar treatments, comorbidities, age at diagnosis, stage at presentation, tumor location, year of diagnosis and sex. Conclusions: The current study demonstrates inferior overall survival for African American head and neck cancer patients independent of primary site and treatment modalities.
Safety of radiotherapy with concurrent and adjuvant MEDI4736 (durvalumab) in patients with locoregionally advanced head and neck cancer with a contraindication to cisplatin: NRG-HN004.
Authors: Mell Loren K. , Torres-Saavedra Pedro A. , Wong Stuart J. , Chang Steven , Kish Julie Ann , Minn Andy , Jordan Richard C. , Liu Tian , Truong Minh Tam , Bauman Julie E. , Powell Steven Francis , Khomani Abderrahim , Riaz Muhammad Kashif , Raben David , Le Quynh-Thu
Published: May 2019

6065

Background: MEDI4736 (durvalumab), a PD-L1 inhibitor, has shown promising antitumor activity and safety in head and neck squamous cell carcinoma (HNSCC). A phase II/III trial with lead-in component was designed to evaluate the safety and efficacy of concurrent and adjuvant MEDI4736 with radiation therapy (RT) for HNSCC patients with a contraindication to cisplatin. Safety data for 10 patients on the lead-in study are reported. Methods: Eligible patients had previously untreated locoregionally advanced unresected SCC of the larynx, hypopharynx, oropharynx (OPX), oral cavity, or unknown head/neck primary (AJCC 7th stage III-IVB). Contraindications to cisplatin included renal or hearing impairment, age ≥ 70 with moderate or severe comorbidity/vulnerability to cisplatin, or age< 70 with severe comorbidity/vulnerability, based on 6 validated indexes. Intravenous MEDI4736 1500 mg was delivered at weeks -2, 2, 6, 10, 14, 18, and 22 with RT (70 Gy in 35 daily fractions weeks 1-7). The primary endpoint was dose-limiting toxicity (DLT), defined as a high-grade adverse event (AE; NCI CTCAE version 4.0) definitely/probably related to MEDI4736 up to 4 weeks following completion of RT; 0-2 DLTs in 8 evaluable patients was considered acceptable. Results: Characteristics of the 10 enrolled patients were: 30% age ≥ 70, 90% male, 100% Caucasian, 40% ECOG performance status 0, 60% modified Charlson Comorbidity Index ≥ 1, 60% >10 pack-years, 20% larynx, 60% p16+ OPX, 50% T3-4 and 80% N2-3 disease. All 10 patients had ≥ 2 contraindications to cisplatin. All 10 patients completed RT and were evaluable. 8 of 10 patients received all 7 doses of MEDI4736 and 1 patient is still on MEDI4736 after 6 doses. 1 patient received 2 doses then discontinued due to AE (diarrhea possibly related to MEDI4736). No DLTs were observed. No grade 4-5 AEs were observed. Grade ≥ 3 AEs possibly related to MEDI4736 were: diarrhea (n=1), nausea (1), and vomiting (1). No grade ≥ 3 AEs were rated as definitely or probably related to MEDI4736. Conclusions: MEDI4736 is safe and feasible to administer concurrently with RT for patients with HNSCC with a contraindication to cisplatin. Clinical trial information: NCT03258554.
Safety of nivolumab and ipilimumab in combination with radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
Authors: Johnson Jennifer Maria , Bar Ad Voichita , Lorber Emily , Poller Dawn , Luginbuhl Adam , Curry Joseph M. , Cognetti David M. , Keith Scott W. , Axelrod Rita Susan , Zinner Ralph , Rodeck Ulrich , Harshyne Larry , Argiris Athanassios
Published: May 2019

6070

Background: Standard cisplatin-based chemoradiotherapy for LA SCCHN is associated with toxicity and less than desirable survival in high-risk patients (pts). The combination of the anti-PD1 antibody nivolumab (nivo) and the anti-CTLA-4 antibody ipilimumab (ipi) has been effective in melanoma and renal cell carcinoma and is under investigation in other solid tumors including SCCHN. Combining RT and immunotherapy (IO) has a strong preclinical rationale and is being evaluated in the clinic. This pilot trial combines IO and RT to build upon these observations. Methods: We enrolled previously untreated high-risk pts with AJCC 7th edition stage IVA-IVB SCCHN of the oral cavity, oropharynx (OP), hypopharynx, larynx. HPV+ OP tumors were T4, or N2c or N3 by AJCC 7th edition criteria. Nivo 3 mg/kg was administered every 2 weeks IV x 17 doses and ipi 1 mg/kg every 6 weeks x 6 doses beginning 2 weeks before IMRT 2 Gy/fraction/day given to total dose 70 Gy. The primary safety endpoint was acute in-field toxicity. Exploratory correlative studies include tumor PD-L1 expression, tumor immune bias, and exosome quantity and composition. The total sample size is 24 pts with 12 enrolled in the first stage and 12 in the expansion cohort. Results: A planned safety analysis was performed in the first 12 pts (8 OP; 1 hypopharynx; 3 larynx). No acute grade (G) 4 or dose-limiting toxicities were seen. Acute G 3 in-field toxicity occurred during RT in 50% of pts: dysphagia (4 pts), mucositis (3), odynophagia (2), hoarseness (1), dermatitis (1). 50% of pts had immune-related toxicity at any time. 3 pts discontinued treatment at > 3 months post RT: 1 for an immune-related cause (G 3 colitis that resolved with steroids), and 2 for non-immune-related causes (1 G 5 bleeding due to carotid rupture secondary to an in-field ulcer at 4 months post RT in a pt with complete response and 1 G 3 OP ulcer resolving with hyperbaric oxygen). 1 pt with a laryngeal primary developed a solitary lung metastasis vs new primary 6 months post RT. 10 of 12 pts are alive with no evidence of disease (follow up 7.2-18.4 months). Conclusions: Preliminary results with this non-platinum-containing RT plus IO regimen are encouraging. Longer follow-up is needed for assessment of late effects and efficacy. Enrollment is ongoing in the expansion cohort. This study is supported by BMS. Clinical trial information: NCT03162731.
Phase II study: Induction chemotherapy and transoral surgery as definitive treatment (Tx) for locally advanced oropharyngeal squamous cell carcinoma (OPSCC)—An update and retrospective review of non-study patients.
Authors: Siegel Robert S. , Joshi Arjun , Taheri Reza , Sadeghi Nader , Thakkar Punam , Vongpachith Anonglack , Goodman Joseph
Published: May 2019

6072

Background: The standard of care for OPSCC includes chemoradiation (CRT) or surgery with adjuvant radiation (RT). However, RT is associated with significant life long morbidity. We assessed the efficacy of a two-drug induction regimen, followed by transoral robotic assisted surgery (TORS) & neck dissection for locally advanced OPSCC. Methods: This is an IRB approved single-arm phase II study for untreated stage III or IVA (AJCC 7th edition) OPSCC patients (pts) with an ECOG < 2 and GFR > 50 cc. Induction cisplatin 75 mg/m2 and docetaxel 75 mg/m2 was administered every 21 days for 3 cycles. Patients then underwent TORS and neck dissection(s). At post-op visits, flexible laryngoscopy, blood tests, and imaging with PET/CT and/or MRI were done. Short and long term toxicity, progression-free survival, overall survival, and quality of life (QOL) were evaluated in all pts. Results: Twenty oropharyngeal pts were treated, 19 were male, 17 were Caucasian, and 19 were HPV+. Median age at dx was 57. Three pts were stage III, and 17 were stage IVA. Pathologic CR at the primary site occurred in 15 pts and CR among LN neck dissections occurred in 13 pts. Four pts were given dose-reduced chemo and 1 pt was changed to carboplatin per protocol because of renal dysfunction. Pre vs post tx QOL scores did not change. At a mean follow-up of 33 months (range 19.6 to 44.1), 18 pts are alive and NED. Three pts recurred a mean of 2.2 mos after surgery, and were treated with salvage CRT. Two pts died of metastatic disease, the third is alive and well. All 3 pts had positive LN (9 LN, 3 LN and 1 LN) at surgery. A fourth pt had 12 pos LN and received radiation. He has not recurred. A retrospective review of an additional 20 twenty pts treated in the same way, were also reviewed for efficacy. Mean age was 61.5. Two pts died of metastatic disease. Fourteen pts have been followed for > 7 mos, and their mean overall survival is 44 mos. Conclusions: Cisplatin + docetaxel followed by TORS & neck dissection(s) appears to be an effective model for the definitive treatment for OPSCC, while avoiding the adverse effects of RT.
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.
Watson for Oncology applied to teaching and remote consulting model.
Authors: Fang Juemin , Guo Xianling , Zhu Zhongzheng , Wang Hui , Hu Fei , Chen Jianhua , Gao Song , Guo Liting , Zhao Yu , Yuan Min , Xu Qing
Published: May 2019

6545

Background: IBM Watson for Oncology (WFO) is developed with artificial intelligence to assist the oncologists in treatment decision-making by providing evidence-based treatment recommendations with priority and personality. We have been exploring the value of applying WFO in teaching and remote consulting among members in the hospital union to improve medical quality and conformity. Methods: Four modes were followed to apply WFO to teaching and remote consulting. Firstly, a teaching hospital conducted instructional teaching for a primary hospital through WFO, or a primary hospital consulted with a teaching hospital on cancer treatment combined with WFO. Secondly, a teaching hospital conducted conference-based teaching and remote consulting for two or three primary hospitals through demonstrating WFO. Thirdly, we cooperated with other teaching hospitals to carry out interactive discussions on cases through WFO with several primary hospitals. Fourthly, we cooperated with other teaching hospitals to conduct WFO demonstration and discussion for several primary hospitals. Remote communication was performed by using third-party video conference software. A survey was conducted to collect feedback from 56 primary hospitals in our hospital union. Results: More than 80% of primary hospitals were willing to learn the standardized treatment and recent treatment progress of tumors by participating in WFO remote consulting in our hospital. The value of four modes to promote the standardized cancer treatment and improve the medical quality and conformity in primary hospitals were all recognized. WFO also contributed to academic exchanges and learning among high-level teaching hospitals, and facilitated the use of artificial intelligence in oncology therapy more rational and appropriate. Conclusions: Non-standardization in cancer care remains to be a big problem in primary hospitals in China. Although limitation of WFO exists in the complex cases of certain tumor types, the rational use of WFO in the teaching and remote consulting could help and promote the standardized cancer treatment in China.
Creation of a virtual cancer care network for remote oncology treatment.
Authors: Passero Vida Almario , Liman Andrew Dede , Allen Kaneen , Speerhas Lucy , Tan Jocelyn Lai , Harrold Laurie , Tokarsky Joyce , Veraldi Kristen , Couch Myra , Hotchkiss John , Gray Deborah L , Rai Hema , Green Jeanne , Shields Jenna
Published: May 2019

6546

Background: The VA Pittsburgh Healthcare System (VAPHS) Virtual Cancer Care Network was launched in January 2018 after we had established an electronic consult service where 555 hematology electronic consults were completed at VAPHS in FY17. The clinical video telehealth (CVT) clinic allows veterans from central Pennsylvania to receive their anticancer therapy at the VA in Altoona, Pennsylvania where the oncology pharmacy, nursing, telehealth, and supportive oncology staff are on site. Patients follow regularly and remotely during treatment via CVT visits with their oncologist located 93 miles away at the VA in Pittsburgh. Methods: A chemotherapy pharmacy and nursing infusion clinic were created at the VA in Altoona. CVT visits started in January 2018. Data including treatment, adverse events defined through CTCAE v5.0, gender, age, zip code, and other details were examined retrospectively. Results: 279 CVT visits for 89 patients were completed January 2018 through Sept 2018. 87 were male, 2 were female. Average age was 70 (range 45-90). Most common primary disease sites were prostate (19.1%), colorectal (13.4%), and lung (9%). 61.8% of patients were on treatment. Non-treatment visits were for surveillance and survivorship. Treatment administered included platinum doublets, fluorouracil doublets, immunotherapy, and oral anticancer therapy. 5.4% of patients had Grade 3-4 events due to febrile neutropenia, increased liver enzymes, and hemolytic anemia. 41.7% had grade 1-2 events due to peripheral neuropathy, neutropenia, anemia, thrombocytopenia, and infusion-related reactions. Using an average commuting speed of 60 mph and a travel cost of $ 0.56 per mile, the total commute distance averted was 49,579 miles. Mean distance averted per patient was 557 miles. Total commute time saved for veterans was 826 hours. Total mileage costs saved for veterans was $27,764. Conclusions: The Virtual Cancer Care Network reduced the travel time and costs for veterans who previously would have travelled from central Pennsylvania to VAPHS for their oncology treatment. Adverse events were tolerable and managed by the VA in Altoona. Integration of CVT secures safe access to cancer care and maintains patients’ primary relationships with their oncologists.
Active search for toxicity reduces delay on chemotherapy.
Authors: Souza Juliana , Neves Daniele
Published: May 2019

6548

Background: Interdisciplinary teamwork involves health care professionals working as a team with the purpose of discussing individual cases and recommending care plans. In october 2015, the breast cancer interdisciplinary team (BCIT) was implemented in our outpatient oncology clinic. This team includes oncology physician, pharmaceutist, psychologist, nutritionist and oncology nurse. Since 2018, the oncology nurse does active search for toxicity (AST) in order to solve early symptoms. Methods: We evaluated outcomes of breast cancer patients who finished neoadjuvant/adjuvant chemotherapy and received BCIT care at our oncology clinic from october 2015 to November 2018. Results: Of 200 pts who had finish treatment, 139 pts (69.5%) received adjuvant chemotherapy and 61 pts (30.5%) neoadjuvant schedule. Median age was 52,64 years (range:30.6-82.3y). At diagnosis, 50 pts (25%) were stage I, 101 pts (50.5%) were stage II, and 49 pts (24.5%) were stage III. When we compared before and after AST, there were no significant difference between mean age (54.13y vs 54.06y, p:0.97), colony stimulating factor use (p:0.10), cold-cap use (p:0.81), and timing of chemotherapy (p:0.13). There were 7 hospitalizations during chemotherapy, with no significant difference with AST (5pt vs 2pt, p: 0.82). However, patients in AST had significantly lower mean delay to complete chemotherapy (9.4 days vs 4.2 days p:0.003). After median follow up 17 months, there were 9 progression disease and 4 deaths. 1-year and 3-year overall survival rate was 99,2% and 95,1%, respectively. Conclusions: AST increased adherence to chemotherapy, with lower delay on chemotherapy treatment. There were no significant difference with colony stimulating factor use, cold-cap use, timing of chemotherapy, and hospitalization.
A blinded evaluation of a clinical decision-support system at a regional cancer care center.
Authors: Suwanvecho Suthida , Shortliffe Edward H , Suwanrusme Harit , Issarachai Surasit , Jirakulaporn Tanawat , Taechakraichana Nimit , Lungchukiet Palita , Thanakarn Nittaya , Decha Wimolrat , Boonpakdee Wisanu , Wongrattananon Pattanawadee , Preininger Anita , Kefayati Sarah , Dankwa-Mullan Irene , Esquivel Jaime , Patel Vimla L , Jackson Gretchen , Kiatikajornthada Narongsak
Published: May 2019

6553

Background: Clinical decision-support systems (CDSS) such as Watson for Oncology (WFO) may reduce treatment variation in oncology, provided options offered by the system are at least as acceptable as expert, evidence-based options. Deviation from expert consensus in practice is not well documented. In this blinded study, WFO therapeutic options and treatment decisions made by individual oncologists at Bumrungrad International Hospital (BIH) were evaluated by expert panel. Methods: Treatments selected by BIH that were labeled as either “for consideration” or “not recommended” by WFO were evaluated by a panel of 3 oncologists in 2018. The panel evaluated WFO options and previous BIH treatments for prospective cases from 2016-2018, blinded to the source of treatment option. Consensus of panel rated treatment pairs as: identical; both acceptable and roughly equivalent; both acceptable, but one preferred; one is acceptable and the other, unacceptable; neither is acceptable. The results of 321 treatment choices for breast, lung, colon and rectal cancers were analyzed, and McNemar’s test, a modified pairwise chi-square, was applied to identify differences between BIH and WFO. Results: 71% of both BIH and WFO treatments across all 4 cancer types were considered acceptable or identical by the panel. In 18 cases (5.6%), WFO treatments were preferred; in 14 cases (4.4%), BIH cases were preferred. Unacceptable treatments by either BIH or WFO were identified in 15% and 23% of treatments, respectively. Statistical analysis of treatment pairs revealed no significant difference between BIH and WFO treatments for breast, colon and rectal cancer. Treatment for lung cancer differed significantly ( p = 0.004); in 6% of cases, WFO was unacceptable and BIH acceptable; in 1% of cases, BIH was unacceptable and WfO was acceptable. Conclusions: This study is one of the first to compare therapeutic options from CDSS to treatment decisions made in practice, evaluated in a blinded fashion by an expert panel. 71% of treatments suggested by WFO CDSS were as acceptable as those selected by clinicians at the point of care, and some were considered superior. Decisions made in practice were unacceptable to the panel in 15% of cases, suggesting a role for CDSS.
A framework for building a clinically relevant risk model.
Authors: Daly Robert Michael , Gorenshteyn Dmitriy , Gazit Lior , Sokolowski Stefania , Nicholas Kevin , Perry Claire , Adams Lynn , Baldwin Abigail , Holland Jessie C. , Zervoudakis Alice , Xiao Han , Salvaggio Rori , Chiu Yeneat O. , Katzen Lauren L. , Rozenshteyn Margarita , Reidy Diane Lauren , Simon Brett A , Perchick Wendy , Wagner Isaac
Published: May 2019

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Background: Acute care accounts for half of cancer expenditures and is a measure of poor quality care. Identifying patients at high risk for emergency department (ED) visits enables institutions to target resources to those most likely to benefit. Risk stratification models developed to date have not been meaningfully employed in oncology, and there is a need for clinically relevant models to improve patient care. Methods: We established and applied a predictive framework for clinical use with attention to modeling technique, clinician feedback, and application metrics. The model employs electronic health record data from initial visit to first antineoplastic administration for patients at our institution from January 2014 to June 2017. The binary dependent variable is occurrence of an ED visit within the first 6 months of treatment. The final regularized multivariable logistic regression model was chosen based on clinical and statistical significance. In order to accommodate for the needs to the program, parameter selection and model calibration were optimized to suit the positive predictive value of the top 25% of observations as ranked by model-determined risk. Results: There are 5,752 antineoplastic administration starts in our training set, and 1,457 in our test set. The positive predictive value of this model for the top 25% riskiest new start antineoplastic patients is 0.53. From over 1,400 data features, the model was refined to include 400 clinically relevant ones spanning demographics, pathology, clinician notes, labs, medications, and psychosocial information. At the patient level, specific features determining risk are surfaced in a web application, RiskExplorer, to enable clinician review of individual patient risk. This physician facing application provides the individual risk score for the patient as well as their quartile of risk when compared to the population of new start antineoplastic patients. For the top quartile of patients, the risk for an ED visit within the first 6 months of treatment is greater than or equal to 49%. Conclusions: We have constructed a framework to build a clinically relevant risk model. We are now piloting it to identify those likely to benefit from a home-based, digital symptom management intervention.
Assessment of enrollment characteristics for Children’s Oncology Group (COG) upfront therapeutic clinical trials 2004-2015.
Authors: Faulk Kelly , Anderson-Mellies Amy , Cockburn Myles , Green Adam
Published: May 2019

6564

Background: Improvements in pediatric cancer survival are attributed to cooperative clinical trials. Under representation of specific demographic groups has been described in adult and pediatric cancer and poses a threat to the generalizability of trial results. A comprehensive evaluation of data provided by the Children’s Oncology Group (COG) of upfront trial enrollment for US patients 0 to 29 years old between 2004 and 2015 was performed to assess for disparities in participation. Methods: Estimates of cancer cases were calculated using the Surveillance, Epidemiology, and End Results registry and the US Census and compared to observed COG cases. Percent enrollment and Standardized Ratios of enrollment were calculated across various demographic, disease, and socioeconomic groups. The COG website was utilized to quantify available upfront trials during the study period and assess age eligibility criteria. Results: 21.3% of estimated US cancer patients age 0 to 19 years enrolled on COG trials. Younger patients were consistently more represented across disease types and race/ethnicities. Patients with hematologic malignancies were more represented compared to solid and central nervous system (CNS) tumors. Conclusions: COG clinical trial enrollment rates are declining, which may be due to challenges in pediatric drug development, difficulty designing feasible trials for highly curable diseases, and issues in ensuring trial availability for the heterogeneous group of solid and CNS tumors. Though racial/ethnic groups and county-level socioeconomic factors were proportionally represented, under representation of the adolescent/young adult (AYA) population and younger patients with solid and CNS tumors remain significant concerns. Targeted enrollment efforts should focus on the identified subgroups and further research should evaluate AYA enrollment across all available trials to provide continued treatment advances for all patients.