bluuebunny/crossref_metadata_2025_split huggingface dataset:
Planned drug holiday in a cohort study exploring the effect of lenvatinib on differentiated thyroid cancer.
Authors: Tahara Makoto , Takami Hiroshi , Ito Yasuhiro , Okamoto Takahiro , Sugitani Iwao , Sugino Kiminori , Takahashi Shunji , Takeyama Hiroshi , Tsutsui Hidemitsu , Hara Hisato , Mitsuma Ayako , Yamashita Hiroyuki , Ohashi Yasuo , Imai Tsuneo 
Published: June 2021

6070 Background: Lenvatinib is now available for unresectable radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). However, toxicities are considerable and require frequent dose interruption and modification. Recently, planned drug holidays, which are dose interruptions in accordance with the timing of severe or intolerable adverse events, have been proposed to avoid severe adverse events due to lenvatinib (Tahara M.ESMO Open 2018). Our retrospective study demonstrated that progression-free survival (PFS) and overall survival (OS) were significantly longer in patients who used planned drug holidays than those who did not (Matsuyama C et.al, 2020 Annual Meeting of the Japan Association of Endocrine Surgeons). Methods: In this prospective observational study, patients with curatively unresectable and progressive RAI-refractory DTC were treated with lenvatinib in a real-world clinical setting. Lenvatinib was administered orally at a dose of 24 mg daily. Dose modification for toxicities were permitted. Primary endpoint was OS, and secondary endpoints were time to treatment failure (TTF), time to failure of strategy (TFS), PFS with clinical progressive disease, response rate, quality of life, safety, and patient reports. This study was registered with UMIN Clinical Trials Registry (UMIN000022243). Results: 262 patients were accrued. Of 255 evaluable, 153 were female; median age was 70 (range 27.0-88.0); histology was papillary thyroid carcinoma/follicular thyroid carcinoma/poorly DTC in 204/45/4; previous therapy was surgery/RAI/molecular targeted drug in 246/164/14; reason for initiation of lenvatinib was disease progression/unsuitable for RAI in 241/4. 1-year OS was 85.6% (95%CI: 80.6-89.4%); 1-year TTF rate was 74.9% (95%CI: 69.1-79.8%); 1-year TFS rate was 80.8% (95%CI: 75.4-85.2%); and 1-year PFS rate was 84.4% (95%CI: 79.3-88.4%). Overall response by RECIST was 3 (1.2%) in CR and 151 (61.9%) in PR. Most common grade 3 or 4 toxicities were hypertension (61.4%), hand foot syndrome (10.2%), fatigue (9.1%), anorexia (8.3%) and diarrhea (4.7%). Grade 5 toxicities occurred in 4 patients (fistula, hypoxia, respiratory failure, trachea stenosis). Of 253 patients evaluable for efficacy, 73 used planned drug holidays. TTF, TFS and PFS were significantly longer in patients who used planned drug holiday than those who did not (Table). Conclusions: Planned drug holiday for lenvatinib demonstrated significantly better clinical outcomes, including TTF, TFS and PFS, than daily oral administration. These data further support use of a planned drug holiday in RAI-refractory DTC patients receiving lenvatinib. Clinical trial information: 000022243. [Table: see text]
Efficacy of selpercatinib after prior systemic therapy in patients with RET mutant medullary thyroid cancer.
Authors: Wirth Lori J. , Sherman Eric Jeffrey , Weiler Daniela , Cabanillas Maria E. , Robinson Bruce , Italiano Antoine , Laskin Janessa J. , Subbiah Vivek , Drilon Alexander E. , Soldatenkova Victoria , French Pearl Plernjit , Wright Jennifer , Kroiss Matthias , Shah Manisha H. 
Published: June 2021

6074 Background: Selpercatinib is a first-in-class, CNS active, highly selective, and potent RET kinase inhibitor which has demonstrated durable antitumor activity in patients (pts) with RET altered thyroid cancer and is approved in multiple countries for the treatment of RET fusion+ lung or thyroid cancers. As response rates to cancer therapy usually decline on subsequent lines of therapy, the efficacy of selpercatinib was examined in the context of the last prior therapy received before trial enrollment. Methods: Pts with RET mutant medullary thyroid cancer (MTC) previously treated with multikinase inhibitors (cabozantinib and/or vandetanib) were enrolled in the global LIBRETTO-001 trial (NCT03157128). This post-hoc exploratory intrapatient analysis, based on March 30, 2020 data cutoff date, was performed to compare the retrospective physician-reported objective response rate (ORR) from the last systemic therapy prior to enrollment, as reported in pts case reports, to ORR by independent review committee per RECIST 1.1 with selpercatinib treatment, with each patient serving as his/her own control. Results: Efficacy-evaluable pts, 64% male, 90% white with a median age of 58 years, received prior therapy for MTC (n = 143). Pts had a median of 2 (range 1-8) prior systemic regimens. The ORR on selpercatinib (69%) was markedly higher than for the last prior therapy (10%) received before enrollment. ORR improvements with selpercatinib were observed regardless of prior therapy: cabozantinib (66% vs 14%) or vandetanib (71% vs 12%). Fewer pts had progressive disease as their best overall response with selpercatinib (2/143; 1.4%) compared to last prior therapy (33/143; 23.1%). Notably selpercatinib achieved 62% ORR in pts that did not respond to their previous line of therapy prior to enrolment. This shift from non-responder to responder on selpercatinib therapy was consistent regardless of prior cabozantinib or vandetanib treatment, where pts achieved 57% and 61% ORR respectively when subsequently treated with selpercatinib. In contrast, only 3% of patients did not respond to selpercatinib after a previous response to the immediate prior therapy. Similarly, 5% and 2% of patients were non-responders on selpercatinib after a prior response with cabozantinib and vandetanib therapy respectively. Conclusions: Prior to selpercatinib, response with previous multikinase therapy was rare. By contrast, selpercatinib demonstrated robust efficacy regardless of response to or specific prior therapy in pts with RET mutant MTC. Clinical trial information: NCT03157128.
The impact of the COVID-19 pandemic on stage at diagnosis of breast and colorectal cancers.
Authors: Zhou Jade , Kane Shelly , Ramsey Celia , Akhondzadeh Melody Ann , Banerjee Ananya , Shatsky Rebecca Arielle , Gold Kathryn A. 
Published: June 2021

6501 Background: Effective cancer screening leads to a substantial increase in the detection of earlier stages of cancer, while decreasing the incidence of later stage cancer diagnoses. Timely screening programs are critical in reducing cancer-related mortality in both breast and colorectal cancer by detecting tumors at an early, curable stage. The COVID-19 pandemic resulted in the postponement or cancellation of many screening procedures, due to both patient fears of exposures within the healthcare system as well as the cancellation of some elective procedures. We sought to identify how the COVID-19 pandemic has impacted the incidence of early and late stage breast and colorectal cancer diagnoses at our institution. Methods: We examined staging for all patients presenting to UCSD at first presentation for a new diagnosis of malignancy or second opinion in 2019 and 2020. Treating clinicians determined the stage at presentation for all patients using an AJCC staging module (8th edition) in the electronic medical record (Epic). We compared stage distribution at presentation in 2019 vs 2020, both for cancers overall and for colorectal and breast cancer, because these cancers are frequently detected by screening. Results: Total numbers of new patient visits for malignancy were similar in 2019 and 2020 (1894 vs 1915 pts), and stage distribution for all cancer patients was similar (stage I 32% in 2019 vs 29% in 2020; stage IV 26% in both 2019 and 2020). For patients with breast cancer, we saw a lower number of patients presenting with stage I disease (64% in 2019 vs 51% in 2020) and a higher number presenting with stage IV (2% vs 6%). Similar findings were seen in colorectal cancer (stage I: 22% vs 16%; stage IV: 6% vs 18%). Conclusions: Since the COVID-19 pandemic, there has been an increase in incidence of late stage presentation of colorectal and breast cancer, corresponding with a decrease in early stage presentation of these cancers at our institution. Cancer screening is integral to cancer prevention and control, specifically in colorectal and breast cancers which are often detected by screening, and the disruption of screening services has had a significant impact on our patients. We plan to continue following these numbers closely, and will present data from the first half of 2021 as it becomes available.
A successful model of biosimilar adoption in a community oncology practice.
Authors: Wilfong Lalan S. , Dave Neal , Garey Jody S. , Toth Sara , Schwartz Jim R. , Ortega Lance , Sellers Chris , Brooks Barry Don 
Published: June 2021

6514 Background: The emergence of biosimilars creates an opportunity for more cost-effective treatment. Utilization of biologics in cancer care has increased and accounts for 70% of oncologic drug spending growth from 2010 to 2015. Biosimilars can play a vital role in controlling this rapid rise in cost. Practices focused on Value Based Care arrangements, such as the Oncology Care Model, can reduce total cost of care by increasing utilization of biosimilars. The process of interchange is complicated by the designation of each biosimilar which prevents simple interchange. Communication with physicians and the healthcare team along with patient education and consent must be performed. We describe a successful model for therapeutic interchange of brand drugs to biosimilars. Methods: Texas Oncology elected to increase utilization of biosimilars in 2020. We collaborated with McKesson Specialty Health to create educational materials for patients and clinical staff. Communication was sent to all personnel about the therapeutic interchange process. A central pharmacy team reviewed all new orders and substituted a biosimilar for brand, unless a payer insisted on origin drug or a biosimilar not in the practice formulary. Additionally, a report was generated weekly of all existing patients who would benefit from switching. The pharmacists, upon consultation with the physician, then substituted a biosimilar for brand drug. Patients were then educated and re-consented. We started with rituximab in 07/2020 followed by bevacizumab in 09/2020 then trastuzumab in 10/2020. Results: The table below shows our conversion rate for all administrations. We were able to increase utilization of biosimilars from January of 2020 to December of 2020 from 5% to 80% for Rituximab, 9% to 88% for bevacizumab and 8% to 74% for trastuzumab. Based on average ASP for a 70 kg patient, the potential savings per administration is $550 for bevacizumab, $850 for trastuzumab, and $1400 for rituximab. In one month alone, this project dramatically reduced cost by $4 million or 21% by conversion to these three biosimilars. Additional savings can be realized with the use of biosimilar multi-dose vials vs single dose vials. Conclusions: Our comprehensive team approach successfully deploys therapeutic interchange of biosimilars for brand drugs in a community oncology practice which leads to substantial cost savings. This has real implications in controlling the total cost of care.[Table: see text]
Individual and institutional predictors of sexual orientation and gender identity data collection in oncology practice: An ASCO survey.
Authors: Kamen Charles Stewart , Quinn Gwendolyn P. , Garrett-Mayer Liz , Kaltenbaugh Melinda , Maingi Shail , Meersman Steve C. , Merrill Janette K. , Pratt-Chapman Mandi L. , Schabath Matthew B. , Schenkel Caroline , Chang Shine 
Published: June 2021

6520 Background: Most oncology practices do not collect patients’ sexual orientation (SO) or gender identity (GI) (SOGI), prohibiting assessment of sexual and gender minority (SGM) patients’ cancer disparities and identification of such patients in cancer care or research. Studies report that 90% of SGM patients would disclose their SOGI, while 78% of clinicians believe that patients would not. Preliminary evidence indicates that SOGI disclosure improves health outcomes. Organizations, including ASCO and NIH, have called for routine SOGI data collection, but institutional barriers, e.g. lack of SOGI fields in EMRs, hinder progress. This study aimed to delineate institutional and individual-level factors related to SOGI data collection in oncology. Methods: From Oct to Nov 2020, an anonymous 54 item online survey was distributed to ASCO members via direct outreach, listservs and social media. The survey assessed whether respondents’ institutions collect SOGI data, factors related to SOGI data collection, respondents’ attitudes about SOGI data and SGM patients, and demographics. Simple and multiple logistic regression modeling determined factors associated with respondents’ reports of SOGI data collection at their institutions. Results: Nearly half of 257 respondents reported their institutions collect SO and GI data (42%, 48%, respectively); over a third reported their institutions did not collect SO or GI data (36%, 34%, respectively); and a fifth were unsure (22%, 18%, respectively). Collection of both SO and GI was associated in unadjusted models with leadership support and having resources for SOGI data collection. SO collection was also associated with type of institution, having an SGM family member, and belief that knowing SO is important for providing quality care. GI collection was associated with the respondent’s role, SO, political leaning, past SGM training, and belief that knowing GI is important for providing care. Odds ratios (OR) from adjusted models with 95% confidence intervals (CI) comparing respondents who reported SO or GI collection as “Yes” vs. “No” are reported (comparisons to “Unsure” not presented). Most respondents (79%) felt it was important to know both SO and GI to provide quality care, while 14% felt neither was important. Conclusions: Whether or not institutions collect SOGI data is related to many factors. Despite limited statistical power, the same three factors emerged as drivers of data collection: leadership support, resources and individuals’ attitudes. These are critical and possibly self-reinforcing elements for collecting SOGI data.[Table: see text]
Socioeconomic status variables contribute to the disparities in female triple negative breast cancer outcome in the United States, 2011-2015: A population study based on NCI Surveillance, Epidemiology and End Results (SEER) database.
Authors: Wang Zikun , Dong Yi , Lu Zheyu , Chen Zhongxue 
Published: June 2021

6521 Background: Cancer disparities pertinent to socioeconomic status (SES) still exist in the American healthcare system. How SES variables impact the outcome of triple negative breast cancer (TNBC) needs identification. Methods: We enrolled 22,434 women diagnosed with invasive TNBC in 2011 – 2015 from the SEER 18 program. The primary outcome was to identify SES risk factors for TNBC cause specific survival (TNBCCSS)and overall survival (OS) via the Cox Proportional Hazard Regression Model. SES information was collected: race, insurance status, marital status, and percentage of families with incomes below the poverty level and adults with less than high school graduate (<HSG) in a county of the patient’s residency; all analyses were also adjusted for clinicopathological characteristics. We categorized rates of poverty and <HSG as quartiles. Results: 18,578 (82.8%) women were insured or insured/ no specifics (NS), and 3,360 (15.0%) received Medicaid upon TNBC diagnosis; only 496 (2.2%) patients were uninsured. The TNBCCSS rates of insured, insured/ NS, Medicaid, and uninsured cohorts were 86.6%, 83.6%, 77.4% and 73.2%, respectively. In multivariable adjusted analyses, the TNBC cause specific mortality risk of patients who were uninsured or receiving Medicaid was significantly higher than that of women who were insured (Hazard ratio [HR] = 1.60, 95% confidence interval [CI]: 1.34-1.92 and HR = 1.29, 95% CI: 1.18-1.41, respectively). Women residing in a county with a high poverty rate (the 3rd quartile [rate of 11.1 – <14.3%]) had significantly worse TNBC cause specific mortality risk as compared to women with residency of the lowest poverty rate (HR = 1.25, 95% CI: 1.10-1.41). Single and widowed cohorts had better HR of TNBCCSS compared with the married population (HR = 0.86, 95% CI: 0.79-0.95 and HR = 0.82, 95% CI: 0.73-0.93, respectively). Notably, we observed a synergistic effect among race, insurance status and TNBC OS: black women receiving Medicaid had significantly lower HR compared with their non-Hispanic white counterparts (HR = 0.86, 95% CI: 0.74-0.98). Rate of <HSG was marginally correlated with the TNBCCSS. Conclusions: SES variables contribute to the disparities in TNBC survival. TNBC cause specific mortality risk of patients without insurance or with Medicaid at the time of TNBC diagnosis is 60% and 29% higher compared with insured women (Table). Race and insurance status act synergistically upon TNBC OS.[Table: see text]
Association of electronic-health record (EHR)-derived race with BRCA testing in patients (pts) with breast cancer (BC) with similar genetic ancestry (GA) in a clinicogenomic database (CGDB).
Authors: Jin Yanling , Fruchtenicht Charlotta , Hu Sylvia , Allen Janis , Meyer Anne-Marie , Ewing Altovise , Huntley Melanie 
Published: June 2021

6524 Background: Disparities in health outcomes can be affected by biological factors associated with GA and social determinants of health. These factors can be teased apart using GA data from comprehensive genomic profiling (CGP) in pts with cancer. CGDBs that link EHR data with CGP enable the selection of pts with similar GA. Holding GA constant provides an opportunity to directly study the effects of reported race in health disparities. This study evaluated a published racial disparity (BRCA testing rates in African American [AA] vs White pts with BC) in a population with fixed, similar GA. Methods: The nationwide (US-based) deidentified Flatiron Health and Foundation Medicine (FMI) BC CGDB (Q3 2020) was used. For each pt, GA fractions from 5 geographic ancestry groups (African [AFR]; Admixed American; East Asian; European [EUR]; South Asian) were derived by FMI using an admixture analysis workflow using genes captured in the CGP assay. To focus on BRCA testing in AA vs White pts and find a sufficient population with similar GA but AA or White race, pts with admixture of both EUR and AFR ancestry were selected. The chosen fractions were: Cohort 1=35%-65% AFR and EUR each; Cohort 2=25%-60% AFR and EUR each; Cohort 3=30%-60% AFR. Cohorts overlap but were chosen to increase sample size. In each cohort, documented BRCA testing prevalence, time from diagnosis to BRCA test date, age at BRCA test and overall survival (OS) were compared between races. Other race (OR) and missing race (MR) were also reported. Results: Most pts (4130/6903) in the BC CGDB had ≥75% EUR ancestry; 129 pts had AFR ancestry fractions ≥25% with EUR ancestry >0%. AA pts had the lowest BRCA testing rates (39%, 43%, 44% for Cohorts 1-3, respectively), which were 18%, 10% and 17% lower compared with White pts, respectively (Table). In Cohorts 1-3, AA pts experienced a longer median time between diagnosis and testing (399, 668, 900 days) compared with White pts (93, 667, 106 days). The median age at BRCA test was 16, 9 and 8 years younger in AA pts (49, 47 and 50 years) compared with White pts. Although pts with MR data had the lowest OS compared with the other races within each cohort, the sample size of each arm for all cohorts was too small to make conclusions. Conclusions: This study demonstrated that when holding GA constant, racial disparities persist in BRCA testing patterns and outcome in pts with BC from a CGDB. With increasing availability of linked clinical and genomic data, further exploration of disparities in genetically similar cohorts can provide deeper insight for cancer outcomes and health disparities research.[Table: see text]
Disparity in telehealth and emergency department use among Medicaid and commercially insured patients receiving systemic therapy for cancer in Washington State following the COVID-19 Pandemic.
Authors: Ramsey Scott David , Panattoni Laura Elizabeth , Li Li , Sun Qin , Fedorenko Catherine R. , Sanchez Hayley , Kreizenbeck Karma L. , Shankaran Veena 
Published: June 2021

6546 Background: Washington was the first US state to experience the COVID-19 pandemic. Transmission risks and patient fears of visiting oncology practices during its onset resulted in rapid adoption of telehealth services. We hypothesized that the pandemic would widen disparities in oncology practice visits between Medicaid and commercially insured patients, resulting higher rates of emergency department (ED) visits during initial treatment. Methods: Linking Washington State SEER records with Medicaid and commercial insurance enrollment and claims records, we compared adults age <65 with new solid tumor malignancies who received systemic treatment at academic and community oncology practices. Persons starting therapy March – June 2020 (COVID) were compared with those starting therapy March-June 2017-2019 (Pre-COVID). Poisson regressions were used to evaluate differences in oncology practice office visits and telehealth visits. Logistic regressions were used to evaluate the likelihood of at least one ED admission among patients starting systemic therapy pre- and post-COVID. Results: Among patients who met inclusion criteria (652 Commercial, 349 Medicaid), Medicaid enrollees had more advanced disease and more comorbidity versus commercial enrollees. In unadjusted analysis of E&M and telehealth service visit codes, office-based visits fell for both insurance groups (Table) while telehealth service visits (negligible pre-COVID) were higher for commercial versus Medicaid enrollees post-COVID. The proportion of persons with ≥ 1 ED visit during therapy fell for both insurance groups. In Poisson models, Medicaid enrollees had significantly fewer total visits (P=0.001) and fewer telehealth visits (p<0.001) compared commercial enrollees during the COVID period. In the logit models, ED visits trended lower for both groups after COVID (OR 0.53 95% CI 0.279 to 1.008). Among Medicaid enrollees, persons ages 40-49 and breast cancer patients were more likely to visit the ED. Among the commercially insured, persons with 2 or more comorbidities were more likely to visit the ED. The pre-post COVID change in likelihood of an ED visit was not significantly different between insurance groups (p=0.355). Conclusions: In Washington State, the COVID-19 pandemic created a substantial disparity in access to office-based and telehealth care for low-income patients receiving systemic therapy for new cancers. Reduced oncology practice visits among Medicaid patients did not widen existing disparities in utilization of emergency care.[Table: see text]