bluuebunny/crossref_metadata_2025_split huggingface dataset:
Life-cycle health technology assessment for precision oncology.
Authors: Regier Dean A , Weymann Deirdre , Chan Brandon , Ho Cheryl , Lim Howard John , Yip Stephen , Rittberg Rebekah , Sun Sophie , Marra Marco A. , Jones Steven J. M. , Laskin Janessa J. , Pollard Samantha 
Published: June 2022

e18704 Background: Rapid advances in precision oncology challenge timely and sustainable reimbursement decisions. Life-cycle health technology assessment (LC-HTA) can enable conditional patient access to promising precision oncology innovations alongside evidence development. Our objective was to create a life-cycle evaluative framework, called PRecision oncology Evidence Development in Cancer Treatment (PREDiCT). Methods: Through an iterative, health system and stakeholder-informed approach, we designed our LC-HTA framework. Elements supporting data and evidence generation were subsequently implemented within British Columbia, Canada’s provincial cancer control system. Our development, refinement, and pilot implementation process included a structured literature review, multi-disciplinary international expert consultation, a formal gap assessment, and a series of pan-Canadian inter-disciplinary stakeholder workshops to refine framework elements. Results: We engaged n = 15 pan-Canadian and international stakeholders to co-develop the LC-HTA framework. Defining framework components include: (a) managed access that defines the time horizon and pricing conditions of real-world healthcare system trialing; (b) collection of core data elements required to enable economic evaluation of precision oncology using real world data; (c) externally leveraged real world data and evidence generation to determine comparative effectiveness, cost-effectiveness, and the value of conducting additional research; and (d) data interpretation updating decisions, including investment, continued evaluation, or disinvestment from managed access. Key to the success of early framework implementation is the expansion of infrastructure to enable routine collection and linkage of genomic sequencing and cancer treatment data, patient quality of life and clinical outcomes, as well as health resource use spanning the diagnostic, treatment, and follow up trajectory. Conclusions: Sustainable integration of precision oncology requires the design and implementation of learning healthcare systems (LHS) that integrate genomic data with other health information. LC-HTA moves beyond static estimates of clinical and cost-effectiveness to continuously generate evidence that reduces evidentiary uncertainty and supports life-cycle decisions. We are embarking on a PREDiCT pilot to implement the framework in real-time to demonstrate the ability of real-world data to support life cycle evaluation.
Clinical application of precision medicine among oncologists: A case study in RET-targeted therapy.
Authors: Marcello Krista , Brose Marcia S. , Owonikoko Taofeek K. , Reckamp Karen L. , Tafe Laura J. , Andrie Rachael , Obholz Kevin 
Published: June 2022

e18705 Background: Precision medicine has revolutionized cancer care across multiple tumor types and new actionable biomarkers and targeted therapies are emerging at an unprecedented pace, creating myriad opportunities to optimize care and mitigate the often-dire sequelae of traditional cancer therapy. Many oncology healthcare professionals (HCPs) in practice are not employing optimal testing methodologies to detect biomarkers in patients who could benefit from novel targeted therapies. In this study, we analyze HCP awareness and application of RET alteration testing and integration of recently approved, new-generation selective RET inhibitors into practice for appropriate patients with NSCLC and thyroid cancer. Methods: In August 2020 HCPs were surveyed on RET alteration testing and use of RET-targeted therapeutics in their current practice. Study eligibility criteria included active HCPs in an oncology, pulmonology, or pathology practice. A curriculum of live and online educational activities was then developed for any interested oncologists and pathologists on RET alteration testing and/or targeted therapy for RET-altered lung and thyroid cancers. These activities included case studies, polling, and evaluations that provided additional insight on self-identified practice trends. In June 2021, at the completion of the educational program, eligible HCPs were surveyed again on RET alteration testing and selection of RET inhibitor therapy for appropriate patients. Results: In August 2020, 123 practicing HCPs completed the initial survey and 33% were testing patients for RET gene alterations and 18% were aware of the most sensitive testing assay for detection of RET fusions. 25% and 7%, respectively, were aware of the current indications for RET inhibitors in RET fusion–positive NSCLC and RET-altered thyroid cancer. Self-identified practice trends identified among the unselected cohort of 12,537 individual HPCs participating in the educational activities also demonstrated similar lack of appropriate testing for RET alterations and use of RET inhibitors. In June 2021, 60 practicing HCPs completed the follow-up survey and 40% were testing patients for RET gene alterations and 25% were aware of the most sensitive testing assay for detection of RET fusions. 52% and 22%, respectively, were aware of the current indications for RET inhibitors in RET fusion–positive NSCLC and RET-altered thyroid cancer. Conclusions: The rate of broad testing for RET alterations across patients with NSCLC and thyroid cancer remains low and many HCPs lack understanding of when to consider treating with a RET inhibitor. These results underscore the lag in adoption of optimal precision medicine approaches in oncology and the need for expert guidance and educational activities to optimize individualized, biomarker-driven treatment approaches for patients with cancer.
Lung cancer treatment patterns in patients with diabetes.
Authors: Stephens Christian , Leiter Amanda , Sigel Keith Magnus , Kong Chung Yin , Wisnivesky Juan 
Published: June 2022

e18723 Background: Lung cancer is the leading cause of cancer death in the United States, with > 85% classified as non-small cell lung cancer (NSCLC). Diabetes mellitus (DM) is a common comorbidity in patients with NSCLC. While surgery is the standard of care for early-stage NSCLC, patients who have DM with end organ damage are considered medically inoperable according to treatment guidelines and whether this influences NSCLC treatment and outcomes is unclear. This study aimed to investigate treatment patterns and outcomes among patients with early-stage NSCLC and DM. Methods: Using the Surveillance, Epidemiology, and End Results database linked to Medicare (2000-2016), we identified patients ≥65 years old with Stage I-IIIA NSCLC treated with lobectomy, limited resection (wedge resection and segmentectomy), or no surgery. DM and complications at the time of NSCLC diagnosis were ascertained through published claims-based algorithms. Patients were categorized as having no DM, DM without severe complications (DM-c), or DM with ≥1 severe complication (i.e., end-organ damage, DM+c). We used multinomial logistic regression to assess if DM was associated with treatment. Association of DM with overall survival (OS) and lung cancer-specific survival (LCSS) was analyzed with Cox regression stratified by treatment type. These analyses controlled for demographics, comorbidities, and NSCLC histology and stage. Results: Of 60,300 patients analyzed, 45,270 (75%) had no DM, 6,873 (12%) had DM-c and 7,887 (13%) had DM+c. More patients with DM+c (N = 4,508[57%]), did not receive surgery vs. patients with DM-c (N = 3,771[55%]) and without DM (N = 23,289[51%]). DM was associated with lower odds of receiving lobectomy vs. no surgery in adjusted analysis (odds ratio [OR]: 0.88; 95% confidence interval [CI]: 0.83-0.93 for DM-c, and OR: 0.91; 95% CI: 0.86-0.97 for DM+c vs. no DM), but not for limited resection vs. no surgery (OR: 0.92; 95% CI: 0.83-1.02 for DM-c and OR: 0.91; 95% CI: 0.92-1.11 for DM+c vs. no DM). Cox regression showed that in patients with lobectomy and limited resection, compared to no DM, DM+c was associated with worse OS (hazard ratio [HR]: 1.21; 95% CI: 1.15 to 1.27 [lobectomy]; HR: 1.17; 95% CI: 1.07-1.28 [limited resection]), but not LCSS (HR: 1.06; 95% CI: 0.99-1.14 [lobectomy]; HR: 1.02; 95% CI: 0.90-1.17 [limited resection]). Among patients who received no surgery, DM+c patients had both worse LCSS (HR: 1.05; 95% CI: 1.00-1.09 and OS (HR: 1.12; 95% CI: 1.08-1.16) vs. no DM. DM-c was not associated with worse LCSS or OS for all treatment categories. Conclusions: Patients with Stage I-IIIA NSCLC and DM+c were less likely to undergo surgery and had worse OS but not LCSS if they underwent full or limited resection, while they had worse OS and LCSS if they did not have surgery. These findings suggest that patients with DM with end-organ damage benefit from more aggressive NSCLC treatment, but research is needed to determine optimal treatments in these patients.
Family history assessment to identify patients at risk for hereditary cancer syndromes in community oncology practices.
Authors: Austin Sarah , Hanson Erika , Griggs Jennifer J. , Resnicow Ken , Stoffel Elena Martinez 
Published: June 2022

e18735 Background: Identification of hereditary cancer syndromes can have implications for cancer treatment and prevention. However, only a fraction of cancer patients undergo germline genetic testing (GT). We employed a family health history tool (FHHT) to assist in identifying cancer patients eligible for GT in the outpatient oncology setting. Methods: Patients with cancer with a visit scheduled at one of two community-based oncology practices received email invitations to complete a web-based FHHT that elicits cancer type and age at diagnosis for 1st and 2nd degree relatives. NCCN guidelines were applied to identify individuals meeting clinical criteria for GT. We compared proportions of individuals eligible for GT by sex and cancer type using Fisher’s exact tests. Results: Of the 1292 cancer patients seen over a 4-month period, 276 (21.4%) completed the FHHT. Of those, 58% were female (N = 160) and breast cancer was the most common cancer diagnosis (N = 73, 26.4%), followed by prostate (N = 25, 9.1%) and colorectal cancer (CRC) (N = 15, 5.4%). 59 (21.3%) patients met criteria for GT, including 49.3% of those with breast cancer (N = 36), 66.7% of those with CRC (N = 10), 28% of those with prostate (N = 7), and 100% of those with pancreatic and ovarian cancers (N = 3 each). Breast cancer accounted for 61% of those meeting GT criteria, including personal history of breast cancer age < 50 (N = 17), and personal history of breast cancer with family history of ovarian cancer (N = 7). The proportion of CRC patients meeting GT criteria was higher than for breast cancer (66.7% vs 49.3%). Seven of 10 (70%) CRC patients meeting GT criteria would not have been identified without their accompanying family history. Overall, women were more likely than men to meet GT criteria (OR 1.8, 95% CI: 1.01 to 3.47, p = 0.045). Conclusions: Approximately 1 in 5 cancer patients who were invited to complete the FHHT met NCCN guidelines for GT. While a personal history of young breast cancer was the most common GT eligibility criterion, the proportion of patients eligible for GT was highest among CRC. Across all cancer types, family history increased the number of patient meeting GT criteria by 42.4%. Implementing a patient-facing family history tool can assist community oncologists in clinically appropriate identification of cancer patients who are eligible for GT. While 48% of patients who completed the FHHT met GT criteria, generalizability is limited due to small sample size.[Table: see text]
Financial impact of biosimilar adoption in the oncology care model for the U.S. Oncology Network.
Authors: Wilfong Lalan S. , Indurlal Puneeth , Dominguez Kaci , Garey Jody S. , Howell Josh , Staggs Stuart , Neubauer Marcus A. 
Published: June 2022

e18749 Background: Biosimilar adoption offers the potential to save significant cost while maintaining high quality of care. The Oncology Care Model (OCM) is structured to reward practices for decreasing total cost of care (TCOC) compared to historical baseline prices that are adjusted by a trend factor accounting for the rising cost of oncology care. Practices are rewarded for bending the cost curve by utilizing lower cost medications. Biosimilar options were introduced for 3 mainstay therapeutic classes in oncology, bevacizumab and trastuzumab in 2019, and rituximab in 2020. This led to a concerted approach for biosimilar adoption in The US Oncology Network (The Network) as an opportunity to reduce TCOC. Here we describe utilization and the financial impact of biosimilar adoption in The Network during OCM performance period 8 (PP8) which enrolled patients from 1/2/2020 to 7/1/2020. Methods: Claims data for the 14 US Oncology Network practices participating in the OCM were used to determine biosimilar utilization for bevacizumab, trastuzumab, and rituximab therapeutic classes. The impact of biosimilar utilization on TCOC was measured by comparing the cost of each dose of a biosimilar vs the estimated cost if the more expensive innovator agent had been used instead. Results: Biosimilar utilization increased for each therapeutic class from prior performance periods. Biosimilar use for bevacizumab was 0% in PP6, 5% in PP7 and 43% in PP8. For trastuzumab, utilization was 0% in PP6, 4% in PP7 and 33% in PP8. Rituximab biosimilar utilization was 0% in PP6, 2% in PP7 and 41% in PP8. We compared the actual cost of these three medications in our OCM claims in PP8 vs. the calculated cost based on Medicare reimbursement as ASP + 6% minus sequestration if the more expensive innovator drugs had been used entirely. The difference in the actual cost vs estimated cost led to a savings of $6.61 million by using the biosimilars over innovator drugs. Conclusions: The increased utilization of biosimilars in The Network generated significant savings in OCM. Continued adoption of biosimilars will increase savings to Medicare in the Oncology Care Model. We estimate that 100% Network adoption of these three biosimilars could save nearly 1.5% of the TCOC in our Network compared to continued use of innovator drugs.
Real-life trends of COVID-19 vaccination and outcomes among patients with cancer in Georgia: One center experience.
Authors: Esakia Tamar , Balanchivadze Nino , Makashvili Ana , Abuladze Mariam , Kacharava Margarita , Melkadze Tamar , Tsiklauri Khatuna , Mariamidze Elene , Tsitsilashvili Sopio , Otkhozoria Nana , Rukhadze Tamari 
Published: June 2022

e18753 Background: Vaccination against COVID-19 decreases the risk of severe COVID 19 disease, hospitalization and death. Despite widespread recommendation from different cancer societies, vaccine hesitancy remains an issue in developing countries. Methods: Records of patients with cancer who received COVID-19 vaccination from March 1, 2021 and December 1, 2021, at Todua Clinic were analyzed retrospectively. Patient reported adverse effects (AE), vaccine related treatment interruptions, COVID -19 infection, and hospitalization rates were recorded. Results: A total of 1728 patients with cancer were treated at Todua Clinic during the study period. Of 177 (10%) patients who received Covid-19 vaccine, 63% were female and 34% were male. All patients were White. Mean age was 62 years. Majority of patients had solid cancer (93%) and only 7% had hematologic malignancies. A total of 76 (43%) patients had metastatic disease. Nearly half (47%) of patients were receiving cytotoxic chemotherapy, while others were receiving different treatment modalities (hormone therapy (33%), concurrent chemo-radiation (9%), chemo-immunotherapy (4%), targeted therapy (3%), immune therapy (2%), radiation therapy (2%)). Majority of the patients were vaccinated during the treatment process (61%), while 18% received covid-19 vaccine prior to treatment initiation and 21% patients received the vaccine after completion of treatment. A total of 124 patients (70%) were vaccinated with Pfizer-BioNTech, 33(19%) patients had received Sinopharm (Beijing), 14(8%) patients were vaccinated with The Oxford/AstraZeneca and 6 (3%) patients with Sinovac/CoronaVac. Only 13 (7%) patients received a booster dose (BD). Injection site pain was main AE for all vaccines (AstraZeneca 50%, Pfizer 33%, Sinopharm 45%, Sinovac 50%). Fever was reported in 14% of patients vaccinated with AstraZeneca, and 2% of those who received Pfizer vaccine. There were isolated cases of lymphadenopathy, fatigue, loss of appetite, joint and muscle pain after Pfizer vaccine and one case of polyneuropathy after a booster dose (Pfizer). No treatment interruptions were attributed to vaccination. Only 23 patients (13%) had confirmed COVID-19 infection (post AstraZeneca 1, Pfizer 13, Sinopharm 8, Sinovac 1). Only 1 case of hospitalization was reported after Sinopharm vaccine. No death was reported due to COVID-19 infection. Majority of patients (80%) were vaccinated following recommendation from their treating oncologist. Conclusions: In our study, COVID-19 vaccination was found to be safe for patients with cancer, and performed well with only one COVID-19 related hospitalization and no deaths. Vaccination rates among cancer patients are marginal in Georgia, and institutional and national policies are needed.
Real-world data comparing atezolizumab plus taxane therapy versus taxane alone as first-line treatment of metastatic triple-negative breast cancer patients in the United States.
Authors: Aran Dvir , Klein-Brill Avital , Fisch Michael Jordan , Amar-Farkash Shlomit 
Published: June 2022

e18767 Background: A recent clinical trial (Impassion131) showed that addition of atezolizumab to paclitaxel does not provide survival benefit for first-line (1L) treatment of metastatic triple-negative breast cancer (mTNBC) patients. The study was in contradiction to a previous study (Impassion130) that did show benefit using atezolizumab plus nab-paclitaxel. Using real-world data, we evaluated the impact on overall survival and post-treatment hospitalizations of 1L Atezolizumab + Taxane (Nab-Paclitaxel) (A+T) vs. Taxane agents alone (Paclitaxel or Nab-Paclitaxel) (T) in individuals with mTNBC. Methods: We performed a retrospective cohort study of 1L mTNBC patients between 1/2016 and 6/2021, utilizing administrative claims data from the Anthem Cancer Care Quality Program. Real-world overall survival (rwOS) was defined as time from diagnosis to death. Cox model with inverse probability of treatment weighting was used to adjust for age, ECOG, Socioeconomic deprivation index (SDI), comorbidity, and liver and bone metastatic sites. Median rwOS was estimated using the weighted Kaplan-Meier method. Adjusted hazard ratios (aHR) were estimated using weighted Cox proportional hazards models. We do not adjust for PD-L1 levels shown to have association with improved OS regardless of treatment, therefore, unlikely to confound our results. Results: The A+T combination therapy became a preferred 1L type of treatment for mTNBC patients since its introduction in 2019. We identified 155 (55%) individuals with 1L mTNBC who received A+T and compared this cohort to 128 (45%) individuals who received T alone. The A+T group were younger and had lower proportion of bone metastatic sites (Table). Percentage of patients with previous chemotherapy in the last year was similar between the groups (p = 0.9). Median rwOS was 13.6 and 17.5 months, in A+T and T group, respectively (p = 0.2). In adjusted survival analysis, the addition of atezolizumab showed insignificant increase in the risk of mortality (aHR: 1.09 (0.74-1.61), p = 0.66). Our post-treatment analysis did not identify statistically significant differences between the groups, in terms of post-treatment hospitalizations, adverse events classes, or length of stay of hospitalized patients. Conclusions: Our retrospective cohort study demonstrated that the addition of atezolizumab to 1L treatment, was not associated with survival benefit or reduce post-treatment adverse events in mTNBC patients.[Table: see text]
Unplanned hospital readmissions in the first month after childhood cancer diagnosis.
Authors: Six Kathryn A , Richman Joshua , Wadhwa Aman , York Jocelyn , Bhatia Smita , Landier Wendy 
Published: June 2022

e18770 Background: Overall, unplanned 30-day readmission rates at children’s hospitals are 6.5% ( JAMA, 2013;309:4). However, the rate of unplanned readmissions within 30 days following a childhood cancer diagnosis is unknown. We aimed to: i) Determine the rate of unplanned readmissions in pediatric oncology patients during the first 30 days following discharge from the hospital after diagnosis; and ii) Identify risk factors associated with these unplanned readmissions. Methods: Newly diagnosed patients enrolled in a study at Children’s of Alabama were followed for 30 days after their initial discharge and data on all readmissions collected. Unplanned readmission rates were calculated using the Agency for Healthcare Research & Quality All-Condition Readmission Measure. Intensity of Treatment Rating (ITR), a validated categorization of the intensity of pediatric cancer treatment (1 = least to 4 = most intense) was assigned based on each patient’s treatment plan. Demographic and clinical variables were summarized using descriptive statistics. Bivariate logistic regression analyses were performed. Patients with less than ten days at risk of readmission were excluded from the regression model. Covariates with a significant association (P < 0.1) with unplanned readmission were included in the multivariable regression models. Results: There were 105 patients included in the study (mean age, 7.7±5.4 yrs; 62% male, 66% non-Hispanic white; 50% with leukemia; 50% with ITR-rating of 3; discharged with a median of 8 [range, 2-14] home medications). The unplanned readmission rate was 48.6% (51 of 105 patients had at least one unplanned readmission during the 30-day post-discharge period). Of the 3135 patient days of follow-up, 887 were inpatient (486 planned and 401 unplanned). The unplanned inpatient days were for treatment of fever (81%), gastrointestinal issues (11%), pain (2%), neurologic issues (5%) and bleeding (1%). The proportion of patients with any unplanned readmission by Intensity of Treatment Rating (ITR) were ITR-2: 39%, ITR-3: 59%, ITR-4: 71%. Multivariable regression (adjusted for sociodemographic and clinical variables) demonstrated the following associations with unplanned readmission: ITR (OR, 1.24 per level; 95% CI, 1.01-1.50); number of discharge medications (OR, 1.05 per medication; 95% CI, 1.01-1.09). Conclusions: The 30-day unplanned readmission rate in newly diagnosed pediatric oncology patients is substantially higher (48.6%) than for children’s hospitals overall (6.5%). The odds of unplanned readmission increased independently with the number of discharge medications prescribed (5% increased odds per medication) and with the Intensity of Treatment Rating (24% increased odds per rating level). These factors may be useful in tailoring anticipatory guidance for families regarding the likelihood of readmission during the first 30 days following a pediatric cancer diagnosis.