bluuebunny/crossref_metadata_2025 huggingface dataset:
Incorporating mediation-based interventions at an academic cancer center: A six-step process.
Authors: Jain Neha M , Schremp Emma , Spalluto Lucy , Osterman Travis John , Friedman Debra L.
Published: June 2022

e18662

Background: A growing body of evidence, including NCCN guidelines for distress management in oncology, supports the use of meditation-based interventions (MBI) in cancer care. However, MBI are generally delivered outside of the cancer treatment setting, with no integration between meditation instructors and the oncology care team. Further, there have been no studies to evaluate implementation of this evidence-based practice into routine cancer care. We report on the implementation process for establishing an integrated MBI program at an NCI-designated comprehensive cancer center. Methods: Guided by the Consolidated Framework for Implementation Research (CFIR), we developed a discrete MBI program as a strategy to implement MBI in our cancer center. Program components included 1) identifying champions and key stakeholders; 2) engaging with patient navigators and patient advocates; 3) partnering with cancer center leadership to gain infrastructure support; 4) establishing a meditation-focused program to increase acceptability amongst providers and patients; 5) launching an IRB-approved study to measure study outcomes; 6) leveraging social media, patient newsletters, and other institutional communication modes to increase awareness. We used the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to define the outcome measures including reach (number of patients who attended an MBI session), adoption (number of providers who referred patients to MBI and number of patients who attended > 1 MBI session), and implementation (feasibility and acceptability). Results: An MBI program has been successfully established within an NCI-designated comprehensive cancer and has received enthusiastic support from oncology providers, research nurses, as well as patient advocate groups. The intervention is delivered three times a week in 30 min sessions via videoconferencing. At the end of each session patients are encouraged to complete a short online survey about their experience. The first class has been established and enrolment is ongoing. Conclusions: Given the high prevalence of psychosocial distress in a rapidly expanding global cancer population, implementation of strategies to integrate psychosocial interventions, such as meditation, into routine care is critical. Well-defined MBI programs such as this can overcome the misperception that MBIs are difficult to implement in cancer centers and support the successful implementation of MBIs within cancer programs. Adoption of this evidence-based strategy can positively impact patient psychological resilience.
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.
The prognostic influence of neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) in stage III non-small cell lung cancer (NSCLC) treated with consolidation durvalumab.
Authors: Nindra Udit , Shahnam Adel , Stevens Samuel Xavier , Pal Abhijit , Yip Po Yee , Adam Tamiem , Lee Jenny HJ , Boyer Michael J. , Nagrial Adnan , Kao Steven Chuan-Hao , Bray Victoria Jane
Published: June 2022

e18773

Background: The neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) has been of prognostic interest in lung cancer. Sustained NLR and PLR after initial chemoradiotherapy (CRT) has been shown to correlate with worse prognosis in other solid organ malignancies. This study aims to add to the available evidence by describing the survival outcomes for patients with stage III NSCLC who are treated with consolidation Durvalumab when stratified by baseline or sustained NLR and PLR. Methods: We conducted a retrospective observational cohort study involving 6 sites across Sydney, Australia, including all patients diagnosed with stage III NSCLC treated with chemoradiation (CRT) and at least one cycle of durvalumab between January 2018 to September 2021. Patients had NLR and PLR collected prior to their first treatment of CRT and prior to their first treatment with Durvalumab. We used NLR and PLR values of 3 and 185 respectively to stratify patients into high and low groups. Patients with sustained NLR or PLR were defined as those with values > = 3 or > = 185 at both pre-CRT and pre-Durvalumab time points. Results: 148 patients were included in the study. The median follow-up from the start of Durvalumab was 15.1 months. The median age was 66 years. 61% (n = 90) of patients were male. The median PFS was 17.6 months in the pre-CRT NLR high cohort and not reached in the pre-CRT NLR low cohort (HR 1.99; 95% CI 1.16 – 3.41; p = 0.01). Median OS was 35.5 months versus 42.0 months in high and low pre-CRT NLR groups respectively (HR 2.62; 95% CI 1.23 – 5.56; p < 0.01). The median PFS was 19.9 months in the pre-CRT high PLR cohort versus and not reached in the pre-CRT low PLR cohort (HR 1.98; 95% CI 1.15 – 3.42; p = 0.02). The median OS was 39.9 months versus 42.0 months in high and low pre-CRT PLR groups respectively (HR 2.29; 95% CI 1.08– 4.88; p = 0.03). Median PFS for sustained NLR elevation was 17.1 months versus NR (HR 1.5, 95% CI 1.1 – 2.2, p < 0.01). Similarly median PFS for sustained PLR elevation was 16.6 months versus NR (HR 1.7, 95% CI 1.1 – 2.4, p < 0.01). Conclusions: Pre-CRT NLR and pre-CRT PLR are associated with OS and PFS outcomes in stage III unresectable NSCLC treated with CRT and Durvalumab. Those with sustained NLR or sustained PLR also have worse progression free survival outcomes.
Covid 19 infection leading to a subsequent new primary cancer diagnosis, Real-world data (RWD) analysis on members of Belong.life, a global cancer application (app).
Authors: Vorobiof Daniel A. , Haikin Bozhena , Litvin Alon , Deutsch Irad , Malki Eliran
Published: June 2022

e18775

Background: Some known viral infections can lead to a diagnosis of cancer (e.g: HPV, HIV, EBV, etc.) Anecdotical reports of a Covid 19 infection, and the subsequent diagnosis of a new cancer have been mentioned by few patients (pts). This relationship has not yet been fully documented. Covid 19 infected persons have been identified to have a suppressed adaptive immunity, which one of its principal functions is to maintain occult cancer cells in an equilibrium state. We studied the possible role of a Covid 19 infection and the subsequent diagnosis of a new primary cancer happening during the Covid pandemic (01/2020 – 12/2021). A survey was sent to all new members of Belong.life, a free and anonymous global cancer app for pts and their caregivers. This study took place prior to the omicron variant surge. Methods: 2579 Belong.life members received randomly, in the app various cancer groups, a 10 questions voluntary survey regarding the onset of a Covid 19 infection and the development of a subsequent new primary cancer diagnosis. 262 replied of whom 124 fulfilled the eligibility criteria and confirmed having had a Covid 19 infection followed by a new cancer diagnosis. Data on the 124 pts was analyzed by Belong analysts, according to age, sex, geographical distribution, Covid 19 infection onset and type and timing of the cancer diagnosis. Results: Most pts were USA based (102/124, 82%), and 1/3 were < 49 years, followed by a 1/3 in the 50-59 and > 60 groups. 71% (88/124) were females. All had a prior Covid 19 infection and only 14 (11%) required hospitalization. 109/124 (88%) had a primary cancer diagnosis and 15 (12%) had disease recurrence. Breast cancer was diagnosed in 38% (47/124), followed by lung and gynecological cancers (10/124, 8% respectively). Time from Covid 19 infection to primary cancer diagnosis was < 6 months in 57 /124 (46%) and 6-12 months in 40/124 (32%). Breast cancer developed earlier (< 12 months) in 87% of the pts. In total 97/124 (78%) pts had their disease diagnosed within less than a year. Conclusions: Known viruses might precede the onset of a new cancer. The role of corona viruses and subsequent development of a cancer is unknown. Adaptive immunity maintains occult cancer cells in a steady state, while a Covid 19 infection interferes with it, causing a weak and delayed immune response, which could be responsible, after a period, for the onset of a new primary cancer. We are presenting RWD on 124 pts with new primary cancers diagnosed after a Covid 19 infection. This represents a 5% incidence in a random pts group (124/2579) as described above. Further studies should be planned to investigate this real world increased incidence and testing of the diverse immune parameters are also warranted to further understand the intersection pathways of Covid 19 infection and cancer development.
The impact of COVID-19 lockdown measures on rates of febrile neutropenia in a cohort of Irish patients receiving chemotherapy.
Authors: Synnott David , Cook James , O'Mahony Deirdre , Murphy Conleth G.
Published: June 2022

e18784

Background: Febrile neutropenia in patients receiving chemotherapy is a life-threatening condition requiring prompt attention. This condition may also result in dose reductions, delays, or discontinuations of chemotherapy which compromise patient outcomes. This study seeks to evaluate the impact of COVID19 “lockdown” public health measures in Ireland on the incidence of febrile neutropenia in patients who were receiving cytotoxic chemotherapy regimens. Methods: All patients receiving chemotherapy at the Bon Secours Hospital Cork who were admitted with neutropenia and fever during two separate time periods were included in the study: 1st April 2018 to 31st March 2019 (“pre-pandemic year”) and 1st April 2020 to 31st March 2021 (“pandemic year”). The pandemic year selected equates to a period of heightened infection control measures in Irish society, featuring public health advice re social distancing, routine mask wearing in public and successive lockdown waves. Retrospective chart review was performed on all patients admitted to the oncology inpatient ward who had blood cultures on admission to determine the number of these patients who were neutropenic at the time of blood culture draw. Similarly, pharmacy records were accessed to determine the number of unique chemotherapy items dispensed in each year in order to establish a rate of febrile neutropenia episodes per 100 chemotherapy items dispensed for each period. The incident rate ratio was calculated using the Exact Poisson Test. Results: During the pre-pandemic year there were 57 individual admissions with febrile neutropenia compared with 32 admissions during the pandemic year. There were 4581 chemotherapy units dispensed during the pre-pandemic year compared to 4628 during the pandemic year. The rate of febrile neutropenia episodes per 100 chemotherapy units dispensed was 1.24 (95% CI 0.94, 1.61) in the pre-pandemic year and 0.69 (95% CI 0.47, 0.98) in the pandemic year. The incident rate ratio is 1.80 (95% CI 1.14, 2.87, two-sided P = 0.007). 9 of 57 (16%) admissions in the pre-pandemic year were associated with positive blood cultures compared with 4 of 32 (13%) in the pandemic year (not significant by Fisher's exact test). Conclusions: Increased precautionary infection control measures during the COVID19 pandemic public health restrictions correlated with a significant reduction in the rate of febrile neutropenia amongst patients receiving cytotoxic chemotherapy. This suggests that there may be a role for similar measures for this patient cohort in the post-pandemic period. Options which patients may consider to employ include social distancing, wearing face-coverings and restricting social contacts while at risk of neutropenia from cytotoxic chemotherapy regimens.
Survival outcomes of patients with relapsed or refractory acute myeloid leukemia after venetoclax combined with hypomethylating agents.
Authors: Zainaldin Carl , Arora Sankalp , Bathini Sri , Pandya Vishruti , Bae Sejong , Gupta Udita , Worth` Sarah , Bachiashvili Kimo , Bhatia Ravi , Godby Kelly Nicole , Jamy Omer , Rangaraju Sravanti , Diamond Barry , Oliver Josh D , Salzman Donna E. , Di Stasi Antonio , Vachhani Pankit
Published: June 2022

e18808

Background: Venetoclax in combination with hypomethylating agents (HMA+Ven) is the standard-of-care treatment for patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. HMA+Ven is also commonly used as salvage therapy for relapsed or refractory (R/R) AML. There is limited data regarding outcomes of AML patients after HMA+Ven failure. In clinical practice, survival following HMA+Ven failure, either as frontline or salvage therapy, is observed to be poor. Methods: We conducted a single center retrospective study to evaluate survival outcomes of AML patients who were R/R to HMA+Ven as frontline or salvage therapy. Patients ≥ 18 years of age with AML who initiated HMA+Ven between 06/2018 and 05/2021 were included. R/R AML was defined as clinically relevant disease with ≥ 5% blasts after prior complete remission/morphologic leukemia free state, refractoriness to at least two cycles of HMA+Ven, or progressive disease despite initiating HMA+Ven. Data cut-off was 02/07/2022. Overall survival (OS) was estimated using Kaplan-Meier method and outcome differences between sub-groups were assessed using the log rank test. Results: Forty-two patients met inclusion criteria. Baseline characteristics and treatment details are summarized in Table. The median OS of the overall cohort was 2.3 months (range 0.1-11.4). There was no significant difference in median OS between patients declared R/R to frontline vs salvage HMA+Ven (2.4 vs 1.8 months, hazard ratio [HR] = 0.84, 95% confidence interval [CI] 0.43-1.62). Patients who received treatment after HMA+Ven failure had longer median OS compared to patients who did not (n = 17, 4.7 vs 1.7 months, HR = 0.29, 95% CI 0.13-0.62). There was no significant difference in OS based on the sub-type of AML, ELN risk group, p53 mutation, or complex karyotype status. Conclusions: Data from our study support the clinical observation that AML patients with disease R/R to HMA+Ven, either as frontline or salvage therapy, have very poor survival outcomes. These results provide important prognostic information for clinicians and highlight the need for novel therapies for R/R AML.[Table: see text]
Survey of biosimilar adoption across oncology pharmacy practices.
Authors: Reed Marina , Przespolewski Eugene , Walsh Mark Doughty , Amsler Michelle , George Anthony , Attwood Kristopher , Riebandt Grazyna
Published: June 2022

e18813

Background: Use of biosimilars is an effective strategy in expanding access to care and lowering healthcare costs. Literature about the successes, challenges, and best practices of biosimilar adoption in oncology is limited. We aim to describe the current state of biosimilars in oncology practices and barriers to adoption. Methods: A 40-question survey was developed to gather information regarding biosimilar use in the following areas: formulary management, product usage, policies, technology, safety, and education. The following biosimilars were evaluated: bevacizumab (B), filgrastim (F), epoetin (E), infliximab (I), pegfilgrastim (P), rituximab (R), and trastuzumab (T). The survey was distributed to Hematology/Oncology Pharmacy Association members. Results: A total of 179 surveys were initiated, with a completion rate of 31%. Six surveys were removed due to duplication, resulting in 50 unique surveys with 21 responses (42%) from NCI-designated comprehensive cancer centers. Inpatient formulary decisions were driven by acquisition cost followed by reimbursement. In the outpatient setting, equal consideration was given to acquisition cost and reimbursement for formulary decisions. Thirty-two percent of institutions restricted biosimilars to their FDA approved indication. Sixty-six percent of institutions had a biosimilar interchangeability policy in place. For the corresponding reference products, overall average utilization of biosimilars was B 74%, F 88%, E 82%, I 57%, P 52%, R 73%, and T 71%. More than 90% of institutions had a preferred biosimilar on formulary. Based on the results, 72% stated payors specified the selection of biosimilars, and 76% stated payor reimbursement limited ability to participate in contract pricing. Insurance reimbursement was recognized as the main barrier to adoption (Table). Medication errors related to biosimilar use were reported by 26% respondents, with the most common cause listed as communication. Thirty-six percent of institutions provided education on the general use of biosimilars and 38% had biosimilar products in treatment specific education. Conclusions: Biosimilar adoption is consistent across responding institutions, with noted utilization shift towards biosimilar products compared to reference. Decisions for biosimilar adoption are made based on cost and reimbursement. Opportunities exist in the collaboration of health systems and payors to align formularies and promote safe and cost-effective care for their members.[Table: see text]
Comparison of different treatment modalities for favorable risk acute myeloid leukemia: Standard-dose anthracycline versus high-dose anthracycline versus addition of gemtuzumab ozogamicin.
Authors: Mort Joseph , Wells Leah , DiBenedetto Samantha , Morse Emily , Mautner Ben , Ghamsari Farid , Pierce Eric , Morris Amy , Keng Michael Kenneth , El Chaer Firas
Published: June 2022

e19016

Background: The standard remission induction regimen for medically fit patients with AML consists of a backbone of cytarabine & an anthracycline (“7+3” therapy). However, the choice & dose of the anthracycline varies between institutions & practitioner preference, particularly in patients with favorable risk cytogenetics. Gemtuzumab ozogamicin (GO) may improve outcomes in this patient population but is associated with increased toxicities. Methods: We performed a retrospective analysis on medically fit patients ≥ 18 yo with favorable risk AML from 2015-2020 treated with 7+3 at the University of Virginia. Patients were stratified based on standard dose (45 or 60 mg/m2 daunorubicin) (SD) vs higher dose (90 mg/m2 daunorubicin or 12 mg/m2 idarubicin) (HD) of anthracycline vs the addition of GO. Measures included rates of remission, EFS, RFS, and OS as well as rates of treatment-related complications. Results: In total, 58 patients were identified, of which 33 received induction with SD, 19 received HD, & 6 received GO. The majority (75%) of patients were < 60 years old & 93% had de novo AML. The rates of complete remission in the SD, HD & GO groups were 90.9%, 89.5% & 100%, respectively (p = 0.57). EFS at 2-years was 43.9%, 36.7%, & 66.7%, respectively (p = 0.85). RFS at 2-years was 53.0%, 39.0%, & 100%, respectively (p = 0.18). OS at 2-years was similar between all groups (58.9%, 56.9%, & 66.7%, p = 0.92). The rate & duration of cytopenias after induction were similar among all groups (median duration 29 days), however cytopenias were more common in the GO group following consolidation. The rates of major bleeding, admission to the intensive care unit (ICU), and new onset cardiomyopathy (EF < 50%) were higher in the GO group (major bleeding: 0% in SD, 5.3% in HD, 33.3% in GO; ICU admission: 12.1% in SD, 21.1% in HD, 33.3% in GO; cardiomyopathy: 12.1% in SD, 26.3% in HD, 33.3% in GO). The rate of infection, liver dysfunction, & acute renal injury were similar among all groups. No patients developed veno-occlusive disease. Conclusions: Patients receiving GO had a trend toward improved EFS & RFS, however with a similar OS at the expense of higher rates of cytopenias, major bleeding, ICU admission, & cardiotoxicity. Patients receiving HD had a trend toward worse outcomes than those who received SD. A major limitation of our study is the small sample size & single institution experience, however multi-institutional analysis is ongoing for further investigation.[Table: see text]
Real-world clinical outcomes in patients receiving either ibrutinib or chemo-immunotherapy (CIT) as first-line (1L) treatment for chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL): A retrospective analysis.
Authors: Wu Linda , Ran Tao , He Jinghua , Panjabi Sumeet , Lu Xiaoxiao
Published: June 2022

e19057

Background: Ibrutinib is an oral, once daily Bruton’s tyrosine kinase inhibitor and is the only targeted treatment that has demonstrated progression-free survival and overall survival in multiple phase 3 trials across age, fitness, and high-risk markers for CLL/SLL. This study examined the trends in genomic testing and compared outcomes of first line (1L) CLL patients treated with ibrutinib or CIT in clinical practice. Methods: The nationwide Flatiron Electronic Health Record-derived de-identified database (03/04/2016-08/31/2021) was used to select patients with CLL/SLL who had ≥2 clinic visits and started 1L therapy with ibrutinib or CIT. Patient baseline characteristics prior to 1L initiation were compared between the two treatment groups. Propensity score-based inverse probability of treatment weighting (IPTW) was used to adjust for baseline differences between treatment groups. Kaplan-Meier (KM) analysis was used to evaluate time to next treatment (TTNT) from 1L initiation. Two subgroup analyses were performed among patients with high-risk cytogenetic markers (deletion 17p, 11q or unmutated IGHV) and those without IGHV testing. Results: Overall, the rate of testing for high-risk markers remain suboptimal, while cytogenetic testing for del17p or del11q improved from 52.3% to 74.3%, coinciding with approval of ibrutinib for del17p in 2014, IGHV testing remains infrequent and low at 37.7%. 1882 patients (61.4%) received 1L ibrutinib monotherapy (mean age 71, median follow-up 26 months), and 1182 (38.6%) received a CIT regimen (mean age 68, median follow-up 33 months). More patients treated with ibrutinib had a known high-risk cytogenetic marker (44% vs. 34%), especially in those with deletion 17p (15% vs. 4%), than those treated with CIT. Ibrutinib-treated patients significantly decreased risk of initiating a subsequent treatment by 51% (Table), the high-risk group by 60%, and those with unknown IGHV status by 49%. Conclusions: Consistent with clinical trial evidence, treatment with ibrutinib among 1L CLL patients resulted in a statistically significantly lower risk of initiating subsequent treatment than those treated with CIT, both overall and in the subgroups of patients with high-risk cytogenetic markers and patients without IGHV testing. Assessment of cytogenetic/molecular risk status for appropriate treatment is vital to optimize clinical outcomes, especially in the novel agent era. Recent IGHV testing in community practice to assess genetic risk in CLL remains suboptimal.[Table: see text]
Profile and survival outcomes among patients with second malignancies following a primary chronic myeloid leukemia: An analysis of the SEER database (1975-2016).
Authors: Akinyemi Oluwasegun , Abodunrin Faith , Elleissy Nasef Kindha , Akinwumi Bolarinwa , Akinyemi Irene , Ojo Ademola , Silberstein Peter T.
Published: June 2022

e19060

Background: A major concern of cancer survivors is the occurrence of a subsequent cancer. A small proportion of patients with CML develop second cancers. Little is known about these patients. In the present study, we determined the profile and determinants of survival among patients with a primary CML who developed subsequent malignancies. Methods: We utilized the SEER 18 Registry 1975-2016 to conduct a retrospective analysis of patients who developed a subsequent malignancy following a primary CML diagnosis. The outcome of interest was the latency interval between the initial primary CML diagnosis and a subsequent malignancy. Utilizing the cox regression model, we determined the factors associated with the overall survival after controlling for disease stage, treatment modalities, and social determinants of health. Results: There were 2, 312 CML Patients who developed a subsequent malignancy in the study period. Among these patients, 76.3% were non-Hispanic Whites, 9.6% were non-Hispanic Blacks, and 8.7% were Hispanics. 63.0% of the study population were males. The mean age at primary diagnosis of CML was 63.2 ± 15.6 yrs. While the mean age at diagnosis of the subsequent malignancy was 66.9 ± 14.5 yrs. The commonest subsequent malignancies were Acute Myeloid Leukemia (12.9%), Prostate cancers (12.7%), Lung and Bronchi cancers (11.5%), and Breast cancers (5.9%). The mean latency interval for developing a subsequent malignancy following a CML was 3.7± 4.4 years. Significant predictors of reduced survival include increasing age (HR = 1.02; 95% CI 1.01-1.03), Latency interval < 5years (HR = 0.32; 95% CI 0.17-0.60) and Hispanic ethnicity (HR = 1.78; 95% CI 1.09-2.92). Conclusions: Common second malignancies following a primary diagnosis of CML include prostate cancers, lung and bronchi cancers, and breast malignancies. Major predictors of adverse outcomes include advanced age, development of second cancers within 5 years of primary CML diagnosis, and Hispanic ethnicity.