Dholakia, Ruchita

1512 Background: In response to the COVID-19 pandemic, many cancer practices adopted telehealth, including telephone and video appointments. Following a period of initial expansion that began in March 2020, sustained telehealth integration has emerged across the Mayo Clinic Cancer Practice (MCCP) in 2021. The primary objective of this study was to identify factors associated with utilization of telehealth appointments. Methods: A cross-sectional, multi-site, retrospective analysis was conducted across MCCP – a multisite, multiregional cancer practice with tertiary referral campuses in Minnesota, Florida, and Arizona, as well as rural, community-based hospitals and clinics throughout the Upper Midwest. Multivariable models were used to examine the association of patient- and provider-level variables with telehealth utilization. Results: Outpatient appointments conducted in July – August 2019 (n = 32,932) were compared with those from 2020 (n = 33,662) and 2021 (n = 35,486). The rate of telehealth appointment utilization increased from <0.01% in 2019 to 11.0% in 2020 and 14.0% in 2021. The strongest provider-level predictor of telehealth utilization was female physician provider type (OR 1.06, 95% CI 1.01 to 1.11; P = 0.0297), a trend consistently observed across career stages, practice locations and settings in 2020 and 2021. Additionally, while the rate of telehealth utilization was not significantly different at referral and community-based campuses in 2020, providers at referral campuses were significantly more likely to utilize telehealth than community-based campuses in 2021 (OR 1.1, 95% CI 1.01 to 1.12; P = 0.0289). Regarding patient-level factors, rural residence (defined by Rural-Urban Commuting Area codes), which accounted for 44.2% of the patient population, was significantly associated with lower telehealth utilization as compared to patients with urban residences, particularly for video appointments (OR 1.04, 95% CI 1.02 to 1.07; P < 0.0001). Notably, the disparity in telehealth utilization between rural and urban populations was found to be less pronounced in 2021 as compared to 2020. Conclusions: Multivariable analysis across a multi-site, multi-regional cancer practice identified several factors associated with increased telehealth utilization. These included female physician provider type, referral-based campuses, and patients residing in urban settings. A detailed understanding of the factors that influence telehealth utilization – a method of care delivery which represents a “new normal” across many cancer practices – will be essential to enable continued equitable access to high-quality, high-impact, patient-centered cancer care.

AbstractTherapy‐related myeloid neoplasms (t‐MN) are aggressive malignancies in need of effective therapies. The BCL‐2 inhibitor venetoclax represents a paradigm shift in the treatment of acute myeloid leukemia. However, the effectiveness of venetoclax has not been studied in a large cohort of t‐MN. We retrospectively analyzed 378 t‐MN patients, of which 96 (25.4%, 47 therapy‐related acute myeloid leukemia, 1 therapy‐related chronic myelomonocytic leukemia, 48 therapy‐related myelodysplastic syndrome) received venetoclax. Median interval from t‐MN to venetoclax initiation was 2.9 (Interquartile range [IQR] 0.7–12) months, and patients received a median of 3 (IQR 1–4) cycles. The composite complete remission (CRc) rate, median progression‐free survival (PFS), and overall survival (OS) were 39.1%, 4.9 months, and 7 months, respectively. The upfront use of venetoclax and achieving CRc were associated with improved survival, whereas the presence of Chromosome 7 abnormalities was associated with an inferior survival. Neither the TP53‐status nor the percent bone marrow blast predicted the likelihood of CRc or survival. Paired genetic analysis performed at venetoclax initiation and failure did not show the evidence of the selection of the TP53‐mutated clone. In a propensity‐matched analysis, the use of venetoclax‐based regimen as the first‐line therapy was associated with a superior survival compared to hypomethylating agent (HMA)‐based first‐line therapy (9.4 vs. 6.1 months, p = .01). We conclude that the upfront use of venetoclax with HMA improved survival, though PFS and OS remain poor. As the phenotype at diagnosis or the percent blasts did not predict outcomes, venetoclax should be studied in all t‐MN phenotypes.

Introduction: Teleneonatology (TN) allows remote neonatologists to provide real-time audio-video telemedicine support to community hospitals when neonates require advanced resuscitation or critical care. Currently, there are no published economic evaluations of U.S. TN programs. Objective: To evaluate the cost of TN from the perspective of the health care system. Methods: We constructed a decision tree comparing TN to usual care for neonates born in hospitals without a neonatal intensive care unit (NICU) who require consultation. Our outcome of interest was total cost per patient, which included the incremental cost of a TN program, the cost of medical transport, and the cost of NICU or non-NICU hospitalization. We performed threshold sensitivity analyses where we varied each parameter to determine whether the base-case finding reverted. Results: For neonates requiring consultation after birth in a hospital without a NICU, TN was less costly ($16,878) than usual care ($28,047), representing a cost-savings of $11,168 per patient. Sensitivity analyses demonstrated that at least one of the following conditions would need to be met for TN to no longer be cost saving compared to usual care: transfer rate with usual care <12% (base-case = 82%), TN reducing the odds of transfer by <8% (base-case = 52%), or TN cost exceeding $12,989 per patient (base-case = $1,821 per patient). Conclusions: Economic modeling from the health system perspective demonstrated that TN was cost saving compared to usual care for neonates requiring consultation following delivery in a non-NICU hospital. Understanding the cost savings associated with TN may influence organizational decisions regarding implementation, diffusion, and retention of these programs.

Abstract Background Yttrium-90 ibritumomab tiuxetan [(90)Y-IT; Zevalin] is a radio-immunoconjugate (RIC) which targets CD20. This study evaluates the utilization and cost-effectiveness of (90)Y-IT in the first line treatment for patients with previously untreated low-grade FL (UFL) and marginal zone lymphoma (UMZL) treated at our institution with (90)Y-IT. Methods We utilized the Advanced Text Explorer (ATE) and the Lymphoma SPORE databases to identify two groups of patients with UFL, WHO grade 1-2, and UMZL who received treatment with either (90)Y-IT or bendamustine plus rituximab (BR) at Mayo Clinic Cancer Center between January 2003 and December 2019. We excluded all patients who had &gt;25% bone marrow involvement with lymphoma for the BR group as this was a requirement for (90)Y-IT treatment. Inverse propensity weighting was utilized to balance the groups for baseline patients and disease characteristics. We use progression-free survival (PFS) as a denominator for the cost effectiveness/utilization evaluation. We identified meaningful and retrospectively measurable outcomes to compare between the groups. we extracted the following data; number of clinic visits in the first year after therapy, emergency room visits, number of hospital admissions, number of hospitalization days, numbers of days on the floor and ICU, number of infections, number of neutropenic fever hospitalizations, number of C-difficile events, number of blood products transfusions, overall use of growth factors due to therapy induced neutropenia, average number of times a growth factor was used, and the number of therapeutic use days. We defined days of therapeutic use as the number of days a treatment was administered on. We also calculated the average cost of the induction treatment when utilizing either (90)Y-IT or BR. The therapeutic cost included only the cost of the medications/therapies and their administration. Results Our cohort consists of a total of 143 patients - 64% (92/143) received BR and 36% (51/143) received (90)Y-IT (see Table-1 for clinical characteristics).The median follow-up from the time of therapeutic administration for the (90)Y-IT group was 5.3 years (95% CI; 4.2, 6.2) with one death and 4.7 years (95% CI; 3.9, 4.9) for the BR group with 6 deaths. The ORR was 100% in (90)Y-IT group with 94% achieving complete response (CR) while ORR in the BR group was 98% with 95% achieving CR. Rituximab maintenance was utilized in 33% of BR patients compared to only 6% in patients who received (90)Y-IT, p=0.002. After utilizing inverse propensity weighting (Figure-1), 5 years PFS was 76% for the (90)Y-IT group and 75% for the BR group, p=0.63 (Figure-2). We evaluated the average treatment effect of (90)Y-IT compared to BR on utilization outcomes, Table-2. (90)Y-IT required an average of 4.5 clinic visits less within the first year after treatment compared to BR group, p&lt;0.001. (90)Y-IT patients had an average of 10 days less of therapeutic use days compared to the BR group, p&lt;0.001. Patienta had similar admission rates to the hospital in both groups. However, when patients were admitted to the hospital in the first year after treatment, those who received (90)Y-IT spent an average of 1.5 days less in the hospital compared to the BR group, p=0.046. The overall use of growth factors was 40% less in the (90)Y-IT group as compared to the BR group, p&lt;0.001. The therapeutic cost of induction of (90)Y-IT was 54% less than that of 6 cycles of BR. Transformation to a high grade of lymphoma was seen in 4 patients in the BR group and 2 patients in the (90)Y-IT group. There was only one case of myelodysplastic syndrome in the BR group and none in the (90)Y-IT group. Conclusion Radio-immunoconjugate therapy with (90)Y-IT is a very convenient and cost-effective treatment for low-grade UFL and UMZL. This is especially important amidst the COVID-19 pandemic as it requires less contact with the health system with decreased number of therapeutic days, clinic visits, use of growth factors and number of hospitalization days. The cost of the therapeutic agents and their administration was also significantly lower for the (90)Y-IT which could help reducing the burden on the health system. Figure 1 Figure 1. Disclosures Cerhan: Regeneron Genetics Center: Other: Research Collaboration; Genentech: Research Funding; Celgene/BMS: Other: Connect Lymphoma Scientific Steering Committee, Research Funding; NanoString: Research Funding. Tun: Mundipharma, Celgene, BMS, Acrotech, TG therapeutics, Curis, DTRM: Research Funding; Gossamer Bio, Acrotech: Consultancy. OffLabel Disclosure: We are describing the use of Yttrium-90 ibritumomab tiuxetan in the first line setting in comparison to the bendamustine plus rituximab which is the standard of care

Abstract Introduction: Therapy-related myeloid neoplasm (t-MN) is defined as the development of a myeloid neoplasm in the context of prior DNA damaging therapies. t-MN is an aggressive disease with no effective therapies. BCL2-inhibitor venetoclax (VEN) represents a novel treatment for acute myeloid leukemia (AML) patients including those with high-risk features. Available VEN studies included only a small portion of t-AML patients, and its efficacy in t-MDS is not known. Our aim was to study the efficacy and outcomes of VEN in t-MN. Methods: Patients diagnosed with t-MN based on the WHO criteria who received VEN were identified. Minimal residual disease (MRD) assessment was performed in a subset of patients by multiparametric flow cytometry or molecular marker as available. Best response to VEN was divided into 3 categories: 1) MRD(-) complete remission (CR); 2) other CR [including complete morphological remission, MRD(+) CR, and CR with incomplete count recovery]; and 3) partial response/progressive disease/stable disease (PR/PD/SD). Progression-free (PFS) and overall survival (OS) were calculated from the time of initiation of VEN therapy using Kaplan-Meier analysis using Wilcoxon test. Logistic regression analysis was performed using Cox Proportional Hazard method. Statistical analysis was performed using JMP (v14.1, SAS Institute) and significance was defined as P&lt;0.05. Results: Of 332 t-MN patients identified (248 at Mayo Clinic, 84 at the Central Adelaide Health Network), 65 (19.6%) received VEN. Clinical and pathological characteristics of patients that received VEN and did not receive VEN (non-VEN) were matched except: a higher proportion of VEN patients had t-AML (49.2% vs. 32.6%, P=0.004), higher peripheral (2% vs. 0%, P=0.02), and bone marrow blasts (18% vs. 8%, P=0.02). VEN patients had a higher proportion of abnormality of chromosome 17, complex karyotype, and monosomal karyotype compared to non-VEN patients. The proportion of patients with pathogenic/likely pathogenic variant (PV) in TP53 or RAS genes was not different. The proportion of patients receiving stem cell transplant for t-MN was not different (Table 1). The indication for VEN was treatment naïve t-MN, relapsed/refractory (R/R) disease, and maintenance in 31 (47.7%), 32 (49.2%), and 2 (3.1%) patients respectively. Prior to VEN, patients received a median of 1 (range 0-4) lines of therapy. The median duration of VEN exposure was 3 cycles (IQR 1-4). VEN was administered with azacitidine, decitabine, low dose cytarabine, intensive chemotherapy, single agent, and &gt;1 agents in 37.9%, 40.9%, 12.1%, 4.5%, 4.5%, and 2.9% respectively. The best and the final responses to VEN are shown in Table 2. Median PFS and OS from initiation of VEN was 5 months (IQR 2-9.5, Fig. A) and 6.5 months (2-14.5, Fig. B) respectively. Female sex (vs. male, χ 2 9.6, P=0.03), VEN as the 1 st line of therapy (vs. other line of therapy, χ 2 8.3, P=0.02), and hypomethylating agent (HMA)-backbone (vs. other, χ 2 12.1, P=0.02) were associated with a significantly higher likelihood of achieving CR. Abnormality of chromosome 7 was associated with a shorter PFS (3.5 vs. 6 months, P=0.03) and OS (4.7 vs. 10.5 months, P=0.02). Using VEN as the 1 st line therapy was associated with an improved PFS (5.5 vs. 2.7 months, P&lt;0.01) and a trend towards improved OS (9.3 vs. 5.1 months, P=0.06). Using HMA (n=51), Ara-C based (n=8), and single agent VEN (n=3) was associated with median PFS of 5.5, 4.2, and 1.5 months (P&lt;0.01) and OS of 9.1, 4, and 1.5 months (P&lt;0.01, Fig. C) respectively. Achieving MRD(-) CR (n=7), other CR (n=17), and PR/PD/SD (n=36) was associated with a median PFS of 7.7, 9.5, and 2 months (P&lt;0.001) and median OS not reached, 12.9, and 2.9 months respectively (P&lt;0.01, Fig. D). Finally, best response rate, PFS, and OS did not differ based on morphological diagnosis [t-MDS vs. t-AML] at diagnosis or bone marrow blast percent [&lt;20% vs. ≥20%] at the start of VEN therapy. On multivariate analysis, only the best response remained an independent predictor of PFS and OS. Conclusion: VEN induced remission, including MRD(-) remission, in a subset of patients. However, progression was noted in 83% patients with continued use, and PFS and OS were overall short. The morphological diagnosis of t-MDS/t-AML or blast percentage at the start of VEN therapy did not impact outcome. Earlier use of VEN, using HMA-based therapies, and achieving deeper responses were associated with improved outcomes. Figure 1 Figure 1. Disclosures Al-Kali: Novartis: Research Funding; Astex: Other: Research support to institution. Patnaik: StemLine: Research Funding; Kura Oncology: Research Funding. Wei: Astra Zeneca: Membership on an entity's Board of Directors or advisory committees, Research Funding; Agios: Membership on an entity's Board of Directors or advisory committees; Genentech: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Macrogenics: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Celgene/BMS: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Astellas: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Abbvie: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Tiong: Pfizer: Consultancy; Amgen: Speakers Bureau; Servier: Consultancy, Speakers Bureau. Hiwase: Novartis: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: venetoclax is not approved in the treatment of myelodysplastic syndrome.