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Background: Eribulin mesylate was approved in the United States (US) in 2010 as third-line or later treatment (after an anthracycline and a taxane) of mBC. Multiple patient demographic and clinical characteristics have been reported to impact clinical outcomes in mBC patients. The objective of these analyses was to assess real-world clinical outcomes of eribulin therapy in three subgroups that generally have poorer prognoses: elderly (≥65 years), African American, and those with liver metastases in clinical practice in the US. Methods: A retrospective chart review study was conducted across community oncology practices in the US. Adult female patients with mBC who initiated treatment with eribulin as per US prescribing information between 2011 and 2017 were included. Data were extracted by prescribing physicians from individual patient’s electronic health records and captured via an electronic case report form. All patient data were de-identified prior to analyses. Clinical outcomes including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were assessed in patients who were elderly, African American, or who had liver metastases. Results: Current analyses were based on data from 278 patients including 175 (63%) patients with liver metastases, 98 (35%) elderly patients, and 73 (26%) African American patients. Mean age at initiation of eribulin in each group was: liver metastases, 59; elderly, 71; and African American, 58. Proportion of patients with ECOG-PS ≥2 at initiation of eribulin was: liver metastases, 46%; elderly, 52%; and African American, 47%. The majority of patients received eribulin in 3rd line: liver metastases, 80%; elderly, 87%; and African American, 85%. ORR to eribulin was 34% in patients with liver metastases, 35% in elderly, and 48% in African Americans. Median PFS from initiation of eribulin was 5.2 months in patients with liver metastases, 5.8 months in elderly, and 7.6 months in African Americans. Landmark OS from initiation of eribulin at 6, 12 and 24 months were 71%, 36% and 18%, respectively, in patients with liver metastases, 72%, 35% and 23% in elderly, and 78%, 46%, and 28% in African Americans. Conclusion: Effectiveness of eribulin in clinical practice in patients with liver metastases, elderly, and African Americans was confirmed within this real-world study in the US. Citation Format: Sarah S. Mougalian, Jonathan K. Kish, Jingchuan Zhang, Djibril Liassou, Bruce A. Feinberg. Effectiveness of eribulin in poor prognosis subgroups of metastatic breast cancer (mBC) patients (elderly, African Americans, and patients with liver metastases) in the United States [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-37.

Introduction Eribulin was approved in the United States (US) in 2010 for patients with metastatic breast cancer (MBC) who previously received at least two chemotherapeutic regimens, including anthracycline and taxane in the adjuvant or metastatic setting. With significant changes to the treatment landscape over the past decade, assessment of the real-world effectiveness of eribulin in clinical practice when used according to the approved US indication is valuable. Methods Patients with MBC were identified by community oncologists through a retrospective, multi-site patient chart review; de-identified data were abstracted into electronic case report forms. Eligible patients initiated eribulin consistent with approved US indication between 1 January 2011 and 31 December 2017. Clinical outcomes assessed included objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in all patients and those with triple negative breast cancer (TNBC). Results The analysis included 513 patients (median 59.0 years; 38.8% with Eastern Cooperative Oncology Group status ≥ 2). Eribulin was third-line therapy for 78.0% of patients, and fourth-line or later for the remainder. ORR was 54.4%, median PFS was 6.1 months (95% CI: 5.8, 6.6), and median OS was 10.6 months (95% CI 9.9, 11.7) in all patients. Among the 49.9% of patients with TNBC, ORR was 55.1%, median PFS was 5.8 months (95% CI 5.1, 6.4), and median OS was 9.8 months (95% CI 8.6, 11.0). Conclusion The current retrospective chart review study reinforces the clinical effectiveness of eribulin in patients with MBC, including those with TNBC, when used according to the approved US indication in real-world clinical practice.

Objectives Real-world evidence (RWE) has gained increased attention in recent years as a complement to traditional clinical trials. The use of RWE to establish the efficacy of oncology drugs for Food and Drug Administration (FDA) approval has not been described. In this paper, we review 5 recent examples where RWE was submitted in support of the FDA approvals of original or supplementary indications for oncology drugs. Methods To identify cases where RWE was used, we reviewed drug approval packages available at Drugs@FDA for oncology drugs approved between 2017 and 2019. Five cases were selected to present a broad overview of different types of RWE, different circumstances under which RWE has been used for regulatory approvals, and how FDA evaluated the data in each case. The type of RWE submitted, the indication, limitations identified by FDA reviewers, and the outcome of the submission are discussed. Results RWE, particularly historical controls for rare or orphan indications, has been used to support both original and supplementary oncology drug approvals. Types of RWE included data from electronic health records, claims, post-marketing safety reports, retrospective medical record reviews, and expanded access studies. Small sample sizes, data quality, and methodological issues were among concerns cited by FDA reviewers. Conclusion By bridging the gap between the constraints of the trial setting and the realities of clinical practice, RWE can add value to a regulatory submission. These early examples provide insight into how regulators evaluated RWE submitted as evidence of efficacy for oncology drugs.

Introduction Lenvatinib has become the most commonly prescribed first-line (1L) agent for the treatment of radioactive iodine-refractory differentiated thyroid cancer (RAI-r DTC) since its approval in 2015. With no real-world studies describing clinical outcomes of 1L lenvatinib and subsequent therapy, the current study aimed to assess treatment sequencing and related clinical outcomes in patients treated with 1L lenvatinib in the USA Methods We conducted a multisite, retrospective chart review of US patients with a diagnosis of RAI-r DTC who had initiated 1L therapy with lenvatinib from January 1, 2016 through May 31, 2017 with follow-up through October 17, 2018. Physicians completed electronic case report forms for two patient cohorts: patients still receiving 1L lenvatinib (cohort 1) and those who had initiated second-line (2L) therapy prior to data cutoff (cohort 2). Real-world objective response rate (ORR) was assessed for both cohorts. Progression-free survival (PFS) and overall survival (OS) were assessed for cohort 2. Results A total of 252 patients met the study criteria with 71 in cohort 1 and 181 in cohort 2. Patients were predominantly female, had papillary DTC, and had lung metastases. The ORR was 64.8% for cohort 1 and 53.6% for cohort 2. In cohort 2, median PFS from 1L lenvatinib initiation was 14.0 months (95% CI 12.7–15.0). Second-line treatments included sorafenib (49.7%), cabozantinib (19.3%), and other targeted/chemotherapy/immuno-oncology agents. The ORR in 2L therapy was 15.5%. For cohort 2, the 12-, 18-, and 24-month OS from initiation of 1L lenvatinib was 92.8%, 81.5%, and 66.9%, respectively. Conclusions In this first real-world examination of clinical effectiveness of 1L lenvatinib and subsequent therapy among patients in the US, the results demonstrated that treatment with 1L lenvatinib followed by another 2L therapy may deliver a clinical benefit, thus allowing a number of potential 2L options following 1L lenvatinib for patients with RAI-r DTC.

Aim: To estimate the real-world incidence and timing of radiation pneumonitis following chemoradiotherapy for Stage III non-small-cell lung cancer and compare costs between patients with and without radiation pneumonitis. Methods: Retrospective analysis using the Symphony Health Integrated Dataverse. Results: Pneumonitis incidence was 12.4% with a 177-day mean time to onset. Patients with versus without pneumonitis were more frequently admitted to the hospital (33.8 vs 19.2%, p

511 Background: Treatment landscape in advanced/unresectable hepatocellular carcinoma (uHCC) has been rapidly changing. In June 2020, the first immuno-oncologic (I/O) + IV anti-angiogenic regimen for uHCC was approved as first line (1L) treatment in the US. As with any new therapy, it is key to understand the prevalence of medical conditions listed in patient medical history/comorbidities that could potentially influence physician choice of 1L therapy in uHCC patients. Methods: We conducted a retrospective chart review study using Cardinal Health's Oncology Provider Extended Network (OPEN). US medical oncologists identified newly diagnosed adult uHCC patients initiating 1L systemic therapy from June 2020 to April 2022. Based on the warnings and precautions section of the US FDA labels, medical conditions reported as part of patient medical history or comorbidities [including gastrointestinal (GI) bleeding risk, chronic kidney disease, autoimmune disorders, thromboembolic events] were identified from patient medical records. Less suitable was defined as the occurrence of ≥ 1 medical condition/comorbidity reported in the medical record. All patient data were deidentified. Proportions of patients with the above medical conditions or with physician-reported record of an esophagogastroduodenoscopy (EGD) procedure to assess risk of bleeding were calculated. Results: In the cohort of 433 uHCC patients initiating 1L systemic therapy, majority were male 287 (66%), Caucasian 244 (56%) with average age of 64 years. At 1L initiation, majority of the patients were 333 BCLC Stage C (77%) and 316 (73%) had ECOG performance status of 0 or 1. Approximately 160 (37%) were Child-Pugh B, 99 (23%) had non-alcoholic steatohepatitis (NASH), 176 (41%) had Hep-C etiology (among those tested), and 294 (68%) had liver cirrhosis. Prior to therapy initiation, 254 (59%) received EGD within 3 months. In the overall cohort, 221 (51%) patients were reported to have at least one condition listed as medical history/comorbidity that could make them less suitable to receive I/O + IV anti-angiogenic regimen. Upper/lower GI bleeding risk and chronic kidney disease were reported in 164 (38%) and 64 (15%) patients, respectively. History of thromboembolic events and autoimmune disorders were reported in 50 (12%) and 22 (5%) of patients, respectively. Conclusions: A significant proportion of the newly diagnosed uHCC patients were found to have at least one condition listed as medical history/comorbidity that would make them potentially less suitable for I/O + IV anti-angiogenic regimen. Our findings reinforce the importance of medical history and co-morbidity assessment in uHCC patients prior to therapy selection to optimize benefit-risk ratio for each patient.

ObjectiveCancer survival rates have improved over the past few decades, yet socioeconomic disparities persist. Social determinants of health (SDOH) have consistently been shown to correlate with health outcomes. The objective of this study was to characterise oncologists’ perceptions of the impact of SDOH on their patients, and their opinions on how these effects could be remediated.DesignCross-sectional survey of physicians.SettingWeb-based survey completed prior to live meetings held between February and April 2020.ParticipantsOncologists/haematologists from across the USA.ExposureClinical practice in a community-based or hospital-based setting.Main outcome and measurePhysician responses regarding how SDOH affected their patients, which factors represented the most significant barriers to optimal health outcomes and how the impact of SDOH could be mitigated through assistance programmes.ResultsOf the 165 physicians who completed the survey, 93% agreed that SDOH had a significant impact on their patients’ health outcomes. Financial security/lack of insurance and access to transportation were identified most often as the greatest barriers for their patients (83% and 58%, respectively). Eighty-one per cent of physicians indicated that they and their staff had limited time to spend assisting patients with social needs, and 76% reported that assistance programmes were not readily accessible. Government organisations, hospitals, non-profit organisations and commercial payers were selected by 50% or more of oncologists surveyed as who should be responsible for delivering assistance programmes to patients with social needs; 42% indicated that pharmaceutical manufacturers should also be responsible.ConclusionOur survey found that most oncologists were aware of the impact of SDOH on their patients but were constrained in their time to assist patients with social needs. The physicians in our study identified a need for more accessible assistance programmes and greater involvement from all stakeholders in addressing SDOH to improve health outcomes.

Aim: Targeted therapy (TT) and immuno-oncology (IO) drugs are approved for patients with BRAF mutant metastatic melanoma (MM). We compared real-world outcomes for first-line (1L) TT versus 1L IO to evaluate optimal sequencing. Materials & methods: Physicians-identified BRAF mutant MM patients initiating 1L TT or IO therapies and extracted treatment, disease and clinical outcomes including disease response which were compared between TT and IO and individual regimens. Results: 440 MM patients (TT = 283, IO = 157) were identified. A higher proportion of TT patients had liver metastases (46.3 vs 35.0%) and abnormal lactate dehydrogenase (61.1 vs 42.7%). IO-treated had a RECIST-determined response rate of 45.9 versus 60.1% for TT and time on treatment of 7.2 versus 11.4 months, respectively. There was no survival difference between cohorts. Conclusion: Despite higher risk patients, 1L TT resulted in higher response rate and longer treatment duration suggesting a preferred 1L sequence.

Background Although recent pivotal trials (PROMID, CLARINET) have established somatostatin analogs (SSAs) as first-line agents for neuroendocrine tumors (NETs), their use in clinical practice is largely unknown. We aimed to understand real-world management and treatment of gastroenteropancreatic (GEP) NETs. Materials and Methods Patients with metastatic GEP-NETs treated with SSAs, lanreotide depot or octreotide long-acting release (LAR), between January 1, 2015, and December 31, 2015, were identified from a U.S. claims database supplemented with chart review for a subset of patients. Descriptive statistics summarized patients’ demographics, clinical characteristics, treatment patterns, and healthcare resource use. Univariate and multivariate comparisons were made across SSA groups. Results Among 548 patients treated with an SSA for metastatic GEP-NET (lanreotide = 108; octreotide = 440), demographic and clinical characteristics were similar across groups, except more patients with pancreatic NETs were treated with lanreotide (38.7% vs. 6.3%, p < .01). More octreotide patients had a diagnosis of carcinoid syndrome compared with lanreotide patients (19.8% vs. 11.1%, p = .02). Approximately 1.1% of patients received lanreotide (>120 mg every 4 weeks [Q4W]) at a dose above label compared with 12.7% of octreotide patients (>30 mg Q4W; p < .01). At 1.5 years after SSA initiation, 85.7% (95% confidence interval, 74.3%–92.3%) were still on index SSA as reported by the physician. Variances between chart review and claims data were significant. Conclusion SSAs were common in first-line systemic intervention, but dose escalations and dosing deviations outside of label were noted. Variances between claims and chart review warrant additional research to compare methodologies. With an increasing focus on value-based care in oncology, it is critical to understand the use of, and outcomes with, these agents in community practices. Implications for Practice The aim of this study was to enhance understanding of real-world management and treatment of metastatic neuroendocrine tumors (NETs), with particular focus on systemic therapy with a somatostatin analog (SSA). As per published guidelines, SSAs are common in first-line systemic intervention, but dose escalations and dosing deviations outside of the label are noted for symptom control. Nevertheless, oncologists must weigh the implications of the use of above-label dosing of SSAs to manage and treat patients with metastatic NET within a value-based care framework.

e21534 Background: Nivolumab is approved in the United States and other countries as an adjuvant treatment for patients with completely resected stage III–IV melanoma based on results of the phase 3 CheckMate 238 trial, though the trial enrolled a limited number of patients with stage IIIA disease (AJCC-8). The objective of this real-world study is to describe characteristics, treatment patterns, and outcomes of patients with resected stage IIIA melanoma (AJCC-8) treated with adjuvant nivolumab or monitored with observation. Methods: In this retrospective, chart-review study, physicians from Cardinal Health’s proprietary Oncology Provider Extended Network (OPEN) extracted data from electronic health records of patients who had undergone complete surgical resection of stage IIIA melanoma between Jan. 1, 2018, and Dec. 31, 2019. Recurrence-free survival (RFS) and overall survival (OS) were evaluated from the date of resection and compared between the adjuvant nivolumab and observation cohorts using log-rank tests and adjusted Cox proportional hazards models (covariates included age, sex, race, region, payer type, ECOG PS, and Charlson Comorbidity Index). Discontinuations and deaths due to adjuvant nivolumab toxicity were assessed. Results: This study included 171 patients treated with adjuvant nivolumab and 38 patients monitored with observation. In the adjuvant nivolumab and observation cohorts, respectively, mean age was 57.4 and 68.1 years; most patients were male (59% and 68%) and white (90% and 87%); and median follow-up from resection was 20.7 and 25.0 months. Sentinel lymph node tumor burden of < 1 mm was reported in 12% (n = 20) and 16% (n = 6) of patients in the adjuvant nivolumab and observation cohorts, respectively. The scheduled treatment course with adjuvant nivolumab was completed by 91% of patients (n = 155). RFS and OS rates were numerically higher with adjuvant nivolumab than with observation (Table). There was a trend toward RFS and OS benefit with adjuvant nivolumab versus observation (unadjusted RFS HR 0.53, 95% CI 0.26–1.09; adjusted RFS HR 0.62, 95% CI 0.28–1.40; unadjusted OS HR 0.55, 95% CI 0.19–1.57; adjusted OS HR 0.81, 95% CI 0.25–2.61). Discontinuation of adjuvant nivolumab due to toxicity occurred in 2% of patients (n = 4); no treatment-related deaths were reported. Conclusions: These real-world results confirm that patients with resected stage IIIA melanoma (AJCC-8) have a good prognosis. Treatment with adjuvant nivolumab may provide modest survival benefit over observation in this population, though increased sample size and additional follow-up are warranted.[Table: see text]

1036 Background: Trastuzumab Deruxtecan (T-DXd) was associated with an increased risk of interstitial lung disease (ILD)/pneumonitis (P) in metastatic breast cancer (mBC) patients (pts) in clinical trials, leading to ILD/P monitoring and management guidelines in the product label. This study aims to describe the monitoring and management of ILD/P during T-DXd therapy among US community oncology practices. Methods: Oncologists in the Cardinal Health Oncology Provider Extended Network (OPEN) participated in a cross-sectional survey on monitoring approaches for ILD/P among mBC pts. Participating physicians provided data from medical charts of up to 10 pts who were treated with T-DXd regarding presence of ILD/P symptoms, management, and outcomes of ILD/P symptoms. Results: Twenty-eight physicians from across the U.S participated and provided data on 149 T-DXd pts. Nearly all physicians reported they were monitoring ILD/P after T-DXd initiation by physical examination (n = 27), symptoms checklist (n = 25) and pulse oximetry (n = 23) at every visit, whereas fewer reported performing lung CT scan (n = 18), echocardiogram (n = 13), chest X-ray (n = 12), lung PET scan (n = 10), pulmonary function tests (n = 8) and diffusion testing (n = 7) on a less frequent basis. Among 149 T-DXd pts, 4 pts were diagnosed with ILD/P over an average T-DXd treatment duration of 5.5 months. All 4 cases initiated T-DXd treatment at 5.4mg/kg every 3 weeks, experienced ILD/P within the first 5 cycles of T-DXd, were diagnosed with lung CT scan and initially presented with Grade 2 symptomology (2 cases progressed to Grade 3). For both cases that remained as Grade 2, ILD/P completely resolved within 23 days. One case received IV methylprednisolone (1000mg daily; duration of therapy (DOT): 3 days) during hospitalization, oxygen therapy and T-DXd was permanently discontinued; whereas the other one received oral prednisone (started at 40mg daily and tapered to 5mg daily; DOT: 7 days) and T-DXd dose was held. For the two grade 3 cases, one received IV methylprednisolone (125mg daily; DOT: 7 days) during hospitalization, T-DXd dose was held, and ILD/P completely resolved within 11 days; whereas the other case received oral prednisone (started at 80mg daily and tapered to 5mg daily; DOT: 63 days), oxygen therapy, T-DXd was permanently discontinued, and ILD/P resolved with sequela within 46 days. Conclusions: ILD/P incidence in this small study sample of patients receiving T-DXd treatment was 2.7%. Although general awareness of ILD and routine screening by pulse oximetry and physical exam were common, management approaches for ILD/P were not always consistent with T-DXd prescribing information. Further physician education may be needed to improve appropriate management of ILD/P and outcomes for T-DXd pts.

e18525 Background: Research suggests that between thirty and fifty percent of patients with cancer experience psychiatric disorders across the cancer trajectory. As part of standard cancer care, mental health care can reduce distress and psychological morbidity for patients and improve their quality of life. Mental health treatment may even improve cancer survival rates.Considering the mental health issues relevant to cancer, implementation of mental health care into routine clinical care remains a challenge among community-based hematologists/oncologists (cH/O). Methods: Practicing U.S. cH/O completed a cross-sectional, web-based survey from September through November 2021. The survey collected demographic information and assessed physicians’ experiences and awareness regarding mental health diagnosis, frequency, severity, and management among their patients. Data were summarized using descriptive statistics. Results: Participants (N = 243) specialized in hematology/oncology (63%), medical oncology (36%) (1% other). The majority practiced in community-based settings unaffiliated with an academic center or hospital (73%). The majority (92%) agreed that mental health can significantly impact the health outcomes of patients with cancer. The majority (80%) frequently see patients coping with mental illness or distress. More than a quarter of the participants reported that their practice has clinical psychologists (27%), and nearly half (46%) have social workers on staff. About half (51%) occasionally refer patients for mental health services/treatment while 15% rarely or never refer. Nearly half (49%) indicated they do not have adequate resources to support the mental health needs of their patients with cancer. Conclusions: Our findings that oncologists have high levels of awareness about mental health issues among their patients with cancer is encouraging as is their incorporation of professionals on the care team to address this need. However, oncologists indicated that their available mental health resources are inadequate to meet patients’ needs and external referrals are limited. These findings suggest that additional resources and referrals are needed to ensure that patients will consistently receive the mental health care they need. Future research to assess the impact of mental health care on clinical outcomes including quality of life in patients with cancer is warranted.

3075 Background: The utilization of circulating tumor DNA (ctDNA) as a non-invasive biomarker for the detection of minimal residual disease, prediction of recurrence in the post-operative setting, and real-time monitoring of treatment efficacy has the potential to vastly improve the care and outcomes of patients with colorectal cancer (CRC). In August of 2020, ctDNA testing first gained approval for use in solid tumors and its prognostic benefit after curative intent surgery has been demonstrated to exceed that of prior standard of care clinicopathological criteria in CRC patients. The comprehensive integration of validated ctDNA approaches into the routine clinical care of patients with CRC would not only fundamentally change how risk of recurrence is assessed but could also reduce treatment with unneeded/unwarranted toxic therapies and allow for earlier recognition and treatment in cases with a high risk of relapse. This survey-based study aimed to evaluate the utilization of ctDNA testing in the management of CRC among practicing community oncologists in the U.S. Methods: Questions related to ctDNA utilization for patients with CRC were presented to community oncologists during a virtual meeting held in July 2021. Descriptive statistics were used to analyze the results. Results: Of 55 participating oncologists geographically distributed across the U.S., 49% indicated not using ctDNA to make treatment decisions in CRC. A proportion of physicians reported using ctDNA to detect recurrence (27% of physicians); make decisions around post-resection adjuvant therapy (25%); monitor disease progression/relapse (18%); and track tumor resistance during treatment (9%). The most frequently cited barriers to ordering ctDNA testing for patients with metastatic CRC were reimbursement issues (reported by 56% of oncologists), insufficient clinical evidence (46%), and limited familiarity with ctDNA use (28%). Oncologists reported that the following would increase their utilization of ctDNA testing: more clinical evidence of the utility of ctDNA (reported by 66% of physicians), increased education on methodology (60%), more education on the use of ctDNA (57%), more financial aid and reimbursement support for patients (49%), more decision support tools (47%), and better communication between physicians and vendors (26%). Conclusions: These findings demonstrate limited adoption of ctDNA testing by community oncologists in the care of CRC patients. Insufficient demonstration of clinical utility, limited familiarity with methodology, and reimbursement issues were cited as barriers to uptake. Education for community oncology providers about ctDNA testing and its demonstrated clinical utility, and increased financial support for patients may improve its utilization and adoption in CRC to improve patient outcomes and care.

Aim: To characterize real-world neurological adverse events (AEs) associated with chimeric antigen receptor T-cell therapies in patients with refractory/relapsed large B-cell lymphomas. Materials & methods: Postmarketing case reports from the US FDA AEs reporting system involving axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) for large B-cell lymphomas were analyzed. Results: Of 804 AE cases identified (637 axi-cel, 167 tisa-cel), 428 (67%) of axi-cel cases and 43 (26%) of tisa-cel cases reported neurological AEs. Compared with cases without neurological AEs, significant associations were observed between neurological AEs and use of axi-cel, age ≥65 years, and the outcome of hospitalization. Conclusion: Neurological AEs were common with chimeric antigen receptor T-cell therapy in the real world and largely reflected those reported in clinical trials.

Objective: To determine the perceptions of US community-based hematologists/oncologists regarding approved CAR-T therapies in relapsed/refractory large B-cell lymphoma and barriers to their adoption in practice. Materials & methods: In February and November 2019, US physicians with diverse geographic representation submitted responses via a web-based survey prior to or via an audience response system at the live meetings. Results: In February and November, 46 and 29% of physicians indicated that they had not referred any patients for CAR-T therapy, respectively. Cumbersome logistics, high cost and toxicity were defined as major barriers to prescribing CAR-T therapy. Conclusions: These findings highlight a need to improve processes, and address costs, to ensure timely access to this potentially curative therapy for relapsed/refractory large B-cell lymphoma patients.

Chimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment for relapsed or refractory large B-cell lymphoma (LBCL) with the Food and Drug Administration (FDA) approvals of axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel). Although the incidence of LBCL is highest among patients age ≥ 65, clinical trials supporting approval of these 2 products primarily enrolled younger patients. Safety data for axi-cel and tis-cel in older patients is limited.In this analysis, we queried the FDA Adverse Events Reporting System (FAERS) database for cases associated with axi-cel or tis-cel from the FDA approval dates for the LBCL indication for each product through December 31, 2019, and compared adverse events (AEs) reported for cases involving patients aged65 and ≥ 65.A total of 804 cases were retrieved, with 333 (41%) involving patients age ≥ 65. Cytokine release syndrome (CRS) was the most common AE reported in both age groups. Cases involving older patients had a significantly higher proportion of neurological AEs, including CAR T-cell-related encephalopathy syndrome (8% vs. 4%, p = 0.03). Some individual clinical features of CRS were significantly more common among younger age group cases, including pyrexia (33% vs. 23%, p 0.01), tachycardia (10% vs. 5%, p 0.01), and thrombocytopenia (4% vs. 2%, p = 0.03).In this age-based analysis of FAERS reports for patients treated with axi-cel or tis-cel, we identified differences in patterns of AEs experienced. This large-scale post-marketing study complements clinical trial safety data and may help inform clinicians' decision making when treating adult patients with CAR-T cell therapy.

120 Background: Metastatic castration-resistant prostate cancer (mCRPC) is a difficult-to-treat cancer with poor patient outcomes. In June 2021, 177Lu-PSMA-617 was granted U.S. FDA breakthrough designation for the treatment of mCRPC based on results from the phase III VISION trial showing a 4-month increased median overall survival (15.3 v 11.3 m; HR 0.62 [0.52-0.74], P < 0.001) and a 5.3-month increased radiographic progression-free survival (8.7 v 3.4 m; HR 0.40 [0.29-0.57] for 177Lu-PSMA-617 versus standard of care (SOC). If approved, 177Lu-PSMA-617 has the potential to improve patient outcomes, but its impact will depend significantly on how community-based medical oncologists (cbMO) plan to integrate it into patient management. The present study surveyed cbMO regarding their perceptions of the VISION trial data and potential barriers to 177Lu-PSMA-617 use in mCRPC. Methods: Between June and October 2021, practicing U.S.-based cbMO were invited to attend a virtual meeting and were presented with the VISION trial data. Their reactions to the data and preferences were collected using audience response technology. Results are presented using descriptive statistics. Results: Among the 287 participating cbMO, median years in practice was 17 (1-45), and median time spent in direct patient care was 90% (20-100%). In the past year, 46% of cbMO managed 6-15 patients with mCRPC, and 27% managed 16 or more. CbMO reported that at the time of referral, their patients with mCRPC had commonly been treated with androgen deprivation therapy (77%) and one (49%) or two plus (20%) novel hormonal agents. After reviewing the recent data from the VISION trial showing improved survival outcomes in mCRPC, 51% of cbMO reported that both the safety and efficacy data were compelling, and they were very likely to prescribe 177Lu-PSMA-617 if approved; 33% indicated that the efficacy data alone was compelling and were likely to prescribe 177Lu-PSMA-617. The top 2 limitations of the VISION trial were identified as PSMA gallium positivity for eligibility (54%) and the disallowance of radium-223 on the SOC arm (48%). Regarding perceived barriers to future use of 177Lu-PSMA-617, 68% and 64% of cbMO reported availability of a PSMA-gallium scan and availability/access of the therapy itself, respectively, would be the greatest barriers. Additional barriers included cost (42%) and difficulty with reimbursement (30%), highlighting the importance of addressing access and financial considerations associated with 177Lu-PSMA-617. Conclusions: Most cbMO found the VISION trial data of 177Lu-PSMA-617 in mCRPC compelling and indicated that they are likely to incorporate it into their patient management, if approved. However, major barriers such as the incorporation of PSMA-gallium scans, 177Lu-PSMA-617 availability, and cost will need to be addressed to encourage widespread adoption of this new therapy.

311 Background: The immuno-oncology (IO) therapy combination nivolumab + ipilimumab, and the IO-tyrosine kinase inhibitor (TKI) combination pembrolizumab + axitinib, received US FDA approvals in 2018 and 2019, respectively, as first-line (1L) therapy for advanced renal cell carcinoma (aRCC). We examined physician perceptions of concerns about and barriers to 1L treatment by class of regimen (IO-IO, IO-TKI, and single-agent TKI [SA-TKI]) in the United States. Methods: US-based oncologists treating ≥ 5 aRCC patients in the prior 12 months were identified from the Cardinal Health network, a community of > 800 oncologists. Physicians were surveyed about concerns in prescribing and barriers to treating by class (scale of 1–5; 1 = no concern/not a barrier, 5 = most concerning/major barrier); mean scores are reported. Adverse events (AEs) of concern were selected from a prespecified list and respondents rank-ordered from most to least concerning by class. Physicians were also asked to gauge affordability and to rank-order 13 characteristics to identify key factors in prescribing preference. The impact of COVID-19 on aRCC care in practice was also assessed. Results: A total of 49 providers (84% community, 16% academic) treating a median of 20 (IQR 14–30) aRCC patients from across the United States participated. For IO-IO, the top 3 concerns in prescribing were AEs (4.3), patient out-of-pocket costs (OOP; 3.7), and unexpected late AEs (3.6), whereas patient OOP (4.3), AEs (4.1), and patient adherence (3.9) were of most concern for IO-TKI. For SA-TKIs, the top 3 concerns were patient adherence (3.9), patient OOP (3.9), and AEs (3.6). High patient OOP and impact on quality of life were the top 2 barriers in using IO-TKI therapy. The most concerning AEs were colitis, pneumonitis, and hypertension for IO-IO or IO-TKI, and diarrhea, fatigue, hand-foot syndrome, and hypertension for SA-TKI. Overall survival (OS), progression-free survival (PFS), and complete response (CR) were ranked 1st, 2nd, and 3rd factors in prescribing preferences while patient compliance, patient preference, and practice reimbursement ranked 11th, 12th, and 13th. Patient OOP and drug acquisition costs (DAC) were the most important factors when considering the affordability of treatment, with the perception that IO-IO was the most expensive among the classes of therapy. The overall impact of COVID-19 on caring for aRCC patients was very limited, with a moderate increased use of telemedicine and a slight impact on the timing and number of routine care visits. Conclusions: OS, PFS, and CR ranked highest among the most important factors influencing selection of 1L treatment for aRCC. Factors of concern and barriers varied by class of treatment, with patient adherence and OOP affecting use of TKI or IO-TKI therapies, and AEs affecting the use of IO-based therapy. This study revealed perceptions of high patient OOP and DAC of IO-IO therapy, in contrast to our expectations.

Biosimilars are biological compounds that contain an active substance that is similar to the active substance in an already approved biologic. This commentary focuses on the barriers to the use of biosimilars in the United States.

Background Rapidly evolving understanding of cancer biology has presented novel opportunities to translate that understanding into clinically relevant therapy. Palbociclib, a novel, first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor was approved in the USA in February 2015 for the treatment of advanced/metastatic breast cancer. We examined real-world evidence in the first year post approval to understand the clinical and demographic characteristics of patients treated with palbociclib in community oncology practices and the dosing, treatment, and complete blood count (CBC) monitoring patterns. Methods This was a retrospective observational study of structured data from a US electronic medical record (EMR) database. Female patients receiving palbociclib after 31 January 2015 were followed through 31 March 2016. Our methodological rules were constructed to aggregate drugs received according to the order in which they are given, i.e., identify the line of therapy as first, second, or third line, etc., using treatment order and course description fields from the EMR. Results There were 763 patients initiating palbociclib who met the selection criteria. Of those, 612 (80.2%) received palbociclib concomitantly with letrozole. Mean follow up was 6.4 months and mean age at palbociclib initiation was 64 years. Of patients with a known starting dose (n = 417), 79.9% started on palbociclib 125 mg. Dose reductions were observed in 20.1% of patients. Percentages of patients according to line of therapy at initiation of palbociclib were first-line, 39.5%; second-line, 15.7%; third-line, 13.1%; and fourth-line therapy or later, 31.7%. On average, two CBC tests were conducted during the first cycle of palbociclib treatment. Overall, 74.6% of patients had a neutropenic event during follow up including 47.3% and 8.0% of patients with a grade 3 or 4 occurrence, respectively. Conclusions Real-world palbociclib use one year post US approval demonstrates a more heterogeneous patient population than that studied in the clinical trials with more than half of the patients receiving palbociclib plus letrozole in later lines of therapy. CBC testing rates suggested good provider compliance with monitoring guidelines in the USA prescribing information. The occurrence of grade 3 and 4 neutropenia (based on laboratory results) was consistent with the rates of grade 3 and 4 neutropenia in two phase-III studies (PALOMA-2, 56% and 10%; PALOMA-3, 55% and 11%, respectively). Understanding palbociclib utilization in real-world patients and how drug dosing and monitoring are performed aids in the understanding of safe and effective use of the drug. Electronic supplementary material The online version of this article (10.1186/s13058-018-0958-2) contains supplementary material, which is available to authorized users.

Introduction: As of July 31, 2021, 5 CAR-T therapies have been approved in the U.S. to treat lymphomas (large B cell, follicular, and mantle cell), acute lymphoblastic leukemia, and multiple myeloma. These individualized, autologous cell therapies are expensive; involve complex manufacturing, transportation, and storage requirements; and have a unique set of serious adverse events associated with their use. Thus, the use of CAR-T therapies is limited mainly to tertiary care centers that have been licensed to administer these agents. Over half of all U.S. patients with cancer are treated in community-based oncology practices. Understanding the adoption of novel therapies by community hematologists/oncologists (cH/O) is critical to assessing their future utilization and impact on clinical outcomes in the real-world setting. We have assessed CAR-T adoption among cH/O in lymphoma (Gajra et al. Immunotherapy. PMID: 32552151) and with the expansion in number of agents and indications, we sought to assess the evolution of their use of, referrals for, and barriers to CAR-T therapy. Methods: Between January and April 2021, oncologists from across the U.S. were invited to complete a web-based survey about their CAR-T therapy utilization, referral patterns, barriers experienced, and overall impression of this class of therapy. Participant demographics and practice characteristics were also captured in the survey. Participants were not aware of the specific content of the survey as other areas in hematology/oncology were also addressed. Participants were compensated for their participation. Responses were aggregated and analyzed using descriptive statistics. Results: Of the 371 cH/O invited, 100% completed the survey; 63% identified their primary specialty as hematology oncology and 36% medical oncology. The median time in practice was 16 years with a median of 20 patients seen per day on clinic days. The top 3 hematologic malignancies treated by survey participants are CLL, AML, and B-cell NHL. Among the participants, 72% and 53% have referred patients for CAR-T therapy since the first approval and the preceding 6 months respectively; 16% of those who referred in preceding 6 months, reported that none of their referrals ultimately received the CAR-T product infusion. The top 2 barriers impacting timely referral for these participants include a slow approval process by payers (34%) and a slow intake process at the CAR-T center itself (23%). While patient deterioration is a significant challenge to 40% of the participants, other CAR-T center-related challenges perceived by the participants include the CAR-T product not being manufactured, lack of communication from the CAR-T center during the process, and lack of clear instructions to the referring oncologist about follow-up care. Common perceived barriers to prescribing/recommending CAR-T therapy include lack of long-term survival data (14%), therapy-related toxicity (30%), cumbersome logistics of administration (37%), and cost (39%). Among 309 participants queried about cost, 60% feel the price is acceptable for this breakthrough therapy. To facilitate their prescribing/recommendation of CAR-T therapies, the participants agreed that better support to community providers regarding post therapy management, easier referral process to CAR-T centers, timelier approval from payers, and more long-term clinical trial and real-world data are needed. As more CAR-T therapies gain approval and come to market, additional resources requested by the participants included more financial aid/support for patients (59%), more education for prescribing physicians (53%) and patients (29%), more decision support tools (38%), and better coordination and communication between community physicians and sites of care (37%). Conclusions: Most cH/O surveyed have referred patients for CAR-T therapies in hematologic malignancies but there is room for improvement in the referral and intake process as well as the treatment and post-infusion phase. Significant barriers of logistics and cost are potential deterrents to appropriate use. cH/O would welcome additional resources to aid the utilization of CAR-T. These results can inform stakeholders (manufacturers, payers, hospitals, and practices) regarding the need to improve processes and develop payment models to address cost in order to facilitate access of these agents to the appropriate patients. Figure 1 Figure 1. Disclosures Gajra: Cardinal Health: Current Employment, Current equity holder in publicly-traded company. Jeune-Smith: Cardinal Health: Current Employment. Feinberg: Cardinal Health: Current Employment.

Introduction: In August 2019, fedratinib (FEDR) became the second treatment (in addition to ruxolitinib [RUX]) to be approved for intermediate- or high-risk primary or secondary myelofibrosis (MF). No real-world data (RWD) have been presented on demographics, clinical characteristics, and treatment patterns of FEDR for patients receiving FEDR per US label post RUX failure. Methods: Adults with intermediate- or high-risk MF who initiated FEDR on or after August 16, 2019 (FEDR approval date) after discontinuing RUX, with ≤ 90 days of follow-up post FEDR initiation (and having completed ≥1 cycle of FEDR) and who had a spleen size assessment at initiation of FEDR, were identified from community oncology practices in the USA. The patients' treating physicians selected eligible patients and completed electronic case report forms. Providers abstracted patient clinical characteristics at diagnosis and during RUX and FEDR therapy, including bone marrow fibrosis grade, biomarkers, risk score, performance status, spleen size (centimeters above the costal margin), symptoms (listing per the Modified Myelofibrosis Symptom Assessment Form version 4.0), and complete blood count data. Dose, dose modifications (reductions, interruptions, or increases), and dates/rationale for RUX treatment failure per provider report were collected. Primary reasons for RUX failure were designated a priori and included refractory or suboptimal response, disease progression, or intolerance to RUX therapy. Results: For 150 eligible patients, median age at diagnosis was 68 years, 55% of patients were male, 68% were non-Hispanic White, 85% had primary MF, 55% were JAK2 V617F positive, and 9% were JAK2/MPL/CALR negative. Dose at RUX initiation was ≥ 20 mg twice a day (bid) for 50% of patients. At RUX initiation, 65% of patients had ECOG 0/1 scores, and 90% had palpable spleen. Median platelet count was 118 ×10 9/L. Dose reductions during RUX were reported in 13% (n = 19), treatment interruptions in 3%, and dose increases in 12% of patients. Rationale for reductions were neutropenia (7/19), thrombocytopenia (6/19), other (3/19), patient request (2/19), and anemia (1/19). Dose increases were due to titration to therapeutic dose (13/18) and persistent MF symptoms (5/18). Interruptions were due to thrombocytopenia (2/4), neutropenia (1/4), and patient request (1/4). Overall 37% of patients experienced an adverse event while on RUX including thrombocytopenia (25 total; 4 ≥ grade 3), anemia (24 total, 3 ≥ grade 3), fatigue (24 total, 1 ≥ grade 3) and nausea (10 total, 1 ≥ grade 3). Primary rationale for discontinuation of RUX was disease progression (70%), refractory or suboptimal response (25%), and intolerance (5%). Among those with refractory response, providers most commonly reported < 25% reduction of spleen size as the indicator of refractory disease (46%), no improvement in MF symptoms or quality of life (32%), and other reasons (22%). Among patients deemed to have progression as the rationale for RUX discontinuation, the most common reason cited was return of MF symptoms (65%), increase of spleen size to > 50% versus best achieved response (23%), and other reasons (12%). Median duration of RUX was 4.4 (range 1-21) months among refractory or intolerant patients, and 14 (range 2-65) months among those with disease progression. FEDR was initiated at 400 mg bid for 74% of patients. At FEDR initiation, 43.3% of patients had International Prognostic Scoring System (IPSS)/ Dynamic IPSS (DIPSS) High-risk, 36.7% Intermediate (Int)-2 risk, 9.3% Int-1, and 10.0% unknown risk (Table). At initiation of FEDR, 88% of patients had palpable spleen, mean spleen size was 16 cm, and median platelet count was 98 × 10 9/L (Table 1). Symptoms reported at FEDR initiation included fatigue (72%), abdominal discomfort (51%), night sweats (44%), early satiety (25%), bone pain (18%), itching (13%), and pain under the left rib (13%). Dose modifications were observed for 6% of patients while receiving FEDR during follow-up. Conclusions: This study represents the first RWD description of patient characteristics and treatment journey from MF diagnosis through RUX therapy and FEDR treatment. Patients had shorter duration of RUX therapy and had poorer spleen and blood counts at the time of FEDR initiation compared with at initiation of RUX. Patients at risk of early failure of RUX should be considered for earlier intervention with FEDR. Figure 1 Figure 1. Disclosures Harrison: CTI BioPharma: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sierra Oncology: Honoraria; Gilead Sciences: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Shire: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Geron: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Keros: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AOP Orphan Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Promedior: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte Corporation: Speakers Bureau; BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Constellation Pharmaceuticals: Research Funding; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Galacteo: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Mascarenhas: Galecto: Consultancy; Prelude: Consultancy; Geron: Consultancy; PharmaEssentia: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Geron: Consultancy, Research Funding; Genentech/Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kartos: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Constellation: Consultancy, Membership on an entity's Board of Directors or advisory committees; CTI Biopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Forbius: Research Funding; Celgene/BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sierra Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; Promedior: Consultancy, Membership on an entity's Board of Directors or advisory committees; Merus: Research Funding. Abraham: Bristol Myers Squibb: Current Employment. Kee: Bristol Myers Squibb: Current Employment. Nadal: Bristol Myers Squibb: Current Employment. Balanean: Cardinal Health: Current Employment; Georgia State University: Other: former student and employee. McBride: BMS: Current Employment. Kish: Cardinal Health: Current Employment, Current equity holder in publicly-traded company, Research Funding. Liassou: Cardinal Health: Current Employment. Feinberg: Cardinal Health: Current Employment. Gerds: PharmaEssentia Corporation: Consultancy; Novartis: Consultancy; Sierra Oncology: Consultancy; AbbVie: Consultancy; Celgene/Bristol Myers Squibb: Consultancy; Constellation: Consultancy; CTI BioPharma: Research Funding.

Introduction: Relief of symptoms and splenomegaly is an important treatment goal for all patients with myelofibrosis (MF). In August 2019, fedratinib (FEDR) became the second treatment to be approved for intermediate- or high-risk primary or secondary MF. This study sought to describe clinical outcomes (spleen size, and hematologic and MF-specific symptoms) during the initial 6 months of FEDR therapy among real-world patients prescribed FEDR per label in the USA after prior treatment with ruxolitinib (RUX). Methods: Patients with intermediate- or high-risk MF who initiated FEDR on or after August 16, 2019 (FEDR approval date) with ≥ 90 days of follow-up were identified from community oncology practices in the USA. The patients' treating physicians selected eligible patients and completed an electronic case report form. Data collection occurred in February and March 2021. Eligible patients were adults with MF treated with RUX and then FEDR, had spleen palpation conducted at initiation of FEDR, and had completed ≥ 1 cycle of FEDR. Providers abstracted patient clinical characteristics, dose of FEDR, spleen size, a symptom list derived from the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0), platelet count, hemoglobin (Hb), and white blood cell (WBC) count at each provider visit up to the first 6 months of FEDR therapy. Mean spleen size by month and best percentage change in spleen size over follow-up are described (eg, greatest numeric reduction in spleen size at any point compared with at initiation of FEDR). Mean spleen size, symptom count, platelet count, Hb, and WBC count at initiation of FEDR versus 3 months post FEDR, and versus 6 months post FEDR, were compared via paired 2-sided t-test. Proportions (ie, percentage reduction in spleen size and proportion of transfusion-dependent patients) between initiation of FEDR versus 3 and 6 months, respectively, were compared via 1-sided chi-square test. Only patients assessed at initiation (ie, with palpable spleen or complete blood counts available) and with a corresponding assessment at 3 months or 6 months were included in the comparative analysis. P value < 0.05 was considered statistically significant. Results: Data for 150 eligible patients were collected and analyzed. Mean age at time of FEDR initiation was 68 (range, 36-85) years. Median duration of RUX prior to FEDR was 7.6 (range, 0.3-65.5) months; 50% received RUX at a dose ≥ 20 mg twice a day. At FEDR initiation, 43% of patients had International Prognostic Scoring System (IPSS)/Dynamic IPSS High-risk disease, 37% Intermediate (Int)-2 risk, 9% Int-1 risk, and 10% unknown. FEDR was started at 400 mg once a day in 74% of patients. Median time of follow-up post-FEDR initiation was 5 (range, 3-17) months. The median duration of FEDR was 4.4 (range, 3.5-7.0) months. At data cutoff, 55% of patients were still on FEDR. Rationale for discontinuation of FEDR included disease progression (43%), patient choice (19%), allogeneic stem cell transplant (18%), toxicity (6%), persistent symptoms (5%), and other (9%); 44 patients died after discontinuation. The median duration of treatment for patients still on FEDR at data cutoff was 4.9 (range, 3.0-17.3) months versus 4.0 (range, 3.0-10.6) months for patients who had discontinued FEDR prior to data cutoff. At initiation of FEDR, 88% of patients had palpable spleen: mean spleen size was 16.0 (standard deviation [SD], 5.8) cm, which declined to 13.2 (SD, 7.9) cm at 3 months (P = 0.0001) and 7.2 (SD, 7.4) cm at 6 months (P = 0.01) (Table). Mean number of symptoms declined significantly, and mean platelet count increased significantly at 3 and 6 months (Table). Mean best percentage change in spleen size was −29.2% (median, −9.8%) (Figure); complete resolution of palpable spleen occurred in 21% of patients. Conclusions: This study provides some of the first real-world evidence of the effectiveness of FEDR when used post RUX failure in patients with intermediate- or high-risk MF. In this study, FEDR provided statistically significant reductions in spleen size and reported number of MF-related symptoms. A longer duration of FEDR led to greater clinical benefits in relation to these parameters, illustrating the real-world benefit of FEDR when utilized post RUX discontinuation. Figure 1 Figure 1. Disclosures Mascarenhas: Merus: Research Funding; CTI Biopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Geron: Consultancy, Research Funding; Sierra Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech/Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; Forbius: Research Funding; Prelude: Consultancy; Promedior: Consultancy, Membership on an entity's Board of Directors or advisory committees; Geron: Consultancy; Constellation: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene/BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kartos: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Galecto: Consultancy; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; PharmaEssentia: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Gerds: PharmaEssentia Corporation: Consultancy; Novartis: Consultancy; Sierra Oncology: Consultancy; AbbVie: Consultancy; Celgene/Bristol Myers Squibb: Consultancy; Constellation: Consultancy; CTI BioPharma: Research Funding. Kee: Bristol Myers Squibb: Current Employment. Kish: Cardinal Health: Current Employment, Current equity holder in publicly-traded company, Research Funding. Abraham: Bristol Myers Squibb: Current Employment. Balanean: Cardinal Health: Current Employment; Georgia State University: Other: former student and employee. Nadal: Bristol Myers Squibb: Current Employment. Liassou: Cardinal Health: Current Employment. Feinberg: Cardinal Health: Current Employment. McBride: BMS: Current Employment. Harrison: Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sierra Oncology: Honoraria; Incyte Corporation: Speakers Bureau; Shire: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Galacteo: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Keros: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Geron: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Constellation Pharmaceuticals: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; CTI BioPharma: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead Sciences: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AOP Orphan Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Promedior: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Introduction Chimeric antigen receptor T-cell (CAR T) therapy has resulted in a treatment paradigm shift for certain hematologic malignancies, with United States Food and Drug Administration approval of several products for patients with relapsed/refractory (RR) aggressive B cell lymphomas (BCL). Although most BCL patients are initially treated by cH/O physicians, current delivery of CAR T is limited to major academic centers. Consequently, there is a dearth of reporting on the complex aspects of cH/O involvement before and after CAR T therapy administration, which complicates determination of the magnitude of potential benefits. To appropriately incorporate this therapeutic option, and optimize patient care, communication and cooperation between cH/O and the CAR T center is critical; at a minimum, the referring cH/O's access to all aspects of the CAR T therapy continuum is paramount. To that end, this study surveyed cH/O physicians to determine: 1) whether adequate data were recorded and available to the cH/O; 2) timing of referral, leukapheresis, and CAR T infusion; 3) treatment prior to CAR T referral, and 4) physician perceptions on patient eligibility, barriers to access, and noncompliance. Methods This retrospective, observational, multicenter chart review assessed adult patients with RR DLBCL who received CAR T therapy in 2019. Patients with ≥6 months of post-CAR T therapy administration follow-up were identified by cH/O physicians participating in the Cardinal Health Oncology Provider Extended Network (OPEN). cH/O physicians provided their perceptions and experience with CAR T therapy via survey and abstracted patient data using electronic case report forms. Patient demographic/clinical/treatment characteristics and physician perceptions were summarized descriptively. Results Surveyed Perceptions: Top barriers to CAR T referral: patient choice (39%), location of CAR T center (31%), and preference for other therapy (31%); 39% reported no specific barriers. Rapid disease progression (69%) was the main reason patients would not undergo CAR T therapy after referral, followed by patient ineligibility (62%), patient choice (62%), and insurance coverage/patient cost (46%). Chart Abstraction: Data on 65 RR DLBCL patients were collected from 13 cH/O practices in all 4 U.S. regions (Table). Median duration of follow-up from CAR T therapy referral was 15 months. Median age at RR DLBCL diagnosis was 60 years, and most patients were male (63%) and White (79%). Most patients (92%) received anti-CD20 monoclonal antibody (mAb) + CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) as 1L therapy. At referral, 80% of patients (48/60) had lactate dehydrogenase levels above the upper limit of normal. Prior to CAR T infusion, all patients were reported to receive lymphodepletion treatment with fludarabine + cyclophosphamide. Median intervals among patients with and without disease progression, respectively, were: 9 weeks (8 vs 10) from CAR T referral to CAR T infusion, which comprised 5 weeks (4 vs 6) from CAR T referral to leukapheresis and 4 weeks (both groups) from leukapheresis to CAR T infusion. Conclusions The cH/O physicians' perceived barriers to CAR T therapy for their patients appear to conflict with the patient data; 69% thought that rapid disease progression precluded CAR T therapy but the reported 9-week interval from referral to CAR T infusion suggests reasonably timely intervention. This highlights the critical need for early referral with a commitment to prompt patient evaluation by the treatment center. The cH/O physician is vital for CAR T referrals and treatment decisions, and the recent increasing access to patients via telemedicine may help better integrate the cH/O, the patient, and the treatment center to promote access of patients to CAR T cell therapies, particularly when limited other options are available. Figure 1 Figure 1. Disclosures Porter: DeCart: Membership on an entity's Board of Directors or advisory committees; American Society for Transplantation and Cellular Therapy: Honoraria; Incyte: Membership on an entity's Board of Directors or advisory committees; ASH: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Genentech: Current equity holder in publicly-traded company, Ended employment in the past 24 months; Kite/Gilead: Membership on an entity's Board of Directors or advisory committees; National Marrow Donor Program: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees, Patents & Royalties, Research Funding; Tmunity: Patents & Royalties; Wiley and Sons Publishing: Honoraria. Klink: Cardinal Health: Current Employment, Current holder of stock options in a privately-held company. Balanean: Cardinal Health: Current Employment; Georgia State University: Other: former student and employee. McAllister: Cardinal Health: Current Employment. Feinberg: Cardinal Health: Current Employment.

Introduction Gene therapies, defined as the introduction, removal, or change in genetic material into a patient's cells to treat a specific disease, represent a significant advance in medicine, with the potential to cure or significantly improve outcomes of various benign and malignant hematologic disorders (American Society of Gene Therapy). Gene therapies have received approvals for subsets of patients with spinal muscular atrophy or retinal dystrophy, and almost a thousand studies are actively recruiting patients for various gene therapy trials. Aside from CAR-T therapies, several gene therapies are in advanced clinical development in the U.S. for disorders such as hemophilia, hemoglobinopathies, and congenital immunodeficiency syndromes. Results of many such trials were presented at the 2020 ASH annual meeting. While approvals for some gene therapy products are expected in the near future, the complexity of treatment, knowledge gaps among providers, or barriers with accessibility or cost may limit the integration of these treatments into routine clinical practice. Therefore, the present study surveyed U.S.-based community oncologists/hematologists (cO/H) to evaluate their perceptions of the utility of gene therapies and barriers to adoption or integration into clinical practice. Methods Between February and April 2021, cO/H from across the U.S. were invited to complete a web-based survey about gene therapies. Physician demographics and practice characteristics were also captured in the survey. Responses were aggregated and analyzed using descriptive statistics. Results A total of 369 cO/H completed the survey; 36% identified as a medical oncologist and 63% as a hematologist/oncologist. cO/H had an average of 19 years of clinical experience and spent an average of 86% of their working time in direct patient care and saw an average of 17 patients per day on clinic days. Half of cO/H stated that they were not aware of recent data of gene therapies for adult hematology/oncology indications (35% "not very aware"; 15% "not at all aware"). When asked to report the number of approved gene therapy products (excluding CAR-T products) in the U.S. in early 2021, 27% of participants reported 0, 24% reported 1, and 20% reported 2 products were currently available. Regarding gene therapy use for adult hematologic/oncologic indications in the next 2 years, 53% of cO/H reported that they expect gene therapies to mostly be administered and managed by academic centers to which they will refer their patients; 27% reported that indications will be limited and unlikely to affect their practice (Table 1). cO/H perceived cost as the greatest barrier to adopting gene therapies into their clinical practice; specifically, cO/H cited cost limitations by payers (49%), the prohibitive cost to patients (46%), and the prohibitive cost to practices/hospitals (37%). Other barriers to adoption were limited real-world efficacy data (18%) and long-term complications (13%). Most cO/H reported a moderate (39%) or high (43%) comfort level with prescribing a gene therapy for adult hematology/oncology indications if it were reimbursed. Conclusions Many cO/H were not aware of recent data of gene therapy products, with over half expecting to refer their patients to large academic centers for gene therapies. While most cO/H would be comfortable prescribing gene therapies for their patients, cost was perceived as prohibitive. This information can inform various stakeholders, including patients, advocacy groups, pharmaceutical manufacturers, payers, and professional societies, in laying the foundations for gene therapy products in hematology. Future work should focus on enhancing education of gene therapy products to community providers as well as identifying support programs that lessen the burden of cost. Figure 1 Figure 1. Disclosures Gajra: Cardinal Health: Current Employment, Current equity holder in publicly-traded company. Fortier: Cardinal Health: Current Employment. Jeune-Smith: Cardinal Health: Current Employment. Feinberg: Cardinal Health: Current Employment.

45 Background: The COVID-19 pandemic has adversely impacted healthcare workers globally, leading to high rates of burnout, especially among frontline workers. We conducted a study to assess the pandemic’s impact on community-based medical oncologists and hematologists (mO/H) in the U.S. before the widespread distribution of vaccines. Methods: Between October and December 2020, mO/H participated in a compensated, online survey addressing the impact of COVID-19 on oncologists’ professional and personal lives and other issues in oncology; demographic, clinical, and practice-based questions were also asked. Results are presented using descriptive statistics. Results: A total of 259 geographically diverse mO/H, with a median of 18 (1-42) years in practice, completed the survey. At the time of the study, local trends in COVID-19 cases were reported as increasing, stable, or decreasing by 29%, 51%, and 20%, respectively. The summative view of the pandemic was “proud of my work as a physician in the frontlines” (37%), “a challenge to get through” (35%), and “no significant impact” (23%). Over half reported a moderate to severe impact on their professional (60%) and personal lives (65). The top 3 factors adversely impacting professional life were: concern of transmitting COVID-19 to patients or staff (52%), difficulty providing patient care (45%), and loss of income (41%). The top 4 factors adversely impacting personal life were: concerns of safety for self and family (84%), a sense of anxiety (50%), loss of family income (24%), and a sense of depression/doom (22%). Fifty percent agreed or strongly agreed that they had increased burnout at work since the beginning of the pandemic. However, workload was assessed as stable (51%) or reduced (33%) during the pandemic. The top 3 factors contributing to burnout were: loss of face-to-face patient interaction (46%), financial loss by practice (42%), and reduced patient volume (35%). The factors thought to impact income were: use of virtual patients visits (38%), pay cuts from the employer (33%), and cancellation of elective procedures (31%). Overall, 41% reported receiving funds from government-based programs (e.g., CARES act) during the pandemic. While about half (52%) did not believe that the pandemic would impact their retirement, some felt that the pandemic would likely hasten (17%) or delay (17%) their plans to retire. Conclusions: This study confirms greater feelings of burnout among U.S. community-based mO/H in the wake of the pandemic and offers insight into drivers of professional and personal dissatisfaction. While mO/H have concerns about loss of income, notably, loss of in-person patient interaction is also a key factor impacting their professional satisfaction. Given the high baseline rate of burnout among mO/H, it is critical to prevent, mitigate and control additional risks imposed by pandemic-related factors.

285 Background: The COVID-19 pandemic has dramatically impacted access to and delivery of healthcare in the U.S. At the height of the pandemic, many practices began initiating or increasing telemed visits to meet care demands in a quarantined environment. The objective of this descriptive study was to assess mO/H perceptions of benefits and barriers to current and post-pandemic use of telemed in oncology. Methods: Web-based surveys were fielded to mO/H before virtual meetings held between September and November 2020. Participants submitted their demographic information and responses to questions about pandemic impacts on their practice and patients. Responses were aggregated and analyzed using descriptive statistics. Results: A total of 259 mO/H across the U.S. completed the survey; 73% practice in a community setting; 44% identify as hospital employees. The participants spend a median of 90% of their working time in direct patient care, have a median of 18 years of clinical experience, and see a median of 20 patients per day on clinic days. Before the pandemic, 92% of the participants’ practices had telemed capabilities but of those, 77% were not utilizing telemed for any visits. During the pandemic, almost all the participants’ practices were offering telemed, with 97% reporting some patient visits being conducted via telemed. Most (78%) anticipate continuing to offer or conduct some patient visits via telemed. Two-thirds stated that up to 25% of their patient visits could be converted to telemed outside of a pandemic environment. The types of visits that most believe are suitable for telemed include reviewing test/lab results, routine surveillance of chronic conditions, and survivorship care visits. Most (60%) stated that their patients view telemed favorably. About half reported a positive overall experience with telemed, with 47% reporting a better-than-expected experience. Most (79%) estimated that pivoting to telemed equates to a revenue loss of up to 50% for that visit; 53% feel that telemed has had an overall negative financial impact on their practice. Two-thirds have experienced challenges getting reimbursed for telemed claims. The most common challenges with telemed reported were reluctance or inability of patients to participate in telemed (39%) and technology challenges (37%). The most common benefit of telemed reported was safety, i.e., less potential exposure to COVID-19 for providers and staff (65%). Conclusions: Telemed use was infrequent before the pandemic, but utilization has dramatically increased during the pandemic. Despite favorable experiences with telemed, mO/H expect telemed use to decline significantly post-pandemic. This prediction may be driven by the perceived loss of revenue when an in-person visit is converted to telemed visit. Further research is needed in identifying factors that may allow for the long-term adoption of telemed for appropriate patients.

70 Background: The enactment of the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015 initiated the transition from a fee-for-service to a fee-for-value payment system in healthcare. Two government-sponsored VBC models (Oncology Care Model [OCM] and Merit-Based Incentive Payment System [MIPS]) were introduced in 2016 and 2017. Several commercial payers followed suit with similar value-based contracts. Implementing and complying with the performance metrics of these models comes with challenges. This qualitative research study sought to assess participation in both government-sponsored and commercial-insurance-sponsored VBC models among oncology providers and their perceptions regarding the ability to perform successfully. Methods: Between February and April 2021, medical oncologists/hematologists (mO/H) from across the U.S. were invited to complete a web-based survey about various trends and critical issues in oncology care. Demographics about the physicians and characteristics of their practices were captured as well in the survey. Responses were aggregated and analyzed using descriptive statistics. Results: A total of 307 mO/H across the U.S. completed the survey: 73% practice in a community setting; 47% identify as hospital employees. The participants spend a median of 90% of their working time in direct patient care, have a median of 16 years of clinical experience, and see a median of 20 patients per day on clinic days. Half participate in a government-sponsored VBC model (21% MIPS and 28% OCM), and 20% participate in a commercial VBC model. A third reported that it is difficult to perform favorably in VBC models (37% government and 35% commercial). Primary challenges deterring favorable performance were navigating the payer landscape and reimbursements (27%), identifying cost-reduction opportunities (20%), tracking costs across an episode (18%), and clinical decision support and compliance (17%). One-third are not satisfied with currently available technology to effectively support their performance in VBC models. Almost half would like to see more seamless integration into practice workflows (49%) and interoperability across platforms including EHRs (42%), and 24% would like artificial intelligence or machine learning features integrated into solutions tools. Conclusions: Oncology practices find it challenging to perform favorably in government and private payer-sponsored VBC models. They are generally dissatisfied with current technology and see an unmet need for interoperability and artificial intelligence to better support their performance in these programs. Further research is needed to determine how best to design and implement VBC programs.

141 Background: Oncologists interacting with PCEM may be unaware of RA/IB, yet data show lower-quality care. Helping oncologists recognize this may improve quality of patient-provider interaction, care, and outcomes. We conducted a descriptive study of medical/hematologic oncologists to assess perceptions of RA/IB impact on PCEM interaction. Methods: From February to April 2021, U.S.-based medical/hematologic oncologists participated in an online survey of perceptions on cancer care and outcomes in PCEM (part of broader survey of various clinical and practice-related concerns). Questions used a modified 5-point Likert scale with an option of declining to answer, and respondents were aware data would be anonymized and aggregated. Results: Among 369 physicians surveyed, median years in practice were 17 (range 2-49). Most (72.4%) were in community settings; 64.0% were age 40 to 59 years; 20.6% identified as female, 70.5% male, and 8.7% declined to disclose. Racial distribution was 32.0% White, 33.1% Asian, 7.0% Black, 4.1% Hispanic/Latinx, and 18.7% declined to disclose. When asked the degree of RA/IB White providers had toward PCEM, 39.6% chose low/none, 33.3% moderate, 14.9% high/very high, and 12.2% declined. When asked whether RA/IB among White providers adversely affects PCEM, 37.1% somewhat/strongly agreed, 29.3% somewhat/strongly disagreed, 23.6% neither agreed nor disagreed, and 10.0% declined. Also, 7.9% declined to estimate percent of non-White patients managed. Perceived frequency of scenarios involving RA/IB impacting PCEM interaction at their practices was also assessed (Table). Notably, 12.0% to 14.0% declined to answer regarding their own practices. Although most oncologists (76.4%) perceived RA/IB among White providers toward PCEM, only 37.1% agreed it had adverse effects. Conclusions: Discrepancy in perception of RA/IB among White providers and its effect on PCEM suggests a need to show causality, and declining to respond suggests mistrust/apprehension in expressing true views. Findings suggest oncologists may benefit from improved education and awareness regarding RA/IB in PCEM interaction, treatment, and outcomes. Provider responses (N=369).[Table: see text]

318 Background: EMRs are devised to improve the quality and efficiency of healthcare delivery and to reduce medical errors. Despite the widespread use of EMRs, various factors can limit their effectiveness in improving healthcare quality. General EMR use has been cited as a factor contributing to increased workload and clinician burnout in oncology and other specialties. The objective of this qualitative research study was to identify barriers perceived by medical oncologists and hematologists (mO/H) in utilizing EMR software and factors associated with levels of satisfaction. Methods: Between January and April 2021, mO/H from across the U.S. were invited to complete a web-based survey about various trends and critical issues in oncology care. Demographics about the physicians and characteristics of their practices were captured as well in the survey. Responses were aggregated and analyzed using descriptive statistics. Results: A total of 369 mO/H completed the survey: 72% practice in a community setting; 47% identified as a hospital employee; they have an average of 19 years of clinical experience and spend on average 86% of their working time in direct patient care, seeing 17 patients per day on average on clinic days. Most (99%) of mO/H surveyed use an EMR software at their practice, with Epic (45%) and OncoEMR (16%) being the most common. Regarding satisfaction, 16% and 50% reported feeling highly satisfied and satisfied, respectively, with their current EMR, and 3% and 11% reported feeling very dissatisfied or dissatisfied, respectively. Some (19%) stated that they have considered changing their EMR, and 68% are unsure how EMR licensing fees for their practice are paid. EMR pain points most commonly experienced were: time-consuming, e.g., too many steps/click (70%); interoperability, e.g., difficulty sharing information across institutions or other EMR software (45%); data entry issues, e.g., difficulty entering clinical information, scheduling patient visits and reminders, or ordering multiple labs (38%); and poor workflow support (31%). The most useful aspects/features of their EMR software reported were availability of information, e.g., preloaded protocols, chemotherapy regimens and pathways (64%); data access (64%); and multiple access points, including remote access (37%). Conclusions: Satisfaction with EMR were generally positive among the mO/H surveyed. However, there are multiple deterrents to the efficient use of current EMR systems. This information is essential in the design of next-generation EMR (an Intelligent Medical Records system) to allow for incorporation of aspects most useful to the end-users, such as pathway access, preloaded information on cancer management as well as ease of access and portability, and a user experience that minimizes clicks and reduces physician time with EMR.

The ASCO Value Framework, National Comprehensive Cancer Network Evidence Blocks, Memorial Sloan Kettering’s DrugAbacus, and Institute for Clinical and Economic Review incremental cost-effectiveness ratio calculator are value-based methodologies that attempt to address the disproportionate increase in cancer care spending. These calculators can be used as an initial step for discussing cost versus value, but they fall short in recognizing the importance of the cancer journey because they do not fully factor the patient’s perspective or the global cost of care. This timely review highlights both the limitations and the advantages of each value calculator and suggests opportunities for refinement. Practicing oncologists, payers, and manufacturers should be familiar with value-based calculators because the role these tools play in cost containment is likely to be hotly debated.

Background Palbociclib was approved in the U.S. in February 2015 for the treatment of advanced/metastatic breast cancer (MBC) in combination with letrozole as initial endocrine based therapy for post-menopausal women with ER+/HER2- disease. We examined the demographic, clinical characteristics and treatment patterns of patients initiating palbociclib (PAL) + letrozole (LET) in real-world, community oncology practices. Methods This was a retrospective observational study of female breast cancer patients identified in the Navigating Cancer (NC) EMR database. The NC database collects EMR data, in both structured and unstructured fields (patient/clinical progress notes), from over 975 oncology and hematology providers across more than 50 locations in 25 states. Female patients with record of treatment with PAL after 01/31/2015 were selected. Combination treatment with LET was defined as having a record for LET within 30 days of the PAL prescription. Line of therapy (LOT) was assessed from the date of metastatic diagnosis and assigned by evaluating treatment plans pre-and post PAL initiation. Bi-monthly cohorts were constructed based on the month of initiation of PAL from 02/01/2015-01/31/2016. Interim results are presented; data from an additional three months of follow-up (through 03/31/2016) are pending. Results Overall, 931 unique patients were identified as having initiated PAL treatment. Of those, 608 (65.3%) received PAL + LET. Mean follow-up was relatively short at 5.4 mo (SD=3.5). Confirmed ER+/HER2- was observed in 71.6% of patients and 50.3% were age ≥65, mean age was 64.3 yrs. Of patients with available ECOG-PS at treatment initiation (n=424): 0/1=78.5%, 2=17.5% and 3=4.0%. Of patients with a known starting dose (n=418), 69.9% initiated with PAL 125mg, 22.0% at 100mg and 8.1% at 75mg. Compared to women < 65, women ≥ 65 were more often started with 100mg (25.4% vs. 18.9%) and 75mg (10.0% vs 6.5%). Any dose reductions were observed in 20.6% of patients (21.5% of patients receiving 125mg). During the year following approval, 39.8% of patients initiated PAL + LET at LOT1, 15.6% at LOT2, 13.0% at LOT3 and 31.6% at LOT4+, following MBC diagnosis. Over time the proportion of late use (LOT4+) declined from 39.7% in Feb/Mar '15 to 23.9% in Dec '15/Jan '16 with more patients utilizing in LOT3 (from 7.9% in Feb/Mar '15 to 19.5% in Dec '15/Jan '16). Number of Patients Initiating PAL + LET by LOT and Month. AllFeb/Mar '15Apr/May '15Jun/Jul '15Aug/Sep '15Oct/Nov '15Dec'15/Jan '16N (%)608(100)63(10.4)108(17.8)125(20.6)108(17.8)91(14.5)113(18.6)LOT1 (%)242(39.8)23(36.5)45(41.7)53(42.4)45(41.7)33(36.3)43(38.1)LOT2 (%)95(15.6)10(15.9)12(11.1)19(15.2)15(13.9)18(19.8)21(18.6)LOT3 (%)79(13.0)5(7.9)10(9.3)18(14.4)12(11.1)12(13.2)22(19.5)LOT4+ (%)192(31.6)25(39.7)41(38.0)35(28.0)36(33.3)28(30.8)27(23.9) Conclusions There was a trend toward earlier utilization of PAL + LET from Feb-Jul '15, an increase in later use during Aug/Sep '15, and a return towards earlier use in subsequent cohorts reaching the lowest proportion of LOT 4+ use observed in Dec '15/Jan '16. After a mean follow-up of 5.4 mo, 21.5% of patients receiving the 125 mg dose had a dose reduction. Final results, with additional follow-up, will be presented at conference. Citation Format: Kish JK, Ward MA, Garofalo D, Ahmed HV, McRoy L, Laney J, Zanotti G, Yu H-T, Feinberg BA. Early utilization pattern of palbociclib 1 year post-approval in the United States [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-16-05.