Background/Objectives: Young women with breast cancer (aged ≤ 40 years) have distinct prognostic characteristics, yet little is known about how modifiable body composition factors influence outcomes in this age group. This study examined whether CT-derived body composition measures could identify thresholds that predict overall survival (OS). Methods: This was a single-center, 10-year, matched case–control study nested within a cohort, utilizing retrospectively collected data. Using an institutional database (2009–2018) and the initial cohort of 112 patients, we performed a subset analysis of patients with stage I–III breast cancer at diagnosis who had available pretreatment CT scans to estimate associations with body composition metrics and OS. The final analytic dataset included 89 individuals (49 survivors and 40 deceased). CT scans at the L3 level were analyzed using Slice-O-Matic software to quantify visceral (VAT), subcutaneous (SAT), intermuscular (IMAT), total adipose tissue (TAT), skeletal muscle density (SMD), skeletal muscle gauge (SMG), and skeletal muscle index (SMI). Cox proportional hazard models determined optimal cutpoints for OS. Multivariable models included adjustments for disease stage and hormone receptor status. Results: The median age was 35 (IQR, 32–38); 47% were White and 37% were Black. The majority (78%) were not Hispanic or Latina. Most (67%) were overweight/obese. Specific thresholds for IMAT index (>2.57), VAT (>31.38), and SMG (<2419.89) were associated with worse survival (all p < 0.05), while no cutpoints were identified for other variables. Conclusions: These findings show that muscle fat infiltration and reduced muscle quality have important prognostic value in young women with breast cancer. Exploratory cutpoints derived from routine staging CT scans may help inform risk stratification and generate hypotheses for targeted nutritional or exercise interventions, but require validation in larger, independent cohorts before clinical application.

CONTEXT:Palliative care (PC) and end-of-life (EOL) care utilization for adults of dharmic religions (DR; Hinduism, Buddhism, Sikhism, and Jainism) with cancer in the US is unknown. OBJECTIVES:To measure PC utilization and EOL outcomes among hospitalized DR adults with cancer METHODS: We reviewed electronic health record (EHR) data for PC utilization and National Quality Framework (NQF)-endorsed EOL metrics at a dedicated cancer hospital and interviewed hospitalized DR patients and chaplains. RESULTS:Of 54,828 hospitalized adults, DR individuals (2.1% of study population) had higher PC utilization compared to non-DR (NDR) individuals (14.6% vs. 11.8%; P = 0.004). In multivariate analysis, advanced illness (OR 18.57) was the strongest predictor of PC utilization. Compared to NDR individuals, DR individuals had higher inpatient deaths (27% vs. 12%; P < 0.001), hospice enrollment ≤3 days before death (5% vs. 2%; P = 0.021), chemotherapy use ≤ 14 days before death (11% vs. 8%; P < 0.001), and ICU care ≤ 30 days before death (12% vs. 5%; P < 0.001). Qualitative findings highlighted DR preferences for Ayurveda and dietary practices, the role of beliefs in coping with a cancer diagnosis, inconsistent communication of EOL preferences, and opportunities to improve care. CONCLUSION:For DR adults with cancer, PC is triggered by higher acute care utilization at the EOL. Interviews uncovered unmet socio-cultural needs. To improve outcomes, medical oncology and PC teams need to proactively address values across the cancer trajectory.

e24063 Background: Unintentional weight loss is common in people with pancreatic cancer and predicts poor outcomes. This study characterized temporal patterns of weight change following a pancreatic cancer diagnosis in a large, diverse patient population in a community oncology setting. Methods: Adults diagnosed with stage I–IV pancreatic cancer from 2020–2024 were identified from an internal registry. Longitudinal weights from six months prior to and 18 months after diagnosis were extracted from electronic medical records (EPIC). Among 635 eligible patients, 402 had baseline weights within one week of diagnosis. Percent weight change from diagnosis was modeled with separate pre- and post-diagnosis slopes, adjusted for age, sex, and stage, with patient-level random effects. Kaplan-Meier methods estimated length of follow-up and landmark overall survival. P<0.05 was considered statistically significant. Results: Median age was 69 (range 34-93) years; 48% were female, 71% White and non- Hispanic/Latino (98%). 52% had stage IV disease. Weight declined by 0.57% (95% CI, −0.64 to −0.49) per week before diagnosis and 0.28% (95% CI, −0.32 to −0.22) per week after diagnosis. Mean cumulative change was +14.7% (95% CI, +12.9% to +16.5%) at six months pre-diagnosis, +7.3% (95% CI, +6.5% to +8.2%) at 3 months pre-diagnosis, -3.6% (95% CI, -4.2% to -2.9%) at 3 months post-diagnosis, -7.1% (95% CI, -8.4% to -5.9%) at 6 months post-diagnosis, and -14.3% (95% CI, -16.7% to -11.9%) at 12 months post-diagnosis. Median follow-up was 19.6 months; 225 deaths (56%) occurred. One- and two-year survival rates were 0.53 and 0.34, respectively. Conclusions: Weight loss began up to six months before diagnosis and persisted afterward, averaging a 14% reduction within a year. These findings highlight the need for nutritional intervention at diagnosis and demonstrates the value of consistent and longitudinal weight management to identify at risk for future severe weight loss.

INTRODUCTION Distress negatively affects cancer outcomes. The National Comprehensive Cancer Network (NCCN) recommends screening patients for distress by a self-reported scale (0-10) and to refer those with scores ≥ 4 to supportive services (SS). Little is known about the prevalence of distress and healthcare utilization in classical Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs): polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF). METHODS We retrospectively identified MPN patients at our center to measure the proportions of patients with distress ≥ 4 evaluated by a SS [chaplaincy, integrative oncology, palliative medicine, psychiatry, psychology, and social work (SW)] or had acute care utilization (ACU; ≥ 1 ED visit or hospitalization) within six months of electronic distress screening (EDS). We also obtained sociodemographic, disease characteristics, and symptom score data to stratify variables associated with distress. RESULTS Among 141 patients (44 PV, 49 ET, 48 MF), the median age was 63 years (range, 25-89). Most patients identified as female (62%), White (77%), and completed EDS within three months of diagnosis (55%). Of 75/141 (53%) who reported distress ≥ 4, only 25/75 (33%) were evaluated by SS, and 23/75 (31%) had ACU within six months of EDS. Patients with distress ≥ 4 evaluated by SS had significantly higher ACU (48% vs. 14%; p=0.009). Distress was associated with higher symptom scores and more ED visits but not gender, race, ethnicity, diagnosis, relationship status, or insurance. CONCLUSION Despite consensus recommendations, most patients with distress ≥ 4 were not evaluated by SS. Future work should identify ways to better use patient-reported outcomes to promote early intervention.

We evaluated the prognostic value of circulating tumor cell (CTC) counts and androgen receptor splice variant 7 (AR-V7) status at baseline and after docetaxel in the previously published ENZADA trial. We analyzed data for 35 participants with both baseline and postdocetaxel CTC counts. CTC count status at two thresholds (≥2 vs <2 cells/μl; ≥3 vs <3 cells/μl) was not prognostic for a 26-wk or 52-wk prostate-specific antigen (PSA) complete response (CR), overall survival (OS), or time to castration resistance (TTCR). CTC count status (>0 vs 0 cells/μl) after docetaxel was not associated with 26-wk PSA CR, OS, or TTCR. However, there was a trend towards a higher 52-wk PSA CR rate among those with detectable CTCs after docetaxel (92% vs 52%; p = 0.03). A binary variable indicating the change in CTC level (increased or remained stable/decreased) from baseline after docetaxel was also not associated with OS, TTCR, or landmark 26-wk or 52-wk PSA CR rates. However, in the group with 52-wk PSA CR data, a rise in postdocetaxel CTC level was associated with shorter TTCR (hazard ratio [HR] 9.8, 95% confidence interval [CI] 1.1–88.1) and a trend towards shorter OS (HR 7.3, 95% CI 0.76–70.6). AR-V7 was only detected in one patient at each time point. The CTC count was not prognostic for patients with metastatic hormone-sensitive prostate cancer treated with chemohormonal therapy in this small cohort, although a rise in CTC count after docetaxel may identify patients at high risk of progression among those with a PSA CR. Patient summary: For men with metastatic prostate cancer treated with hormone therapies and chemotherapy, we looked at whether the level of tumor cells circulating in the blood (CTCs) was associated with the PSA (prostate-specific antigen) response and survival time. The CTC level was checked before treatment and after six doses of chemotherapy. We found no association with prostate cancer outcomes. However, in the group of patients whose PSA became undetectable after treatment, a CTC increase after chemotherapy identified men with a higher risk of cancer progression and death.

Introduction: Primary central nervous system lymphoma (PCNSL) is a rare non-Hodgkin lymphoma with a high relapse risk in the absence of high-dose methotrexate (HDMTX)-based induction and subsequent consolidation therapy. Autologous stem cell transplantation (ASCT) and whole brain radiation therapy (WBRT) are two well-studied consolidation options and are associated with superior overall survival than no consolidation. We aim to describe the treatment patterns and outcomes of PCNSL treated with HDMTX-based regimens in a real-world setting. Methods: This retrospective study was approved by the Wake Forest School of Medicine IRB. Patients with newly diagnosed PCNSL with diffuse large B-cell lymphoma histology, and received HDMTX-based induction chemotherapy for at least 1 cycle at Levine Cancer Institute or Wake Forest Baptist Comprehensive Cancer Center between 3/1/2022 and 11/1/2024, were included. We collected information including patient demographics, baseline characteristics, comorbidities, timing of initiation of induction, HDMTX dosing, response to induction, choice of consolidation, and reasons for not receiving consolidative ASCT. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier methods and stratified by ASCT status (ASCT vs non-ASCT), treatment delay from clinical presentation (≤ 4 vs > 4 weeks from presentation to start of HDMTX), treatment delay from diagnosis (≤ 7 vs > 7 days from diagnosis to start of HDMTX), and induction regimen (MTX+R vs MTX+R+ additional chemotherapy). Log-rank tests were used to compare strata and univariate Cox proportional hazards models estimated hazards of time from presentation to MTX initiation and time from diagnosis to MTX initiation as continuous variables of days. Results: Forty-one patients met inclusion criteria. Median age was 67 years (range, 32-81), 22 (54%) were female, and 7 (18%) were racial minority or Hispanic ethnicity. Chronic renal, cardiac and pulmonary dysfunction were each seen in 12%. The median time from clinical presentation to initiation of HDMTX was 29 days, and from diagnosis to initiation was 7 days. During induction, 59% received HDMTX+rituximab (R), 39% received HDMTX+R+additional (A) chemotherapy such as temozolomide (MTR) (15%) and cytarabine/thiotepa (MATRix) (15%). The median dose of HDMTX was 3.5 g/m2, 29% received a dose >3.5 g/m2. The overall response rate to induction was 80% (75% with HDMTX+R; 94% with HDMTX+R+A). Nine (22%) patients received ASCT. Thiotepa (TT)/BCNU was used for conditioning in 8 patients, and TT/Busulfan/Cyclophosphamide in 1. Compared with non-ASCT patients, more ASCT patients were female (89% v 44%; p=0.02). Between ASCT and non-ASCT patients, overall response rate (100% vs 75%, p=0.16) and complete remission rate (56% vs 38%, p=0.45) to induction were not statistically different. No other statistically significant difference, including age, was observed between ASCT and non-ASCT patients. Reasons for not receiving ASCT (not mutually exclusive) included induction failure (n=8, 31%), patient refusal (n=7, 27%), advanced age (n=4, 15%), challenging comorbidities (n=6, 23%) or performance status (n=6, 23%); two (6%) received WBRT. Median follow up was 20.1 months. Fourteen (33%) deaths and 15 (37%) PFS events were observed. All 9 ASCT recipients remained alive and progression free with a median follow up of 20.1 months (range, 7.7-34.9), one WBRT recipient remained alive and progression free at 7.6 months, whereas the other died from progression at 11 months. Those who did not receive ASCT had a median PFS and OS of 15.8 and 34.5 months, significantly shorter than ASCT recipients (p=0.020 and p=0.021, respectively). No significant associations were observed between dichotomized time from presentation or diagnosis to initiation of MTX in both PFS (p=0.16 and p=0.98, respectively) and OS (p=0.23 and p=0.98, respectively). Moreover, differences in PFS or OS were not observed when the times from diagnosis or presentation to HDMTX were tested as continuous variables. Further, the choice of MTX-based combination therapy did not significantly impact PFS or OS (p=0.47 and p=0.55, respectively). Conclusion: HDMTX-based induction chemotherapy is effective in patients with PCNSL, even in those with delayed diagnosis or initiation of therapy. Although a minority of patients received consolidation with ASCT, it was associated with 100% progression-free survival.

Introduction: Autologous stem cell transplant (ASCT) is widely accepted as the standard consolidation therapy for primary CNS lymphoma (PCNSL) in first remission, with whole brain radiation therapy (WBRT) used in selected cases. However, older and frail patients with PCNSL often cannot tolerate ASCT or WBRT due to increased risk of treatment-related toxicities, such as infections and neurocognitive impairment. Without consolidation, survival outcomes are poor, with a median progression free survival (PFS) ranging from 10 to 20 months. Therefore, novel therapeutic approaches are needed for older PCNSL patients. Nivolumab, an anti-PD1 antibody, has demonstrated promising activity in relapsed or refractory PCNSL, and we hypothesized that adding nivolumab in the frontline setting would be safe and improve survival in older PCNSL patients who are ineligible for ASCT or WBRT. Methods: In this multicenter phase 1/1B study (NCT 04022980), patients aged ≥ 65 with previously untreated PCNSL received up to 6 cycles of nivolumab consolidation after receiving at least 3 cycles of high-dose methotrexate (HD-MTX)-containing induction chemotherapy. Patients with systemic lymphoma or known ocular involvement were excluded. Stage 1 aimed to evaluate the safety of nivolumab consolidation following HD-MTX-containing induction chemotherapy. A 3+3 design was used for the safety run-in, enrolling 6 patients on nivolumab at the FDA-approved single-agent dose and monitoring for dose-limiting toxicities (DLTs) during Cycle 1. Stage 2 assessed the efficacy of nivolumab consolidation based on 2-year PFS. Neurological function was evaluated at baseline and throughout the study follow-up using the Neurologic Assessment in Neuro-Oncology (NANO) scale. Kaplan-Meier methods were used to estimate overall survival (OS) and PFS, with both time-to-event endpoints calculated from the initiation of nivolumab consolidation therapy. Results: Fourteen patients were enrolled across four U.S. sites between April 2020 and December 2022. The median age was 72 years (range 65-79), 71% were female, and 36% had an ECOG score of 2-3 at enrollment. Induction chemotherapy regimens included 36% R-MPV (rituximab, methotrexate, procarbazine, and vincristine), 21% MRT (methotrexate, rituximab, and temozolomide), 21% MR (methotrexate and rituximab), and 7% MATRix (methotrexate, cytarabine, thiotepa, and rituximab). Following induction chemotherapy, 64% achieved a complete response (CR), 29% achieved a partial response (PR), and 7% had a stable disease (SD). Patients received a median of 6 nivolumab cycles (range 1 – 6). No DLTs occurred during Cycle 1 of nivolumab in Stage 1. The most common grade ≥ 3 adverse events (AEs) were neutropenia (14%) and fatigue (7%). One patient developed grade 4 Stevens-Johnson syndrome, leading to treatment discontinuation after Cycle 1. Among those receiving ≥ 1 cycle of nivolumab consolidation, the overall response rate was 86%, with a CR rate of 79%. Three patients improved from PR or SD post-induction to CR after nivolumab consolidation. At a median follow-up duration of 33 months, median OS and PFS were not reached. The 2-year OS and PFS rates were 79% and 63%, respectively. All deaths (3/3) were due to disease progression. Two patients were found to have active lymphoma during or immediately after Cycle 1 and were subsequently discontinued from the trial. In one case, intraocular involvement was diagnosed during Cycle 1, likely undetected at screening due to its occult presentation. Eleven patients completed all planned cycles of nivolumab consolidation, and 73% remain in remission at the last follow-up. Conclusion: This study demonstrates favorable safety and clinical outcomes with nivolumab consolidation in older PCNSL patients unsuitable for ASCT or WBRT. No DLTs were observed during the safety run-in phase, and there were no unexpected toxicities associated with nivolumab, although one early discontinuation occurred due to Stevens-Johnson syndrome, a rare but known AE of nivolumab. Overall, the absence of DLTs and encouraging survival outcomes support further investigation. Ongoing analyses aim to identify predictive biomarkers, including 9p24.1 and 6p21.3 amplifications, that may correlate with response to nivolumab in PCNSL. Additionally, NANO assessments are being analyzed to measure neurological changes in this population.

BACKGROUND:Spiritual care provided by chaplains plays a key role in cancer care in the United States, yet little is known about chaplaincy utilization among people of Dharmic religions (Hinduism, Buddhism, Sikhism, Jainism) with cancer. METHODS:This multi-methods study reviewed the records of patients (aged 18 years and older) who were hospitalized at a dedicated cancer hospital (2015-2019) and conducted interviews with chaplains and adults of Dharmic religions (2020). Primary outcomes included measuring chaplaincy utilization (at least one chaplain visit) across different religions and identifying perceptions of chaplaincy. Secondary outcomes involved measuring unmet spiritual needs on admission, types of spiritual care needs, and variables associated with chaplaincy utilization. RESULTS:Of 54,828 patients, 2% were of Dharmic religions (n = 1163; 58.4% Hindu, 33.2% Buddhist, 4.8% Sikh, 3.4% multiple, <1% Jain). Compared with others, those of Dharmic religions were younger (median age, 59 vs. 63 years; p < .001), predominantly East or South Asian (78.7% vs. 5.6%; p < .001), and had higher rates of advanced illness (22.6% vs. 15.2%; p < .001) but lower chaplaincy utilization (31.6% vs. 36.7%; p < .001). There were no significant differences in unmet spiritual needs on admission (Dharmic religions vs. others, 8.7% vs. 9.4%; p = .41). Ritual care was the most frequently documented spiritual care need (72%). Multivariable analysis indicated that longer length of stay, non-Dharmic religion, and advanced illness were associated with higher chaplaincy utilization. Themes identified from the interviews included unfamiliarity with chaplaincy, concerns about faith-discordant care, addressing spiritual care needs independently, and solutions for concordant care. CONCLUSIONS:People of Dharmic religions with cancer were less likely to use chaplaincy services. Barriers included unfamiliarity and faith discordance. Spiritual care incorporating faith-specific resources is urgently needed.

Young women constitute a special subpopulation of breast cancer patients with distinct tumor characteristics, prognosis, and survivorship considerations. Information on modifiable risk factors, including body composition measures specific to young women, is limited and often differs from older ages. This retrospective observational study examined CT-based muscle characteristics of young women (<= 40 years) with breast cancer. At diagnosis, 33% of young women in the study had low muscle mass (sarcopenia), and 56% had poor muscle quality. We found that poor muscle quality at breast cancer diagnosis was associated with shorter progression-free survival in this specific population. Background: Low skeletal muscle mass and poor muscle quality are associated with poor outcomes in women with breast cancer. However, gaps exist in our understanding of prognostic factors for young women (<= 40 years), as they often have different body composition than older women. We evaluated pretreatment body composition measures in young women with breast cancer, including associations with overall survival (OS) and progression-free survival (PFS). Methods: The Young Women's Database at Levine Cancer Institute was queried for women aged 18 to 40 at diagnosis (2009-2018) of single primary breast cancer (N = 870); patients with Stage 0 and 4 were excluded. Deceased patients with pretreatment computed tomography (CT) scans were identified (N = 40) and matched (1:1) to patients presumed alive by age, diagnosis year, and disease characteristics. CT-derived body composition measures included skeletal muscle index (SMI) and intramuscular adipose tissue corrected (IMAT-C). Sarcopenia (low muscle mass) was defined as SMI<40. Results: Of 80 subjects, median age at diagnosis was 35 years. Median follow-up 8.6 years. Total 33% had low muscle mass (sarcopenic), and 56% had poor muscle quality (high IMAT-C). Independent of age, clinical disease stage, and primary insurer, high IMAT-C was associated with shorter PFS (HR 2.33, 95% CI 1.15-4.72; P = .020). Conclusions: Poor muscle quality at diagnosis was associated with shorter progression-free survival in young women with breast cancer. Future research should determine the significance of changes in muscle quality throughout treatment.

Romiplostim is a thrombopoietin receptor agonist indicated for previously treated primary immune thrombocytopenia (ITP) that leads to dose-dependent increases in platelet counts. Higher initial doses than the standard starting dose of 1 μg/kg may have the potential to lead to faster platelet responses. We conducted a single-center, retrospective, observational study to evaluate the efficacy of romiplostim dosing strategies in adult patients with primary ITP who initiated romiplostim in the acute care setting. Patients were classified into low-dose (<3 μg/kg) or high-dose (≥3 μg/kg) based on the initial weight-based dose administered. The primary outcome was time to achieve a platelet count greater than 30 × 10 9 /l. Secondary objectives included time to platelet count greater than 50 × 10 9 /l, healthcare resource utilization, thrombotic events, and bleeding incidents. Sixty-five patients were included in the study. Patients in both dosing cohorts achieved a platelet response of greater than 30 × 10 9 /l at a median of 7 days ( P = 0.871). There were no significant differences in healthcare resource utilization or safety events between dosing cohorts. Initial high-dose romiplostim for acute ITP did not demonstrate an improvement in time to platelet response compared to initial low-dose romiplostim.

PURPOSE Venetoclax has made a significant impact in the treatment of chronic lymphocytic leukemia (CLL) due to its ability to induce deep and durable remissions with a finite duration of oral therapy. However, it can lead to tumor lysis syndrome (TLS) which is mitigated with dose escalation strategies. Patients who initiate venetoclax need to follow rigorous, and potentially burdensome, TLS monitoring during dose ramp-up. The frequency with which this rigorous monitoring leads to therapeutic interventions in clinical practice has not been well described. We conducted a study to assess the incidence of TLS and interventions needed after initiation of venetoclax in patients with CLL. METHODS Adult patients with CLL who started treatment with venetoclax between July 2017 and March 2021 at Levine Cancer Institute were included in this study. Adherence to the venetoclax package insert (PI) for tumor lysis monitoring, incidence of laboratory as well as clinical TLS, and interventions resulting from the monitoring of TLS were collected. RESULTS We report outcomes on 73 consecutive patients with CLL who initiated venetoclax. The majority of patients had low (49%) or medium (44%) tumor burden. During venetoclax ramp-up, 66% of patients adhered strictly to TLS monitoring as per the venetoclax PI. One patient developed laboratory TLS, and no patients developed clinical TLS. Six patients received unplanned interventions to treat TLS; all had medium or high tumor burden. There were no unplanned interventions in patients with low tumor burden. CONCLUSION In patients with low and medium tumor burden CLL who start venetoclax, the incidence of TLS is very low, and interventions are uncommonly needed.

OBJECTIVE:Compare radioactive seed localization (RSL) and wire-guided localization (WL) for nonpalpable malignant breast disease. BACKGROUND:While WL has been the most common approach for localization of nonpalpable breast tumors, other techniques such as RSL, intraoperative ultrasound, radioactive intraoperative occult lesion localization, hematoma localization, radar localization, and magnetic seed localization have been suggested as safe and efficacious alternatives. However, very few randomized controlled trials have compared these localization techniques. METHODS:Between July 2015 and January 2021, 400 women with nonpalpable malignant breast disease were randomized 1:1 to RSL or WL, stratified by the surgeon and invasive disease status. The primary outcome was initial resection negative margin rates. Secondary outcomes included time efficiencies, cost, and satisfaction. RESULTS:There was no significant difference in negative margin rates between RSL and WL [RSL 0.80 (95% CI: 0.75-0.86) vs WL 0.85 (95% CI: 0.80-0.89); P=0.29]. RSL received better patient scores for anxiety [OR=2.62 (95% CI: 1.79-3.84); P<0.01], pain [OR=2.50 (95% CI: 1.69-3.71); P<0.01], and overall satisfaction [OR=3.24 (95% CI: 1.70-6.22); P<0.01] compared with WL. Radiologists and surgeons associated RSL with better convenience [OR=3.32 (95% CI: 1.65-6.69); P<0.01] and satisfaction of surgical procedure conduct [OR=1.67 (95% CI: 1.09-2.58); P=0.02]. Time in radiology did not differ [RSL mean (SD) 12.8±9.5 min vs. WL 11.4±6.0 min; P=0.18]. RSL incurred a $600 higher cost than WL. CONCLUSIONS:The results of the largest randomized controlled trial in the United States support RSL as an acceptable alternative to WL in the treatment of nonpalpable malignant breast disease. While RSL was not superior to WL in achievement of negative margins, patients and providers reported improved satisfaction scores.

Polycythemia vera (PV) is a myeloproliferative neoplasm characterized by unregulated red blood cell production resulting in elevated hemoglobin and/or hematocrit levels. Patients often have symptoms such as fatigue, pruritus, and painful splenomegaly, but are also at risk of thrombosis, both venous and arterial. Ruxolitinib, a selective Janus kinase inhibitor, is approved by the US Food and Drug Administration as second-line cytoreductive treatment after intolerance or inadequate response to hydroxyurea. Although ruxolitinib has been widely used in this setting, limited data exist in the literature on ruxolitinib treatment patterns and outcomes among patients with PV in routine clinical practice. We report a retrospective, observational, cohort study of patients treated for PV with ruxolitinib across three US centers (academic and regional practice) from December 2014-December 2019. The study included 69 patients, with a median follow-up duration of 3.7 years (95% CI, 2.9-4.4). Our data demonstrate very high rates of hematocrit control (88% of patients by three months and 89% by six months); few patients required dose adjustments or suspension. No arterial thromboses were observed; however, the follow-up duration does not allow for the generation of meaningful conclusions from this. Three patients had thrombotic events; one was in the setting of a second malignancy, one post-operative, and a third related to prolonged immobility. We also found that 28% of patients initiated ruxolitinib as a result of poorly controlled platelet counts, second only to hydroxyurea intolerance (46%) as a reason to start therapy. In clinical practice, ruxolitinib continues to be effective in controlling hematocrit levels after three and six months of treatment in patients and is associated with low thrombotic risk.

Outcomes1. To describe spiritual care needs of hospitalized patients with cancer of Dharmic religions.2. To identify opportunities for better accommodating the religious practices of hospitalized patients with cancer of Dharmic religions.Key MessageRitual was the most common spiritual care need documented by hospital chaplains caring for patients with cancer of Dharmic religions (Hinduism, Buddhism, Sikhism, Jainism). While most practiced their religion independently, chaplains reported challenges fulfilling requests for a community-based faith leader. Access to faith-specific resources can address unmet needs.IntroductionSpiritual care (SC) is an integral component of cancer care in the US, but the needs of patients who identify with a Dharmic religion (DR; Hinduism, Buddhism, Sikhism, Jainism) are unknown.ObjectiveThis study measures and explores the SC needs of hospitalized DR patients with cancer.MethodsWe conducted a secondary analysis of data from a separate retrospective study of utilization of chaplaincy services by patients hospitalized at a specialty cancer center in New York City between 2015 and 2019. SC needs were identified from chaplaincy documentation based on the National Comprehensive Cancer Network Guidelines for Chaplaincy Care. Sociodemographic and clinical variables were summarized with descriptive statistics. In 2020, we prospectively conducted semi-structured qualitative interviews to explore SC needs among DR patients at this hospital. Data were coded and analyzed independently and iteratively by two investigators; themes were identified.ResultsAmong 54828 patients, 1163 DR patients were identified (58% Hindu, 33% Buddhist, 5% Sikh, 3% multiple faiths, < 1% Jain); 100 (9%) had a documented SC need. Ritual was the most common SC need (72%), including prayer, scripture, or request for a community-based faith leader (CBFL). Twenty-two patients (91% Hindu, 9% Sikh) and 11 non-DR chaplains were interviewed. Patients practiced their faith independently through prayer, meditation, chants, and murtis (consecrated images of God); however, some were concerned about being misunderstood when sharing a room with another patient. None had used the chapel, some associated it with Christianity and felt uncomfortable. Chaplains reported challenges with identifying a CBFL: limited connections, logistics, language barriers, and privacy concerns. Suggestions included increasing access to the chapel, articles of faith (e.g., scriptures), and CBFL.ConclusionRitual was the most common SC need among hospitalized DR patients with cancer. While most practiced independently, facilitating access to faith-specific resources can address unmet needs.KeywordsDiversity, Equity, Inclusion, Belonging, Justice / Existential / Humanities / Spirituality / Religion

Background: Based on the landmark VIALE-A trial of azacitidine + venetoclax (AZA-VEN) versus (vs) placebo-AZA, hypomethylating agent (HMA) therapy with VEN is the gold standard for frontline treatment in elderly/unfit patients (pts) with acute myeloid leukemia (AML). Due to improved response rates and overall survival (OS) with this regimen in elderly/unfit pts, there are ongoing trials to compare HMA-VEN to intensive chemotherapy in younger/fit pts. Despite improvements in outcomes for AML pts with this regimen and its expected increased use in fitter pts, the real-world usage of HMA-VEN is quite complex, and toxicities leading to dose modifications are common. As a result, dosing and administration of HMA-VEN can be inconsistent, and it is unclear how variability in dosing impacts outcomes for AML pts receiving this regimen. We hypothesized that toxicities and dose adjustments are observed frequently with AZA-VEN for elderly or unfit AML and that outcomes may be inferior to AZA-VEN treated pts with long-term follow-up on VIALE-A. Methods: Newly diagnosed AMLpts deemed unfit for intensive induction and initiated on frontline AZA-VEN at our center between 8/2018 and 6/2022 were included. Disease and pt characteristics, stem cell transplant (SCT) status, and survival outcomes were collected. European LeukemiaNet (ELN) 2017 criteria were used to assign AML risk. Treatment details for the first three cycles (C) of AZA-VEN, including dosing, treatment duration, and toxicities were retrospectively reviewed. OS was defined as time from initiation of AZA-VEN to death from any cause, with surviving subjects censored at time of last follow-up. Kaplan-Meier method was used to summarize OS between pts receiving <28 days VEN (including 21, 14, and 7 days) and ≥ 28 days (including 28 days or > if cycle length was extended). Outcomes in this cohort vs long-term follow up results of the VIALE-A AZA-VEN arm were compared with Fisher exact tests. Results: 53 pts received frontline AZA-VEN and were included in this analysis. Median age at diagnosis was 72 (range, 24-83), and 58% were male. Race (92% White and 8% Black) and ethnicity (96% not Hispanic/Latino) were self-reported. ELN risk was 11% favorable, 47% intermediate, and 42% adverse. With 100% of pts on concomitant azole (91% on posaconazole), VEN 100 mg was the most common dose received in C1 (74%), C2 (69%), and C3 (64%). Despite VEN adjustments mostly due to toxicity in 42% of pts in C1, 54% in C2, and 60% in C3, 28 days was the most common duration received (49% in C1, 46% in C2, and 28% in C3) followed by 21 days; 14-day duration was provided in 4% of pts in C1 and increased to 28% in C2 and 20% of pts in C3. Among pts with dose adjustments due to toxicity, cytopenia was most common, indicated for 57% of toxicities in C1, 79% in C2, and 100% in C3. In C1 only, GI toxicity and tumor lysis syndrome were indicated for 14% and 19% of reported toxicities, respectively. 16 pts had bone marrow biopsy (BMBx) between C1 and C2, 17 between C2 and C3, and 2 after C3. Best response was available for 58% pts with 45% achieving CR, 26% CRi, 19% MLFS, and 10% refractory. With median follow-up of 34.6 months (mo) (range, 0.8 to 52), median OS was 15.2 mo (95% CI 6.8 to 33.7). No significant difference was seen in OS for C1 VEN duration <28 days vs ≥28 days (HR 1.67, P=0.15). Comparison of this cohort to VIALE-A VEN-AZA pts revealed the following: median follow-up 34.6 vs 43.2 mo, median age 72 vs 76, median OS 15.2 vs 14.7 mo, 24 mo OS 42.2% vs 37.5%, CR rate 45.2% v 38.8% (P=0.56), CR/CRi rate 71.0% vs 67.8% (P=0.69), and SCT 19% vs 1% (P<0.001). Conclusions: With similar median follow up to VIALE-A, median OS and 24 mo OS were comparable in our cohort. Despite pts initially being deemed unfit and the median age of 72 in our cohort, 19% of pts received SCT compared to 1% in VIALE-A, highlighting the potential for consolidative SCT in select pts receiving upfront AZA-VEN. Despite variable dosing and duration of VEN in our cohort, no significant difference was observed in OS for those receiving 28 days vs <28 days. BMBx was performed in only 58% of pts, highlighting a pertinent aspect of care warranting further attention in real-world use of AZA-VEN. Based on these results, we seek to further optimize dosing strategies for AZA-VEN by evaluating interpatient variability through an ongoing prospective study of the genetic determinants of toxicity and response to AZA-VEN in newly diagnosed AML.

BackgroundMalnutrition is common in hospitalized patients with cancer and adversely affects clinical outcomes. We evaluated the prevalence of malnutrition risk, dietitian-identified malnutrition (DIMN), and physician-diagnosed malnutrition (PDMN) at admission.MethodsThis retrospective study included adults diagnosed with a stage I-IV solid tumor malignancy and admitted to Atrium Health Carolinas Medical Center from January 2016 to May 2019. Malnutrition risk was determined by a score >= 2 on the Malnutrition Screening Tool (MST) administered by a registered nurse during the intake process. Registered dietitian nutritionist (RDN) assessments were reviewed for DIMN and grade (mild, moderate, or severe). PDMN included malnutrition International Classification of Diseases, Tenth Revision codes in the discharge summary. Univariate models were estimated; multivariate logistic regression models identified associations between clinicodemographic factors and malnutrition prevalence with stepwise selection.ResultsA total of 5143 patients were included. Median age was 63 (range 18-102) years, 48% were female, 70% were White, and 24% were Black. Upper gastrointestinal (21%), thoracic (18%), and genitourinary (18%) cancers were most common. A total of 28% had stage IV disease. MST scores were available for 4085 (79%); 1005 of 4085 (25%) were at malnutrition risk. Eleven percent (n = 557) had malnutrition coded by a physician or documented by an RDN; 4% (n = 223) of these were identified by both clinicians, 4% (n = 197) by RDNs only, and 3% (n = 137) by physicians only.ConclusionMalnutrition appears to be underdiagnosed by both RDNs and physicians. Underdiagnosis of malnutrition may have significant clinical, operational, and financial implications in cancer care.

Outcomes1. Identify the barriers to faith-concordant EOL care encountered by patients with a serious illness who identify with a Dharmic religion.2. Identify opportunities to deliver faith-concordant EOL care to patients with a serious illness who identify with a Dharmic religion.Key MessageCompared to other faiths, cancer patients of Dharmic religions (DR) had higher EOL care utilization. Few patients who desired faith-based EOL care had discussed these preferences with clinicians. Future work should improve staff's understanding of DR-specific EOL practices and increase patients' access to faith-concordant resources.ImportanceSpiritual support of cancer patients has been associated with improved EOL outcomes; however, little is known about EOL experiences among cancer patients who identify with a Dharmic religion (DR; Hinduism, Buddhism, Sikhism, Jainism).ObjectivesThe primary objective was to measure EOL care utilization [hospice enrollment in the last 3 days (H); chemotherapy use in the last 14 days (C); urgent care center (UCC) visits or ICU admissions within the last 30 days; inpatient deaths (ID)] among DR and non-DR (NDR) cancer patients.Scientific Methods Utilized1) We conducted a secondary analysis of data from a separate retrospective study of utilization of chaplaincy services by patients hospitalized at a specialty cancer center in New York City (2015-2019). Bivariate analyses examined associations between religious affiliation and EOL care metrics. 2) We conducted semi-structured interviews with hospitalized patients and chaplains (2020) to explore EOL care preferences. Data were coded and analyzed independently and iteratively by two investigators, and themes were identified.ResultsAmong 28711 patients (DR 2.3%), DR patients had significantly higher rates of EOL care utilization compared to NDR patients: H (5.2% vs 2.1%, p< 0.001), C (11% vs. 7.7%; p=0.021), UCC (48% vs. 23%, p< 0.001), ICU (12% vs. 5.1%; p< 0.001), ID (28% vs. 12%; p< 0.001). In interviews [22 patients (20 Hindu, 2 Sikh); 11 chaplains (7 Christian, 2 Muslim, 2 Jewish)], few patients felt religion influenced their preferences for resuscitative measures. Some desired faith-based EOL care though did not always expect staff to be aware. Several chaplains acknowledged lacking knowledge in EOL practices. Suggestions for improvement included improving chaplaincy training and developing relationships with community-based leaders and volunteers.Conclusion(s)While DR patients had higher EOL care utilization, most did not report religion influenced their EOL care preferences. Although patients desired faith-based EOL care, few had discussed these preferences and not all chaplains were familiar with DR-specific EOL practices.ImpactFuture work should improve healthcare staff's understanding of DR-specific EOL practices and increase access to faith-concordant support.KeywordsCultural diversity/Qualitative and mixed methods research

12066 Background: A large patient cohort study found functional impairments (FI) are associated with cancer-related fatigue (CRF). This was before anti-cancer treatment for solid tumors. Another found functional limitations increased with self-reported pain severity. We hypothesize that both (a) a direct association between pain and CRF and (b) an indirect association between the symptoms through a mediation pathway involving FI may exist. Our retrospective, single-institutional study evaluated this model. Methods: We sourced Electronic Distress Screening (EDS) and Cancer Registry databases (Jan 2017 - Jan 2022). Patients identified were ≥18 years old and completed EDS within two (±2) weeks of a solid tumor diagnosis and before any anti-cancer therapy. Three EDS questions assessed FI with a two-week recall: 1) “How well have you managed your daily life?”; 2) “Has your physical health kept you from doing things like household chores or climbing stairs?”; 3) “Do you have limited movement in any body part?”. Pain and CRF were assessed on a numerical rating scale [0 (none) to 10 (worst possible)]. Structural equation modeling tested the multiple mediation model. The 95% confidence intervals of the estimated total and FI domain-specific indirect effects, the effects of pain on CRF working through FI, were assessed to exclude zero. Results: N=4326. Median age = 63 years (range 18 - 97); 69% female and 78% White. The commonest tumor site groups were breast (30%), upper GI (17%), and gynecologic (16%); 21% had Stage 4 disease. Median CRF was 4 (range 0-10); 57% had clinically significant CRF (fatigue ≥4). Median pain was 3 (range 0-10); 51% had clinically significant pain (pain ≥3). A significant minority had FI. N=753 (17%) had either “very poor” or “fairly poor” management of day-to-day life. N=778 (18%) had “a lot” of difficulty in performing chores. N=1252 (29%) had limited movement of any body part. FI partially mediated the pain/CRF relationship (indirect effect (IEtotal)=0.25, 95% CI 0.24-0.27). Two mediators had statistically significant contributions to the total indirect effect: management of daily life (IEmanage=0.12, 95% CI 0.11-0.13); and difficulty in performing chores (IEchores=0.13, 95% CI 0.11-0.14). The limited movement of any body part did not impact the pain/CRF relationship (IEmovement=-0.01, 95% CI -0.01-0.01). Conclusions: Most patients had clinically significant pain and CRF at diagnosis. A significant minority had FI at diagnosis. FI partially mediated the direct relationship between pain/CRF severity. This helps us understand that FI accounts for some of the relationship between pain and CRF. It is insufficient to conduct symptom assessments without also evaluating FI before treatment or at diagnosis.

INTRODUCTION:Breast cancer, although the second most common malignancy in women in the United States, is rare in patients under the age of 40 y. However, this young patient population has high recurrence and mortality rates, with chemotherapy frequently used as adjuvant treatment. We aimed to determine whether age is an independent predictor of chemotherapy recommendation and subsequent treatment and the relationship to Oncotype Dx (ODX) recurrence score (RS). METHODS:The National Cancer Database was retrospectively reviewed from 2010-2016 to identify women with early-stage (pT1-pT3, pN0-pN1mic, M0), hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer who underwent ODX RS testing. RESULTS:Of 95,382 patients who met the inclusion criteria, risk groups using the traditional ODX RS cutoffs were 59% low, 33% intermediate, and 8% high. Using Trial Assigning Individualized Options for Treatment RS cutoffs, risk groups were 23% low, 62% intermediate, and 15% high. Chemotherapy recommendation decreased as age at diagnosis increased (P < 0.001). Increasing age was associated with decreased odds of chemotherapy recommendation in univariate models both continuously (odds ratio: 0.98, 95% confidence interval 0.97-0.98; P < 0.001) and categorically by decade (P < 0.001). Age by decade remained an independent prognosticator of chemotherapy recommendation (P < 0.001), adjusted for risk groups. CONCLUSIONS:Chemotherapy recommendation and treatment differs by age among patients with early-stage hormone receptor positive breast cancer who undergo ODX testing. While molecular profiling has been shown to accurately predict the benefit of chemotherapy, younger age at diagnosis is a risk factor for discordant use of ODX RS for treatment strategies in breast cancer; with patients aged 18-39 disproportionately affected.