Rabow, Michael W.

PURPOSE Leptomeningeal metastatic disease (LMD) is associated with poor prognosis and imposes severe symptomatic limitations on functional status and quality of life. In recent years, the range of diagnostic and therapeutic options available to patients with LMD has expanded, but the impact of these innovations on clinical characteristics and outcomes remains unclear. We conducted a retrospective study to define the LMD patient population, symptoms experienced, and the frequency of accessing specialty palliative care (PC) services, at a large tertiary referral center. METHODS We conducted a retrospective electronic medical record review on the basis of a convenience sample of 104 patients diagnosed and treated with LMD with dates of diagnosis between January 1, 2016, and October 1, 2022. Variables were generated on the basis of patient demographics, reported symptoms, and clinical course. Data were analyzed using Stata 16. RESULTS Of 104 patients in the analysis, the most common symptoms reported were headache and extremity weakness (52% of patients reported each). The mean number of weeks between LMD diagnosis and date of death was 41.4, with a median of 27.9 weeks, and a range of 1.4-143.4 weeks. Forty-five percent of patients had at least one documented visit with an inpatient or outpatient PC provider. CONCLUSION Patients with an LMD diagnosis face a high symptom burden. Our findings highlight that prognosis may be longer than what is typically quoted in the literature, but further study would be needed to understand this discrepancy. Fewer than half of the patients in our sample had a documented visit with a PC specialist, suggesting a missed opportunity in this population to connect with providers specialized in managing symptom burden and doing nuanced advance care planning.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Adult Cancer Pain provide recommendations for the comprehensive management of pain in patients with cancer. This article will focus on methods for screening for pain, safe and appropriate prescription of opioid and miscellaneous analgesics, and the optimization of nonpharmacologic interventions including integrative and interventional strategies for treatment of cancer-related pain. Additionally, the NCCN Guidelines discuss methods for the safe reduction of opioids when appropriate, as well as techniques for encouraging the judicious use of opioids. The complete version of the NCCN Guidelines for Adult Cancer Pain addresses additional issues that are not covered here, including management of pain during a pain crisis, management of procedure-related pain and anxiety, pain management for cancer survivors, and the use of nonopioid and adjuvant analgesics for cancer-related pain.

12011 Background: Patients (pts) with high HCT-Comorbidity Index scores (HCT-CI of ≥3), older age (≥65 years), and/or who are frail per gait speed (<0.8 meters/second) have increased morbidity and mortality after allo-HCT compared to younger and healthier counterparts. We report the phase II analysis (PIIA) and interim phase III primary outcome analysis (PIIIA) of a seamless phase II/III prospective, randomized clinical trial conducted at 11 transplant centers to test new approaches to improve quality of life (QOL) in this population. Methods: Phase II compared specialist-administered supportive and palliative care (SPC), patient-administered management of comorbidities (MC, e.g. physical exercise, stress reduction, etc), both (SPC+MC), and usual care (UC) for change in Functional Assessment of Cancer Therapy – Bone Marrow Transplantation (FACT-BMT) QOL scores from baseline to day 90 (D90). Pts deceased prior to D90 were assigned FACT-BMT score=0. The winning phase II arm moved forward versus UC in phase III. Results: PIIA was done after enrolling 35 pts to each of the 4 study arms. Calculating the difference between FACT-BMT scores on D90 minus baseline, excluding missing data, indicated that only SPC resulted in a small improvement in QOL compared to either MC or SPC+MC (Table); hence SPC was the winning phase II arm. The PIIIA was conducted after enrolling 158 SPC pts and 153 UC pts. The SPC and UC arms were well balanced with median age (both 68 years), HCT-CI ≥3 (49% vs 55%), frailty per gait speed (13% vs 12%), female sex (41% vs 34%), non-white race (9.5% vs 11.5%), and Hispanic or unreported ethnicity (7.7% vs 5.7%), respectively. After median follow-up of 362 days, 45 pts had died in each arm. The mean QOL difference between D90 and baseline was 2.83 for SPC and 4.27 for UC (difference of differences, -1.44, 95% CI of difference, -5.03 to 2.14, p=0.43). Fitting a generalized linear model that included baseline, D30, and D90 values and testing the null hypothesis that the slope of scores differs between SPC and UC resulted in p=0.85. Using the Kaplan Meier method, no difference in survival was observed across arms (HR 1.13 [0.75-1.73]). Conclusions: Specialist-administered palliative care showed no meaningful improvement in QOL, nor a survival advantage, compared to usual care in frail, older and comorbid allo-HCT recipients, resulting in the cessation of this Phase II/III trial. Analysis of the whole patient population for primary and secondary outcomes is in progress. Clinical trial information: NCT03870750 . Change in FACT-BMT (D90 value minus baseline value) comparing the 4 arms of phase II. Group Mean difference (sd) Median difference (range) SPC (n=28) -2.93 (28.52) 0.25 (-102 to 38.22) CM (n=18) -18.37 (33.80) -9.50 (-98.33 to 11) SPC+CM (n=27) -15.76 (32.69) -7.67 (-90 to 32)

INTRODUCTION While prognostic understanding (PU) is important for all patients (pts) considering hematopoietic stem cell transplantation (HCT), it may be particularly important for older (&gt;65 years), medically infirm, and/or frail pts deciding whether to undergo allogeneic HCT (allo-HCT). This abstract reports on PU and concordance with transplant physician (hereafter MD) PU for pts participating in an ongoing seamless, phase II-III randomized clinical trial (ACE-BMT) comparing 4-arms: a pt-administered comorbidity management intervention (CM), specialist-administered palliative care (PC), a combined arm of CM and PC to standard of care. Here we report preliminary data on the concordance between pt and MD PU on the chance of cure 1-year (yr) post allo-HCT. METHODS Pt PU was compared to MD PU (gold standard) to determine concordance. MD and pt answers were compared on a single validated question asked at enrollment to the study (typically 2 weeks prior to HCT). Both pts and MD's estimated the chance of cure 1 yr after allo-HCT by selecting one of six possible response options: very good (more than 90%), good (75-90%), better than 50% (50-74%), worse than 50% (25-49%), bad (10-24%) or very bad (less than 10%). PU was “concordant” or “accurate” if MD and pt selected the same response option. Pts with discordant PU were labeled “pessimistic” if the pt selected a response option with a lower chance of cure than the MD (and “optimistic” if a higher chance). Response options were further simplified to greater than or less than 50% chance of cure and MD and pt PU were compared again. Descriptive statistics, chi-square for categorical and t-tests for continuous variables were used. Logistic regression was used to determine the association between pt prognostic concordance and pt socio-demographic and clinical characteristics. RESULTS All pts consented to date were included (n=358), except those who did not answer the prognosis question (n=61). 54.2% (n=194) had HCT-Comorbidity Index (HCT-CI) of ≥3, 67.9% (n=243) were older than 65 yrs and 4.5% (n=16) were frail, defined by walk speed &lt;0.8 m/s. Median age was 68 yrs (range 20-80). 39.7% (n=141) were female. 89.9% (n=322) identified as White, 4.2% (n=15) Asian, and 1% each as Black/African American and Native Hawaiian/Other Pacific Islander. 5.3% (n=19) identified Hispanic. 11.5% (n=44) had high school education or less. 54.1% (n=183) made less than $100,000/yr. 40.1% (n=136) had acute myelogenous leukemia, 25.4% (n=86) had high-risk myelodysplastic syndrome and 10.6% (n=36) had a myeloproliferative cancer. 72.1% (n=245) had matched, 82.5% (n=283) unrelated and 95.0% (n=36) peripheral blood allo-HCT. 9% (n=31) had KPS of 100%, 35% (n=121) KPS 90%, and 47.5% (n=147) KPS 80%. Pts reported having a very good, good, better than 50%, worse than 50% and bad/very bad chance of cure 1 yr post allo-HCTL 34.4% (n=123), 30.7% (n=110), 26.0% (n=93), 7.3% (n=26) and 1.7% (n=6), respectively. 91.1% (n=326) of pts felt they had a &gt;50% chance of being cured 1 yr post allo-HCT. MD answers were missing for 159/358 (44.4%) pts. MDs reported pt had a very good, good, better than 50%, worse than 50% and bad/very bad chance of being cured 1 yr post allo-HCT, 3.0% (n=6), 6.5% (n=13), 52.8% (n=105), 35.7% (n=71) and 2% (n=4) respectively. 62.3% (n=124) of MDs felt the pt had a &gt;50% chance of being cured 1 yr post allo-HCT. For the subset of pts with MD prognostic data (n=199), pt's PU was concordant 20.6% (n=41) of the time when compared across all 6 response options. Overall, 71.9% (n=143) of pts erred toward optimism, while 7.5% (n=15) of pts were pessimistic. 60.8% of MD and pts agreed on prognosis when dichotomized to better or worse than 50% chance of being cured 1 yr post allo-HCT. Prognostic concordance was not significantly associated with any pt socio-demographic factors, HCT-CI or KPS via descriptive statistics or regression analysis. CONCLUSIONS In this prospective randomized trial focusing on a population of older, medically infirm, and/or frail pts receiving allo-HCT, pts' PU was not concordant with MD prognosis approximately 80% of the time. While some pts were pessimistic, the majority overestimated the likelihood they would be cured of disease compared to MD estimates. Future studies should investigate the true accuracy of both MD and pt prognosis, as well as how to improve communication about prognosis and pt PU (if inaccurate based on best available information) prior to HCT.

Importance Numerous studies show that early palliative care improves quality of life and other key outcomes in patients with advanced cancer and their caregivers, although most lack access to this evidence-based model of care. Objective To evaluate whether delivering early palliative care via secure video vs in-person visits has an equivalent effect on quality of life in patients with advanced non–small cell lung cancer (NSCLC). Design, Setting, and Participants Randomized, multisite, comparative effectiveness trial from June 14, 2018, to May 4, 2023, at 22 US cancer centers among 1250 patients within 12 weeks of diagnosis of advanced NSCLC and 548 caregivers. Intervention Participants were randomized to meet with a specialty-trained palliative care clinician every 4 weeks either via video visit or in person in the outpatient clinic from the time of enrollment and throughout the course of disease. The video visit group had an initial in-person visit to establish rapport, followed by subsequent virtual visits. Main Outcomes and Measures Equivalence of the effect of video visit vs in-person early palliative care on quality of life at week 24 per the Functional Assessment of Cancer Therapy-Lung questionnaire (equivalence margin of ±4 points; score range: 0-136, with higher scores indicating better quality of life). Participants completed study questionnaires at enrollment and at weeks 12, 24, 36, and 48. Results By 24 weeks, participants (mean age, 65.5 years; 54.0% women; 82.7% White) had a mean of 4.7 (video) and 4.9 (in-person) early palliative care encounters. Patient-reported quality-of-life scores were equivalent between groups (video mean, 99.7 vs in-person mean, 97.7; difference, 2.0 [90% CI, 0.1-3.9]; P = .04 for equivalence). Rate of caregiver participation in visits was lower for video vs in-person early palliative care (36.6% vs 49.7%; P &amp;lt; .001). Study groups did not differ in caregiver quality of life, patient coping, or patient and caregiver satisfaction with care, mood symptoms, or prognostic perceptions. Conclusions and Relevance The delivery of early palliative care virtually vs in person demonstrated equivalent effects on quality of life in patients with advanced NSCLC, underscoring the considerable potential for improving access to this evidence-based care model through telehealth delivery. Trial Registration ClinicalTrials.gov Identifier: NCT03375489

LBA3 Background: National guidelines recommend the early integration of palliative and oncology care for patients with advanced cancer, given robust evidence showing that this care model improves quality of life (QOL) and other important outcomes. However, most patients do not receive early palliative care (EPC) in the outpatient setting due to limited access and resources. To overcome these barriers, we conducted a large-scale comparative effectiveness trial of EPC delivered via secure video versus in person among patients with advanced non-small cell lung cancer (NSCLC) and their caregivers. Methods: Between 6/14/2018 and 5/4/2023, we enrolled 1250 patients with advanced NSCLC, diagnosed in the past 12 weeks, into a randomized trial of telehealth versus in-person EPC across 22 cancer centers in the US. Patients were randomly assigned to meet with a palliative care clinician every four weeks from enrollment through the course of disease either via video or in the outpatient clinic. Participants completed self-report measures at baseline and weeks 12 and 24. The primary aim was to evaluate the equivalence of the effect of telehealth versus in-person EPC on QOL at week 24, using regression modeling with an equivalence margin of ±4 points on the Functional Assessment of Cancer Therapy-Lung (FACT-L, range = 0-136). We also compared rates of caregiver participation in EPC visits and patient-reported depression and anxiety symptoms (Patient Health Questionnaire-9; Hospital Anxiety and Depression Scale), coping (Brief COPE), and perceptions of prognosis (Perceptions of Treatment and Prognosis Questionnaire) between groups. Study recruitment ceased for two months at the onset of the COVID-19 pandemic. Results: Participants (mean age = 65.5 years; 54.0% female; 82.1% White) had a mean of 4.75 and 4.92 palliative care encounters by week 24 in the telehealth and in-person groups, respectively. Due to the pandemic, the in-person group had 3.9% of visits occur via video. QOL scores at week 24 for patients assigned to the telehealth group were equivalent to those receiving in-person EPC (adjusted means: 99.67 versus 97.67, p < 0.043 for equivalence). The rate of caregiver participation in EPC visits was lower in the telehealth versus in-person group (36.6% versus 49.7%, p < 0.0001). Study groups did not differ in depression and anxiety symptoms, use of coping skills, or perceptions of the goal of treatment and curability of their cancer. Conclusions: The delivery of EPC via video versus in-person visits demonstrated equivalent effects on QOL in patients with advanced NSCLC. The two modalities also did not differ across a range of patient-reported outcomes, though caregivers attended more in-person versus video visits. The findings underscore the considerable potential for improving access to and broader dissemination of this evidence-based care model through telehealth delivery. Clinical trial information: NCT03375489 .

ASCO Guidelines provide recommendations with comprehensive review and analyses of the relevant literature for each recommendation, following the guideline development process as outlined in the ASCO Guidelines Methodology Manual . ASCO Guidelines follow the ASCO Conflict of Interest Policy for Clinical Practice Guidelines . Clinical Practice Guidelines and other guidance (“Guidance”) provided by ASCO is not a comprehensive or definitive guide to treatment options. It is intended for voluntary use by providers and should be used in conjunction with independent professional judgment. Guidance may not be applicable to all patients, interventions, diseases, or stages of diseases. Guidance is based on review and analysis of relevant literature, and is not intended as a statement of the standard of care. ASCO does not endorse third-party drugs, devices, services, or therapies and assumes no responsibility for any harm arising from or related to the use of this information. See complete disclaimer in Appendix 1 and 2 (online only) for more. PURPOSE To provide evidence-based guidance to oncology clinicians, patients, nonprofessional caregivers, and palliative care clinicians to update the 2016 ASCO guideline on the integration of palliative care into standard oncology for all patients diagnosed with cancer. METHODS ASCO convened an Expert Panel of medical, radiation, hematology-oncology, oncology nursing, palliative care, social work, ethics, advocacy, and psycho-oncology experts. The Panel conducted a literature search, including systematic reviews, meta-analyses, and randomized controlled trials published from 2015-2023. Outcomes of interest included quality of life (QOL), patient satisfaction, physical and psychological symptoms, survival, and caregiver burden. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS The literature search identified 52 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS Evidence-based recommendations address the integration of palliative care in oncology. Oncology clinicians should refer patients with advanced solid tumors and hematologic malignancies to specialized interdisciplinary palliative care teams that provide outpatient and inpatient care beginning early in the course of the disease, alongside active treatment of their cancer. For patients with cancer with unaddressed physical, psychosocial, or spiritual distress, cancer care programs should provide dedicated specialist palliative care services complementing existing or emerging supportive care interventions. Oncology clinicians from across the interdisciplinary cancer care team may refer the caregivers (eg, family, chosen family, and friends) of patients with cancer to palliative care teams for additional support. The Expert Panel suggests early palliative care involvement, especially for patients with uncontrolled symptoms and QOL concerns. Clinicians caring for patients with solid tumors on phase I cancer trials may also refer them to specialist palliative care. Additional information is available at www.asco.org/supportive-care-guidelines .

Early integrated palliative care (EIPC) significantly improves clinical outcomes for patients with advanced cancer. Telehealth may be a useful tool to deliver EIPC sustainably and equitably. Palliative care clinicians completed a survey regarding their perceptions of the barriers, facilitators, and benefits of using telehealth video visits for delivering EIPC for patients with advanced lung cancer. Forty-eight clinicians across 22 cancer centers completed the survey between May and July 2022. Most (91.7%) agreed that telehealth increases access to EIPC and simplifies the process for patients to receive EIPC (79.2%). Clinicians noted that the elderly, those in rural areas, and those with less-resourced backgrounds have greater difficulty using telehealth. Perceived barriers were largely patient-based factors, including technological literacy, internet and device availability, and patient preferences. Clinicians agreed that several organizational factors facilitated telehealth EIPC delivery, including technological infrastructure (85.4%), training (83.3%), and support from study coordinators (81.3%). Other barriers included systems-based factors, such as insurance reimbursement and out-of-state coverage restrictions. Patient-, organization-, and systems-based factors are all important to providing and improving access to telehealth EIPC services. Further research is needed to investigate the efficacy of telehealth EIPC and how policies and interventions may improve access to and dissemination of this care modality.