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223 Background: Colorectal cancer (CRC) is a life changing process, which impacts survivors’ health-related quality of life (HRQoL). CRC survivors face new uncertainties and have specific information needs. While advances in CRC treatment have increased the number of survivors, little is known about how information needs differ across groups of survivors, or whether information deficits influence HRQoL. Methods: In 2019-2020 we surveyed patients who, in 2014-18, underwent resection of Stage III colorectal cancer and were seen at a community oncology practice, an academic cancer center, or reported to Georgia SEER (51% RR). Patients were asked questions about survivorship, including their need for additional information (NAI) about CRC follow-up care. HRQoL was measured using PROMIS—29+2 Profile v2.1. Patients also self-reported their race and their belief about whether they were cancer free. Associations between patients’ NAI and covariates (including race and belief in being cancer free) were assessed with logistic regression, while associations between HRQoL scores and covariates were assessed with one-way analysis of variance (ANOVA). We used linear regression to assess relationships between NAI and HRQoL. Results: Data from 380 patients were included in these analyses. 44% were > age 65, 84% white, 22% had < high school education, and 32% had a household income of less than $60,000. 55% indicated a need for more information about CRC follow-up care. 90% believed that they were currently cancer free. Black CRC survivors were significantly more likely to report an information need compared to White patients (OR 2.446, 95% CI 1.147-5.217; p = 0.02). Patients who believed they were currently cancer-free were significantly less likely to report an information need compared to patients who did not believe they were cancer-free (OR 0.357, 95% CI 0.169-0.750; p < 0.01). Having a need for additional information was significantly associated with worse HRQoL (difference in mean HRQoL score -0.26, standard error 0.19; p < 0.01). Conclusions: Black CRC survivors were 2.4 times more likely to have an information need than White survivors. Survivors who believed they were currently cancer-free were 35% less likely to have an information need than those who did not share the same belief. Having an information need was associated with worse HRQoL. Tailored survivorship communications and patient education related to managing recurrence risk may help improve HRQoL among CRC survivors.

378 Background: There is great need to build and evaluate tools and strategies to improve cascade genetic risk evaluation in families at high risk for hereditary cancer. The Genetic Information and Family Testing (GIFT) Trial is a population-based intervention that will examine features of a virtual platform that provides genetic risk education (GRE) and low-cost genetic testing (GT) to relatives of 5000 adult patients diagnosed with cancer in 2018-19 in Georgia and California and who tested positive for a clinically actionable germline pathogenic variant (PV). We present findings of a pilot study that informed the GIFT Trial protocol and platform features. Methods: We surveyed 277 women diagnosed with breast cancer in 2017, reported to the Georgia SEER registry, and who tested positive for a clinically actionable PV in a cancer-associated gene. We then invited respondent patients to enroll in the intervention phase which provided online GRE, human pretest genetic navigator support, and an offer of low-cost GT through Color Health, Inc. to all untested 1st or 2nd degree relatives. Respondent patients were eligible for the intervention if they reported a PV on genetic testing and had at least one relative who had not received GT. Enrolled patients invited relatives through the platform by providing email addresses. Family clusters were block randomized to free vs $50 test costs at the time of the initial patient invitation. Results: 125 of 277 patients (45.2%) returned surveys: median age was 51 and 22% were African American. The most common PV reported by patients were BRCA2 (25.7%), BRCA1 (19.5%), CHEK2 (20.4%), ATM (8.8%) and PALB2 (7.1%). Disclosure of genetic test results to relatives was quite high: 83.6% of patients reported that they discussed results with all their daughters vs 69.4% with sons; 78.1% discussed their results with all sisters vs 61.8% with all brothers. The median number of patient-reported untested relatives in a family was 9 (25th-75th percentile: 4-14). Most respondents were eligible for the trial offer (113 of 125, 90.4%). Overall, results were similar between the free test arm and $50 test arm: In the free testing arm, 20 patient participants invited 28 relatives; 12 relatives enrolled, and all 12 relatives ordered testing. In the $50 arm, 16 patient participants invited 38 relatives of whom 18 enrolled and all 18 ordered testing. For the 66 relatives invited by the patient participants: 47 (71.2%) were first degree (8 parents, 22 siblings, and 17 children) and about half of the relatives were men (47.0%). Conclusions: Breast cancer patients with PVs make substantial efforts to communicate with family members about genetic risk but most relatives do not receive GT. Our study findings suggest that a low-cost online navigator-supported intervention can directly engage relatives to increase cascade genetic risk education and testing with little difference in uptake by test cost arms.

373 Background: Long term adverse symptoms following treatment for prostate cancer are prevalent and can negatively impact quality of life and increase healthcare seeking, even though many symptoms can be effectively self-managed. There remains a need for tools to support long term survivors to feel confident in their ability to self-manage their symptoms, potentially translating to more efficient health care utilization. Methods: We conducted a RCT of an automated tailored self-management support intervention (vs. newsletter) for long term (> 1 year) Veteran survivors of prostate cancer recruited from 4/2015-2/2017 across four VA sites. Participants were randomized (278 per arm) and assessed via survey at 5 months and 12 months post enrollment. The intervention delivered tailored information regarding symptoms for urinary, sexual, bowel and general health over 3 months, allowing participants to choose focus areas. At 12 months, we assessed secondary trial outcomes; participants’ reports of use of services relative to their symptoms (urinary, bowel, sexual, general health) and their confidence in symptom self-management (scale from 5-15). We also assessed use of procedures and medications related to each symptom area via medical charts. We tested differences in reported and documented service use between arms using T-tests and Chi-square tests. We further assessed participants engagement in components of the intervention. Results: Of those randomized, 81.7% completed the 12-month survey assessment (N = 226 Intervention and N = 228 Control). The average age was 66.7, 28% were Black, and 49% were high school graduates or less. Participants in the intervention arm reported greater confidence in symptom self-management than controls (Mean: 13.5 vs. 12.9; P = 0.01). Intervention participants reported less often using services related to urinary (43.9% vs. 56.0%, P = 0.03) and sexual (42.3% vs. 57.6%, P = 0.04) health over the prior 7 months. Review of intervention paradata found that urinary and sexual health were the topics most frequently engaged with among intervention subjects. No significant differences in medical chart documented procedures related to symptom areas were found. Conclusions: This secondary trial analysis found that 12 months post enrollment, Veterans who engaged with a tailored self-management intervention were more confident in their ability to self-manage their symptoms. The associated finding of fewer visits for the most commonly chosen areas for symptom self-management suggests that such an intervention may hold promise for helping long term survivors to effectively self-manage adverse symptoms. Clinical trial information: NCT01900561.

PURPOSE For many patients with differentiated thyroid cancer, use of radioactive iodine (RAI) does not improve survival or reduce recurrence risk. Yet there is wide variation in RAI use, emphasizing the importance of understanding patient perspectives regarding RAI decision making. PATIENTS AND METHODS All eligible patients diagnosed with thyroid cancer from 2014 to 2015 from the Georgia and Los Angeles SEER registries were surveyed (N = 2,632; response rate, 63%). Patients in whom selective RAI use is recommended were included in this analysis (n = 1,319). Patients were asked whether they felt like they had a choice to receive RAI (yes or no), how strongly their physician recommended RAI (5-point Likert-type scale), whether they received RAI (yes or no), and how satisfied they were with their RAI decision (more [score of 4 or greater] v less). Multivariable, weighted logistic regression with multiple imputation was used to assess the associations between patient characteristics and perception of no RAI choice and between perception of no RAI choice with receipt of RAI and decision satisfaction. RESULTS More than half of respondents (55.8%) perceived they did not have an RAI choice, and the majority of patients (75.9%) received RAI. The odds of perceiving no RAI choice was greater among those whose physician strongly recommended RAI (adjusted odds ratio [OR], 1.56; 95% CI, 1.13 to 2.17). Patients who perceived they did not have an RAI choice were more likely to receive RAI (adjusted OR, 2.50; 95% CI, 1.64 to 3.82) and report lower decision satisfaction (adjusted OR, 2.31; 95% CI, 1.67 to 3.20). CONCLUSION Many patients did not feel they had a choice about whether to receive RAI. Patients who perceived they did not have a choice were more likely to receive RAI and report lower decision satisfaction, suggesting a need for more shared decision making to reduce overtreatment.

PURPOSE This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden. METHODS A total of 556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites. Participants were randomly assigned to intervention (n = 278) or usual care (n = 278) groups. We compared differences in the primary (symptom burden according to Expanded Prostate Cancer Index Composite-26 [EPIC], confidence in self-management) and secondary outcomes between groups using intent-to-treat analyses. We compared domain-specific changes in symptom burden from baseline to 5 and 12 months among the intervention group according to the primary symptom focus area (urinary, bowel, sexual, general) of participants. RESULTS Most of the prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7% v 46.2% who underwent surgery), and the mean age was 67 years. There were no baseline differences in urinary, bowel, sexual, or hormonal domain EPIC scores across groups. We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant. No differences were found in secondary outcomes; however, coping appraisal was higher (2.8 v 2.6; P = .02) in intervention-arm patients at 5 months. In subgroup analyses, intervention participants reported improvement from baseline at 5 and 12 months in their symptom focus area domains. CONCLUSION This intervention was well received among veterans who were long-term survivors of prostate cancer. Although overall outcome differences were not observed across groups, the intervention tailored to symptom area of choice may hold promise to improve associated burden.

10602 Background: There is great need to build and evaluate tools and strategies to improve cascade genetic risk evaluation in families at high risk for hereditary cancer. The Genetic Information and Family Testing (GIFT) Trial (CA254822) is a population-based intervention that examines features of a virtual platform that provides genetic risk education (GRE) and low-cost genetic testing (GT) to relatives of adult patients diagnosed with cancer in 2018-19 in Georgia and California and tested positive for a clinically relevant germline pathogenic variant (PV). We present findings of a pilot study intended to inform the GIFT Trial protocol and platform features. Methods: We surveyed 277 women diagnosed with breast cancer in 2017, reported to the Georgia SEER registry, and received genetic testing (95% of whom had a clinically relevant PV). We then invited respondent patients to enroll in the intervention phase which provided online GRE, human pretest genetic navigator support, and an offer of low-cost GT through Color Health, Inc. to all untested 1st or 2nd degree relatives. Respondent patients were eligible for the intervention if they reported a PV on genetic testing and had at least one relative who had not received GT. Enrolled patients invited relatives through the platform by providing email addresses. Family clusters were block randomized to free vs $50 test costs at the time of the initial patient invitation. Results: At study midpoint, 117 of 277 patients (42%) had returned surveys: median age was 51 and 22% were African American. The most frequent PVs reported by the patients were BRCA1/2 (41%), CHEK2 (21%), and PALB2 (8%). Half (54%) had previously encouraged all of their brothers to get GT and 71% had encouraged all of their sisters to get GT. Three-quarters (78%) strongly agreed it was important for relatives to understand their genetic risk for cancer, and half (54%) strongly agreed they would like to make it easier for relatives to get genetic testing. The median number of patient-reported untested relatives in a family was 8.5 (25th-75th percentile: 4-14). Most respondent patients were eligible for the intervention phase (N = 108, 93%). About one-quarter had enrolled in the intervention at midpoint (16 of 53 in no-cost arm vs 16 of 55 in $50 arm). Patients in the no-cost arm invited 21 relatives, 10 of whom had enrolled with 8 ordering GT (38% of invited relatives). Patients in the $50 arm invited 38 relatives, 18 of whom had enrolled with 17 ordering GT (45% of invited relatives). Overall, about half of enrolled relatives (46%) were men. Conclusions: Breast cancer patients with PVs make substantial efforts to communicate with family members about genetic risk; but they strongly endorse the need for additional support to facilitate this complex communication. Interim pilot findings suggest that a low-cost online navigator-supported intervention can directly engage relatives with little difference in GT uptake by test cost arms.

5082 Background: Immunotherapy has limited efficacy in castration-resistant prostate cancer. Androgen deprivation therapy (ADT) has significant immunomodulatory effects and initially induces a complex immune infiltrate before castration-resistance develops. However, ADT also recruits immunosuppressive myeloid cells to the tumor microenvironment by increasing interleukin-8 (IL-8). We conducted a phase Ib/II clinical trial of immunotherapy plus ADT in men with recurrent castration-sensitive prostate cancer (CSPC). We hypothesized that anti-PD-1 (nivolumab) +/- anti-IL-8 (BMS-986253) given at the time of castration could induce anti-tumor immune responses and decrease disease progression. Methods: MAGIC-8 was a multicenter, phase Ib/II study evaluating nivolumab +/- BMS-986253 combined with a short course of degarelix acetate in patients with recurrent CSPC and rapid PSA doubling time (≤ 12 mos). In the Phase Ib portion, patients were treated with nivolumab (480mg Q4W) for 8 wks followed by nivolumab plus degarelix for an additional 16 wks. In the phase II portion, patients were randomized 1:2 to nivolumab + degarelix (Arm A) versus nivolumab + BMS-986253 (2400mg Q2W) + degarelix (Arm B). The primary endpoints were PSA recurrence at 10 mos following randomization and safety. Key secondary endpoints included biochemical recurrence-free survival (bPFS), time to recovery of testosterone (> 150ng/dl), and bPFS after recovery of testosterone. Results: Between October 16, 2019 and March 9, 2021, 59 patients were enrolled. The first 15 patients were treated on Arm A followed by 1:2 randomization to Arm A (N = 15) versus Arm B (N = 29). Median follow up was 11.6 mos at the data cutoff (1/24/22). Patients treated on Arm A had a significantly lower rate of PSA relapse (17.39%) at 10 mos compared to historical controls (p = < 0.001), including a subgroup of patients (6.67%) with recovery of testosterone and no PSA relapse at > 2 years of follow up. Median time-to-recovery of testosterone was 12.7 mos, median bPFS was 14.0 mos and median bPFS after recovery of testosterone was 5.5 mos. In Arm B, there was no difference in PSA relapse at 10 mos (35%, p = 0.09), median time-to-recovery of testosterone, median bPFS and median bPFS after recovery of testosterone compared to historical controls. Treatment in both arms was well tolerated with a lower rate of grade 3-4 treatment-related adverse events in Arm B compared to Arm A (3.5% vs 12.9%). Conclusions: A short course of ADT plus nivolumab may decrease the rate of PSA relapse and lead to durable long-term responses after recovery of testosterone in a subset of patients. These data support further evaluation of combining nivolumab with ADT in CSPC. Although the addition of BMS-986253 did not improve rate of PSA relapse, we observed significantly less toxicity with the addition of IL-8 inhibition. Clinical trial information: NCT03689699.

e17055 Background: Many men with prostate cancer will be exposed to ADT at some point during cancer survivorship. Unfortunately, ADT overuse in low-value scenarios is not uncommon (e.g., monotherapy in localized prostate cancer, biochemically-recurrent non-metastatic disease) resulting in more harms than benefits. We conducted an innovative survey study to unpack ADT overuse to inform behavior change and de-implementation strategies. Methods: Our survey used the Theoretical Domains Framework (TDF), and the Capability, Opportunity, Motivation – Behavior (COM-B) Model. The survey was fielded to the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on their likelihood of stopping ADT monotherapy in the case of a localized prostate cancer patient presenting to their office (yes/probably yes, probably no/no), and characterized Likert scale responses to 7 COM-B statements. We used multivariable logistic regression to identify associations between stopping ADT and COM-B responses across a dichotomized Likert scale of “strongly disagree/disagree/neutral” and “agree/strongly agree.”. Results: Our survey was completed by 84 respondents (13% response rate), with 27% indicating ‘probably no’/‘no’ to stopping low-value ADT monotherapy in the case of a localized prostate cancer patient presenting to their office. Our multivariable model identified 2 COM-B statements significantly associated with lower likelihood of stopping low-value ADT. Conclusions: Using an innovative, behavioral theory-informed survey, we identified that providers less likely to stop low-value ADT had greater concern about patient worry and were more interested in providing ADT recommendations consistent with peers, informing de-implementation strategy selection. Clinical trial information: MCT03579680. [Table: see text]

e17009 Background: [68Ga]-PSMA-11 positron emission tomography (PSMA PET) detects sites of biochemically recurrent prostate cancer (BCR) at higher rates than conventional imaging. We hypothesized that PSMA PET would lead to high change in management (CIM) rates in this setting. Methods: We prospectively recruited patients (pts) with BCR, defined as confirmed PSA > 0.2 ng/mL > 6 weeks post-surgery or PSA ≥2 ng/mL above nadir post-radiation therapy, to undergo Ga-68 PSMA-11 PET. Some also had equivocal lesions on CT, MRI, bone scan, or fluciclovine PET obtained prior to PSMA PET. Pre-PET intended treatment, PSA (ng/mL), and PSA doubling time (PSAdt, months) from most recent 3 values were recorded prior to imaging. Post-PET treatment (intended or actual) was collected from medical record. CIM was categorized as major (change in or addition of treatment modality) vs minor (change within treatment modality, such as altered radiation field). Any lesion with uptake above blood pool was interpreted as positive for prostate cancer by an experienced PET reader (DLC). All values were represented as the median [interquartile range, IQR]. Kruskal Wallis analysis tested for significant differences among groups. Results: 44 pts with BCR age 71 [10] with Gleason scores (GS) at diagnosis of 6 (N = 2), 7 (N = 23), 8 (N = 5), and 9 (N = 13) enrolled, 14/44 with equivocal lesions on conventional imaging. 42 had post-PSMA PET treatment decisions available in medical records for CIM analysis. Time from PSA nadir to PSA at time of PSMA PET was 5 [7.25] months. PSMA PET was positive in 33 (8/33 with equivocal lesions on prior imaging; 7 local disease only; 11 regional nodal metastases, 2/11 also with local disease; and 15 with distant metastases, 4/15 also with local disease, 9/15 with regional nodal metastases), negative in 6, and equivocal in 5 pts. Of those with distant metastases, 8 had oligometastases, defined as 3 or fewer distinct sites (1 site = single nodal region or single bone lesion), 4 in bones and 4 in distant nodes. CIM rate was 71% (30/42) overall, 65.5% (16/29 major, 3/29 minor) in pts with BCR and negative conventional imaging; 84.6% (11/13, all major) in pts with equivocal lesions on conventional imaging. Of the patients with major CIM, a treatment modality was added in 21/27, modality switched in 3/27, and a modality removed in 3/27. PSA was significantly lower (p = 0.04) for those with negative or equivocal PSMA PET (0.5 [2.7]) than those with localized disease (4.1 [2.8]), regional nodal (1.1 [3.4]) or distant metastases (3.8 [5.3]), but not PSAdt (p = 0.2, negative/equivocal PET 5 [6.5], localized 15 [36], regional nodal metastases 11 [13], distant metastases 6 [6]). Conclusions: PSMA PET may impact decision making in pts with BCR after treatment of localized prostate cancer, particularly for those with equivocal findings on conventional imaging, regardless of clinical risk at diagnosis. Clinical trial information: NCT04777071.

Purpose To provide an updated joint ASCO/Infectious Diseases Society of America (IDSA) guideline on antimicrobial prophylaxis for adult patients with immunosuppression associated with cancer and its treatment. Methods ASCO and IDSA convened an update Expert Panel and conducted a systematic review of relevant studies from May 2011 to November 2016. The guideline recommendations were based on the review of evidence by the Expert Panel. Results Six new or updated meta-analyses and six new primary studies were added to the updated systematic review. Recommendations Antibacterial and antifungal prophylaxis is recommended for patients who are at high risk of infection, including patients who are expected to have profound, protracted neutropenia, which is defined as < 100 neutrophils/µL for > 7 days or other risk factors. Herpes simplex virus–seropositive patients undergoing allogeneic hematopoietic stem-cell transplantation or leukemia induction therapy should receive nucleoside analog-based antiviral prophylaxis, such as acyclovir. Pneumocystis jirovecii prophylaxis is recommended for patients receiving chemotherapy regimens that are associated with a > 3.5% risk for pneumonia as a result of this organism (eg, those with ≥ 20 mg prednisone equivalents daily for ≥ 1 month or on the basis of purine analog usage). Treatment with a nucleoside reverse transcription inhibitor (eg, entecavir or tenofovir) is recommended for patients at high risk of hepatitis B virus reactivation. Recommendations for vaccination and avoidance of prolonged contact with environments that have high concentrations of airborne fungal spores are also provided within the updated guideline. Additional information is available at www.asco.org/supportive-care-guidelines .

Purpose Little is known about the extent to which genetic counseling is integrated into community practices for patients newly diagnosed with breast cancer. We examined the receipt of clinically indicated genetic counseling in these patients. Patients and Methods We surveyed 5,080 patients between the ages of 20 and 79 years, diagnosed from July 2013 to August 2015 with early-stage breast cancer and reported to the SEER registries of Georgia and Los Angeles County. Surveys were linked to SEER clinical data and genetic test results. The study sample (N = 1,711) comprised patients with indications for formal genetic risk evaluation. Results Overall, 47.4% did not get tested, 40.7% tested negative, 7.4% had a variant of uncertain significance only, and 4.5% had a pathogenic mutation. Three quarters (74.6%) received some form of genetic counseling (43.5%, formal counseling and 31.1%, physician-directed discussion). Virtually all tested patients (96.1%) reported some form of genetic discussion (62.2%, formal counseling and 33.9%, physician-directed discussion). However, only one half (50.6%) of those not tested received any discussion about genetics. Younger women were more likely to report some type of counseling, controlling for other factors: odds ratio, 4.5 (95% CI, 2.6 to 8.0); 1.9 (95% CI, 1.1 to 3.3); and 1.5 (95% CI, 1.0 to 2.3) for women younger than 50 years of age, 50 to 59 years of age, and 60 to 69 years of age versus those 70 years of age and older. Patients’ assessments of the amount of information they received about whether to get tested were similarly high whether they were counseled by a genetics expert or by a physician only (80.8% v 79.4% stated information was just right, P = .59). Conclusion Less than one half (43.5%) of patients with clinical indications received formal genetic counseling. There is a large gap between mandates for timely pretest formal genetic counseling in higher-risk patients and the reality of practice today.

Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions—both informed and values concordant—regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.

142 Background: Goals of care conversations are associated with less aggressive end of life care and may be most effective in an outpatient setting. Yet, the relationship between initial utilization of care and subsequent hospice enrollment is unknown. We evaluated whether inpatient, outpatient and emergency department (ED) evaluation and management (E/M) visits differed by patient race/ethnicity, and whether less outpatient management was associated with failure to enroll in hospice in a sample of women dying of ovarian cancer. Methods: Women diagnosed with first and only ovarian cancer who died between 2000 and 2016 and had ≥ one inpatient and outpatient ovarian cancer E/M encounter between diagnosis and the last two months of life in SEER-Medicare were included (N = 8,806). Women whose proportion of outpatient E/M encounters fell below the median were classified as having low outpatient management (vs. high). Multivariable-adjusted logistic regression was used to estimate the association of: (1) race/ethnicity with outpatient management, and (2) outpatient management with hospice enrollment, stratified by race/ethnicity. Models were adjusted for stage at diagnosis, histology, survival time, age, Charlson score, geographic region, and year. Results: In this sample, 29.2% of ovarian cancer E/M took place in an inpatient setting, 66.4% outpatient, and 4.4% in the ED. Non-Hispanic Black women had 53.9% of their E/M occur in an outpatient setting, compared to 67.6% in non-Hispanic White women, 60.7% in Hispanic women, and 64.2% in women of other races (p

250 Background: The number of men on active surveillance (AS) for low-risk prostate cancer is rapidly increasing. While AS requires routine clinical exams, labs, imaging, and prostate biopsies, many men do not receive all recommended components. Understanding the perspectives of key stakeholders regarding recommended surveillance is critical to ensuring the optimization of AS as a management strategy. Methods: We conducted in-depth, semi-structured, virtual interviews with a purposive sample of 15 men with low-risk prostate cancer who were on AS as their primary management strategy and their partners, and 15 urologists and 19 primary care providers (PCPs) with experience in AS management between June 2020 and March 2021. We used the Theoretical Domains Framework (TDF), an implementation science framework developed to understand determinants of behaviors and to inform the design of interventions, to guide our interview guide. Questions assessed knowledge, barriers and facilitators, and preferences for provider roles in AS management. Interviews were recorded, transcribed, and deductively coded into TDF domains and constructs. Three independent coders iteratively developed and used a shared coding framework. Participant recruitment continued until data saturation by group. Results: Our study included 15 men (on AS between 1-16 years), 5 partners, 15 urologists (3 female, 5 in private practice, 3 in academic medical centers), and 19 PCPs (9 female, 4 in community practices, 15 in academic medical centers). The TDF domain of “knowledge” and the construct, “barriers and facilitators” were most commonly reported as factors impacting receipt of recommended surveillance across all groups. While urologists were most knowledgeable about AS, PCPs noted limitations in understanding for whom AS is recommended, and what it entails. Patients who had made an effort to research or learn about AS found that this knowledge enabled them to be proactive about receiving all recommended components. Urologists and patients noted several common procedural barriers to receiving recommended surveillance, including pain with repeated biopsies, and becoming lost to follow-up. Patients and PCPs were uncertain about what tests were needed and when. Urologists were concerned about PCP knowledge while PCPs described insufficient communication from urologists as barriers to shared care. Procedural facilitators included electronic medical records (EMR) to remind providers and patients of frequency and timing of tests. Conclusions: Key opportunities for optimizing AS include improving patient and PCP knowledge about the components and delivery of AS, facilitating communication between providers, and leveraging EMR to ensure those on AS are followed. The development of an intervention that combines several of these components will be critical to ensuring men on AS receive the recommended surveillance.

4510 Background: The HCRN GU16-260 trial reported on the efficacy and toxicity of nivo monotherapy in treatment naïve clear cell RCC (Cohort A) and the efficacy of nivo/ipi salvage therapy in pts with tumors resistant to initial nivo monotherapy (Atkins JCO 2020.38.15_suppl.5006). Limited information is available on the effects of such an approach in pts with advanced nccRCC. Methods: Eligible pts with treatment-naïve nccRCC received nivo 240mg IV q2 wk x 6 doses followed by 360mg IV q3 wk x 4 doses followed by 480 mg q4 wk until progressive disease (PD), toxicity, or completion of 96 wks of treatment (Part A). Pts with PD prior to or stable disease (SD) at 48 wks (pSD) were potentially eligible to receive salvage nivo (3mg/kg) /ipi (1 mg/kg) q3 wk x 4 doses followed by q4 wk nivo maintenance for up to 48 wks (Part B). All pts were required to submit tissue from a metastatic lesion obtained within 12 months (mo) prior to study entry and prior to enrolling on Part B for correlative studies. Results: 35 pts with nccRCC were enrolled between 5/2017 and 12/2019 at 12 participating HCRN sites. Median age 63 (range 35-84 years); 89% male. IMDC favorable 8 (23%), intermediate 18 (51%) and poor risk 9 (26%). Of the 35 pts 19 (54%) had papillary, 6 (17%) chromophobe and 10 (29%) unclassified histology. RECIST defined ORR was 5 of 35 (14.3%) [CR 2 (5.7%), PR 3 (8.6%)], SD 16 (45.7%), PD 14 (40.0%). Immune-related ORR was 8 of 35 (22.9%). RECIST ORR by histology was: papillary - 1/19 (5%); chromophobe - 1/6 (17%); unclassified - 3/10 (30%). 9 pts (26%) had tumors with sarcomatoid features with 3 (33%) (2 unclassified, 1 papillary) responding. Median PFS was 4.0 (2.7, 4.3) mo. 21 pts remain alive. None of the responders have progressed or died. 28 pts (25 PD, 3 pSD) were potentially eligible for salvage nivo/ipi (Part B), but 12 did not enroll due to symptomatic PD (2), grade 3-4 toxicity on nivo (3), or other including no biopsy tissue (7). In the 16 Part B pts, best response to nivo/ipi was: PR (1, 6%) – (unclassified/non-sarcomatoid); SD (7, 44%); PD (8, 50%). Grade 3 Treatment-related adverse events (TrAEs) were seen in 7/35 (20%) on nivo. Grade 3-5 TrAEs were seen in 7/16 (44%) on nivo/ipi with 1 pt experiencing sudden death. Correlative studies including PD-L1 status, WES and RNAseq are pending. Conclusions: Nivo monotherapy has limited activity in treatment naïve nccRCC with most responses (4 of 5) seen in pts with sarcomatoid and/or unclassified tumors. Toxicity is consistent with prior nivo studies. Salvage treatment with nivo/ipi was provided in 16 of 28 (57%) pts with PD/pSD on nivo monotherapy, with 1 response observed. Clinical trial information: NCT03117309.