CONTEXT:Patients with advanced cancer are living longer, which can impact pain trajectories and management approaches. Opioids are commonly used to treat pain in these patients, yet there is limited data on current opioid management in this population. OBJECTIVE:We present baseline data from a prospective cohort study of patients with newly diagnosed advanced cancer. METHODS:Participants with a confirmed new diagnosis of advanced cancer and no history of long-term opioid use were recruited from five US oncology programs. Demographic information and validated patient-reported measures for pain (PEG score), comorbidities, and substance use measures were collected. We conducted descriptive statistics and assessed differences in PEG by short-duration opioid use with the Wilcoxon Rank Sum test. RESULTS:Of the 490 participants in the baseline analysis, median age was 67 years. Most participants identified as male (56%) and White (79%); digestive cancer was most common (35%). Most participants (58%) reported at least one non-cancer comorbidity. Approximately, 30% reported no pain, 36% reported mild pain, 22% reported moderate pain, and 12% reported severe pain. The PEG score was higher (P < 0.001) in those who used opioids in the past 3 months. Approximately, one-third (38%) of individuals reported recent short-term prescription opioid use. High-risk substance use was reported for alcohol (62% lifetime and 9% within the past 3 months) and, to a lesser extent, tobacco and cannabis. CONCLUSION:Older age, comorbidities, and substance use patterns noted in this population can impact pain trajectories and opioid safety.
MOTIVATION:Palliative Care (PC) is a small, relatively young interprofessional sub-specialty; hence mentorship for early-career research faculty is widely dispersed across schools and universities. We developed the Junior Visiting Professor Program (JVPP) to provide junior faculty in palliative care (PC) with opportunities to meet multidisciplinary PC researchers from other institutions and to advance their research through networking and presenting their work. We describe how we designed and implemented the program, and we report on the first cohort of participants. METHODS:We invited PC research groups from US schools of medicine and nursing to participate in this 5-year interprofessional exchange program by nominating junior faculty and serving as hosts. We matched nominees to host institutions based on nominee training experiences, nominee research interests, and host institution faculty expertise. In addition, we provided logistical guidance on visit planning. Post-visit, we surveyed both hosts and junior visiting professors (JVPs) regarding their satisfaction, perceived value, and suggestions regarding the program. RESULTS:We recruited 13 schools to participate and matched 10 nominees to host institutions in our first year. Nine JVPs completed their visit; 6 JVPs and 8 host faculty/staff responded to the post-visit survey. Overall, JVPs were highly satisfied with their matches and the visiting professor experience. Hosts were generally satisfied with their matches and believed the program to be mutually beneficial. The most frequent suggestion was for greater administrative support to plan visits. CONCLUSIONS:Structured, well-supported opportunities for networking across institutions is beneficial for emerging PC researchers and for building PC research capacity.
BACKGROUND:18F-Fluciclovine positron emission tomography (PET) was FDA-approved in the U.S. in 2016 and was the most sensitive imaging modality for prostate cancer (PC) until the approval of prostate-specific membrane antigen (PSMA) PET in 2020. However, providers' reasons for ordering 18F-Fluciclovine PET/CT (FluPET) in practice and impact on patient care remain poorly defined. This prospective registry at a tertiary academic center describes patterns of FluPET use and outcomes prior to the FDA approval of PSMA PET in December 2020. METHODS:Providers ordering FluPET for patients with PC were surveyed before, ≤2 weeks after, and ≥1 year after imaging to assess reasons for obtaining FluPET, projected treatment plan, changes in plan due to FluPET findings, and toxicity attributable to the change in treatment plan. Baseline patient characteristics, FluPET results, and longitudinal outcomes were collected. RESULTS:Between 12/2018-09/2021, 62 patients with localized PC (8.1%), biochemical recurrence (BCR; 80.6%), non-metastatic castration-resistant PC (CRPC) (3.2%), metastatic castration-sensitive PC (3.2%), or metastatic CRPC (4.8%) were enrolled and underwent FluPET. Most scans (90.3%) were performed prior to the FDA approval of PSMA PET 12/2020. FluPET was most often obtained to guide local salvage or metastasis-directed therapies (90.3%); other reasons (non-exclusive) were initial staging (9.6%) or clarifying equivocal lesions from other imaging (9.6%). FluPET detected ≥1 PC lesion in 74.2% of patients. After FluPET, 48.4% of providers reported changing treatment plans, which was more likely when FluPET was positive (60.9% vs 12.5%, P<0.001), and often involved initiation of systemic therapy (19.4%). Treatment changes were reported in 57% of patients with BCR1 and 48.2% of patients with BCR2. In contrast, only 20% of patients with distant metastatic disease had a change in treatment. Among patients in the BCR1 and BCR2 cohort, treatment plan changes were associated with a median time to next treatment that was not reached after a median follow-up of 67.6 months. There was no statistically significant difference in overall survival between patients with biochemical recurrence (BCR) who did and did not have a treatment plan change. A year after FluPET, reported potential toxicities from treatment plan changes were minimal. CONCLUSION:FluPET was utilized across the disease spectrum of PC, primarily to guide local salvage or metastasis-directed therapies, given its improved sensitivity for detecting prostate bed recurrence due to the slow physiologic excretion of 18F-fluciclovine. Notably, a positive FluPET frequently prompted initiation of systemic therapy; however, the clinical benefit of such management remains uncertain. Moreover, providers often selected multiple, sometimes conflicting, treatment plans following FluPET, reflecting uncertainty in translating imaging findings into definitive management decisions. A larger, prospective registry using PSMA PET with a requirement for providers to select a single post-scan treatment strategy is warranted to better assess whether imaging-guided treatment changes improve clinical outcomes.
385 Background: Tyrosine kinase inhibitors (TKI) and immuno-oncology (IO) agents alone or in combination have revolutionized the landscape of management for untreated metastatic renal cell carcinoma (mRCC). Baseline quality of life (QOL) outside of interventional clinical trials and rationale for management decisions in mRCC are poorly understood. Methods: In this prospective observational study of 800 mRCC pts in the US, pts must: have a diagnosis of mRCC (any histology) with no prior systemic therapy (ST) for mRCC; be age ≥19 at informed consent; be able to comply with completion of PROs. Exclusion criteria include being treated for active malignancy other than mRCC or not intending to follow up at a study site within PCORnet. Pts undergo consent and baseline assessments by the study site team, with subsequent follow up by the central coordinating center. The primary objective is to determine distinct patterns of change in QOL and symptom burden of mRCC pts. A key secondary objective is to identify patterns of clinical management in the real world setting of mRCC across treatment regimens. Minimally important differences are defined as 3- and 7-points for FKSI-19 and FACT-G respectively. ClinicalTrials.gov ID: NCT04919122. Results: As of 9/1/2023, 173 pts have been enrolled (126 ST, 47 no ST [NST]): 75% male, 87% white, 73% clear cell, 52% intermediate risk and 47% poor risk. 47% had radical nephrectomy and 22% another solid tumor. ST pts as compared to NST pts were more likely to be poor risk (52% vs 16%); but differences in baseline pain were not significant. Of ST pts, 44 were treated with IO-IO (ipilimumab + nivolumab), 50 with IO-TKI (cabozantinib + nivolumab 38%, axitinib + pembrolizumab 38%, lenvatinib + pembrolizumab 24%) and 32 other (IO alone 34%, TKI alone 31%, investigational drug 25%). Reasons for NST included active surveillance (AS, 50%), other (21%), local therapy (13%). Mean differences between ST and NST for baseline FKSI-19 and FACT-G were 5.7 (95% CI: 1.2 – 10.2) and 3.3 (-2.6 – 9.3). There were no differences in pain or PROs between IO-IO and IO-TKI pts. Mean differences in FKSI-19 and FACT-G between AS vs IO-IO were 10.6 (4.8 – 16.4) and 8.6 (1.1 – 16.0); and vs IO-TKI were 11.0 (4.9 – 17.0) and 10.3 (3.5 – 17.1). On physician surveys, primary reasons for treatment selection were (in order of % selected): complete response (CR), prolonged survival (OS), prognostic factors (Px), treatment-free interval for IO-IO; versus delaying progression (PFS), OS, CR, Px for IO-TKI. Conclusions: Our data suggest differences in baseline QoL in pts treated with ST vs NST, as well as AS vs IO-IO or IO-TKI, in the real world. Reasons for selection of ST regimen differed among combination regimen classes. Completion of ODYSSEY will clarify baseline and longitudinal differences in pain and PROs among management strategies and give novel insights into the rationale for real world management of untreated pts with mRCC. Clinical trial information: NCT04919122 .
TPS595 Background: Erdafitinib and enfortumab vedotin are available treatment options in mUC patients with somatic FGFR2/3 GAs after progression on platinum-based chemotherapy and PD-1/L1 inhibitors. However, due to decline in their clinical condition, the sequential delivery of these agents is challenging. Tubulin antagonists induce a G2-M cell-cycle block, while FGFR inhibitors cause a G1 block, with studies suggesting that their combination may be additive or synergistic. Retrospective studies suggest that the activity of EV is not compromised by somatic FGFR2/3 GAs. Hence, there is rationale to evaluate the feasibility of the combination of EV and E, to overcome the difficulties of resistance and sequencing these agents in mUC patients with FGFR2/3 GAs. Methods: This is a phase Ib, single arm, multicenter study in patients with mUC harboring somatic FGFR2/3 GAs who have progressed after platinum and PD-1/L1 inhibitor therapies with enrollment of up to 30 patients. Pts are required to have predominant urothelial component, ECOG-PS 0-2, neuropathy ≤ grade 1 and no ophthalmologic conditions precluding treatment with E. FGFR2/3 GAs may be identified by tumor tissue or circulating tumor (ct)-DNA profiling. The primary objective is feasibility and establishing a recommended phase-2 dose (RP2D). Secondary objectives include objective response rate, duration of response, progression-free survival and overall survival. The dose-escalation component will enroll up to 18 pts with 3+3 design (dosing cohorts in table), followed by dose-expansion component of 12 pts. The dose limiting toxicities (DLTs) will be evaluated using a sequential Bayesian toxicity monitoring that allows a maximum DLT rate of 0.33 during the dose-expansion phase. Exploratory biomarker analyses will be performed including 1) tumor PD-L1, Nectin-4 assessment by immunohistochemistry and association with response 2) ct-DNA evaluation at baseline and progression to evaluate resistance pathways 3) pharmacokinetic studies will assess plasma levels of E and free monomethyl auristatin-E (MMAE). This is led by North American Star Consortium as part of Experimental Therapeutics. Clinical trial information: NCT04963153. [Table: see text]
Background and Objectives: Mixed success with primary palliative care delivery models may be related to inadequate communication between members of the care team. We sought to describe the previously unexamined role of oncologists in an oncology nurse-led primary palliative care intervention study.Design, Setting, and Subjects: We conducted a secondary analysis of data from Care Management by Oncology Nurses to Address Supportive Care Needs, a cluster-randomized controlled trial of a nurse-led primary palliative care intervention for adults with advanced cancer conducted at 17 community oncology clinics in Western Pennsylvania from 2016 to 2020. Nurses conducted three monthly study visits during which they developed care plans (CPs) with the patient and after which they updated the patient's oncologist. We characterized the level of oncologist involvement with the intervention.Results: Of the 336 patients randomized to receive primary palliative care, 266 completed at least one study visit and 233 (88%) had at least one visit where the oncologist was updated afterward. Across 674 total study visits, the oncologist was updated in 553 (82%) of the visits, signifying the oncologist awareness of the intervention. Of the times the nurse updated the oncologist, a CP was presented 29% of the time (163/553).Conclusion: In a large trial of oncology nurse-led primary palliative care, oncologists were often aware of but infrequently involved with the intervention. Future primary palliative care interventions should consider communication and engagement among team members.
2592 Background: Pembrolizumab (pembro) is an intravenous immune checkpoint inhibitor used for anti-cancer treatment, with equivalent monotherapy dosing options of 200 mg every 3 weeks (Q3W) or 400 mg every 6 weeks (Q6W). Pembro Q6W dosing was approved for use in April 2020 after the Q3W dose had already been established. As pembro dosing patterns in real-world practice are not well-described, we evaluated this in a large cancer center network consisting of a central site (CS) and 36 community network sites (NS). Methods: We retrospectively reviewed the charts of all patients who received pembro monotherapy for cancer treatment between 4/2020 – 4/2022 at UPMC Hillman Cancer Center sites across the state of Pennsylvania, as well as sites in New York and Ohio. We performed statistical comparisons using the Fisher’s exact test and Wilcoxon rank-sum test. Results: We identified 1,640 patients who received pembro monotherapy, including 377 patients at the CS and 1,263 patients in the NS, with characteristics displayed. Pembro Q6W dosing was significantly more common at the CS than in the NS (42% vs. 15%, p<0.0001). When analyzed by tumor type, pembro Q6W dosing was significantly more common at the CS than in the NS for head & neck (53% vs. 11%, p<0.0001), thoracic (49% vs. 15%, p<0.0001), skin (60% vs. 19%, p<0.0001), and genitourinary (30% vs. 16%, p=0.015) cancers, but not for other tumor types. Within the NS, 30% (11/36) of sites only utilized pembro Q3W dosing and never administered Q6W dosing to patients. Of note, some patients who received pembro Q6W dosing received pembro Q3W dosing initially, either as part of a pembro-containing multidrug regimen or as monotherapy. Excluding patients initially treated with a multidrug regimen to reduce confounding factors, we found that of the patients who received pembro Q6W dosing, 47% (65/137) at the CS and 28% (48/169) in the NS were initially treated with pembro Q3W monotherapy before transitioning to Q6W monotherapy (p=0.0008). Conclusions: In our large cancer center network, pembro Q6W dosing was significantly more common at the CS than in the NS. Switching from pembro Q3W to Q6W dosing was also significantly more common at the CS. Further work is needed to clarify the patient, provider, and institutional factors influencing differences in pembro dosing patterns in real-world practice, as well as the impact of dosing patterns on care delivery outcomes such as cost and accessibility. [Table: see text]
264 Background: Patients with advanced cancer are recommended to receive palliative care (PC) early, but a limited PC specialty workforce limits feasibility. Primary PC, administered by providers outside the PC specialty, has been proposed as a way to increase access to PC. However, prior studies of primary PC have not demonstrated benefit, possibly due to lack of collaboration within the care team. We examine oncologist involvement in the largest primary PC study to date, where primary PC was delivered by oncology nurses. Methods: CONNECT (NCT02712229) was a cluster-randomized controlled trial of a primary PC intervention conducted at 17 community oncology clinics in Western Pennsylvania from 2016-2020. Selected clinic nurses (N=23) were trained to deliver up to 3 monthly primary PC visits, formulating a care plan after each visit. Nurses were asked to update the patient’s oncologist after each visit and to document this communication. We use descriptive statistics to examine level of oncologist involvement in these primary PC visits, based on nurse documentation. Results: Of 336 patients randomized to receive the primary PC intervention, 266 completed at least one study visit, and 233 (87.6%) had at least one visit where the nurse reported updating the oncologist afterwards. Of 674 total study visits, nurses reported updating the oncologist in 553 (82.0%) of them, most commonly in person (77.0%), followed by email (13.4%) and phone (9.6%). For in person or phone exchanges, mean length of interaction was 8.3 (SD 5.7) minutes, with a median of 5.0 minutes. For visits where communication occurred between the nurse and oncologist, the nurse reported presenting their specific care plan only 29.5% of the time (163/553 visits). In 96.9% (158/163) of cases, the oncologist was reported as receptive to the presented care plan, with no further details given in the 5 instances where the oncologist was reported as not receptive. When the oncologist was receptive to the care plan, it was reported that no changes were made by the oncologist in 94.3% (149/158) of cases. In the handful of cases where changes were made, changes involved ordering additional tests (3), changes to non-oncologic medications or therapeutics (2), involving other providers (1), changing oncologic treatment (1), and modifying the patient’s visit schedule (1). Conclusions: In a large trial of oncology nurse-led primary PC, oncologist involvement in care plans was not robust. More extensive team collaboration may be required in future primary PC interventions to increase the efficacy of primary PC. Clinical trial information: NCT02712229 .
e17019 Background: Patients with PC often live for many years and can experience burdensome symptoms associated with PC and its treatment. The longitudinal fluctuations in symptom burden for a given individual with PC, or for groups with different PC disease states, are not well-described. We assessed self-rated performance status (PS), pain interference with daily activities, bother from sexual dysfunction, depression, and anxiety symptoms longitudinally for a cohort of patients with PC. Methods: For one year, patients with PC and ≥1 Urology or Medical Oncology clinic visit in the prior 6 months were emailed surveys every 60 days containing the ECOG PS instrument (range 0-4, higher scores = worse PS), PROMIS Pain Interference Short Form 4a (normalized range 1-5, higher scores = greater pain interference), PROMIS Sexual Bother (Male) items SFBOT 204, 205, and 206 (normalized range 1-5, higher scores = greater bother), PHQ-9 depression scale (range 0-27, score ≥10 considered positive for moderate symptoms), and GAD-7 anxiety scale (range 0-21, score ≥10 considered positive for moderate symptoms). We used chart review to obtain baseline characteristics and one-way ANOVA for comparisons. Results: For 201 enrolled patients, mean (SD) number of surveys completed was 5.8 (1.8) over a mean (SD) of 10.6 (3.1) months. At baseline, 50.7% had localized PC (LPC), 18.9% biochemically recurrent PC (BCR-PC), and 30.3% metastatic PC (MPC). 40.8% of patients were on androgen deprivation therapy, which was not associated with greater sexual bother (p = 0.17). Mean (SD) values for ECOG PS, pain interference, sexual bother, the PHQ-9, and the GAD-7 are shown by PC disease state (Table). For patients who completed ≥2 surveys (N = 192), mean (SD) ranges for these scales were 0.4 (0.6), 0.8 (0.9), 1.2 (0.8), 3.7 (3.3), and 2.6 (2.6), respectively. Mean range differed by PC disease state for ECOG PS (0.31 LPC vs 0.63 BCR-PC vs 0.59 MPC, p = 0.003) and pain interference (0.63 LPC vs 1.02 BCR-PC vs 0.95 MPC, p = 0.03). For patients with ≥1 positive PHQ-9 (N = 36) or GAD-7 (N = 11) screen over ≥2 surveys, a mean (SD) of 41% (30%) and 39% (33%), respectively, of their total screens were positive. Mean (SD) ranges for these patients were 8.4 (3.6) for the PHQ-9 and 8.5 (3.4) for the GAD-7 (both p < 0.001 compared with those who never screened positive). Conclusions: Patients with more advanced PC had worse PS, pain, and depression, but those with BCR-PC reported greater longitudinal fluctuations in PS and pain. Patients who screened positive for depression or anxiety only did so in ~40% of their surveys, and had greater longitudinal variability in their PHQ-9/GAD-7 scores than those who never screened positive. [Table: see text]
TPS739 Background: The landscape for treatment of metastatic renal cell carcinoma (mRCC) has changed dramatically over the past 7 years with the approvals of tyrosine kinase inhibitors and immune-oncology (IO) agents alone or in combination for untreated mRCC. However, multiple knowledge gaps remain. While active surveillance remains an option for selected pts, prospective evidence on selection of and outcomes for pts is limited. Recent phase III trials all used a common comparator, sunitinib, so no comparative effectiveness data on the new IO-based regimens exists. There are also no routinely used predictive biomarkers in mRCC pt management. Therefore, a better understanding of the biologic determinants associated with cancer heterogeneity and clinical outcomes through blood, tumor, and radiographic based assessments is needed. Importantly, longitudinal changes in health-related quality of life (QOL) and symptom burden of patients with mRCC initiated on new IO–based regimens outside of an interventional clinical trial are poorly understood. Pt reported outcomes (PRO) are rarely captured in a systematic manner. Addressing the evidence gap for how real world pts symptomatically change with treatment combinations and sequences over time is a pressing unmet need. Methods: This is a prospective, observational cohort, phase IV study of 800 mRCC pts in the US. Pts must: be age ≥19 at informed consent; have a diagnosis of mRCC (any histology) with no prior systemic therapy for mRCC (surgery and radiation therapy, prior neoadjuvant/adjuvant therapy for non-mRCC, and pts currently not on systemic therapy and being observed are all permitted); and be able to comply with completion of PROs. Those being treated for active malignancies other than mRCC or not intending to undergo follow up care at a study site within PCORnet are excluded. Pts will undergo consent and baseline assessments, including research blood collection and processing, by the study site team. A novel aspect of this study is the use of PCORnet and Medicare data to minimize data collection burden on sites. PCORnet, the National Patient-Centered Clinical Research Network, is a network of networks that curates EHR data from multiple health systems using a common data model. This allows subsequent follow up to be centrally coordinated by the coordinating center. PRO will be collected at baseline (pre-treatment), every 3 mos for 2 yrs, and then every 6 mos until end of follow up (minimum 18 mos follow-up; maximum 36 mos follow-up). The primary objective is to determine distinct patterns of change in QOL and symptom burden of mRCC pts receiving therapy. Secondary objectives include quantifying the time to treatment discontinuation of pts, identifying patterns of clinical management in the real world setting of mRCC pts on various treatment regimens, and evaluating overall survival of mRCC pts. ClinicalTrials.gov Identifier: NCT04919122 Clinical trial information: NCT04919122 .
10501 Background: Approximately 10% of men with metastatic prostate cancer (mPC) have germline DNA damage response gene mutations (gDDRm), indicating candidacy for precision treatment. Consequently, national guidelines recommend germline genetic testing be offered to all men with mPC. It is currently unclear what the rates of testing are in the community, and barriers to testing are not well understood. We conducted a population-based study to better understand current rates of germline genetic testing in men with newly diagnosed mPC, and to determine whether removing major barriers of cost and access could expand uptake of germline genetic testing. Methods: This is a prospective observational study that identifies men ages 35-79y with mPC residing in a 13-county area of Washington State through the Surveillance, Epidemiology, and End Results (SEER) program (NCT04254133). Men with new diagnoses of mPC are contacted by mailed invitation and follow-up phone inquiry. Interested men are then invited to provide informed consent and complete a questionnaire about personal and family health history. A saliva collection kit for a 30-gene targeted panel of cancer predisposition genes (Color Genomics) is mailed to participants’ homes free of charge. Results are issued by phone and/or email with genetic counseling support, including discussion about cascade genetic testing if relevant. Results: As of Feb 9, 2022, 484 men with incident mPC diagnosed 1/2018-6/2021 were identified through SEER. 430 men were reached via a letter to their home address sent > 3 months after diagnosis. 175 of 430 (40.6%) men expressed interest and completed the questionnaire, the majority preferring to complete testing through mail after a phone-initiated introduction to the study. 164 of 175 men completed the consent process and were eligible. Of these 164 men, 45 (27.4%) reported prior genetic testing, and reports were requested and reviewed to ensure adequate testing. Ultimately, 121 of 164 (73.8%) participants initiated and 101/121 (83.5%) have completed genetic testing through the study. Nine percent (9/101) of participants completing testing as part of the study were found to have gDDRm. Conclusions: We used a population-based approach to understand the proportion of men with mPC undergoing germline genetic testing through clinical care, and the subsequent uptake of genetic testing when access and cost barriers are removed. The uptake of guideline-based germline genetic testing among men with mPC in the community prior to study enrollment is only 27.4%. With study interventions in the form of free testing through mail, and phone-based support, 83.5% of men in this community successfully completed testing. Further work in this study will aim to elucidate and attempt to eliminate other barriers in germline genetic testing to further improve testing rates in this community.
5023 Background: Untreated depression and anxiety are associated with worse outcomes in patients with cancer. Despite recommendations for longitudinal screening, many patients are only assessed at the start of care. Men with PC often experience many phases of disease or treatment over a span of years, and androgen deprivation therapy (ADT) is associated with mood changes and depression. How depressive or anxiety symptoms fluctuate in men with PC, influenced by disease and treatment factors, is not well-described. Methods: Men with ≥1 Urology or Medical Oncology clinic visit for PC in the prior 6 months were emailed the PHQ-9 and GAD-7 depression and anxiety screening tools every 60 days; a score of ≥10 (moderate to severe symptoms) on either was considered a positive screen. Baseline characteristics and disease/treatment changes (PSA, radiographic, or biopsy progression, treatment change or start, or discontinuation of treatment due to lack of efficacy or toxicity) were collected by survey and chart review. We report early findings of factors associated with a positive screen or change in screening status with χ2 and forward stepwise binary logistic regression (model inputs: receipt of ADT or disease/treatment change during study, and variables previously associated with depression or anxiety: age, race, marital status, education, income, history of psychiatric disorder, use of psychoactive medication, time since diagnosis, and localized, biochemically recurrent, or metastatic disease). Results: From 6/2021-12/2021, 201 men enrolled. At baseline, 50.7% had localized, 18.9% biochemically recurrent, and 30.3% metastatic disease; 40.8% were on ADT; 30.8% had a history of psychiatric disorder (22.9% depression, 19.9% anxiety, 9.0% other); and 24.9% were on psychoactive medication (19.9% antidepressant, 8.5% anxiolytic, 2.0% antipsychotic). 184 men completed at least 2 screens with mean follow-up 6.5 months (SD 1.3). 32 men (15.9%) screened positive at least once (15.4% PHQ-9, 4.5% GAD-7), of which half (N = 16) initially screened negative and later positive. Changing from a negative to positive screen was more likely when a disease/treatment change occurred during the study (18.3% vs 4.5%, p = 0.003). A higher proportion of men on ADT screened positive, especially if newly started during the study or in the 60 days preceding (35.7% new ADT vs 24.7% continuing ADT vs 8.0% no ADT, p = 0.002). In fully adjusted multivariable analyses, factors associated with a positive screen were history of psychiatric disorder (OR 6.3, 95% CI 2.6-15.4, p < 0.001), receipt of ADT (OR 3.8, 95% CI 1.5-9.5, p = 0.005), and lower income bracket (OR 1.7, 95% CI 1.3-2.5, p = 0.002). Conclusions: Longitudinal screening for depression and anxiety in PC identifies men who initially screen negative. Symptoms are associated with ADT and disease or treatment changes, which may inform optimal screening practices.
Enfortumab vedotin (EV) is the first antibody-drug conjugate approved for locally advanced or metastatic urothelial cancers (la/mUCs), a disease group historically associated with limited prognosis and therapeutic options. EV consists of monomethyl auristatin E, a microtubule-disrupting agent linked to an antibody targeting Nectin-4. In clinical trials, EV demonstrated high response rates and superior survival in the third-line setting for la/mUC compared with chemotherapy. Peripheral neuropathy and rash were among the most common serious adverse events. EV is currently approved in multiple countries for the treatment of la/mUC in the later-line setting. Ongoing trials seek to expand the indication for EV and to study therapeutic combinations with other agents.
219 Background: Patients with prostate cancer (PC) have high rates of depression (15-20%), which is associated with worse oncologic outcomes. The PHQ-9 is commonly used in depression screening, but men with depression may present differently than women, and male-specific screening tools such as the Gotland Male Depression Scale (GMDS) have also been developed and validated. The use of supportive care services in men with PC and depression is not well-described. Methods: Men with ≥1 Urology or Medical Oncology clinic visit for PC in the prior 6 months were emailed the PHQ-9 and GMDS every 60 days. Men who screened positive (score ≥10 on PHQ-9 or ≥13 on GMDS, consistent with moderate to severe depression) were contacted by phone to discuss the positive screen; during that conversation patients were offered a referral to an oncology social worker for a formal needs assessment and connection to supportive care services. Patient characteristics and use of supportive care services (palliative care, psychiatry, counseling, support groups, or spiritual health) at baseline and as a result of study screening were collected by survey and chart review. Results: Between 6/2021-12/2021, 201 men enrolled (Table). 184 completed ≥2 screens with mean follow-up 6.5 months (SD 1.3). 31 men (15.4%) had ≥1 positive PHQ-9 screen and 11 (5.5%) had ≥1 positive GMDS screen, 9 of whom also screened positive on the PHQ-9. Of the 33 men offered clinical social work referrals based on PHQ-9 or GMDS screening, 12 (36%) initially accepted and 7 (21%) ultimately met with social work. Of these 7 men, two ultimately received ongoing supportive counseling from social work, two were referred to support groups or peers in the community, and one was referred to financial services; the remaining two men were not followed longitudinally or referred to any services by the social worker, but were given the option to re-contact the social worker as needed. For the two patients who screened positive on the GMDS but not the PHQ-9, one declined social work referral, and one initially accepted but never scheduled an appointment. Conclusions: Use of supportive care services in men with PC was low, including when services were actively offered as a result of depression screening. Beyond the PHQ-9, the GMDS did not identify any men who engaged in supportive care services. More work is needed to optimally identify men with PC who may benefit from supportive care services and barriers to use.[Table: see text]
1557 Background: Patients with prostate cancer are diagnosed through a prostate needle biopsy (PNB). Information contained in PNB pathology reports is critical for informing clinical risk stratification and treatment; however, patient comprehension of PNB pathology reports is low, and formats vary widely by institution. Natural language processing (NLP) models trained to automatically extract key information from unstructured PNB pathology reports could be used to generate personalized educational materials for patients in a scalable fashion and expedite the process of collecting registry data or screening patients for clinical trials. As proof of concept, we trained and tested four NLP models for accuracy of information extraction. Methods: Using 403 positive PNB pathology reports from over 80 institutions, we converted portable document formats (PDFs) into text using the Tesseract optical character recognition (OCR) engine, removed protected health information using the Philter open-source tool, cleaned the text with rule-based methods, and annotated clinically relevant attributes as well as structural attributes relevant to information extraction using the Brat Rapid Annotation Tool. Text pre-processing for classification and extraction was done using Scispacy and rule-based methods. Using a 75:25 train:test split (N = 302, 101), we tested conditional random field (CRF), support vector machine (SVM), bidirectional long-short term memory network (Bi-LSTM), and Bi-LSTM-CRF models, reserving 46 training reports as a validation subset for the latter two models. Model-extracted variables were compared with values manually obtained from the unprocessed PDF reports for clinical accuracy. Results: Clinical accuracy of model-extracted variables is reported in the Table. CRF was the highest performing model, with accuracies of 97% for Gleason grade, 82% for percentage of positive cores ( < 50% vs. ≥50%), 90% for perineural or lymphovascular invasion, and 100% for presence of non-acinar carcinoma histology. On manual review of inaccurate results, model performance was limited by PDF image quality, errors in OCR processing of tables or columns, and practice variability in reporting number of biopsy cores. Conclusions: Our results demonstrate successful proof of concept for the use of NLP models in accurately extracting information from PNB pathology reports, though further optimization is needed before use in clinical practice.[Table: see text]
Background Genetic testing, particularly for BRCA1/2, is increasingly important in prostate cancer (PCa) care, with impact on PCa management and hereditary cancer risk. However, the extent of public awareness and online discourse on social media is unknown, and presents opportunities to identify gaps and enhance population awareness and uptake of advances in PCa precision medicine. Objective The objective of this study was to characterize activity and engagement across multiple social media platforms (Twitter, Facebook, and YouTube) regarding BRCA and genetic testing for PCa compared with breast cancer, which has a long history of public awareness, advocacy, and prominent social media presence. Methods The Symplur Signals online analytics platform was used to obtain metrics for tweets about (1) #BRCA and #breastcancer, (2) #BRCA and #prostatecancer, (3) #genetictesting and #breastcancer, and (4) #genetictesting and #prostatecancer from 2016 to 2020. We examined the total number of tweets, users, and reach for each hashtag, and performed content analysis for a subset of tweets. Facebook and YouTube were queried using analogous search terms, and engagement metrics were calculated. Results During a 5-year period, there were 10,005 tweets for #BRCA and #breastcancer, versus 1008 tweets about #BRCA and #prostatecancer. There were also more tweets about #genetictesting and #breastcancer (n=1748), compared with #genetic testing and #prostatecancer (n=328). Tweets about genetic testing (12,921,954) and BRCA (75,724,795) in breast cancer also had substantially greater reach than those about PCa (1,463,777 and 4,849,905, respectively). Facebook groups and pages regarding PCa and BRCA/genetic testing had fewer average members, new members, and new posts, as well as fewer likes and followers, compared with breast cancer. Facebook videos had more engagement than YouTube videos across both PCa and breast cancer content. Conclusions There is substantially less social media engagement about BRCA and genetic testing in PCa compared with breast cancer. This landscape analysis provides insights into strategies for leveraging social media platforms to increase public awareness about PCa germline testing, including use of Facebook to share video content and Twitter for discussions with health professionals.
29 Background: FluPET, a next-generation imaging modality approved in 2016 for suspected PC recurrence with elevated PSA after prior therapy, is becoming more widely available; however, practice patterns and impact on outcomes is unknown. We hypothesize FluPET is ordered for a variety of reasons, with findings often leading to changes in treatment plan. Methods: In this prospective registry, providers are surveyed before, 1-2 weeks after, and 1 year after FluPET to assess reasons for obtaining FluPET, projected treatment plan, changes in plan due to FluPET findings, and toxicity potentially attributable to change in treatment plan. Baseline patient characteristics, FluPET results, and longitudinal outcomes are collected. We report early descriptive findings with χ2 and student’s t-test used for univariate analyses. Results: 50 patients enrolled 12/2018-08/2020 had baseline characteristics described in Table; 46 underwent FluPET. Rationale for ordering included initial staging prior to definitive local therapy (6.1%), guidance of salvage local therapy for 1st biochemical recurrence (BCR) (46.9%), guidance of additional salvage after ≥2 local therapies and 2nd BCR (36.7%), and confirmation of equivocal metastatic disease (10.2%). When queried on next steps, providers considered observation (67.3%), androgen deprivation therapy (ADT) (26.5%), ADT + docetaxel or novel anti-androgens (AA) (20.4%), and salvage therapy with surgery, radiation, or cryotherapy (26.5%), often selecting ≥1 option. FluPET found ≥1 PC lesion in 73.9% of cases, ≥1 indeterminate lesion in 8.7%, and no lesions in 17.4%. 45.5% of providers reported changing treatment plan based on FluPET results; 6.8% changed to observation, 20.5% to systemic therapy, 13.6% to local salvage therapy, and 4.5% to a combination of local and systemic therapies. Change in therapy was associated with positive FluPET (54.5% vs. 18.2%, p=0.044), and within those cases, with higher SUVMax (mean 7.7 vs. 5.2, p=0.021) but not number of lesions (p=0.804). Conclusions: FluPET is often obtained to guide salvage therapy after BCR but is also used for initial staging or resolving equivocal findings of metastases. Many providers changed intended treatment based on FluPET findings, especially if positive; de-escalation to observation was rare. [Table: see text]
459 Background: First-line platinum-based combination chemotherapy (fPBC) is standard of care for fit patients with mUC. Further lines of therapy include immuno-oncology agents, erdafitinib, and enfortumab vedotin, but patients ineligible for these therapies or who subsequently progress may be considered for further chemotherapy. As the choice of chemotherapy regimen is unclear for these patients, we compared the efficacy of subsequent platinum-based chemotherapy (sPBC) and subsequent non-platinum-based chemotherapy (sNPBC) in patients with mUC. Methods: Data was analyzed from the Retrospective International Study of Cancers of the Urothelium (RISC), comprising patients from 28 international centers treated 2005-2012. Inclusion criteria were diagnosis of mUC, receipt of fPBC for mUC, and receipt of ≥2 cycles of subsequent chemotherapy. Patients who had received prior platinum-based chemotherapy in the non-metastatic setting were excluded. A multivariate Cox proportional hazards model was used to compare overall survival (OS), while χ2 and student’s t-test were used for univariate analyses. A two-sided p value of <0.05 was considered statistically significant. Results: Of 296 patients, 135 received sPBC and 161 received sNPBC. Common sNPBC regimens contained gemcitabine, taxanes, or pemetrexed. Baseline characteristics were similar, including Charlson Comorbidity Index (CCI) and performance status (PS), except more patients in the sPBC group had achieved investigator-designated stable disease or response (SD/R) with fPBC (75.4% vs. 63.3%, p = 0.031) and had higher hemoglobin values (median 11.9 vs. 11.1 g/dL, p = 0.004). OS was superior for patients receiving sPBC (median 7.9 months) compared to sNPBC (median 5.5 months) after adjusting for CCI, PS, presence of liver metastases, time since fPBC, and number of fPBC cycles received (HR 0.72, 95% CI 0.53-0.98, p = 0.035). 70 patients (57.4%) achieved SD/R with sPBC and 65 (44.8%) with sNPBC (p = 0.041). Achieving SD/R with subsequent chemotherapy was not associated with number of fPBC cycles received, but for sPBC was associated with longer time since fPBC (median 5.9 vs. 2.9 months, p = 0.033); the same was not true for sNPBC (median 2.2 vs. 2.6 months, p = 0.057). Achieving SD/R with fPBC was associated with greater likelihood of SD/R with sPBC (63.2% vs. 29.6%, p = 0.002), but not sNPBC (50.5% vs. 38.8%, p = 0.185). Liver metastases were negatively associated with likelihood of SD/R with sPBC (43.8% vs. 63.6%, p = 0.038), but not sNPBC (36.2% vs 49.0%, p = 0.147). Conclusions: After treatment with fPBC for mUC, patients able to receive sPBC had better OS compared to those who received sNPBC in a multivariate model. Patients were also more likely to achieve SD/R with sPBC; factors associated with achieving SD/R with sPBC but not sNPBC included longer interim since fPBC, achieving SD/R to fPBC, and absence of liver metastases.
BACKGROUND Genetic testing is increasingly important in prostate cancer (PCA) care, with impact on PCA management and hereditary cancer risk, particularly for BRCA1/2 mutations. However, the extent to which the public discusses these topics on social media is unknown, which may hinder population-level uptake of advances in precision medicine. OBJECTIVE To characterize activity and engagement across multiple social media platforms (Twitter, Facebook, and YouTube) regarding BRCA and genetic testing for PCA compared to breast cancer. METHODS Symplur Signals online analytics platform was used to obtain all tweets in 2018 about #BRCA and #breastcancer, #BRCA and #prostatecancer, #genetictesting and #breastcancer, and #genetictesting and #prostatecancer. We examined the total number of tweets, users and reach for each hashtag, and performed content analysis for a subset of tweets. Facebook and YouTube were queried using analogous search terms, and engagement metrics were calculated. RESULTS During a one-year period, there were 3566 tweets for #BRCA and #breastcancer, versus 221 about #BRCA and #prostatecancer. There were also more tweets about #genetictesting and #breastcancer (418), compared to #genetic testing and #prostatecancer (92). Tweets about genetic testing and BRCA in breast cancer also had substantially greater reach than those about PCA. Sharing the link to an article was the most common type of tweet and misinformation was rare. Facebook groups and pages regarding PCA and BRCA/genetic testing had fewer average members, new members, and new posts, as well as fewer likes and followers, compared to breast cancer. Facebook videos had more engagement than YouTube videos across both PCA and breast cancer content. CONCLUSIONS There is substantially less social media engagement about BRCA and genetic testing in PCA compared to breast cancer. This landscape analysis provides insights into strategies for leveraging social media platforms to increase public awareness of PCA germline testing.
BACKGROUND:Fit patients with metastatic urothelial carcinoma (mUC) receive first-line platinum-based combination chemotherapy (fPBC) as standard of care and may receive additional later-line chemotherapy after progression. Our study compares outcomes with subsequent platinum-based chemotherapy (sPBC) versus subsequent non-platinum-based chemotherapy (sNPBC). MATERIALS AND METHODS:Patients from 27 international centers in the Retrospective International Study of Cancers of the Urothelium (RISC) who received fPBC for mUC and at least two cycles of subsequent chemotherapy were included in this study. A multivariable Cox proportional hazards model compared overall survival (OS) and progression-free survival (PFS). RESULTS:One hundred thirty-five patients received sPBC and 161 received sNPBC. Baseline characteristics were similar between groups, except patients who received sPBC had higher baseline hemoglobin, higher disease control rate with fPBC, and longer time since fPBC. OS was superior in the sPBC group (median 7.9 vs 5.5 months) in a model adjusting for comorbidity burden, performance status, liver metastases, number of fPBC cycles received, best response to fPBC, and time since fPBC (hazard ratio, 0.72; 95% confidence interval, 0.53-0.98; p = .035). There was no difference in PFS. More patients in the sPBC group achieved disease control than in the sNPBC group (57.4% vs 44.8%; p = .041). Factors associated with achieving disease control in the sPBC group but not the sNPBC group included longer time since fPBC, achieving disease control with fPBC, and absence of liver metastases. CONCLUSION:After receiving fPBC for mUC, patients who received sPBC had better OS and disease control. This may help inform the choice of subsequent chemotherapy in patients with mUC. IMPLICATIONS FOR PRACTICE:Patients with progressive metastatic urothelial carcinoma after first-line platinum-based combination chemotherapy may now receive immuno-oncology agents, erdafitinib, enfortumab vedotin, or sacituzumab govitecan-hziy; however, those ineligible for these later-line therapies or who progress after receiving them may be considered for subsequent chemotherapy. In this retrospective study of 296 patients, survival outcomes and disease control rates were better in those receiving subsequent platinum-based rechallenge compared with non-platinum-based chemotherapy, suggesting that patients should receive platinum rechallenge if clinically able. Disease control with platinum rechallenge was more likely with prior first-line platinum having achieved disease control, longer time since first-line platinum, and absence of liver metastases.