Background Female underrepresentation in oncology clinical trials can result in outcome disparities. We evaluated female participant representation in US oncology trials by intervention type, cancer site, and funding. Materials and Methods Data were extracted from the publicly available Aggregate Analysis of ClinicalTrials.gov database. Initially, 270 172 studies were identified. Following the exclusion of trials using Medical Subject Heading terms, manual review, those with incomplete status, non-US location, sex-specific organ cancers, or lacking participant sex data, 1650 trials consisting of 240 776 participants remained. The primary outcome was participation to prevalence ratio (PPR): percent females among trial participants divided by percent females in the disease population per US Surveillance, Epidemiology, and End Results Program data. PPRs of 0.8-1.2 reflect proportional female representation. Results Females represented 46.9% of participants (95% CI, 45.4-48.4); mean PPR for all trials was 0.912. Females were underrepresented in surgical (PPR 0.74) and other invasive (PPR 0.69) oncology trials. Among cancer sites, females were underrepresented in bladder (odds ratio [OR] 0.48, 95% CI 0.26-0.91, P = .02), head/neck (OR 0.44, 95% CI 0.29-0.68, P < .01), stomach (OR 0.40, 95% CI 0.23-0.70, P < .01), and esophageal (OR 0.40 95% CI 0.22-0.74, P < .01) trials. Hematologic (OR 1.78, 95% CI 1.09-1.82, P < .01) and pancreatic (OR 2.18, 95% CI 1.46-3.26, P < .01) trials had higher odds of proportional female representation. Industry-funded trials had greater odds of proportional female representation (OR 1.41, 95% CI 1.09-1.82, P = .01) than US government and academic-funded trials. Conclusions Stakeholders should look to hematologic, pancreatic, and industry-funded cancer trials as exemplars of female participant representation and consider female representation when interpreting trial results.

Background: Advances in supportive care and novel therapies have driven improved outcomes for patients with Multiple myeloma (MM) and Light Chain Amyloidosis (AL). Unfortunately, this progress demands a heavy toll - higher patient costs. Financial toxicity (FT) is the adverse impact of cancer on a patient's financial well-being, contributing to increased distress, lower medication compliance, and even reduced survival. We aimed to evaluate MM and AL patients for financial toxicity over time to better understand its impact on various quality of life (QOL) domains. Methods: Adult patients with MM or AL that receive care at Mayo Clinic, Rochester MN, were recruited for a prospective study between December 2019 and March 2021. FT was measured using the validated COmprehensive Score for financial Toxicity (COST) questionnaire at the time of enrollment, 3 months, and 6 months follow-up. COST scores range from 0-44, with higher scores indicating lower FT. We defined patients with a COST score of ≤ 23 as having substantial FT. Domains of QOL were assessed via the Patient Reported Outcome Measurement Information System (PROMIS)-29 survey. Patient demographics and clinical information were abstracted from the electronic medical record. Statistical analysis included a comparison of COST scores among groups through Wilcoxon rank-sum, Kruskal-Wallis, and Jonckheere-Terpestra tests for binary, unordered, and ordered categorical variables, respectively. Results: One hundred and sixteen patients (96 MM, 83%; AL 20, 17%) enrolled in this study. The cohort is characterized as follows: 49% age 65+ (51% age 35-64), 54% male, 93% White, 4.3% Black, 3.5% Hispanic, 44% with incomes > USD 75k/yr (26% < USD 50k/yr), 77% with at least some college education (32% graduate or doctoral degree), 52% insured through Medicare (4.3% through Medicaid), 36% employed (53% retired), and 71% married (16% divorced). Forty-three percent of patients enrolled in the study were newly diagnosed (56% relapsed), and 72% had received an autologous stem cell transplant. Baseline mean COST score was25.9 (N=116; SD 10.2), with 37% reporting FT. A total of 101 patients (85 MM; 16 AL) completed a baseline and either 3- or 6-month COST survey. Thirty-eight of these patients (38%) reported FT at the time of enrollment. Among those reporting baseline FT, 71% continued to report FT at 3 or 6 months; 29% showed reduced FT. Of the 62% of patients who reported low FT at baseline, 78% showed continued low FT at 3 or 6 months; 22% showed increased FT. Results of longitudinal follow-up are outlined in Figure 1. FT was significantly associated with increased anxiety, depression, and pain intensity domains on the PROMIS-29. Substantial FT was associated with: women, Medicaid as primary insurance, and being divorced. FT was also greater in unemployed/disabled vs retired individuals. Conversely, low FT was associated with: males, earning > USD 75k/yr, Medicare as primary insurance, having at least some college education, being retired, and traveling 300+ miles for care. Financial toxicity did not differ significantly by age, race, ethnicity, disease status (newly diagnosed vs relapsed), or transplant status. Discussion : Financial toxicity was present in more than one-third of AL and MM patients in this high-earning and well-educated cohort. Financial toxicity was associated with increased anxiety, depression, and pain intensity, contributing to lower patient quality of life. Longitudinal follow-up has shown financial toxicity to be dynamic, necessitating routine evaluation of patient financial burdens. Future work will focus on automating FT assessment with incorporation into routine care and developing care processes to support patients. Figure 1 Figure 1. Disclosures Dispenzieri: Alnylam: Research Funding; Takeda: Research Funding; Pfizer: Research Funding; Oncopeptides: Consultancy; Sorrento Therapeutics: Consultancy; Janssen: Consultancy, Research Funding.

Central vision loss in a 44-year-old womanA 44-year-old woman presented to the emergency department following 1 week of sudden, painless, central vision loss in the left eye and 1 day of headache preceded by intermittent fl oaters and fl ashing lights. The headache was a dull, aching pain in the left temple. For the preceding 2 months, she had been treated by an outside ophthalmologist for bilateral anterior uveitis, unresponsive to topical prednisolone. She additionally noted recent hair loss and a rash on the palms. She denied light sensitivity, eye pain, trauma, blurred vision, fever, chills, chest pain, shortness of breath, abdominal pain, nausea, dizziness, blurred vision, or syncope prior to presentation.Medical comorbidities included 15 years of systemic lupus erythematosus (SLE) and antiphospholipid syndrome that fi rst manifested as a cerebrovascular accident (CVA). Serum analysis at time of SLE diagnosis revealed strongly positive antinuclear antibodies, elevated Sjögren syndrome antibodies, double-stranded DNA, beta-2-glycoprotein immunoglobulin G, anticardiolipin immunoglobulin G, and lupus anticoagulant.The patient's presentation of vascular thrombosis with positive antiphospholipid antibodies met the Sydney criteria for diagnosis of triple-positive antiphospholipid antibody syndrome. Following appropriate anticoagulation, she experienced occasional skin rashes, Raynaud phenomenon, and sicca symptoms. Other medical comorbidities included migraines and focal epilepsy. Her regular medications included prednisone 7.5 mg daily, methotrexate, hydroxychloroquine, warfarin, and topiramate. She was sexually active. ■ INITIAL EVALUATION AND MANAGEMENTAt presentation, the patient's temperature was 99.1°F (37.3°C), heart rate 80 beats per minute, blood pres-

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