AIM:Recurrent rectal cancer (RRC) can be morbid and optimising cancer survivorship is a priority. The longitudinal trajectories of survivorship associated with RRC have not been prospectively depicted. METHODS:We prospectively enrolled patients with RRC. Participants self-reported quality of life (QOL) using validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and CR29, and pain using the Brief Pain Inventory, at baseline and then every 6 months for up to 5 years or until death. Baseline scores and the longitudinal trajectory of scores were examined using linear mixed-effects modelling. RESULTS:Among 104 patients, 73 (70.2%) received multimodality salvage treatment with curative intent, while the remainder received best palliative treatments. Curative-intent salvage including surgery was associated with a 30-day operative morbidity rate of 49% and a 5-year overall survival of 51%. Patients undergoing curative-intent salvage versus palliative treatments did not differ in baseline QOL or pain, but the longitudinal trajectory after curative-intent salvage showed sustained improvement of QOL and symptoms over time. This contrasted with the initial transient improvement but persistent decline with palliative treatments. Baseline QOL was significantly impacted by the anatomical site of RRC, with posterior location associated with worst QOL (P = 0.012). Long-term QOL was impacted by anatomical site and status of residual tumour. Pain scores were worse among men. CONCLUSION:Trajectories of cancer survivorship for patients with RRC diverge, mainly influenced by anatomical site of the RCC, residual tumour status, and ability to complete curative-intent salvage. These should inform treatment planning. Optimising selection and success of multimodality therapy remains the cornerstone for durable cancer survivorship.

Wellness interventions are important for improving outcomes, including physical function (PF), in cancer survivors. The COACH study is a randomized, wait-list controlled trial assessing feasibility of a 6-month digital health coaching (DHC) program for individuals within one year of completing primary cancer therapy, and those with metastatic disease. Diverse patient-reported outcome (PRO), wearable, device, gut microbiome, and dietary data are collected up to once monthly from 675 individuals over 12 months. This interim analysis examined change in PF using the PROMIS Short Form v2.0-PF 10a. The analysis included a pooled sample of participants who completed baseline and 6-month assessments as of November 2024. Descriptive statistics evaluated trends in physical function by age, sex, enrollment site, metastatic disease, and tumor and primary treatment type. Summary Data: Among the 352 individuals enrolled across 7 study sites, 177 completed baseline and 6-month assessments to date. Mean age of participants was 59.7 (R 30-83, SD 11.8). Fourteen participants (8%) identified as Black or African American, 9 (5%) as Hispanic or Latino, 147 (83%) as non-Hispanic White, and 7 (4%) as other, including Asian, American Indian, or Alaskan Native. Mean PROMIS PF scores by analysis group are presented in Table 1. An interim analysis of PF data demonstrated trending improvements across all groups from baseline to 6 months, except at one site enrolling only individuals with metastatic breast cancer, for whom mean difference is lower than in those with non-metastatic disease. Minimally important differences in PROMIS PF for individuals with advanced cancer is 4-6 points. At study completion (July 2026), a full analysis will be conducted to explore differences in PF by various patient characteristics, and if and how DHC may impact these trends over time. Marilyn Hammer, Robin Lally, Barbara Halpenny, Hajime Uno, Ijeoma Eche-Ugwu, Whitney Posada, Inga Van Wieren, Alexi Wright, Ayodeji Adeniji, Sarah Alzahid, Lauren A. Anderson, Betty Arceneaux, Jerry Armah, Elizabeth Arthur, Kristen Fessele, Laura Flora, Alyssa Garcia, Anneliese Gonzalez, Michael Harrison, Brian Hulbert, Mariah Jackson, Kaukab Jafry, Rebecca Johnson-Beller, Abbey Kaler, Ginny Kirklin, Jessica Krok-Schoen, Hilda H. Lewis, Jennifer Loftis, Debra Lyon, Kathrin Milbury, Ariana Mohan, Jasmine Moore, Estee Murray-Ross, Darcy Ponce, Leorey Saligan, Elham Samami, Rachael Schmidt, Grace Smith, Angela Starkweather, Maria Chang Swartz, Martha Thompson, Gisele Tlusty, Meagan Whisenant, Gloria Yang, Kelly J. Brassil. Comprehensive outcomes for after cancer health (COACH): Interim analysis of physical function data for individuals with diverse tumor types following primary cancer therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 794.

PURPOSE:Although detection of ctDNA weeks after surgery is linked to recurrence for other solid tumors, the optimal time point for ctDNA assessment as a prognostic biomarker following chemoradiation for anal cancer is undefined. EXPERIMENTAL DESIGN:Patients with stages I to III anal cancer treated with chemoradiation between December 2020 and March 2024 were evaluated for human papillomavirus (HPV) ctDNA status at baseline, at the end of chemoradiation, and during surveillance using a droplet digital HPV ctDNA PCR assay, targeting HPV E6 and E7 oncogenes for 13 oncogenic HPV types. Median recurrence-free survival (RFS) according to HPV ctDNA status was estimated via Kaplan-Meier and compared using a log-rank test. RESULTS:Detection of HPV ctDNA at ≥3 months after chemoradiation was associated with recurrence (80% vs. 2%; OR, 168; 95% confidence interval (CI), 13.6-2,080; P < 0.0001) and inferior RFS [4.9 months vs. not reached; HR, 39.2; 95% CI, 4.6-330; P < 0.0001] relative to HPV ctDNA-negative status. Sensitivity and specificity for recurrence according to HPV ctDNA detection were 89% and 95%, respectively, with positive and negative predictive values of 80% and 98%, respectively. Differences in RFS according to HPV ctDNA status were not observed at the end of treatment (median RFS, not reached for both; HR, 1.6; 95% CI, 0.35-7.4; P = 0.48). CONCLUSIONS:With a novel, highly sensitive assay, detection of HPV ctDNA at least 3 months after chemoradiation was associated with unfavorable survival. Future clinical trials should incorporate this 3-month post-treatment time point to identify patients with HPV-positive anal cancer at elevated recurrence risk according to HPV ctDNA status. See related commentary by Bercz et al., p. 2261.

Background:The optimal dose for patients with early-stage squamous cell carcinoma of the anus (SCCA) is unknown. We aimed to evaluate the impact of modest dose escalation (54 Gray (Gy)) compared with standard dose (50 Gray) on the disease-free survival and toxicity outcomes for patients with T1-2N0 SCCA. Methods:Patients with T1-T2N0 SCCA treated with definitive radiation from 1/1/2003 until 6/31/2022 were included in this retrospective analysis. Regression discontinuity analysis was performed to evaluate for a potential causal effect of modest dose escalation on freedom from local recurrence (FFLR). Cox proportional hazards model was generated to estimate the effect of modest dose escalation on FFLR, and an additional analysis was performed restricting the dataset to individuals with tumors measuring 1.5-2.5cm. Ordinal logistic regression was used to identify factors associated with several graded toxicity outcomes including acute and late gastrointestinal (GI), genitourinary (GU), dermatologic, and acute pain toxicities. Results:Two hundred thirty-four patients with T1N0 (N = 85, 36%) or T2N0 (N = 149, 64%) SCCA were included. Eighty-four (35.9%) received 50 Gy, 147 (62.8%) received 54Gy and 3 (1.3%) received 54-55 Gy. The median [IQR] time from the end of radiation to last follow up was 78 [44-119] months. Two- and 5-year FFLR were 90.7% and 88.6%. There was no significant association between modest dose escalation and FFLR (HR 0.6, 95% CI 0.2-1.9, P = 0.4) in patients with tumors 1.5-2.5 cm. In the global multivariable Cox regression model including all 234 patients, only positive HIV status (HR 5.2 [95% CI 1.2-21.5], P = 0.02) persisted as a significant predictor of worse FFLR on multivariate analysis. Modest dose escalation (P = 0.3) and tumor size (P = 0.6) did not predict FFLR. Modest dose escalation was associated with worse acute GU toxicity (OR 3.28, 95% CI 1.40-8.59, p = .01) and worse acute pain toxicity (OR 3.63, 95% CI 2.03- 6.65, p <.001). Conclusions:Modest dose escalation was not associated with improved FFLR among patients with T1-2N0 SCCA; however, it was associated with worse acute GU and pain toxicity. Future efforts should focus on biomarkers to identify patients who may potentially benefit from treatment escalation.

Escalated doses of radiotherapy associate with improved local control and overall survival (OS) in intrahepatic cholangiocarcinoma (iCCA), but personalization remains limited because conventional size-based CT criteria correlate poorly with outcomes. We hypothesized that quantitative enhancement measurements would better predict clinical outcomes and guide individualized RT optimization. In a retrospective cohort of 154 patients, we analyzed pre- and post-RT CT scans using quantitative European Association for Study of Liver (qEASL) to derive viable tumor volumes, comparing enhancement-based metrics with size-based RECIST and linking them to outcomes via survival and mathematical modeling. Change in enhancement volume was strongly associated with OS after adjustment, outperforming RECIST, and a ≥ 33% reduction optimally distinguished responders. From modeling analyses, the patient-specific tumor growth rate parameter emerged as the dominant mechanistic predictor, achieving 80.5% classification accuracy. Importantly, CT-derived mathematical parameters from this framework may inform RT planning and dose adaptation, particularly for resistant tumors, by bridging imaging with mechanistic insight.

We hypothesized that pre-consult patient education videos can improve patient understanding about their diagnosis, lead to high satisfaction and low distress. In this pilot study, we developed a patient education video curriculum for patients with newly-diagnosed anal cancer. Comprehension of key content was evaluated by comparing pre- and post-test scores. Patient satisfaction scores were collected. Patient distress scores (0-10) were collected at the beginning of their consult visit prior to seeing the physician. We found that patient education videos prior to consult improved patient understanding, resulted in high patient satisfaction, and low patient distress at the time of consult.

Background A growing number of studies suggest that job loss has detrimental effects on cancer survivors. However, the underlying mechanisms are not well understood. Furthermore, minorities including Asian American cancer survivors remain understudied, yet they suffer from job loss more often. The present study examined the prevalence of job loss in Chinese American breast cancer survivors (CABCS) and investigated the relationship between job loss and well-being in this group and the underlying mechanisms. Method CABCS completed a questionnaire that included demographic, employment, and clinical information, as well as measures of psychosocial well-being. Descriptive analyses were conducted to gauge the prevalence of job loss, linear regressions were used to test associations between job loss and well-being, and path analyses were conducted to test mediations. Results About 45.4% of survivors lost their job after being diagnosed with cancer, and only 35.2% of those who lost their job regained employment up to the assessment time. Job loss was associated with reduced income, which was associated with higher perceived stress, which, in turn, was associated with lower overall quality of life (QoL) and greater depressive symptoms. Conclusions Findings highlight the high prevalence of job loss and its negative effects on QoL and depression among CABCS. It is important for health care professionals to be sensitive to adverse financial events affecting minority BCS. In addition to offering BCS necessary practical assistance, psychosocial interventions focusing on reducing perceived stress associated with the cancer experience may be effective in mitigating some long-term consequences of job loss.

PurposeCervical cancer patients undergoing chemoradiation have high symptom burden. We performed an analysis of prospectively collected patient-reported outcomes(PROs) to determine characteristics predictive of poor treatment experience.MethodsBetween 2021-2023, we prospectively collected PROs from cervical cancer patients undergoing definitive chemoradiation. EORTC-QLQ-C30 and EORTC-QLQ-CX24 were completed at baseline(BL) and at the end of treatment(EOT). Poor treatment experience was defined as EOT poor health-related quality of life (HRQOL), low physical function, or significant overall symptom burden. Predictive factors analyzed included demographic, clinical, disease-specific factors, and baseline financial toxicity, depression, social function, and emotional function. ROC analysis provided appropriate predictive cut-off values. Univariable(UVA) and multivariable(MVA) linear regression analyses were performed.ResultsFourty-nine patients completed BL and EOT questionnaires. Median age was 43 (range, 18-85). Most patients (59%) had stage III disease. Baseline financial toxicity ≥66.7, depression ≥66.7, social function ≤50 and emotional function ≤58 on the EORTC linear transformed scale of 0-100 were significant predictors for poor treatment experience (p≤0.04) based on ROC analysis. On MVA poor BL social function was associated with reduced EOT HRQOL (β-9.3,_95%CI_-16.1_to_-2.6,_p<0.008), decreased physical function (β-24.4,_95%CI_-36.3_to_-12.6,_p<0.001), and high symptom burden_(β26.9,_95%CI_17.5_to_36.3,_p<0.001). Earlier disease stage predicted for decreased symptom burden_(β-6.7,_95%CI_-13.1_to_-0.3,_p=0.039). BL financial toxicity was a significant predictor on UVA (p=0.001-0.044) and showed a significant interaction term on MVA (p=0.024-0.041) for all three domains of poor treatment experience. Demographic and treatment-related factors were not predictive.ConclusionCervical cancer patients with poor baseline social function or high financial toxicity were at-risk for increased symptom burden and poor HRQOL. Screening for these factors provides an opportunity for early intervention to improve treatment experience.

Background: Despite the increasing utilization of sphincter and/or organ-preservation treatment strategies, many patients with low-lying rectal cancers require abdominoperineal resection (APR), leading to permanent ostomy. Here, we aimed to characterize overall, sexual-, and bladder-related patient-reported quality of life (QOL) for individuals with low rectal cancers. We additionally aimed to explore potential differences in patient-reported outcomes between patients with and without a permanent ostomy. Methods: We distributed a comprehensive survey consisting of various patient-reported outcome measures, including the FACT-G7 survey, ICIQ MLUTS/FLUTS, IIEF-5/FSFI, and a specific questionnaire for ostomy patients. Descriptive statistics and univariate comparisons were used to compared demographics, treatments, and QOL scores between patients with and without a permanent ostomy. Results: Of the 204 patients contacted, 124 (60.8%) returned completed surveys; 22 (18%) of these had a permanent ostomy at the time of survey completion. There were 25 patients with low rectal tumors (≤5 cm from the anal verge) who did not have an ostomy at the time of survey completion, of whom 13 (52%) were managed with a non-operative approach. FACTG7 scores were numerically lower (median 20.5 vs. 22, p = 0.12) for individuals with an ostomy. Sexual function measures IIEF and FSFI were also lower (worse) for individuals with ostomies, but the results were not significantly different. MLUTS and FLUTS scores were both higher in individuals with ostomies (median 11 vs. 5, p = 0.06 and median 17 vs. 5.5, p = 0.01, respectively), suggesting worse urinary function. Patient-reported ostomy-specific challenges included gastrointestinal concerns (e.g., gas, odor, diarrhea) that may affect social activities and personal relationships. Conclusions: Despite a limited sample size, this study provides patient-centered, patient-derived data regarding long-term QOL in validated measures following treatment of low rectal cancers. Ostomies may have multidimensional negative impacts on QOL, and these findings warrant continued investigation in a prospective setting. These results may be used to inform shared decision making for individuals with low rectal cancers in both the settings of organ preservation and permanent ostomy.

AbstractIntroductionWith locally advanced pancreatic cancer (LAPC), uncontrolled local tumor growth frequently leads to mortality. Advancements in radiotherapy (RT) techniques have enabled conformal delivery of escalated‐dose RT (EDR), which may have potential local control and overall survival (OS) benefits based on retrospective and early prospective studies. With evidence for EDR emerging, we characterized the adoption of EDR across the United States and its associated outcomes.MethodsWe searched the National Cancer Database for nonsurgically managed LAPC patients diagnosed between 2004 and 2019. Pancreas‐directed RT with biologically effective doses (BED10) ≥39 and ≤70 Gy was labeled conventional‐dose RT (CDR), and BED10 >70 and ≤132 Gy was labeled EDR. We identified associations of EDR and OS using logistic and Cox regressions, respectively.ResultsAmong the definitive therapy subset (n = 54,115) of the entire study cohort (n = 91,493), the most common treatments were chemotherapy alone (69%), chemotherapy and radiation (29%), and RT alone (2%). For the radiation therapy subset (n = 16,978), use of pancreas‐directed RT remained between 13% and 17% over the study period (ptrend > 0.999). Using multivariable logistic regression, treatment at an academic/research facility (adjusted odds ratio [aOR] 1.46, p < 0.001) and treatment between 2016 and 2019 (aOR 2.54, p < 0.001) were associated with greater receipt of EDR, whereas use of chemotherapy (aOR 0.60, p < 0.001) was associated with less receipt. Median OS estimates for EDR and CDR were 14.5 months and 13.0 months (p < 0.0001), respectively. For radiation therapy subset patients with available survival data (n = 13,579), multivariable Cox regression correlated EDR (adjusted hazard ratio 0.85, 95% confidence interval 0.80–0.91; p < 0.001) with longer OS versus CDR.Discussion and ConclusionsUtilization of EDR has increased since 2016, but overall utilization of RT for LAPC has remained at less than one in five patients for almost two decades. These real‐world results additionally provide an estimate of effect size of EDR for future prospective trials.

PURPOSE:The EXTEND trial tested the hypothesis that adding comprehensive metastasis-directed therapy (MDT) to chemotherapy would improve progression-free survival (PFS) over chemotherapy alone among patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC). METHODS:EXTEND (ClinicalTrials.gov identifier: NCT03599765) is a multicenter, phase II basket trial randomly assigning patients with ≤five metastases 1:1 to MDT plus systemic therapy versus systemic therapy. Disease progression was defined by radiologic criteria (RECIST v1.1), clinical progression, or death. The primary end point was PFS in the per-protocol population, evaluated after all patients achieved at least 6 months of follow-up. Exploratory end points included systemic immune response measures. RESULTS:Between March 19, 2019, and February 13, 2023, 41 patients were randomly assigned and 40 were eligible for the primary analysis of PFS (19 patients in the MDT arm; 21 patients in the control arm). At a median follow-up time of 17 months, the median PFS time was 10.3 months (95% CI, 4.6 to 14.0) in the MDT arm versus 2.5 months (95% CI, 1.7 to 5.1) in the control arm. PFS was significantly improved by the addition of MDT to systemic therapy (P = .030 for stratified log-rank test) with a hazard ratio of 0.43 (95% CI, 0.20 to 0.94). No grade ≥3 or greater adverse events related to MDT were observed. Systemic immune activation events were associated with MDT and correlated with improved PFS. CONCLUSION:This study supports the addition of MDT to systemic therapy for patients with oligometastatic PDAC. Induction of systemic immunity is a possible mechanism of benefit. These results warrant confirmatory trials to refine treatment strategy and provide external validation.

Purpose:Chemoradiation therapy (CRT) is the standard treatment for squamous cell carcinoma of the anus (SCCA). This study aimed to investigate the relationship between vaginal dosimetry and long-term patient-reported dyspareunia after treatment. We further aimed to use the anterior vaginal wall (AVW) as an organ at risk to define an actionable dosimetric clinical goal to decrease the risk of patient-reported dyspareunia. Methods and Materials:Women with SCCA treated with intensity modulated radiation therapy-based CRT were surveyed at least 2 years after successfully completing therapy. A Female Sexual Function Index (FSFI) pain subscore ≤4 was used to define dyspareunia. Dosimetric parameters were calculated for both the full vaginal canal and AVW. Multivariable linear regression models were created to identify predictors of FSFI pain subscore using backward selection to identify final variables include in the models. An actionable dosimetric predictor for dyspareunia was established using the Youden index method for cutoff optimization. Results:Of 184 women who were contacted, 90 (49%) returned completed surveys. Of those who completed surveys, 51 (56.7%) reported being sexually active, and 47 had dosimetric data available for review. Of sexually active respondents, 32 (68%) had an FSFI pain subscore ≤4. Multiple regression models were generated using the full vaginal canal and AVW as organs at risk, and both models showed similar predictive relationships with volumetric dose parameters emerging as the best dosimetric predictors for dysparenuia. Age over 65 years was also associated with higher FSFI pain subscores (eg, less pain with intercourse) in both models. AVW V35 Gy < 60% was identified as the optimal cutoff to reduce the risk of patient-reported dyspareunia. Conclusions:Increased dose to the vaginal canal is significantly associated with worse patient-reported dyspareunia following CRT for SCCA. Minimizing dose to the AVW to V35 Gy < 60% may reduce the risk of this quality of life-limiting toxicity. Further prospective evaluation is needed to validate these findings.

Cardiovascular disease (CVD) represents a significant financial burden on patients and families, compounded by both direct and indirect healthcare costs. The increasing prevalence of CVD, coupled with the rising costs of treatment, exacerbates financial toxicity-defined as the economic strain and associated physical, emotional, and behavioral consequences on patients. This review explores the scope of financial toxicity in CVD care, detailing its prevalence, associated risk factors, and the complex interplay with social determinants of health such as income, insurance status, and comorbidities. Drawing from models in oncology, we highlight key interventions aimed at mitigating financial toxicity, including patient counseling, financial navigation, and enhanced patient-physician cost discussions. By adopting these approaches, healthcare providers can better support patients with CVD in managing both their health and financial well-being, potentially improving clinical outcomes. Future research is needed to develop standardized assessment tools for financial toxicity in CVD and implement system-wide mitigation strategies.

4067 Background: Localized gastric cancer is a potentially curable condition and long-term outcomes depend on YP staging. Currently, preferred adjunctive therapy depends on geographic location. Preliminary data from NCT01928394 have shown promising clinical activity of immunotherapy (IO) agents nivolumab (nivo) +/- ipilimumab (ipi) in the metastatic setting. We conducted a single-arm study using IO + chemotherapy followed by immune-chemoradiation prior to surgery, followed by adjuvant IO, in patients with localized gastric adenocarcinoma. Our primary objective was to determine safety and toxicity with this approach. Secondary objectives included efficacy by YP staging and R0 resection rate. Methods: Patients with localized gastric adenocarcinoma were enrolled into NCT03776487 (n=30). Participants received the following: (1) biweekly chemotherapy with 4 doses of 5-Fluorouracil (5-FU)/Oxaliplatin, (2) nivo 240mg q2weeks (x3) and ipi 1mg/kg q6weeks (x1), (3) immune-chemoradiation (biweekly nivo + 5FU Mon-Fri concurrently with a total of 45 Gy given in 25 fractions), and (4) surgical resection. Those with residual disease received adjuvant nivolumab monthly for 6 doses. Correlative studies are planned. To assess preliminary efficacy, the clinical and pathologic complete response rates (pCR) were estimated along with the corresponding exact 95% confidence interval. Adverse events and toxicities were summarized using descriptive statistics. Results: Median follow-up was 27.4 months at the time of data cutoff. Of 30 enrolled, 23 patients completed surgery and seven did not due to progression of disease(n=5) and worsening co-morbidities(n=2). The side effect profile was similar to prior IO studies, with no grade 5 events observed. Three patients (10%) experienced grade 4 events (acute kidney injury, myocarditis, and neutropenia). The most frequent grade 3 toxicity was nausea and vomiting (10%). From the 23 participants that underwent resection, 22 had pathologic data at the time of analysis, with 9 achieving ypT0ypN0 (40.9%, 95% CI: 20.7%, 63.7%). There was an 86% R0 resection rate. Conclusions: Our results are encouraging and support further development of this strategy for localized gastric adenocarcinomas. The regimen is safe and potentially generalizable. Clinical trial information: NCT03776487 .

ImportanceProton beam therapy is an emerging radiotherapy treatment for patients with cancer that may produce similar outcomes as traditional photon-based therapy for many cancers while delivering lower amounts of toxic radiation to surrounding tissue. Geographic proximity to a proton facility is a critical component of ensuring equitable access both for indicated diagnoses and ongoing clinical trials.ObjectiveTo characterize the distribution of proton facilities in the US, quantify drive-time access for the population, and investigate the likelihood of long commutes for certain population subgroups.Design, Setting, and ParticipantsThis population-based cross-sectional study analyzed travel times to proton facilities in the US. Census tract variables in the contiguous US were measured between January 1, 2017, and December 31, 2021. Statistical analysis was performed from September to November 2023.ExposuresDrive time in minutes to nearest proton facility. Population totals and prevalence of specific factors measured from the American Community Survey: age; race and ethnicity; insurance, disability, and income status; vehicle availability; broadband access; and urbanicity.Main Outcomes and MeasuresPoor access to proton facilities was defined as having a drive-time commute of at least 4 hours to the nearest location. Median drive time and percentage of population with poor access were calculated for the entire population and by population subgroups. Univariable and multivariable odds of poor access were also calculated for certain population subgroups.ResultsGeographic access was considered for 327 536 032 residents of the contiguous US (60 594 624 [18.5%] Hispanic, 17 974 186 [5.5%] non-Hispanic Asian, 40 146 994 [12.3%] non-Hispanic Black, and 195 265 639 [59.6%] non-Hispanic White; 282 031 819 [86.1%] resided in urban counties). The median (IQR) drive time to the nearest proton facility was 96.1 (39.6-195.3) minutes; 119.8 million US residents (36.6%) lived within a 1-hour drive of the nearest proton facility, and 53.6 million (16.4%) required a commute of at least 4 hours. Persons identifying as non-Hispanic White had the longest median (IQR) commute time at 109.8 (48.0-197.6) minutes. Multivariable analysis identified rurality (odds ratio [OR], 2.45 [95% CI, 2.27-2.64]), age 65 years or older (OR, 1.09 [95% CI, 1.06-1.11]), and living below the federal poverty line (OR, 1.22 [1.20-1.25]) as factors associated with commute times of at least 4 hours.Conclusions and RelevanceThis cross-sectional study of drive-time access to proton beam therapy found that disparities in access existed among certain populations in the US. These results suggest that such disparities present a barrier to an emerging technology in cancer treatment and inhibit equitable access to ongoing clinical trials.

Background: We evaluated sociodemographic and clinical predictors of financial toxicity (FT) among patients with breast cancer with higher risk clinical factors warranting regional nodal irradiation (RNI). Methods: Among 183 participants in a clinical trial of conventional vs. hypofractionated treatment with RNI, 125 (68 %) completed a pilot survey of FT measured using the validated Economic Strain and Resilience in Cancer (ENRICh) instrument, scored from 0 (minimal) to 10 (severe) FT. Associations with predictors were evaluated using Pearson correlation coefficients and Kruskal Wallis, Mann-Whitney U, and Jonckheere-Terpstra tests. Predictors of severe FT (ENRICh >= 5) were tested using multivariable logistic regression with odds ratios converted to relative risks (RR). Results: Of the sample, all received RNI, 92 % chemotherapy, 67 % axillary dissection, 26 % mastectomy without reconstruction, and 32 % mastectomy with reconstruction. At a median follow up of 1.48 years, median FT score was 2.13 (IQR 0.93-4.6), with 20.8 % of patients experiencing severe FT. Unadjusted worse FT score was associated with younger age (P = 0.003), Hispanic ethnicity (P = 0.006), lower income (P = 0.02), shorter interval from diagnosis to FT assessment (P = 0.02), and chemotherapy receipt (P = 0.05), but not with breast surgery type (P = 0.42), axillary surgery type (P = 0.33), or pathologic T (P = 0.68) or N stage (P = 0.47). In multivariable analysis, triple negative subtype was the sole clinical factor predicting severe FT (RR = 3.38; 95 % CI 1.48-4.99; P = 0.01). Conclusion: Among patients with breast cancer receiving RNI, triple negative subtype was associated with severe FT, suggesting that tumor receptor subtype may help identify a key breast cancer subpopulation for early FT intervention.