BackgroundPatient navigation (PN) is a promising yet underused approach to address Hispanic/Latino (H/L) cancer survivors' unmet supportive care needs. The authors conducted a randomized trial to evaluate the effect of a culturally tailored PN program with the LIVESTRONG Foundation's Cancer Navigation Services (PN-LCNS) on reducing unmet needs in H/L survivors.MethodsFrom 2012 to 2015 at two US sites, 288 H/L survivors diagnosed with breast, prostate, or colorectal cancer were randomized to a PN-LCNS program or to standard PN. Participants assigned to the PN-LCNS program received 3-month PN services; access to phone-based, bilingual, one-on-one support; and additional resources (i.e., guidebook, health journal, and care plan). Participants completed assessments at baseline and at 3, 9, and 15 months post-baseline. The Supportive Care Needs Survey was used to assess unmet needs across five domains: psychological, health system and information, physical and daily living, patient care and support, and sexuality. Intervention effects were tested by using separate multilevel growth models for women and men.ResultsWomen randomized to the PN-LCNS program, relative to those who received standard PN, had a statistically significant reduction in unmet needs (i.e., overall and for the health systems and information, physical and daily living, and patient care and support domains). Among men, younger age was associated with greater unmet needs at baseline. Prostate cancer survivors reported greater unmet sexual health needs compared with colorectal cancer survivors. There was no significant change in unmet needs among H/L men.ConclusionsA culturally tailored PN program can reduce unmet supportive care needs among H/L women cancer survivors. However, interventions specifically targeting unmet needs in H/L men and sexual health are still necessary (ClinicalTrials.gov identifier NCT02275754).Plain Language Summary Hispanic/Latino (H/L) cancer survivors often report concerns or needs that are not adequately addressed by the health care team, which could be related to psychological, health system and information, patient care and support, physical and daily living, and sexuality issues. In this randomized controlled trial of 288 H/L survivors diagnosed with breast, prostate, or colorectal cancer, women assigned to a culturally tailored patient navigation program experienced a reduction in unmet needs compared with those who received standard patient navigation. H/L men did not experience a change in unmet needs.

5503 Background: OUTBACK (ACTRN12610000732088), an open-label, international, randomized phase 3 trial of 919 participants (pts) with LACC, showed that adding adjuvant chemotherapy (ACT) after chemoradiotherapy (CRT) increased adverse events without improving overall survival compared to CRT alone. PRO objectives of OUTBACK were to determine the: 1) prevalence of patient-reported moderate-severe symptom issues at years 1-3 post-randomisation 2) duration of common issues; 3) long-term psycho-sexual health. Methods: Pts completed the EORTC core questionnaire QLQ-C30; cervical cancer module QLQ-CX24 (questions 50-54 only for sexually active pts); EORTC Item Library questions on abdominal, urinary, bowel and chemotherapy side-effects; & FACT-GOG-NTX4 neurotoxicity over 36 months. A moderate-severe long-term symptom issue was defined as a score in the worst 2 response categories (EORTC items), a total score ≤8/16 on FACT-GOG-NTX4 at years 1, 2 or 3 for Objectives 1-2, or equivalent subscale score for Objective 3. The availability of PROs for analysis was not related to 11 pre-specified demographic/clinical variables so no imputation for missing data was performed. Results: PRO completion rates were 94% at baseline, 64% at year 1 & 37% by year 3. Table 1 shows the 10 top-ranked issues at year 1 & their persistence or resolution by years 2-3. These may be underestimates, due to lower PRO completion rates at years 2-3. Issues and frequencies were similar across treatment arms by year 1. Moderate-severe peripheral neuropathy affected 24% post CRT+ACT & 18% post CRT (year 1); 19% post CRT+ACT & 12% post CRT (year 3). At baseline, 77% reported no sexual activity in the past 4 weeks. Overall, 92% of pts reported low sexual activity at years 1, 2 or 3; 68% reported low enjoyment, 40% moderate-severe vaginal tightness, 37% vaginal dryness during sex and 32% were moderately-severely worried sex would be painful. Conclusions: Long-term symptom issues & sexual health concerns are common & persistent following CRT +/-ACT for LACC and need dedicated survivorship care. Clinical trial information: 12610000732088 . Frequency and duration of top-ranked moderate-severe symptoms. Item CRT + ACTn (%) CRT alonen (%) All participants n (%) Issue rated moderate-severe at Year 1 Issue rated moderate-severe at Year 1 Issue rated moderate-severe at Year 1 Issue from Year 1 resolved by Year 2 or 3 Issue from Year 1 persistent at Year 2 or 3 Worried future health 76 (50) 59 (38) 135 (44) 14 (10) 49 (36) Hot flushes/ sweats 68 (39) 64 (35) 132 (37) 24 (18) 49 (37) Frequent urination 67 (38) 59 (32) 126 (35) 24 (19) 45 (36) Sexual activity (not) enjoyable 59 (63) 66 (65) 125 (64) 11 (9) 43 (34) Trouble sleeping 62 (35) 55 (30) 117 (32) 19 (16) 37 (32) Tired 53 (30) 51 (28) 104 (29) 22 (21) 33 (32) Changed bowel habit 56 (32) 46 (25) 102 (28) 22 (22) 41 (40) Financial difficulties 51 (27) 50 (28) 101 (28) 17 (17) 32 (32) Pain 54 (29) 42 (24) 96 (27) 21 (22) 23 (24) Dissatisfied with body 48 (26) 47 (27) 95 (26) 21 (22) 27 (28)

NRG/RTOG 0436 evaluated cetuximab added to chemoradiation (CRT) for non-operative esophageal cancer management. PRO objectives assessed improvement in the FACT-Esophageal cancer subscale (ECS), version 4, with cetuximab, and if improved ECS correlated with clinical complete response (cCR). Patients were randomized to cisplatin/paclitaxel/radiation ± cetuximab. Overall survival (OS) was the primary endpoint, with a 420 patient target, which also provided 82

Background Standard treatment for locally advanced cervical cancer is chemoradiotherapy, but many patients relapse and die of metastatic disease. We aimed to determine the effects on survival of adjuvant chemotherapy after chemoradiotherapy.Methods The OUTBACK trial was a multicentre, open-label, randomised, phase 3 trial done in 157 hospitals in Australia, China, Canada, New Zealand, Saudi Arabia, Singapore, and the USA. Eligible participants were aged 18 year or older with histologically confirmed squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma of the cervix (FIGO 2008 stage IB1 disease with nodal involvement, or stage IB2, II, IIIB, or IVA disease), Eastern Cooperative Oncology Group performance status 0-2, and adequate bone marrow and organ function. Participants were randomly assigned centrally (1:1) using a minimisation approach and stratified by pelvic or common iliac nodal involvement, requirement for extended-field radiotherapy, FIGO 2008 stage, age, and site to receive standard cisplatin-based chemoradiotherapy (40 mg/m2 cisplatin intravenously once-a-week for 5 weeks, during radiotherapy with 45 center dot 0-50 center dot 4 Gy external beam radiotherapy delivered in fractions of 1 center dot 8 Gy to the whole pelvis plus brachytherapy; chemoradiotherapy only group) or standard cisplatin-based chemoradiotherapy followed by adjuvant chemotherapy with four cycles of carboplatin (area under the receiver operator curve 5) and paclitaxel (155 mg/m2) given intravenously on day 1 of a 21 day cycle (adjuvant chemotherapy group). The primary endpoint was overall survival at 5 years, analysed in the intention-to-treat population (ie, all eligible patients who were randomly assigned). Safety was assessed in all patients in the chemoradiotherapy only group who started chemoradiotherapy and all patients in the adjuvant chemotherapy group who received at least one dose of adjuvant chemotherapy. The OUTBACK trial is registered with ClinicalTrials.gov, NCT01414608, and the Australia New Zealand Clinical Trial Registry, ACTRN12610000732088.Findings Between April 15, 2011, and June 26, 2017, 926 patients were enrolled and randomly assigned to the chemoradiotherapy only group (n=461) or the adjuvant chemotherapy group (n=465), of whom 919 were eligible (456 in the chemoradiotherapy only group and 463 in the adjuvant chemotherapy group; median age 46 years [IQR 37 to 55]; 663 [72%] were White, 121 [13%] were Black or African American, 53 [6%] were Asian, 24 [3%] were Aboriginal or Pacific islander, and 57 [6%] were other races) and included in the analysis. As of data cutoff (April 12, 2021), median follow-up was 60 months (IQR 45 to 65). 5-year overall survival was 72% (95% CI 67 to 76) in the adjuvant chemotherapy group (105 deaths) and 71% (66 to 75) in the chemoradiotherapy only group (116 deaths; difference 1% [95% CI -6 to 7]; hazard ratio 0 center dot 90 [95% CI 0 center dot 70 to 1 center dot 17]; p=0 center dot 81). In the safety population, the most common clinically significant grade 3-4 adverse events were decreased neutrophils (71 [20%] in the adjuvant chemotherapy group vs 34 [8%] in the chemoradiotherapy only group), and anaemia (66 [18%] vs 34 [8%]). Serious adverse events occurred in 107 (30%) in the adjuvant chemotherapy group versus 98 (22%) in the chemoradiotherapy only group, most commonly due to infectious complications. There were no treatment-related deaths. Interpretation Adjuvant carboplatin and paclitaxel chemotherapy given after standard cisplatin-based chemoradiotherapy for unselected locally advanced cervical cancer increased short-term toxicity and did not improve overall survival; therefore, it should not be given in this setting.

Aim The goal of this study is to compare microbiome composition in three different sample types in women, namely stool brought from home vs. solid stool samples obtained at the time of an unprepped sigmoidoscopy vs. biopsies of the colonic mucosa at the time of an unprepped sigmoidoscopy, using alpha- and beta-diversity metrics following bacterial 16S rRNA sequencing. The findings may have relevance to health and disease states in which bacterial metabolism has a significant impact on molecules/metabolites that are recirculated between the gut lumen and mucosa and systemic circulation, such as estrogens (as in breast cancer) or bile acids. Methods Concomitant at-home-collected stool, endoscopically-collected stool, and colonic biopsy samples were collected from 48 subjects (24 breast cancer, 24 control.) After 16S rRNA sequencing, an amplicon sequence variant (ASV) based approach was used to analyze the data. Alpha diversity metrics (Chao1, Pielou’s Evenness, Faith PD, Shannon, and Simpson) and beta diversity metrics (Bray-Curtis, Weighted and Unweighted Unifrac) were calculated. LEfSe was used to analyze differences in the abundance of various taxa between sample types. Results Alpha and beta diversity metrics were significantly different between the three sample types. Biopsy samples were different than stool samples in all metrics. The highest variation in microbiome diversity was noted in the colonic biopsy samples. At-home and endoscopically-collected stool showed more similarities in count-based and weighted beta diversity metrics. There were significant differences in rare taxa and phylogenetically-diverse taxa between the two types of stool samples. Generally, there were higher levels of Proteobacteria in biopsy samples, with significantly more Actinobacteria and Firmicutes in stool (all p < 0.001, q-value < 0.05). Overall, there was a significantly higher relative abundance of Lachnospiraceae and Ruminococcaceae in stool samples (at-home collected and endoscopically-collected) and higher abundances of Tisserellaceae in biopsy samples (all p < 0.001, q-value < 0.05). Conclusion Our data shows that different sampling methods can impact results when looking at the composition of the gut microbiome using ASV-based approaches.

Purpose The aim of this study was to characterize the prevalence of cardiometabolic comorbidities (i.e., diabetes, peripheral vascular disease, myocardial infarction, congestive heart failure, cerebrovascular disease) among Hispanic/Latino cancer survivors and examine the impact of cardiometabolic comorbidities on health-related quality of life (HRQoL), unmet supportive care needs, patient-provider communication self-efficacy, satisfaction with cancer care, and increases in healthy behaviors. Methods Hispanics/Latinos diagnosed with breast, prostate, or colorectal cancer ( N = 288) were assessed within 15 months of primary treatment completion. Results One-quarter (24.7%) of survivors were diagnosed with diabetes and one-fifth (20.8%) were diagnosed with peripheral vascular disease. Survivors with at least one cardiometabolic comoribidity were older ( t (278) = -.3.622, p < .001) and more likely to have a household income of less than $25,000 ( X 2 = 8.369, p = .004). When adjusting for sociodemographic and medical covariates, survivors with cardiometabolic comorbidities demonstrated worse overall HRQoL ( B = -4.792, p = .050), emotional ( B = -1.479, p = .018) and physical ( B = -2.228, p = .005) wellbeing, a higher odds of unmet psychological (OR = 2.095, p = .027) and sexuality (OR = 2.898, p = .004) needs, and greater patient-provider communication self-efficacy ( B = .179, p = .045). There were no differences in healthy behavior changes or satisfaction with cancer care. Conclusions Cardiometabolic comorbidities may be highly prevalent among Hispanic/Latino cancer survivors and increase the risk of worse HRQoL and unmet supportive care needs. Targeted interventions are needed to optimize health among Hispanic/Latino cancer survivors with cardiometabolic comorbidities.

IMPORTANCE For many types of epithelial malignant neoplasms that are treated with definitive radiotherapy (RT), treatment prolongation and interruptions have an adverse effect on outcomes. OBJECTIVE To analyze the association between RT duration and outcomes in patients with esophageal cancer who were treated with definitive chemoradiotherapy (CRT). DESIGN, SETTING, AND PARTICIPANTS This study was an unplanned, post hoc secondary analysis of 3 prospective, multi-institutional phase 3 randomized clinical trials (Radiation Therapy O ncology Group [RTOG] 8501, RTOG 9405, and RTOG 0436) of the National Cancer Institute-sponsored NRG Oncology (formerly the National Surgical Adjuvant Breast and Bowel Project, RTOG, and Gynecologic Oncology Group). Enrolled patients with nonmetastatic esophageal cancer underwent definitive CRT in the trials between 1986 and 2013, with follow-up occurring through 2014. Data analyses were conducted between March 2022 to February 2023. EXPOSURES Treatment groups in the trials used standard-dose RT (50 Gy) and concurrent chemotherapy. MAIN OUTCOMES AND MEASURES The outcomes were local-regional failure (LRF), distant failure, disease-free survival (DFS), and overall survival (OS). Multivariable models were used to examine the associations between these outcomes and both RT duration and interruptions. Radiotherapy duration was analyzed as a dichotomized variable using an X-Tile software to choose a cut point and its median value as a cut point, as well as a continuous variable. RESULTS The analysis included 509 patients (median [IQR] age, 64 [57-70] years; 418 males [82%]; and 376 White individuals [74%]). The median (IQR) follow-up was 4.01 (2.93-4.92) years for surviving patients. The median cut point of RT duration was 39 days or less in 271 patients (53%) vs more than 39 days in 238 patients (47%), and the X-Tile software cut point was 45 days or less in 446 patients (88%) vs more than 45 days in 63 patients (12%). Radiotherapy interruptions occurred in 207 patients (41%). Female (vs male) sex and other (vs White) race and ethnicity were associated with longer RT duration and RT interruptions. In the multivariable models, RT duration longer than 45 days was associated with inferior DFS (hazard ratio [HR], 1.34; 95% CI, 1.01-1.77; P = .04). The HR for OS was 1.33, but the results were not statistically significant (95% CI, 0.99-1.77; P = .05). Radiotherapy duration longer than 39 days (vs <= 39 days) was associated with a higher risk of LRF (HR, 1.32; 95% CI, 1.06-1.65; P = .01). As a continuous variable, RT duration (per 1 week increase) was associated with DFS failure (HR, 1.14; 95% CI, 1.01-1.28; P = .03). The HR for LRF 1.13, but the result was not statistically significant (95% CI, 0.99-1.28; P = .07). CONCLUSIONS AND RELEVANCE Results of this study indicated that in patients with esophageal cancer receiving definitive CRT, prolonged RT duration was associated with inferior outcomes; female patients and those with other (vs White) race and ethnicity were more likely to have longer RT duration and experience RT interruptions. Radiotherapy interruptions should be minimized to optimize outcomes.

10541 Background: It is well known that estrogen exposure is a major risk factor for breast cancer (BC). Estrogen levels can be affected by the gut microbiome through enterohepatic circulation. No studies regarding gut microbiome changes in BC have examined the colonic mucosal microbiome; and there is no data on which types of gut microbiome studies would be most relevant to the study of the microbiome in BC. Methods: We examined differences in the gut microbiome composition in BC and control subjects using the following sample types: Home-collected stool, endoscopically collected stool, and colonic biopsy samples (for all groups, n=48 total, n=24 BC, n=24 controls). Here, we used both operational taxonomic unit (OTU) and amplicon sequence variant (ASV) based approaches in QIIME2 for 16S rDNA sequencing analysis. Alpha diversity metrics (Chao1, Pielou’s Evenness, Faith PD, Shannon, and Simpson) and beta diversity metrics (Bray-Curtis, Weighted and Unweighted Unifrac) were calculated. LefSe was used to analyze differences in the abundance of various taxa between sample types. Results: Alpha and beta diversity metrics were different between the three sample types when using both OTU or ASV-based analysis, however there were some minor differences between analysis types in these samples. Comparing the 3 sample types, Actinobacteria and Firmicutes (Log10 LDA score >4) were the predominant phyla in home stool samples, while Bacteroidetes and Proteobacteria (Log10 LDA score >4) were higher in abundance in the colonic biopsy samples. Conclusions: Our data shows that alpha and beta diversity metrics differ between sampling methods (home-collected stool, endoscopically collected stool, and colonic biopsies) when looking at the composition of the gut microbiome in BC. Results remained the same regardless of ASV or OTU-based analysis. [Table: see text]

We aimed to identify subgroups of Hispanic/Latino (H/L) cancer survivors with distinct health behavior patterns and their associated sociodemographic, medical, and psychosocial characteristics. Baseline data were used from a randomized clinical trial evaluating the efficacy of an enhanced patient navigation intervention in H/L cancer survivors. Participants (n = 278) completed the Lifestyle Behavior Scale and validated questionnaires on health-related quality of life (HRQOL), supportive care needs, distress, and satisfaction with cancer care. Latent class analysis was used to determine the latent classes and associated characteristics. Three latent classes emerged: class 1 (survivors who increased health behaviors [e.g., exercising and eating healthy] since diagnosis); class 2 (no changes in health behaviors since diagnosis); and class 3 (a “mixed class,” with a higher or lower engagement across various health behaviors since diagnosis). Participants in class 1 were significantly more educated and less likely to be foreign born. Participants in class 2 were significantly older and more likely to have prostate cancer. H/L cancer survivors in class 3 had a significantly lower income, were less educated, and reported greater unmet supportive care needs, more distress, and poorer HRQOL. Survivors who report engaging in health behaviors less frequently since diagnosis may be experiencing psychosocial challenges and health disparities. Hispanic/Latino cancer survivors may benefit from screening for social determinants of health and mental health needs, prompt referral to supportive care services, community resources, and public services, and participating in culturally informed psychosocial interventions to address their unique needs.

e18649 Background: Molecular biomarker testing is integral to NSCLC cancer care, but adoption and testing practices in the community are varied and often suboptimal. Testing practices, such as standard testing protocols and results turnaround time (TAT), impact timely treatment decisions. We examined adoption and testing practices for guideline recommended NSCLC biomarkers among National Cancer Institute Community Research Program (NCORP) sites. The study was conducted in collaboration with Wake Forest NCORP Research Base. Methods: An online survey was administered to onsite labs affiliated with NCORP sites April 2019 – June 2020. We assessed testing practices for 7 NCCN recommended biomarkers, including 3 with category 1 recommendation (EGFR, ALK, PD-L1) and 4 with category 2 recommendations (BRAF, ROS1, MET, RET). Guideline concordant result TAT was defined as return of EGFR and ALK results in ≤ 10 days (Lindeman 2018) (see Table for other outcomes). We used proportions, including two-sided Fischer exact tests, to compare outcomes by site characteristics (safety net, practice size). Results: The survey response rate was 69% (58/85). All responding labs offered testing for category 1 biomarkers (EGFR, ALK and PD-L1); only 10% conducted these tests in-house (Table). The majority of labs also tested for category 2 biomarkers (67%). TAT varied, with most labs returning results in ≤ 10 days for EGFR and ALK (69%, but only a minority meet this TAT for all biomarkers. Larger practice size (> 1400 new cancer cases a year) was associated with in-house testing of EGFR, ALK, PD-L1 (p=0.03) and having standard testing protocols (p<0.001). Safety net affiliation did not significantly impact practices. Conclusions: We found universal adoption of NCCN category 1 biomarkers among the labs affiliated with NCORP sites, with the majority meeting guideline concordant results TAT. There is opportunity for improvement in adoption of category 2 biomarkers and result TAT, for example, by using standard testing protocols. Reassuringly, no difference in testing practices was detected by safety net affiliation.[Table: see text]

Background: Upfront docetaxel (UD) with androgen deprivation therapy (ADT) has been demonstrated to improve survival outcomes in metastatic castration-sensitive prostate cancer (mCSPC). However, existing studies have included predominantly Caucasian patients. Study Question: To compare the efficacy of addition of UD to ADT in mCSPC to ADT alone among minority patients. Study Design: Retrospective study of mCSPC patients. Measures and Outcomes: Patients treated with UD and ADT between January 2014 and December 2017 (UD + ADT, n = 44) were compared with those treated with ADT alone between January 2008 and January 2017 (ADT, n = 38); patients of Caucasian ethnicity were excluded. The outcome of interest was progression-free survival (PFS), which was estimated using Kaplan-Meier analysis and Cox proportional hazard analysis. Results: Overall, 63 (76.8%) patients were African American and 16 (19.5%) were Hispanic. Fifty-five (67%) patients had high-volume mCSPC. The median follow-up was 14 months [95% confidence interval (CI): 10.4-16.5] for UD + ADT and 42 months (95% CI: 17-66.9) for ADT. Median PFS did not differ between groups: UD + ADT: 16 versus ADT: 18 months [hazard ratio (HR) for UD + ADT = 0.88, 95% CI: 0.48-1.62; P = 0.70]. In patients with high-volume disease, median PFS remained similar (UD + ADT: 16 vs. ADT: 14 months (HR for UD + ADT = 0.64, 95% CI: 0.33-1.25; P = 0.19). On multivariable analysis, prolonged time to nadir PSA, HR = 0.83 (95% CI: 0.76-0.90), was independently associated with PFS. The most common toxicities in UD + ADT were anemia and fatigue. Major limitations include small sample size and potential for selection bias due to the retrospective study design. Conclusions: In this retrospective review of a minority mCSPC cohort, UD + ADT was not associated with improved PFS compared with ADT alone. Although further study with larger sample size is needed, these results underscore the importance of ensuring accrual of minorities in clinical trials, reflective of the real-world setting.

Objectives: To identify areas for improvement and design system-based strategies to address challenges in the provision of quality ovarian cancer care, we undertook a quality improvement (QI) program at 2 large US-based hospital systems. Methods: At baseline, between 9/2019 and 2/2020, we audited 200 EMR records (100 from each system) of adult patients with recurrent ovarian cancer for assessing physicians’ performance of quality-based and National Comprehensive Cancer Network (NCCN) guideline-directed biomarker testing, maintenance treatment, monitoring, and patient-centered practices. Multidisciplinary ovarian cancer teams in each center participated in QI interventions including feedback on baseline EMR results and development of action plans. Post-intervention, 200 additional recurrent ovarian cancer patient EMRs were retrospectively reviewed in each center between 2/2020 and 9/2020 to determine the effect of the intervention on ovarian cancer care. Results: At baseline, for 200 patients diagnosed with ovarian cancer who's EMR were audited, the mean age was 66 years and the average time since diagnosis was 3 years. In these patients, documentation of BRCA1/2 testing, use of maintenance therapy, patient follow-up, and shared decision-making (SDM) were sub-optimal (Table). Action plans, such as development of resources for guidance with regard to therapy sequencing and patient management strategies, development of a new adverse event management plan, and improvements in documentation and care coordination procedures, were implemented. In the post-intervention EMR audits, 200 patient's demographics were similar to baseline: the mean age was 62 years and the average time since diagnosis was 3 years. At follow-up, EMR audits demonstrated a significant 46% improvement in BRCA1/2 testing (P<0.001). Maintenance therapy use for patients who responded to platinum-based chemotherapy was numerically, though not significantly, improved from 39% to 47% (P=0.170); the use of PARP inhibitors for maintenance therapy was significantly improved from 4% to 13% (P=0.005). Numerical, though not significant improvements, were also seen in documentation of adverse event monitoring. Documentation of patient monitoring for recurrence were significantly improved over baseline: recurrence monitoring improved from 33% at baseline, to 95% at follow-up (P<0.001). Finally, significant improvements in documentation of aspects of SDM were seen at follow-up including improvements in patients who were asked or counselled about treatment goals (44% improvement), treatment expectations (22% improvement), and concerns and fears (29% improvement). Conclusions: These results demonstrate that aligning care with guidelines can be challenging; however, implementation of system- and team-based interventions can lead to improved documentation of care practices. These methods and findings from this program are relevant for the future design of intervention to improve the quality of recurrent ovarian cancer care. To identify areas for improvement and design system-based strategies to address challenges in the provision of quality ovarian cancer care, we undertook a quality improvement (QI) program at 2 large US-based hospital systems. At baseline, between 9/2019 and 2/2020, we audited 200 EMR records (100 from each system) of adult patients with recurrent ovarian cancer for assessing physicians’ performance of quality-based and National Comprehensive Cancer Network (NCCN) guideline-directed biomarker testing, maintenance treatment, monitoring, and patient-centered practices. Multidisciplinary ovarian cancer teams in each center participated in QI interventions including feedback on baseline EMR results and development of action plans. Post-intervention, 200 additional recurrent ovarian cancer patient EMRs were retrospectively reviewed in each center between 2/2020 and 9/2020 to determine the effect of the intervention on ovarian cancer care. At baseline, for 200 patients diagnosed with ovarian cancer who's EMR were audited, the mean age was 66 years and the average time since diagnosis was 3 years. In these patients, documentation of BRCA1/2 testing, use of maintenance therapy, patient follow-up, and shared decision-making (SDM) were sub-optimal (Table). Action plans, such as development of resources for guidance with regard to therapy sequencing and patient management strategies, development of a new adverse event management plan, and improvements in documentation and care coordination procedures, were implemented. In the post-intervention EMR audits, 200 patient's demographics were similar to baseline: the mean age was 62 years and the average time since diagnosis was 3 years. At follow-up, EMR audits demonstrated a significant 46% improvement in BRCA1/2 testing (P<0.001). Maintenance therapy use for patients who responded to platinum-based chemotherapy was numerically, though not significantly, improved from 39% to 47% (P=0.170); the use of PARP inhibitors for maintenance therapy was significantly improved from 4% to 13% (P=0.005). Numerical, though not significant improvements, were also seen in documentation of adverse event monitoring. Documentation of patient monitoring for recurrence were significantly improved over baseline: recurrence monitoring improved from 33% at baseline, to 95% at follow-up (P<0.001). Finally, significant improvements in documentation of aspects of SDM were seen at follow-up including improvements in patients who were asked or counselled about treatment goals (44% improvement), treatment expectations (22% improvement), and concerns and fears (29% improvement). These results demonstrate that aligning care with guidelines can be challenging; however, implementation of system- and team-based interventions can lead to improved documentation of care practices. These methods and findings from this program are relevant for the future design of intervention to improve the quality of recurrent ovarian cancer care.

We tested whether a low-literacy-friendly, multimedia information and assessment system used in daily clinical practice enhanced patient-centered care and improved patient outcomes. This was a prospective, parallel-group, randomized controlled trial with 2 arms, CancerHelp-Talking Touchscreen (CancerHelp-TT) versus control, among adults with Stage I–III breast or colorectal cancer receiving chemotherapy and/or radiation therapy in safety net settings. Each patient was assessed for outcomes at 4 timepoints: after starting treatment (baseline), during treatment, immediately after treatment, and at follow-up assessment. The primary outcomes were health beliefs, cancer knowledge, self-efficacy, and satisfaction with communication about cancer and its treatments. Health-related quality of life (HRQOL) was a secondary outcome. A total of 129 patients participated in the study (65 intervention and 64 control), and approximately 50% of these completed the study. Patients randomized to receive the CancerHelp-TT program had a significantly larger increase in their cancer knowledge in comparison to those randomized to the control arm (effect size = .48, P = .05). While effect sizes for differences between randomized groups in self-efficacy, health beliefs, HRQOL, and satisfaction with communication were small (.10–.48), there was a consistent trend that participants in the intervention group showed larger increases over time in all outcomes compared to the control group. The CancerHelp-TT software was favorably rated by intervention participants. The CancerHelp-TT program showed promise to increase vulnerable cancer patients’ cancer knowledge and adaptive health beliefs and attitudes. However, vulnerable patients may need additional interventional support in settings outside cancer clinics.

e15143 Background: Hyper progressive disease (HPD) refers to the paradoxical acceleration of tumor growth following immune-checkpoint inhibitor (ICI) therapy. We aimed to evaluate the factors associated with HPD and its impact on overall survival (OS) in patients treated with ICI in our institution. Methods: We retrospectively reviewed the charts of 104 patients with solid tumors diagnosed from 04/01/2011 to 06/30/2018 who received ICI at John H. Stroger Jr. Hospital of Cook County, Chicago, IL. The OS, incidence of HPD and their demographic, clinical and laboratory correlates were recorded. HPD was defined as tumor growth ratio > = 2 on CT imaging after treatment with at least 2 cycles. The Log-rank method survival analysis was done to compare survival of patients with and without HPD. Results: Majority of patients were treated with either nivolumab (71.1%) or pembrolizumab (21.2%) in the second (50%) or third line (29.8%) setting. After excluding two patients without follow up scans, 14 out of 102 patients (13.7%) had HPD during the course of study. The patients with small cell lung cancer had higher incidence of HPD (4 out of 9). Patients who had evidence of HPD had significantly shorter OS (22.21±16.23 months versus 37.52±230.8 months, P value = 0.01). The variables associated with HPD were liver metastasis (Pearson Chi squared = 18.68, P value < 0.001) and persistently high LDH ( > 240 IU/L) during therapy (Pearson Chi squared = 16.85, P value < 0.001). Other variables that were significantly associated with HPD on univariate analysis, but not on multivariate analysis are as below. Conclusions: Although the etiopathogenesis of HPD is incompletely understood, the correlation of LDH to HPD is intriguing and warrants further studies as possible predictive marker of HPD. [Table: see text]

Chemotherapy-induced peripheral neuropathy (henceforth, neuropathy) is often dose limiting and is generally managed by empirical dose modifications. We aimed to (1) identify an early time point that is predictive of future neuropathy using a patient-reported outcome and (2) propose a dose-adjustment algorithm based on simulated data to manage neuropathy. In previous work, a dose-neuropathy model was developed using dosing and patient-reported outcome data from Cancer and Leukemia Group B 40502 (Alliance), a randomized phase III trial of paclitaxel, nanoparticle albumin-bound paclitaxel or ixabepilone as first-line chemotherapy for locally recurrent or metastatic breast cancer. In the current work, an early time point that is predictive of the future severity of neuropathy was identified based on predictive accuracy of the model. Using the early data and model parameters, simulations were conducted to propose a dose-adjustment algorithm for the prospective management of neuropathy in individual patients. The end of the first 3 cycles (12 weeks) was identified as the early time point based on a predictive accuracy of 75% for the neuropathy score after 6 cycles. For paclitaxel, nanoparticle albumin-bound paclitaxel, and ixabepilone, simulations with the proposed dose-adjustment algorithm resulted in 61%, 48%, and 35% fewer patients, respectively, with neuropathy score >= 8 after 6 cycles compared to no dose adjustment. We conclude that early patient-reported outcome data on neuropathy can be used to guide dose adjustments in individual patients that reduce the severity of future neuropathy. Prospective validation of this approach should be undertaken in future studies.

e14134 Background: Immune-related endocrine dysfunction is unique to immunotherapy (IT). We aimed to explore the clinical parameters associated with development of thyroid disorder (TD) in patients receiving IT and their outcome. Methods: We designed a retrospective study of patients treated with anti-CTLA4 and/or anti-PD1/PDL1 IT at Cook County Hospital, Chicago between January 2015 to January 2018. Patients with incomplete charts and those who received less than two cycles of IT were excluded. Demographics, clinical and pathologic data were recorded at the time of diagnosis and prior to start of IT. Pearson Chi-square, independent sample t-test and logistic regression were used for data analysis. Results: We included 104 patients in the study, out of whom 66 were male and 38 were female. Most common diagnosis was non-small cell lung cancer (42.4%) followed by squamous cell cancer of head and neck (21.2%), renal cell cancer (12.5%), small cell lung cancer (12.5%) and melanoma (8.7%). Majority of patients (91.4%) had metastasized and were treated with either Nivolumab (71.1%) or Pembrolizumab (21.2%) in the 2nd (50%) or 3rd line (29.8%) setting. Twenty-eight patients developed TD while on IT, out of whom, 13 developed hypothyroidism, 12 developed hyperthyroidism followed by hypothyroidism and 3 developed hyperthyroidism. TD developed between 1st to 6th cycle of IT in 96.5% patients. Older age (p-0.009), history of radiation (RT) to neck (p-0.007), history of RT to chest (p-0.015), history of venous thrombosis (p-0.007) and higher thyroid stimulating hormone (TSH) level (17.76±35.67) prior to starting IT (p-0.029) were significantly associated with TD. Multivariate logistic regression showed that history of RT to neck was a significant predictor of developing TD after adjustment for age, race and sex (adjusted OR 9.64, 95% CI 1.88-49.36, p-0.007). No patient reported thyroid related symptom and IT was continued uninterrupted in all patients. Levothyroxine was the drug of choice for treating hypothyroidism. No patient received steroids or antithyroid medications. Conclusions: History of radiation therapy to neck is significantly associated with development of thyroid dysfunction in patients receiving immunotherapy. Thyroid replacement therapy is sufficient to bring down the levels of TSH and immunotherapy need not be interrupted.

525 Background: Exposure to cytotoxic chemotherapy (CC) has been observed to be associated with significant changes in body composition, namely marked lean muscle mass losses, with implications for treatment-related toxicity and oncologic outcomes. However, prior studies predominately include elderly patients who, a priori, are at risk for sarcopenia or severe skeletal muscle deficiency. To date, the impact of CC on body composition in young men with testicular cancer remains undefined. Methods: A retrospective analysis of 19 patients with metastatic testicular cancer treated with CC was performed (2015-17). Lumbar skeletal muscle index (SMI), visceral (VAI), subcutaneous (SCAI), and intramuscular adipose (IMAI) indices (cm2/m2), as well as fat-free mass (FFM, kg) and fat mass (FM, kg) were calculated using cross-sectional soft tissue area measurements on pre- and post-CC computed tomography (CT) axial scans and compared using paired Wilcoxon Signed Rank Tests. Results: Median age was 29 years. According to the NHANES FMI-based classification, 5 (26.3%), 9 (47.4%), 4 (21.1%), and 1 (5.3%) patients had normal, excess, class I, and class II obesity, respectively. Median pre- and post-CC BMI was 27.7 vs. 29.6 kg/m2(p = 0.03). Median pre- and post-CC SMI, VAI, SAI, and IAI were 63.5 vs 57.8 (p = 0.14), 19.9 vs 30.8 (p = 0.01), 47.9 vs 58.2 (p = 0.03), and 3.0 vs 5.2 (p = 0.002), respectively. Median muscle density pre- and post-CC were 47.0 vs 43.6 HU (p = 0.002). Pre- and post-chemotherapy FFM were 21.5 vs 19.5 kg, representing an overall median loss of 2.8%, (IQR -10.1, +4.7; Range -49.5 - +16.3; p = 0.14). Conversely, pre- and post-CC FM were 6.6 vs 7.5 kg, representing an overall median gain of 13.3% (IQR -3.3, +17.0; -24.9 - +50; p = 0.01). Median time between imaging assessments was 121 days. Specific median measures of adiposity each increased significantly, such that VIA increased by 29% (p = 0.01), SCAI increased by 39.7% (p = 0.03), and IMIA increased by 39.7% (p = 0.002). Conclusions: While lean muscularity remained stable, we observed significant increases in total body adipose mass with decreased muscle density in this consecutive case series of testicular cancer patients following CC.