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Serial ctDNA genomic profiling integrated with a networked molecular tumor board in first-line advanced NSCLC: The COPE randomized phase II trial.

8551 Background: Circulating tumor DNA (ctDNA) complements tissue profiling and may provide early response information in advanced NSCLC, but prospective evidence is limited. Methods: COPE is an open-label, multicenter, randomized (2:1), two-arm non-comparative phase II trial in stage IIIB/IV NSCLC (NCT04258137). Arm A included FoundationOneLiquidCDx ctDNA profiling at baseline, week 3, each radiologic assessment, and progression with centralized molecular tumor board (MTB) review; Arm B used baseline tissue profiling and standard imaging. ctDNA-guided treatment changes were discretionary. The primary endpoint was18-month (mo) overall survival (OS) rate in Arm A vs a prespecified historical benchmark; secondary/exploratory endpoints included profiling success, objective response rate (ORR), ctDNA dynamics, and genomic evolution. Results: From 2020–2023, 176 patients (pts) were enrolled (Arm A n = 117; Arm B n = 59). At median follow-up 24.0 mo, 18-mo OS was 53.8% (95% CI 44.3–62.5) in Arm A (median OS 22.4 mo) and 65.7% (95% CI 52.0–76.3) in Arm B. Baseline plasma profiling rescued genotyping in 32/35 pts with tissue insufficiency, increasing genotyping success from 69% (tissue alone) to 97% (tissue + plasma). In Arm A, 90/117 had evaluable paired baseline and week-3 plasma samples. Among pts receiving first-line (1L) chemo-immunotherapy (chemo + ICI), early molecular response (MR), defined as ctDNA no longer detected at day 21 was strongly associated with more favorable outcomes, including higher ORR (81.8% vs 50.0%), longer progression-free survival (median PFS 22.9 vs 5.9 mo), and OS (18-mo OS 81.8% vs 57.1%). Similar results were observed in the overall study population. MR50, defined as ≥50% reduction at day 21, showed similar associations with more favorable outcomes. In pts on chemo + ICI with further ctDNA testing, those with durable MR50 through mo 5-9 had longer mPFS (23 mo vs 11 mo), similar to pts with early ctDNA clearance. Importantly, excluding pts who progressed at/before week 3, the median lead time in detecting progression on chemo + ICI with ctDNA prior to radiographic progression was 3.5 mo (N = 19pts). Among 59 responders with paired baseline and any on treatment plasma, 35 were treated with 1L chemo + ICI and 13 with 1L targeted therapy. Tumor-associated emergent alterations were detected in 37 pts (63%), with treatment-specific resistance patterns observed across therapeutic classes. Conclusions: COPE is, to our knowledge, the first randomized prospective study of sequential ctDNA profiling in 1L advanced NSCLC. Serial ctDNA analysis within a networked MTB model was feasible, improved baseline molecular profiling, and provided a strong exploratory early molecular response signal, supporting future ctDNA-guided interventional trials. Clinical trial information: NCT04258137 .

Real-world patterns of dose reduction and early discontinuation of abemaciclib for early-stage, hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer in insured United States adults.

e12718 Background: The MonarchE clinical trial of adjuvant abemaciclib 150 mg twice daily in women with early-stage HR+/HER2- breast cancer showed a high adverse event burden leading to frequent dose reductions over two years of treatment. There is limited real-world data characterizing dose of abemaciclib used over time for early-stage HR+/HER2- breast cancer. We sought to describe variation in dose used at initiation, frequency of dose reductions over time, and rates of early discontinuation using a large national claims database. Methods: We conducted an observational, retrospective analysis of 2021-23 MerativeTM Marketscan Commercial and Medicare claims (Copyright ©2026 Merative; All Rights Reserved). The protocol was reviewed and deemed exempt by the Institutional Review Board. Adult females who initiated abemaciclib (150, 100, or 50 mg) in 2022-23 were included if, prior to the first abemaciclib claim, they were continuously enrolled in a plan with drug coverage, had ≥2 breast cancer diagnosis codes, used an aromatase inhibitor or tamoxifen, had no HER2+ breast cancer medications, and had no claims for secondary or non-breast neoplasms. Patients were followed until disenrollment, diagnosis with a secondary or non-breast neoplasm, or end of available data (Dec. 31, 2023). We categorized dose at initiation (150, 100, or 50 mg) and estimated cumulative incidence of dose reduction and treatment discontinuation, conservatively defined as a gap in days’ supply of ≥12 weeks to avoid misclassification of temporary stoppages due to adverse events or other reasons. Results: Among 874 females initiating abemaciclib for early-stage breast cancer, 25% were ages 18-44 years, 36% were 45-54 years, and 40% were ≥55 years; 97% used an aromatase inhibitor and 3% tamoxifen. Most (83%) started abemaciclib at 150 mg; 13% started at 100 mg and 4% at 50 mg. Patients were followed for a median of 249 days (IQR 117-417) before censoring due to disenrollment (18%), diagnosis with secondary/non-breast neoplasm (5%), and end of data (77%). The overall one-year cumulative incidence of discontinuation in the full sample was 25% (95% CI 21%,29%), and was 23% (95% CI 20%,27%) for those initiating at the 150 mg dose vs. 33% (95% CI 24%,44%) in those initiating at 100 or 50 mg. Among the subset initiating at doses of 100 mg or higher, the one-year cumulative incidence of dose reduction was 44% (95% CI 40%,49%), and was higher for patients who initiated at 150 mg (48% [95% CI 44%,53%]) vs. 100 mg (23% [95% CI 17%,33%]). Conclusions: The one-year incidences of dose reduction and discontinuation observed in this study were higher than those reported in MonarchE. More research is needed to understand effects of dose reductions and early discontinuation on effectiveness and safety outcomes in real-world populations.

Rates of inadequate ovarian suppression in premenopausal breast cancer patients receiving ovarian function suppression.

e12730 Background: Ovarian function suppression (OFS) improves outcomes for premenopausal patients with high-risk estrogen receptor-positive (ER+) breast cancer. However, real-world monitoring of estradiol (E2) levels and the adequacy of biochemical suppression remain understudied. We evaluated patterns of OFS use, E2 testing, and suppression effectiveness across a large academic cancer center network. Methods: We retrospectively analyzed 3,113 patients ≤55 years with stage I-III ER+ breast cancer treated with definitive surgery and adjuvant endocrine therapy from 2018-2024 across 23 sites of the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center. Demographics, clinic-pathologic information, OFS receipt, endocrine therapy, E2 testing, and suppression inadequacy (E2 ≥15 pg/mL) were collected. Logistic regression identified predictors of OFS use. Survival was assessed using stage-adjusted and time-varying Cox models. Results: Among 3,113 patients, 2,051 were premenopausal, of whom 672 (33%) received OFS. In adjusted logistic models, younger age (odds ratio [OR] per one-year increase: 0.91; 95% CI: 0.89-0.93), nodal involvement (N1: OR 1.85; 95% CI: 1.34-2.56), higher grade (Grade III: OR 1.60; 95% CI: 1.12-2.29), elevated Ki-67 ≥20% (OR 1.33; 95% CI: 1.04-1.70), and chemotherapy receipt (OR 1.42; 95% CI: 1.11-1.80) strongly predicted OFS use. Among 640 patients with known OFS start dates, only 53% underwent any E2 testing. Inadequate ovarian suppression occurred in 50% of monitored patients. Younger age strongly predicted inadequate suppression (50% if < 40 vs 26% if 45-50; p < 0.005). Inadequate suppression was more common with tamoxifen than AIs (54.9% vs 41.2%; OR 1.73, p < 0.005). Both liquid chromatography-mass spectrometry and sensitive immunoassays detected significant rates of inadequate suppression (29% and 14% of tests, respectively), with similar overall distribution patterns. In survival analyses, the low number of events limited the power to detect overall survival or disease-free survival differences in standard Cox models. However, in a time-varying Cox model among premenopausal patients, OFS was associated with 82% reduction in mortality (HR = 0.18, p = 0.001) when accounting for immortal time bias. Conclusions: In this large real-world cohort, OFS was more frequently used in higher-risk patients. However, E2 monitoring was infrequent, and nearly half of the monitored patients experienced inadequate ovarian suppression, particularly younger women and those on tamoxifen. It is unclear if E2 values can be interpreted accurately as Tamoxifen is associated with increased serum E2 levels. These findings highlight the need for standardized E2 monitoring protocols and timely OFS administration to ensure consistent ovarian suppression in real-world clinical practice.

Dexrazoxane for anthracycline cardiotoxicity prevention in pediatric and AYA cancers: Systematic review and meta-analysis.

e24201 Background: Anthracyclines remain curative in many pediatric and adolescent/young adult (AYA) cancers but confer dose-dependent cardiotoxicity. Dexrazoxane reduces cardiac injury; however, concerns persist regarding potential impact on oncologic outcomes. Methods: We conducted a PRISMA-compliant systematic review and meta-analysis of studies comparing anthracycline therapy with versus without dexrazoxane in pediatric/AYA populations. Databases included MEDLINE, Embase, and CENTRAL. Outcomes included cardiac function (LVEF decline, clinical heart failure), event-free survival (EFS), overall survival (OS), relapse, and second malignant neoplasms (SMN). Random-effects meta-analysis pooled hazard ratios (HRs) for time-to-event outcomes and risk ratios (RRs) for binary endpoints. Results: Twelve studies with 1,384 patients were included. Dexrazoxane significantly reduced risk of clinical heart failure (RR 0.34, 95% CI 0.21–0.55) and preserved LVEF compared with controls. No significant differences were observed in EFS (HR 0.97, 95% CI 0.84–1.12), OS (HR 0.95, 95% CI 0.81–1.11), relapse (RR 1.02, 95% CI 0.87–1.19), or SMN incidence (RR 1.05, 95% CI 0.78–1.41). Benefits were consistent across cancer types, cumulative anthracycline doses, and follow-up durations. Conclusions: Dexrazoxane provides substantial cardio protection in pediatric and AYA patients receiving anthracyclines without compromising oncologic outcomes or increasing risk of SMNs. Clinical Takeaway: Routine incorporation of dexrazoxane in high-risk anthracycline regimens can prevent cardiotoxicity while maintaining curative potential.

Investigation of structural, optical and dielectric properties of the zinc oxide thin films

Impact of a resident-led quality improvement intervention on colorectal cancer screening completion at a federally qualified health center.

e23306 Background: Colorectal cancer (CRC) remains a leading cause of cancer-related mortality, yet screening rates remain suboptimal, particularly in underserved populations. At a Federally Qualified Health Center (FQHC) in Central Texas, patients face barriers including limited health literacy, logistical challenges, and missed opportunities for preventive counseling. Resident physicians, often the first point of contact for these patients, are positioned to promote preventive health behaviors. Prior studies demonstrate that physician-led counseling improves cancer screening adherence. Our objective was to improve CRC screening completion rates at FQHC by 20% over baseline through resident-led educational and patient follow-up intervention. Methods: Internal medicine residents participated in a one-time educational session on CRC screening guidelines, stool-based test options (with emphasis on the InSure FIT test), and patient-centered communication strategies. Visual reminders were posted in resident work, and a standardized “.crcscreening” dot phrase was created to reinforce consistent documentation. Residents conducted structured patient follow-up by reviewing lists of patients with incomplete screenings, contacting them via phone or MyChart to address barriers, and documenting reasons for non-completion in an Excel-based tracking tool. A designated clinic nurse supported coordination. Baseline and post-intervention data on resident counseling behaviors, confidence, screening orders, and CRC screening completion rates were collected. Resident panel CRC completion rates were extracted from the Epic electronic health record at baseline and one quarter post-intervention. Results: All 64 residents completed the educational intervention. Based on survey data, the proportion of residents who always counseled patients on CRC screening increased from 46.4% pre-intervention to 98.4% post-intervention (p < 0.0001). Similarly, residents who reported being comfortable explaining the InSure FIT test increased from 42.0% to 95.3% (p < 0.0001). Of the 64 residents who completed the intervention, 38 were assigned continuity clinics at the FQHC. Among 38 residents with paired pre- and post-intervention patient panel data, mean CRC screening completion rates increased from 47% at baseline to 59% one quarter after the intervention (+12%, p < 0.001). Conclusions: This resident-driven initiative illustrates a practical, scalable strategy to improve CRC screening in an underserved population. By integrating provider education, workflow tools, and structured patient follow-up, this intervention achieved significant gains in both resident counseling behaviors and patient-level CRC screening completion. This model advances health equity, promotes early cancer detection, while embedding preventive care into routine practices.

Trends in rural-urban disparities in U.S. cervical cancer mortality before and after the HPV vaccine introduction: A CDC analysis, 1999-2023.

5535 Background: Cervical cancer mortality has declined in the United States following the introduction of HPV vaccination. However, disparities by urbanization, geography, and race may persist. Rural women remain up to 40% more likely to die from cervical cancer. Understanding rural–urban trends is essential to guiding equitable prevention strategies. Methods: CDC WONDER mortality data for females ≥15years with cervical cancer (ICD-10 C53) were analyzed. Age-adjusted mortality rates (AAMR) per 100,000 population were analyzed. Urbanization data were available till 2020 and were used for urban–rural stratification (NCHS classification). Temporal trends were assessed using joint point regression to determine average annual percent change (AAPC). Results: Between 1999 and 2023, 102,205 cervical cancer deaths were identified. The overall AAMR declined from 1.52 to 1.28 during the pre-vaccine era (1999–2005; AAPC = –2.95%, 95% CI –4.0 to –1.8) and further to 1.09 during the post-vaccine era (2006–2023; AAPC = –0.86%, 95% CI –1.0 to –0.7). Rural-urban mortality (AAMR) ratio increased in post-vaccine era from 1.13 vs 1.15 with 1.47% increase in disparity. By urbanization, declines were greatest in central metropolitan areas (AAMR 1.72 to 1.48 pre-vaccine; 1.14 post-vaccine; AAPC = –1.40%, 95% CI –1.6 to –1.2), while small metro (1.36 to 1.29 pre-vaccine; 1.11 post-vaccine; AAPC = –0.93%, 95% CI –1.2 to –0.6) and micropolitan areas (1.70 to 1.44 pre-vaccine; 1.32 post-vaccine; AAPC = –0.34%, 95% CI –1.3 to 0.6) showed slower improvement which widened mortality gap. Subgroup analyses showed the steepest mortality declines among women aged ≥75 years (AAPC = –3.66%), among Black women (AAPC = –2.81%), and in the Northeast region (AAPC = –2.16%). Conclusions: U.S. cervical cancer mortality declined after the HPV vaccine introduction; however, rural–urban, racial, and regional disparities persisted. Declines were slower in small metropolitan and nonmetropolitan areas and highest among Black individuals, underscoring the need for targeted vaccination, screening efforts and access-to-care.

Assessment of HPV’s influence on survival in head and neck cancer: A pioneering large-scale cohort analysis and insights into HPV’s long-term prognostic impact stratified by smoking status.

e18129 Background: Human papillomavirus (HPV) infection is a prominent risk factor for head and neck cancers (HNC) of the lip, oral cavity, and pharynx, often linked to improved prognosis. However, its long-term effects on survival and systemic comorbidities, particularly modulated by nicotine dependence, warrant further elucidation to inform precision oncology strategies. Methods: We investigated the long-term influence of HPV status on all-cause mortality and selected comorbidities in HNC patients, with stratification by nicotine dependence. This retrospective cohort study utilized deidentified electronic medical records from the TriNetX federated network. Adult patients (≥18 years) diagnosed with HNC were categorized into HPV-positive (HPV+) and HPV-negative (HPV-) cohorts, analyzed overall and within a nicotine-dependent subgroup. Propensity score matching (1:1) balanced cohorts on age, sex, race, ethnicity, body mass index, and ECOG performance status. Results: The overall matched cohort included 9,187 HPV- and 9,187 HPV+ patients. HPV+ status was associated with comparable mortality risk (risk difference (RD), -0.009 [95% CI, -0.021 to 0.003]) but enhanced survival (median survival, 6017 vs 5689 days; end-window probability, 46.67% vs 38.66%; log-rank P < .001; HR, 0.84 [CI, 0.79-0.89]). HPV+ patients showed increased volume depletion (RD, -0.025 [CI, -0.041 to -0.009]; HR, 0.81 [CI, 0.76-0.87]) and decreased lipid metabolism disorders (RD, 0.021 [CI, 0.006-0.036]), with favorable HRs for kidney disease (0.88 [CI, 0.80-0.95]) and ischemic heart disease (0.87 [CI, 0.79-0.94]). The nicotine-dependent matched cohort comprised 5,628 patients per group. Mortality was similar (RD, 0.008 [CI, -0.008 to 0.025]; HR, 0.95 [CI, 0.88-1.02]). HPV+ was linked to elevated malaise/fatigue risk (RD, -0.025 [95% CI, -0.044 to -0.006]; HR, 0.83 [CI, 0.76-0.91]), without significant differences in other comorbidities. Conclusions: HPV positivity in HNC is associated with superior long-term survival overall, but this benefit is attenuated in nicotine-dependent patients, underscoring the synergistic adverse effects of smoking and HPV. Elevated risks of electrolyte imbalances and fatigue in HPV+ subgroups highlight the need for tailored monitoring and supportive care to mitigate these complications.

Adjuvant immune checkpoint inhibitor therapy after curative-intent resection or ablation for high-risk hepatocellular carcinoma: A systematic review and meta-analysis of randomized controlled trials.

e16289 Background: The risk of recurrence of hepatocellular carcinoma (HCC) remains high after curative-intent resection or local ablation. We evaluated the efficacy and safety of adjuvant immune checkpoint inhibitor (ICI) based therapy. Methods: PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched for RCTs comparing adjuvant ICI-based therapy versus placebo/active surveillance after resection/ablation in patients with high-risk HCC. High-risk HCC was defined using trial-specific criteria for elevated recurrence risk after curative-intent therapy, based on tumor burden/pathologic features like tumor size and number, microvascular invasion, portal vein invasion, poor differentiation, or protocol-specified recurrence-risk stratification. Included regimens were atezolizumab + bevacizumab, pembrolizumab, and sintilimab. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints were overall survival (OS) and grade ≥3 adverse events (AEs). Hazard ratios (HRs) for time-to-event outcomes and risk ratios (RRs) for binary outcomes were pooled using inverse-variance random-effects models. Heterogeneity was assessed with I². Results: Three RCTs were included: IMbrave050 (atezolizumab+bevacizumab vs surveillance), Wang et al (sintilimab vs surveillance), and KEYNOTE-937 (pembrolizumab vs placebo; total N = 1,825). All trials enrolled Child-Pugh A and ECOG 0-1 patients. Across trials reporting baseline demographics (IMbrave050 and Wang et al; n = 866), 143/866 (16.5%) were female, median age ranged from 53–60 years, and HBV was the predominant etiology (561/866, 64.8%), followed by HCV (77/866, 8.9%). High-risk features were common: in IMbrave050, 52–60% had tumors > 5 cm, 60–61% had microvascular invasion and 6–8% had Vp1/Vp2 invasion (segmental portal vein invasion), in Wang et al, 52–59% had tumors > 5 cm and 35–40% had preoperative AFP > 400 ng/mL. KEYNOTE-937 stratified randomization by using AFP level at diagnosis and a protocol-defined recurrence-risk stratification, but the interim report did not specify the exact recurrence risk criteria. Adjuvant ICI-based therapy did not significantly improve RFS HR 0.76 (95% CI 0.51-1.14; I² = 82.8%) or OS HR 0.97 (95% CI 0.60-1.56; I² = 63.1%). Grade ≥3 AEs were more frequent with adjuvant therapy (308/907 vs 159/912) RR 2.12 (95% CI 1.20-3.77; I² = 87.3%). Conclusions: Adjuvant ICI-based therapy after curative-intent therapy for trial-defined high-risk HCC showed no significant overall RFS or OS benefit, with increased grade ≥3 adverse events. Results were heterogeneous, suggesting that any benefit may vary by regimen and patient risk profile; longer follow-up is needed to identify which patients are most likely to benefit, ongoing phase 3 trials will further clarify the role of adjuvant ICI.

A prognostic prediction model for neoadjuvant chemotherapy in locally advanced breast cancer integrating deep learning and pathomics.

e12564 Background: Breast cancer is the most prevalent malignant tumor among women worldwide, constituting a significant threat to women’s health. Neoadjuvant chemotherapy(NAC) has emerged as one of the standard treatment approaches for locally advanced breast cancer patients. However, individual responses to NAC vary considerably, leading to divergent treatment outcomes and complicating the timely adjustment of therapeutic strategies.Therefore, predicting the likelihood of achieving pathological complete response (pCR) and the risk of recurrence and metastasis based on pre-NAC biopsy findings is a critical clinical challenge for personalizing treatment plans. Methods: This study included 261 breast cancer patients who completed NAC between 2015 and 2022 in Cancer Hospital of Shantou University Medical College ,who were divided into a training group (n = 180) and a validation cohort (n = 81). Clinical and pathological data, including stage, and surgical details,were extracted from electronic medical records .The association between pCR and survival outcomes—disease-free survival (DFS), distant recurrence-free survival (DRFS), and overall survival (OS)—was analyzed using mixed-effects Cox proportional hazards models, with survival curves estimated by the Kaplan-Meier method. The ResNet50 deep learning architecture was employed to extract and learn histopathological features from whole-slide images (WSIs) of both pre-NAC biopsy tissues and post-NAC surgical specimens. Finally, an integrated model was developed to predict prognosis for patients with locally advanced breast cancer following NAC. Model performance was evaluated using the F1-score, time-dependent receiver operating characteristic (ROC) curves, and the concordance index (C-index). Results: Over a median follow-up of 5.6 years (IQR, 3.2-11.1），the 5-year DFS was 65.90%，and the 5-year OS rate was 81.61%.An integrated model combining clinical data with features from pre-NAC biopsy WSI achieved an area under the curve (AUC) of 0.72 for predicting recurrence and metastasis risk.To enhance predictive accuracy, features from post-NAC surgical specimen WSIs were incorporated, resulting in an improved integrated model with an AUC of 0.79. The F1-score, time-dependent ROC analysis, and C-index consistently supported the model's effectiveness in predicting both pCR and the risk of recurrence and metastasis. Conclusions: We developed an integrated model that synthesizes histopathological features from pre-NAC biopsy and post-NAC resectionspecimens with various key clinical parameters. This model holds promise for assisting clinicians in in accurately predicting patient prognosis prior to initiating neoadjuvant chemotherapy, thereby facilitating earlier and more timely formulation of personalized treatment strategies.

Temporal trends of mortalities in ovarian carcinoma and hypertension: Comorbidity-related mortality from 1999-2020.

e17590 Background: Ovarian cancer and essential hypertension are both associated with substantial morbidity and mortality in the United States. Hypertension may further worsen outcomes in patients with ovarian cancer, yet population-level mortality patterns remain incompletely characterized. We examined long-term trends and demographic disparities in hypertension-associated mortality among women with ovarian cancer. Methods: We conducted a retrospective population-based cohort study using the CDC WONDER multiple-cause-of-death database (1999–2023). Deaths among women aged ≥45 years with ovarian cancer (ICD-10: C56) and essential hypertension (ICD-10: I10) listed as underlying or contributing causes were identified. Analyses followed STROBE guidelines. Age-adjusted mortality rates (AAMRs) per 100,000 population were calculated using the 2000 U.S. standard population. Trends were stratified by age group, race/ethnicity, urbanization, and U.S. census region. Joinpoint regression was used to estimate annual percent change (APC) and average annual percent change (AAPC) with 95% confidence intervals. Results: From 1999 to 2023, 21,225 deaths occurred among women aged ≥45 years with both ovarian cancer and hypertension (overall AAPC 2.52%; 95% CI 1.19–3.86; p=0.0002). The AAMR increased from 0.71 in 1999 to 1.35 in 2005, declined to 1.19 in 2017, and rose again to 1.47 by 2023. Mortality was higher among women aged ≥65 years (AAPC 1.94%; 95% CI 0.74–3.15) compared with those aged 45–64 years (AAPC 2.95%; 95% CI 1.97–3.94). Non-Hispanic Black women exhibited the highest AAMR (peak 1.86 in 2009; AAPC 1.74%; 95% CI −0.46 to 3.99). Hispanic women demonstrated a gradual increase in AAMR over the study period. Rural areas showed higher mortality rates than urban areas (AAPC 2.47% vs 2.76%), with statistical significance observed for urban trends (p=0.004). Regionally, the South recorded both the lowest AAMR in 1999 (0.58) and the highest in 2022–2023 (1.68). Conclusions: Hypertension-associated mortality among women with ovarian cancer increased from 1999 to 2023, with higher rates among older adults, non-Hispanic Black women, and rural populations. Regional disparities were most pronounced in the Southern United States. These findings support the importance of integrating cardiovascular risk assessment and hypertension management into ovarian cancer care, particularly for high-risk groups. Age-adjusted mortality rate trends for hypertension-related mortality rate among US females with ovarian cancer from 1999 to 2023, stratified by age, race and census region. Serial no. Characteristics AAMR(1999-2023) AAPC (95%CI) JP, No 1 Overall (Female) 0.71-1.47 2.52 (1.19 - 3.86) 2 2 Hispanic 0.9-1.47 1.15 (0.17 - 2.14) 0 3 non-Hispanic black 0.89-1.83 1.74 (-0.46 - 3.99) 2 4 non-Hispanic white 0.68-1.47 2.79 (1.48 - 4.12) 2 5 45-64 year 0.12-0.42 2.95 (1.97 - 3.94) 0 6 65+ year 1.75-3.25 1.93(0.74-3.15) 2 7 Census region 1 0.71-1.14 0.84 (-1.65 - 3.4) 2 8 Census region 2 0.84-1.15 1.33 (-0.17 - 2.86) 3 9 Census region 3 0.58-1.68 2.35 (1.59 - 3.11) 0

Does anatomical subsite matter in acral melanoma?: A cohort study of clinical and molecular features.

e21595 Background: Acral melanoma is a rare and biologically distinct melanoma subtype, frequently diagnosed at advanced stages and associated with a low prevalence of actionable molecular alterations. Whether anatomical subsite within acral locations influences tumor aggressiveness and clinical outcomes remains uncertain, particularly in real-world cohorts from Latin America. Methods: We retrospectively analyzed patients with pathologically confirmed acral melanoma treated at a A.C. Camargo Cancer Center, Brazil, between 2020 - 2025. Among 196 patients initially evaluated with a clinical suspicion of acral melanoma, 57 cases were histologically confirmed and included. Primary anatomical location was classified by site and subsite. Survival outcomes were estimated using Kaplan–Meier methods, and associations between anatomical subsite, clinicopathological features and outcomes were explored using log-rank tests and logistic regression analyses. Results: Median age: 59 years (IQR 51–71) and 59% of patients were female. Primary tumors were most frequently located on the plantar surface of the foot (56%), followed by non-ungual digital sites (29%), subungual melanoma (7%), other acral non-plantar/non-digital sites (3.5%) and other locations (3.5%). At diagnosis, 43% of tumors were T3–T4, nodal involvement was present in 14% and distant metastasis in 1.8%. Somatic mutations were detected in 10.5% of cases [ BRAF V600E (8.8%) and KIT (1.8%)]. During follow-up, metastatic progression occurred in 24.6% of patients and local recurrence in 10.5%. The 60-month progression-free survival (PFS) was 73.1% (95% CI, 57.9–92.3) and overall survival (OS) at 60 months was 89.2% (95% CI, 79.7–99.9%). No statistically significant differences in PFS or OS were observed according to primary anatomical location. Exploratory analyses by anatomical subsite demonstrated a trend toward more advanced clinical stage (II–IV) in tumors arising from the plantar heel (global p = 0.062). In multivariable analysis adjusted for ulceration, anatomical subsite was not independently associated with advanced stage, whereas ulceration remained a strong predictor (OR 10.5, 95% CI 2.50–57.7). When stratified by clinical stage, patients diagnosed at advanced stages (II–IV) had significantly worse overall survival compared with those diagnosed at early stages (IS–I) (log-rank p = 0.03). A non-significant trend toward worse progression-free survival was observed in advanced-stage disease (log-rank p = 0.13). Conclusions: Anatomical subsite was not independently associated with survival outcomes in this cohort of acral melanoma. However, plantar heel tumors showed exploratory signals of more advanced presentation, largely mediated by ulceration. Advanced clinical stage was significantly associated with worse overall survival, underscoring the importance of early diagnosis in acral melanoma.

Cancer incidence and mortality among US young adults younger than 50 years.

e23093 Background: Early-onset cancers are increasingly recognized as a growing public health concern. We aimed to evaluate national trends in cancer incidence and mortality among individuals younger than 50 years in the US over more than two decades. Methods: We performed a population-based analysis using the United States Cancer Statistics database. Age-adjusted rates per 100,000 for cancer incidence (1999-2022) and mortality (1999-2023) among adults younger than 50 years were analyzed. Joinpoint regression estimated annual percent change (APC) and average annual percent change (AAPC). Analyses were stratified by sex, and leading cancer types were determined for males and females separately. Results: A total of 5,333,524 cancer cases and 884,750 deaths were recorded among individuals younger than 50. The most common cancers by incidence varied by sex. Among females, breast cancer was the most frequently diagnosed malignancy, followed by thyroid, colorectal, melanoma, and uterine cancers. Among males, colorectal cancer ranked first, followed by kidney, melanoma, leukemia, and non-Hodgkin lymphoma. Overall incidence per 100,000 increased from 99.5 in 1999 to 111 in 2022, with a significant increase from 1999-2008 (APC 1.10%), followed by stabilization from 2008-2022, resulting in an overall AAPC of 0.42% (95% CI 0.23 to 0.65). Females experienced a marked increase from 124.3 to 147.1 with an AAPC of 0.66% (95% CI 0.48 to 0.84), whereas male incidence showed a modest change from 74.3 to 75.2. In terms of mortality among females, breast cancer was the leading cause, followed by colorectal, cervical, lung, and brain/nervous system cancers. Among males, colorectal cancer led, followed by brain/nervous system tumors, lung, leukemia, and pancreatic cancer. Mortality declined substantially overall, dropping from 21.2 in 1999 to 14.2 in 2023 with an AAPC of −1.63% (95% CI −1.81 to −1.45). Cancer mortality rates saw comparable decreases for both sexes. For females, mortality fell from 21.8 to 15.4 (AAPC = −1.53%), although the rate of decline slowed after 2018. Male mortality decreased from 20.6 to 13.1 (AAPC −1.91%), stabilizing after 2019. Conclusions: Cancer incidence among US young adults has risen over the past two decades, driven predominantly by increases in females, while male incidence has remained stable, resulting in a widening gap between sexes. Despite rising incidence, mortality declined substantially in both sexes, although these improvements have recently plateaued. The disproportionate rise in female incidence likely reflects a combination of increased awareness, updates in screening guidelines, and a true increase in disease burden, potentially driven by cumulative hormonal and metabolic exposures. These findings warrant a closer examination of sex-specific risk factors driving mainly the increase in female-predominant cancer incidence and a reevaluation of current screening recommendations for adults under 50.

Aumolertinib as first-line therapy for locally advanced or metastatic <i>EGFR</i> -mutant non–small cell lung cancer: A single-arm meta-analysis.

e20715 Background: Patients with EGFR-mutated non-small-cell lung cancer (NSCLC) have a high risk of recurrence and post-surgical mortality. Aumolertinib, a third-generation EGFR tyrosine-kinase inhibitor, is approved in China for adjuvant treatment in patients with EGFR-mutated NSCLC either with an exon 19 deletion (ex19del) or exon 21 substitution (Leu858Arg) mutation. We aimed to perform a single-arm meta-analysis to evaluate the efficacy of Aumolertinib in EGFR-mutated NSCLC patients. Methods: We conducted a systematic search on PubMed, Scopus, Web of Science (WOS), and Cochrane Central from inception until January 15th 2026. All studies assess the effect of aumolertinib in patients with EGFR-mutated NSCLC. Our primary outcome was the progression free survival (PFS), while secondary outcomes were objective response rate (ORR) and disease control rate (DCR). Results: A total of 18 studies with 1,488 patients were included. The pooled PFS rate was 41% (95% CI: 31%–51%), with substantial heterogeneity (I² = 93.1%). The pooled ORR was 70% (95% CI: 62%–77%; I² = 85.8%), while the pooled DCR reached 97% (95% CI: 94%–99%; I² = 71.4%). All pooled outcomes were statistically significant (p &lt; 0.001). Conclusions: This single-arm meta-analysis demonstrates that aumolertinib is associated with favorable efficacy outcomes in patients with EGFR-mutated NSCLC, achieving high ORR and DCR with a moderate PFS benefit. Despite notable heterogeneity across studies, these findings support the clinical effectiveness of Aumolertinib as a therapeutic option for this population. Further randomized controlled trials are needed to confirm these results and define its comparative efficacy.

Molecular landscape and outcomes of Black and White adults diagnosed with acute myeloid leukemia.

6519 Background: Acute myeloid leukemia (AML) is characterized by poor survival with Black patients (pts) experiencing worse outcomes compared to White pts. While patient-specific factors such as race have emerged as important predictors for survival in AML, the biologic mechanisms driving these factors are not well characterized. Here, we analyzed the molecular profiles of adults diagnosed with AML to identify potential differences in the frequency of genes commonly mutated in AML and their impact on survival. Methods: This was a retrospective cohort study of adults diagnosed with AML at the Cleveland Clinic between 2008 and 2022. Patients were identified as Black or White based on self-reported race/ethnicity. Molecular data were obtained from next-generation sequencing (NGS) performed at the time of diagnosis. Survival analysis was limited to pts receiving intensive induction chemotherapy and estimated using the Kaplan-Meier method and compared with the log-rank test. Results: 1,144 pts were included in this study: 10% (n = 115) Black and 90% (n = 1029) White. Median age at diagnosis (years) was lower in Black pts compared to White pts (62 vs 66) (p = 0.005). Cytogenetics analysis (MRC 2010) showed a higher proportion of Black pts with favorable-risk disease compared to White pts (15% vs. 8%; p = 0.04) while rates of poor-risk cytogenetics were similar (31% vs. 30%). Mutations in IDH1 , CBL , CEBPA , and NOTCH1 were more common in Black pts than in White pts (p &lt; 0.05). Conversely, mutations in NPM1 were lower in Black pts (16%) vs. White pts (24%) (p = 0.22). We did not observe a difference in the type of induction chemotherapy received (p = 0.23). However, more White pts underwent hematopoietic cell transplant (HCT) compared to Black pts (32% vs. 21%; p = 0.02). The median overall survival (OS) for the whole cohort was 18 months (95% CI: 16-21 months) with a 5-year OS of 31% (95% CI: 27-34%); median follow up time of 63 months. Univariable analysis showed that worse overall survival was associated with older age, poor risk cytogenetics, therapy-related and secondary AML, and not undergoing HCT (p &lt; 0.05), but median OS and 5-year OS rates were similar between Black and White pts (24 months, 28% vs. 17 months, 31%). After adjusting for prognostic variables, age, HCT status and cytogenetic risk remained significant (p &lt; 0.05). Conclusions: Unlike previously reported studies, we did not observe a survival disparity in race in our study cohort. However, we observed lower rates of treatment with HCT in Black pts. We also identified a higher frequency of mutations in genes involved in myeloid transcriptional regulation, epigenetic modification, and cellular signaling. Adequate assessment of the prognostic relevance of these genes is limited by a small sample size and variability in NGS platforms over time. Future studies may explore pooled genetic data across several institutions and genetic ancestry testing over self-reported race/ethnicity.

TRIPLE-SWITCH (SWOG/CCTG-PR26): A randomized phase III clinical trial for the addition of docetaxel to androgen receptor pathway inhibitors in patients with metastatic castration sensitive prostate cancer (mCSPC) and suboptimal PSA response (NCT06592924).

TPS5149 Background: Management of patients (pts) with mCSPC remains a challenge due to its incurable nature and heterogeneous response to androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI). Analyses of phase III ADT + ARPI trials have indicated that pts with mCSPC with suboptimal PSA response (≥0.2ng/ml at 6-12 months) have a short time to castration-resistance (CRPC) and poor median overall survival (OS) of 30-36 months. There is equipoise about the use of docetaxel in mCSPC pts on ARPI because of: 1) an absence of randomized data for docetaxel in this setting; 2) toxicity of docetaxel with impact on quality of life; and 3) selection of docetaxel treatment by disease volume rather than disease biology. Methods: PR26 is a joint CCTG-SWOG international, open-label, randomized phase III trial comparing continuing standard ADT + ARPI with the addition of up to 6 cycles of docetaxel to ADT + ARPI in mCSPC pts with suboptimal PSA response(PSA ≥0.2 ng/mL after 6-12 months of ADT and ≥4 months of ARPI). Stratification will be based on PSA levels, ARPI type, presence of liver metastasis, disease recurrence status, and time since ADT initiation. The sample size is 830 pts to detect a targeted 33% improvement in overall survival (hazard ratio 0.75) using a 1-sided 0.025 level test with 85% power. Key eligibility criteria are: ≥18 years, histologically confirmed prostate adenocarcinoma, metastatic disease present and confirmed by conventional imaging (CT and/or bone scan), PSA ≥5.0 ng/mL prior to ADT, receipt of ADT for 6-12 months and ARPI for ≥4 months, PSA ≥0.2 ng/mL within 14 days of enrolment, adequate organ and marrow function, ECOG performance status 0-2, eligible for docetaxel chemotherapy, no evidence of disease or biochemical progression on ADT prior to enrolment. Primary endpoint is OS. Secondary endpoints include PSA response, PSA kinetics, and clinical progression free-survival. Correlative studies will explore the prognostic and predictive value of circulating tumor DNA and the association between molecular signatures and clinical outcomes. Conduct to date: Study activation, January 2025. First patient enrolled, May 2025. Accrual to date: 6. Supported by CIHR grant 39527, NCTN grant #CA180863 and CCS grant #707213.

SEER-based projections of U.S. meningioma and glioblastoma incidence and survival through 2050.

e14052 Background: Forecasting future central nervous system tumor burden is needed for workforce planning &amp; trial feasibility. We quantified U.S. incidence trends, projected incidence to 2050, &amp; evaluated overall survival (OS) for meningioma &amp; glioblastoma (GBM). Methods: Retrospective registry study using SEER*Stat case listings (Nov 2024 submission). We identified first primary GBM (ICD-O-3 9440/3; SEER Research Data, 17 registries; 2000-2022) &amp; first meningioma (benign/borderline/malignant; SEER Research Limited-Field Data, 21 registries; 2000-2022). Age-adjusted incidence (per 100,000; 2000 U.S. standard) was modeled with log-linear annual percent change (APC) in prespecified primary windows (GBM 2000-2022; meningioma 2004-2022). Projections extrapolated fitted trends from 2022 to estimate 2050 incidence. OS was estimated by Kaplan-Meier &amp; modeled with Cox regression adjusted for age group, sex, &amp; race/ethnicity (missing retained as a category). SEER data are de-identified; IRB review not required. Analyses were performed in Python (Anaconda). Results: We analyzed 48,019 GBM and 261,643 meningioma cases. GBM incidence was stable overall (APC 0.12%/y; 95% CI -0.03 to 0.28; p=0.128) but increased in females (0.27%/y; 0.07 to 0.47; p=0.014). Meningioma incidence increased substantially (APC 2.62%/y; 2.14 to 3.10; p&lt;0.001). Projected 2050 incidence rose modestly for GBM (3.00 in 2022 to 3.19 per 100,000) but more than doubled for meningioma (11.50 to 25.55); a sensitivity including Illinois was similar. GBM median OS was 9 months. Death occurred in 90.4% of GBM &amp; 32.0% of meningioma patients. Male sex was associated with higher mortality (GBM HR 1.07, 95% CI 1.05-1.09; meningioma HR 1.50, 1.47-1.52; both p&lt;0.001). Conclusions: In SEER, GBM incidence is largely stable, whereas meningioma incidence is rising steeply and is projected to drive a substantially larger U.S. incidence burden by 2050. These findings support planning for increased diagnostic/surgical capacity and long-term survivorship resources for meningioma while sustaining therapeutic innovation for GBM. Key incidence, projection, and survival endpoints. Measure GBM (overall) GBM (female) Meningioma Cases, n 48,019 19936 261,643 APC (%/y), primary window 0.12 (-0.03 to 0.28); p=0.128 0.27 (0.07 to 0.47); p=0.128 2.62 (2.14 to 3.10); p&lt;0.001 Age-adjusted incidence 2022 (per 100,000) 3.00 2.40 11.50 Projected incidence 2050 (per 100,000; % change) 3.19 (+6.3%) 2.64 (+10%) 25.55 (+122.2%) Male vs female mortality (Cox HR, 95% CI) 1.07 (1.05-1.09) - 1.50 (1.47-1.52) APC, annual percent change; CI, confidence interval; HR, hazard ratio. Incidence rates are per 100,000 &amp; age-adjusted to the 2000 U.S. standard population. APC from log-linear models (GBM 2000–2022; meningioma 2004–2022).Cox models adjusted for age group, sex, &amp; race/ethnicity (missing retained as category).

The burden of childhood cancers in the South Asian Association for Regional Cooperation (SAARC) region: A GLOBOCAN 2022 analysis.

10022 Background: Countries of the South Asian Association for Regional Cooperation (SAARC) are home to approximately 600 million children aged 0–14 years, representing a quarter of the global child population. We report incidence and mortality for childhood cancers among South Asia's eight nations to inform priority setting for research, programming for health services, and policy for childhood cancers. Methods: Incidence and mortality of new childhood cancer diagnoses for all cancers combined and for selected leading diagnostic groups were retrieved from the GLOBOCAN 2022 database of Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka. Age-standardized incidence rates (ASR) and mortality-to-incidence ratios (MIR) were calculated, together with statistical examination of cross-country variation in diagnostic structure and survival trends. Results: In SAARC nations, 37,716 new childhood cancer diagnoses and 17,700 deaths were estimated in 2022. India contributed 68.7% of subregional cases (25,939), and Pakistan contributed 20.8% (7,841). Age-standardized rates differed and were greatest in Sri Lanka (10.4/100,000) and Pakistan (10.1) and lowest in Bhutan (2.3) and Bangladesh (3.7). Boys represented 60% of cases overall, with significant cross-country variation in sex distribution (χ²=18.0, p=0.012). Leukemia was the most common cancer in all countries (35–50%), followed by central nervous system (CNS) tumors. MIR ranged from 0.30 (Sri Lanka) to 0.57 (Afghanistan), reflecting extreme survival differences, with CNS tumors demonstrating disproportionately high mortality relative to incidence. Conclusions: SAARC childhood cancer trends reflect both population size influences and health system capacity, with a preponderance of leukemia but alarming survival gaps, particularly for CNS cancers. These findings highlight actionable priorities, including strengthening population-based childhood cancer registries, centralizing care pathways for CNS tumors, expanding standardized leukemia treatment protocols with abandonment-prevention strategies, and improving equitable access to specialty care through subregional collaboration.

Metastatic renal cell carcinoma treated with pembrolizumab–lenvatinib versus nivolumab–cabozantinib: A real-world analysis.

e16519 Background: Pembrolizumab plus lenvatinib (P-L) and nivolumab plus cabozantinib (N-C) are approved first-line options for patients with metastatic renal cell carcinoma (RCC). While each regimen has demonstrated efficacy in clinical trials, direct comparisons of their real-world outcomes remain limited. Methods: We conducted a retrospective, multi-institutional cohort study across 60 healthcare organizations using the TriNetX network, including patients with metastatic RCC diagnosed after January 2021 who received first-line P-L or N-C within 6 months of diagnosis. To minimize confounding, 1:1 propensity score matching was performed based on demographics, comorbidities, body mass index, laboratory parameters (hemoglobin, LDH, and albumin), the presence of visceral, bone, and brain metastases, and prior systemic corticosteroid exposure. Outcomes included all-cause mortality, emergency department (ED) visits, inpatient hospitalization, intensive care unit (ICU) admission, immune-related adverse events (dermatologic, endocrine, gastrointestinal, hepatic, and pulmonary), and systemic corticosteroid use. Risk ratios (RR) and hazard ratios (HR) with 95% confidence intervals (CI) were calculated. Results: A total of 752 patients were identified, including 504 in the N–C group and 248 in the P–L group. After 1:1 propensity score matching, 238 patients were included in each cohort. The mean age at treatment initiation was 62 years, and 72% of patients were male. Median follow-up was 14 months in the N–C group and 16 months in the P–L group. Median overall survival was not reached in either cohort as mortality remained below 50%, though survival outcomes were comparable (HR 0.97; 95% CI, 0.72–1.30; p = 0.852). All-cause mortality was comparable between groups at 1 year (RR 1.07; 95% CI, 0.78–1.47; p = 0.669) and 2 years (RR 1.02; 95% CI, 0.80–1.32). ED visits, inpatient hospitalizations, and ICU admissions were similar between groups within 1 year and 2 years. The most common immune-related adverse events were endocrine, dermatologic, and gastrointestinal, with no significant differences between groups in dermatologic (RR 0.96; 95% CI, 0.74–1.25), endocrine (RR 1.12; 95% CI, 0.94–1.33), gastrointestinal (RR 1.02; 95% CI, 0.71–1.46), or systemic corticosteroid use (RR 1.01; 95% CI, 0.92–1.11). Conclusions: In this real-world cohort of first-line therapy, P–L and N–C were associated with similar overall survival and comparable 1- and 2-year all-cause mortality, healthcare utilization, and immune-related adverse events. With comparable survival outcomes in this matched analysis, treatment selection between P–L and N–C may be guided by patient-specific factors, toxicity profiles, and cost considerations rather than anticipated differences in efficacy, though these findings should be interpreted in the context of this retrospective, real-world analysis.

Initial results of a phase 1 dose exploration and expansion study of xaluritamig plus abiraterone acetate (AA) in patients (pts) with mCRPC.

5070 Background: Xaluritamig (xalu) is a STEAP1 x CD3 T-cell engager, that has shown potent, durable monotherapy activity in pts with mCRPC progressing on taxane chemotherapy. This activity may be further enhanced when given in combination with an androgen receptor pathway inhibitor (ARPI) prior to chemotherapy or radioligand therapy. We therefore evaluated xalu + AA in chemotherapy-naïve pts with mCRPC as a potential chemo-sparing strategy. Here, we report initial safety and efficacy findings. Methods: This open-label, multicenter phase (ph) 1 dose exploration and expansion study (NCT04221542) enrolled pts who were taxane-naïve in mCRPC and had received ≤ 2 prior ARPIs (no prior AA permitted). In dose exploration, xalu was administered at a target dose of 0.3, 0.75 or 1.5 mg weekly (QW) via 1-, 2- or 3-step up regimen with 1000 mg AA and predniso(lo)ne daily. Expansion cohort was 3-step up dosing to target dose of 1.5 mg QW then 1.5 mg Q2W. Primary endpoints were safety and tolerability; secondary endpoints were pharmacokinetics and antitumor activity. Results: As of data cutoff (15 Oct 2025), 39 pts were enrolled with a median age of 68 years (range: 43–81). Patients received a median of 2 prior therapies, including 56% with prior taxane for mHSPC. Most common treatment-emergent adverse events (all grade [G]/ ≥G3) were myalgia (92.3%/41%), cytokine release syndrome (CRS; 64.1%/7.7%), and anemia (46.2%/12.8%); there were 2 G4 (decrease in lymphocyte count and blood calcium) and no G5 treatment-related AEs reported. Dose-limiting toxicities (n=4) were reported across all dose levels (soft tissue swelling and CRS, 0.3 mg; myalgia n=2, 0.75 and 1.5 mg). Escalation completed at the planned 1.5 mg QW target dose and 1.5 mg Q2W was selected for dose expansion to align with RP3D monotherapy regimen. In the expansion cohort (n=20), confirmed PSA50, PSA90, and objective response rates (RECIST v1.1) were 58%, 47%, and 43%, respectively (Table). Median PSA response duration and radiographic progression free survival were 6.7 (95% CI: 3.8–not estimable [NE]) and 10.5 (95% CI: 8.1–NE) months, respectively. Median OS was not yet reached with 12 months median follow up (95% CI: 11.8–12.3). Seven pts across escalation and expansion remained on treatment. Conclusions: Xalu + AA demonstrated manageable safety and promising antitumor activity in taxane- naive mCRPC and is now being evaluated in the randomized ph3 XALience study (NCT07213674). Clinical trial information: NCT04221542 . Dose Escalation0.3─0.75 mg QWN=11 Dose Escalation1.5 mg QWN=8 Dose Expansion1.5 mg Q2WN=20 TotalN=39 PSA evaluable 11 7 19 37 PSA50 response, n (%) 6 (54.5) 7 (100) 11 (57.9) 24 (64.9) PSA90 response, n (%) 5 (45.5) 7 (100) 9 (47.4) 21 (56.8) Best Overall Response RECIST evaluable 6 1 7 14 Complete response, n (%) 1 (16.7) 0 0 1 (7.1) Partial response, n (%) 3 (50) 1 (100) 3 (42.9) 7 (50) Stable disease, n (%) 1 (16.7) 0 4 (57.1) 5 (35.7) Not evaluable, n (%) 1 (16.7) 0 0 1 (7.1)