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Palliative care utilization and outcomes among hospitalized cancer patients with severe non–cancer-related complications.
e24084 Background: Cancer patients hospitalized with acute non-oncologic complications experience substantial morbidity, mortality, and resource utilization. Early palliative care (PC) integration improves quality of life and outcomes. It reduces healthcare utilization in patients with advanced cancer, yet its integration during hospitalizations for severe inpatient complications remains poorly characterized. We evaluated PC utilization and quantified failure-to-transition rates among cancer hospitalizations complicated by acute non-cancer conditions using a nationally representative dataset. Methods: We conducted a retrospective cohort study using the National Inpatient Sample (NIS) from 2016–2020. Adult cancer-associated hospitalizations complicated by sepsis/septic shock, respiratory failure, acute kidney injury (AKI), end-stage renal disease (ESRD), liver failure/decompensated cirrhosis, gastrointestinal bleeding, cardiogenic shock, or neutropenic fever were included. Palliative care utilization was identified using the ICD-10-CM code Z51.5. Admissions were weighted using discharge weights to generate national estimates. Outcomes included PC utilization, failure-to-transition rate (no PC among eligible admissions), in-hospital mortality, length of stay (LOS), and total hospital charges. Results: A total of 1,182,807 unweighted hospitalizations, representing over 10 million weighted U.S. cancer hospitalizations, met the inclusion criteria. PC rates ranged from 8.0% in neutropenic fever to 30.3% in cardiogenic shock, corresponding to failure-to-transition rates of 69.7%–92.0%. Despite high severity, PC utilization remained limited even among complications with substantial mortality, including cardiogenic shock (44.5% mortality; PC rate 30.3%), respiratory failure (22.1%; 24.9%), and sepsis (18.9%; 22.1%). Mean LOS ranged from 7.4 to 11.2 days, and mean hospital charges exceeded $100,000 across all complication categories, reaching more than $200,000 for cardiogenic shock. Conclusions: Palliative care is markedly underutilized among cancer hospitalizations complicated by acute non-oncologic conditions, even in settings of high mortality, prolonged hospitalizations, substantial healthcare costs, and resource use. Failure-to-transition rates exceed 75% for most complications, highlighting substantial missed opportunities for earlier palliative care integration during acute, high-risk admissions. These findings support targeted inpatient triggers to improve timely PC engagement during severe complications in hospitalized cancer patients.
Geographic disparities in surveillance adherence among individuals with <i>DICER1</i> pathogenic variants.
e22656 Background: Individuals with pathogenic DICER1 variants require lifelong surveillance to enable early cancer detection. However, adherence to recommended surveillance varies widely, and the contribution of geographic and sociodemographic factors to adherence remains poorly understood. We evaluated adherence patterns in a single clinic (in-person and telemedicine visits) multi-state cohort to identify disparities in adherence that may inform targeted interventions. Methods: We conducted a retrospective cross-sectional study of individuals with DICER1 pathogenic variants followed at Huntsman Cancer Institute in Salt Lake City, Utah. Adherence was defined as completion of all age-appropriate recommended imaging until December 2025 (“Fully Adherent” vs “Non-Adherent”). Demographic variables included age, sex, race, insurance type, and residential geography using Rural–Urban Commuting Area (RUCA) codes. RUCA was dichotomized as Urban (1–3) vs Rural (4–10). Patterns in adherence were assessed using descriptive statistics. Results: Of 86 individuals with DICER1 variants, 66% were female, 78% identified as White, and 76% as non-Hispanic. Nearly 40% of patients (n=37) had a tumor, 6 patients had ≥1 tumor, and mean age at first tumor was 13 years. The most common tumors included sarcomas (n=10), pleuropulmonary blastomas (n=8), and ovarian Sertoli–Leydig cell tumors (n=7). Tumor development did not differ by RUCA category (urban vs rural), with similar proportions in both groups (38% vs 35%). Overall adherence to recommended surveillance imaging and follow-up clinic visits was low. Only 32 patients (37%) were up to date with recommended surveillance clinic visits, and 30 (35%) were adherent with guideline-recommended imaging (fully adherent). A significant geographic disparity emerged: 0% of rural-residing patients were fully adherent with guideline-recommended imaging compared with 45% of urban patients (Fisher p < 0.0001). When we examined up-to-date clinic attendance by rural/urban geography, we found a similarly pronounced difference: 0% of rural patients were up to date with clinic follow-up compared with 58% of urban patients (Fisher p < 0.0001). Additional Fisher’s tests and Wilcoxon rank-sum tests to examine distributions of surveillance imaging by sex, race, insurance, and age demonstrated no statistically significant differences according to these categories. Conclusions: Rural residence was strongly associated with non-adherence to DICER1 surveillance, with no rural patients meeting full adherence criteria. These findings highlight a critical geographic inequity in access to or uptake of recommended surveillance. Interventions tailored to rural populations — including telehealth-based surveillance pathways, decentralized imaging strategies, and navigation support — may be essential to improving outcomes for individuals with DICER1 pathogenic variants.
Leukemia mortality in Latin America and the United States: A population-based analysis.
1597 Background: Leukemia outcomes depend on timely diagnosis, specialized care, and access to effective therapies. Despite improvements in high-income settings, population-level leukemia mortality in Latin America remains incompletely characterized. Comparisons across regions are further complicated by differences in diagnostic capacity and mortality reporting. We compared leukemia mortality across Latin American countries and the United States (US), using U.S. Hispanic individuals as the reference population, to characterize regional disparities, age-specific patterns, and temporal trends. Methods: We conducted a population-based analysis of leukemia mortality using the WHO Mortality Database for 15 countries and U.S. National Vital Statistics/SEER data. The burden of leukemia mortality was assessed from 2008 to 2019. Mortality rate ratios (MRRs) were estimated using Poisson regression. Trends were assessed using Joinpoint regression, and associations with the Human Development Index (HDI) were evaluated using linear regression. Results: Among children (0-19 years), most Latin American countries had significantly higher leukemia mortality than U.S. Hispanic children (MRRs 1.23-3.18), with the highest rates observed in Mexico (2.58/100,000; MRR = 3.18) and Ecuador (2.49/100,000; MRR = 3.06). In contrast, U.S. non-Hispanic White, African American, Asian/Pacific Islander, and American Indian/Alaska Native children had lower mortality than U.S. Hispanic children. Among adults (≥20 years), leukemia mortality patterns were heterogeneous. U.S. non-Hispanic White adults had higher mortality than U.S. Hispanic adults (9.6/100,000; MRR = 1.74), as did higher-HDI Latin American countries, including Uruguay and Costa Rica, whereas most countries demonstrated comparable or lower mortality. Childhood leukemia deaths were dominated by ALL, while adult mortality showed greater subtype heterogeneity, with a predominance of AML, chronic leukemias and a high proportion of deaths coded as leukemia not otherwise specified (NOS). Higher HDI was associated with lower mortality among young adults, but higher reported mortality among elderly adults. Conclusions: Leukemia mortality across Latin America and the US remains highly heterogeneous, with substantial excess mortality among children and older adults in several countries. Age associations with HDI and the high burden of leukemia NOS coding suggest disparities and limitations in diagnostic capacity and registry. Leukemia mortality* and subtype distribution. Population Children Mortality Rate Children MRR Adult Mortality Rate Adults MRR U.S. non-Hispanic White 0.5 0.65 9.6 1.74 Mexico 2.58 3.18 5.76 0.92 Ecuador 2.49 3.06 5.47 0.88 Colombia 2.22 2.5 6.05 0.85 Uruguay 1.31 1.1 7.15 1.35 Costa Rica 1.28 1.05 7.09 1.13 Leukemia subtype Children (%) Adults (%) ALL 50–70 10–20 AML 15–25 25–40 Chronic leukemias <5 20–35 Leukemia NOS 8–40 17–50 *Reference group: U.S. Hispanics.
First-in-human trial of the TEAD inhibitor ODM-212 in patients with advanced solid tumors (TEADES).
3111 Background: The Hippo pathway is implicated in multiple human cancers including mesothelioma and epithelioid hemangioendothelioma (EHE). When Hippo signalling is inactive, Yes-associated protein 1 (YAP1) and WW-domain-containing transcription regulator 1 (TAZ) locate to the nucleus, activating TEA domain family member (TEAD) transcription factors (TEAD1-4) to impact transcription and key oncogenic cellular processes. ODM-212 is a small molecule oral pan-TEAD inhibitor with in vitro and in vivo antitumour activity in solid tumours. Methods: TEADES is a multi-site, open-label, first-in-human trial of ODM-212 enrolling patients ≥18 years of age with various types of advanced, metastatic solid tumours where the Hippo pathway is implicated, with or without relevant genetic alterations. The study followed a Bayesian optimal interval (BOIN) design with a dose escalation with backfill cohorts, followed by expansion in tumour types of interest. Main objectives were safety (including dose-limiting toxicity (DLT)), preliminary efficacy and pharmacokinetics. ODM-212 was administered orally, once or twice daily, in a continuous 4-week cycle. Results: Between 7 November 2023 and 5 January 2026, 76 patients (mesothelioma 29, EHE 15, other 32) of mean age 62.1 years and all ECOG 0-1 received ODM-212 at doses between 20-320 mg/day, with 44 continuing on treatment at time of data cut-off. Previous treatment included checkpoint inhibitors (N=38), chemotherapy (N=59) or both (N=36). The longest exposure at data cut-off was 18-months. ODM-212 was well tolerated. No DLTs were reported and the maximum tolerated dose (MTD) was not identified. The most frequent treatment-related adverse event (TRAE) was proteinuria (19.7%), which was reversible and resulted in treatment adjustment in 6 (7.9%) patients. Other common TRAE’s were increased lipase (15.8%) and nausea (10.5%). Grade ≥3 TRAE’s occurred in 6.6% patients (anemia and increases in amylase, lipase, alanine aminotransferase and aspartate aminotransferase). Treatment responses by RECIST 1.1 were observed across multiple doses (ORR 7/45 = 15.6%), predominantly in patients with mesothelioma (ORR 27.8% in 18 evaluable patients, disease control rate (DCR) 77.8%) and EHE (ORR 22.2% in 9 evaluable patients, DCR 100%). ODM-212 demonstrated a predictable pharmacokinetic profile, with steady state achieved by 15 days and mean elimination half-life of 1-2 days, supporting once or twice daily dosing. Conclusions: ODM-212 administration to extensively treated patients with advanced cancer was well tolerated and resulted in some promising tumour responses (particularly in mesothelioma and EHE). The phase 2 portion of TEADES is currently enrolling patients. Clinical trial information: NCT06725758 .
Comparison of efficacy between 2 and 3 cycles of neoadjuvant immunotherapy combined with chemotherapy for LA HNSCC.
6101 Background: To compare efficacy, safety and long-term survival of 2 vs 3 cycles of neoadjuvant PD-1 inhibitor plus chemotherapy for LA HNSCC, providing evidence for optimizing treatment cycles. Methods: Retrospective analysis of LA HNSCC patients treated with the above neoadjuvant regimen at Beijing Tongren Hospital (Jan 2022-Dec 2024) was performed. Initially 76 (2-cycle) and 102 (3-cycle) cases were enrolled. Propensity score matching (1:1) balanced baseline differences, resulting in 65 cases per group. Chi-square, Kappa, Kaplan-Meier and Log-rank tests were used for comparisons, consistency analysis and survival assessment. Stratified analyses focused on HPV-negative and poorly differentiated subgroups. Results: After matching, 3-cycle group had higher ORR (95.4% vs 80.0%, P=0.008) and pCR rate (72.3% vs 55.4%, P=0.045). Subgroup analyses showed superior pCR in 3-cycle group for HPV-negative (68.9% vs 42.1%, P=0.014) and poorly differentiated (82.6% vs 35.7%, P=0.004) patients. Weak consistency existed between imaging and pathology (Kappa=0.176, P=0.044). Immune-related adverse events were more common in 3-cycle group (24.6% vs 10.8%, P=0.039). No significant 1-/2-year PFS/OS differences were noted, but 3-cycle group showed favorable numerical trend. Conclusions: Three cycles of the regimen significantly improve ORR and pCR in LA HNSCC, especially in HPV-negative and poorly differentiated subgroups. Despite higher immune-related adverse events, it is clinically preferable. Multi-dimensional evaluation is needed due to poor imaging-pathology consistency, with longer follow-up required for definitive prognosis assessment.
CAR T-cell detection and clonality assessment in immune effector cell–associated enterocolitis following ciltacabtagene autoleucel.
7537 Background: Ciltacabtagene autoleucel (cilta-cel) is an FDA approved chimeric antigen receptor (CAR) T cell therapy for relapsed/refractory multiple myeloma (RRMM). Cilta-cel is associated with gastrointestinal (GI) toxicities including immune effector cell (IEC)-associated enterocolitis. The pathophysiology of IEC-associated enterocolitis is poorly understood and may represent a clonal CAR T cell lymphoproliferative disorder. Methods: Retrospective review of patients with RRMM treated with standard of care (SOC) cilta-cel at a single center between 07/21/2022-10/31/2025. Baseline characteristics, outcomes, and GI toxicities were collected. CAR transgene was detected via digital droplet polymerase chain reaction (ddPCR) in GI tissue and peripheral blood samples. CAR T cell clonality was assessed via T cell receptor (TCR) fragment analysis and TCR Beta Constant Region 1 (TRBC1) assessment via IHC or flow cytometry. Results: In total 201 patients were included of whom 20 (10%) exhibited GI toxicity. Diarrhea accounted for most cases (15/20). CAR T cells were detected in 5/20 (25%) GI biopsies (Table 1). A clonal CAR T-cell lymphoproliferative disorder affected predominantly the duodenum, evidenced by TRBC1-restricted CD4- or CD8-positive T cells in lamina propria. The cells were positive for CD3 and TCRalpha while negative for CD103 and TCRdelta. MUM1, CD138 and BCMA demonstrated absence of plasma cells in all samples. TCR fragment analysis identified clonal TCR rearrangements in 3/5 evaluable cases. The remaining 2 cases showed equivocal fragment analysis with prominent but subthreshold peaks, likely reflecting low tumor burden. Symptoms resolved in 13/15 patients without detectable CAR T cells compared to 1/5 patients with detectable CAR T cells. Of the remaining 4/5 patients, 2 died and 2 had ongoing symptoms at time of last follow-up. Conclusions: GI toxicity was observed in 10% of patients treated with cilta-cel. CAR T-cell infiltration, predominantly duodenal, was detected in 25% of symptomatic patients consistent with IEC-associated enterocolitis. TRBC1-restricted CAR T cell populations were detected in all cases supporting the presence of a clonal CAR T cell lymphoproliferative disorder. At the meeting we will present additional translational studies from GI and peripheral blood CAR T cells including whole genome sequencing, spectral flow cytometry, and single cell RNA sequencing. Clinical and pathologic features of IEC-associated enterocolitis. ID Onset Outcome Site CAR ddPCR TRBC1/CD3 IHC TCR Fragment Analysis (Day) Tissue Blood 1 60 Death Duodenum 25.12% NA 7.30% Clonal 2 42 Ongoing Duodenum, Jejunum 6.60% 1.30% 84.70% Borderline clonal 3 169 Death Duodenum 14% 0.25% 31.60% Clonal 4 111 Ongoing Duodenum, Antrum, Ileum, Colon 22.40% 1.32% 88.40% Clonal 5 39 Resolved Duodenum 1.70% 0.03% 26.20% Borderline clonal
Severe immune-related adverse events in the neoadjuvant and adjuvant setting.
e24184 Background: Immune checkpoint inhibitors (ICIs) are increasingly used in early-stage cancers in the peri-operative setting. Yet while severe immune related adverse events (irAEs) are well-characterized in the metastatic setting, less is known about the presentations and outcomes of severe irAEs, particularly those requiring hospitalization, in neoadjuvant and adjuvant settings. Methods: This retrospective cohort study included patients hospitalized at Massachusetts General Hospital (MGH) and diagnosed with severe irAEs related to neoadjuvant ICI (regardless of whether they ultimately underwent surgery) or adjuvant ICI from 2/2011 to 4/2025. Patients were identified via institutional pharmacy records linked to hospital admission databases. Chart review was performed to collect demographics and characterize irAEs. Results: From 2/2011 to 4/2025, 87 patients were admitted to MGH for severe irAEs in the setting of neoadjuvant or adjuvant ICI. Of those, 29 (33.3%) had hospitalizations attributable to irAEs in the neoadjuvant setting and 58 (66.7%) to irAEs in the adjuvant setting. The most common cancers were melanoma (37.9%), lung (25.3%), and breast (16.1%). Most patients had stage II (19.5%) or III (67.8%) cancers, and most (83.9%) received anti-PD(L)1 therapy. Among the study cohort of 87 patients admitted with severe irAEs, the most common irAEs were endocrine (27.6%), gastrointestinal (21.8%), liver (19.5%), and cardiac (19.5%), and 29.9% of patients experienced multiple severe irAEs. Most patients had grade 3 irAEs (86.2%), but there was also a subset with grade 4 (10.3%) or 5 (2.3%) irAEs. Regarding irAE timing, most patients presented within 6 months of ICI initiation (66.7%), though 21.8% presented between 6-12 months, and 11.5% over 12 months after ICI initiation. Among 71 patients with non-endocrine irAEs, 94.4% received systemic steroids and 53.5% second-line immunosuppression. Premature ICI discontinuation due to irAEs occurred in 80.5% of 82 patients with non-fatal hospitalizations. Of 26 neoadjuvant patients with non-fatal hospitalizations, the majority (84.6%) underwent surgical resection (decisions to forego surgery were unrelated to irAEs); of those, 27.3% experienced an irAE-associated surgical delay (median delay 21 days, IQR 11 – 45.3). Among 82 total patients with non-fatal hospitalizations, 18.3% were re-challenged with ICI, 7.3% peri-operatively and 12.2% upon cancer recurrence. Of the 82 patients with non-fatal hospitalizations, 62.2% developed chronic irAEs (i.e. irAEs persisting ≥12 weeks). Conclusions: Severe irAEs requiring hospitalization represent a consequential source of morbidity among patients receiving neoadjuvant or adjuvant ICI and carry risks for mortality, surgical delay, premature ICI discontinuation, and chronic toxicity. Characterizing severe irAEs in the curative intent setting is crucial not only for acute management, but also for survivorship.
Patient characteristics, treatment patterns, social determinants of health, and safety in patients prescribed nivolumab and hyaluronidase-nvhy by early adopters.
1530 Background: Subcutaneous (SC) nivolumab and hyaluronidase-nvhy (nivo + hyal) is approved for administration across most adult solid tumor indications previously treated with intravenous (IV) nivolumab (nivo) and offers substantially shorter administration time (3-5 minutes). While clinical trial data demonstrate comparable efficacy and safety, real-world evidence on early adoption, patient selection, access-to-care considerations, and safety in community oncology settings remains limited. This study provides early real-world insight into the use of SC nivo + hyal in routine clinical practice. Methods: This non-interventional, retrospective medical chart review collected routine-care data from Florida Cancer Specialists & Research Institute LLC. Adults receiving ≥ 1 dose of nivo + hyal SC or nivo IV in 2025 were included. Follow-up extended from index (first receipt of SC or IV) through last available record, disenrollment, death, or database cutoff. Patient demographics, disease characteristics, treatment patterns, social determinants of health (SDOH; including proximity-to-care measures), and safety outcomes were summarized descriptively. Results: Ninety-eight patients were included (SC n=49; IV n=49). Baseline demographic and disease characteristics were comparable between cohorts, include age, sex, performance status, and metastatic disease prevalence. A greater proportion of SC-treated patients resided in suburban settings (45% SC, 37% IV). Mean travel distance to care was greater among SC recipients, with similar median distances and overlapping interquartile ranges; the longest observed travel distance occurred in a patient receiving SC therapy (110 miles vs 33 miles for IV). Treatment patterns were similar between groups; all patients receiving concurrent therapy were treated with oral anti-cancer agents. SC administration was primarily abdominal (90%). Among SC-treated patients, 54% initiated therapy in the first line setting, while remaining use reflected conversion from IV therapy, most commonly following nivo IV + ipilimumab induction, where SC administration is not currently indicated. No new or unexpected safety signals were observed with SC administration compared with IV nivo. Conclusions: In this early real-world community oncology analysis, nivo + hyal SC use demonstrated patient characteristics, treatment patterns, and safety comparable to nivo IV. Difference in proximity-to-care measures, including greater variability and longer travel distances among SC recipients, suggest SC administration may support treatment delivery for patients with higher geographic burden. Findings should be interpreted cautiously given the limited sample size but offer early insight into real-world adoption and access considerations for subcutaneous immunotherapy.
Synovial sarcoma misdiagnosis and potential utility of NGS testing patient identification for autologous T cell therapy: Retrospective analysis of Tempus database.
11543 Background: Metastatic synovial sarcoma (SS) is commonly treated with anthracycline and other chemotherapy with poor survival outcomes. Afamitresgene autoleucel (Tecelra) is a genetically modified autologous T cell therapy that was FDA approved in August 2024, based on ORR of 43.2% and median DoR of 6 months. It is indicated for previously treated HLA-A*02:01-03 and 06 allele positive patients (pts) with unresectable or metastatic SS whose tumors express MAGE-A4. SS is characterized by SS18-SSX gene fusion in > 95% of cases and this gene fusion is not found in other neoplasms. Commercial NGS testing may contribute to identification of eligible pts. Methods: Pts with diagnosis of SS and/or SS18 gene fusion were identified by retrospective analysis of the Tempus database. Demographic and disease characteristics were described for each pt and assessed for correlation with diagnosis and presence of the SS18 gene fusion. RNA was sequenced with the Tempus RS and RS.v2 assays. Gene expression values in this analysis were normalized by transcripts-per-million (TPM) and transformed to log2(TPM+1) units. The threshold of 1.62 (log2(TPM+1)) was set as the cut off for determining true positive of MAGEA4 expression. HLA type and RNA expression of MAGE-A4 was used to identify pts potentially eligible for associated T cell therapies. Results: 110 pts were analyzed, including 86 pts (78%) with SS diagnosis with SS18 fusion, 12 pts (11%) with SS diagnosis but no detected SS18 fusion (SS/SS18-), and 12 pts (11%) with SS18 fusion but a non-SS diagnosis. Age at diagnosis, sex, race, state of diagnosis, and institution type (academic vs non-academic) were not associated with misalignment between the reported diagnosis and presence or absence of the SS18 fusion. For SS/SS18- pts the location of the tumor did not differ from expected SS primary locations, and the Tempus tumor of origin predicted SS diagnosis in 2/12 pts, non-SS diagnosis in 7/12 pts, and not reported 3/12 pts. The most common predicted non-SS diagnosis was malignant peripheral nerve sheath tumor (MPNST, 5 pts). Non-SS/SS18+ pts did occur in unusual locations (Pancreas, small intestine, bone, peripheral nervous system), and 10/12 were predicted by the tempus tumor of origin algorithm to be SS. The recorded diagnosis in these 12 pts was more commonly another sarcoma subtype (10/12), rather than a non-sarcoma diagnosis (2/12). MAGE-A4 expression > 1.62 TPM was detected in 71% of all pts, 74% SS/SS18+ pt, 58% of SS/SS18- and 58% of non-SS/SS18 pts. When considering the required HLA type and MAGEA4 expression then 35% of all pts would be potentially eligible for afami-cel. Conclusions: Commercial NGS testing may increase identification of pts with SS, which is important for novel T cell therapy eligibility. A low threshold should be considered for diagnosing SS in unusual locations when the SS18 fusion is detected.
Trends in mortalities due to pneumonitis in esophageal cancer in the United States, 1999-2020: A population-based analysis.
e16146 Background: Esophageal cancer is an aggressive malignancy with a high global burden and poor survival. In 2020, it accounted for over 0.6 million new cases and approximately 0.54 million deaths worldwide. In the United States, an estimated 22,530 new cases and 16,290 deaths are projected for 2026. Pneumonitis secondary to aspiration pneumonia is a significantly preventable cause of death in these patients. Our retrospective analysis of the CDC WONDER database, spanning 1999-2020, further identifies contributory patterns that warrant targeted future interventions, thereby helping us address aspiration-related issues in these patients. Methods: The data were obtained from the Centers for Disease Control and Prevention (CDC WONDER) database. The age-adjusted mortality rates (AAMR) were adjusted and analyzed per 100,000 people using the 2000 U.S standard population. Annual percentage changes (APCs) were calculated using the Join point regression to identify temporal trends of mortality. Results: From 1999 to 2020, males exhibited higher age-adjusted mortality rates (AAMR) than females (males: 0.274; females: 0.053). The AAMR was higher in whites than in blacks. The AAMR varied across U.S. Census regions, with a slight increase in the Midwest and West, while the AAMR remained in the northeast and south, despite little fluctuation between the study periods. Conclusions: Higher pneumonitis-related mortality in males is attributed to higher incidence of smoking and occupational exposures, higher rate of underlying chronic lung disease, and more advanced cancers requiring aggressive management. Regional and racial differences may be due to unequal access to advanced oncology care and radiation techniques, and healthcare infrastructure. Environmental factors like air pollution, along with socioeconomic barriers, may affect early diagnosis and treatment adherence. Differences in comorbidities and insurance coverage may further influence mortality patterns. Improving outcomes depends on optimized radiation planning, early risk identification, smoking cessation, and close monitoring of high-risk patients, and reducing access-related disparities.
Association between survival outcomes in patients with multiple myeloma and treatment facility volume.
7529 Background: Oncology research previously demonstrated a volume-outcome relationship, where patients treated at healthcare centers with higher (vs lower) treatment volumes have improved survival. In multiple myeloma (MM), evidence supporting this association remains limited. Most patients with MM are treated at lower volume centers; it is important to recognize and prioritize partnerships between higher and low-volume centers. Methods: Adults (≥18 years) receiving ≥1 active MM therapy—IMiD, PI, anti-CD38 mAb, CAR-T, ASCT—from 2017 - 2023 with ≥6-month pre-index enrollment were identified in Komodo Health’s Healthcare Map. Patients lacking facility data or treated outside their diagnosing site were excluded. Facilities were segmented based on volume, defined as the average number of new patients with MM per year: ≤1 (very low), 1–5 (low), >5–10 (medium volume), >10 (higher volume). Outcomes included overall survival (OS) and event-free survival (EFS), the latter separately defined as time to 1) therapy change and 2) first symptomatic progression (based on CRAB criteria). Multivariable mixed-effects Cox models were adjusted for diagnosis year, demographics, comorbidities, payer type and treatment exposure. Subgroup analysis of patients initiating 2L therapy was also conducted. Results: 18,646 MM patients and 2,049 facilities were identified. Volume distribution was highly skewed: 81.0% were treated at very low volume centers and ~1.9% were treated at higher volume centers. Higher volume centers had the highest use of ASCT (63.7%) and CAR-T (2.1%). Among all patients, use of IMiD-, PI-, and anti-CD38–based regimens were 51.42%, 63.55% and 35.69%, respectively. Although median OS was not reached for any of the segments, higher volume centers had the highest unadjusted median EFS using therapy-based (771 days) and CRAB-defined progression (213 days) definitions (p<.001 vs all other segments). After adjustment, lower-volume segments (very low, low and medium volume centers) had shorter median OS (HRs: 1.03-1.26, 95% CI 0.88-1.46) than higher volume centers. However, compared with higher volume centers, median EFS was similar in lower-volume segments (HRs: 0.97-1.09, 95% CI 0.86-1.23). Among 2L patients, OS models and CRAB-defined EFS showed similar volume-related patterns compared with adjusted overall results. Conclusions: Higher-volume centers had more experience with novel therapies and combination of therapies. Experience from high volume centers can effectively be used to partner with smaller volume centers to advance MM care and be able to improve outcomes for patients. Adjusted EFS and OS hazard ratios by treatment facility segment. Change in Therapy EFS OS Facility Volume Segment Overall 95% CI Overall 95% CI Higher volume Ref Ref Ref Ref Medium volume 0.97 (0.86, 1.09) 1.03 (0.88, 1.21) Low volume 1.03 (0.92, 1.16) 1.15 (0.99, 1.34) Lower volume 1.09 (0.97, 1.23) 1.26 (1.09, 1.46)
Phase 1 study of ARV-393, a PROTAC BCL6 degrader, as monotherapy in patients with advanced non-Hodgkin lymphoma (NHL) or combined with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL).
TPS7103 Background: Despite recent advancements in NHL therapies, many patients experience disease progression or relapse. Agents with novel mechanisms of action and combination strategies are needed to improve clinical outcomes. B-cell lymphoma 6 (BCL6) is a master transcriptional regulator of immune cells, particularly of germinal center B cells, and an established oncogenic driver in NHL. ARV-393 is an oral PROteolysis TArgeting Chimera (PROTAC) BCL6 degrader that binds an E3 ubiquitin ligase and BCL6 to induce ubiquitination of BCL6 and its subsequent proteasomal degradation. ARV-393 monotherapy potently inhibited tumor growth and induced tumor regressions across NHL cell-derived xenograft (CDX) and patient-derived xenograft models, including models of DLBCL, transformed follicular lymphoma, and nodal T-follicular helper cell lymphoma (nTFHL). Furthermore, administration of ARV-393 with a CD20×CD3 bispecific antibody, glofitamab, demonstrated combinatorial antitumor activity in a humanized high-grade B-cell lymphoma CDX model, inducing deeper tumor growth inhibition and increased tumor regressions vs either monotherapy. These preclinical findings demonstrated single-agent ARV-393 antitumor activity across NHL subtypes and suggested mechanistic synergy with glofitamab, supporting clinical investigation of monotherapy in NHL and this chemotherapy-free combination in patients with DLBCL. Methods: This global, multicenter, open-label, first-in-human, phase 1 dose escalation and optimization/expansion study (NCT06393738) is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ARV-393 as monotherapy in relapsed or refractory (R/R) NHL or in combination with glofitamab in R/R DLBCL, with a primary objective of determining provisional doses for further exploration. Patients eligible for ARV-393 monotherapy are adults with confirmed R/R B-cell NHL who previously received ≥2 lines of systemic therapy (including rituximab), or nTFHL who previously received standard of care therapy. Patients eligible for ARV-393 in combination with glofitamab are adults with pathologically confirmed R/R DLBCL, DLBCL not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma who were treated with ≥2 prior lines of systemic therapy. ARV-393 will be administered orally once daily in 28-day cycles alone or in combination with intravenous glofitamab during 21-day cycles. Approximately 255 patients will be enrolled across study cohorts. As of January 2026, enrollment is ongoing. Copyright © 2026 AACR. Originally presented at AACR 2026. Reprinted with permission. Clinical trial information: NCT06393738 .
CD56 and P16 expression in the differential diagnosis of papillary thyroid carcinoma and benign follicular neoplasms.
e18057 Background: The differential diagnosis between papillary carcinoma and follicular thyroid neoplasia is sometimes very difficult, for example, in cases of follicular subtypes of papillary carcinoma and follicular carcinoma or adenomas. Rarely, the pathologist studies core needle biopsies or incidentally finds ectopic thyroid tissue in patients with papillary thyroid carcinoma, which may lead us to suspect metastasis. In these situations, immunohistochemistry is an important tool. Methods: A prospective study was conducted, evaluating a total of 51 thyroid neoplasms in 38 women and 13 men, ranging in age from 17 to 79 years, with a mean age of 52.3 years. Immunohistochemical staining for CD56 and p16 was performed on 38 papillary carcinomas, 8 follicular adenomas, 2 oncocytic cell adenomas, 2 adenomas with papillary architecture, and 1 NIFTP. Data were stored in a Microsoft Excel database and analyzed using chi-square tests in SPSS version 29.0. Results: p16 staining positivity and loss of CD56 expression were statistically significant (p<0.01) for the papillary carcinoma group, both separately and in a double panel (p<0.01); likewise, p16 negativity and preservation of CD56 positivity were statistically significant (p<0.01) for benign follicular neoplasms, both separately and in a double panel (p<0.01). A second set of comparisons was performed between follicular subtypes of papillary thyroid carcinoma versus benign follicular neoplasms using a double panel, obtaining statistically significant results (p<0.05). Conclusions: p16 expression becomes a highly sensitive marker for malignancy, while the loss of CD56 expression is highly specific for malignancy. The use of the CD56 and p16 dual panel is statistically significant for differentiating between papillary thyroid carcinomas and their follicular subtypes from benign follicular neoplasms, making it an important support tool for cases that are difficult to differentiate using immunohistochemical staining techniques available in our country. CD56 expression by immunohistochemistry. Follicular Neoplasm Benign Papillary Carcinoma Total Negative 0 20 20 Positive 10 0 10 Total 10 (33.3%) 20 (66.7%) 30 (100%) Chi-square test: p<0.001.
Actionable genomic alterations and outcomes in lung squamous and adenosquamous cell carcinoma.
8632 Background: Actionable genomic alterations (AGA) are uncommon in lung squamous/adenosquamous carcinoma (LUSC/LUASC) and may contribute to poorer survival than lung adenocarcinoma (LUAD). Though a subset of LUSC patients harbor AGA and may benefit from targeted therapy, outcomes are poorly characterized. We hypothesized that AGA-LUSC patients treated with first-line (1L) targeted therapy have superior survival to those receiving chemotherapy and that AGA-LUSC has a distinct immune tumor microenvironment (TME) compared to non-AGA-LUSC. Methods: We identified and analyzed LUSC (6,970) and LUASC (227) patients from the Tempus Lens database with DNA (xT, 648-gene) and whole-transcriptome RNA (xR) NGS using the Lens Platform. AGA were defined as ALK , ROS1 , RET , NTRK1 /2/3 fusions, EGFR , KRAS , BRAF p.V600E, MET exon 14 skipping, or ERBB2 alterations. KRAS , BRAF p.V600E, and MET exon 14 skipping were classified as immune-associated AGA. RNA data were quantified as transcripts per million (TPM) and reported as log2(TPM+1). We assessed tumor mutational burden (TMB), TTF1 and TP63 gene expression, and TME (via quanTIseq). OS and PFS were measured from 1L treatment initiation to death, progression/death or last follow up, respectively. Results: AGA incidence was 7.5% in LUSC and 45% in LUASC. Non-immune AGA had significantly lower median TMB than immune-AGA and non-AGA in both LUSC (5.3 vs 7.4 vs 7.9) and LUASC (3.7 vs 5.5 vs 8.4) (both p < 0.001) and had numerically lower CD8 T-cell infiltration in LUSC. TTF1 expression did not differ among AGA and non-AGA groups; but TP63 expression was significantly higher in LUSC than LUASC (8.70 vs 6.23, p < 0.001) and in non-AGA compared to AGA in both LUSC (p < 0.001) and LUASC (p = 0.027). In AGA-LUSC, 1L targeted therapy (n = 15) was associated with numerically longer PFS (27.7 mo vs 8.1 mo, p = 0.17) and OS (19.2 mo vs 15.7 mo, p = 0.78) compared with chemoimmunotherapy/chemotherapy. No difference in outcomes was observed between non-AGA and AGA LUSC patients treated with chemoimmunotherapy/chemotherapy. Conclusions: Given the observed rates of AGA in both LUSC and LUASC and numerically improved outcomes in AGA-LUSC patients receiving 1L targeted therapy, routine NGS testing is warranted. TME differs between non-immune and immune-AGA, and TP63 expression is inversely associated with AGA in both tumor types. LUSC LUASC Overall N = 6,970 Non-AGA N = 6,449 Non-immune AGA N = 142 Immune-AGA N = 379 Overall N = 227 Non-AGA N = 124 Non-immune AGA N = 37 Immune-AGA N = 66 Classic EGFR alteration (exon 19 deletion or L858R) 51 (0.7%) 0 (0%) 51 (36%) 0 (0%) 21 (9.3%) 0 (0%) 21 (57%) 0 (0%) Other EGFR short variant 31 (0.4%) 0 (0%) 30 (21%) 1 (0.3%) 8 (3.5%) 0 (0%) 7 (19%) 1 (1.5%) ALK fusion 25 (0.4%) 0 (0%) 24 (17%) 1 (0.3%) 5 (2.2%) 0 (0%) 5 (14%) 0 (0%) KRAS G12C 117 (1.7%) 0 (0%) 0 (0%) 117 (31%) 21 (9.3%) 0 (0%) 0 (0%) 21 (32%) Other KRAS short variant 192 (2.8%) 0 (0%) 0 (0%) 192 (51%) 32 (14%) 0 (0%) 0 (0%) 32 (48%)
Evolution of symptom burden across prostate cancer disease states in the EHR-facilitated Cancer Symptom Control (E2C2) trial.
e23276 Background: More than 50,000 patients with cancers of all stages were enrolled in the E2C2 trial, which captured patient-reported data across 6 symptom domains (SPPADE): sleep, pain, impaired physical function, anxiety, depression, and energy deficit or fatigue. This trial offers a unique opportunity to evaluate the evolution of symptom burden as prostate cancer (PCa) advances and the association of symptom burden with prognosis in the various disease states. Methods: The cohort was derived by cross-referencing participants in the E2C2 study with the Mayo Clinic Cancer Registry for more granular data on disease state and treatment characteristics, focusing on PCa. Symptoms were patient-reported on a 0-10 numerical rating scale, categorized as none/mild (0-3), moderate (4-6), and severe (7-10). We compared the prevalence of symptom burden across disease states, using the first survey completed by patients, in 3 groups: (1) non-metastatic (localized, locally advanced, and biochemically recurrent), (2) metastatic hormone sensitive (mHSPC), and (3) castration resistant (CRPC), using chi square tests. We then used log-rank tests to compare survival distributions based on symptom severity within each disease state. Results: A total of 1,011 patients were included. The distribution of moderate to severe symptoms by disease state is shown in Table 1. Fatigue, impaired physical function, and pain were more prevalent in patients with advanced disease, whereas the prevalence of depression and anxiety was not statistically different by disease state. Greater fatigue and physical impairment were consistently associated with poorer OS across all disease states, including patients with non-metastatic disease (p < 0.001). Pain was most strongly associated with inferior outcomes in the more advanced disease states of mHSPC (p < 0.001) and CRPC (p < 0.001). Anxiety (p < 0.001) and depression (p = 0.001) were only prognostic in CRPC patients. Conclusions: SPPADE symptoms are common in PCa. Physical symptoms are greater in more advanced disease, yet the high burden of unmet psychologic needs is similar across the disease states. Notably, severe patient-reported fatigue and physical dysfunction are strongly prognostic even in early disease, suggesting they are markers of physiologic vulnerability. Structured symptom monitoring may improve the identification of high-risk patients. Clinical trial information: NCT03892967 . Moderate to severe symptoms by disease state. Non-Metastatic (N= 243) mHSPC (N= 479) CRPC (N= 289) P-value Pain, n (%) 51 (21.3) 121 (25.5) 100 (35.1) 0.001 Fatigue, n (%) 92 (38.3) 230 (48.6) 163 (57.2) <0.001 Impaired Physical Function, n (%) 79 (32.5) 180 (37.7) 146 (50.7) <0.001 Sleep Disturbance, n (%) 72 (30.1) 167 (35.2) 104 (36.1) 0.3 Depression, n (%) 47 (19.6) 92 (19.4) 63 (22.0) 0.67 Anxiety, n (%) 56 (23.4) 93 (19.6) 68 (23.9) 0.3
Impact of IBI3017, an innovative bispecific anti-Trop2 and B7H3 antibody-drug conjugate, on anti-tumor efficacy in a wide range of tumors.
e20508 Background: Bispecific ADCs (bsADCs) are positioned as an emerging, next-generation, class of therapeutics, combining the dual-targeting capabilities of bispecific antibodies (bsAbs) with the potent cytotoxicity of antibody-drug conjugates (ADCs). Trophoblast cell surface antigen 2 (Trop2) and B7 homolog 3 (B7H3) are tumor-associated antigens that are highly co-expressed in a variety of tumors, e.g., non-small cell lung cancer (NSCLC), prostate adenocarcinoma (PRAD) and breast cancer (BC), among others. IBI3017 is a novel first-in-class bispecific antibody-drug conjugate targeting Trop2 and B7H3. It is composed of an anti-Trop2/B7H3 bispecific antibody conjugated to a novel topoisomerase I inhibitor, NT1, with a drug-to-antibody homogeneity ratio of 8 (DAR8). Since Trop2 ADCs have shown on-target/off-tumor toxicity such as stomatitis and mucositis in clinical studies, we designed IBI3017 to have a reduced binding affinity to Trop2, making it weaker than its binding affinity to B7H3. This enhances the selectivity for Trop2-B7H3 co-expressing tumors while minimizing toxicity to normal tissues. Methods: The pharmacologic profiles of IBI3017 were assessed in vitro and in vivo including efficacy, pharmacokinetics and safety in Trop2 and B7H3 positive cell lines, cell-derived xenograft (CDX) models and cynomolgus monkeys. Results: IBI3017 demonstrated comparable or better cytotoxicity to parental Trop2 and B7H3 ADCs in cancer cell lines across various tumor types. In addition, IBI3017 showed superior in vitro bystander effect compared to Trop2 and B7H3 ADCs. In vivo efficacy was evaluated in various CDX models with different Trop2 and B7H3 expression levels. IBI3017 exhibited superior antitumor activity to Trop2 and B7H3 ADCs. IBI3017 displayed good safety profile in monkey GLP toxicology study (HNSTD = 25 mg/kg). Conclusions: In summary, IBI3017 demonstrates promising potential for delivering potent and broad anti-tumor activity across a range of solid tumors, offering broad clinical application opportunities.
Comprehensive epigenomic profiling of plasma for non-invasive detection of MET activation to uncover MET-associated biology in patients with <i>EGFR</i> -mutated advanced NSCLC and progression on osimertinib.
8642 Background: Genomic overexpression or amplification of MET is an established bypass resistance mechanism in EGFR-mutated (EGFRm) NSCLC, observed in up to 34% of patients whose tumors progress on osimertinib. Savolitinib, an oral, highly selective MET TKI, demonstrates clinical activity in tumors classified as MET-high by tissue-based IHC or FISH. However, tissue at progression is often inaccessible or insufficient for repeated assessment, constraining dynamic characterization of MET pathway dependence and emerging resistance mechanisms. To overcome these limitations, we applied an epigenomic liquid biopsy platform to a subset of patients enrolled in the Phase II SAVANNAH trial that combined osimertinib and savolitinib after progression on 1L osimertinib (NCT03778229), where we evaluated the feasibility of capturing MET activity and additional resistance markers from plasma. Methods: Baseline samples from 40 patients enrolled in the SAVANNAH trial with progression on 1L osimertinib, were profiled using an epigenomic assay (Precede Biosciences, Boston MA) on 1mL of plasma. Tissue-based analysis from the SAVANNAH cohort scored 15/40 tumors as MET-high/+ (FISH 10+, IHC 3+ ≥90%+) and 25 samples as MET-low/- (FISH < 10, IHC 3+ < 90%). A plasma-based MET classifier integrating comprehensive epigenomic features was applied to these samples and its performance evaluated against tissue MET status. ctDNA fraction was independently estimated. Pathway analyses on genome-wide differential epigenomic activity were performed to define MET-associated biology and infer tumor gene expression from plasma. Results: The plasma-based MET classifier demonstrated strong agreement with tissue-based MET status (AUC 0.97; balanced accuracy 88%), with an estimated limit of quantification (LoQ) of ~0.8% ctDNA. MET+ samples displayed enrichment of epigenomic signatures consistent with MET-dependence, including MYC targets, metabolic signatures, and invasive and developmental programs. In contrast, MET-negative (MET-) samples were enriched for IFN-driven immune pathways and apoptotic priming. Gene expression models across multiple ADC targets applied to patient plasma samples from SAVANNAH also identified elevated EGFR and HER2 expression in select cases. Conclusions: Comprehensive epigenomic profiling of plasma demonstrated high concordance with tissue-based approaches, identifying MET pathway activation and additional putative resistance-associated targets, from 1 mL of plasma in EGFRm NSCLC patients. This provides an accessible and scalable blood-based test to increase identification of patients post-EGFR inhibitor treatment, who may benefit from MET-targeted therapy, resistance monitoring, and informing future combination or sequential MET-directed strategies.
Biomarker-defined outcomes in metastatic clear cell renal cell carcinoma (mccRCC) receiving first-line (1L) immune checkpoint inhibitor-based therapy.
4546 Background: Dual immune checkpoint inhibitor (IO-IO) and immune checkpoint inhibitor plus VEGF receptor tyrosine kinase inhibitor (IO-TKI) regimens are approved 1L treatments for mccRCC, yet treatment selection remains empiric in the absence of prospective comparisons and validated predictive biomarkers. While prior retrospective studies have linked genomic alterations such as PBRM1 with favorable immunotherapy outcomes (Miao et al., 2018), the impact of these alterations across IO-IO vs. IO-TKI regimens is not well characterized. We evaluate PD-L1 expression and tumor genomic alterations in relation to clinical outcomes among patients receiving 1L IO-based therapy. Methods: Adults with mccRCC diagnosed through 2/4/2025 were identified in ConcertAI’s Patient360, a U.S. de-identified database integrating health records, claims, genomics, and mortality data. Patients initiating 1L IO-IO (ipilimumab + nivolumab) or IO-TKI (cabozantinib + nivolumab, pembrolizumab + axitinib, or lenvatinib + pembrolizumab) were included. Molecular testing performed prior to or during 1L therapy was collected. PD-L1 positivity was defined as ≥1% tumor cell staining. Overall survival (OS) and progression-free survival (PFS) were estimated via Kaplan-Meier methods; associations by treatment and biomarker status were assessed using Cox models. Results: Among 4,845 patients with mccRCC, 3,225 patients had 1L treatment data, of whom 1,007 (31.2%) received IO-based therapy. IO-based therapy included IO-IO (508 patients; 50.4%) and IO-TKI (499 patients; 49.6%). Among patients receiving IO-based therapy, median age was 62 years, and 63.6% had de novo metastatic disease. Tumor genomic alterations were identified in 125 patients, including VHL (77.6%), PBRM1 (50.4%), BAP1 (28.8%), and SETD2 (4.8%). Patients with any alterations in VHL , PBRM1 , or BAP1 demonstrated significantly longer median PFS with IO-TKI compared with IO-IO (37.9 vs. 18.4 months, respectively; p=0.04). In gene-specific analyses, similarly large numerical differences in PFS were observed with IO-TKI vs. IO-IO amongst patients with VHL (38.0 vs. 18.4 months) and PBRM1 (34.4 vs. 18.4 months) alterations. In the overall cohort, median PFS was 32.2 vs. 20.8 months (p=0.06), and median OS was 58.4 vs. 56.7 months (p=0.60) for IO–TKI and IO–IO, respectively. Among 102 patients with available PD-L1 status, 25.5% were PD-L1-positive and 74.5% were PD-L1-negative. Among PD-L1-positive patients, OS and PFS did not significantly differ between regimens. Conclusions: Among patients with mccRCC receiving 1L IO-based therapy, those harboring VHL , PBRM1 , or BAP1 alterations were collectively associated with numerically longer PFS when treated with IO-TKI. These findings represent one of the first and largest biomarker-stratified comparisons of outcomes between IO-TKI and IO-IO regimens.
CancerTrialsBR: An open-access, collaborative platform to improve visibility and access to cancer clinical trials in Brazil.
1546 Background: Lack of timely and understandable information is a major barrier for cancer trials recruitment, particularly outside high-income countries. ClinicalTrials.gov (CTGov) has been widely used to address this need, but language barriers and inconsistent identification of research facilities limit its use. Large language models (LLMs) now offer opportunities to address these limitations. We describe CancerTrialsBR, a pilot platform that integrates CTGov, Google Maps (GMaps), and LLMs to provide Portuguese-language geographically contextualized cancer trial information in Brazil. Methods: Clinical trials data and listed research sites are retrieved from CTGov on a daily basis with condition as “cancer”, location as “Brazil”, and status as “recruiting”. Using prompt engineering techniques (CoT and few-shot), trial information is processed by LLM to generate a Portuguese brief summary, ideal patient profile, and trial descriptors according to primary site (N=39), treatment settings (N=8, i.e. first-line), and biomarkers (N=18, i.e. PDL1). For each site, its address components (i.e. name, city) are queried through the GMaps API for standardized facility identification. A LLM performs facility-matching validation, and invalid cases are manually reviewed. This enriched database is made available as an open-access clinical research platform of the Brazilian Society of Clinical Oncology since November 4th, 2025 (https://pesquisaclinica.sboc.org.br), where users can suggest real-time status updates. We report facility identification metrics, database statistics, and site interactions since launch. Results: Of 2,873 unique CTGov addresses, 654 (22.76%) retrieved zero results from GMaps, of which 612 (93.57%) were subsequently identified by zip code. For the 2,219 GMaps retrieved locations, LLM validation demonstrated an accuracy of 85.78%, with positive and negative predictive values of 96.9% and 59.0%. Overall, only 93 (3.2%) addresses remained unidentifiable after human review. As of January 19th, 2026, the database comprised 272 trials conducted across 191 research facilities, encompassing 22 of 27 Brazilian states and 76 cities. The median (IQR) of clinical trials per facility was 2 (1-9) with 8 facilities hosting 40 trials or more. São Paulo (260/272, 95.6%), Rio Grande do Sul (195/272, 71.6%), and Rio de Janeiro (108/272, 39.7%) had the largest availability of trials. The platform had 2,320 visits from 220 cities within 76 days, and the leading searched cancer was breast. Users feedback resulted in 34 of 57 (59.6%) suggested status updates incorporated in the database. Conclusions: CancerTrialsBR demonstrates the feasibility of integrating LLMs and GMaps to deliver accessible, real-time cancer trial information in Brazil, with early adoption highlighting unmet need and offering insights into the country's cancer research infrastructure.
The influence of immune checkpoint inhibitors on treatment results in cancer patients: Real-world evidence from a single institution in a low-middle-income country.
e23370 Background: Immune checkpoint inhibitors (ICIs) enhance anti-tumor immunity by modulating specific immune pathways. Despite demonstrated improvements in survival and quality of life, their use in low and middle-income countries (LMICs) remains constrained by high costs and limited insurance coverage. This study aims to evaluate the effectiveness of ICIs across various cancer subtypes in the South Asian population. Methods: A retrospective cross-sectional study was conducted at the Department of Oncology, Aga Khan University Hospital, Karachi (AKUH), Pakistan. The study included patients aged 18–80 years with biopsy-proven malignancies at any stage who received immune checkpoint inhibitors as part of their treatment between January 2019 and December 2023. Statistical analysis is performed using SPSS, employing descriptive statistics (means, standard deviations, frequencies, and percentages) and inferential tests (t-tests, chi-square tests, ANOVA, correlation, and regression) to assess relationships between variables. The Kaplan-Meier curve is used to calculate progression-free survival (PFS) and overall survival (OS). A p-value of < 0.05 is considered statistically significant. Results: A total of 126 patients were included in the analysis. The cohort showed a male predominance (57.9%), with over half of the patients (55.3%) presenting with stage IV disease, and more than 80% having an ECOG performance status of 0-1. The most frequently observed cancer types were genitourinary (29%), lung (25%), and breast (15%). Majority of the patients (95.1%) received ICIs with chemotherapy, predominantly pembrolizumab (78%), followed by durvalumab (13%). In the entire cohort, the median PFS was 40 months, the median OS was 50 months, and the overall mortality was 32.8%. Across the ICI subgroup, the median PFS and OS in the pembrolizumab group were 58 (95% CI: 45.0–111.5) months and 90 (95% CI: 37.4–142.6) months, respectively. Likewise, in the GU, lung, and breast cancer subgroups, the median PFS was 16 months, 15 months, and 25 months (p = 0.17, HR:0.87, 95% CI: 0.6-1.0), while the median OS was 21 months, 48 months, and 28 months (p = 0.1, HR:0.7, 95% CI: 0.5-1.0), respectively. In multivariate analysis, poor ECOG PS (p < 0.001), diabetes mellitus (p = 0.018), hypertension (p = 0.026), grade ≥ 3 gastrointestinal (p = 0.019), and neurotoxicity (HR = 3.94, p = 0.022) were all independently linked to lower survival. Conclusions: The findings indicate that ICIs improve survival among cancer patients in resource-limited settings. Furthermore, the optimal outcomes depend not only on clinical efficacy, but also on regulatory frameworks, insurance coverage, and institutional capacity, which collectively influence access to ICIs. Larger, multicenter studies are needed to refine patient selection and better manage treatment-related toxicity.