BACKGROUND:Although gemcitabine-based palliative chemotherapy remains widely used for advanced biliary tract cancer (BTC), practical pretreatment prognostic factors are needed. This study identified baseline prognostic factors associated with overall survival (OS) and explored a simple risk stratification approach for 12-month survival in advanced BTC patients treated with gemcitabine-based chemotherapy. METHODS:This retrospective cohort study included advanced BTC patients treated with gemcitabine-based palliative chemotherapy between 2011 and 2025. Baseline clinical and laboratory variables were collected at treatment initiation. The Kaplan-Meier method estimated OS. Univariable and multivariable Cox proportional hazards regression analyses identified prognostic factors. A post hoc exploratory risk score was developed using routinely available factors independently associated with OS. RESULTS:A total of 154 patients were included, gemcitabine plus cisplatin was administered to 95 patients, whereas 59 received gemcitabine plus carboplatin. Median OS was 9.43 months. Multivariable analysis showed that ECOG performance status ≥ 2 (adjusted HR, 5.68; 95% CI, 2.52-12.81), alkaline phosphatase (ALP) ≥ 2 × ULN (adjusted HR, 1.53; 95% CI, 1.01-2.33), and neutrophil-to-lymphocyte ratio (NLR) ≥ 3 (adjusted HR, 1.51; 95% CI, 1.03-2.20) were associated with worse OS. An exploratory score assigning one point to each factor stratified patients into low-, intermediate-, and high-risk groups. The estimated 12-month OS rates were 59.6%, 40.4%, and 10.8%, respectively. CONCLUSIONS:Poor performance status, elevated ALP, and elevated NLR were associated with worse OS in advanced BTC patients receiving gemcitabine-based palliative chemotherapy. However, the associations for ALP and NLR were modest and should be interpreted cautiously. A simple exploratory score based on routinely available factors demonstrated distinct 12-month survival across risk groups and may help inform prognostic discussions in routine practice. This approach should be considered hypothesis-generating, and external validation is warranted.

LBA4000 Background: TACE, a global standard of care (SoC) for unresectable eeHCC, induces a tumor immune response. STRIDE (Single Tremelimumab [T] Regular Interval Durvalumab [D]) has shown OS benefit at 6-year follow-up and is a SoC for unresectable advanced HCC. We report preplanned analyses from EMERALD-3 (NCT05301842), which combined STRIDE ± lenvatinib (L) with TACE. Methods: Eligible pts (≥18 yr) with confirmed eeHCC were randomized 1:1:1 to STRIDE (T 300 mg + D 1500 mg on Day 1 then D 1500 mg Q4W) + L (8 or 12 mg QD) + TACE; STRIDE + TACE; or TACE until reaching 175 pts/arm. Randomization continued 1:1 until STRIDE + L + TACE and TACE reached 275 pts/arm. D and L continued for ≤36 months (mo), until disease progression, unacceptable toxicity, or withdrawn consent. Pts were stratified by region, any prior palliative embolization, and baseline tumor burden by the Up-To-Seven criteria. The primary endpoint was PFS for STRIDE + L + TACE vs TACE by a stratified Cox proportional hazards model and stratified log-rank test. Key secondary endpoints were OS (STRIDE + L + TACE vs TACE), and PFS plus OS (STRIDE + TACE vs TACE). Results: As of Feb 23, 2026, 293 pts were randomized to STRIDE + L + TACE, 175 to STRIDE + TACE, and 292 to TACE. Baseline characteristics were broadly balanced across arms. STRIDE + L + TACE showed a statistically significant improvement in PFS vs TACE (HR, 0.70; 95% CI, 0.57–0.86; p=0.0007), and a positive OS trend (HR, 0.84; 95% CI, 0.65–1.09; p=0.1814). STRIDE + TACE also improved PFS (HR, 0.71; 95% CI, 0.56–0.91) and OS (HR, 0.70; 95% CI, 0.51–0.95) vs TACE. STRIDE ± L + TACE showed higher 24-mo OS rate vs TACE (Table). The incidence of treatment-related AEs of maximum grade 3/4 was 62.7% for STRIDE + L + TACE, 48.6% for STRIDE + TACE, and 18.6% for TACE. Conclusions: STRIDE + L + TACE significantly improved PFS vs TACE. At interim analysis, with ≤45% maturity, a positive trend for OS with STRIDE ± L + TACE vs TACE was observed. STRIDE + TACE also improved PFS vs TACE. AEs were aligned with known safety profiles of individual therapies. The EMERALD-3 results support STRIDE ± L + TACE as potential new treatment option in unresectable eeHCC. Clinical trial information: NCT05301842 . STRIDE + L + TACE(n=293) TACE(n=292) STRIDE + L + TACE(n=first 175) STRIDE + TACE(n=175) TACE (n=first 175) PFS (95% CI) HR 0.70 (0.57–0.86)p = 0.0007* 0.71 (0.56–0.91) † Maturity 64%* 75% † Median, mo 13.0 (12.2–16.7)* 9.8 (8.0–11.4)* 13.1 (11.0–17.7) † 12.9 (10.2–15.9) † 8.1 (6.5–10.2) † OS (95% CI) HR 0.84 (0.65–1.09) p = 0.1814 † 0.70 (0.51–0.95) † Maturity 40% † 45% † Median, mo 39.5 (34.1–NC) † 34.7 (28.8–NC) † 39.5 (32.6–NC) † NC (37.7–NC) † 32.9 (24.1–43.2) † 24-mo rate, % 66.9 (61.0–72.2) † 61.5 (55.4–67.0) † 67.8 (60.3–74.2) † 68.0 (60.4–74.5) † 57.8 (50.1–64.9) † NC, not calculable. Based on Data cutoff 1: *Sep 2, 2025; 2: † Feb 23, 2026.

Cancer remains a major global health challenge and is a leading cause of morbidity and mortality in Thailand. Industry-sponsored oncology trials (ISOTs) provide critical access to innovative therapies, including targeted agents, immunotherapies (IO), and antibody–drug conjugates (ADCs), particularly in resource-limited settings. We conducted a retrospective multicenter study to characterize temporal trends, geographic distribution, and clinical trial characteristics of ISOTs across institutions participating in the Thai Society of Clinical Oncology (TSCO) network between January 2012 and September 2024. Data on trial characteristics, geographic distribution, and patient enrollment were collected from institutions affiliated with the TSCO using a standardized data collection instrument. A total of 651 ISOTs were identified. Analyses were performed using available data for each variable, with complete-case analyses (n = 581) applied where complete trial-level information was required. Most trials were conducted in Bangkok (67

Purpose: Ampullary adenocarcinoma is a rare malignancy with limited evidence on the efficacy of systemic chemotherapy for advanced disease. This study aimed to evaluate the treatment outcomes of gemcitabine- and fluoropyrimidine-based regimens and the benefits of platinum combination therapy. Patients and Methods: This retrospective study reviewed the data of patients with advanced ampullary adenocarcinoma treated at a university hospital in Southern Thailand between 2005 and 2024. Results: Among the 97 patients, 71 (73.2%) received palliative chemotherapy, including 43 (60.6%) receiving gemcitabine-based regimens and 28 (39.4%) receiving fluoropyrimidine-based regimens. Median overall survival (OS) and progression-free survival (PFS) for gemcitabine-based vs. fluoropyrimidine-based regimens were 14.4 vs. 11.5 months (adjusted hazard ratio [HR] 0.85; 95% CI 0.34-2.13; P = 0.725) and 8.67 vs. 7.18 months (adjusted HR 0.60; 95% CI 0.26-1.36; P = 0.219), respectively. No significant difference in OS or PFS was observed between platinum combination and single-agent chemotherapy. The objective response rate (ORR) was 9.3% for gemcitabine-based therapy, 14.3% for fluoropyrimidine-based therapy, and 26.9% for platinum combination therapy, compared to 2.2% for monotherapy. Conclusion: Gemcitabine- and fluoropyrimidine-based regimens demonstrated comparable survival outcomes. Platinum-combination chemotherapy was associated with a higher ORR, but no significant OS or PFS benefit was observed. Therefore, platinum-combination regimens may be considered in selected patients requiring tumor shrinkage, and these findings should be interpreted as hypothesisgenerating real-world evidence.

PURPOSE:The bispecific antibodies lomvastomig and tobemstomig block the immune checkpoint receptor PD-1 and either TIM-3 or LAG-3, respectively. This phase 2 study assessed their efficacy compared with nivolumab in CPI-naïve patients with unresectable advanced or recurrent ESCC who were refractory or intolerant to one prior line of chemotherapy. PATIENTS AND METHODS:This active-controlled, blinded, multicenter study randomized patients (1:1:1) to treatment with lomvastomig (2100 mg Q2W), tobemstomig (2100 mg Q2W), or nivolumab (240 mg Q2W). The primary endpoint was overall survival, secondary endpoints included objective response, progression-free survival, pharmacodynamic changes, safety/tolerability, immunogenicity, and pharmacokinetics. RESULTS:190 patients were randomized, 27 to lomvastomig (this group was discontinued early), 82 to tobemstomig, and 81 to nivolumab. The median overall survival was lower in the lomvastomig (4.8 months; 80%CI, 2.8-5.8) and tobemstomig (6.7 months; 80%CI, 5.4-8.7) arms than in the nivolumab arm (8.1 months; 80%CI, 6.7-9.0). The objective response rate was 3.7%, 9.8%, and 8.6%, respectively. An exploratory biomarker analysis of tobemstomig-treated patients showed improved survival in the PD‑L1‑high (CPS≥10) versus the PD-L1-low (CPS<10) subgroup, with the greatest benefit in patients with concurrent high expression of PD-L1 and LAG-3 (>median). Adverse events with lomvastomig and tobemstomig were manageable, and the safety profiles of all three compounds remained consistent with their known immune-mediated side effects profiles. CONCLUSIONS:Neither lomvastomig nor tobemstomig improved survival compared to nivolumab in the overall patient population. However, in the PD-L1-high (CPS≥10) and PD-L1-high/LAG3-high subgroups, tobemstomig was associated with prolonged survival, supporting PD-L1-guided treatment selection for tobemstomig in ESCC.

Gemcitabine plus cisplatin (GemCis) has been served as an important first-line chemotherapy backbone for unresectable locally advanced or metastatic biliary tract cancer (BTC). However, cisplatin is unsuitable for all patients. Gemcitabine plus carboplatin (GemCarbo) is frequently used as an alternative, but direct comparative data remain limited. We retrospectively review patients with unresectable locally advanced or metastatic BTC who received first-line GemCis or GemCarbo at Songklanagarind Hospital between 2011 and 2025. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and selected laboratory-based safety outcomes. Propensity score matching was applied to reduce baseline treatment selection bias. Among 154 eligible patients, 95 received GemCis and 59 received GemCarbo. In the overall cohort, median OS was 8.44 months with GemCarbo and 9.82 months with GemCis (HR, 1.18; 95% CI, 0.82-1.70; p = 0.382). After propensity score matching, median OS was 8.44 months with GemCarbo and 11.63 months with GemCis (HR, 1.26; 95% CI, 0.84-1.90; p = 0.271). Median PFS was 4.27 and 5.75 months (HR, 0.91; 95% CI, 0.62-1.33; p = 0.617). ORR and DCR were comparable among evaluable patients. Increased serum creatinine was more frequent with GemCis, whereas hematologic toxicities were comparable. GemCarbo showed no statistically significant difference in OS or PFS compared with GemCis, suggesting that it may be considered as an alternative when cisplatin is unsuitable. However, prospective validation is warranted.

Background: Epstein–Barr virus-associated gastric cancer (EBVaGC) represents a distinct molecular subgroup with potential responsiveness to immunotherapy approved for programmed death-ligand 1 (PD-L1)-positive gastric cancer. This retrospective study aimed to assess the prevalence and association between EBVaGC and PD-L1 positivity among patients with gastric adenocarcinoma treated at a university hospital in Southern Thailand from January 2017 to October 2023. Methods: The EBV status of the patients and PD-L1 expression were determined using in situ hybridization and immunohistochemistry, respectively. Results: The prevalence of EBVaGC was 4.5% among 132 patients, whereas 9.1% of patients exhibited a PD-L1 combined positive score (CPS) of ≥1, with no significant association observed between them. EBVaGC was more prevalent in males, non-antral tumors, diffuse/mixed histologic subtypes, and poorly differentiated tumors. Median overall survival for patients with EBVaGC and PD-L1 CPS ≥ 1 was 9.48 and 14.19 months, respectively, compared with 10.32 and 9.79 months for those with non-EBVaGC (hazard ratio: 1.24; 95% CI: 0.50–3.04; p = 0.645) and PD-L1 CPS < 1 (hazard ratio: 0.82; 95% CI: 0.40–1.69; p = 0.590), respectively. Conclusions: Our findings revealed a low prevalence of EBVaGC and PD-L1 positivity in Thailand, with no significant association or survival impact observed. These findings highlight the regional variation in these biomarkers and support EBV as an independent biomarker from PD-L1. However, further research, particularly studies evaluating immunotherapy outcomes, is warranted to clarify the predictive and clinical significance of EBV in gastric cancer.

Background: Small-bowel cancers (SBCs) are rare, histologically diverse malignancies with limited data from Asian populations. This study aimed to describe histological subtype distribution, clinical features, survival outcomes, and prognostic factors in SBCs over a 20-year period. Methods: We retrospectively reviewed patients diagnosed with SBC at a tertiary referral center in Southern Thailand (2005–2024). Clinical, pathological, and radiological data were analyzed by histologic subtype. Results: A total of 158 patients were included: adenocarcinoma (81.0%), gastrointestinal stromal tumor (GIST, 5.7%), well-differentiated neuroendocrine tumor (NET, 5.7%), other sarcomas (5.1%), and poorly differentiated neuroendocrine carcinoma (NEC, 2.5%). Adenocarcinoma predominantly affected older patients and frequently presented with advanced-stage disease and poor performance status, whereas NET and NEC occurred in younger patients typically at early NET and metastatic NEC stages. Median overall survival (OS) varied by subtype: adenocarcinoma (8.3 months), GIST (63.6 months), NEC (8.9 months), NET (not reached), and other sarcomas (9.8 months). Five-year OS rates were 14.0%, 55.6%, 0%, 88.9%, and 18.8%, respectively. Eastern Cooperative Oncology Group performance status ≥2, duodenal location, and metastatic disease were independently associated with worse OS. Conclusions: SBCs display distinct clinical and prognostic profiles by subtype. Overall prognosis remained poor, underscoring the need for earlier detection and subtype-specific management.

Importance:Treating locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) involves any combination of surgery, radiation, and chemotherapy, followed by routine monitoring for local recurrence or distant metastases. Given the poor patient outcomes, a significant unmet clinical need for improved treatment options remains. Objective:To evaluate efficacy and safety of maintenance atezolizumab in patients with LA SCCHN at high risk of disease progression after multimodal definitive treatment. Design, Setting, and Participants:IMvoke010 was a phase 3, global, double-blind, randomized clinical trial. Patients were recruited at 128 sites in 23 countries between April 3, 2018, and February 14, 2020 (clinical cutoff date: September 27, 2023). Eligible patients had LA SCCHN (stage IVa/IVb involving the oral cavity, larynx, hypopharynx, or human papillomavirus-negative oropharynx, or stage III human papillomavirus-positive oropharynx [AJCC Cancer Staging Manual, eighth edition]) without disease progression after multimodal definitive treatment. Intervention:Patients were randomized (1:1) to receive atezolizumab 1200 mg or placebo every 3 weeks for 1 year or until disease recurrence, disease progression, unacceptable toxicity, or consent withdrawal. Main Outcomes and Measures:The primary end point was investigator-assessed event-free survival. Other end points included overall survival and safety. Results:Overall, 406 patients were randomized to receive atezolizumab (n = 203) or placebo (n = 203); baseline demographics were balanced between both treatment groups (<65 years, 142 [70.0%] vs 155 [76.4%]; male, 168 [82.8%] vs 174 [85.7%]; Asian, 68 [35.6%] vs 61 [31.0%]; Black, 1 [0.5%] vs 1 [0.5%]; and White, 121 [63.4%] vs 135 [68.5%], respectively). At clinical cutoff (median follow-up, 46.5 months), median investigator-assessed event-free survival was 59.5 months (95% CI, 46.8 to not estimable) with atezolizumab vs 52.7 months (95% CI, 41.4 to not estimable) with placebo (hazard ratio, 0.94; 95% CI, 0.70-1.26; P = .68). There was no difference in overall survival between atezolizumab and placebo (24-month overall survival, 82.0% vs 79.2%, respectively). No new or unexpected safety signals were identified. Conclusions and Relevance:In this study, atezolizumab did not improve clinical outcomes in patients with LA SCCHN at high risk of disease progression after multimodal definitive treatment. These data contribute to evidence on the limited activity of checkpoint inhibitors in the global population of this disease setting. Overall, the role of immunotherapy for patients with LA SCCHN remains to be determined. Trial Registration:ClinicalTrials.gov Identifier: NCT03452137.

Purpose:HER2-low status is a predictive factor for novel anti-HER2 therapies in metastatic hormone receptor-positive breast cancer (HR+ MBC). However, its impact on endocrine therapy outcomes remains uncertain. We aimed to explore the effect of HER2-low and HER2-zero status in HR+ MBC patients treated with first-line aromatase inhibitors (AIs) with or without CDK4/6 inhibitors (CDK4/6i). Methods:We retrospectively reviewed postmenopausal women with HR+ MBC treated with first-line AI ± CDK4/6i between January 1, 2017, and December 31, 2022, from six tertiary hospitals in Thailand. HER2-low was defined as HER2 IHC 1+ or IHC 2+ with ISH-negative. Progression-free survival (PFS) and overall survival (OS) were compared in unadjusted and adjusted cohorts using stabilized inverse probability of treatment weighting (sIPTW), adjusting for age, ECOG performance status, de novo metastasis, endocrine sensitivity, visceral metastasis, number of metastatic sites, and treatment year. Interaction analyses were performed to assess effect modification by HER2 status and other clinical subgroups. Results:Among 504 patients, 219 (43.5%) were HER2-low, and 285 (56.5%) were HER2-zero. Median follow-up was 31 months (IQR 19-47). CDK4/6i + AI was administered to 52.5% of HER2-low and 43.9% of HER2-zero patients. After sIPTW adjustment, CDK4/6i + AI prolonged median PFS to 22.1 months compared with 21.5 months for AI alone in the HER2-low cohort (HR = 0.80, 95% CI 0.54-1.18; p = 0.26) and to 20.1 months compared with 13.5 months in the HER2-zero cohort (HR = 0.65, 95% CI 0.45-0.93; p = 0.02). Median OS was 49.3 months with CDK4/6i + AI versus 48.4 months with AI alone in HER2-low (HR = 0.81, 95% CI 0.48-1.36; p = 0.43) and 45.8 versus 42.3 months in HER2-zero (HR = 0.85, 95% CI 0.43-1.05; p = 0.52). Subgroup analyses showed consistent benefit of CDK4/6i + AI across most clinical categories. The interaction test for treatment × HER2 status was not significant (HR = 1.21, 95% CI 0.74-1.98; p = 0.44), indicating no effect modification by HER2-low status. Conclusions:HER2-low status was not associated with prognosis or predictive value for CDK4/6i efficacy, supporting CDK4/6i + AI as the standard first-line therapy irrespective of HER2 expression level.

Background: Cancer epidemiology data for people living with human immunodeficiency virus (PLWH) in Thailand, particularly in the era of combination antiretroviral therapy (ART), remain limited. In this study, we describe the prevalence, temporal trends, clinical characteristics, and survival outcomes of patients with AIDS-defining cancers (ADCs) and non-AIDS-defining cancers (NADCs). Methods: We retrospectively reviewed adult PLWH diagnosed with malignancy at Songklanagarind Hospital in Thailand during 2003-2023. Demographic, human immunodeficiency virus (HIV)-related, and clinical data were analyzed using chi-square and Wilcoxon rank-sum tests and the Kaplan-Meier method. Results: Among 444 patients, 231 had NADCs and 213 had ADCs. The NADC proportion increased markedly over time. Common ADCs included non-Hodgkin lymphoma and cervical cancer; common NADCs included lung cancer, non-nasopharyngeal head and neck cancer, and hepatocellular carcinoma. Compared with patients with ADCs, those with NADCs were older, more often male, and had higher proportions of undetectable HIV viral load, CD4 counts ≥200 cells/µL, and ART use. Approximately one-third of patients presented with advanced-stage disease, and the median overall survival was 15.9 months. Conclusions: Over two decades, NADCs have become the predominant malignancy in Thai PLWH, associated with older age, male sex, and improved immune function. This reflects the evolving cancer risk in the era of combination ART. We suggest employing multidisciplinary approaches involving HIV and cancer care to improve survival outcomes and integrating age-appropriate screening for common NADCs into HIV care.

Purpose:Small bowel adenocarcinoma (SBA) is a rare gastrointestinal malignancy with limited evidence guiding systemic treatment in the advanced stages. This study evaluated the effectiveness of palliative chemotherapy and revealed the prognostic factors associated with survival in patients with metastatic or unresectable SBA. Patients and Methods:We conducted a retrospective cohort study of patients diagnosed with advanced SBA at a single tertiary center in Thailand between 2005 and 2024. The patients were treated with palliative systemic chemotherapy or best supportive care (BSC). Survival outcomes were assessed using Kaplan-Meier estimates and Cox regression analyses. Propensity score-matching (PSM) was performed to adjust for baseline imbalances. Results:This study included 106 patients; of these, 39 (36.8%) received palliative chemotherapy. After 1:1 PSM, 39 matched pairs were analyzed. Chemotherapy significantly improved overall survival (OS) compared with that of the BSC, with a median OS of 10.4 vs 2.6 months (hazard ratio 0.36; 95% confidence intervals 0.22-0.59; P <0.001). Among chemotherapy-treated patients, the median progression-free survival was 5.95 months, and the objective response rate was 10.3% overall, increasing to 21.1% among evaluable patients receiving doublet regimens. Multivariate analysis revealed that poor Eastern Cooperative Oncology Group performance status (≥2), poorly differentiated histology, and duodenal tumor location independently predicted worse OS. Conclusion:Palliative chemotherapy significantly prolongs survival in patients with advanced SBA compared with that of BSC, particularly in those with a good performance status. Doublet fluoropyrimidine-based regimens offered superior outcomes. These findings support the use of systemic chemotherapy for this rare malignancy, highlighting the significance of patient selection and performance status in guiding treatment decisions.

PURPOSE The incidence and survival rates of head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC) vary globally, influenced by factors such as ethnicity, lifestyle, and health care systems. METHODS A retrospective analysis was conducted on patients with HNSCC treated between 2008 and 2020 in four major Thai academic cancer centers, using a multidisciplinary multicenter database. The study focused on the evolution of patient characteristics, survival changes, and treatment landscape alterations over time. RESULTS Among 6,319 patients, the most common primary sites were nasopharynx (33%), oral cavity (23%), oropharynx (17%), larynx (15%), and hypopharynx (8%). An increase in human papillomavirus–related oropharyngeal carcinoma was noted, from 13% in 2008 to 42% in 2019-2020. The majority of patients presented with locally advanced (LA) stages (IVa/b: 50%, III: 26%). Chemoradiotherapy (54%) and surgery (24%) were the main treatments, with cisplatin (79%) being most commonly used in chemoradiation. Overall survival (OS) improved annually across all subsites, correlating with an increase in intensity-modulated radiotherapy (IMRT) use, from 25% in 2008 to 90% in 2019-2020. The median follow-up duration was 4.59 years, with a minimum of 2.75 years. Patients treated with IMRT had significantly longer OS compared with those treated with non-IMRT techniques, in both NPC and non-NPC HNSCC ( P < .001). CONCLUSION To our knowledge, this is the largest study in Thailand that demonstrates increasing survival outcomes in patients with HNSCC and NPC, despite commonly presenting with LA stages. The increasing use of IMRT may be contributing to improved survival outcomes in both patients with NPC and non-NPC HNSCC patients.

6051 Background: Nasopharyngeal cancer (NPC), a malignancy of the nasopharynx, is strongly associated with Epstein-Barr virus (EBV) infection. Although rare in Western countries, NPC is significantly more prevalent in Southeast Asia, likely due to a combination of environmental and dietary factors, though these remain incompletely understood. Current treatments, primarily radiation and chemotherapy, may not fully address the unique challenges posed by NPC. This study aims to conduct a comprehensive genomic analysis, including circulating tumor DNA (ctDNA), and microbial analysis to clarify NPC pathogenesis by examining patient backgrounds in Asian populations. Methods: This is an Asian multicenter prospective observational study conducted by nine institutions in Japan, Philippines, Malaysia, Thailand, Singapore, Taiwan and Vietnam. Eligible patients had histological diagnosis of NPC with metastatic and/or recurrent disease. ctDNA will be analyzed in blood samples collected at newly initial diagnosis of metastatic disease and/or at disease progression. Genomic profiling will be analyzed using TruSight Oncology 500 ctDNA for plasma (Illumina) and TruSight Oncology 500 (Illumina) for tumor tissue, respectively. Furthermore, we analyzed more than 3,000 viral genes using tumor tissue. Results: Seventy-two samples from 72 NPC patients were analyzed. The median age of the patients was 52 years old (range, 25-78), with 53 (73.6%) males. All the patients were Asian, and the details are as follows: 23 Vietnamese, 15 Chinese, 7 Thai, 6 Taiwanese, 5 Iban, 4 Filipino, 3 Japanese and 3 Malay. The number of patients with a history of surgery and radiotherapy was 10 (13.9%) and 45 (62.5%), respectively. Forty-nine patients (68.1%) had a history of chemotherapy, and all had a history of platinum-based drug administration, while eight (11.1%) had a history of immuno-checkpoint inhibitors administration. Pathogenic variants in ctDNA were detected in 40 out of 72 patients (55.6%). The most frequently deleterious mutations were TP53, NRAS and TGFBR2 . Copy number alteration was observed in 33 patients (45.8%). Comprehensive viral and bacterial analysis was available in 20/72 patients (27.8%), with EBV found in 17 patients and none of the viruses in 3 patients. Actinomyces was dominant in all cases, although the bacterial flora was somewhat different. Conclusions: In this study, we conducted comprehensive genomic and microbial analyses of samples collected from NPC patients in Asia, and detected various genomic features as well as elucidating the characteristics of the microbial flora present in the background. As a result, it was shown that anaerobic bacteria may be involved in the pathogenesis of NPC. These bacterial groups form a tumor microenvironment through inflammation and immune modulation, and it is suggested that they promote tumor formation. Clinical trial information: NCT05099978 .

Background: Small bowel adenocarcinoma (SBA) is a rare malignancy, and the role of adjuvant chemotherapy following curative resection remains unclear owing to limited supporting evidence. In this study, we aimed to evaluate the real-world effectiveness of adjuvant chemotherapy in patients with resected SBA. Methods: We retrospectively reviewed data from patients with localized SBA who underwent curative resection at a single tertiary referral center in Southern Thailand between 2005 and 2024. Results: Of 128 patients diagnosed with SBA, 52 (40.6%) had localized disease and underwent curative resection. Among them, 29 patients (55.8%) received adjuvant chemotherapy and 23 (44.2%) were managed with observation alone. The median disease-free survival (DFS) was 18.1 and 16.2 months in the adjuvant chemotherapy and observation groups, respectively (p = 0.642). The median overall survival (OS) was 42.8 vs. 26.7 months, respectively (p = 0.179). Subgroup analyses revealed trends favoring adjuvant chemotherapy in patients with pathological T4 disease, nodal involvement, younger age, and non-underweight body mass indices. Positive surgical margins were associated with inferior DFS, and T4 stage was associated with worse OS. Disease recurrence occurred in 59% of patients, predominantly as distant metastasis. Conclusions: Adjuvant chemotherapy showed a trend toward improved survival, particularly in patients with high-risk features; however, these findings should be interpreted with caution given the limited sample size and retrospective design. These results highlight the importance of individualized treatment decisions and underscore the need for larger multi-institutional studies to clarify the role of adjuvant chemotherapy and identify prognostic biomarkers for this rare malignancy.

Background: The treatment landscape for advanced hepatocellular carcinoma (HCC) has evolved significantly recently; however, access to novel agents remains limited because of high costs. This study aimed to evaluate the systemic treatment patterns and survival outcomes for advanced HCC across different systemic treatment sequences under real-world resource constraints. Methods: This retrospective study was conducted at a tertiary center in Southern Thailand. The medical records of patients (n = 330) with advanced HCC treated with systemic therapy between 2010 and 2024 were reviewed. Outcomes included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Prognostic factors for OS were investigated. Results: First-line therapies included tyrosine kinase inhibitor (TKI; 69.7%), chemotherapy (23.3%), immunotherapy (IO)/targeted therapy (3.6%), dual IO (1.8%), and IO monotherapy (1.5%). The median OS, PFS, and ORR for each cohort were 7.2, 5.2, 10.9, 8.5, and 8.6 months; 3.94, 3.22, 3.48, 6.19, and 2.69 months; and 9.6%, 10.4%, 16.7%, 0%, and 20.0%, respectively. OS improved with increasing lines of therapy (4.5, 12.2, 19.4, and 40.7 months for one to four lines, respectively). Portal vein tumor thrombus, ascites, elevated bilirubin level, high alpha-fetoprotein level, and poor Eastern Cooperative Oncology Group performance status were associated with poor prognosis; multiple treatment lines and overweight status were associated with improved OS. Conclusions: In this large real-world cohort, TKIs remained the mainstay effective treatment option because of limited access to IO-based regimens. Sequential systemic therapy significantly improved survival, emphasizing the importance of preserving treatment eligibility and multidisciplinary team involvement. Chemotherapy could be considered a viable option in resource-limited settings.

Background No widely used prognostic tool exists to demonstrate the benefit of oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX4) in patients with advanced hepatocellular carcinoma (HCC). We aimed to establish a prognostic score and demonstrate the real-world efficacy of FOLFOX4 chemotherapy in Thai patients. Methods Between August 2017 and December 2021, we identified 58 FOLFOX4-treated patients with HCC. Overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) were assessed. The prognostic score was constructed by stepwise Cox proportional hazards regression analysis to select variables for the best model with the lowest Akaike information criterion from all potential variables. Results Forty-four patients (76%) received FOLFOX4 as first-line therapy. The ORR in the entire cohort was 8.6%, and the disease control rate was 29.3%. The PFS and OS were 3.7 and 4.8 months, respectively. Four clinically relevant variables were included in the new prognostic score to predict 6-month OS: L, the presence of lung metastasis; A, alcoholic cirrhosis; B, elevated total bilirubin level; and S, sorafenib-naïve status. Using the LABS score, patients were classified into low-, intermediate-, and high-risk groups, demonstrating OS values of 9.3, 4.2, and 2.1 months, respectively ( p < 0.0001). The C-index and area under the receiver-operating characteristic curve of the score were 0.71 and 0.73, respectively. Conclusions The proposed LABS score could discriminate patients who would derive benefit from FOLFOX4 chemotherapy. FOLFOX4 chemotherapy is an option for patients who cannot receive immunotherapy and targeted therapy, particularly those with a low-risk score. However, further validation of this model via larger cohorts is warranted.

Abstract Background: Treatment (tx) for LA SCCHN includes a combination of surgery, radiation and/or chemotherapy followed by monitoring for local recurrence/distant metastases as standard of care. Given poor outcomes, there remains a clear unmet need in this pt population. IMvoke010 (NCT03452137) evaluated the efficacy and safety of atezo in pts with LA SCCHN who are at high-risk for disease progression following multi-modal definitive tx. Methods: Eligible pts with LA SCCHN (Stage IVa or IVb involving the oral cavity, larynx, hypopharynx, HPV negative oropharynx or Stage III HPV positive oropharynx [per AJCC 8th edition]) with no disease progression after multi-modal definitive tx were randomized (1:1) to receive atezo 1200 mg or placebo. Tx was given every 3 weeks for 1 year or until disease progression, unacceptable toxicity or consent withdrawal. Primary endpoint: investigator-assessed event-free survival (INV-EFS). Other key endpoints: overall survival (OS, secondary for efficacy) and safety. Results: A total of 406 pts were randomized to receive either atezo (n=203) or placebo (n=203). 156 (38.4%) pts underwent surgery as part of definitive tx. At clinical cutoff (27 September 2023), median follow-up was 46.5 months (mos). Median INV-EFS was 59.5 mos with atezo vs 52.7 mos with placebo (HR, 0.94; 95% CI, 0.70-1.26). INV-EFS results were generally consistent across all subgroups. OS showed no difference between arms for atezo vs placebo. Safety data are reported (Table). Conclusion: This study did not meet the primary endpoint of INV-EFS, a numerical improvement in INV-EFS was observed for atezo in pts with LA SCCHN, but this was not statistically significant. Atezo was generally well tolerated, and no new safety signals were identified. Table: Key efficacy and safety results Efficacy Atezo (n=203)* Placebo (n=203) Median INV-EFS, mos 59.5 52.7 HR (95% CI) 0.94 (0.70-1.26) P-value 0.6804† Median OS, mos NE NE HR (95% CI) 0.96 (0.68-1.36) Safety, n (%) Grade 3-4 AEs 55 (27.2) 43 (21.2) TRAEs Grade 3-4 20 (9.9) 12 (5.9) Grade 5 AEs 3 (1.5) 5 (2.5) SAEs 32 (15.8) 32 (15.8) AEs leading to tx discontinuation 18 (8.9) 9 (4.4) CI, confidence interval; HR, hazard ratio; *safety-evaluable pts (n=202); †α boundary: 0.0427 Citation Format: Deborah J. Wong, Jérôme Fayette, Maria Teixeira, Kumar Prabhash, Ricard Mesia, Andrzej Kawecki, Arunee Dechaphunkul, José Dinis, Ye Guo, Muneyuki Masuda, Ching-Yun Hsieh, Maria Grazia Ghi, Claudia Vaz de Melo Sette, Tao Jiang, Yibing Yan, Monika Kaul, Ritika Jagtiani, Christina Matheny, Vaikunth Cuchelkar, Robert Haddad. IMvoke010: A phase III, double-blind randomized trial of atezolizumab (atezo) after definitive local therapy vs placebo in patients (pts) with high-risk locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT009.