TPS5624 Background: The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery increases progression-free and overall survival for patients with stage III ovarian cancer in two randomized controlled trials (OV-HIPEC-01 and KOV-HIPEC-01). This trial aims to identify the survival benefit of HIPEC in stage III & IV ovarian cancer in the era of maintenance therapy of bevacizumab and/or PARP inhibitors. Methods: Ovarian cancer patients will be randomized at the time of interval cytoreductive surgery with achieving complete cytoreduction or cytoreduction with no more than 2.5mm size of residual disease to receive HIPEC (41.5 cisplatin 75mg/m 2 , 90 minutes) or not (Control arm). After recovery from surgery, patients will receive postoperative platinum-based adjuvant chemotherapy followed by maintenance therapy with PARP inhibitor or bevacizumab. The primary objective of the trial is to evaluate OS in two groups. Secondary objectives are PFS, cancer-specific survival, time to first subsequent therapy (TFST), safety, CA-125 KELIM, and quality of life. Assuming that the enrollment period is 5 years and the follow-up period is 3 years, the total number of events required is 263. Based on the log-rank test, the total number of subjects required to prove HR 0.67 with a two-sided alpha of 0.05 and 90% power is 494. Considering 5% drop-out, 520 patients are finally studied. Results: The first patient was randomized on June 06, 2023. Until Jan. 26, 2025, 279 (53%) patients are randomized. There are no available results at the time of submission. Conclusions: The role of HIPEC during interval cytoreductive surgery will be discovered in stage III & IV ovarian cancer with this randomized trial (KOV-04, FOCUS) in the era of maintenance therapy of bevacizumab and/or PARP inhibitors for the first time. Clinical trial information: NCT05827523 .

BACKGROUND:Our previous randomized controlled trial reported that Helicobacter pylori eradication reduced the risk of metachronous gastric cancer over a median follow-up of 5.9 years in patients with early gastric cancer (EGC) and improved corpus gastric atrophy (GA) at the specific 3 year follow-up time. This study aimed to evaluate the long-term effects of H. pylori eradication on GA and intestinal metaplasia (IM) at trial closeout. METHODS:Among 470 patients randomized between 2003 and 2013, 327 who were assessed for GA and IM at both baseline and 3-year follow-up time were included in the study. At trial closeout, H. pylori status, GA, and IM were assessed. Main outcomes were improvement in GA and IM at the corpus lesser curvature (LC) according to the H. pylori status at the closeout time. The secondary outcomes included the Operative Link for Gastritis Assessment (OLGA) and Operative Link for Gastric Intestinal Metaplasia assessment (OLGIM) stage improvements. RESULTS:At a median follow-up of 5.9 years (interquartile range: 4.0-8.2 years), an improvement in GA grades at the corpus LC was observed in 88 of the 150 patients (58.7%) in the H. pylori-eradicated group and 31 of the 158 patients (19.6%) in the H. pylori-persistent group (odds ratio [OR] in the H. pylori-eradicated group, 5.81; 95% confidence interval [CI], 3.49-9.68). IM grades showed greater improvement in the H. pylori-eradicated group (42.4% [67/158 patients]) compared with the H. pylori-persistent group (18.6% [31/167 patients]); OR in the eradicated group (3.23; 95% CI, 1.96-5.33). Similarly, the H. pylori-eradicated group exhibited significantly higher rates of improvement in both OLGA (OR 6.48; 95% CI, 3.85-10.91) and OLGIM stages (OR 2.31; 95% CI, 1.42-3.77). CONCLUSIONS:In patients with EGC who have far advanced histologic changes in the background mucosa, H. pylori eradication was associated with a significant improvement in GA and IM.

To confirm the accurate pN0 status in patients with cT1–2N0 esophageal squamous cell carcinoma (ESCC) and recommend an optimal lymph node (LN) count for accurate nodal staging. A total of 1855 patients who underwent upfront surgery for cT1–2N0 ESCC at two tertiary academic hospitals in Korea between 1995 and 2019 were included. The probability of false-negative lymphadenectomy and the Nodal Staging Score (NSS) were calculated to assess adequate staging. The mean age was 63.4 ± 8.0 years, with 93.1

6059 Background: PD-(L)1 inhibitors are a standard first-line (1L) backbone for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, many patients progress after 1L PD-(L)1–based therapy, and optimal post-progression strategies remain undefined. In particular, the benefit of continuing or rechallenging PD-(L)1 inhibitors beyond progression is unclear. Methods: In this multicenter retrospective study, we included patients diagnosed with R/M HNSCC (oral cavity, oropharynx, larynx, and hypopharynx) between 2016 and May 2025 at Samsung Medical Center and Mass General Brigham. Eligible patients received 1L PD-(L)1–containing regimen, experienced disease progression, and underwent subsequent second-line systemic therapy. Patients were categorized by post-progression strategy: continuation or rechallenge with PD-(L)1 inhibitors versus non–PD-(L)1–based therapy. Overall survival (OS) was defined as the time from initiation of 1L therapy to death from any cause. Results: A total of 252 patients with R/M HNSCC met eligibility criteria. Median age was 64; 191 (76%) were male; 68 (27.0%) were HPV-positive; and 217 (86%) were PD-L1 positive (CPS ≥1). Twenty-six patients (10.3%) received anti-PD-(L)1 monotherapy, and 84 (33%) remained on 1L therapy for ≥6 months. Median OS for the entire cohort was 18 months (95% CI, 15.9-20.1). Median OS was 21.1 months among patients who continued or were rechallenged with PD-(L)1 inhibitor (n = 112) versus 14.4 months in those who were not (n = 140) (p < 0.001). On multivariable analysis including post-progression PD-(L)1 continuation/rechallenge, HPV status, PD-L1 expression, age, sex, ECOG performance status, and duration of 1L PD-(L)1 therapy, continuation or rechallenge with PD-(L)1 inhibitors (HR 0.583, p=0.003) and 1L PD-(L)1 duration ≥6 months (HR 0.487, p<0.001) were independently associated with improved OS. Conclusions: In this study, continuation or rechallenge with PD-(L)1 inhibitors after progression on 1L therapy was associated with improved OS in patients with R/M HNSCC, independent of PD-L1 expression or HPV status. Prolonged benefit from 1L PD-(L)1 therapy was also independently associated with favorable survival. These findings suggest that selected patients may derive continued clinical benefit from anti-PD-(L)1–based strategies beyond progression and support prospective studies to refine patient selection and optimize post-progression treatment strategies.

Abstract Background: Immune checkpoint inhibitors (ICIs) have significantly improved survival outcomes in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). However, disease progression after first-line ICI therapy remains a major clinical challenge, and the benefit of ICI continuation or rechallenge after progression has not been fully elucidated. Methods: In this multicenter retrospective study, we included patients diagnosed with HNSCC between 2016 and May 2025 at Samsung Medical Center and Massachusetts General Hospital. This study included patients who received first-line ICI therapy with or without other agents. Overall survival (OS) was compared between patients who received second-line ICI continuation (ICI-based regimens) and those who received non-ICI treatments. Results: A total of 278 patients received first-line ICI therapy with or without chemotherapy, including 85 (30.6%) with HPV-positive HNSCC, 133 (47.8%) with HPV-negative disease, and 60 (21.6%) with unknown HPV status. Among them, 242 patients (87.0%) experienced disease progression after first-line ICI ± chemotherapy, and 210 proceeded to second-line treatment. Of these 210 patients, 73(34.8%) received ICI-based therapy— while the remaining 137 (65.2%) received cytotoxic chemotherapy or other non-ICI regimens. The median OS from the start of first-line therapy was 17.0 months (95% CI, 14.5-19.5). Median OS was 21.1 months for patients who received second-line ICI continuation and 14.3 months for those who received non-ICI treatments (HR 0.61, 95% CI 0.43-0.85, P = 0.004). The median OS from the start of second-line therapy was 12.2 months for patients who received ICI with or without other agents and 8.0 months for those who received chemotherapy (P = 0.003). In subgroup analyses stratified by first-line ICI efficacy, patients with a first-line treatment duration of < 6 months showed a modest OS advantage with ICI-based second-line therapy compared with non-ICI regimens (11.2 vs. 8.0 months; P = 0.042). In patients whose first-line treatment duration was ≥ 6 months, the difference was substantially more pronounced, with ICI-based therapy demonstrating a markedly longer OS compared with non-ICI treatment (12.7 vs. 7.8 months; P = 0.035). Conclusions: ICI continuation was associated with a significant OS benefit compared with non-ICI regimens in patients with recurrent or metastatic HNSCC who progressed after first-line ICIs. These findings indicate that continuing ICI-based treatment may be a feasible option regardless of the duration of first-line PFS, with a more pronounced benefit in patients who initially achieved durable disease control with first-line ICI therapy. Citation Format: Hyun Ae Jung, Young Kim, Ross Merkin, Thomas Roberts, Manisha Patel, Boram Park, Jinyong Kim, Sehhoon Park, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Myung-Ju Ahn, Lori J. Wirth, Jong Chul Park. Continuation of immune checkpoint inhibitor therapy after progression in head and neck squamous cell carcinoma: A multicenter study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 1 (Regular Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(7 Suppl):Abstract nr 7773.

Technological advancements have made it possible to measure vital signs through wearable devices. This study evaluated the accuracy of wrist skin temperature (WST) measured by a continuous monitoring biosensor in the Galaxy Watch 5 for predicting ovulation dates. We recruited 106 women to measure WST during sleep, oral temperature upon waking, and perform ovulation tests around expected ovulation dates. Ovulation was confirmed via progesterone blood test. We analyzed 225 cycles (85 women) in the full analysis set (FAS), and 156 cycles (52 women) in the per-protocol (PP) set. WST predicted ovulation dates within 2 days in 64.0% (FAS) and 64.1% (PP) of cycles, and within 3 days in 77.8% (FAS) and 78.9% (PP) of cycles. Next menstrual cycle prediction accuracy was 68.2% (FAS) and 69.9% (PP) within 2 days, and 77.8% (FAS) and 84.1% (PP) within 3 days. WST and oral temperature showed moderate correlation (FAS: r=0.423; PP: r=0.448). While predicting ovulation within 2 days wasn’t statistically significant, prediction within 3 days showed significant results. In conclusion, WST measurement using a continuous monitoring biosensor during sleep may be helpful in predicting ovulation date and next menstruation dates, offering another useful application for wearable devices in reproductive health monitoring.

PURPOSE:The surveillance protocol for early-stage non-small cell lung cancer (NSCLC) is not contingent upon individualized risk factors for recurrence. This study aimed to use comprehensive data from clinical practice to develop a deep-learning model for practical longitudinal monitoring. METHODS:A multimodal deep-learning model with transformers was developed for real-time recurrence prediction using baseline clinical, pathological, and molecular data with longitudinal laboratory and radiologic data collected during surveillance. Patients with NSCLC (stage I to III) who underwent surgery with curative intent between January 2008 and September 2022 were included. The primary outcome was predicting recurrence within 1 year after the monitoring point. This study demonstrates the timely provision of risk scores (RADAR score) and determined thresholds and the corresponding AUC. RESULTS:A total of 14,177 patients were enrolled (10,262 with stage I, 2,380 with stage II, and 1,703 with stage III). The model incorporated 64 clinical-pathological-molecular factors at baseline, along with longitudinal laboratory and computed tomography imaging interpretation data. The mean baseline RADAR score was 0.324 (standard deviation [SD], 0.256) in stage I, 0.660 (SD, 0.210) in stage II, and 0.824 (SD, 0.140) in stage III. The AUC for predicting relapse within 1 year of the monitoring point was 0.854 across all stages, with a sensitivity of 86.0% and a specificity of 71.3% (AUC = 0.872 in stage I, AUC = 0.737 in stage II, and AUC = 0.724 in stage III). CONCLUSION:This pilot study introduces a deep-learning model that uses multimodal data from routine clinical practice to predict relapses in early-stage NSCLC. It demonstrates the timely provision of RADAR risk scores to clinicians for recurrence prediction, potentially guiding risk-adapted surveillance strategies and aggressive adjuvant systemic treatment.

Some genetic variants are associated with lung function decline and chronic obstructive pulmonary disease (COPD), but functional studies are necessary to confirm causality. We investigated the genetic susceptibility-associated lung function decline with or without COPD, using data from a community-based cohort (N = 8554). A genome-wide interaction study was conducted to identify the association between genetic variants and pulmonary function, and the way variants relate to lung impairment in accordance with smoking status and amount was examined. We further used a linear mixed model to examine the association and interaction to time effect. We found annual mean FEV1 declines of 41.7 mL for men and 33.4 mL for women, and the annual rate of decline in FEV1 was the fastest for current smokers. We also found a previously identified locus near FAM13A, the most significant SNPs from the results of two likelihood ratio tests for FEV1/FVC (P = 1.56 × 10−10). These selected SNPs were located in the upstream region of FAM13A on chromosome 4 and had similar minor allele frequencies (MAFs). Furthermore, we found that certain SNPs tended to have lower FEV1/FVC values, and lung function decreased much faster with time interactions. The SNP most associated with lung function decline was the rs75679995 SNP on chromosome 7, and those SNPs located within the TAD of the DNAH11 region and the eQTL of rs9991425 revealed a higher expression of MFAP3L and AADAT genes (P = 2.28 × 10−7 and 2.01 × 10−6, respectively). This is the first study to investigate gene–time interactions in lung function decline as a risk factor for COPD in the Korean population. In addition to replicating previously known signals for FAM13A, we identified two genomic regions (DNAH11, AADAT) that are potentially involved in gene–environment interactions, warranting further investigation to confirm their roles.

Background:Surgical resection and ablation therapy are both primary treatment options for very early stage hepatocellular carcinoma (HCC). Accurate risk stratification is important, since patients at higher risk of recurrence may derive greater benefit from curative resection than from ablation. We investigated whether the mitotic index is associated with early recurrence in HCC and may serve as a prognostic marker to refine risk assessment in very early stage disease. Methods:The number of mitoses was counted in representative tumor slides from 942 cases of surgically resected HCC from Samsung Medical Center. A high mitotic index was defined as more than eight mitoses in 10 high-power fields. The relationship between mitotic index, clinicopathological characteristics, and prognosis were analyzed. External validation was performed using 112 HCC cases obtained from Hallym University Sacred Heart Hospital. Results:High mitotic index was identified in 296 patients and was significantly associated with aggressive clinicopathological features including higher Edmondson grade, advanced American Joint Committee on Cancer T stage, and early tumor recurrence. Patients with a high mitotic index displayed a significantly shorter early recurrence-free survival (e-RFS). In subgroup analysis of patients with very early stage, the high mitotic index group showed unfavorable influences on e-RFS. Conclusion:High mitotic index is a significant predictor of early recurrence in HCC patients and may provide useful prognostic information in very early stage disease. While its direct role in guiding primary treatment selection is limited, the mitotic index could contribute to risk stratification and postoperative management strategies.

To evaluate the prognostic impact of radiation therapy (RT)-induced lymphopenia on survival outcomes in patients with cervical cancer treated with RT. Study design: We retrospectively reviewed 215 patients with histologically confirmed cervical cancer who received RT with concurrent chemotherapy between January 2001 and December 2017. The severity of lymphopenia was quantified using the ratio of pretreatment absolute lymphocyte count (ALC) to nadir ALC during RT (∆ALC/preALC). The optimal cutoff of ∆ALC/preALC for survival analysis was determined to be 0.88. Survival outcomes were assessed using Kaplan-Meier analysis and Cox proportional hazard models. Results: The median follow-up duration was 61.0 months. Patients with severe lymphopenia (∆ALC/preALC > 0.88) had significantly worse disease-free survival (DFS) and overall survival (OS). On multivariable analysis, ∆ALC/preALC > 0.88 remained an independent prognostic factor for both DFS (HR 2.18, p = 0.011) and OS (HR 2.54, p = 0.009). The impact of lymphopenia on survival was most pronounced in patients receiving extended field RT compared to whole pelvis RT (mean ∆ALC/preALC: 0.85 vs. 0.77, p < 0.001). Subgroup analysis showed lymphopenia was a significant prognostic factor only in the extended field RT group. Conclusion: RT-induced lymphopenia is associated with inferior survival in cervical cancer patients, particularly those receiving extended field RT. Strategies to mitigate lymphopenia, such as minimizing RT fields or using advanced bone marrow-sparing techniques, may improve patient outcomes.

OBJECTIVE:To propose a new ypTNM grouping system to address these limitations and improve prognostic relevance. SUMMARY BACKGROUND DATA:The current 8th edition of the American Joint Committee on Cancer (AJCC) ypStage system shows unsatisfactory prognostic relevance in patients with esophageal squamous cell carcinoma (ESCC) treated with neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy. METHODS:The study cohort included 501 ESCC patients who received nCRT followed by esophagectomy at the Samsung Medical Center in Korea between 1994 and 2018 (development cohort) and 422 patients treated at Asan Medical Center (validation cohort). Recursive partitioning with a tree-structured regression model was used to develop and validate a new ypStage grouping system. RESULTS:In the new ypStage grouping system, ypStage I includes ypT0N0 only; ypStage II includes ypTis-T2N0 or ypT0-T2N1; ypStage III includes ypT3N0-N1; and ypStage IV includes ypT4N0-N1 or ypTanyN2-3. This system adequately addressed the limitations of the existing AJCC classification system, including overlapping and reversal of survival rates. Moreover, the discrimination ability of the new system was higher than that of the existing system [concordance-index (C-index): 61.9%] in the development (C-index: 66.6%) and validation (C-index: 66.0%) cohorts. NRIe was 0.17 [95% confidence interval (CI): 0.09-0.26, P-<0.001) and 0.18 (95% CI: 0.10-0.27, P-<0.001)] in the development and validation cohorts, respectively. CONCLUSIONS:The current study proposes a clear revised version of the 8th edition of the AJCC ypStage grouping system that exhibits superior prognostic stratification in patients with ESCC treated with nCRT followed by esophagectomy.

BACKGROUND:The effect of lymph node (LN) dissection on the overall survival of patients with esophageal squamous cell carcinoma (ESCC) treated by neoadjuvant chemoradiation therapy (nCRT) followed by esophagectomy has been controversial. This study investigated the patterns of metastatic LNs after nCRT and the benefits of LN dissection using the efficacy index (EI). METHODS:The EI was calculated by multiplying the frequency (%) of metastases to a zone and the 5-year overall survival rate (%) of patients with metastases to that zone and then dividing by 100. EIs were compared according to the primary lesion location, response to nCRT, and preoperative radiation coverage. RESULTS:Among 573 patients, the mean age was 62.66 ± 8.10 years, and 533 (93.02%) were male. The mean number of dissected LNs was 37.62 ± 14.76. In all patients, bilateral recurrent laryngeal LNs and paracardial and left gastric LNs showed high EIs compared with other LN stations, and these patterns were maintained regardless of the primary lesion location. The EIs of bilateral recurrent laryngeal LNs and paracardial and left gastric LNs were still high in complete pathologic responders (ypT0) to nCRT and regardless of preoperative radiation coverage. CONCLUSION:In ESCC treated with nCRT followed by esophagectomy, the EI of LNs varied between stations. High EIs of bilateral recurrent laryngeal LNs and paracardial and left gastric LNs after nCRT revealed the importance of adequate and complete dissection of these LN stations regardless of the pathologic response to nCRT and the radiation coverage.

Background: Gallbladder cancer (GBC) is a rare and aggressive malignancy with poor prognosis and high recurrence rates, even after curative surgical resection. Early recurrence, defined as recurrence within one year after surgery, remains a major clinical concern. This study aimed to identify preoperative prognostic factors and develop a predictive model for early recurrence and overall survival in resected GBC patients. Methods: We retrospectively analyzed data from 251 patients who underwent curative-intent resection for GBC between 2008 and 2017. Logistic regression was used to identify preoperative factors associated with early recurrence. Significant variables were used to construct a nomogram, which was externally validated using a cohort of 176 patients from three independent tertiary centers. Results: The independent predictors of early recurrence included male sex, chronic liver disease, preoperative symptoms, elevated carcinoembryonic antigen (CEA), sarcopenic obesity, clinical T3 or higher stage, and suspected metastatic lymph nodes. The nomogram demonstrated strong predictive performance with an AUC of 0.872 (95% CI: 0.817-0.927) in internal validation and 0.703 (95% CI: 0.613-0.793) in external validation. Conclusions: We developed and externally validated a novel nomogram that predicts early recurrence in GBC using only preoperative factors. This model may support individualized risk assessment and aid surgeons and patients in shared decision-making prior to high-risk surgery.

The American Joint Committee on Cancer (AJCC) 8th edition and Japanese classification 12th edition can be applied for esophageal cancer staging. This retrospective study aimed to compare these two staging systems in patients with surgically treated esophageal squamous cell carcinoma (ESCC). We retrospectively reviewed 2,853 patients who underwent esophagectomy and lymphadenectomy from 1994 to 2020. Patients were divided into the upfront (n = 2156) and neoadjuvant (n = 697) groups. The mean age of the patients was 63.5 ± 8.2 years with a median follow-up of 7.6 years. Comparing both staging systems showed that patients were more likely to be staged lower by the Japanese classification. Survival curves for overall survival (OS) and disease-free survival in the upfront group were well separated in the two staging systems (p < 0.01), and the HR for survival significantly increased as the stage increased. In the neoadjuvant group, there were crossovers of survival curves between stages II and III in the AJCC, and crossovers between stages I and II, and stages III and IV in the Japanese classification. The HR for OS demonstrated less statistical differences in the neoadjuvant group. The AJCC 8th edition and Japanese classification 12th edition predicted survival well for patients received the upfront surgery, whereas both showed crossovers of survival curves for patients undergoing neoadjuvant therapy. More accurate staging systems for patients with ESCC who received neoadjuvant therapy and surgery are needed.

Background: Accurate documentation of cardiopulmonary resuscitation (CPR) is essential. However, traditional methods, particularly handwriting, often introduce errors and increase the workload of the medical staff. This study aimed to describe the process of developing a tablet application for documenting CPR and to evaluate its accuracy in comparison with a paper-based method. Methods: We organized a multidisciplinary team of medical professionals, developers, and designers. We used a participative human-centered design (HCD) approach that consisted of discovering, defining, developing and delivering solutions. We conducted a simulation study to compare the accuracy of the CPR documentation application with that of the handwriting method, focusing on documentation completeness and temporal fidelity. We evaluated the usability of the application using a System Usability Scale (SUS) and semi-structured interviews. Results: We developed the "CPReCoder" in accordance with the HCD process. The study application consists of two screens: a CPR recording screen and a reporting screen. The CPR recording screen is divided into three zones: zone 1 (patient and prehospital area), zone 2 (CPR code button area) and zone 3 (time information and log area). In the simulation study, the documentation completeness of the "CPReCoder" was significantly higher than that of the handwritten record (96.8% vs. 88.1%, p < 0.001). Both approaches exhibit comparable temporal fidelity. The SUS score of the application was 87.9 points, indicating excellent usability. According to the responses in the interviews, the main benefit of CPReCoder was its ability to reduce workload. Conclusions: We described the process of creating a CPR recording application. Use of the application resulted in a more complete documentation than the handwriting method, and its usability was excellent.

PURPOSE:Evidence for the effectiveness of intensive nutritional counseling in reducing weight loss among patients who have undergone gastrectomy for gastric cancer is limited. We evaluated the effectiveness of intensive nutritional counseling in reducing weight loss after subtotal gastrectomy. MATERIALS AND METHODS:We conducted a prospective, parallel-assigned, double-blind randomized clinical trial to assess the effectiveness of intensive counseling (IC) compared with simplified counseling (SC) in reducing weight loss among patients who underwent subtotal gastrectomy for early gastric cancer. Patients were randomly assigned to either the IC or SC group between March 2021 and February 2023, with a final follow-up in September 2024. Patients in the IC group participated in an IC program delivered by specialized clinical dietitians. Patients in the SC group received only standard counselling sessions before discharge. The primary outcome was the percentage change in body weight from baseline to 12 months after subtotal gastrectomy. RESULTS:A total of 258 patients were enrolled and randomized (122 in the IC group and 136 in the SC group), with 249 patients (96.5%) completing the 18-month follow-up period. At 12 months postgastrectomy, no statistically significant difference was observed in the percentage change in body weight between the 2 groups (0.09 percentage points; 95% confidence interval, -1.43 to 1.60). Other nutritional factors also showed no significant differences between the groups. CONCLUSIONS:Intensive nutritional counseling did not significantly reduce weight loss among gastric cancer patients after subtotal gastrectomy. Standard dietary counseling may be sufficient for dietary modification, although alternative approaches may be necessary. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT04798820.

Undifferentiated-type (UD-type) gastric cancer is associated with a high frequency of lymph node metastasis (LNM); however, recent reports indicate that LNM frequency varies according to specific histologic components. We conducted a multicenter study to define criteria for distinguishing low- and high-risk histology groups for LNM in UD-type gastric cancers. Histologic components were classified into four types: poorly cohesive signet ring cells (SRC), poorly cohesive non-signet ring cells (non-SRCs), poorly differentiated tubular (PD), and differentiated-type (D-type). Their proportions were measured semi-quantitatively. The proportion of extracellular mucin (EMC) and the predominant histologic components within EMC were also recorded. LNM risk was analyzed based on pathological findings. Overall, 2256 mucosal and 688 submucosal UD-type cancers were analyzed. A higher SRC amount was linked to lower LNM frequency. Non-SRCs showed no association with LNM. Increased PD and D-type were linked to more frequent LNM; however, PD-predominant cases (PD >= 90%) showed paradoxically lower LNM frequency. SRC proportion > 10% was essential for low LNM probability. PD or D-type proportion > 10% is important for high LNM probability. Most compositions with low LNM probability (< 5%) showed a SRC majority (SRC > 50%) and <= 10% of PD or D-type. Pure poorly cohesive carcinomas with > 10% SRC and no PD or D-type were classified as low-risk histology (LNM probability 2.6%-3.4%). We developed a risk assessment method for tumor histology based on the composition of all histologic components and defined criteria to identify low-risk histology for LNM among UD-type cancers.

Introduction/Background OPEB-01/APGOT-OV4 was a phase II clinical trial that investigated the efficacy and safety of triplet maintenance (olaparib, pembrolizumab, and bevacizumab) in BRCA wildtype, platinum-sensitive recurrent ovarian cancer. Here, we report the impact of biomarker status (PD-L1 and HRD status) on therapeutic outcomes. Methodology Patients showing a complete or partial response after second-line platinum-based chemotherapy were eligible. The primary endpoint was the 6 months progression-free survival (PFS) rate, with secondary endpoints including PFS, overall survival (OS), and safety. As pre-specified exploratory analysis, biomarkers such as PD-L1 and HRD were investigated. Results The primary endpoint was met, with 6 months PFS rate of 88.6% (95% CI 69.3–92.0). The median PFS was 22.4 months (20.4–∞), and the 12-months PFS rate of 84.0% (95% CI 69.3–92.0), indicating durable responses. Patient demographics were not different with respect to PD-L1 or HRD status. Out of 43 patients with available PD-L1 status, 28 patients had PD-L1 positive tumors (combined positive score [CPS] ≥ 1), while 15 had PD-L1 negative tumors (CPS <1). PD-L1 positive patients exhibited significantly better PFS and OS compared to the PD-L1 negative patients. Median PFS were 18.6 months (16.3 to ∞) in the PD-L1 negative and not reached (27.7 to ∞) in the PD-L1 positive group (p=0.0008). Out of 42 patients with available HRD status, 24 patients were HRD positive and 18 were negative. HRD positive patients exhibited significantly better PFS compared to the HRD negative patients. Median PFS were 27.7 months (21.2 to ∞) in the HRD positive and 21.8 (17.1 to ∞) in the HRD negative group (p=0.043). Conclusion PD-L1 positive and HRD positive status were each associated with a superior response to triplet maintenance therapy. Disclosures None.

Objectives: Advanced non-small cell lung cancer patients harboring EGFR mutation or ALK fusion have achieved significant survival benefit with targeted agents. In contrast, EGFR-wild type and ALK negative lung adenocarcinoma still have poor survival outcome. This study assessed the impact of participating in clinical trials on clinical outcomes in patients with EGFR-wild-type and ALK-negative lung adenocarcinoma. Materials and methods: This study included patients with advanced EGFR-wild-type and ALK-negative lung adenocarcinoma who received systemic treatment between March 2017 and June 2022. We compared clinical outcomes between patients who participated in clinical trials and those treated with standard-of-care (SOC) using propensity score matching (PSM). Results: Overall, 1,686 patients with EGFR-wild-type and ALK-negative advanced lung adenocarcinoma were included in the final analysis. Of these, 1,380 (81.9 %) received SOC only and 306 (18.1 %) patients were enrolled in at least one clinical trial during their cancer journey. After PSM (1:1), 612 patients were matched to the SOC (n = 306) and clinical trial (n = 306) groups. Among those who participated in clinical trials, 27.8 % and 72.2 % were included in clinical trials involving targeted therapy and immunotherapy respectively. In the clinical trial group, more patients received targeted therapy (31.7 % vs. 5.5 %, p < 0.001) and immunotherapy (88.6 % vs. 62.8 %, p < 0.001) compared to the SOC group. The median overall survival was 17.1 months (95 % confidence interval [CI], 13.2-21.4) in the SOC group and 27.3 months (95 % CI, 22.1-32.4) in the clinical trial group (hazard ratio = 0.71, [95 % CI, 0.58-0.88, P = 0.002]). Conclusions: This study demonstrated that participating in clinical trials resulted in a survival benefit that reduced the risk of death by 29.6% compared to receiving SOC in EGFR-wild-type and ALK-negative lung adenocarcinoma.