Asia-Pacific journal of clinical oncology最新文献

{"title":"Clinical Efficacy and Influencing Factors of Apatinib Combined With Sintilimab in the Treatment of Advanced Non-Small-Cell Lung Cancer.","authors":"Yuan Zhang, Jiao Zhang","doi":"10.1111/ajco.70165","DOIUrl":"https://doi.org/10.1111/ajco.70165","url":null,"abstract":"<p><strong>Background: </strong>Most advanced non-small cell lung cancer (NSCLC) patients develop drug resistance after first-line treatment with limited subsequent options. Apatinib plus Sintilimab has therapeutic potential, but clinical evidence is scattered, and key factors like PD-L1 expression and gene mutations remain undefined.</p><p><strong>Objective: </strong>Objective to explore the clinical efficacy of Apatinib combined with Sintilimab in the treatment of advanced NSCLC, and analyze the related factors affecting the efficacy, so as to provide reference for the formulation of clinical individualized treatment plan.</p><p><strong>Method: </strong>This study is a retrospective clinical study. 336 patients with advanced NSCLC treated in the Department of oncology of our hospital from May 2018 to May 2022 were selected. All patients received the combination therapy of Apatinib and Sintilimab. The observation indexes included the following main efficacy indexes: objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS). The influencing factors were analyzed by univariate analysis (log rank test) and multivariate Cox proportional hazards regression model.</p><p><strong>Result: </strong>Results demonstrated that the ORR reached 34.5%, DCR was 72.6%, median PFS was 6.6 months (95% CI: 6.420-6.580), and median OS was 12.6 months (95% CI: 12.336-13.264). Univariate and multivariate Cox regression analyses verified that ECOG PS score of 0-1 and PD-L1 positivity were independent favorable prognostic factors for PFS and OS, whereas TNM stage IV, prior immunotherapy, EGFR mutation, and brain metastasis were independent unfavorable prognostic factors. Regarding safety, most adverse events were Grade 1-2, with fatigue being the most common, and no treatment-related mortality was observed.</p><p><strong>Conclusion: </strong>Apatinib plus Sintilimab in advanced NSCLC yields ORR 34.5% and DCR 72.6% with manageable safety. Favorable predictors: ECOG PS 0-1, Stage IIIB, and PD-L1+. Poor PFS/OS predictors: prior immunotherapy, EGFR mutation, and brain metastasis.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Population-Based Evaluation of Quality Indicators for Uterine Cancer Care in Queensland, 2013-2022.","authors":"Danny R Youlden, Helen Hunt, Karen Sanday, Nathan A Dunn, Penelope M Webb, Neal Rawson, Victoria Donoghue","doi":"10.1111/ajco.70167","DOIUrl":"https://doi.org/10.1111/ajco.70167","url":null,"abstract":"<p><strong>Aim: </strong>To evaluate how diagnostic procedures, treatments, access, and outcomes for uterine cancer have evolved over the last decade using real-world data.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted. Unit record data were sourced from the population-based Queensland Oncology Repository. Eighteen quality indicators were investigated. Patients with uterine cancer were stratified into two groups according to year of diagnosis (2013-2017 and 2018-2022). Poisson regression and multivariable flexible parametric survival modeling were used to evaluate changes over time, adjusted for key demographic and clinical characteristics.</p><p><strong>Results: </strong>The study cohort consisted of 5423 patients. Sentinel lymph node biopsy among patients who had a definitive resection increased dramatically from 14% to 61% (relative likelihood [RL] = 4.24, 95% CI 3.76-4.79; p < 0.001). Use of laparoscopic procedures also increased significantly for both Stages I/II (RL = 1.12, 95% CI 1.08-1.15; p < 0.001) and Stages III/IV (RL = 1.48, 95% CI 1.30-1.68; p < 0.001). The percentage of uterine cancer patients who received a definitive resection within 30 days of diagnosis fell from 56% to 51% (RL = 0.92, 95% CI 0.88-0.97; p = 0.001), with Aboriginal and Torres Strait Islander women faring worse (29%). There was no significant difference in the likelihood of dying within five years of definitive resection by period of diagnosis (adjusted hazard ratio = 0.87, 95% CI 0.74-1.03; p = 0.11).</p><p><strong>Conclusion: </strong>Our results have the dual purpose of highlighting opportunities for improvement while also providing benchmarks for the evaluation of uterine cancer care in Queensland into the future.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Selective, Rather Than Universal, Omission of Sentinel Lymph Node Biopsy in Encapsulated Papillary Carcinoma of the Breast.","authors":"Rıza Deryol","doi":"10.1111/ajco.70162","DOIUrl":"https://doi.org/10.1111/ajco.70162","url":null,"abstract":"","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring Long Noncoding RNA CASC11 as a Biomarker for Bladder Cancer Detection.","authors":"Huarong Luo, Chengdang Xu, Shengtong Huang, Tianru Wang, Yan Gu","doi":"10.1111/ajco.70139","DOIUrl":"https://doi.org/10.1111/ajco.70139","url":null,"abstract":"<p><strong>Objectives: </strong>Long noncoding RNAs (lncRNAs) exhibit dysregulated expression in various cancers, influencing cancer progression. Many lncRNAs are encapsulated in exosomes, impacting cancer development. However, the specific role of exosomal lncRNAs in bladder cancer remains unclear. This study aimed to investigate the expression of lncRNA CASC11 in bladder cancer.</p><p><strong>Methods: </strong>RNA-seq and bioinformatics analyses were performed to identify the differentially expressed lncRNAs in human bladder cancer tissues. The expression of lncRNA CASC11 in bladder cancer tissues was detected. Quantitative real-time PCR (qRT-PCR) was used to detect the expression of lncRNA CASC11 in the urine exosomes of patients with bladder cancer before and after treatment. Western blotting assay was performed to identify protein markers of exosomes.</p><p><strong>Results: </strong>LncRNA CASC11 was prominently upregulated in bladder cancer tissues (p < 0.05). Expression of exosomal lncRNA CASC11 in patients with bladder cancer was significantly increased compared with the healthy control group (p < 0.05). Both exosomes and exosomal lncRNA CASC11 levels in bladder cancer increased gradually with the deepening of tumor stage (p < 0.05).</p><p><strong>Conclusions: </strong>The expression level of lncRNA CASC11 in bladder cancer tissues was upregulated, while exosomal lncRNA CASC11 was elevated in patients with bladder cancer. These findings suggest that exosomal lncRNA CASC11 may serve as a potential noninvasive biomarker for bladder cancer detection and postoperative monitoring.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consolidative Radiotherapy After Gemcitabine-Platinum Chemotherapy in De Novo Metastatic Nasopharyngeal Carcinoma: Impact of Chemotherapy Backbone and Prognostic Factors on Survival.","authors":"Joyce L Y Wan, James C H Chow","doi":"10.1111/ajco.70159","DOIUrl":"https://doi.org/10.1111/ajco.70159","url":null,"abstract":"<p><strong>Introduction: </strong>De novo metastatic nasopharyngeal carcinoma (NPC) has a poor prognosis despite modern chemotherapy. Gemcitabine-cisplatin is the standard chemotherapy backbone, whereas carboplatin is commonly used as a cisplatin alternative for its better tolerability. This study evaluated high-dose locoregional radiotherapy (LRRT) after standardized gemcitabine-platinum chemotherapy and identified prognostic factors for patient selection.</p><p><strong>Methods: </strong>This retrospective study included patients with de novo metastatic NPC treated at two Hong Kong tertiary centers (2014-2024) with first-line gemcitabine-platinum chemotherapy followed by high-dose LRRT (≥60 Gy). Baseline characteristics, treatment details, toxicities, and outcomes were collected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method, and prognostic factors were evaluated with log-rank tests and multivariable Cox regression.</p><p><strong>Results: </strong>Sixty-six patients were included (median age 58 years; 83.3% male). At diagnosis, 27.3% had liver metastases and 83.8% had >1 metastatic lesion. Most (81.8%) completed six chemotherapy cycles (56.1% gemcitabine-cisplatin; 42.4% gemcitabine-carboplatin). LRRT completion rate was 93.9%. The rates of grade 3 dermatitis and mucositis were 18.2% and 7.6%. Two treatment-related deaths were recorded. At a median follow-up of 42 months, median PFS and OS were 6.8 and 22.3 months, respectively; distant progression was the predominant failure pattern (71.2%). On multivariable analysis, liver metastasis and gemcitabine-carboplatin use independently predicted poorer PFS, while gemcitabine-carboplatin and >1 metastatic lesion portended poorer OS.</p><p><strong>Conclusion: </strong>High-dose LRRT after gemcitabine-platinum was feasible with acceptable toxicity but yielded modest PFS in an unselected population of de novo metastatic NPC, with outcomes strongly influenced by metastatic burden, liver involvement, and platinum choice. Gemcitabine-cisplatin remains the preferred chemotherapy backbone, and LRRT may be best reserved for carefully selected patients in the contemporary chemo-immunotherapy era.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148759254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Outcomes of Consolidation Durvalumab After Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Retrospective Cohort Study From Vietnam.","authors":"Hau Thi Tran, Kien Hung Do, Huong T T Nguyen, Hoa T N Nguyen, Phuong T B Nguyen, The Minh Dao, Tai Van Nguyen, Tuan Anh Nguyen, Hang Nguyet Doan, Ngoc Bao Hoang","doi":"10.1111/ajco.70148","DOIUrl":"https://doi.org/10.1111/ajco.70148","url":null,"abstract":"<p><strong>Introduction: </strong>Durvalumab administered after definitive chemoradiotherapy has changed the treatment landscape for patients with unresectable stage III non-small cell lung cancer (NSCLC). Evidence describing treatment outcomes in routine clinical settings, particularly in Southeast Asian populations, remains relatively limited.</p><p><strong>Methods: </strong>We performed a retrospective cohort study at the Vietnam National Cancer Hospital including consecutive patients treated with consolidation durvalumab following concurrent chemoradiotherapy between March 2021 and June 2025. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and safety. Prespecified subgroup analyses evaluated outcomes according to age, molecular alteration status, and timing of durvalumab initiation.</p><p><strong>Results: </strong>Seventy-nine patients were analyzed, with a median follow-up of 32.9 months (95% CI: 30.9-37.0 months). The mean age was 59.5 ± 9.3 years, and 79.7% were male; 60.7% were current or former smokers with an ECOG 0. Non-squamous histology accounted for 81% of cases, and EGFR or ALK alterations were identified in 27.8%. The ORR was 32.9%. Median PFS was 29.8 months, while median OS was not reached. Older patients showed longer PFS than younger patients (33.0 vs. 15.1 months; p = 0.13). EGFR or ALK alterations were associated with significantly shorter PFS (8.33 vs. 39.65 months; p = 0.009). Morning initiation of durvalumab was associated with numerically longer PFS than afternoon administration (39.65 vs. 16.38 months; p = 0.34). Multivariable analysis identified mutation status as independently associated with PFS, with no significant predictors for OS. Grade 3-5 adverse events occurred in 5.1% of patients, and treatment discontinuation was reported in 8.9%.</p><p><strong>Conclusion: </strong>In this real-world cohort, consolidation durvalumab showed encouraging clinical outcomes with acceptable safety in patients with unresectable stage III NSCLC.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148696966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evolving Trends in Laryngeal Cancer Mortality in the United States, 1999-2024: A Population-Based Analysis With Subgroup Stratified Trends through 2020.","authors":"Aryan Tareen, Anoud Khan, Saqib Raza Khan, Muhammad Faez Tahir, Fatima Ibrahim Ahmed, Imaan Shoaib Mufti, Maryam Karam, Rija Tahir, Rinad Akhtar, Muntaha Irfan, Riham Zubair","doi":"10.1111/ajco.70152","DOIUrl":"https://doi.org/10.1111/ajco.70152","url":null,"abstract":"<p><strong>Background: </strong>Laryngeal cancer (LC) represents one-third of all head and neck cancers, with global deaths rising by 36.7% between 1990 and 2021. Although mortality has declined over the past two decades, recent data indicate a potential slowdown in this progress. This study evaluated temporal trends in laryngeal cancer mortality in the United States.</p><p><strong>Methods: </strong>LC mortality data from 1999 to 2024 were obtained from the CDC WONDER database. Age-adjusted mortality rates (AAMRs) per 100,000 population and annual percentage changes (APCs) with 95% confidence intervals (CIs) were calculated using Joinpoint regression analysis to assess temporal trends.</p><p><strong>Results: </strong>Between 1999 and 2024, 129,275 LC-related deaths were recorded in the United States. The overall age-adjusted mortality rate (AAMR) declined from 3.76 to 2.25 per 100,000, with a significant decrease from 1999-2016 (APC: -2.75%; 95% CI, -2.92 to -2.58; p < 0.001), followed by a non-significant change from 2016-2024 (APC: -0.38%; 95% CI, -0.87 to 0.11; p = 0.12). Mortality was consistently higher in males than females, declining from 7.00 to 3.94 and 1.40 to 0.85 per 100,000, respectively. In 1999-2020 analyses, NH-Black individuals had the highest mortality, followed by NH-American Indian or Alaska Native and NH-White populations, with significant declines across all racial/ethnic groups (p < 0.001). Highest state-level AAMRs were observed in Kentucky, West Virginia, Louisiana, Tennessee, Ohio, and the District of Columbia (reported separately as a federal district). Mortality declined across all age groups and was consistently higher in non-metropolitan than metropolitan areas (all trend tests p < 0.05).</p><p><strong>Conclusion: </strong>LC mortality in the United States has declined since 1999, but the rate of decline has slowed in recent years. Marked disparities persist by sex, race/ethnicity, age, and geographic region, with higher mortality in males, NH-Black individuals, older adults, and non-metropolitan areas. These findings underscore the need for continued surveillance and targeted interventions.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148672980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Role of Tonsillectomy in Cervical Squamous Cell Carcinoma With Unknown Primary in Human Papillomavirus-Negative Patients: A Prospective Observational Study.","authors":"Prateek V Jain, Bibek Khanal, Vikram Kekatpure, Kapila Manikantan, Gurucharan Sahu, Sanjoy Chatterjee, Indranil Mallick, Pattatheyil Arun","doi":"10.1111/ajco.70150","DOIUrl":"https://doi.org/10.1111/ajco.70150","url":null,"abstract":"<p><strong>Introduction: </strong>Management of cervical squamous cell carcinoma with unknown primary (SCCUP) continues to evolve with emphasis on tonsillectomy for identification of the primary. While the data from an HPV positive population is compelling, surgical ablation of potential primary sites in the oropharynx with the goal of identifying the primary in HPV negative tumors is debated.</p><p><strong>Methods: </strong>In this prospective observational study, 21 patients with SCCUP underwent bilateral tonsillectomy in an attempt to identify a possible site of primary.</p><p><strong>Results: </strong>Median age of this cohort was 59 years (39-74 years). Two of twenty patients were p16 positive. Only 1 patient (p16 positive) revealed a primary in the tonsil. Fifteen patients received adjuvant concurrent chemoradiation (CTRT), whereas two patients received adjuvant radiotherapy (RT). Median follow up was 17.6 months (0.26-60 months). The 2-year overall and disease-free survival rates were 81.5% (52.6%-93.7%) and 70.1% (42.1%-86.4%), respectively. No patient evinced mucosal recurrence.</p><p><strong>Conclusions: </strong>Prevalence of human papilloma virus in patients with SCCUP is very low in India. Role of bilateral tonsillectomy to identify primary lesion in p16 negative patients is questionable.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148668265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Healthcare Utilization and Out-of-Pocket Expenditure Among Adults With and Without Cancer in Korea-Analysis of the Korea Health Panel Survey.","authors":"Durga Datta Chapagain, Vasuki Rajaguru, Do Hee Kim, Tae Hyun Kim, Whiejong M Han","doi":"10.1111/ajco.70142","DOIUrl":"https://doi.org/10.1111/ajco.70142","url":null,"abstract":"<p><strong>Background: </strong>Cancer imposes substantial clinical and financial burdens worldwide. Although Korea operates a universal National Health Insurance system, concerns remain regarding healthcare utilization and out-of-pocket (OOP) costs among cancer patients. This study compared healthcare utilization and OOP expenditure between adults with and without cancer in Korea and quantified adjusted differences associated with cancer.</p><p><strong>Methods: </strong>Data were obtained from the 2023 Korea Health Panel Survey and included adults aged ≥ 19 years. Healthcare utilization outcomes included outpatient visits, hospitalizations, emergency visits, total health encounters. OOP expenditures included inpatient, outpatient, emergency, pharmacy, and total annual healthcare expenditure. Survey-weighted Poisson or negative binomial regression models and generalized linear models with gamma distribution and log link were used to estimate adjusted differences in healthcare utilization and OOP expenditures associated with cancer status after controlling for sociodemographic, socioeconomic, behavioral, insurance-related, and clinical covariates.</p><p><strong>Results: </strong>Among 10,911 participants, 626 (5.7%) reported a history of cancer and 10,285 (94.3%) had no history of cancer. Mean annual healthcare utilization was significantly higher among participants with cancer than those without cancer including hospitalization (0.78 vs. 0.19), outpatient visits (32.93 vs. 18.59), emergency visits (0.20 vs. 0.11), and total utilization (33.91 vs. 18.89) Cancer was independently associated with an adjusted difference of 8.93 total visits, 0.49 hospitalizations, 8.36 outpatient visits, and 0.08 emergency visits annually (all p < 0.001). OOP expenditure was substantially higher among cancer patients ($1,828 vs. $676; p < 0.001), with significant adjusted differences in total OOP expenditure ($917), inpatient ($639), outpatient ($224), and pharmacy ($53). Lung ($2453), cervical ($1341), colorectal ($1113), and other cancers ($1201) showed the highest expenditure.</p><p><strong>Conclusion: </strong>Cancer is associated with markedly greater healthcare utilization and significant OOP expenditure burden despite Korea's National Health Insurance (NHI) coverage. Strengthening financial protection, expanding coverage for high-cost care, reinforcing OOP caps, and supporting vulnerable households are essential. Future longitudinal studies incorporating cancer stages, treatment pathways, and indirect costs are warranted.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148652961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Established Prognostic Scores Predict Screen Failure But Not Post-Enrollment Outcomes in Phase 1 Oncology Trials: A Single Centre Retrospective Audit.","authors":"Ortis Estacio, Eve Malsem, Georgia McGuiness, Megan Kesper, Hui Gan, Damien Kee, Sagun Parakh, Sarah Healy, Andrew Weickhardt","doi":"10.1111/ajco.70151","DOIUrl":"https://doi.org/10.1111/ajco.70151","url":null,"abstract":"<p><strong>Background: </strong>Real-world safety and outcome data from Phase 1 trial populations-including screen failures-remain limited. We conducted a retrospective audit to evaluate the predictive utility of established Phase 1 prognostic scores for screen failure and post-enrollment outcomes, and to describe safety and clinical outcomes in a contemporary cohort.</p><p><strong>Methods: </strong>A single-center retrospective audit was conducted of patients screened for Phase 1 trials between January 2020 and December 2024. Data were collected from electronic medical records, including demographics, comorbidities, enrollment outcomes, treatment regimens, toxicity, trial discontinuation, and survival.</p><p><strong>Results: </strong>Of 165 patients screened, 34 (20.6%) did not enroll. All 131 enrolled patients commenced treatment. Median age was 61 (range: 27-83) years, with predominantly good performance status (ECOG ≤ 1 = 99.2%). Most received immunotherapy-based regimens (74.0%), with combination regimens slightly more common than monotherapy. The overall objective response rate for patients who had an assessable response was 21.1% (27/128). For the 15 patients who received an antibody drug conjugate, the objective response rate was 46.7%. Unplanned admissions within 90 days of treatment occurred in 43 patients (32.8%), though only 8.3% were treatment-related. Unplanned admissions within 30 days occurred in 26/131 patients (19.8%). Disease progression was the main reason for trial discontinuation (79.8%), with toxicity accounting for 10.0%. Subsequent therapy was received by 45%. Median overall survival was 12.6 months (95% CI 9.5, 16.7), with 13.0% of patients dying within 90 days of treatment initiation and no deaths were attributed to treatment toxicity. Age was not associated with 90-day mortality, early admissions, or screen failure. Established prognostic scores in the Phase 1 trial setting (Royal Marsden, MD Anderson-ICI, and Gustave Roussy immune score) predicted screen failure but not post-enrollment outcomes.</p><p><strong>Conclusions: </strong>Treatment-related toxicity and mortality were uncommon in this real-world Phase 1 cohort, and outcomes were driven by disease progression. Prognostic scores predicted screen failures but not clinical outcomes suggesting their utility lies in screening rather than stratification. These findings support the safety and feasibility of Phase 1 trials in appropriately selected patients.</p>","PeriodicalId":8633,"journal":{"name":"Asia-Pacific journal of clinical oncology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}