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A comparative analysis of Palbociclib and Ribociclib in metastatic hormone receptor-positive, HER2-negative breast cancer: a prospective mid term follow-Up study from an Indian cohort. Palbociclib和Ribociclib在转移激素受体阳性,her2阴性乳腺癌中的比较分析:一项来自印度队列的前瞻性中期随访研究。
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-18 DOI: 10.1186/s12885-025-14270-1
Nihanthy D Sreenath, Suresh Pandalanghat, Amul Kapoor, Rajath Govind, M R Kaushik, Rajesh Nair, Dipen Bhuva, Anvesh Rathore, Manish Kumar, Deepak Mulajker
{"title":"A comparative analysis of Palbociclib and Ribociclib in metastatic hormone receptor-positive, HER2-negative breast cancer: a prospective mid term follow-Up study from an Indian cohort.","authors":"Nihanthy D Sreenath, Suresh Pandalanghat, Amul Kapoor, Rajath Govind, M R Kaushik, Rajesh Nair, Dipen Bhuva, Anvesh Rathore, Manish Kumar, Deepak Mulajker","doi":"10.1186/s12885-025-14270-1","DOIUrl":"10.1186/s12885-025-14270-1","url":null,"abstract":"<p><strong>Introduction: </strong>Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, such as Palbociclib and Ribociclib, have significantly improved outcomes for patients with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer. Although clinical trials have established the efficacy of these agents globally, real-world data from India is limited. This study compares the clinical effectiveness and safety profiles of Palbociclib and Ribociclib in a cohort of Indian patients.</p><p><strong>Materials and methods: </strong>This prospective study included 60 patients with metastatic HR+/HER2- breast cancer treated at Army hospitals and research centers in India between 2020 and 2023. Progression-free survival (PFS), overall survival (OS), and safety profiles were analyzed to assess the real-world performance of Palbociclib and Ribociclib. Patients were treated with either Palbociclib or Ribociclib in combination with standard endocrine therapy.</p><p><strong>Results: </strong>Among the 60 patients, the median PFS was 39.40 months for the Palbociclib group and 42.93 months for the Ribociclib group (p = 0.26), indicating no statistically significant difference. The median OS was 41.98 months in the Palbociclib group and 45.51 months in the Ribociclib group (p = 0.15), with Ribociclib showing a slight but non-significant survival advantage. The most common adverse event was neutropenia, which occurred in 26% of patients receiving Palbociclib and 23% of patients on Ribociclib. Deranged liver function tests (LFTs) and fatigue were also reported in both groups.</p><p><strong>Conclusions: </strong>Palbociclib and Ribociclib demonstrated comparable efficacy and safety profiles in this Indian cohort. While no statistically significant differences in PFS or OS were observed, the data suggest a marginal survival benefit with Ribociclib. These findings underscore the importance of individualized treatment plans in HR+/HER2- breast cancer, taking into consideration patient-specific factors. Larger studies with longer follow-up are needed to further clarify the nuances between these two agents.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1337"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12362974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Predicting cancer mortality using machine learning methods: a global vs. Iran analysis. 使用机器学习方法预测癌症死亡率:全球vs伊朗分析。
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-18 DOI: 10.1186/s12885-025-14796-4
Hossein Sadeghi, Fatemeh Seif
{"title":"Predicting cancer mortality using machine learning methods: a global vs. Iran analysis.","authors":"Hossein Sadeghi, Fatemeh Seif","doi":"10.1186/s12885-025-14796-4","DOIUrl":"10.1186/s12885-025-14796-4","url":null,"abstract":"<p><strong>Background: </strong>Cancer remains a leading cause of morbidity and mortality worldwide, with significant variations in incidence, mortality, and survival rates across regions. This study leverages Machine Learning (ML) to analyze global and Iran-specific cancer data, aiming to improve predictive accuracy for cancer mortality.</p><p><strong>Methods: </strong>Using datasets from Global Cancer Observatory (GLOBOCAN) and the Iran National Cancer Registry (INCR), we evaluate the performance of ML models, including XGBoost, Random Forest, and Support Vector Machines, in predicting cancer outcomes.</p><p><strong>Results: </strong>XGBoost achieved superior performance globally ([Formula: see text] = 0.83, AUC-ROC = 0.93) compared to Iran-specific data ([Formula: see text] = 0.79, AUC-ROC = 0.89), highlighting the influence of region-specific risk factors such as Helicobacter pylori infections in Ardabil. Additionally, we explore the application of ML in predicting Second Primary Cancer (SPC) risk, emphasizing the role of radiation dose, age, and genetic mutations as key predictors.</p><p><strong>Conclusion: </strong>This research underscores the potential of ML to inform personalized treatment plans and improve cancer care while addressing challenges such as data imbalances and regional disparities. The findings provide valuable insights for policymakers, researchers, and healthcare providers in developing targeted interventions to reduce the global cancer burden.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1329"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12359947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The efficacy and safety of immune combination therapy in patients with driver gene-negative non-small cell lung cancer with liver metastasis: a systematic review and network meta-analysis. 免疫联合治疗驱动基因阴性非小细胞肺癌伴肝转移患者的疗效和安全性:系统综述和网络荟萃分析
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-18 DOI: 10.1186/s12885-025-14712-w
Weixing Zhao, Bo Li, Yujia Gu, Xiaoni Jin, Zirui Li, Wanjing Guo, Xinxin Lu, Jun Jiang
{"title":"The efficacy and safety of immune combination therapy in patients with driver gene-negative non-small cell lung cancer with liver metastasis: a systematic review and network meta-analysis.","authors":"Weixing Zhao, Bo Li, Yujia Gu, Xiaoni Jin, Zirui Li, Wanjing Guo, Xinxin Lu, Jun Jiang","doi":"10.1186/s12885-025-14712-w","DOIUrl":"10.1186/s12885-025-14712-w","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to systematically evaluate the efficacy and safety of combination therapies with immune checkpoint inhibitors (ICIs) in patients with driver gene-negative non-small cell lung cancer (NSCLC) and liver metastases. These patients typically have poor prognosis and limited responses to immunotherapy. This study synthesized existing literature by conducting a network meta-analysis to determine the most effective first-line ICI combination regimen to guide clinical treatment decisions.</p><p><strong>Methods: </strong>We systematically searched the PubMed, Embase, Web of Science, and Cochrane Library databases for Phase III randomised controlled trials published up to 1 August 2024. Eligible studies underscored on patients with driver gene-negative NSCLC with liver metastases and reported progression-free survival (PFS), overall survival (OS), and treatment-related adverse events. Bayesian network meta-analysis was conducted using R (version 4.4.1) and STATA (version 17), with the results reported as hazard ratios (HRs) and 95% confidence intervals (CIs).</p><p><strong>Results: </strong>Fourteen studies including 1,291 patients and 11 ICIs combination regimens were included. Pembrolizumab plus chemotherapy remarkably improved OS (HR, 0.64; 95% CI, 0.41-0.98). For PFS, tislelizumab plus chemotherapy (HR, 0.44; 95% CI, 0.26-0.74) and pembrolizumab plus chemotherapy (HR, 0.59; 95% CI, 0.39-0.90) were superior to other treatments. PD-1 inhibitors, such as pembrolizumab, combined with chemotherapy have shown greater efficacy than PD-L1 inhibitors, particularly for non-squamous cell carcinoma. High-grade adverse events, including hepatotoxicity, were more frequent in patients with liver metastases.</p><p><strong>Conclusion: </strong>ICI-chemotherapy combinations offer a promising first-line treatment for driver gene-negative NSCLC with liver metastases. The pembrolizumab and tislelizumab combination demonstrated improved OS and PFS with distinct efficacy and safety profiles. Enhanced monitoring of liver function is recommended because of the risk of hepatotoxicity. Further studies are needed to confirm these findings and optimise individualised treatment strategies.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1332"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12359923/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring the mutational spectrum of key kinase genes PIK3CA, BRAF, EGFR, ALK and ROS1 in oral squamous cell carcinoma. 探讨口腔鳞状细胞癌中关键激酶基因PIK3CA、BRAF、EGFR、ALK和ROS1的突变谱。
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-18 DOI: 10.1186/s12885-025-14609-8
Fouzia Nawab, Wafa Naeem, Sadia Fatima, Asif Ali, Ali Talha Khalil, Aamir Mehmood, Muhammad Fazeel, Hilal Ahmad, Mohammed Alorini, Muslim Khan, Ishtiaq Ahmad Khan, Muhammad Irfan, Syed Ali Khurram
{"title":"Exploring the mutational spectrum of key kinase genes PIK3CA, BRAF, EGFR, ALK and ROS1 in oral squamous cell carcinoma.","authors":"Fouzia Nawab, Wafa Naeem, Sadia Fatima, Asif Ali, Ali Talha Khalil, Aamir Mehmood, Muhammad Fazeel, Hilal Ahmad, Mohammed Alorini, Muslim Khan, Ishtiaq Ahmad Khan, Muhammad Irfan, Syed Ali Khurram","doi":"10.1186/s12885-025-14609-8","DOIUrl":"10.1186/s12885-025-14609-8","url":null,"abstract":"<p><p>Oral Squamous Cell Carcinoma (OSCC) is the sixth most aggressive type of oral cancer. Mutations in cancer-driving genes such as protein kinase are well known in cancer progression. We selected candidate genes (PIK3CA, BRAF, EGFR, ALK, and ROS1) for mutations exploration in the OSCC patients belonging to Khyber Pakhtunkhwa (KP) through Next Generation-Whole Exome Sequencing (NG-WES) using Formalin Fixed Paraffin Embedded (FFPE) tissue blocks (27 tumor and 7 paired normal) for the 1st time followed by in-silico characterization. A total of 33 mutations were identified which constituted 28/33 (84.84%) SNVs, 4/33 (12.12%) frameshift deletions and 1/33 (3.03%) stop-gain mutation. While, of the 33 mutations, 12.6% (4/33) were novel and had not been previously reported in public mutation databases such as COSMIC or dbSNP. Among the total somatic mutations (24/33; 72.72%), 08/33 mutations were observed in multiple patients. Mutations of the ALK i.e. ALK<sup>p.I1461V</sup>, ALK<sup>p.K1491R</sup> and ALK<sup>p.D1529E</sup> were found in 27/27, 21/27 and 20/27 tumor samples and hence can have potential biomarker applications. ISPRED-SEQ identified 07/33 interaction site mutations i.e. EGFR<sup>p.R521K</sup>, EGFR<sup>p.R831C</sup>, ROS1<sup>p.S2229C</sup>, ROS1<sup>p.E1902K</sup>, ROS1<sup>p.K2228Q</sup>, ROS1<sup>p.D2213N</sup>, and ROS1<sup>p.P221S</sup>. SAAFEQ-SEQ predictions revealed that (28/29; 96.5%) SNVs destabilize protein except for ROS1<sup>p.D2213N</sup>. ConSurf predictions indicated 17.3% (5/33) mutations (e.g., ROS1<sup>p.N2240K</sup> (score 9) and ROS1<sup>p.L567V</sup> (score 8), as highly conserved, likely disrupting kinase function and stability, unlike variable mutations with milder effects. MD simulations for interacting sites (IS) SNVs revealed structural deviations, with mutant proteins revealing larger gyration radius and fluctuations in root mean square deviation (RMSD) studies indicating a disrupted folding behavior. To conclude, we identified potential mutations on ROS1 that can have potential biomarker applications, however, we recommend studies in large Pakhtun cohorts in KP, Pakistan.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1333"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12359856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
TOPK promotes immune suppression in kidney renal clear cell carcinoma and emerges as a prognostic and therapeutic target. TOPK促进肾透明细胞癌的免疫抑制,并成为预后和治疗靶点。
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-18 DOI: 10.1186/s12885-025-14665-0
Zeyuan Zheng, Renhui Xiong, Xiuyuan Sui, Liyan Li, Huimin Sun, Chen Shao
{"title":"TOPK promotes immune suppression in kidney renal clear cell carcinoma and emerges as a prognostic and therapeutic target.","authors":"Zeyuan Zheng, Renhui Xiong, Xiuyuan Sui, Liyan Li, Huimin Sun, Chen Shao","doi":"10.1186/s12885-025-14665-0","DOIUrl":"10.1186/s12885-025-14665-0","url":null,"abstract":"","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1334"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12359846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Spatially resolved analysis of TGF/BMP signalling in pancreatic ductal adenocarcinoma by digital pathology identifies patient subgroups with adverse outcome. 数字病理学对胰腺导管腺癌中TGF/BMP信号的空间分辨分析确定了不良结局的患者亚组。
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-18 DOI: 10.1186/s12885-025-14751-3
Konstantin Bräutigam, Philipp Zens, Stefan Reinhard, Jessica L Rohrbach, Simon J Leedham, Anna S Wenning, Beat Gloor, Viktor H Koelzer, Martin Wartenberg
{"title":"Spatially resolved analysis of TGF/BMP signalling in pancreatic ductal adenocarcinoma by digital pathology identifies patient subgroups with adverse outcome.","authors":"Konstantin Bräutigam, Philipp Zens, Stefan Reinhard, Jessica L Rohrbach, Simon J Leedham, Anna S Wenning, Beat Gloor, Viktor H Koelzer, Martin Wartenberg","doi":"10.1186/s12885-025-14751-3","DOIUrl":"10.1186/s12885-025-14751-3","url":null,"abstract":"<p><strong>Background: </strong>Transforming Growth Factor (TGF) and Bone Morphogenetic Protein (BMP) signalling critically influence pancreatic ductal adenocarcinoma (PDAC) progression, with TGF-B paradoxically exerting both tumour-promoting and -suppressive effects. Parallel to this observation, the specific context-dependent, spatial dynamics of these pathways and their interaction with the tumour microenvironment (TME) remain poorly understood.</p><p><strong>Methods: </strong>We performed a spatially resolved analysis of PDAC on a multi-region tissue microarray cohort of 117 curatively resected PDAC specimens consisting of tumour centre (TC), tumour front (TF), and stromal(-predominant) tissue cores each. Protein (ID1, pSMAD2) and mRNA (TGF-A, TGF-B1/2, BMP4, GREM1) expression were assessed in each tissue compartment by immunohistochemistry and in situ hybridization, respectively, quantified by digital image analysis, and correlated with clinicopathologic features.</p><p><strong>Results: </strong>ID1 was significantly overexpressed in PDAC cells compared to associated stroma (p < 0.01), while pSMAD2 was largely absent in PDAC cells, but preserved among associated stroma compartments, particularly in TF cores (p = 0.04). Higher stromal GREM1 signal correlated with reduced overall tumoural ID1 protein expression (p = 0.02), and TGF-B2<sup>high</sup>/TGF-A<sup>low</sup> stroma was significantly associated with worse survival (p < 0.01). Intratumoural TGF-B2 was inversely correlated with stromal pSMAD2 expression (p = 0.03) and was associated with lymph node involvement (p = 0.02). FOXP3<sup>+</sup> regulatory T-cells were significantly reduced in TGF-B2<sup>high</sup> tumours (p = 0.04), while higher tumoural TGF-B1 exhibited a trend towards increased FOXP3<sup>+</sup> cells (p = 0.08).</p><p><strong>Conclusions: </strong>Our spatial analysis reveals intratumoural heterogeneity of TGF/BMP signalling and its significance for PDAC progression. Notably, stromal TGF-B2 emerges as a prognostic biomarker, while TGF-B1 and ID1 are implicated in adverse clinical and pathologic features. These findings highlight the importance of TGF/BMP signalling niches in the TME with implications for PDAC biology and can inform the development of future therapeutic strategies.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1327"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12359875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of ovarian function suppression on prognosis in premenopausal patients with HR+/HER2 + early-stage breast cancer: a multi-center retrospective study. 卵巢功能抑制对绝经前HR+/HER2 +早期乳腺癌患者预后的影响:一项多中心回顾性研究
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-18 DOI: 10.1186/s12885-025-14774-w
Weibin Lian, Liangqiang Li, Chengye Hong, Debo Chen
{"title":"Impact of ovarian function suppression on prognosis in premenopausal patients with HR+/HER2 + early-stage breast cancer: a multi-center retrospective study.","authors":"Weibin Lian, Liangqiang Li, Chengye Hong, Debo Chen","doi":"10.1186/s12885-025-14774-w","DOIUrl":"10.1186/s12885-025-14774-w","url":null,"abstract":"<p><strong>Background: </strong>The impact of adjuvant ovarian function suppression (OFS) in premenopausal patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+) breast cancer remains unclear. The study aims to evaluate the value of OFS for patients with HR+/HER2 + early-stage breast cancer treated with trastuzumab.</p><p><strong>Methods: </strong>Kaplan-Meier curves and the log-rank test were used to compare disease-free survival (DFS). Univariate and multivariate Cox regression analyses were performed to identify significant prognostic factors. Multivariable logistic regression model was used to predict the utilization of OFS.</p><p><strong>Results: </strong>A total of 1,338 patients from multiple centers were enrolled, including 570 who received OFS treatment. Patients treated with selective estrogen receptor modulators (SERM) or aromatase inhibitors (AI) plus OFS as adjuvant endocrine therapy showed significantly better DFS compared to those who received SERM alone (HR = 0.496; 95% CI: 0.307-0.803; p = 0.004). Univariate and multivariate Cox regression analysis further confirmed that receiving SERM/AI plus OFS as adjuvant endocrine therapy was an independent prognostic factor in HR+/HER2 + early-stage breast cancer patients. Subgroup analysis indicated that patients with estrogen-receptor (ER) expression below 50%, histological grade 3, tumors larger than 2 cm, or lymph node-positive could benefit from OFS. In addition, age<35 years, nodal involvement, histological grade 3 and ER expression below 50% were more likely to receive OFS compared with control group.</p><p><strong>Conclusion: </strong>Our study confirms that premenopausal patients with HR+/HER2 + early-stage breast cancer could benefit from additional OFS after trastuzumab treatment.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1331"},"PeriodicalIF":3.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12359915/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nab-paclitaxel plus cisplatin versus gemcitabine plus cisplatin as first-line treatment in advanced biliary tract cancer: results of a multicentre, randomised, phase II trial. nab -紫杉醇加顺铂与吉西他滨加顺铂作为晚期胆道癌一线治疗:一项多中心、随机、II期试验的结果
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-16 DOI: 10.1186/s12885-025-14581-3
Xiao Yang, Yu-Hong Dai, Hui Peng, Ming-Sheng Zhang, Qiang Fu, Shun-Fang Liu, Li Sun, Yan-Mei Zou, Hai-Sheng Xu, Ping Qiu, Hong Qiu, Qiao Huang, Heng-Hui Cheng, Liang Zhuang
{"title":"Nab-paclitaxel plus cisplatin versus gemcitabine plus cisplatin as first-line treatment in advanced biliary tract cancer: results of a multicentre, randomised, phase II trial.","authors":"Xiao Yang, Yu-Hong Dai, Hui Peng, Ming-Sheng Zhang, Qiang Fu, Shun-Fang Liu, Li Sun, Yan-Mei Zou, Hai-Sheng Xu, Ping Qiu, Hong Qiu, Qiao Huang, Heng-Hui Cheng, Liang Zhuang","doi":"10.1186/s12885-025-14581-3","DOIUrl":"10.1186/s12885-025-14581-3","url":null,"abstract":"<p><strong>Background: </strong>The efficacy and safety of conventional first-line chemotherapeutic regimens for the treatment of advanced biliary tract carcinomas (ABTCs) have been unsatisfactory.</p><p><strong>Objectives: </strong>We aimed to explore alternative chemotherapeutic regimens capable of providing improved efficacy and fewer side-effects.</p><p><strong>Design: </strong>Multicentre, randomised, phase II clinical trial.</p><p><strong>Methods: </strong>Patients with unresectable advanced-stage tumors, or those who have developed recurrence or metastasis following initial radical surgery, between January 2021 and November 2022 were included. The participants were randomised to either a gemcitabine-cisplatin group (GC) or an albumin-paclitaxel-cisplatin group (NC). Progression-free survival (PFS) was the primary outcome, whereas overall survival (OS), and objective response rate (ORR) were the secondary outcomes.</p><p><strong>Results: </strong>The trial enrolled 75 patients and had a median follow-up period of 11 months. The median PFS (mPFS) was 7.8 m (95% confidence interval [CI]: 5.4-14.0 m) in the NC group, and 7.0 m (95%CI: 3.9-10.1 m) in the GC group (p = 0.0034, hazard ratio [HR] = 0.5136, 95%CI: 0.3136-0.8411). Median OS for the NC group was 12.4 m (95%CI: 7.3-22.3 m) and for the GC group was 12.1 m (95%CI: 6.7-20.7 m), with no significant differences (p = 0.4592, HR = 0.811, 95%CI: 0.463-1.442). PFS rates at 6 and 8 months were 52.6% vs. 73.0% and 13.2% vs. 35.1% for the NC and the GC group, respectively (p < 0.05). As the secondary endpoint, ORR rates, there was no significant difference between the two groups. GC group had 13 (34.2%) patients achieved ORR, while NC group had 14 (37.8%). Regarding safety, In the context of thrombocytopenia, the incidence was significantly lower in the NC group compared to the GC group (27% vs 50%, P = 0.041). Conversely, with regard to sensory neuropathy, the NC group demonstrated a higher incidence (62.1% vs 36.8%, P = 0.028).</p><p><strong>Conclusion: </strong>In this phase II non-inferiority trial, NC demonstrated comparable efficacy to GC in advanced BTC, with a trend toward improved PFS and a potentially favorable hematological toxicity profile. Further studies are warranted to confirm these findings in the context of a modern immunotherapy-based standard.</p><p><strong>Trial registration: </strong>Clinical Trials.gov identifiers: NCT04692051. Registered October 31, 2018.  https://www.chictr.org.cn/showproj.html?proj=38440 .</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"1321"},"PeriodicalIF":3.4,"publicationDate":"2025-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12357391/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144862134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical efficacy of immune checkpoint inhibitors for cancer of unknown primary: a multi-center retrospective study. 免疫检查点抑制剂治疗原发不明癌症的临床疗效:一项多中心回顾性研究
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-16 DOI: 10.1186/s12885-025-14778-6
Haowen Wang, Siqi Song, Yuzhou Nie, Jinting Wu, Linyue Pan, Qizhen Zou, Gaizhen Kuang, Chen Chen, Xiaochen Zhang, Wenfeng Li, Shirong Zhang
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引用次数: 0
Impact of loneliness on depression among cancer survivors: a comparison between adolescents and young adults and other age groups. 孤独对癌症幸存者抑郁的影响:青少年、年轻人和其他年龄组的比较。
IF 3.4 2区 医学
BMC Cancer Pub Date : 2025-08-16 DOI: 10.1186/s12885-025-14734-4
Ken Kurisu, Masako Okamura, Keiko Ozawa, Saki Harashima, Kazuhiro Yoshiuchi, Yosuke Uchitomi, Maiko Fujimori
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引用次数: 0
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