{"title":"The impact of sleep interventions combined with enhanced nutritional support on sleep quality, nutritional status, pain management, psychological well-being, and quality of life in postoperative colon cancer patients.","authors":"Gang Wang, Shengjie Pan","doi":"10.1007/s00432-025-06093-1","DOIUrl":"10.1007/s00432-025-06093-1","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the synergistic effects of combined sleep interventions and enhanced nutritional support on postoperative recovery in colon cancer patients, with a focus on sleep quality, nutritional status, pain management, psychological well-being, and quality of life.</p><p><strong>Methods: </strong>This randomized controlled trial included 290 postoperative colon cancer patients admitted to the First Affiliated Hospital of Soochow University between May 2021 and May 2023. Participants were randomized into two groups: the intervention group, which received standard care supplemented with sleep and nutritional interventions, and the control group, which received standard care alone. Outcomes were assessed pre- and post-intervention, including the Pittsburgh Sleep Quality Index (PSQI), nutritional markers (serum albumin, prealbumin, body weight, etc.), Visual Analog Scale (VAS) for pain, Self-Rating Anxiety and Depression Scales (SAS, SDS), and EORTC QLQ-C30 quality of life scores.</p><p><strong>Results: </strong>The intervention group demonstrated significantly greater improvements across all assessed domains compared to the control group ( P < 0.005 after Bonferroni correction). Sleep quality (PSQI: 7.81 vs. 10.43, d = 0.81) and nutritional markers (e.g., prealbumin: 230.19 mg/L vs. 188.01 mg/L, d = 1.21 ) improved markedly. Similarly, reductions in pain (VAS: 2.65 vs. 5.19,d = 1.09 ), anxiety (SAS: 42.03 vs. 49.45, d = 0.88), and depression (SDS: 38.17 vs. 49.77,d = 1.02 ) were observed. Quality of life scores significantly increased in the intervention group compared to the control group (EORTC QLQ-C30: 99.29 vs. 88.41, d = 0.92).</p><p><strong>Conclusion: </strong>The combined intervention of sleep enhancement and nutritional support significantly accelerated postoperative recovery in colon cancer patients, demonstrating synergistic effects that improved physical, psychological, and quality-of-life outcomes. These findings underscore the value of integrating multifaceted interventions into standard postoperative care to optimize recovery trajectories and overall well-being.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 2","pages":"50"},"PeriodicalIF":2.7,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11772530/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Retraction Note to: Construction and validation of a machine learning-based immune-related prognostic model for glioma.","authors":"Qi Mao, Zhi Qiao, Qiang Wang, Wei Zhao, Haitao Ju","doi":"10.1007/s00432-025-06099-9","DOIUrl":"10.1007/s00432-025-06099-9","url":null,"abstract":"","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 2","pages":"49"},"PeriodicalIF":2.7,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143038866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xinyao Zhao, Lehui Du, Na Ma, Xin Tan, Xiao Lei, Pei Zhang, Baolin Qu
{"title":"The role of cGAS-STING pathway in the development of radiation-induced lung injury.","authors":"Xinyao Zhao, Lehui Du, Na Ma, Xin Tan, Xiao Lei, Pei Zhang, Baolin Qu","doi":"10.1007/s00432-025-06088-y","DOIUrl":"10.1007/s00432-025-06088-y","url":null,"abstract":"<p><strong>Background and purpose: </strong>Radiation-induced lung injury (RILI) limits the efficacy of thoracic radiotherapy. However, the underlying mechanism of RILI remains unclear. cGAS-STING pathway is reported to be involved in the recognization of cytosolic dsDNA and various inflammatory diseases. This study aimed to investigate the role of cGAS-STING pathway in the development of RILI.</p><p><strong>Materials and methods: </strong>A pre-clinical mouse model of RILI was established by whole thorax irradiation and confirmed using H&E and Masson's trichrome staining. STING agonist (DMXAA) and antagonist(C-176) were administrated to modulate cGAS-STING pathway in vivo. Western blot and ELISA were used to determine the expression levels of different proteins.</p><p><strong>Results: </strong>Quantitation analysis showed dsDNA accumulation in lung tissue and western blot showed the up-regulation of cGAS and STING protein level post-irradiation, indicating pathway activation. Histological evaluation showed that C-176 administration ameliorated radiation-induced pulmonary inflammation and fibrosis, while DMXAA exhibited contrary effects. In further in vitro study, the release of dsDNA induced by radiation led to the activation of cGAS-STING pathway in RAW 264.7 cells, resulting in the polarization into M1 phenotype and pro-inflammatory production.</p><p><strong>Conclusion: </strong>In summary, our data demonstrated a link between cGAS-STING pathway and the development of RILI, indicating its potential application in clinic.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 2","pages":"48"},"PeriodicalIF":2.7,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11761121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143038891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiaopeng Wang, Jingjing Ye, Daoning Liu, Liang Yan, Shuquan Li, Ang Lv, Chengpeng Li, Jianhui Wu, Hui Qiu, Chunyi Hao
{"title":"Bibliometric analysis of liposarcomas treatment from 2004 to 2023.","authors":"Xiaopeng Wang, Jingjing Ye, Daoning Liu, Liang Yan, Shuquan Li, Ang Lv, Chengpeng Li, Jianhui Wu, Hui Qiu, Chunyi Hao","doi":"10.1007/s00432-025-06094-0","DOIUrl":"10.1007/s00432-025-06094-0","url":null,"abstract":"<p><strong>Background: </strong>Liposarcomas are mesenchymal malignant tumors characterized by varying degrees of adipocytic differentiation that comprises approximately 20% of soft tissue sarcomas. Despite advancements in this field, there remains a need for a comprehensive understanding of the mechanisms, diagnosis, and treatment of liposarcomas. Currently, there is a lack of bibliometric surveys on the development trajectory of liposarcomas treatment, research hotspots, and author and team collaboration.</p><p><strong>Methods: </strong>In this study, we obtained publications from the Web of Science database from 2004 to 2023, with a specific focus on the treatment of liposarcomas. By utilizing bibliometric methods, the data were processed to facilitate visual analysis of various aspects, including authors, countries, institutions, cocitations, keywords, references, and gene characteristics.</p><p><strong>Results: </strong>The number of publications on liposarcomas treatment has increased over the past two decades, from 39 in 2004 to 232 in 2023, with the United States of America contributing the most publications. Among the institutions, the Memorial Sloan Kettering Cancer Center had the highest volume of 87 publications. Notably, Alessandro Gronchi published 63 articles on the treatment of liposarcomas in the last 20 years. Cancers is the journal with the highest number of 57 publications. High-frequency keywords in these publications included \"soft tissue sarcoma\", \"liposarcoma\", \"retroperitoneal sarcoma\", \"surgery\", \"dedifferentiated liposarcoma\", \"trabectedin\" and \"radiotherapy\". Recent trends, identified through strong citation bursts from 2020 to 2023, include next-generation sequencing, radiotherapy, and patient-derived cell lines. High-frequency genes in the liposarcomas treatment field include TP53, MDM2, CDK4, DDIT3, and CD274.</p><p><strong>Conclusions: </strong>The treatment of liposarcomas has garnered increasing attention worldwide in the last 20 years. The treatment approach has shifted from surgical resection to multidisciplinary therapy. The molecular and biological characteristics of different tumor subtypes have attracted more research attention, providing an important reference for the choice of treatment. The findings of this study contribute to providing a comprehensive understanding of liposarcomas treatment among researchers. Moreover, they offer valuable perspectives that can guide future research.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 2","pages":"47"},"PeriodicalIF":2.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762222/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143038855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annabelle Volk, Charlotte von Bülow, Aysche Stern, Ronald Simon, Eike Burandt, Guido Sauter, Barbara Schmalfeldt, Leticia Oliveira-Ferrer
{"title":"Stromal PDGFR-beta expression is a prognostic factor in high-grade serous ovarian cancer patients but is it also predictive for response to antiangiogenic treatment?","authors":"Annabelle Volk, Charlotte von Bülow, Aysche Stern, Ronald Simon, Eike Burandt, Guido Sauter, Barbara Schmalfeldt, Leticia Oliveira-Ferrer","doi":"10.1007/s00432-025-06090-4","DOIUrl":"10.1007/s00432-025-06090-4","url":null,"abstract":"<p><strong>Objective: </strong>In advanced ovarian cancer, the majority of patients receive anti-angiogenic treatment with bevacizumab. However, its use is often associated with severe side effects, and not all patients benefit from the therapy. Currently, there are no reliable biomarkers to predict response to treatment. Given their role as key regulators of angiogenesis, platelet-derived growth factor receptor-beta (PDGFR-beta) and vascular endothelial growth factor receptor-2 (VEGFR-2) are promising candidates for predictive biomarkers. This study evaluates their potential.</p><p><strong>Methods: </strong>PDGFR-beta and VEGFR-2 expression was evaluated using immunohistochemistry in a tissue microarray assay including 391 ovarian tissue samples. Correlation analyses with clinical and histopathological parameters were performed in a homogeneous cohort of 199 high grade serous ovarian cancer samples (HGSOC).</p><p><strong>Results: </strong>In HGSOC, strong stromal PDGFR-beta expression was associated with significantly shorter overall survival compared to weak/moderate expression. The impact of stromal PDGFR-beta expression on patient survival was however not restricted to the subgroup of patients receiving therapy with bevacizumab, and therefore cannot be considered as a predictive factor. For VEGFR-2, no or weak protein expression was found in the majority of the tumor samples. Survival analyses showed a more favorable prognosis with no or weak VEGFR-2 expression.</p><p><strong>Conclusions: </strong>High stromal expression levels of PDGFR-beta correlate with shorter overall survival in HGSOC. Thus, stromal PDGFR-beta might serve as a prognostic biomarker. No predictive effect in response to bevacizumab therapy could be attributed.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 2","pages":"44"},"PeriodicalIF":2.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759463/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143028467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Identification of cold tumor induction-related markers in pancreatic cancer and the clinical implication of PCDH7.","authors":"Yuki Mochida, Kenoki Ohuchida, Bo Zhang, Yutaka Yamada, Chikanori Tsutsumi, Akihiro Kubo, Koki Oyama, Tomohiko Shinkawa, Chika Iwamoto, Nobuhiro Torata, Toshiya Abe, Noboru Ideno, Naoki Ikenaga, Kohei Nakata, Yoshinao Oda, Masafumi Nakamura","doi":"10.1007/s00432-025-06095-z","DOIUrl":"10.1007/s00432-025-06095-z","url":null,"abstract":"<p><strong>Purpose: </strong>Pancreatic ductal adenocarcinoma (PDAC) is considered a \"cold\" tumor because the tumor immune microenvironment (TIME) exhibits poor intratumoral T-cell infiltration. This study aimed to identify the marker genes associated with induction of cold TIME in PDAC cells.</p><p><strong>Methods: </strong>We orthotopically transplanted 10 primary cultures of PDAC derived from KrasG12D/+; Trp53R172H/+; Pdx-1-Cre (KPC) mice into immunocompetent mice and evaluated TIME by immunohistochemistry (IHC) staining of CD8. We divided primary cultures into two groups: cold TIME group with low CD8<sup>+</sup> T-cell infiltration and a hot TIME group with high infiltration. RNA sequencing was performed to identify specific genes in the cold TIME group, and single-cell RNA sequencing (scRNA-seq) data was used for validation. IHC was performed to evaluate expressions in human PDAC samples.</p><p><strong>Results: </strong>We identified six genes specific in PDAC cells to the cold TIME group by RNA sequencing; these were defined as \"cold tumor induction-related genes\". Human PDAC scRNA-seq data revealed that cold tumor induction-related genes were significantly and negatively correlated with the number of CD8<sup>+</sup> T-cells (p = 0.0341). These genes included protocadherin 7 (PCDH7). High expression of PCDH7 significantly and negatively correlated with the number of CD8<sup>+</sup> T-cells in scRNA-seq (p = 0.0474) and IHC (p = 0.0110) data using human PDAC samples. PCDH7 was an independent factor for poor prognosis in PDAC (overall survival: hazard ratio = 2.07, p = 0.0367).</p><p><strong>Conclusion: </strong>PCDH7 is a prognostic marker associated with CD8<sup>+</sup> T-cell infiltration for PDAC patients.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 2","pages":"45"},"PeriodicalIF":2.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11761478/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143038861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"CDCA4 promotes bladder cancer progression by JAK/STAT signaling pathway.","authors":"Peng Wan, Yuan Ren, Hao Deng, Hongtao Li","doi":"10.1007/s00432-025-06109-w","DOIUrl":"10.1007/s00432-025-06109-w","url":null,"abstract":"<p><strong>Background: </strong>The cell division cycle associated 4 (CDCA4) plays a crucial role in various biological processes and is implicated in the progression of several tumors, however, the mechanisms by which it operates in bladder cancer remain unclear.</p><p><strong>Methods: </strong>Utilizing data from the TCGA and GEO datasets of bladder cancer patients, we analyzed the expression of CDCA4 and its prognostic significance. We then constructed stable overexpression and knockdown bladder cancer cell lines to investigate the effects of CDCA4 on cell proliferation, migration, and invasion in vitro, employing CCK-8, colony formation, transwell, and wound healing assays. Additionally, we validated the potential downstream pathways of CDCA4 through data analysis and western blot assays.</p><p><strong>Results: </strong>Our study found that CDCA4 expression is elevated in bladder cancer cells and correlates with poor prognosis in patients. Inhibition of CDCA4 expression reduces the proliferation, migration, and invasion of bladder cancer cells, as well as inhibit the epithelial-mesenchymal transition (EMT) process. Conversely, promoting CDCA4 expression enhances the malignancy of bladder cancer cells. Investigation into the mechanism of CDCA4 revealed that it promotes bladder cancer progression by activating the JAK/STAT signaling pathway, and the JAK inhibitor AG490 can reverse the promoting effects of CDCA4.</p><p><strong>Conclusion: </strong>Our findings suggest that CDCA4 enhances the proliferation, migration, and invasion of bladder cancer cells by positively regulating the JAK/STAT signaling pathway, indicating that CDCA4 may serve as a novel molecular target for bladder cancer treatment.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 2","pages":"46"},"PeriodicalIF":2.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11762220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143038858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and safety of first-line nivolumab plus ipilimumab treatment in elderly patients (aged ≥ 75 years) with non-small cell lung cancer.","authors":"Satoshi Endo, Hisao Imai, Atsuto Mouri, Kasumi Tsukamoto, Kenji Masaki, Kosuke Hashimoto, Yu Miura, Ayako Shiono, Ou Yamaguchi, Junichi Nakagawa, Kyoichi Kaira, Kunihiko Kobayashi, Hiroshi Kagamu","doi":"10.1007/s00432-025-06089-x","DOIUrl":"10.1007/s00432-025-06089-x","url":null,"abstract":"<p><strong>Purpose: </strong>Nivolumab plus ipilimumab (Nivo-Ipi) combination therapy is an effective first-line treatment for advanced non-small cell lung cancer (NSCLC). However, its effectiveness and feasibility in elderly patients (aged ≥ 75 years) remain unclear. This study aimed to investigate the efficacy and safety of first-line Nivo-Ipi therapy in elderly patients with NSCLC.</p><p><strong>Methods: </strong>This retrospective study included 57 patients with NSCLC (52 men and 5 women), aged ≥ 75 years (range: 75-86) who received first-line Nivo-Ipi therapy from December 2020 to November 2022 at four institutes in Japan. Patient characteristics, therapeutic efficacy, and the incidence and severity of adverse events (AE) were assessed.</p><p><strong>Results: </strong>The overall response rate was 42.1%, the disease control rate was 73.6%, the median progression-free survival (PFS) was 7.1 months, and the median overall survival (OS) was 14.1 months. Common Grade ≥ 3 AEs included pneumonitis, elevated aspartate transaminase, elevated alanine transaminase, adrenal insufficiency, and colitis. No treatment-related deaths were reported. PFS and OS were longer in patients who experienced treatment-related AEs. Patients with and without AEs had a median PFS of 11.7 and 2.8 months, respectively. Similarly, the median OS of patients with and without AEs was 20.4 and 9.0 months, respectively.</p><p><strong>Conclusion: </strong>First-line Nivo-Ipi therapy is effective in elderly patients with NSCLC. Although there was an increased incidence of pneumonitis, the treatment was manageable and presented as a viable treatment option. Notably, the occurrence of treatment-related AEs was associated with improved clinical outcomes, suggesting a potential prognostic value of AEs in this population.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 1","pages":"43"},"PeriodicalIF":2.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11754340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Retraction Note: Screening and identification of susceptibility genes for cervical cancer via bioinformatics analysis and the construction of an mitophagy-related genes diagnostic model.","authors":"Zhang Zhang, Fangfang Chen, Xiaoxiao Deng","doi":"10.1007/s00432-025-06100-5","DOIUrl":"10.1007/s00432-025-06100-5","url":null,"abstract":"","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 1","pages":"42"},"PeriodicalIF":2.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11754377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer.","authors":"Jingshu Wang, Xiuping Lai, Herui Yao, Hui Yang, Xiaolong Cao, Xiaochen Wang, Ying Wang, Weiqi Nian, Xiaodong Zheng, Qingxiu Mai, Anding Liu, Xiaozhi Lv, Xiaoying Bi, Junyi Chen, Junyan Wu, Suiwen Ye","doi":"10.1007/s00432-025-06086-0","DOIUrl":"10.1007/s00432-025-06086-0","url":null,"abstract":"<p><strong>Purpose: </strong>The primary objectives of this trial were aimed at exploring the pharmacokinetic profiles and the human bioequivalence of an intravenous liposomal injection of doxorubicin hydrochloride in comparison with a reference formulation in Chinese patients diagnosed with metastatic breast cancer.</p><p><strong>Methods: </strong>To achieve these goals, the trial employed a randomized, open-label, two-formulation crossover dosing strategy among Chinese patients with metastatic breast cancer. Pharmacokinetic (PK) evaluation was conducted through the collection of blood samples, and the liquid chromatography tandem mass spectrometry (LC/MS/MS) method was leveraged to quantify plasma concentrations of both liposome-encapsulated doxorubicin and non-encapsulated doxorubicin in patients. Throughout the trial, all adverse events observed in the patients were meticulously assessed.</p><p><strong>Results: </strong>The results indicated that the maximum concentration (Cmax), AUC from time zero to the last measurable concentration (AUC<sub>0-t</sub>), and AUC extrapolated to infinity (AUC<sub>0-∞</sub>) of in vivo non-encapsulated doxorubicin after administration of both formulations fell within the 80.00%-125.00% range at a 90% confidence interval.</p><p><strong>Conclusion: </strong>These findings strongly indicated that the tested formulations were bioequivalent to the reference formulation. The results also demonstrated that both formulations were well-tolerated, further establishing their safety profile in the context of metastatic breast cancer treatment.</p><p><strong>Trial registration: </strong>Chinadrugtrials.org.cn Identifier: CTR20200878.</p>","PeriodicalId":15118,"journal":{"name":"Journal of Cancer Research and Clinical Oncology","volume":"151 1","pages":"41"},"PeriodicalIF":2.7,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11750939/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}