Chinese clinical oncology最新文献

{"title":"The global impact of the General Data Protection Regulation: implications, challenges, and future outlook in oncology clinical research sponsors.","authors":"Xiao Liu, Denis Lacombe, Stephane Lejeune","doi":"10.21037/cco-25-31","DOIUrl":"10.21037/cco-25-31","url":null,"abstract":"<p><p>Oncology clinical trial involves processing of vast amounts of personal health data, including medical history, treatment, biomarker, genetic information, etc., much of which qualifies as special category data under the General Data Protection Regulation (GDPR). While it sought to harmonize the data protection standards across the European Union (EU), its implementation has a profound impact on the operational and regulatory practice for oncology clinical trial sponsors. Its interaction with the Clinical Trials Regulation (CTR), diverse national health data laws, and emerging data localization mandates has made privacy compliance in multi-country clinical trials exceptionally complex for both EU and non-EU sponsors. This narrative review examines how core GDPR principles and requirements play out in the context of oncology clinical trials in the EU, and where tensions arise with CTR obligations and real-world operations. We highlight recurrent challenges in practice, including the need to distinguish ethical consent from GDPR legal bases, to honour data subject rights without unblinding, and to ensure proportionate data collection as study endpoints evolve. Additional difficulties arise from managing biospecimen storage and secondary use, addressing long retention horizons, navigating Member State and intra‑state variations in ethics committee and data protection officer expectations, and overcoming localization barriers that hinder cross-border pooling of rare molecular-marker data. With the evolving complex privacy compliance landscape in EU and beyond, full compliance with all privacy requirements becomes unrealistic for the oncology clinical trial sponsors. Instead of seeking perfection in compliance, which is not the main mission for oncology clinical trials, sponsors should adopt a risk-based approach to prioritize the mitigation of the most significant risks. Drawing on the recurrent challenges identified in this narrative review, we propose such an approach that begins with early scoping of the study type, distinguishing CTR-governed investigational medicinal product trials from other designs, and mapping member state legal bases alongside layered transparency materials. It also involves implementing site-mediated subject rights workflows, carefully justifying the inclusion of \"buffer\" variables or biospecimens, and planning differentiated retention strategies for samples and data. Sponsors should further incorporate privacy-by-design through country-specific mapping and, where cross-border transfers are constrained, consider federated or \"data-visiting\" analytics. At the system level, we recommend adopting modular consent language, clarifying controller and processor roles through guidance, maintaining public registers of national derogations, and investing in federated infrastructures and accredited biobanks. These insights aim to help oncology sponsors, as well as other clinical sponsors, ethics committees, privacy professionals,","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"54"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480812","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":"The novel approach with antibody-drug conjugate targeting CLDN18.2 trial's insights and future perspectives.","authors":"Izuma Nakayama","doi":"10.21037/cco-25-39","DOIUrl":"https://doi.org/10.21037/cco-25-39","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"61"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480985","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":"Causal association between local infection of Epstein-Barr virus and gastric cancer risk: a rapid meta-analysis.","authors":"Zhuo-Yu Li, Rui Wang, Xin-Zu Chen","doi":"10.21037/cco-25-93","DOIUrl":"https://doi.org/10.21037/cco-25-93","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"64"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480860","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":"The potential of (177Lu)-PSMA-617 in the first-line combination therapy with enzalutamide for metastatic castration-resistant prostate cancer: clinical insights from the ENZA-p trial.","authors":"Renning Zheng, Stephen J Freedland, Anthony T Nguyen","doi":"10.21037/cco-25-65","DOIUrl":"https://doi.org/10.21037/cco-25-65","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"63"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480978","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":"Patient-related reported outcomes (PROs) from TALAPRO-2: the PROs and cons.","authors":"Edoardo Francini","doi":"10.21037/cco-25-62","DOIUrl":"10.21037/cco-25-62","url":null,"abstract":"","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":" ","pages":"62"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336435","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":"Afatinib for patients with non-small-cell lung cancer harboring major EGFR G719X + S768I co-mutations: a retrospective, observation study in Xuanwei and Fuyuan, China.","authors":"Ruoyu Deng, Lin Wang, Jialing Lv, Feineng Liu, Tengfei Zhang, Chunyan Li, Chongxin Li, Zhijun Zhang, Huahua Zhou, Wen Zhang, Chao Zhang","doi":"10.21037/cco-25-43","DOIUrl":"10.21037/cco-25-43","url":null,"abstract":"<p><strong>Background: </strong>Real-world data on afatinib for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) G719X + S768I co-mutations remains limited. This study aims to evaluate the efficacy and safety of afatinib in a relatively large cohort of NSCLC patients with these uncommon mutations in Xuanwei and Fuyuan counties, China.</p><p><strong>Methods: </strong>A retrospective study was conducted on 96 NSCLC patients from Xuanwei and Fuyuan, China, between August 2019 and March 2024. Patients with advanced-stage NSCLC harboring EGFR G719X + S768I co-mutations or single EGFR G719X/S768I mutations who received first-line afatinib treatment were included in the study. The parameters analyzed included the progression-free survival (PFS), and overall survival (OS). While treatment-related adverse events (AEs) were assessed for the safety of afatinib.</p><p><strong>Results: </strong>All of the 96 patients, 59 were female and 37 were male, with a median age was 59.2±9.0 years. The mutations were classified as single EGFR G719X/S768I mutations (n=34; 35.4%) and G719X + S768I co-mutations (n=62; 64.6%). The median progression-free survival (mPFS) for all patients was 12 months (95% CI: 9.5-14.5), and median overall survival (mOS) was 29 months (95% CI: 18.0-40.0). Patients with the G719X + S768I co-mutations exhibited significantly longer mPFS (17 vs. 8 months, P<0.001) and mOS (33 vs. 15 months, P=0.04) compared to those with and single EGFR G719X/S768I mutation. Common treatment-related AEs included diarrhea (n=80; 83.3%), skin rash/acne (n=77; 80.2%), paronychia (n=53; 55.2%), and stomatitis (n=33; 34.4%), all of which were manageable. There was no significant difference in AEs between the two mutation groups.</p><p><strong>Conclusions: </strong>This study represents the largest cohort of NSCLC patients with EGFR G719X + S768I co-mutations treated with first-line afatinib. Our findings confirmed the effectiveness and safety of afatinib in this patient population. Furthermore, the presence of the G719X + S768I co-mutations serves as an independent predictor of favorable PFS for NSCLC patients. This study will provide new clinical evidence supporting afatinib therapy for patients with EGFR G719X + S768I co-mutations, both in China and globally. This study fills an important gap in the existing literature by providing robust, large-scale clinical data, offering new insights for the treatment of NSCLC patients with these uncommon mutations.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"53"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480877","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":"Paclitaxel and carboplatin combination therapy-induced pure red cell aplasia in endometrial cancer patient and favorable response to low-dose corticosteroid treatment: a case report.","authors":"Chengyulong Zheng, Meng Chen, Jiayu He, Ying Zhang, Lixiang Yan, Zhexin Shi","doi":"10.21037/cco-25-32","DOIUrl":"10.21037/cco-25-32","url":null,"abstract":"<p><strong>Background: </strong>Endometrial cancer, the sixth most common malignancy in women, is frequently treated with carboplatin-paclitaxel chemotherapy. While myelosuppression is a common adverse effect, drug-induced pure red cell aplasia (PRCA) is exceedingly rare. This report presents a case of refractory PRCA induced by this regimen, which was successfully reversed with low-dose corticosteroids, underscoring its clinical significance.</p><p><strong>Case description: </strong>A postmenopausal patient with endometrial cancer (stage IA, high p53 expression) received adjuvant paclitaxel and carboplatin chemotherapy. She subsequently developed severe anemia (reticulocytes 0.001×1012/L). Bone marrow examination revealed an absence of erythroid precursor cells. PRCA was diagnosed after excluding hemolysis, hematologic malignancies, infections, and autoimmune disorders. Given normal pre-chemotherapy hemoglobin (Hb) levels, drug-induced PRCA was suspected. Chemotherapy was discontinued, and stanozolol was initiated; however, Hb remained stable at 60 g/L without improvement. Low-dose corticosteroids (0.5 mg/kg) were added one week later, resulting in Hb increasing to 82 g/L within 2 weeks. Levels normalized within four weeks and remained stable after corticosteroid taper.</p><p><strong>Conclusions: </strong>This case highlights PRCA as a potential complication of carboplatin-paclitaxel therapy, emphasizing the importance of obtaining reticulocyte counts and bone marrow studies in cases of refractory chemotherapy-induced anemia. Early low-dose corticosteroid intervention proved effective and safe. Clinicians should include PRCA in the differential diagnosis during chemotherapy toxicity surveillance to optimize supportive care in cancer patients.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"58"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480856","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":"Induction chemotherapy followed by radiotherapy in primary small cell neuroendocrine carcinoma of the parotid gland: a case report and literature review.","authors":"Ruoyu Deng, Lin Wang, Jialing Lv, Fang Wang, Tengfei Zhang, Feineng Liu, Chunyan Li, Wen Zhang, Chao Zhang","doi":"10.21037/cco-24-129","DOIUrl":"10.21037/cco-24-129","url":null,"abstract":"<p><strong>Background: </strong>Small cell carcinoma is a highly aggressive neoplasm that commonly arises in the lungs. The occurrence of this tumor in the salivary gland, particularly the parotid gland, is extremely rare, accounting for less than 1% of all cases of malignant parotid gland tumors, and is associated with poor prognosis. Owing to its rarity, there remains no consensus on standardized therapeutic protocols.</p><p><strong>Case description: </strong>A 58-year-old woman presented with a 4-month history of a progressively enlarging left preauricular mass and was ultimately diagnosed with small cell neuroendocrine carcinoma (SCNC) of the parotid gland. Evaluations including ultrasound, contrast-enhanced computed tomography (CT), and biopsy revealed a left parotid mass with cervical lymph node involvement, no metastases, specific histopathological and immunohistochemical features. Molecular testing showed TP53 and HRAS mutations, a programmed death ligand-1 (PD-L1) expression level of 30%, and the clinical staging was IVA (cT3N2bM0). A novel therapeutic strategy of induction chemotherapy in combination with sequential radiotherapy exhibited substantial therapeutic efficacy for this rare malignancy. We conducted a narrative review spanning 2000-2024 to elucidate the epidemiologic characteristics, diagnostic challenges, therapeutic paradigms, and prognostic determinants associated with parotid gland SCNC.</p><p><strong>Conclusions: </strong>These findings yield valuable insights into the biological and clinical behaviors of this rare parotid gland neoplasm. Furthermore, this work enhances the understanding of the epidemiological characteristics and optimal management strategies for parotid gland SCNC.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"57"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480816","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":"Natural compounds targeting mitochondrial metabolism in cancer therapy: a literature review.","authors":"Grazielle Silva Paz, Janaina Fernandes","doi":"10.21037/cco-25-51","DOIUrl":"10.21037/cco-25-51","url":null,"abstract":"<p><strong>Background and objective: </strong>Cancer is a public health problem and is considered the leading cause of death around the globe. Despite the advances in cancer therapies, many patients suffer from adverse side effects and drug resistance. Among the cancer hallmarks, metabolic reprogramming is essential for supporting the higher energy demand of cancer cells. Due to the Warburg effect, a misconception that oxidative phosphorylation (OXPHOS) and other mitochondrial-related metabolic pathways are dispensable for tumor cells was created. Nowadays, many studies have been demonstrating the importance of mitochondria and their metabolism to cancer bioenergetics and progression. Through this review, we aim to show natural compounds that regulate mitochondrial metabolism to exert their anticancer activity.</p><p><strong>Methods: </strong>In this literature review, studies found in PubMed, in English and published between 1925-2025 were considered.</p><p><strong>Key content and findings: </strong>Throughout this review, we discussed the importance of mitochondrial metabolism for carcinogenesis, updated and brought new natural products as potential therapies to target mitochondrial metabolism to counteract cancer progression. Furthermore, we discussed the future directions to overcome the limitations of the use of natural products as anticancer compounds.</p><p><strong>Conclusions: </strong>Natural compounds can act in different pathways of mitochondrial metabolism to exert their antitumoral effects, however, some limitations need to be overcome. Developing natural product-based hybrids through the conjugation of natural compounds with bioactive molecules has gained interest to surpass these limitations, representing a good strategy to enhance the anticancer treatment effectiveness of natural products.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":"14 5","pages":"56"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480885","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":"Primary hyperparathyroidism due to water-clear cell carcinoma of the parathyroid gland: a case report and literature review.","authors":"Leenah Abdulgader, Abdullah Esmail, Bayan Khasawneh, Ebtesam Al-Najjar, Ghazi Alharbi, Saad Al Awwad","doi":"10.21037/cco-25-25","DOIUrl":"10.21037/cco-25-25","url":null,"abstract":"<p><strong>Background: </strong>Water-clear cell carcinoma of the parathyroid gland is an exceedingly rare malignancy, with the majority of published cases focusing on adenomas that are typically large and associated with mild elevations in parathyroid hormone (PTH) levels.</p><p><strong>Case description: </strong>We present the case of a 43-year-old woman who presented with a pelvic pathological fracture and very high serum calcium of 15.5 mg/dL, along with a severely elevated PTH level (>2,500 pg/mL). Imaging studies, including ultrasound, computed tomography (CT), and technetium-99m sestamibi (99mTc-MIBI) subtraction scintigraphy, revealed a mass in the inferior parathyroid gland on the left side of the thyroid gland. The patient underwent surgical resection, and the excised tumor measured 3 cm × 2.5 cm × 1.5 cm and weighed 10.7 grams. Histopathological examination confirmed the diagnosis of water-clear cell carcinoma of the parathyroid gland, with prominent vascular invasion.</p><p><strong>Conclusions: </strong>This case is particularly significant as it represents the largest water-clear cell carcinoma of the parathyroid gland reported in the literature to date. The patient was closely monitored postoperatively, and at 1-year follow-up, there were no signs of distant metastases or recurrence of hyperparathyroidism. This case underscores the aggressive nature of water-clear cell carcinoma, highlighting the need for early detection and prompt surgical intervention in such rare and potentially life-threatening tumors.</p>","PeriodicalId":9945,"journal":{"name":"Chinese clinical oncology","volume":" ","pages":"59"},"PeriodicalIF":2.5,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144944731","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}