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Navigating Gynecological Oncology with Different Versions of ChatGPT: A Transformative Breakthrough or the Next Black Box Challenge? 用不同版本的ChatGPT导航妇科肿瘤学:一个变革性的突破还是下一个黑匣子挑战?
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-12-17 DOI: 10.1159/000543173
Nur Dokuzeylul Gungor, Fatih Sinan Esen, Tolga Tasci, Kagan Gungor, Kaan Cil

Introduction: The study evaluates the performance of large language model versions of ChatGPT - ChatGPT-3.5, ChatGPT-4, and ChatGPT-Omni - in addressing inquiries related to the diagnosis and treatment of gynecological cancers, including ovarian, endometrial, and cervical cancers.

Methods: A total of 804 questions were equally distributed across four categories: true/false, multiple-choice, open-ended, and case-scenario, with each question type representing varying levels of complexity. Performance was assessed using a six-point Likert scale, focusing on accuracy, completeness, and alignment with established clinical guidelines.

Results: For true/false queries, ChatGPT-Omni achieved accuracy rates of 100% for easy, 98% for medium, and 97% for complicated questions, higher than ChatGPT-4 (94%, 90%, 85%) and ChatGPT-3.5 (90%, 85%, 80%) (p = 0.041, 0.023, 0.014, respectively). In multiple-choice, ChatGPT-Omni maintained superior accuracy with 100% for easy, 98% for medium, and 93% for complicated queries, compared to ChatGPT-4 (92%, 88%, 80%) and ChatGPT-3.5 (85%, 80%, 70%) (p = 0.035, 0.028, 0.011). For open-ended questions, ChatGPT-Omni had mean Likert scores of 5.8 for easy, 5.5 for medium, and 5.2 for complex levels, outperforming ChatGPT-4 (5.4, 5.0, 4.5) and ChatGPT-3.5 (5.0, 4.5, 4.0) (p = 0.037, 0.026, 0.015). Similar trends were observed in case-scenario questions, where ChatGPT-Omni achieved scores of 5.6, 5.3, and 4.9 for easy, medium, and hard levels, respectively (p = 0.017, 0.008, 0.012).

Conclusions: ChatGPT-Omni exhibited superior performance in responding to clinical queries related to gynecological cancers, underscoring its potential utility as a decision support tool and an educational resource in clinical practice.

本研究评估了chatgpt -3.5、ChatGPT-4和chatgpt - omniin的大语言模型(LLM)版本在解决妇科癌症(包括卵巢癌、子宫内膜癌和宫颈癌)诊断和治疗相关查询中的性能。方法:共804个问题平均分布在四个类别:真假、选择题、开放式和案例-场景,每个问题类型代表不同的复杂程度。使用6分李克特量表评估表现,重点是准确性、完整性和与既定临床指南的一致性。结果:对于真假查询,ChatGPT-Omni在简单问题上的准确率为100%,在中等问题上的准确率为98%,在复杂问题上的准确率为97%,高于ChatGPT-4(94%, 90%, 85%)和ChatGPT-3.5 (90%, 85%, 80%) (p分别=0.041,0.023,0.014)。在多项选择中,与ChatGPT-4(92%, 88%, 80%)和ChatGPT-3.5(85%, 80%, 70%)相比,ChatGPT-Omni在简单查询中保持了100%的准确率,在中等查询中保持了98%,在复杂查询中保持了93%的准确率(p=0.035, 0.028, 0.011)。对于开放式问题,ChatGPT-Omni的平均李克特分数为简单5.8分,中等5.5分,复杂5.2分,优于ChatGPT-4(5.4, 5.0, 4.5)和ChatGPT-3.5 (5.0, 4.5, 4.0) (p=0.037, 0.026, 0.015)。在Case-Scenario问题中也观察到类似的趋势,ChatGPT-Omni在简单、中等和困难水平上分别获得了5.6、5.3和4.9分(p=0.017、0.008、0.012)。结论:ChatGPT-Omni在回答妇科癌症相关的临床问题方面表现优异,强调了其作为决策支持工具和临床实践中的教育资源的潜在效用。
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引用次数: 0
Factors Associating with Bone-Only Metastasis in Chinese Breast Cancer Patients in the Absence of Anti-Human Epidermal Growth Factor Receptor 2-Targeted Therapy. 中国乳腺癌患者在未接受抗 HER2 靶向治疗的情况下发生骨转移的相关因素。
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-12-16 DOI: 10.1159/000543137
Zhensheng Li, Liang Chen, Huina Han, Yuguang Shang, Yue Li, Zhifeng Jia, Yunjiang Liu
<p><strong>Introduction: </strong>Bone-only metastasis (BOM) is a distinct clinical phenomenon in which cancer cells disseminate exclusively to the bones, without involvement of other distant organs. We investigated the factors associated with the BOM state versus other states of metastasis in breast cancer patients with bone metastasis (BM) at their first relapse. The results could help tailor the screening and preventive therapy strategies for BM in breast cancer.</p><p><strong>Methods: </strong>The study included 231 women who underwent mastectomy for primary unilateral non-metastatic breast cancer in 1997 or later and were subsequently diagnosed with BM at first relapse in 2008-2018 at the Fourth Hospital of Hebei Medical University in China. Factors such as patient age at primary breast cancer diagnosis, tumor clinicopathological characteristics, chemotherapy, radiotherapy, endocrine therapy (ET), time to progression (TTP), and others were analyzed. ET compliance was categorized from medication adherence. Multivariate logistic regressions were used to estimate the odds ratio (OR) and p value.</p><p><strong>Results: </strong>Only three (3.8%, 3/79) human epidermal growth factor receptor 2-positive (HER2+) breast cancer patients (n = 79) used anti-HER2-targeted agents in the adjuvant setting. After excluding them, the remaining 228 patients were analyzed. They had an average age of 47.3 years and median TTP 29.4 months at their first relapse. Overall, patients with BOM accounted for 26.8%. The BOM state was similarly presented in the hormone receptor-positive (HR+) patients (n = 182) and in the HR-negative (HR-) patients (n = 45) (28.6% vs. 17.8%, p = 0.142). However, it was significantly lower in the HER2+ patients (n = 76) than in the HER2-negative (HER2-) patients (n = 129) (13.2% vs. 31.8%, p = 0.003). Multivariate analyses showed that the BOM state was not associated with the HR+ (vs. HR-, OR 1.253, p = 0.723) and full ET compliance (vs. no/partial, OR 1.346, p = 0.545) status. Nonetheless, the BOM state was significantly associated with a lower chance in the HER2+ patients overall (OR 0.240, p = 0.008) and in the HR+ patients (OR 0.145, p = 0.005) but not in the HR- patients (OR 1.012, p = 0.991) than one in the HER2- patients. A lower chance of BOM state was also associated with TTP ≥24 months (p < 0.05). There were no other associated factors identified.</p><p><strong>Conclusion: </strong>Differently from HR status and other clinicopathological factors, the HER2+ status is associated with a lower chance of the BOM state in breast cancer patients with first BM. Such association appears to be reflected in HR+ patients only.</p><p><strong>Introduction: </strong>Bone-only metastasis (BOM) is a distinct clinical phenomenon in which cancer cells disseminate exclusively to the bones, without involvement of other distant organs. We investigated the factors associated with the BOM state versus other states of metastasis in breast cancer patient
骨转移(bone -only metastasis, BOM)是一种独特的临床现象,肿瘤细胞仅向骨转移而不累及其他远端器官。我们研究了乳腺癌骨转移(BM)患者首次复发时BOM状态与其他转移状态的相关因素。研究结果有助于制定乳腺癌乳腺转移瘤的筛查和预防治疗策略。方法:该研究纳入了1997年或之后因原发性单侧非转移性乳腺癌接受乳房切除术,随后于2008 - 2018年在中国河北医科大学第四医院首次复发时被诊断为BM的231名女性。分析原发性乳腺癌患者诊断年龄、肿瘤临床病理特征、化疗、放疗、内分泌治疗(ET)、进展时间(TTP)等因素。ET依从性分为药物依从性。采用多元逻辑回归估计奇数比(OR)和p值。结果:只有3例(3.8%,3/79)HER2阳性(HER2+)乳腺癌患者(n = 79)在辅助治疗中使用了抗HER2靶向药物。排除后,对剩余228例患者进行分析。他们首次复发时的平均年龄为47.3岁,中位TTP为29.4个月。总体而言,BOM患者占26.8%。激素受体阳性(HR+)患者(n = 182)和HR阴性(HR-)患者(n = 45)的BOM状态相似(28.6% vs 17.8%, p = 0.142)。然而,HER2+患者(n=76)明显低于HER2阴性(HER2-)患者(n= 129) (13.2% vs. 31.8%, p = 0.003)。多变量分析显示,BOM与HR+ (vs. HR-, OR 1.253, p = 0.723)和完全ET合规(vs.无/部分,OR 1.346, p = 0.545)状态无关。尽管如此,BOM状态与HER2+患者的总体BOM发生率(OR 0.240, p = 0.008)和HR+患者(OR 0.145, p = 0.005)较低的发生率显著相关,但HR-患者(OR 1.012, p = 0.991)与HER2-患者无关。TTP≥24个月的患者BOM状态发生率较低(p < 0.05)。没有发现其他相关因素。结论:与HR状态及其他临床病理因素不同,HER2+状态与首次BM的乳腺癌患者发生BOM状态的几率较低相关。这种关联似乎只反映在HR+患者中。
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引用次数: 0
Gender as a Contextual Factor in Quality of Life of Cancer Survivors: A Literature Review. 性别作为癌症幸存者生活质量的背景因素:文献综述。
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-12-13 DOI: 10.1159/000543067
Irene Göttgens, Sabine Oertelt-Prigione

Background: Cancer survivorship brings numerous challenges extending beyond physical health to include psychological, social, and functional aspects that define the quality of life (QoL) of survivors. Although recognizing that diverse gender experiences lead to different ways of coping with these challenges, many clinical trials fail to account for the distinct constructs of "sex" and "gender," often conflating the two. This review highlights how gender-related aspects can manifest in core QoL domains for cancer survivors, emphasizing the importance of inclusive and effective support systems and interventions.

Summary: While interest in the impact of gender is increasing in cancer survivor research, the terms "sex" and "gender" are still often conflated in research. Gender is a social concept consisting of multiple dimensions, such as gender identity, gender roles and norms, and gender relations. Each of these dimensions can have a distinct impact on the QoL domain of cancer survivors. Research indicates that not gender identity, but gender roles, norms, and relations can significantly influence coping behaviors that, subsequently, impact QoL domains such as physical, emotional, social, and role functioning. Understanding the interplay of gender roles, norms, and their relations with other contextual social factors is crucial for developing inclusive and effective support systems and interventions for cancer survivors.

Key messages: Gender roles and norms impact important QoL domains of cancer survivors. It is important to recognize that gendered behaviors, as a result of internalized or socially desired gender roles and norms, can both help and hinder effective coping with cancer, affecting QoL.

背景 癌症幸存者所面临的挑战远不止身体健康,还包括决定幸存者生活质量(QoL)的心理、社会和功能方面。尽管认识到不同的性别经历会导致应对这些挑战的不同方式,但许多临床试验未能考虑到 "性 "和 "性别 "这两个不同的概念,往往将两者混为一谈。本综述强调了与性别相关的方面如何体现在癌症幸存者的核心 QoL 领域中,并强调了包容性和有效的支持系统和干预措施的重要性。摘要 虽然癌症幸存者研究中对性别影响的关注与日俱增,但 "性 "和 "性别 "这两个术语在研究中仍经常被混淆。性别是一个社会概念,包括多个方面,如性别认同、性别角色和规范以及性别关系。这些维度中的每一个都会对癌症幸存者的生活质量领域产生明显的影响。研究表明,不是性别认同,而是性别角色、规范和关系都会对应对行为产生重大影响,进而影响到身体、情感、社交和角色功能等生活质量领域。了解性别角色、规范及其与其他社会环境因素之间的相互影响,对于为癌症幸存者开发包容、有效的支持系统和干预措施至关重要。
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引用次数: 0
Real-World Survival Outcomes in Patients with Different Types of Cancer Managed with Immune Checkpoint Inhibitors. 使用免疫检查点抑制剂治疗不同类型癌症患者的真实生存结果
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-12-04 DOI: 10.1159/000542958
Carsten Nieder, Siv Gyda Aanes, Luka Stanisavljevic, Bård Mannsåker, Ellinor Christin Haukland

Introduction: Immune checkpoint inhibitors (ICIs) are now standard of care in systemic treatment for many types of metastatic cancer, often together with cytotoxic chemotherapy. Monitoring of treatment efficacy against clinical trial benchmarks in real-world populations and subgroups such as elderly patients is necessary. Based on the results of a previous study, we evaluated age-related survival differences in a larger cohort.

Methods: Retrospective analysis of 272 patients managed in a rural real-world setting, after exclusion of those who had received neoadjuvant, adjuvant, or maintenance ICI treatment. We defined four different survival categories: death within 3 months of the first ICI dose, 3-6 months survival, 6-12 months survival, and >12 months survival. All surviving patients were followed for >12 months. Actuarial overall survival was assessed too. Age was stratified in 10-year increments.

Results: Non-small cell lung cancer (NSCLC) and malignant melanoma represented the most common tumor types. Median age was 70 years. Median actuarial overall survival was 13.6 months (5-year estimate 16%). The best survival was recorded in patients 61-70 years of age. The highest rate of early death within 3 months (29%) was seen in those aged >80 years. Long-term survival was not observed in this age group, in contrast to all others.

Conclusion: Satisfactory survival was observed in this elderly patient cohort, but survival varied with tumor type and performance status. Age was not a major determinant of survival. However, the oldest patients were at higher risk of short survival.

免疫检查点抑制剂(ICI)现在是许多类型转移性癌症全身治疗的标准护理,通常与细胞毒性化疗一起。有必要根据临床试验基准对现实世界人群和亚组(如老年患者)的治疗效果进行监测。基于先前的研究结果,我们在一个更大的队列中评估了与年龄相关的生存差异。方法:回顾性分析在农村现实环境中管理的272例患者,排除那些接受新辅助、辅助或维持ICI治疗的患者。我们定义了四种不同的生存类别:首次注射ICI后3个月内死亡、3-6个月生存、6-12个月生存和10 -12个月生存。所有存活患者随访10 ~ 12个月。精算总生存率也进行了评估。年龄以10年为单位分层。结果:非小细胞肺癌(NSCLC)和恶性黑色素瘤是最常见的肿瘤类型。中位年龄为70岁。精算总生存中位数为13.6个月(5年估计为16%)。61 ~ 70岁的患者生存率最高。3个月内早期死亡率最高(29%)见于年龄在80 ~ 80岁之间的人群。与其他所有年龄组相比,该年龄组未观察到长期生存。结论:该老年患者的生存率较好,但生存率随肿瘤类型和运动状态的不同而不同。年龄不是生存的主要决定因素。然而,年龄最大的患者短期生存的风险更高。
{"title":"Real-World Survival Outcomes in Patients with Different Types of Cancer Managed with Immune Checkpoint Inhibitors.","authors":"Carsten Nieder, Siv Gyda Aanes, Luka Stanisavljevic, Bård Mannsåker, Ellinor Christin Haukland","doi":"10.1159/000542958","DOIUrl":"10.1159/000542958","url":null,"abstract":"<p><strong>Introduction: </strong>Immune checkpoint inhibitors (ICIs) are now standard of care in systemic treatment for many types of metastatic cancer, often together with cytotoxic chemotherapy. Monitoring of treatment efficacy against clinical trial benchmarks in real-world populations and subgroups such as elderly patients is necessary. Based on the results of a previous study, we evaluated age-related survival differences in a larger cohort.</p><p><strong>Methods: </strong>Retrospective analysis of 272 patients managed in a rural real-world setting, after exclusion of those who had received neoadjuvant, adjuvant, or maintenance ICI treatment. We defined four different survival categories: death within 3 months of the first ICI dose, 3-6 months survival, 6-12 months survival, and >12 months survival. All surviving patients were followed for >12 months. Actuarial overall survival was assessed too. Age was stratified in 10-year increments.</p><p><strong>Results: </strong>Non-small cell lung cancer (NSCLC) and malignant melanoma represented the most common tumor types. Median age was 70 years. Median actuarial overall survival was 13.6 months (5-year estimate 16%). The best survival was recorded in patients 61-70 years of age. The highest rate of early death within 3 months (29%) was seen in those aged >80 years. Long-term survival was not observed in this age group, in contrast to all others.</p><p><strong>Conclusion: </strong>Satisfactory survival was observed in this elderly patient cohort, but survival varied with tumor type and performance status. Age was not a major determinant of survival. However, the oldest patients were at higher risk of short survival.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"82-91"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780066","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}
引用次数: 0
The Critical Role of Sex and Gender in Medicine. 性别和社会性别在医学中的关键作用。
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-12-18 DOI: 10.1159/000542508
Kathrin Heinrich, Marie von Lilienfeld-Toal
{"title":"The Critical Role of Sex and Gender in Medicine.","authors":"Kathrin Heinrich, Marie von Lilienfeld-Toal","doi":"10.1159/000542508","DOIUrl":"10.1159/000542508","url":null,"abstract":"","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"1-3"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854762","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}
引用次数: 0
Palbociclib in Combination with either Aromatase Inhibitors or Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer in Germany: Final Results of the Phase 2 Multicohort INGE-B Trial. Palbociclib 联合芳香化酶抑制剂或氟维司群治疗德国晚期 HR+/HER2- 乳腺癌患者--INGE-B 多队列 2 期试验的最终结果。
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-11-15 DOI: 10.1159/000542459
Manfred Welslau, Karin Potthoff, Matthias Zaiss, Lothar Müller, Cosima Brucker, Christoph Salat, Michael Untch, Johannes Meiler, Diana Lüftner, Anja Welt, Steffen Dörfel, Volker Hagen, Alexander Stein, Rüdiger Liersch, Thomas Kuhn, Hans Ulrich Siebenbach, Gerlinde Bing, Corinne Vannier, Norbert Marschner, Katja Gratzke
<p><strong>Introduction: </strong>The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. In addition, so far lacking evidence for efficacy and safety on the combination of PAL with anastrozole, exemestane (1L), or letrozole (later line) was investigated.</p><p><strong>Methods: </strong>The prospective, multicenter, multicohort phase 2 trial INGE-B enrolled adult patients with locally advanced, inoperable, or metastatic HR+/HER2- breast cancer in Germany. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Secondary endpoints were overall response rate, progression-free survival (PFS), overall survival (OS), safety, and quality of life. Data were analyzed with descriptive statistics.</p><p><strong>Results: </strong>Between 2016 and 2018, 388 patients were enrolled at 64 German sites. Among patients with measurable disease treated with PAL in 1L (n = 157), the CBR was 63.7% (100/157). Among all patients treated with PAL 1L (n = 219), PFS was 20.1 months (95% CI 14.6-24.0), and OS was 40.9 months (95% CI 35.1-49.2). The most common grade 3/4 adverse event was neutropenia (33.4% n = 77). There were no treatment-related deaths.</p><p><strong>Conclusion: </strong>The INGE-B trial demonstrated good efficacy and tolerability of PAL with letrozole (1L) or fulvestrant (first and later line) in accordance with the PALOMA trials. In addition, the so far lacking proof of efficacy and safety of PAL in combination with anastrozole or exemestane in 1L and with letrozole in later line was provided by INGE-B.</p><p><strong>Introduction: </strong>The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. In addition, so far lacking evidence for efficacy and safety on the combination of PAL with anastrozole, exemestane (1L), or letrozole (later line) was investigated.</p><p><strong>Methods: </strong>The prospective, multicenter, multicohort phase 2 trial INGE-B enrolled adult patients with locally advanced, inoperable, or metastatic HR+/HER2- breast cancer in Germany. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Secondary endpoints were overall response rate, progression-free survival (PFS), overall survival (OS), safety, and quality of life. Data were analyzed with descriptive statistics.</p><p><strong>Results: </strong>Between 2016 and 2018, 388 patients were enrolled at 64 German sites. Among patients with measurable disease treated with PAL in 1L (n = 157), the CBR was 63.7% (100/157). Among all patients treated with PAL 1L (n = 219), PFS was 20.1 months (95% CI 14.6-24.0), and OS was 40.9 months (95%
引言 INGE-B试验(NCT02894398)旨在证实PALOMA试验中帕博西尼(PAL)与来曲唑一线(1L)治疗或PAL与氟维司群一线和二线治疗患者的疗效和安全性数据。此外,还研究了帕博西尼与阿那曲唑、依西美坦(一线)或来曲唑(二线)联合用药的疗效和安全性。方法 前瞻性、多中心、多队列 2 期试验 INGE-B 在德国招募了局部晚期、无法手术或转移性 HR+/HER2- 乳腺癌成年患者。主要终点是根据RECIST v1.1标准可测量疾病患者的临床获益率(CBR)。次要终点为总反应率(ORR)、无进展生存期(PFS)、总生存期(OS)、安全性和生活质量。数据采用描述性统计进行分析。结果 2016年至2018年期间,64个德国研究机构共招募了388名患者。在接受PAL 1L治疗的可测量疾病患者中(n=157),CBR为63.7%(100/157)。在所有接受 PAL 1L 治疗的患者中(219 人),PFS 为 20.1 个月(95% CI 14.6 - 24.0),OS 为 40.9 个月(95% CI 35.1-49.2)。最常见的3/4级不良事件是中性粒细胞减少(33.4% n=77)。无治疗相关死亡病例。结论 INGE-B 试验证明,PAL 与来曲唑(1L)或氟维司群(一线和二线)的疗效和耐受性良好,与 PALOMA 试验一致。此外,INGE-B 还提供了迄今为止尚缺乏的 PAL 与阿那曲唑或依西美坦联用(一线)以及与来曲唑联用(二线)的疗效和安全性证据。
{"title":"Palbociclib in Combination with either Aromatase Inhibitors or Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer in Germany: Final Results of the Phase 2 Multicohort INGE-B Trial.","authors":"Manfred Welslau, Karin Potthoff, Matthias Zaiss, Lothar Müller, Cosima Brucker, Christoph Salat, Michael Untch, Johannes Meiler, Diana Lüftner, Anja Welt, Steffen Dörfel, Volker Hagen, Alexander Stein, Rüdiger Liersch, Thomas Kuhn, Hans Ulrich Siebenbach, Gerlinde Bing, Corinne Vannier, Norbert Marschner, Katja Gratzke","doi":"10.1159/000542459","DOIUrl":"10.1159/000542459","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. In addition, so far lacking evidence for efficacy and safety on the combination of PAL with anastrozole, exemestane (1L), or letrozole (later line) was investigated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The prospective, multicenter, multicohort phase 2 trial INGE-B enrolled adult patients with locally advanced, inoperable, or metastatic HR+/HER2- breast cancer in Germany. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Secondary endpoints were overall response rate, progression-free survival (PFS), overall survival (OS), safety, and quality of life. Data were analyzed with descriptive statistics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Between 2016 and 2018, 388 patients were enrolled at 64 German sites. Among patients with measurable disease treated with PAL in 1L (n = 157), the CBR was 63.7% (100/157). Among all patients treated with PAL 1L (n = 219), PFS was 20.1 months (95% CI 14.6-24.0), and OS was 40.9 months (95% CI 35.1-49.2). The most common grade 3/4 adverse event was neutropenia (33.4% n = 77). There were no treatment-related deaths.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The INGE-B trial demonstrated good efficacy and tolerability of PAL with letrozole (1L) or fulvestrant (first and later line) in accordance with the PALOMA trials. In addition, the so far lacking proof of efficacy and safety of PAL in combination with anastrozole or exemestane in 1L and with letrozole in later line was provided by INGE-B.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. In addition, so far lacking evidence for efficacy and safety on the combination of PAL with anastrozole, exemestane (1L), or letrozole (later line) was investigated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The prospective, multicenter, multicohort phase 2 trial INGE-B enrolled adult patients with locally advanced, inoperable, or metastatic HR+/HER2- breast cancer in Germany. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Secondary endpoints were overall response rate, progression-free survival (PFS), overall survival (OS), safety, and quality of life. Data were analyzed with descriptive statistics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Between 2016 and 2018, 388 patients were enrolled at 64 German sites. Among patients with measurable disease treated with PAL in 1L (n = 157), the CBR was 63.7% (100/157). Among all patients treated with PAL 1L (n = 219), PFS was 20.1 months (95% CI 14.6-24.0), and OS was 40.9 months (95% ","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"14-25"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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 Diagnostic Utility of cfDNA and ctDNA in Liquid Biopsies for Gastrointestinal Cancers over the Last Decade. 过去十年胃肠道癌症液体活检中 cfDNA 和 ctDNA 的诊断效用。
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-12-16 DOI: 10.1159/000543030
Nur Rahadiani, Marini Stephanie, Amelia Fossetta Manatar, Ening Krisnuhoni

Background: Cell-free DNA (cfDNA) is a fragmented DNA that is released into the blood through necrosis, apoptosis, phagocytosis, or active secretion. cfDNA includes a subclass called circulating tumor DNA (ctDNA) released from cancer cells and constitutes a varied proportion of the total cfDNA. Both cfDNA and ctDNA hold significant potential as diagnostic biomarkers in gastrointestinal cancers.

Summary: cfDNA and ctDNA are promising diagnostic biomarkers for gastrointestinal cancers with varied diagnostic values in different types of cancers. cfDNA offers higher sensitivity that makes it more suitable for screening methods and constant monitoring, particularly in integration with conventional biomarkers or in a multimarker model. On the contrary, ctDNA gives a real-time picture of tumor genetics and is more suitable for definitive diagnosis due to its specificity for tumor-associated alterations. Different types of samples and methods of detection can influence sensitivity, and the amount of cfDNA is higher in serum but plasma is used for cfDNA analysis because it contains less cellular contamination. In summary, cfDNA is more sensitive than ctDNA, although they have comparable or slightly lower specificity.

Key message: Further studies are needed to create common guidelines, minimize the cost of analysis, and perform extensive clinical trials to demonstrate the utility of circulating cfDNA and ctDNA in the vast majority of gastrointestinal cancer stages. Therefore, with the advancement in these technologies, cfDNA and ctDNA will be highly beneficial and evolve cancer diagnostics and therapy.

背景:无细胞DNA (cfDNA)是一种片段DNA,通过坏死、凋亡、吞噬或活性分泌释放到血液中。cfDNA包括一种叫做循环肿瘤DNA (ctDNA)的亚类,从癌细胞中释放出来,构成了总cfDNA的不同比例。cfDNA和ctDNA都具有作为胃肠道癌症诊断生物标志物的巨大潜力。摘要:cfDNA和ctDNA是很有前景的胃肠道肿瘤诊断标志物,在不同类型的肿瘤中具有不同的诊断价值。cfDNA具有更高的灵敏度,使其更适合筛选方法和持续监测,特别是与传统生物标志物或多标志物模型结合使用时。相反,ctDNA提供了肿瘤遗传学的实时图像,由于其对肿瘤相关改变的特异性,更适合于明确诊断。不同类型的样品和检测方法会影响灵敏度,血清中cfDNA的含量较高,但血浆用于cfDNA分析,因为它含有较少的细胞污染。总之,cfDNA比ctDNA更敏感,尽管它们的特异性相当或略低。关键信息:需要进一步的研究来制定共同的指导方针,最大限度地降低分析成本,并进行广泛的临床试验来证明循环cfDNA和ctDNA在绝大多数胃肠道癌症分期中的效用。因此,随着这些技术的进步,cfDNA和ctDNA将非常有益并发展癌症的诊断和治疗。
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引用次数: 0
Use of Follow-Up Psycho-Oncology Consultations in Urological Cancer after Transition from Inpatient to Outpatient Care. 泌尿系统癌症患者从住院治疗转为门诊治疗后,肿瘤心理咨询随访的使用情况。
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2025-01-01 Epub Date: 2024-11-07 DOI: 10.1159/000542458
Dominik Fugmann, Steffen Holsteg, Ralf Schäfer, Lars Kreuznacht, Daniela Speer, Günter Niegisch, Ulrike Dinger, André Karger
<p><strong>Introduction: </strong>In urological oncology, the physical and psychological effects of cancer and its treatment post-discharge highlight the importance of follow-up psycho-oncology consultations. This study examines their utilisation and identifies predictors in urological cancer patients after inpatient care.</p><p><strong>Methods: </strong>A prospective, single-centre clinical observational study was conducted. Inpatients with urological cancer and ≥5 points on the Distress Thermometer and/or request for psycho-oncological support were recruited, offered an initial psycho-oncology consultation, and can attend up to five online or on-site appointments within 3 months of discharge. The following variables were collected: socio-demographics, psycho-oncological baseline documentation (PO-BADO), psychosocial distress (Distress Thermometer with problem list), anxiety and depressive symptoms (GAD-2 and PHQ-2), and performance status (ECOG).</p><p><strong>Results: </strong>A total of 501 patients were screened, 139 were included, and 108 were analysed. Twenty five patients used psycho-oncological follow-up care (n = 16 online). The final hierarchical model predicting the use of follow-up psycho-oncological support included the two predictors: age (OR 0.93, 95% CI 0.90-0.96) and anxiety (OR 1.60, 95% CI 1.11-2.44).</p><p><strong>Conclusion: </strong>Nearly 1 in 4 urological cancer patients use follow-up psycho-oncology consultations, mostly online. Predictors for this usage are younger age and higher levels of anxiety. To improve care, (1) online services reduce barriers; (2) older patients require support with these services; and (3) screening specifically for depression is crucial to ensure that follow-up appointments are scheduled as a mandatory part of hospitalisation.</p><p><strong>Introduction: </strong>In urological oncology, the physical and psychological effects of cancer and its treatment post-discharge highlight the importance of follow-up psycho-oncology consultations. This study examines their utilisation and identifies predictors in urological cancer patients after inpatient care.</p><p><strong>Methods: </strong>A prospective, single-centre clinical observational study was conducted. Inpatients with urological cancer and ≥5 points on the Distress Thermometer and/or request for psycho-oncological support were recruited, offered an initial psycho-oncology consultation, and can attend up to five online or on-site appointments within 3 months of discharge. The following variables were collected: socio-demographics, psycho-oncological baseline documentation (PO-BADO), psychosocial distress (Distress Thermometer with problem list), anxiety and depressive symptoms (GAD-2 and PHQ-2), and performance status (ECOG).</p><p><strong>Results: </strong>A total of 501 patients were screened, 139 were included, and 108 were analysed. Twenty five patients used psycho-oncological follow-up care (n = 16 online). The final hierarchical model predi
背景:在泌尿肿瘤学领域,癌症及其出院后治疗对患者的身心影响凸显了肿瘤心理咨询随访的重要性。本研究探讨了泌尿系统肿瘤患者在住院治疗后对心理肿瘤咨询的利用情况,并确定了预测因素:方法:进行了一项前瞻性、单中心临床观察研究。研究招募了罹患泌尿系统癌症且压力温度计得分≥ 5 分和/或请求肿瘤心理支持的住院患者,为其提供了首次肿瘤心理咨询,并在出院后三个月内提供了多达五次在线或现场预约。该研究收集了以下变量:社会人口统计学、肿瘤心理基线文件(PO-BADO)、社会心理困扰(带有问题清单的困扰温度计)、焦虑和抑郁症状(GAD-2 & PHQ-2)以及表现状态(ECOG):共筛查了 501 名患者,纳入 139 名,分析 108 名。25名患者使用了肿瘤心理随访护理(n = 16在线)。预测使用后续肿瘤心理支持的最终层次模型包括两个预测因子:年龄(OR 0.93,95% CI 0.90-0.96)和焦虑(OR 1.60,95% CI 1.11-2.44):讨论:近四分之一的泌尿系统癌症患者使用肿瘤心理咨询随访,其中大部分是在线咨询。年龄较轻和焦虑程度较高是使用这种服务的预测因素。为了改善护理:1)在线服务减少了障碍;2)老年患者需要这些服务的支持;3)专门针对抑郁症的筛查至关重要,以确保将随访预约作为住院治疗的必备部分。
{"title":"Use of Follow-Up Psycho-Oncology Consultations in Urological Cancer after Transition from Inpatient to Outpatient Care.","authors":"Dominik Fugmann, Steffen Holsteg, Ralf Schäfer, Lars Kreuznacht, Daniela Speer, Günter Niegisch, Ulrike Dinger, André Karger","doi":"10.1159/000542458","DOIUrl":"10.1159/000542458","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;In urological oncology, the physical and psychological effects of cancer and its treatment post-discharge highlight the importance of follow-up psycho-oncology consultations. This study examines their utilisation and identifies predictors in urological cancer patients after inpatient care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A prospective, single-centre clinical observational study was conducted. Inpatients with urological cancer and ≥5 points on the Distress Thermometer and/or request for psycho-oncological support were recruited, offered an initial psycho-oncology consultation, and can attend up to five online or on-site appointments within 3 months of discharge. The following variables were collected: socio-demographics, psycho-oncological baseline documentation (PO-BADO), psychosocial distress (Distress Thermometer with problem list), anxiety and depressive symptoms (GAD-2 and PHQ-2), and performance status (ECOG).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 501 patients were screened, 139 were included, and 108 were analysed. Twenty five patients used psycho-oncological follow-up care (n = 16 online). The final hierarchical model predicting the use of follow-up psycho-oncological support included the two predictors: age (OR 0.93, 95% CI 0.90-0.96) and anxiety (OR 1.60, 95% CI 1.11-2.44).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Nearly 1 in 4 urological cancer patients use follow-up psycho-oncology consultations, mostly online. Predictors for this usage are younger age and higher levels of anxiety. To improve care, (1) online services reduce barriers; (2) older patients require support with these services; and (3) screening specifically for depression is crucial to ensure that follow-up appointments are scheduled as a mandatory part of hospitalisation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;In urological oncology, the physical and psychological effects of cancer and its treatment post-discharge highlight the importance of follow-up psycho-oncology consultations. This study examines their utilisation and identifies predictors in urological cancer patients after inpatient care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A prospective, single-centre clinical observational study was conducted. Inpatients with urological cancer and ≥5 points on the Distress Thermometer and/or request for psycho-oncological support were recruited, offered an initial psycho-oncology consultation, and can attend up to five online or on-site appointments within 3 months of discharge. The following variables were collected: socio-demographics, psycho-oncological baseline documentation (PO-BADO), psychosocial distress (Distress Thermometer with problem list), anxiety and depressive symptoms (GAD-2 and PHQ-2), and performance status (ECOG).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 501 patients were screened, 139 were included, and 108 were analysed. Twenty five patients used psycho-oncological follow-up care (n = 16 online). The final hierarchical model predi","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"4-13"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809518/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
New Insights from Long-Term Clinical Use of Circulating Tumor DNA-Based Minimal Residual Disease Monitoring in Translocation-Associated Sarcomas. 基于ctdna的微小残留疾病监测在易位相关肉瘤中的长期临床应用的新见解
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2024-12-23 DOI: 10.1159/000543223
Sophie Joch, Maria Anna Smolle, Karl Kashofer, Andrea Thüringer, Joanna Szkandera, Martin Benesch, Amin El-Heliebi, Bernadette Liegl-Atzwanger, Andreas Leithner, Markus G Seidel

Introduction: Assessment of circulating tumor DNA (ctDNA) as a means to monitor disease activity in translocation-associated tumors has become very popular in clinical practice. However, there are still few studies on its clinical application to date. Our study evaluates the clinical applicability of ctDNA as a biomarker for monitoring minimal residual disease (MRD) in patients with translocation-associated sarcomas.

Methods: In this retrospective study, we correlated 285 ctDNA samples from 34 patients diagnosed with translocation-associated sarcoma with the clinical course and images. Blood samples were collected at multiple time points during follow-up (median: 97 weeks, range: 7-398).

Results: We discovered a significant association between ctDNA levels and the clinical course of the disease, particularly noting differences between patients in remission or with progressive disease (p = 0.001). Furthermore, although we noted that ctDNA levels remained undetectable in a few cases of unilocular recurrence (n = 3), they were consistently higher in patients with multilocular recurrence (n = 14; p = 0.008).

Conclusion: Monitoring ctDNA levels provides highly specific, additional information enabling early recurrence detection in patients with translocation-associated sarcomas during the follow-up and can be integrated into clinical practice. However, MRD monitoring by ctDNA quantification alone does not allow the reliable detection of 100% of unilocular recurrences and should be complemented by the use of conventional imaging techniques.

简介:循环肿瘤DNA (ctDNA)评估作为监测易位相关肿瘤疾病活动性的手段已在临床实践中非常流行。然而,迄今为止,关于其临床应用的研究还很少。我们的研究评估了ctDNA作为监测易位相关肉瘤患者微小残留病(MRD)的生物标志物的临床适用性。方法:在这项回顾性研究中,我们将34例被诊断为易位相关肉瘤的患者的285个ctDNA样本与临床病程和图像相关联。在随访期间的多个时间点采集血样(中位数:97周,范围:7-398周)。结果:我们发现ctDNA水平与疾病的临床病程之间存在显著关联,特别是在缓解期和进展期患者之间存在差异(p = 0.001)。此外,尽管我们注意到ctDNA水平在少数单房复发患者(n = 3)中仍未检测到,但在多房复发患者中ctDNA水平始终较高(n = 14;P = 0.008)。结论:监测ctDNA水平提供了高度特异性的额外信息,可以在随访期间对易位相关肉瘤患者进行早期复发检测,并可纳入临床实践。然而,单纯通过ctDNA定量进行MRD监测并不能可靠地检测100%的单眼复发,应辅以使用常规成像技术。
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引用次数: 0
HER2(-Low) Expression on Circulating Tumor Cells and Corresponding Metastatic Tissue in Metastatic Breast Cancer. 转移性乳腺癌(MBC)循环肿瘤细胞(ctc)和相应转移组织中HER2(低)表达。
IF 2 4区 医学 Q3 ONCOLOGY Pub Date : 2024-11-28 DOI: 10.1159/000542830
Lara M Tretschock, Hannah Clemente, Katharina Smetanay, Carlo Fremd, Verena Thewes, Kathrin Haßdenteufel, Anna S Scholz, Klaus Pantel, Sabine Riethdorf, Andreas Trumpp, Andreas Schneeweiss, Laura Michel, Thomas M Deutsch

Introduction: Significant progress has been made in the targeted therapy of metastatic breast cancer (mBC) in recent years. In this context, new biomarkers enable personalized therapy management and individualized therapy monitoring. Therefore, the systemic treatment is based increasingly on the biological characteristics of the tumor disease. Given the challenges of obtaining fresh tumor tissue through biopsies, the significance of liquid biopsies for assessing circulating tumor cells (CTCs) or circulating tumor DNA is of growing importance for the detection of prognostic and predictive biomarkers. Multiple studies have shown that the number of CTCs decreases under therapy, especially under anti-HER2-targeted therapy, and that the expression of the HER2 status on CTCs could play a role in predicting therapy response and therapeutic monitoring. The aim of this study was to analyze the HER2 status of CTCs in mBC patients before and after 3 months of systemic therapy to evaluate changes in the number of HER2-positive CTCs. The study focuses on HER2-low, which plays an increasingly important role in clinical practice due to new developments of HER2 targeting antibody-drug conjugates. In this context, temporal and spatial heterogeneity of the disease represent a major diagnostic challenge.

Methods: A total of 324 patients with complete immunohistochemistry of biopsied metastases were divided into five groups: HER2 negative (-)/hormone receptor (HR) negative (-), HER2 -/HR positive (+), HER2 +/HR±, HER2-low/HR+, and HER2-low/HR-. Before and after 3 months of a new therapeutic line for mBC, CTCs were enumerated and analyzed for HER2 expression using the CellSearch® system. Overall survival of all subgroups was calculated.

Results: The analyses revealed a discrepancy between the HER2 status of CTCs and corresponding tumor tissues in 98 patients (30.2%). The number of CTCs in general and the number of HER2+ CTCs decreased during systemic treatment, mainly in HER2+ tumors, but also in the other subgroups.

Conclusions: Discrepancy in the HER2 status of the metastases and of CTCs was observed in approximately one-third of patients. Measuring HER2 on CTCs could potentially offer a means to longitudinally monitor HER2 status during therapy and simultaneously address challenges such as tumor heterogeneity. Therefore, the predictive value of HER2 on CTCs should be further investigated in clinical trials.

近年来,转移性乳腺癌(mBC)的靶向治疗取得了重大进展。在这种情况下,新的生物标志物使个性化治疗管理和个性化治疗监测成为可能。因此,系统治疗越来越多地基于肿瘤疾病的生物学特性。考虑到通过活检获得新鲜肿瘤组织的挑战,液体活检对评估循环肿瘤细胞(CTCs)或循环肿瘤DNA (ctDNA)的意义对于检测预后和预测性生物标志物越来越重要。多项研究表明,在治疗过程中,尤其是在抗HER2靶向治疗过程中,CTCs的数量会减少,而HER2在CTCs上的表达状态可以在预测治疗反应和治疗监测中发挥作用。本研究的目的是分析mBC患者全身治疗3个月前后CTCs的HER2状态,以评估HER2阳性CTCs数量的变化。由于HER2靶向抗体药物偶联物(adc)的新发展,HER2-low在临床实践中发挥着越来越重要的作用。在这种情况下,疾病的时间和空间异质性是一个主要的诊断挑战。方法:将324例活检转移瘤完全免疫组化(IHC)患者分为5组:HER2阴性(-)/激素受体(HR)阴性(-)、HER2- /HR阳性(+)、HER2 +/HR +/-、HER2低/HR +和HER2低/HR -。在新的治疗方案治疗前后3个月,使用Cell-Search®系统对ctc进行计数并分析HER2表达。计算各亚组的总生存率。结果:分析显示98例(30.2%)患者ctc与相应肿瘤组织的HER2状态存在差异。在全身治疗期间,总体CTCs数量和HER2 + CTCs数量减少,主要发生在HER2 +肿瘤中,但也发生在其他亚组中。结论:在大约三分之一的患者中,转移灶和ctc的HER2状态存在差异。测量ctc上的HER2可能提供一种纵向监测治疗期间HER2状态的方法,同时解决肿瘤异质性等挑战。因此,HER2对ctc的预测价值需要在临床试验中进一步研究。
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引用次数: 0
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Oncology Research and Treatment
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