Cancer最新文献_第5页

Enhancing the quality and impact of clinical trials in soft tissue sarcoma. 提高软组织肉瘤临床试验的质量和影响力。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-25 DOI: 10.1002/cncr.35621

Stephen J Luen, Jeremy Lewin

引用次数: 0

Common strategy to diagnose endometrial cancer may not be reliable for Black women 对于黑人妇女来说，诊断子宫内膜癌的常用策略可能并不可靠。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-25 DOI: 10.1002/cncr.35594

Mary Beth Nierengarten

A common diagnostic approach to identifying endometrial cancer based on endometrial thickness (ET) may not be reliable in Black women according to a retrospective study published in JAMA Oncology.1The study found that up to 11% of the time, according to the level of ET considered, pelvic transvaginal ultrasonography (TVUS) failed to diagnose endometrial cancer in a cohort of Black women.Guidelines currently suggest that women with postmenopausal bleeding, a common sign of endometrial cancer, undergo TVUS to assess ET. An ET of 4 mm or greater is a common threshold used to indicate the need for triage for further workup with a tissue biopsy.Kemi M. Doll, MD, a gynecologic oncologist at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center, who served as the lead author of the study, says that the study is the largest to date to use actual patient encounters (real-world clinical scenarios) to assess the accuracy of endometrial thresholds from TVUS in Black women.Doll and her colleagues retrospectively reviewed ultrasound data from 10 health centers for 1494 Black women who underwent a hysterectomy, 210 of whom had endometrial cancer. At the <5-mm ET threshold, an 11.4% probability existed that someone with endometrial cancer would be classified as not having it; at the 4-mm (cumulative) threshold, the probability was 9.5%.Classic risk factors for endometrial cancer, including age, body mass index, and postmenopausal bleeding, did not improve the performance of triaging patients based on ET thickness. On the basis of these results, the authors recommend tissue sampling in all Black women who present with postmenopausal bleeding.Commenting on the study, an editorial board member (who has chosen to remain anonymous) of the journal Cancer noted the limitations of the study, including its retrospective design (which carries the potential for bias) and the sole focus on Black women. “My concern is that this is presented in a Black-only cohort, inferring that it is not the case in non-Black women, which is not necessarily the case,” she says. “If this was a larger study of an unbiased group of women, and they showed a differential outcome of this screening in Black women matched for non-Black women, then I would be jumping on it.”Dr Doll says that the focus on Black women is a strength of the study “given that studies on which current ACOG [American College of Obstetricians and Gynecologists] guidelines are based did not include Black women, and in subsequent work, their numbers were exceedingly small.”She also emphasizes that the primary limitation of the study is that it included only women in whom endometrial cancer had been identified after hysterectomy and did not include women with abnormal uterine bleeding who had not undergone a hysterectomy. “This means the noncancer group is likely more symptomatic than the general

根据发表在《美国医学会肿瘤学杂志》（JAMA Oncology）上的一项回顾性研究，一种基于子宫内膜厚度（ET）来识别子宫内膜癌的常见诊断方法在黑人妇女中可能并不可靠。1 该研究发现，根据所考虑的ET水平，在一组黑人妇女中，盆腔经阴道超声波检查（TVUS）未能诊断出子宫内膜癌的比例高达11%。华盛顿大学医学院和弗雷德-哈钦森癌症中心（Fred Hutchinson Cancer Center）的妇科肿瘤学家、医学博士凯米-多尔（Kemi M. Doll）是这项研究的主要作者，她说，这项研究是迄今为止使用实际患者情况（真实世界的临床场景）评估黑人妇女 TVUS 子宫内膜阈值准确性的最大规模研究。多尔和她的同事回顾性地查看了来自10个医疗中心的1494名接受子宫切除术的黑人妇女的超声数据，其中210人患有子宫内膜癌。在<5毫米的ET阈值下，子宫内膜癌患者被归类为未患子宫内膜癌的概率为11.4%；在4毫米（累积）的阈值下，概率为9.5%.子宫内膜癌的经典风险因素，包括年龄、体重指数和绝经后出血，并不能改善根据ET厚度对患者进行分流的效果。基于这些结果，作者建议对所有绝经后出血的黑人妇女进行组织采样。《癌症》杂志的一位编委（选择匿名）在评论该研究时指出了该研究的局限性，包括其回顾性设计（可能存在偏差）和只关注黑人妇女。"她说："我担心的是，这项研究仅以黑人队列为对象，推断非黑人妇女的情况并非如此，但事实未必如此。"Doll 博士说，"鉴于目前 ACOG（美国妇产科医师学会）指南所依据的研究并不包括黑人妇女，而且在随后的工作中，黑人妇女的人数也少得可怜，因此关注黑人妇女是这项研究的优势所在。"她还强调，这项研究的主要局限性在于，它只包括子宫切除术后发现子宫内膜癌的妇女，而不包括未接受子宫切除术的异常子宫出血妇女。"她说："这意味着非癌症组的症状可能比一般出血妇女更严重。"不过，这并不会改变子宫内膜癌组的构成，她们都会接受子宫切除术，因此也不会改变子宫内膜厚度分析的准确性"。

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引用次数: 0

First person profile: Robert L. Ferris, MD, PhD 第一人简介：罗伯特-L-费里斯医学博士Robert L. Ferris是最早开展新辅助试验以了解免疫疗法药物的免疫作用机制的人之一。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-25 DOI: 10.1002/cncr.35593

Mary Beth Nierengarten

Early in his oncology career, Robert L. Ferris, MD, PhD, was talking with one of his mentors about his research on cellular therapies and challenges to making immunotherapy work, specifically in head and neck cancers—his specialty. The mentor was Olivera (Olja) J. Finn, PhD, founding chair of the Department of Immunology at the University of Pittsburgh, where Dr Ferris had started his oncology career 5 years earlier. It was 2006, and cetuximab had just been approved. “We knew cetuximab benefitted about 15–20% of patients, but we couldn’t figure out who they were or why they benefitted,” he says.That conversation sent him on a new track to find out. He became one of the first adopters of developing neoadjuvant trials to understand the immune mechanisms of action of immunotherapy agents in what he calls “reversing direction” from his prior research attempts. His former research focused on making immunotherapy and dendritic cells work by taking an active agent in the clinic and elucidating its mechanism of action. His initial “splash,” as he refers to it, was to show that cetuximab has immune mechanisms of action in a set of patients via natural killer cells, dendritic cells, and lymphocytes.1Years later, he continues to be part of the now vibrant community of physician–scientists who are using the neoadjuvant operative platform to more quickly and efficiently understand the mechanisms behind why some immunotherapy agents work in some patients and not in others. The approach harnesses his surgical practice and drives his laboratory work.His laboratory is extending this work into looking at why some patients with recurrent metastatic head and neck cancer benefit from the anti–programmed death 1 (PD-1) monoclonal antibody nivolumab, as demonstrated in the pivotal phase 3 CHECKMATE 141 trial,2 of which Dr Ferris was the lead author. The trial was the first positive phase 3 trial showing a benefit of immunotherapy for head and neck cancer and led to the US Food and Drug Administration’s approval of nivolumab for head and neck cancers.3More recently, his laboratory has been trying to figure out how combining PD-1 with other agents may improve responses and develop biomarkers. In a current trial that has accrued approximately 80 patients and is looking at immunotherapy as a single or double antibody, he and his team are finding that different immunotherapies use various pathways and mechanisms to arrive at the same destination—getting the immune system’s cells to a similar final activity level. “The neoadjuvant approach is helping us obtain a really sophisticated and elegant insight into the tumor microenvironment where there are 30-40 cell populations being modulated and interacting in a way that we would not understand without this approach,” Dr Ferris says.In October 2024, Dr Ferris took on a new position as the executive director of the Univer

Ferris 博士一直从事与 HPV 相关的头颈部癌症研究工作，他曾担任两项前瞻性随机试验的首席研究员。其中一项试验研究了通过减少经口机器人手术或激光手术治疗 HPV 阳性口咽癌患者的放射剂量来加强手术治疗的可能性（ECOG 3311）。第二项研究使用了 "高危 "HPV阴性癌的分子生物标志物，比较了在p53发生破坏性或非破坏性改变的患者中单纯辅助放射与顺铂和放射联合治疗的效果（ECOG-ACRIN 3132）。Ferris博士将继续从事由美国国立卫生研究院资助的研究和在UNC的临床实践，但他的大部分时间将用于领导Lineberger综合癌症中心的发展和监督。他还希望在研究三角区发起并领导一条综合肿瘤服务线，并最终在整个北卡罗来纳州为 UNC 医疗系统服务。从艾滋病毒到癌症的转折发生在 20 世纪 90 年代初，他对免疫学的浓厚兴趣助长了这一转折。他说，"当我回首往事时，如果有人把自己的职业生涯投身于不奏效的事情上，那他一定是疯了，"他指的是当时肿瘤学界对免疫疗法的看法。然而，他坚定了信念，30 年后的今天，免疫疗法 "真正成为了第四种治疗方式，并改善了癌症患者的生存结果和生活质量"，他说。在费里斯博士决定从以病毒为重点的免疫学转向以癌症为重点的免疫学的同时，与人乳头瘤病毒相关的头颈部癌症也被发现，这是一个偶然的转机。Ferris博士说："我认为运气总是眷顾有准备的人。"回到母校联合国大学，Ferris博士觉得 "超现实"。作为一名外交官，他打算保持中立的欢呼声，但正如他在匹兹堡所做的那样，他将穿上匹兹堡的 T 恤，戴上 UNC 的帽子，并在中场休息时互换。

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引用次数: 0

Women with more severe forms of endometriosis have a nearly 10-fold higher risk of ovarian cancer 患有较严重子宫内膜异位症的妇女罹患卵巢癌的风险要高出近 10 倍。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-25 DOI: 10.1002/cncr.35595

Mary Beth Nierengarten

Women with a history of endometriosis have a nearly 4-fold higher risk of ovarian cancer than those without one, and those with more severe forms of the disease, namely ovarian endometriomas and deep infiltrating endometriosis, have a nearly 10-fold higher risk, according to a population-based cohort study published in JAMA.1The study also found that women with any kind of endometriosis (e.g., low-grade serous, clear cell, mucinous, and endometrioid) had more than 7 times the risk of developing type 1 ovarian cancer. Those with deep infiltrating endometriosis or ovarian endometriomas had nearly 19 times the risk of developing type 1 ovarian cancer.“As an epidemiologist, seeing numbers like that is really striking,” says Karen Schliep, PhD, MSPH, associate professor in the Department of Family and Preventive Medicine at the University of Utah Health and senior author of the study. In a press release, she compared the 19-fold increased risk to the risk for lung cancer seen with smoking.2Schliep and her colleagues used data from the Utah Population Database to assess the association of endometriosis with the incidence of ovarian cancer, overall and by subtype, as well as the associated ovarian cancer histotype. Women with a history of endometriosis were identified through electronic health records and the cases then categorized by type (superficial endometriosis, ovarian endometriomas, deep infiltrating endometriosis, or other). The retrospective cohort included nearly 79,000 women with endometriosis matched 1:5 with women without endometriosis.A total of 597 women developed ovarian cancer between 1992 and 2019, as recorded in the Utah Cancer Registry; these cancers included high-grade serous carcinoma, low-grade serous carcinoma, endometrioid mucinous carcinoma, clear cell carcinoma, and carcinosarcoma. Among the women without a history of endometriosis, ovarian cancers were evenly distributed among these most common histotypes. Overall, all ovarian cancer histotypes were more common in the women with a history of endometriosis.“This study confirms an elevated risk of epithelial ovarian cancer in patients with a history of endometriosis, mainly due to an increased risk of non-high grade serous histologic subtypes, including endometrioid and clear cell carcinomas,” says Kari L. Ring, MD, a gynecologic oncologist at UVA Health.Dr Ring calls it “interesting” that the highest risk for ovarian cancer was found in patients with ovarian involvement of endometriomas and deep infiltrating disease. “This raises several questions, including whether advanced endometriosis represents progression along the continuum of the malignant transformation of endometriosis or whether more advanced disease may have a higher risk of residual endometriosis following surgical intervention,” she says.Dr Ring says that the findings underscore the need for physicians to ha

根据发表在《美国医学会杂志》（JAMA）1 上的一项基于人群的队列研究，有子宫内膜异位症病史的妇女患卵巢癌的风险比无子宫内膜异位症病史的妇女高出近 4 倍，而那些患有更严重形式的子宫内膜异位症（即卵巢子宫内膜瘤和深部浸润性子宫内膜异位症）的妇女患卵巢癌的风险高出近 10 倍。研究还发现，患有任何一种子宫内膜异位症（如低度浆液性、透明细胞性、粘液性和类子宫内膜异位症）的妇女罹患 1 型卵巢癌的风险是普通妇女的 7 倍多。患有深部浸润性子宫内膜异位症或卵巢子宫内膜异位症的人患 1 型卵巢癌的风险几乎是后者的 19 倍。"作为一名流行病学家，看到这样的数字确实令人震惊，"犹他大学健康学院家庭与预防医学系副教授、该研究的资深作者 Karen Schliep 博士说。2 Schliep 和她的同事利用犹他州人口数据库的数据评估了子宫内膜异位症与卵巢癌发病率的关系，包括总体发病率和亚型发病率，以及相关的卵巢癌组织类型。研究人员通过电子健康记录确定了有子宫内膜异位症病史的妇女，然后按类型（浅表子宫内膜异位症、卵巢子宫内膜异位症、深部浸润性子宫内膜异位症或其他）对病例进行了分类。根据犹他州癌症登记处的记录，1992 年至 2019 年期间，共有 597 名妇女罹患卵巢癌；这些癌症包括高级别浆液性癌、低级别浆液性癌、子宫内膜样粘液癌、透明细胞癌和癌肉瘤。在没有子宫内膜异位症病史的妇女中，卵巢癌在这些最常见的组织类型中分布均匀。这项研究证实，有子宫内膜异位症病史的患者罹患上皮性卵巢癌的风险升高，这主要是由于非高级别浆液性组织学亚型（包括子宫内膜样癌和透明细胞癌）的风险升高所致。Ring 博士称，"有趣的是"，子宫内膜异位症和深度浸润性疾病累及卵巢的患者患卵巢癌的风险最高。"她说："这就提出了几个问题，包括晚期子宫内膜异位症是否代表子宫内膜异位症恶性转化的连续进展，或者更晚期的疾病在手术干预后是否会有更高的子宫内膜异位症残留风险。Ring 博士说，这些发现强调了医生有必要 "在对子宫内膜异位症进行手术干预时，[与患者]就输卵管切除术的风险和益处进行知情讨论，包括讨论卵巢癌的可能风险，尤其是对已知有深度浸润病灶和卵巢受累的患者"。

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引用次数: 0

Expression of Concern: Overexpression of Synuclein-γ in Pancreatic Adenocarcinoma. 关注表达：胰腺腺癌中 Synuclein-γ 的过度表达。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-24 DOI: 10.1002/cncr.35605

引用次数: 0

Anticipation in families with MLH1-associated Lynch syndrome. 与 MLH1 相关的林奇综合征家族的预后。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-22 DOI: 10.1002/cncr.35589

Arti S Pandey, Christine Drogan, Dezheng Huo, Kristen Postula, Shreshtha M Garg, Sonia S Kupfer

Background: Lynch syndrome (LS) is an autosomal-dominant, hereditary cancer predisposition syndrome caused by pathogenic variants (PVs) in one of the mismatch-repair genes MLH1, MSH2/EPCAM, MSH6, or PMS2. Individuals who have MLH1 PVs have high lifetime risks of colorectal cancer (CRC) and endometrial cancer (EC). There is controversy regarding whether a younger age at diagnosis (or anticipation) occurs in MLH1-associated LS. The objective of this study was to assess anticipation in families with MLH1-associated LS by using statistical models while controlling for potential confounders.

Methods: Data from 31 families with MLH1 PVs were obtained from an academic registry. Wilcoxon signed-rank tests on parent-child-pairs as well as parametric Weibull and semiparametric Cox proportional hazards and Cox mixed-effects models were used to calculate hazard ratios or to compare mean ages at CRC/EC diagnosis by generation. Models were also corrected for ascertainment bias and birth-cohort effects.

Results: A trend toward younger ages at diagnosis of CRC/EC in successive generations, ranging from 3.2 to 15.7 years, was observed in MLH1 PV carrier families. A greater hazard for cancer in younger generations was not precluded by the inclusion of birth cohorts in the model. Individuals who had MLH1 variants with no Mlh1 activity were at a 78% greater hazard for CRC/EC than those who retained Mlh1 activity.

Conclusions: The current results demonstrated evidence in support of anticipation in families with MLH1-associated LS across all statistical models. Mutational effects on Mlh1 activity influenced the hazard for CRC/EC. Screening based on the youngest age of cancer diagnosis in MLH1-LS families is recommended.

背景：林奇综合征（LS）是一种常染色体显性遗传性癌症易感综合征，由错配修复基因 MLH1、MSH2/EPCAM、MSH6 或 PMS2 中的一个基因的致病变异（PVs）引起。具有 MLH1 PV 的个体一生中患结直肠癌（CRC）和子宫内膜癌（EC）的风险很高。关于MLH1相关LS的诊断（或预后）年龄是否会更小，目前还存在争议。本研究的目的是在控制潜在混杂因素的同时，利用统计模型评估MLH1相关LS家族的预后情况：方法：从一个学术登记处获得了31个MLH1 PV家族的数据。父母-子女配对的Wilcoxon符号秩检验以及参数Weibull和半参数Cox比例危险模型和Cox混合效应模型用于计算危险比或比较各代CRC/EC诊断的平均年龄。模型还对确诊偏差和出生队列效应进行了校正：结果：在 MLH1 PV 携带者家族中，发现 CRC/EC 诊断年龄有逐代降低的趋势，从 3.2 岁到 15.7 岁不等。在模型中加入出生队列并不排除年轻一代患癌症的风险更大。与保留 Mlh1 活性的人相比，具有 MLH1 变异但没有 Mlh1 活性的人患 CRC/EC 的风险高出 78%：目前的研究结果表明，在所有统计模型中，都有证据支持对MLH1相关LS家族的预测。Mlh1活性的突变效应影响了CRC/EC的发病风险。建议根据MLH1-LS家族癌症诊断的最小年龄进行筛查。

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引用次数: 0

Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE): A randomized controlled trial. 有氧运动与膀胱癌妇女的认知功能（ACTIVATE）：随机对照试验。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-21 DOI: 10.1002/cncr.35540

Jennifer Brunet, Sitara Sharma, Kendra Zadravec, Monica Taljaard, Nathalie LeVasseur, Amirrtha Srikanthan, Kelcey A Bland, Elham Sabri, Barbara Collins, Sherri Hayden, Christine Simmons, Andra M Smith, Kristin L Campbell

Background: As the prevalence of chemotherapy-related cognitive impairment rises, investigation into treatment options is critical. The objectives of this study were to test the effects of an aerobic exercise intervention initiated during chemotherapy compared to usual care (wait list control condition) on (1) objectively measured cognitive function and self-reported cognitive function, as well as on (2) the impact of cognitive impairment on quality of life (QOL) postintervention (commensurate with chemotherapy completion).

Methods: The Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial was a two-arm, two-center randomized controlled trial conducted in Ottawa and Vancouver (Canada). Fifty-seven women (M_age, 48.8 ± 10 years) diagnosed with stage I-III breast cancer and awaiting chemotherapy were randomized to aerobic exercise initiated with chemotherapy (n_EX = 28) or usual care during chemotherapy with aerobic exercise after chemotherapy completion (n_UC = 29). The intervention lasted 12-24 weeks and consisted of supervised aerobic training and at-home exercise. The primary outcome was objective cognitive function measured via 13 neuropsychological tests (standardized to M ± SD, 0 ± 1); secondary outcomes of self-reported cognitive function and its impact on QOL were assessed via questionnaires. Data collected pre- and postintervention (the primary end point) were analyzed.

Results: Although no significant differences between groups were found for objective cognitive function outcomes postintervention after accounting for multiple testing, four of six self-reported cognitive function outcomes showed significant differences favoring the aerobic exercise group.

Conclusions: Among women initiating chemotherapy for breast cancer, aerobic exercise did not result in significant differences in objective cognitive function postintervention after chemotherapy completion; however, the results do support the use of this intervention for improving self-reported cognitive function and its impact on QOL.

背景：随着化疗相关认知障碍发病率的上升，研究治疗方案至关重要。本研究的目的是测试化疗期间开始的有氧运动干预与常规护理（候补对照）相比，对（1）客观测量的认知功能和自我报告的认知功能，以及（2）干预后（与化疗完成时间一致）认知功能障碍对生活质量（QOL）的影响：有氧运动与前列腺癌女性患者认知功能（ACTIVATE）试验是一项双臂、双中心随机对照试验，分别在加拿大渥太华和温哥华进行。57名确诊为I-III期乳腺癌并等待化疗的妇女（年龄为48.8 ± 10岁）被随机分配到在化疗期间进行有氧运动（nEX = 28）或在化疗期间进行常规护理并在化疗结束后进行有氧运动（nUC = 29）。干预措施持续12-24周，包括有指导的有氧训练和居家锻炼。主要结果是通过 13 项神经心理学测试测量的客观认知功能（标准化为 M ± SD，0 ± 1）；次要结果是通过问卷评估自我报告的认知功能及其对 QOL 的影响。对干预前和干预后（主要终点）收集的数据进行了分析：结果：尽管经多重测试后，干预后客观认知功能结果在组间无明显差异，但在六项自我报告的认知功能结果中，有四项结果显示有氧运动组有明显优势：结论：在开始接受乳腺癌化疗的妇女中，有氧运动并没有在化疗结束后的干预后客观认知功能方面产生显著差异；但是，结果确实支持使用这种干预来改善自我报告的认知功能及其对 QOL 的影响。

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引用次数: 0

Erratum to "Unhealthy lifestyle behaviors, overweight, and obesity among childhood cancer survivors in the Netherlands: A DCCSS LATER study. 对 "荷兰儿童癌症幸存者的不健康生活方式行为、超重和肥胖 "的勘误：DCCSS LATER 研究。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-21 DOI: 10.1002/cncr.35604

引用次数: 0

Phase 2 trial of avelumab in combination with gemcitabine in advanced leiomyosarcoma as a second-line treatment (EAGLES, Korean Cancer Study Group UN18-09). 阿维单抗联合吉西他滨治疗晚期良性骨髓肉瘤作为二线治疗的 2 期试验（EAGLES，韩国癌症研究小组 UN18-09）。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-18 DOI: 10.1002/cncr.35609

Miso Kim, Yu Jung Kim, Koung Jin Suh, Se Hyun Kim, Jeong Eun Kim, Juhyeon Jeong, Jung Yong Hong, Jeeyun Lee, Su Jin Lee, Sung Yong Oh, Jung Hoon Kim, Gyeong-Won Lee, Mi Sun Ahn, Wonyoung Choi, Yoon Ji Choi, Taebum Lee, Chiyoon Oum, Jeongkyu Kim, Young Saing Kim, Jin-Hee Ahn

Background: In this single-arm, multicenter, phase 2 trial, the authors evaluated the efficacy and safety of avelumab plus gemcitabine in patients with leiomyosarcoma (LMS) who failed on first-line chemotherapy.

Methods: Patients with advanced LMS received avelumab 10 mg/kg on days 1 and 15 (for up to 24 months) plus gemcitabine 1000 mg/m² on days 1, 8, and 15 of a 28-day cycle until they developed disease progression or intolerable toxicity. The primary end point was the objective response rate (ORR).

Results: In total, 38 patients were enrolled. Of these, 35 patients were evaluable, and the ORR was 20% (95% confidence interval; [CI], 8%-37%). The disease control rate was 71%, and the median duration of response was 21.8 months (range, 7.6 to ≥43.3 months). The median progression free-survival was 5.6 months (95% CI, 4.5-6.8 months), and the median overall survival was 27.5 months (95% CI, 20.4-34.6 months). Grade 3-4 adverse events occurred in 70% of patients, of which neutropenia was the most common (54%). Immune-mediated adverse events occurred in five patients (14%; hypothyroidism, n = 3; hepatitis, n = 2). Patients who had a higher density of tumor-infiltrating lymphocytes (greater than the median) exhibited better ORR (35% vs. 8%; p = .104), progression-free survival (median, 7.3 vs. 3.3 months; p = .024), and overall survival (median, not reached vs. 21.5 months; p = .027).

Conclusions: The combination of avelumab and gemcitabine demonstrated promising efficacy and manageable safety in patients with advanced LMS who progressed on first-line therapy. Tumor-infiltrating lymphocyte density may be an important factor in predicting the response to combining immunotherapy with chemotherapy.

研究背景在这项单臂、多中心、2期试验中，作者评估了阿维单抗加吉西他滨治疗一线化疗失败的亮肌肉瘤（LMS）患者的有效性和安全性：晚期LMS患者在第1天和第15天接受阿维单抗10 mg/kg（最长24个月），同时在28天周期的第1天、第8天和第15天接受吉西他滨1000 mg/m2，直到疾病进展或出现不可耐受的毒性。主要终点是客观反应率（ORR）：共有 38 名患者入组。结果：共有 38 名患者入组，其中 35 名患者可接受评估，客观反应率为 20%（95% 置信区间：8%-37%）。疾病控制率为71%，中位应答持续时间为21.8个月（范围为7.6至≥43.3个月）。中位无进展生存期为5.6个月（95% CI，4.5-6.8个月），中位总生存期为27.5个月（95% CI，20.4-34.6个月）。70%的患者出现了3-4级不良反应，其中以中性粒细胞减少最为常见（54%）。5名患者（14%；甲状腺功能减退，3人；肝炎，2人）出现了免疫介导的不良反应。肿瘤浸润淋巴细胞密度较高（高于中位数）的患者的ORR（35% vs. 8%；p = .104）、无进展生存期（中位数，7.3个月 vs. 3.3个月；p = .024）和总生存期（中位数，未达到 vs. 21.5个月；p = .027）均较好：结论：阿韦鲁单抗和吉西他滨联合疗法对一线治疗进展的晚期LMS患者具有良好的疗效和可控的安全性。肿瘤浸润淋巴细胞密度可能是预测免疫疗法与化疗联合治疗反应的一个重要因素。

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引用次数: 0

Reproductive autonomy and breastfeeding in young breast cancer survivors. 年轻乳腺癌幸存者的生殖自主权和母乳喂养。

IF 6.1 2区医学 Q1 ONCOLOGY

Cancer

Pub Date : 2024-10-18 DOI: 10.1002/cncr.35602

Fedro A Peccatori, Romana Prosperi Porta, Hatem A Azim

引用次数: 0