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NTRK fusion-positive cancer in nonagenarian patient. The importance of comprehensive geriatric assessment in older people for the inclusion in clinical trials 九旬癌症患者NTRK融合阳性。老年人综合老年评估对纳入临床试验的重要性。
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-06-01 DOI: 10.1053/j.seminoncol.2023.06.001
Patricia López Pardo , Miguel Soria Tristán , Mercedes Margarita Cavanagh Podesta , Santos Enrech Francés
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引用次数: 0
Bleeding risk with concomitant administration of VEGF-TKIs and anticoagulant agents 伴有VEGF TKIs和抗凝剂给药的出血风险。
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-06-01 DOI: 10.1053/j.seminoncol.2023.05.002
Melina Verso , Andres Munoz , Giancarlo Agnelli

Anti-cancer treatment is considered an independent risk factor for emergent bleeding during anticoagulant treatment in patients with cancer-associated thrombosis. This increased bleeding risk is perceived as major concern particularly when tyrosine kinase inhibitors (TKIs) targeting the vascular endothelial derived growth factor receptor (VEGFR-TKIs) are co-administered with anticoagulants. We evaluated the effects of the combined administration of a VEGF-TKI and the oral direct anticoagulant (apixaban) or the low-molecular weight-heparin dalteparin in a sub-analysis of the Caravaggio study in patients with a diagnosis of cancer patients with venous thromboembolism. The rate of major bleeding was 4.2% in the 668 patients who received any type of anti-cancer treatment and 3.5% in the 487 patients who did not receive any anti-cancer treatment. The relative risk for patients treated with a VEGF-TKI was 1.58 (95% CI: 0.69–3.68), compared to patients treated with anticancer agents other than a VEGF-TKI and 1.73 (95% CI: 0.73–4.07) compared to patients who did not receive any anticancer treatment. The administration of a VGEF-TKI did not have any impact on the recurrence rate of venous thromboembolism. We observed a numerically not statistically significant increase in major bleeding events in patients on concurrent VEGF-TKI and therapeutic anticoagulation with no excess in those who received apixaban. Further prospective well-designed studies are needed to evaluate whether the concomitant administration of VGEF-TKI and anticoagulant agents may result in an increase of bleeding in patients with a diagnosis of cancer treated for venous thromboembolism.

在癌症相关血栓形成患者的抗凝治疗中,抗癌治疗被认为是突发出血的独立危险因素。这种出血风险的增加被认为是主要的问题,特别是当靶向血管内皮衍生生长因子受体(VEGFR TKIs)的酪氨酸激酶抑制剂(TKIs)与抗凝剂联合给药时。在Caravaggio研究的亚分析中,我们评估了VEGF-TKI与口服直接抗凝剂(阿哌沙班)或低分子量肝素达替帕林联合用药对诊断为癌症静脉血栓栓塞患者的影响。668名接受任何类型抗癌治疗的患者中,大出血率为4.2%,487名未接受任何抗癌治疗的病人中,大流血率为3.5%。与用VEGF-TKI以外的抗癌剂治疗的患者相比,用VEGF-TKI治疗的患者的相对风险为1.58(95%置信区间:0.69-3.68),与未接受任何抗癌治疗的患者比较,相对风险为1.73(95%可信区间:0.73-4.07)。VGEF-TKI的给药对静脉血栓栓塞的复发率没有任何影响。我们观察到,在同时接受VEGF-TKI和治疗性抗凝治疗的患者中,主要出血事件在数字上没有统计学意义的增加,而在接受阿哌沙班的患者中没有过量。需要进一步的前瞻性精心设计的研究来评估VGEF-TKI和抗凝剂的联合用药是否会导致诊断为癌症静脉血栓栓塞治疗患者出血增加。
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引用次数: 0
Acute liver failure secondary to malignant infiltration: A single center experience 继发于恶性浸润的急性肝衰竭:单中心经验。
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-06-01 DOI: 10.1053/j.seminoncol.2023.05.003
Rocío González Grande, Ana Bravo Aranda, Inmaculada Santaella Leiva, Susana López Ortega, Miguel Jiménez Pérez

Acute liver failure (ALF) requires early and very precise treatment decisions for a diagnosis that is not often easy and may lead to erroneous decisions. Accordingly, we undertook a review of ALF secondary to malignant infiltration given the rarity of the condition, plus its singularity and therapeutic implications. This review should aid in establishing future frameworks for action. Analyze cases of ALF secondary to malignant infiltration in our center during the last 5 years and review the literature. We undertook a retrospective review of all cases of ALF due to malignant infiltration in our center between January 2015 and December 2019. Data were recorded on demographic characteristics, clinical presentation, type of tumor, diagnostic techniques used, treatment and evolution. We also undertook a literature review on the subject and compared the results. AFL secondary to malignant infiltration was diagnosed in five patients, four women and one man with a median age 58 years. The most common clinical presentation was jaundice. Three cases were due to infiltration by hematological tumors (non-Hodgkin lymphoma and histiocytosis), one a cholangiocarcinoma and one lung cancer. In all cases a liver biopsy was required for diagnosis, this being conclusive in four cases; diagnosis in the non-conclusive case was by analysis of the hepatectomy sample after transplantation. Three patients died due to AFL in a mean of 13.8 days, another died 5 months after diagnosis as a consequence of the tumor while the patient with a diagnosis of non-Hodgkin lymphoma and transplant recipient remains alive after a follow-up of 6 years and after receiving chemotherapy. AFL due to malignant infiltration is a very unusual condition but with a high rate of mortality. It requires a rapid and precise diagnosis given the relevant treatment options.

急性肝功能衰竭(ALF)需要尽早做出非常精确的治疗决定,因为诊断通常不容易,可能会导致错误的决定。因此,我们对继发于恶性浸润的ALF进行了综述,考虑到这种情况的罕见性,以及它的独特性和治疗意义。这一审查应有助于建立未来的行动框架。分析过去5年来我中心继发于恶性浸润的ALF病例,并回顾文献。我们对2015年1月至2019年12月期间我们中心因恶性浸润导致的所有ALF病例进行了回顾性审查。数据记录了人口统计学特征、临床表现、肿瘤类型、使用的诊断技术、治疗和演变。我们还对该主题进行了文献综述,并对结果进行了比较。5名患者被诊断为继发于恶性浸润的AFL,其中4名女性和1名男性,中位年龄58岁。最常见的临床表现是黄疸。3例是由于血液肿瘤(非霍奇金淋巴瘤和组织细胞增多症)浸润,1例是胆管癌,1例为癌症肺癌。在所有病例中,都需要进行肝活检进行诊断,这在四个病例中是决定性的;非决定性病例的诊断是通过分析移植后的肝切除样本。三名患者在平均13.8天内死于AFL,另一名患者在诊断后5个月死于肿瘤,而被诊断为非霍奇金淋巴瘤的患者和移植接受者在随访6年并接受化疗后仍然活着。恶性浸润引起的AFL是一种非常不寻常的情况,但死亡率很高。考虑到相关的治疗选择,它需要快速准确的诊断。
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引用次数: 0
TOC TOC
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-06-01 DOI: 10.1053/S0093-7754(23)00071-4
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引用次数: 0
Oral selective estrogen receptor degraders (SERDs): The new emperors in breast cancer clinical practice? 口服选择性雌激素受体降解剂(SERD):癌症临床实践中的新皇帝?
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-06-01 DOI: 10.1053/j.seminoncol.2023.08.002
Antonella Ferro , Daniele Generali , Orazio Caffo , Alessia Caldara , Delia De Lisi , Mariachiara Dipasquale , Martina Lorenzi , Sara Monteverdi , Palma Fedele , Yari Ciribilli

Endocrine therapy (ET) targeting estrogen receptor (ER) signaling is still the mainstay treatment option for early or advanced ER-positive breast cancer (BC) and may involve suppressing estrogen production by means of aromatase inhibitors or directly blocking the ER pathway through selective estrogen receptor modulators such as tamoxifen or selective estrogen receptor degraders such as fulvestrant. However, despite the availability of this armamentarium in clinical practice, de novo or acquired resistance to ET is the main cause of endocrine-based treatment failure leading to the progression of the BC. Recent advances in targeting, modulating, and degrading ERs have led to the development of new drugs capable of overcoming intrinsic or acquired ET resistance related to alterations in the ESR1 gene. The new oral selective estrogen receptor degraders, which are capable of reducing ER protein expression and blocking estrogen-dependent and -independent ER signaling, have a broader spectrum of activity against ESR1 mutations and seem to be a promising means of overcoming the failure of standard ET. The aim of this review is to summarize the development of oral selective estrogen receptor degraders, their current status, and their future perspectives.

靶向雌激素受体(ER)信号传导的内分泌治疗(ET)仍然是早期或晚期ER-阳性乳腺癌症(BC)的主要治疗选择,可能涉及通过芳香酶抑制剂抑制雌激素产生,或通过选择性雌激素受体调节剂(如他莫昔芬)或选择性雌激素受体降解剂(如富利斯特。然而,尽管这种药物在临床实践中可用,但对ET的新发或获得性耐药性是导致BC进展的内分泌治疗失败的主要原因。靶向、调节和降解ER的最新进展导致了新药的开发,这些新药能够克服与ESR1基因改变相关的内在或获得性ET耐药性。新型口服选择性雌激素受体降解剂能够降低ER蛋白表达并阻断雌激素依赖性和非依赖性ER信号传导,对ESR1突变具有更广泛的活性,似乎是克服标准ET失败的一种有前途的方法。本文综述了口服选择性雌激素受体降解剂的研究进展、现状及发展前景。
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引用次数: 0
Cancer stage and time from cancer diagnosis to first treatment during the COVID-19 pandemic 新冠肺炎大流行期间从癌症诊断到首次治疗的癌症阶段和时间
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.03.005
Diego Rodrigues Mendonça e Silva , Gisele Aparecida Fernandes , Ivan Leonardo Avelino França e Silva , Maria Paula Curado

The 2019 coronavirus disease (COVID-19) pandemic has impacted cancer care and the diagnosis of new cases of cancer. We analyzed the impact of the COVID-19 pandemic on patients with cancer by comparing the number of newly diagnosed cases, cancer stage, and time to treatment in 2020 with those in 2018, 2019, and 2021. A retrospective cohort of all cancer cases treated at A.C. Camargo Cancer Center in 2018–2021, identified from the Hospital Cancer Registry, was studied. We analyzed single and multiple primary cancer case and patient characteristics—by year and by clinical stage (early v advanced). Times from diagnosis to treatment were compared according to the most frequent tumor sites between 2020 and the other study years. Between 2018 and 2021, a total of 29,796 new cases were treated at the center including 24,891 with a single tumor and 4,905 with multiple tumors, including nonmelanoma skin cancer. The number of new cases decreased by 25% between 2018 and 2020 and 22% between 2019 and 2020, followed by an increase of about 22% in 2021. Clinical stages differed across years, with the number of new advanced cases decreasing from 17.8% in 2018 to 15.2% in 2020. Diagnoses of advanced-stage for lung and kidney cancer decreased between 2018 and 2020, while the number of thyroid and prostate cancer cases diagnosed in advanced-stages increased from 2019 to 2020. The time from diagnosis to treatment decreased between 2018 and 2020 for breast (55.5 v 48 days), prostate (87 v 64 days), cervical/uterine (78 v 55 days) and oropharyngeal (50 v 28 days) cancers. The COVID-19 pandemic affected the numbers of single and multiple cancers diagnosed in 2020. An increase in the number of advanced-stage cases diagnosed was observed only for thyroid and prostate cancer. This pattern may change in coming years due to the possibility that a significant number of cases went undiagnosed in 2020.

2019冠状病毒病(新冠肺炎)大流行影响了癌症护理和癌症新病例的诊断。我们通过将2020年新诊断病例数、癌症分期和治疗时间与2018年、2019年和2021年进行比较,分析了新冠肺炎大流行对癌症患者的影响。对2018年至2021年在A.C.卡马戈癌症中心接受治疗的所有癌症病例的回顾性队列进行了研究,这些病例来自癌症医院注册处。我们分析了单个和多个原发性癌症病例和患者特征,按年份和临床分期(早期和晚期)。根据2020年与其他研究年份之间最常见的肿瘤部位,比较了从诊断到治疗的时间。2018年至2021年间,该中心共治疗了29796例新病例,其中24891例为单一肿瘤,4905例为多发肿瘤,包括非黑色素瘤皮肤癌症。2018年至2020年间,新增病例数量下降了25%,2019年至2020年下降了22%,随后2021年增加了约22%。不同年份的临床分期不同,新的晚期病例数量从2018年的17.8%下降到2020年的15.2%。2018年至2020年间,癌症晚期诊断有所下降,而2019年至2020年晚期诊断的甲状腺和前列腺癌症病例数有所增加。2018年至2020年间,乳腺癌(55.5对48天)、前列腺癌(87对64天)、宫颈癌/子宫癌(78对55天)和口咽癌(50对28天)从诊断到治疗的时间减少。新冠肺炎大流行影响了2020年诊断出的单一和多种癌症的数量。仅甲状腺和前列腺癌症的晚期病例数有所增加。由于2020年可能有大量病例未被确诊,这种模式可能在未来几年发生变化。
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引用次数: 0
Tumor testing and treatment patterns in veterans with metastatic castration-resistant prostate cancer 退伍军人转移性去势耐受性前列腺癌症的肿瘤检测和治疗模式
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.03.001
Anna Hung , Danielle Candelieri , Yanhong Li , Patrick Alba , Brian Robison , Fatai Agiri , Cristina Perez , Kyung-Min Lee , Kara N. Maxwell , Weiyan Li , Himani Aggarwal , Kathryn Pridgen , Shelby D. Reed , Scott DuVall , Yu-Ning Wong , Julie A. Lynch

Introduction

In 2016, the Department of Veterans Affairs (VA) and Prostate Cancer Foundation (PCF) began a partnership to improve access to testing. The primary objective of this analysis was to describe the use of tumor testing and treatment patterns in Veterans who progressed to metastatic castration-resistant prostate cancer (mCRPC) from 2016 to 2021. Secondary objectives including identifying factors associated with receipt of tumor testing, and reporting HRR mutation results among a subset who were tested.

Methods and Materials

Natural language processing algorithms were applied to VA electronic health record data to identify a nationwide cohort of veterans with mCRPC. Tumor testing over time and by region were reported, alongside first-, second-, and third-line treatment patterns. Factors associated with receipt of tumor testing were identified using generalized linear mixed models with binomial distributions and logit links to account for clustering by VA facility.

Results

Of the 9,852 veterans analyzed, 1,972 (20%) received tumor testing, with 73% of testing occurring in 2020–2021. Factors associated with tumor testing included younger age, later diagnosis year, being treated in the Midwest, or Puerto Rico or other compared to the South, and being treated at a PCF-VA Center of Excellence. Fifteen percent of tests were positive for a pathogenic HRR mutation. Seventy-six percent of the study cohort received first-line treatment, and among those, a subsequent 52% received second-line treatment. A subsequent 46% received third-line treatment.

Conclusion

After the VA-PCF partnership, one-fifth of veterans with mCRPC received tumor testing, with most tests occurring in 2020–2021.

简介2016年,退伍军人事务部(VA)和癌症前列腺基金会(PCF)开始合作,以改善检测的机会。该分析的主要目的是描述2016年至2021年进展为转移性去势耐受性癌症(mCRPC)的退伍军人的肿瘤检测和治疗模式的使用情况。次要目标包括确定与接受肿瘤检测相关的因素,并报告接受检测的子集中的HRR突变结果。方法和材料将自然语言处理算法应用于退伍军人事务部的电子健康记录数据,以识别全国范围内患有mCRPC的退伍军人队列。报道了随时间和地区的肿瘤检测,以及一线、二线和三线治疗模式。使用具有二项式分布和logit链接的广义线性混合模型来确定与接受肿瘤检测相关的因素,以说明VA设施的聚类。结果在分析的9852名退伍军人中,1972人(20%)接受了肿瘤检测,73%的检测发生在2020-2021年。与肿瘤检测相关的因素包括年龄较小、诊断年份较晚、在中西部、波多黎各或其他与南部相比的地区接受治疗,以及在PCF-VA卓越中心接受治疗。15%的检测结果为致病性HRR突变阳性。76%的研究队列接受了一线治疗,其中52%接受了二线治疗。随后46%的患者接受了三线治疗。结论在VA-PCF合作后,五分之一的mCRPC退伍军人接受了肿瘤检测,大多数检测发生在2020-2021年。
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引用次数: 0
Improved outcomes in women with BRAF-mutant melanoma treated with BRAF/MEK-targeted therapy across randomized clinical trials. A systematic review and meta-analysis 随机临床试验中BRAF/MEK靶向治疗BRAF突变型黑色素瘤妇女的疗效改善。系统综述和荟萃分析
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.03.003
Laura Pala , Tommaso De Pas , Eleonora Pagan , Saverio Minucci , Chiara Catania , Nunzio Digiacomo , Emilia Cocorocchio , Daniele Laszlo , Antonio Di Muzio , Chiara Barigazzi , Erika Stucchi , Laura De Grandi , Sara Stucchi , Giuseppe Viale , Richard D. Gelber , Vincenzo Bagnardi , Fabio Conforti

Available evidence suggests that in patients with advanced BRAF V600-mutant melanoma treated with the combination of BRAF and MEK inhibitors, gender could be associated with survival outcome. We performed a systematic review and meta-analysis of all randomized clinical trials (RCTs) testing the combination of BRAF and MEK inhibitors, to assess the interaction between treatment effect and patients’ gender. We searched PubMed, MEDLINE, Embase, and Scopus, for phase II and III RCTs up to January 30, 2022. We included all RCTs that enrolled patients with BRAF V600-mutant advanced cutaneous melanoma and assessed combinations of BRAF and MEK inhibitors versus BRAF inhibitor monotherapy. Our aim was to assess differences if any in treatment efficacy between men and women, measured in terms of the differences in progression-free survival (PFS) and overall survival (OS) log-hazard ratios (log-HRs). We calculated the pooled PFS- and OS-HRs with 95% confidence intervals (CIs) in men and women using a random-effects model and assessed the heterogeneity between the estimates using an interaction test. Five RCTs that enrolled a total of 2,113 patients were included in the analysis. In women, the combination of BRAF and MEK inhibitors halved the risk of progression or death as compared with BRAF inhibitor monotherapy with a pooled PFS-HR of 0.50 (95%CI 0.41–0.61). In men, the benefit obtained with BRAF and MEK inhibitors was smaller with a pooled PFS-HR of 0.63 (95%CI 0.54–0.74), P-heterogeneity = .05. A similar trend was observed for OS where the pooled OS-HR was 0.62 (95%CI 0.48–0.80) in women and only 0.78, (95%CI 0.67–0.92) in men, P-heterogeneity = 0.11. These results support meaningful gender-based heterogeneity of response to combination of BRAF and MEK inhibitors targeted therapy in patients with advanced BRAF-mutant melanoma, that should be considered in future research to improve treatment effectiveness.

现有证据表明,在接受BRAF和MEK抑制剂联合治疗的晚期BRAF V600突变黑色素瘤患者中,性别可能与生存结果有关。我们对所有测试BRAF和MEK抑制剂组合的随机临床试验(RCT)进行了系统回顾和荟萃分析,以评估治疗效果与患者性别之间的相互作用。我们搜索了PubMed、MEDLINE、Embase和Scopus,寻找截至2022年1月30日的II期和III期随机对照试验。我们纳入了所有入选BRAF V600突变晚期皮肤黑色素瘤患者的随机对照试验,并评估了BRAF和MEK抑制剂的组合与BRAF抑制剂单一疗法的对比。我们的目的是评估男性和女性之间治疗效果的差异(如果有的话),以无进展生存期(PFS)和总生存期(OS)对数风险比(log HR)的差异来衡量。我们使用随机效应模型计算了男性和女性95%置信区间(CI)的合并PFS和OS HR,并使用交互作用测试评估了估计值之间的异质性。共纳入2113名患者的5项随机对照试验被纳入分析。在女性中,与合并PFS-HR为0.50(95%CI 0.41–0.61)的BRAF抑制剂单药治疗相比,BRAF和MEK抑制剂的联合治疗将进展或死亡风险减半。在男性中,合并PFS-HR为0.63(95%CI 0.54–0.74)的BRAF和MEK抑剂获得的益处较小,P异质性 = .05.OS也有类似的趋势,女性合并OS-HR为0.62(95%CI 0.48-0.80),男性仅为0.78(95%CI 0.67-0.92),P异质性 = 0.11.这些结果支持晚期BRAF突变型黑色素瘤患者对BRAF和MEK抑制剂联合靶向治疗的有意义的基于性别的异质性反应,应在未来的研究中考虑这一点,以提高治疗效果。
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引用次数: 0
Outcomes with panobinostat in heavily pretreated multiple myeloma patients 帕诺司他治疗重度预处理多发性骨髓瘤患者的疗效
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.03.006
Darren Pan , Tarek H. Mouhieddine , Ranjan Upadhyay , Nicole Casasanta , Angela Lee , Nicole Zubizarreta , Erin Moshier , Joshua Richter

Panobinostat is an oral pan histone-deacetylase inhibitor used in the treatment of relapsed and refractory multiple myeloma. Previously published studies of panobinostat demonstrated synergy with bortezomib but included few patients exposed to newer agent combinations (ie, panobinostat plus daratumumab or carfilzomib). Here, we report outcomes of panobinostat-based combinations at an academic medical center among patients whose disease had been heavily pretreated with modern agents. We retrospectively analyzed 105 patients with myeloma treated with panobinostat at The Mount Sinai Hospital in New York City between October 2012 and October 2021. These patients had a median age of 65 (range 37–87) and had received a median of 6 prior lines of therapy while in 53% the disease was classified as triple class refractory and in 54% the disease had high-risk cytogenetics. Panobinostat was most commonly utilized at 20 mg (64.8%) as part of a triplet (61.0%) or quadruplet (30.5%). Aside from steroids, panobinostat was most commonly administered in combination with lenalidomide, pomalidomide, carfilzomib, and daratumumab in descending order of frequency. Among the 101 response-evaluable patients, the overall response rate was 24.8%, clinical benefit rate (≥minimal response) was 36.6%, and median progression-free survival was 3.4 months. Median overall survival was 19.1 months. The most common toxicities ≥grade 3 were hematologic, primarily neutropenia (34.3%), thrombocytopenia (27.6%), and anemia (19.1%). Panobinostat-based combinations produced modest response rates in patients with heavily pretreated multiple myeloma, over half of whom had triple-class refractory disease. Panobinostat warrants continued investigation as a tolerable oral option for recapturing responses in patients whose disease has progressed after receipt of standard-of-care therapies.

Panobinostat是一种口服泛组蛋白脱乙酰酶抑制剂,用于治疗复发和难治性多发性骨髓瘤。先前发表的帕诺司他研究证明了与硼替佐米的协同作用,但很少有患者接触到新的药物组合(即帕诺司特加达拉图单抗或卡非佐米)。在这里,我们报道了在一家学术医疗中心,对那些用现代药物对疾病进行了大量预处理的患者进行基于帕诺司他的组合治疗的结果。我们回顾性分析了2012年10月至2021年10月期间在纽约市西奈山医院接受帕诺司他治疗的105名骨髓瘤患者。这些患者的中位年龄为65岁(范围为37-87),之前接受过6种治疗,53%的患者被归类为三级难治性,54%的患者具有高危细胞遗传学。Panobinostat最常用的剂量为20 mg(64.8%),作为三联体(61.0%)或四联体(30.5%)的一部分。除了类固醇外,Panobinosat最常用的药物是与来那度胺、泊马度胺、卡非佐米和达拉图单抗按频率降序联合用药。在101名可评估疗效的患者中,总有效率为24.8%,临床获益率(≥最低疗效)为36.6%,中位无进展生存期为3.4个月。中位总生存期为19.1个月。最常见的毒性≥3级是血液学,主要是中性粒细胞减少症(34.3%)、血小板减少症(27.6%)和贫血(19.1%)。基于泛诺司他的组合在严重预处理的多发性骨髓瘤患者中产生了适度的缓解率,其中超过一半的患者患有三级难治性疾病。Panobinostat值得继续研究,作为一种可耐受的口服选择,用于在接受标准护理治疗后疾病进展的患者中重新获得反应。
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引用次数: 2
Dexamethasone to prevent everolimus-induced stomatitis (Alliance MIST Trial: A221701) 地塞米松预防依维莫司诱导的口腔炎(Alliance MIST试验:A221701)
IF 4 3区 医学 Q2 ONCOLOGY Pub Date : 2023-02-01 DOI: 10.1053/j.seminoncol.2023.01.001
Kathryn J. Ruddy , David Zahrieh , Jun He , Blake Waechter , Julianne L. Holleran , Lionel D. Lewis , Selina Chow , Jan Beumer , Matthias Weiss , Nikolaos Trikalinos , Bryan Faller , Maryam Lustberg , Hope S. Rugo , Charles Loprinzi

mTOR inhibitors such as everolimus may cause oral stomatitis, often a dose-limiting toxicity. Prior clinical research has suggested that a dexamethasone mouth rinse might help prevent and/or treat this. Alliance A221701 was a randomized phase III trial of patients initiating 10 mg daily oral everolimus that compared dexamethasone mouthwash taken preventively (initial dexamethasone group) versus therapeutically (initial placebo group) to assess two coprimary endpoints: the incidence of mTOR inhibitor-associated stomatitis (mIAS), and the area under the curve (AUC) of mIAS-associated pain over an 8-week treatment period. A Fisher's exact test was used to compare the incidences while a Wilcoxon rank-sum test was used to compare the AUCs. In addition, we performed an exploratory analysis of the association of everolimus trough concentrations and toxicity using a Mann-Whitney U test. Due to slow accrual, this study closed after 39 patients were randomized (19 to upfront placebo and 20 to upfront dexamethasone). There were no significant differences between groups seen in either of the coprimary endpoints; furthermore, we found no association between whole blood everolimus trough concentrations and toxicity. Although limited by poor enrollment, the results of this study do not suggest that prophylactic dexamethasone mouthwash is superior to therapeutic dexamethasone mouthwash (initiated at the first sign of mouth pain) for reducing the incidence or severity of mIAS from everolimus.

mTOR抑制剂如依维莫司可能引起口腔口炎,通常是剂量限制性毒性。先前的临床研究表明,地塞米松漱口液可能有助于预防和/或治疗这种情况。Alliance A221701是一项针对开始每天口服10 mg依维莫司的患者的随机III期试验,该试验比较了预防性(初始地塞米松组)和治疗性(初始安慰剂组)使用的地塞米松漱口水,以及在8周治疗期内mIAS相关疼痛的曲线下面积(AUC)。Fisher精确检验用于比较发生率,而Wilcoxon秩和检验用于比较AUC。此外,我们使用Mann-Whitney U检验对依维莫司谷浓度和毒性的相关性进行了探索性分析。由于积累缓慢,这项研究在39名患者被随机分组后结束(19名患者接受安慰剂治疗,20名患者接受地塞米松治疗)。两组之间在任一共同主要终点方面均无显著差异;此外,我们发现全血依维莫司谷浓度与毒性之间没有关联。尽管受入选率低的限制,但本研究的结果并不表明,预防性地塞米松漱口水在降低依维莫司引起的mIAS的发生率或严重程度方面优于治疗性地塞米松漱漱口水(在出现口腔疼痛的第一个迹象时开始)。
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Seminars in oncology
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