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American Society of Clinical Oncology guideline update on palliative care for patients with cancer: Addressing the reality gap. 美国临床肿瘤学会癌症患者姑息治疗指南更新:解决现实差距。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-19 DOI: 10.1002/cncr.35656
Fionnuala Crowley, Cardinale B Smith, Robert M Arnold, Debora Afezolli
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引用次数: 0
Embrace with caution: The limitations of generative artificial intelligence in responding to patient health care queries. 谨慎拥抱:生成式人工智能在回应患者医疗保健询问方面的局限性。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-19 DOI: 10.1002/cncr.35651
Sarah E Leslie, Jakob A Durden, Sarah E Tevis
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引用次数: 0
Expression of Concern. 表达关切。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-19 DOI: 10.1002/cncr.35645
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引用次数: 0
Global disparities in cancer care: Bridging the gap in affordability and access to medications between high and low-income countries. 全球癌症治疗的差距:缩小高收入国家和低收入国家在药物可负担性和可获得性方面的差距。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-18 DOI: 10.1002/cncr.35590
Arafat H Tfayli, Laura N El-Halabi, Fadlo R Khuri

Background: Cancer remains a significant challenge for health care systems, despite notable progress in the field. These advancements have significant financial implications that disproportionately affect low-income countries. This review article aims to explore the present state of drug development, assessing the availability of drugs in different income countries, and proposing potential solutions to address the inequality in access to new cancer treatments.

Methods: A search was conducted on MEDLINE and PubMed on October 2, 2023 and updated on December 14, 2023, limited to English language articles.

Results: There is a projected rise in cancer cases worldwide, particularly in low-income countries where most cancer-related deaths are expected. Although the approval rate of cancer treatments has risen, their excessive cost and lack of affordability pose significant barriers to widespread access. Disparities in the costs of crucial cancer medications are influenced by geographic location and procurement connections. Potential solutions to address the inequity in drug distribution include sharing production secrets, implementing price discrimination, international funding, improved primary health care measures, and the implementation of cost-effective screening methods.

Conclusion: Preventing, screening for, and treating cancer should be a global priority with minimal differences in access to therapy among various countries.

背景:尽管在癌症领域取得了显著进展,但癌症仍然是医疗保健系统面临的重大挑战。这些进步具有重大的财务影响,对低收入国家的影响尤为严重。这篇综述文章旨在探讨药物开发的现状,评估药物在不同收入国家的可用性,并提出潜在的解决方案,以解决癌症新疗法获取不平等的问题:方法:于 2023 年 10 月 2 日在 MEDLINE 和 PubMed 上进行搜索,并于 2023 年 12 月 14 日更新,仅限于英文文章:预计全球癌症病例将会增加,尤其是在低收入国家,因为这些国家中与癌症相关的死亡人数预计最多。尽管癌症治疗方法的批准率有所上升,但其高昂的费用和负担能力严重阻碍了癌症治疗方法的普及。关键癌症药物成本的差异受到地理位置和采购关系的影响。解决药物分配不公的潜在方案包括共享生产机密、实行价格歧视、国际资助、改善初级卫生保健措施以及实施具有成本效益的筛查方法:结论:癌症的预防、筛查和治疗应成为全球优先事项,各国在获得治疗方面的差异应降到最低。
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引用次数: 0
Patient-reported persistent lymphedema and peripheral neuropathy among long-term breast cancer survivors in the Carolina Breast Cancer Study. 卡罗莱纳乳腺癌研究》中长期乳腺癌幸存者的持续性淋巴水肿和周围神经病变的患者报告。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-17 DOI: 10.1002/cncr.35650
Rina A Yarosh, Hazel B Nichols, Qichen Wang, Rachel Hirschey, Erin E Kent, Lisa A Carey, Sandra C Hayes, Adeyemi A Ogunleye, Melissa A Troester, Eboneé N Butler

Background: Improved breast cancer treatment has lengthened survival but also has long-term impacts. Lymphedema and peripheral neuropathy are treatment-related sequelae that extend into survivorship. Co-occurrence of these conditions may further impair functional well-being. Few studies have estimated the burden of these conditions among diverse survivors.

Methods: Carolina Breast Cancer Study Phase 3 enrolled survivors diagnosed between 2008 and 2013 in North Carolina. Black and younger women (aged <50 years at diagnosis) were oversampled. With the use of ≥10 years of follow-up data, the prevalence of persistent lymphedema, peripheral neuropathy, and their co-occurrence was assessed. Prevalence differences (PDs) and 95% confidence intervals (CIs) were assessed according to patient and disease characteristics.

Results: A total of 1688 survivors were included, with an average of 11.1 years (SD, 0.6) postdiagnosis. The prevalence of persistent lymphedema, peripheral neuropathy, and their co-occurrence was 18.7%, 27.7%, and 8.8%, respectively. Lymphedema was higher among those receiving a mastectomy and with >5 lymph nodes removed, and peripheral neuropathy was higher among women treated with taxane-based chemotherapy. Co-occurrence was higher among women with >5 lymph nodes removed (vs. <5; PD, 5.4; 95% CI, 2.1 to 8.8) and those treated with taxane-based chemotherapy (vs. no chemotherapy; PD, 6.8; 95% CI, 3.9 to 9.7). The burden of lymphedema (PD, 2.7; 95% CI, 0.9 to 6.3) and peripheral neuropathy (PD, 5.8; 95% CI, 1.7 to 9.9) was higher among Black than White women. The prevalence of lymphedema (PD, 1.8; 95% CI, -1.5 to 5.1) and peripheral neuropathy (PD, 4.6; 95% CI, 0.8 to 8.4) was elevated among younger compared to older women.

Conclusions: Lymphedema and peripheral neuropathy affect a substantial proportion of survivors. Interventions are needed to reduce this burden.

背景:乳腺癌治疗方法的改进延长了患者的生存期,但也带来了长期影响。淋巴水肿和周围神经病变是与治疗相关的后遗症,会延续到生存期。同时出现这些症状可能会进一步损害患者的功能。很少有研究对不同幸存者的这些疾病负担进行估算:卡罗莱纳州乳腺癌研究第三阶段招募了 2008 年至 2013 年期间在北卡罗来纳州确诊的幸存者。结果:共有 1688 名幸存者参加了该研究:共纳入了 1688 名幸存者,她们在确诊后平均生活了 11.1 年(SD,0.6)。持续性淋巴水肿、周围神经病变及其并发症的发病率分别为 18.7%、27.7% 和 8.8%。淋巴水肿在接受乳房切除术且切除淋巴结>5个的妇女中发病率较高,而周围神经病变在接受以类固醇为基础的化疗的妇女中发病率较高。在淋巴结被切除多于5个的女性中,同时发生淋巴水肿和周围神经病变的比例更高(与切除多于5个淋巴结的女性相比):淋巴水肿和周围神经病变影响了很大一部分幸存者。需要采取干预措施来减轻这一负担。
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引用次数: 0
Frequency and clinical associations of common mental disorders in adults with high-grade glioma-A multicenter study. 高级别胶质瘤成人常见精神障碍的发生率和临床关联--一项多中心研究。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-17 DOI: 10.1002/cncr.35653
Susanne Singer, Melanie Schranz, Melina Hippler, Robert Kuchen, Carolin Weiß Lucas, Jürgen Meixensberger, Michael Karl Fehrenbach, Naureen Keric, Meike Mitsdoerffer, Jens Gempt, Jan Coburger, Almuth Friederike Kessler, Jens Wehinger, Martin Misch, Julia Onken, Marion Rapp, Martin Voß, Minou Nadji-Ohl, Marcus Mehlitz, Marcos Tatagiba, Ghazaleh Tabatabai, Mirjam Renovanz

Background: One third of adults with cancer suffer from common mental disorders in addition to their malignant disease. However, it is unknown whether this proportion is the same in patients who have brain tumors and which factors modulate the risk for psychiatric comorbidity.

Methods: In a multicenter study, patients with high-grade glioma at 13 neurooncology clinics were enrolled consecutively and interviewed with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID) to diagnose common mental disorders. Predictors of psychiatric comorbidity were investigated using binary logistic regression.

Results: Six hundred ninety-one patients were interviewed. The proportion of patients who had mental disorders was 31% (95% confidence interval [CI], 28%-35%). There was evidence for an association of psychiatric comorbidity with the following factors: younger age (odds ratio [OR], 1.9; 95% CI, 1.1-3.4; p = .04), stable disease versus complete remission (OR, 1.7; 95% CI, 1.1-2.8; p = .04), lower income (OR, 1.7; 95% CI, 1.0-2.8; p = .04), living alone (OR, 1.6; 95% CI, 1.0-2.6; p = .05), fatigue (OR, 1.6; 95% CI, 1.1-2.4; p = .03), and impaired cognitive functioning (OR, 2.3; 95% CI, 1.5-3.6; p < .01). There was no evidence for independent effects of gender, histology, affected lobe, time since diagnosis, or employment status.

Conclusions: Approximately one third of adult patients with high-grade glioma may suffer from a clinically relevant common mental disorder, without notable disparity between the genders. In particular, clinicians should pay attention to possible comorbidities for cases in which patients exhibit compromised subjective cognitive function, are younger than 50 years, maintain a state of stable disease, or live alone.

背景:三分之一的成年癌症患者在患有恶性疾病的同时还患有常见的精神障碍。然而,脑肿瘤患者的这一比例是否相同,以及哪些因素会调节精神疾病合并症的风险,目前尚不清楚:在一项多中心研究中,13家神经肿瘤诊所连续招募了高级别胶质瘤患者,并采用《精神疾病诊断与统计手册》(SCID)结构化临床访谈诊断常见精神疾病。采用二元逻辑回归法研究了精神疾病合并症的预测因素:共对 691 名患者进行了访谈。患有精神障碍的患者比例为 31%(95% 置信区间 [CI],28%-35%)。8;p = .04)、收入较低(OR,1.7;95% CI,1.0-2.8;p = .04)、独居(OR,1.6;95% CI,1.0-2.6;p = .05)、疲劳(OR,1.6;95% CI,1.1-2.4;p = .03)和认知功能受损(OR,2.3;95% CI,1.5-3.6;p < .01)。没有证据表明性别、组织学、受累脑叶、确诊时间或就业状况会产生独立影响:结论:大约三分之一的高级别胶质瘤成年患者可能患有临床相关的常见精神障碍,男女之间没有明显差异。临床医生尤其应注意那些主观认知功能受损、年龄小于 50 岁、病情稳定或独居的患者可能存在的合并症。
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引用次数: 0
Desmoid tumors: Old and new drugs for a rare and challenging disease. 蝶形肿瘤:治疗罕见和挑战性疾病的新旧药物。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-15 DOI: 10.1002/cncr.35603
Bernd Kasper
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引用次数: 0
Sorafenib or anthracycline-based chemotherapy for progressive desmoid tumors. 索拉非尼或以蒽环类为基础的化疗治疗进展期类脂膜瘤。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-14 DOI: 10.1002/cncr.35647
Philippos Apolinario Costa, Arshia Arora, Yannelys Fernandez, Irvin Yi, Baylee Bakkila, Heng Tan, Priscila Barreto Coelho, Leticia Campoverde, Nicole Hardy, Steven Bialick, Andrea Espejo Freire, Gina Z D'Amato, Yu-Cherng Channing Chang, Jacob Peter Mesenger, Ty Subhawong, Andrew Haims, Michael Hurwitz, Kelly Olino, Kiran Turaga, Hari Deshpande, Jonathan Trent

Background: Desmoid tumors can cause morbidity due to local invasion, potentially being fatal when fast growth compromises vital structures. In this context, a timely treatment response is required. This study aims to compare the activity of sorafenib and anthracycline-containing regimens during the first year of treatment.

Methods: The authors conducted a multi-institutional retrospective analysis of desmoid tumor patients treated with either sorafenib or an anthracycline-containing regimen over 1 year. The primary end point was the overall response rate (ORR). The secondary end points were time to response (TTR), progression-free survival (PFS), and adverse events.

Results: From 2005 to 2022, 80 patients received sorafenib and 51 received an anthracycline-containing regimen with similar baseline characteristics. The 1-year ORR was 37% for anthracycline and 13% for sorafenib (p = .016). Median best response was -9% (range, -73 to 51) for anthracycline and -4% (range, -69 to 126) for sorafenib. Median TTR was 5.6 months (95% confidence interval [CI], 3.4-7.8) for anthracycline and 8.7 months (95% CI, 6.3-11.1) for sorafenib (p = .2). One-year PFS was 73% (95% CI, 60-86) for anthracycline and 59% (95% CI, 47-71) for sorafenib (p = .3). Common grade 1-2 adverse events for sorafenib were hand-foot syndrome (40%), diarrhea (25%), and fatigue (22%); for anthracycline, they were nausea (31%), fatigue (16%), and rash (14%). Grade 3 events were higher in the anthracycline group, 27% versus 14% (p < .05).

Conclusion: Anthracycline-based therapy provided a greater 1-year response rate than sorafenib but was associated with a higher rate of serious adverse events. Higher-risk desmoid tumors, which need a more timely response, might benefit from anthracycline-based therapies, whereas average-risk tumors could benefit from sorafenib.

背景:蝶形肿瘤可因局部浸润而导致发病,当快速生长危及重要结构时,则可能致命。在这种情况下,需要及时采取治疗对策。本研究旨在比较索拉非尼和含蒽环类药物方案在治疗第一年的活性:作者对接受索拉非尼或含蒽环类药物治疗一年以上的类脂膜瘤患者进行了一项多机构回顾性分析。主要终点是总反应率(ORR)。次要终点是反应时间(TTR)、无进展生存期(PFS)和不良事件:从2005年到2022年,80名患者接受了索拉非尼治疗,51名患者接受了含蒽环类药物治疗,基线特征相似。蒽环类药物的1年ORR为37%,索拉非尼为13%(p = .016)。蒽环类药物的中位最佳反应为-9%(范围为-73至51),索拉非尼为-4%(范围为-69至126)。蒽环类药物的中位TTR为5.6个月(95% 置信区间[CI],3.4-7.8),索拉非尼为8.7个月(95% CI,6.3-11.1)(P = .2)。蒽环类药物的一年生存率为73%(95% CI,60-86),索拉非尼为59%(95% CI,47-71)(p = .3)。索拉非尼常见的 1-2 级不良事件为手足综合征(40%)、腹泻(25%)和疲劳(22%);蒽环类药物常见的 1-2 级不良事件为恶心(31%)、疲劳(16%)和皮疹(14%)。蒽环类药物组的 3 级事件发生率较高,为 27% 对 14%(P 结论:蒽环类药物组的 3 级事件发生率高于蒽环类药物组:与索拉非尼相比,蒽环类药物治疗的 1 年应答率更高,但与较高的严重不良事件发生率相关。风险较高的类脂膜瘤需要更及时的反应,可能会从蒽环类疗法中获益,而风险一般的肿瘤则可能从索拉非尼疗法中获益。
{"title":"Sorafenib or anthracycline-based chemotherapy for progressive desmoid tumors.","authors":"Philippos Apolinario Costa, Arshia Arora, Yannelys Fernandez, Irvin Yi, Baylee Bakkila, Heng Tan, Priscila Barreto Coelho, Leticia Campoverde, Nicole Hardy, Steven Bialick, Andrea Espejo Freire, Gina Z D'Amato, Yu-Cherng Channing Chang, Jacob Peter Mesenger, Ty Subhawong, Andrew Haims, Michael Hurwitz, Kelly Olino, Kiran Turaga, Hari Deshpande, Jonathan Trent","doi":"10.1002/cncr.35647","DOIUrl":"https://doi.org/10.1002/cncr.35647","url":null,"abstract":"<p><strong>Background: </strong>Desmoid tumors can cause morbidity due to local invasion, potentially being fatal when fast growth compromises vital structures. In this context, a timely treatment response is required. This study aims to compare the activity of sorafenib and anthracycline-containing regimens during the first year of treatment.</p><p><strong>Methods: </strong>The authors conducted a multi-institutional retrospective analysis of desmoid tumor patients treated with either sorafenib or an anthracycline-containing regimen over 1 year. The primary end point was the overall response rate (ORR). The secondary end points were time to response (TTR), progression-free survival (PFS), and adverse events.</p><p><strong>Results: </strong>From 2005 to 2022, 80 patients received sorafenib and 51 received an anthracycline-containing regimen with similar baseline characteristics. The 1-year ORR was 37% for anthracycline and 13% for sorafenib (p = .016). Median best response was -9% (range, -73 to 51) for anthracycline and -4% (range, -69 to 126) for sorafenib. Median TTR was 5.6 months (95% confidence interval [CI], 3.4-7.8) for anthracycline and 8.7 months (95% CI, 6.3-11.1) for sorafenib (p = .2). One-year PFS was 73% (95% CI, 60-86) for anthracycline and 59% (95% CI, 47-71) for sorafenib (p = .3). Common grade 1-2 adverse events for sorafenib were hand-foot syndrome (40%), diarrhea (25%), and fatigue (22%); for anthracycline, they were nausea (31%), fatigue (16%), and rash (14%). Grade 3 events were higher in the anthracycline group, 27% versus 14% (p < .05).</p><p><strong>Conclusion: </strong>Anthracycline-based therapy provided a greater 1-year response rate than sorafenib but was associated with a higher rate of serious adverse events. Higher-risk desmoid tumors, which need a more timely response, might benefit from anthracycline-based therapies, whereas average-risk tumors could benefit from sorafenib.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":""},"PeriodicalIF":6.1,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Implantable cardioverter defibrillators in people dying with cancer: A SEER-Medicare analysis of ICD prevalence and association with aggressive end-of-life care. 癌症患者临终前使用植入式心律转复除颤器:SEER-Medicare 对 ICD 患病率及其与积极的临终关怀的关系的分析。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-14 DOI: 10.1002/cncr.35640
Megan A Mullins, Tianci Wang, Kathryn Shahan, Vlad G Zaha, Rachna Goswami, Melanie Sulistio, David E Gerber, Sandi L Pruitt

Introduction: The shared risk profiles for cancer and heart disease suggest many individuals with cancer may have an implantable cardioverter defibrillator (ICD). ICDs can have dramatic cancer end-of-life care implications including painful and distressing shocks. ICD prevalence and association with aggressive end-of-life care among individuals with breast, colorectal, and pancreatic cancer was evaluated using the Surveillance, Epidemiology, and End Results-Medicare dataset.

Methods: A total of 37,306 Medicare beneficiaries aged ≥66 years with stage 3 or 4 cancer who died between 2005 and 2016 were identified. ICD prevalence, ICD-related care utilization that might present opportunities to discuss end-of-life implications and association with aggressive end-of-life care (>1 emergency department visit, intensive care unit admission, >1 hospitalization, terminal hospitalization, chemotherapy, and invasive or life-extending procedures) in the last month of life was assessed using multivariable logistic regression.

Results: Among cancer decedents, 6% had an ICD. More individuals with an ICD (31%) died in the hospital than individuals without an ICD (25%; p < .001). Half (46%) of individuals with an ICD had device programming or interrogation visits that could be an opportunity for device discussion. In adjusted models, ICD presence was associated with higher odds of every indicator of aggressive end-of-life care other than chemotherapy.

Conclusion: Many older cancer decedents in the United States had an ICD, and those with ICDs received more aggressive care at the end of life. Results suggest there are opportunities to discuss ICD and goals of care, raise awareness and encourage shared decision-making for this population to ensure goal-concordant care, and improve end-of-life care quality.

导言:癌症和心脏病的共同风险特征表明,许多癌症患者可能需要植入心律转复除颤器 (ICD)。ICD 会对癌症患者的临终关怀产生巨大影响,包括令人痛苦和不安的电击。我们使用 "监测、流行病学和最终结果--医疗保险 "数据集评估了乳腺癌、结直肠癌和胰腺癌患者中 ICD 的使用率及其与积极的临终关怀的关系:方法:共确定了 37,306 名年龄≥ 66 岁、患有第 3 或第 4 期癌症并在 2005 年至 2016 年期间死亡的医疗保险受益人。采用多变量逻辑回归法评估了 ICD 患病率、ICD 相关护理利用率(可能会带来讨论临终影响的机会)以及与生命最后一个月的积极临终护理(>1 次急诊就诊、入住重症监护室、>1 次住院、临终住院、化疗、侵入性或延长生命的手术)的关联:结果:在癌症死者中,6% 的人患有 ICD。与未安装 ICD 的患者(25%)相比,安装了 ICD 的患者(31%)死于医院:在美国,许多老年癌症患者都患有 ICD,而那些患有 ICD 的患者在生命的最后阶段得到了更积极的治疗。结果表明,我们有机会讨论 ICD 和护理目标,提高对这一人群的认识并鼓励共同决策,以确保目标一致的护理,并提高临终护理质量。
{"title":"Implantable cardioverter defibrillators in people dying with cancer: A SEER-Medicare analysis of ICD prevalence and association with aggressive end-of-life care.","authors":"Megan A Mullins, Tianci Wang, Kathryn Shahan, Vlad G Zaha, Rachna Goswami, Melanie Sulistio, David E Gerber, Sandi L Pruitt","doi":"10.1002/cncr.35640","DOIUrl":"https://doi.org/10.1002/cncr.35640","url":null,"abstract":"<p><strong>Introduction: </strong>The shared risk profiles for cancer and heart disease suggest many individuals with cancer may have an implantable cardioverter defibrillator (ICD). ICDs can have dramatic cancer end-of-life care implications including painful and distressing shocks. ICD prevalence and association with aggressive end-of-life care among individuals with breast, colorectal, and pancreatic cancer was evaluated using the Surveillance, Epidemiology, and End Results-Medicare dataset.</p><p><strong>Methods: </strong>A total of 37,306 Medicare beneficiaries aged ≥66 years with stage 3 or 4 cancer who died between 2005 and 2016 were identified. ICD prevalence, ICD-related care utilization that might present opportunities to discuss end-of-life implications and association with aggressive end-of-life care (>1 emergency department visit, intensive care unit admission, >1 hospitalization, terminal hospitalization, chemotherapy, and invasive or life-extending procedures) in the last month of life was assessed using multivariable logistic regression.</p><p><strong>Results: </strong>Among cancer decedents, 6% had an ICD. More individuals with an ICD (31%) died in the hospital than individuals without an ICD (25%; p < .001). Half (46%) of individuals with an ICD had device programming or interrogation visits that could be an opportunity for device discussion. In adjusted models, ICD presence was associated with higher odds of every indicator of aggressive end-of-life care other than chemotherapy.</p><p><strong>Conclusion: </strong>Many older cancer decedents in the United States had an ICD, and those with ICDs received more aggressive care at the end of life. Results suggest there are opportunities to discuss ICD and goals of care, raise awareness and encourage shared decision-making for this population to ensure goal-concordant care, and improve end-of-life care quality.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":""},"PeriodicalIF":6.1,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142611701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial. Nivolumab 和舒尼替尼治疗晚期骨肉瘤患者:多中心、单臂、2 期试验。
IF 6.1 2区 医学 Q1 ONCOLOGY Pub Date : 2024-11-14 DOI: 10.1002/cncr.35628
Emanuela Palmerini, Antonio Lopez Pousa, Giovanni Grignani, Andres Redondo, Nadia Hindi, Salvatore Provenzano, Ana Sebio, Jose Antonio Lopez Martin, Claudia Valverde, Javier Martinez Trufero, Antonio Gutierrez, Enrique de Alava, Maria Pilar Aparisi Gomez, Lorenzo D'Ambrosio, Paola Collini, Alberto Bazzocchi, David S Moura, Toni Ibrahim, Silvia Stacchiotti, Javier Martin Broto

Background: Herein, we present the results of the phase 2 IMMUNOSARC study (NCT03277924), investigating sunitinib and nivolumab in adult patients with advanced bone sarcomas (BS).

Methods: Progressing patients with a diagnosis of BS were eligible. Treatment was comprised of sunitinib (37.5 mg/day on days 1-14, 25 mg/day afterword) plus nivolumab (3 mg/kg every 2 weeks). Primary end point was progression-free survival rate (PFSR) at 6 months based on central radiology review. Secondary end points were overall survival (OS), overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and safety.

Results: A total of 46 patients were screened, 40 patients entered the study, and 38 underwent central radiological review and were evaluable for primary end point. Median age was 47 years (range, 21-74). Histologies include 17 (43%) osteosarcoma, 14 chondrosarcoma (35%, 10 conventional, four dedifferentiated [DDCS]), eight (20%) Ewing sarcoma, and one (2%) undifferentiated pleomorphic sarcoma. The PFSR at 6 months was 42% (95% confidence interval [CI], 27-58). With a median follow-up of 39.8 months (95% CI, 37.9-41.7), the median PFS and OS were 3.8 months (95% CI, 2.7-4.8) and 11.9 months (95% CI, 5.6-18.2). ORR by RECIST was 5%, with two of 38 partial responses (one of four DDCS and one of 17 osteosarcoma), 19 of 38 (50%) stable disease, and 17 of 38 (45%) progressions. Grade ≥3 adverse events were neutropenia (six of 40, 15%), anemia (5/40, hypertension (6/40, 15%), 12.5%), ALT/AST elevation (5/40, 12.5%), and pneumonitis (1/40, 2.5%). Seventeen percent of patients discontinued treatment due to toxicity, including a treatment-related grade 5 pneumonitis CONCLUSION: The trial met its primary end point in the BS cohort with >15% of patients progression-free at 6 months. However, the toxicity profile of this regimen was relevant.

研究背景我们在此介绍 IMMUNOSARC 2 期研究(NCT03277924)的结果,该研究探讨了舒尼替尼和 nivolumab 在晚期骨肉瘤(BS)成人患者中的应用:方法:诊断为骨肉瘤的进展期患者均符合条件。治疗包括舒尼替尼(37.5 毫克/天,第 1-14 天,之后为 25 毫克/天)和 nivolumab(3 毫克/公斤,每 2 周一次)。主要终点是根据中央放射学审查结果得出的6个月无进展生存率(PFSR)。次要终点为总生存期(OS)、按实体瘤反应评估标准(RECIST)v1.1测定的总反应率(ORR)和安全性:共筛选出 46 名患者,40 名患者进入研究,38 名患者接受了中央放射学审查,并可对主要终点进行评估。中位年龄为 47 岁(21-74 岁)。组织类型包括17例(43%)骨肉瘤、14例软骨肉瘤(35%,10例为传统型,4例为去分化型[DDCS])、8例(20%)尤文肉瘤和1例(2%)未分化多形性肉瘤。6个月的PFSR为42%(95%置信区间[CI],27-58)。中位随访时间为39.8个月(95% CI,37.9-41.7),中位PFS和OS分别为3.8个月(95% CI,2.7-4.8)和11.9个月(95% CI,5.6-18.2)。根据RECIST标准,ORR为5%,38例中有2例部分反应(4例DDCS中1例,17例骨肉瘤中1例),38例中有19例(50%)病情稳定,38例中有17例(45%)病情进展。≥3级不良反应包括中性粒细胞减少(40例中有6例,占15%)、贫血(5/40、高血压(6/40,占15%,占12.5%)、ALT/AST升高(5/40,占12.5%)和肺炎(1/40,占2.5%)。17%的患者因毒性中止治疗,其中包括与治疗相关的5级肺炎 结论:该试验在BS队列中达到了主要终点,超过15%的患者在6个月时无进展。然而,该疗法的毒性也是相关的。
{"title":"Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial.","authors":"Emanuela Palmerini, Antonio Lopez Pousa, Giovanni Grignani, Andres Redondo, Nadia Hindi, Salvatore Provenzano, Ana Sebio, Jose Antonio Lopez Martin, Claudia Valverde, Javier Martinez Trufero, Antonio Gutierrez, Enrique de Alava, Maria Pilar Aparisi Gomez, Lorenzo D'Ambrosio, Paola Collini, Alberto Bazzocchi, David S Moura, Toni Ibrahim, Silvia Stacchiotti, Javier Martin Broto","doi":"10.1002/cncr.35628","DOIUrl":"https://doi.org/10.1002/cncr.35628","url":null,"abstract":"<p><strong>Background: </strong>Herein, we present the results of the phase 2 IMMUNOSARC study (NCT03277924), investigating sunitinib and nivolumab in adult patients with advanced bone sarcomas (BS).</p><p><strong>Methods: </strong>Progressing patients with a diagnosis of BS were eligible. Treatment was comprised of sunitinib (37.5 mg/day on days 1-14, 25 mg/day afterword) plus nivolumab (3 mg/kg every 2 weeks). Primary end point was progression-free survival rate (PFSR) at 6 months based on central radiology review. Secondary end points were overall survival (OS), overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and safety.</p><p><strong>Results: </strong>A total of 46 patients were screened, 40 patients entered the study, and 38 underwent central radiological review and were evaluable for primary end point. Median age was 47 years (range, 21-74). Histologies include 17 (43%) osteosarcoma, 14 chondrosarcoma (35%, 10 conventional, four dedifferentiated [DDCS]), eight (20%) Ewing sarcoma, and one (2%) undifferentiated pleomorphic sarcoma. The PFSR at 6 months was 42% (95% confidence interval [CI], 27-58). With a median follow-up of 39.8 months (95% CI, 37.9-41.7), the median PFS and OS were 3.8 months (95% CI, 2.7-4.8) and 11.9 months (95% CI, 5.6-18.2). ORR by RECIST was 5%, with two of 38 partial responses (one of four DDCS and one of 17 osteosarcoma), 19 of 38 (50%) stable disease, and 17 of 38 (45%) progressions. Grade ≥3 adverse events were neutropenia (six of 40, 15%), anemia (5/40, hypertension (6/40, 15%), 12.5%), ALT/AST elevation (5/40, 12.5%), and pneumonitis (1/40, 2.5%). Seventeen percent of patients discontinued treatment due to toxicity, including a treatment-related grade 5 pneumonitis CONCLUSION: The trial met its primary end point in the BS cohort with >15% of patients progression-free at 6 months. However, the toxicity profile of this regimen was relevant.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":""},"PeriodicalIF":6.1,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142611840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
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Cancer
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