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Beginning at the End? Rethinking the Timing of Enrollment Into Early Phase Clinical Trials. 从终点开始?重新思考早期临床试验的入组时机。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-30 DOI: 10.1200/OP-24-00488
Aditya Mahadevan, Armon Azizi, Farshid Dayyani
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引用次数: 0
Treating Cancer and Preserving Parenthood. 治疗癌症,保护父母。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-29 DOI: 10.1200/OP-24-00457
Anil Ananthaneni, Gary Burton
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引用次数: 0
Use of a Smartphone Application to Promote Adherence to Oral Medications in Patients With Breast Cancer. 使用智能手机应用程序促进乳腺癌患者坚持口服药物治疗。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-26 DOI: 10.1200/OP.24.00187
Claire Sathe, Rohit Raghunathan, Sophie Ulene, Fiona McAuley, Kishan A Bhatt, Julia E McGuinness, Meghna S Trivedi, Neil Vasan, Kevin M Kalinsky, Katherine D Crew, Khadija F Faheem, Erik Harden, Cynthia Law, Dawn L Hershman, Melissa K Accordino

Purpose: Medication nonadherence is common among patients with breast cancer (BC) and increases BC mortality and complications from comorbidities. There is growing interest in mobile health interventions such as smartphone applications (apps) to promote adherence.

Methods: Use of Medisafe, a medication reminder and tracking app, was tested over 12 weeks among patients on BC treatment and at least one oral medication. Study participants were instructed to generate adherence reports every 4 weeks through Medisafe and were deemed to have completed the intervention if >50% of reports were generated. The primary end point was feasibility of the intervention, defined as a completion rate of ≥75% of consented patients. Secondary end points included changes in self-reported nonadherence from baseline to 12 weeks and patient-reported outcomes including reasons for nonadherence and satisfaction with Medisafe. We conducted univariable and multivariable analyses to evaluate demographic and clinical factors associated with intervention completion.

Results: Among 100 patients enrolled, 78 (78.0%) completed the intervention. Age, race, ethnicity, clinical stage, and type of medication were not associated with odds of intervention completion. Self-reported nonadherence rates did not improve from baseline to postintervention in the overall study population. However, among patients with self-reported nonadherence at baseline, 26.3% reported adherence postintervention; these patients frequently reported logistical barriers to adherence. Study participants reported high levels of satisfaction with Medisafe, noting that the app was highly functional and provided high-quality information.

Conclusion: Smartphone apps such as Medisafe are feasible and associated with high patient satisfaction. They may improve adherence in nonadherent patients and those who face logistical challenges interfering with medication-taking. Future trials of mobile health interventions should target patients at high risk for medication nonadherence.

目的:不遵医嘱用药在乳腺癌(BC)患者中很常见,会增加BC死亡率和并发症。人们对智能手机应用程序(App)等移动健康干预措施的兴趣日益浓厚:方法:研究人员在 12 周的时间内,对接受 BC 治疗并至少服用一种口服药物的患者使用 Medisafe(一种药物提醒和跟踪应用程序)的情况进行了测试。研究人员指导参与者每4周通过Medisafe生成一次用药报告,如果报告生成率大于50%,则视为完成了干预。主要终点是干预的可行性,即同意患者的完成率≥75%。次要终点包括自我报告的不依从性从基线到 12 周的变化,以及患者报告的结果,包括不依从的原因和对 Medisafe 的满意度。我们进行了单变量和多变量分析,以评估与干预完成相关的人口统计学和临床因素:在 100 名入选患者中,78 人(78.0%)完成了干预。年龄、种族、民族、临床阶段和药物类型与完成干预的几率无关。在整个研究人群中,自我报告的不依从率从基线到干预后没有改善。不过,在基线时自我报告不坚持治疗的患者中,有 26.3% 在干预后报告坚持治疗;这些患者经常报告在坚持治疗方面存在后勤障碍。研究参与者对Medisafe的满意度很高,认为该应用功能强大,能提供高质量的信息:结论:Medisafe 等智能手机应用程序是可行的,患者满意度也很高。结论:Medisafe 等智能手机应用程序是可行的,患者的满意度也很高。它们可以提高非依从性患者和因后勤问题而影响服药的患者的依从性。未来的移动医疗干预试验应针对不坚持服药的高风险患者。
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引用次数: 0
Patterns of Survivorship Follow-Up Care Among Patients With Breast Cancer: A Retrospective Population-Based Cohort Study in Ontario, Canada, Between 2006 and 2016. 乳腺癌患者的生存期随访护理模式:加拿大安大略省 2006 年至 2016 年基于人群的队列回顾性研究》。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-25 DOI: 10.1200/OP.23.00813
Jonathan Sussman, Joshua O Cerasuolo, Gregory R Pond, Daryl Bainbridge, Hsien Seow

Purpose: Many cancer survivors have ongoing follow-up with their oncologist(s), despite evidence that this care can be competently managed by primary care and transitioning well survivors could relieve growing pressure on cancer care systems. We analyzed population-based administrative data from Ontario, Canada, to examine rates of transition to primary care-led follow-up care during the survivorship phase, including clinical and demographic predictors associated with being transitioned.

Methods: We conducted a retrospective cohort study to describe the patterns of survivorship follow-up care among all patients with breast cancer in Ontario from 2006 to 2016. Data were derived from the Ontario Cancer Registry and other linked data sets. We defined the survivorship phase of care beginning at 2 years after initial diagnosis. Logistic regression was used to explore factors potentially prognostic of no oncology visits in each of the years after survivorship.

Results: Our survivorship cohort was composed of 71,719 patients with breast cancer, 42% of whom were considered to have transitioned from oncology to primary care 2 years after diagnosis. Although the number of patients having oncology visits diminished over time, a quarter of the cohort continued being seen in year 5 of survivorship. Regression analysis found older age, early cancer stage, living farther from a cancer center, not receiving radiation or chemotherapy, and high well-being to be associated with transitioning to primary care.

Conclusion: Our findings contribute to the development of low-risk profiles among survivors to inform optimal transition from oncology to primary care. Further research examining qualitative perspectives from oncologists, cancer survivors, and primary care is also required to illuminate other sentinel factors to be considered when transitioning during follow-up.

目的:尽管有证据表明基层医疗机构可以胜任这项护理工作,而且良好的幸存者过渡可减轻癌症护理系统日益增长的压力,但许多癌症幸存者仍需接受肿瘤专家的持续随访。我们分析了加拿大安大略省基于人口的行政数据,以研究在幸存者阶段过渡到由初级医疗机构主导的随访护理的比率,包括与过渡相关的临床和人口预测因素:我们开展了一项回顾性队列研究,以描述 2006 年至 2016 年期间安大略省所有乳腺癌患者的生存期随访护理模式。数据来自安大略省癌症登记处和其他关联数据集。我们定义了从初次诊断后 2 年开始的生存期护理阶段。我们使用逻辑回归法来探讨在生存期后的每一年中没有去肿瘤科就诊的潜在预后因素:我们的幸存者队列由 71,719 名乳腺癌患者组成,其中 42% 的患者在确诊 2 年后被认为已从肿瘤科转为初级保健科。虽然随着时间的推移,肿瘤科就诊的患者人数有所减少,但有四分之一的患者在生存期的第 5 年继续就诊。回归分析发现,年龄较大、癌症分期较早、居住地离癌症中心较远、未接受放疗或化疗以及幸福感较高与向初级保健过渡有关:我们的研究结果有助于在幸存者中建立低风险档案,为从肿瘤科向基层医疗机构的最佳过渡提供依据。还需要进一步研究肿瘤学家、癌症幸存者和初级保健人员的定性观点,以阐明在随访期间过渡时需要考虑的其他前哨因素。
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引用次数: 0
Real-World Outcomes of Immunotherapy for Melanoma Brain Metastases in New Zealand. 新西兰黑色素瘤脑转移免疫疗法的实际效果。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-25 DOI: 10.1200/OP.24.00208
Niamh Walsh, Rosalie Stephens, Alvin Tan, Vanessa Durandt, Jennifer McLachlan, Jody Jordan, Kate Gregory, Sean Sutton, Catherine Barrow, Annie N M Wong

Purpose: Melanoma brain metastases (BMs) are associated with poor survival. Combination immune checkpoint inhibitors (ICIs) with anti-PD1 and anti-CTLA-4 are the international standard-of-care treatment. Most landmark clinical trials excluded real-world patients with symptomatic disease, poor performance status (PS), and steroid use. Despite the high incidence of melanoma in New Zealand (NZ), the only publicly funded systemic treatment is anti-PD1 monotherapy. The real-world outcomes for BMs after ICIs in NZ are unknown.

Methodology: Medical records of patients with melanoma BMs in seven cancer centers across NZ between September 1, 2016, and September 1, 2020, were evaluated. Clinicopathologic characteristics, treatment, intracranial (IC) tumor response rates, IC progression-free survival, and overall survival (OS) are reported.

Results: One hundred and forty-four patients received at least one dose of ICI. One hundred and thirty-three (93%) patients received anti-PD1 monotherapy. Almost a quarter of patients had poor baseline PS, 56% were symptomatic, and 33% had corticosteroids. Patients also received local therapies: 61 (42%) patients underwent surgery, 42 (29%) received whole brain radiation, and 47 (33%) received stereotactic radiation. The median OS was 15 months, and a third of patients were alive at 2 years. The toxicity of ICIs was at 28% and 15% for Common Terminology Criteria for Adverse Events grade 1-2 and 3-4 events, respectively. Of the patients who are still alive, 76% of patients remained symptomatic neurologically at last follow-up.

Conclusion: Most patients in this NZ real-world study were symptomatic and received anti-PD1 monotherapy. Approximately one-third of treated patients are alive at 2 years, but most patients remained symptomatic. This highlights the need for more effective treatment and prospective management of their neurologic rehabilitation needs.

目的:黑色素瘤脑转移(BMs)与生存率低有关。抗-PD1和抗-CTLA-4联合免疫检查点抑制剂(ICIs)是国际标准治疗方法。大多数具有里程碑意义的临床试验都排除了现实世界中患有无症状疾病、表现状态不佳(PS)和使用类固醇的患者。尽管新西兰(NZ)的黑色素瘤发病率很高,但唯一由政府资助的系统性治疗是抗PD1单药治疗。新西兰接受 ICIs 治疗后的 BMs 真实世界结果尚不清楚:方法:评估了 2016 年 9 月 1 日至 2020 年 9 月 1 日期间新西兰七个癌症中心的黑色素瘤 BM 患者的医疗记录。报告了临床病理特征、治疗、颅内(IC)肿瘤反应率、IC无进展生存期和总生存期(OS):结果:144 名患者至少接受了一次 ICI 治疗。133名患者(93%)接受了抗PD1单药治疗。近四分之一的患者基线PS较差,56%的患者有症状,33%的患者使用皮质类固醇。患者还接受了局部治疗:61 例(42%)患者接受了手术,42 例(29%)接受了全脑放射治疗,47 例(33%)接受了立体定向放射治疗。中位生存期为15个月,三分之一的患者在2年内存活。在不良事件通用术语标准1-2级和3-4级事件中,ICIs的毒性分别为28%和15%。在仍存活的患者中,76%的患者在最后一次随访时仍有神经症状:在这项新西兰真实世界研究中,大多数患者都有症状,并接受了抗PD1单药治疗。约三分之一接受治疗的患者在 2 年后仍然存活,但大多数患者仍无症状。这凸显了对更有效治疗和前瞻性神经康复管理的需求。
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引用次数: 0
Real-World Noninferiority Assessment of Two Filgrastim Biosimilars in Patients Receiving Myelosuppressive Chemotherapy. 在骨髓抑制性化疗患者中对两种 Filgrastim 生物仿制药进行真实世界非劣效性评估
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-24 DOI: 10.1200/OP.24.00047
Ye Ji Lee, Thomas Delate, Rita L Hui, Kim Le, Catherine Pham

Purpose: Although multiple filgrastim biosimilars are now available in the United States, no studies comparing clinical outcomes between products have been reported. This analysis evaluated real-world outcomes of filgrastim-aafi and filgrastim-sndz in patients with select solid tumors receiving myelosuppressive chemotherapy to compare the two filgrastim biosimilars.

Methods: This was an observational, noninferiority, cohort study of patients from three integrated health care systems who received myelosuppressive chemotherapy and were prophylactically initiated on filgrastim-sndz between January and November 2021 or filgrastim-aafi between June and November 2022. Patients were followed from filgrastim biosimilar initiation until the start of their next chemotherapy cycle. The primary outcome of severe neutropenia was analyzed using a binary noninferiority test with a 5% upper margin. Secondary outcomes included the incidence of emergency department or hospital encounters due to febrile neutropenia and systemic antibiotic/antifungal medication use. If noninferiority was met, adjusted logistic regression modeling was conducted.

Results: A total of 2,730 patients who initiated filgrastim-aafi (n = 880) or filgrastim-sndz (n = 1,850) during the study period were included. The overall mean age was 55 years, 87.4% were female, 42.3% were White, and 76.6% had breast cancer. Severe neutropenia occurred in 1.8% and 1.7% of patients initiated on filgrastim-aafi and filgrastim-sndz, respectively (P < .01 for noninferiority). The adjusted odds ratio for severe neutropenia with filgrastim-aafi compared with filgrastim-sndz was 0.91 (95% CI, 0.49 to 1.68; P = .76). Noninferiority was met for all secondary outcomes (P < .01), and there were no adjusted statistically significant differences between the groups (all P > .05).

Conclusion: Among patients with select solid tumors receiving myelosuppressive chemotherapy, severe neutropenia outcomes were comparable between filgrastim-aafi and filgrastim-sndz biosimilars. Findings from this study may support utilization of different filgrastim biosimilars in clinical practice.

目的:尽管目前美国已有多种非格司亭生物仿制药上市,但尚未有比较两种产品临床疗效的研究报告。本分析评估了接受骨髓抑制性化疗的特定实体瘤患者使用菲格列汀-aafi和菲格列汀-sndz的实际疗效,以比较这两种菲格列汀生物仿制药:这是一项观察性、非劣效性队列研究,研究对象是来自三个综合医疗保健系统、接受骨髓抑制性化疗并在2021年1月至11月期间开始预防性使用filgrastim-sndz或在2022年6月至11月期间使用filgrastim-aafi的患者。从开始使用非格司亭生物仿制药到下一个化疗周期开始,对患者进行随访。严重中性粒细胞减少症这一主要结果采用二元非劣效性检验进行分析,5% 上限边际。次要结果包括因发热性中性粒细胞减少症和全身使用抗生素/抗真菌药物导致的急诊科或医院就诊率。如果符合非劣效性,则进行调整后的逻辑回归建模:共纳入2730名在研究期间开始使用非格司亭-aafi(n = 880)或非格司亭-sndz(n = 1850)的患者。总平均年龄为 55 岁,87.4% 为女性,42.3% 为白人,76.6% 患有乳腺癌。在开始使用非格司亭-aafi和非格司亭-sndz的患者中,分别有1.8%和1.7%的患者出现严重中性粒细胞减少症(非劣效性P < .01)。与filgrastim-sndz相比,使用filgrastim-aafi出现严重中性粒细胞减少症的调整后几率为0.91(95% CI,0.49至1.68;P = .76)。所有次要结果均符合非劣效性要求(P < .01),组间无调整后的显著统计学差异(所有P > .05):结论:在接受骨髓抑制性化疗的特定实体瘤患者中,filgrastim-aafi和filgrastim-sndz生物仿制药的严重中性粒细胞减少症疗效相当。这项研究的结果可能支持在临床实践中使用不同的非格司亭生物仿制药。
{"title":"Real-World Noninferiority Assessment of Two Filgrastim Biosimilars in Patients Receiving Myelosuppressive Chemotherapy.","authors":"Ye Ji Lee, Thomas Delate, Rita L Hui, Kim Le, Catherine Pham","doi":"10.1200/OP.24.00047","DOIUrl":"https://doi.org/10.1200/OP.24.00047","url":null,"abstract":"<p><strong>Purpose: </strong>Although multiple filgrastim biosimilars are now available in the United States, no studies comparing clinical outcomes between products have been reported. This analysis evaluated real-world outcomes of filgrastim-aafi and filgrastim-sndz in patients with select solid tumors receiving myelosuppressive chemotherapy to compare the two filgrastim biosimilars.</p><p><strong>Methods: </strong>This was an observational, noninferiority, cohort study of patients from three integrated health care systems who received myelosuppressive chemotherapy and were prophylactically initiated on filgrastim-sndz between January and November 2021 or filgrastim-aafi between June and November 2022. Patients were followed from filgrastim biosimilar initiation until the start of their next chemotherapy cycle. The primary outcome of severe neutropenia was analyzed using a binary noninferiority test with a 5% upper margin. Secondary outcomes included the incidence of emergency department or hospital encounters due to febrile neutropenia and systemic antibiotic/antifungal medication use. If noninferiority was met, adjusted logistic regression modeling was conducted.</p><p><strong>Results: </strong>A total of 2,730 patients who initiated filgrastim-aafi (n = 880) or filgrastim-sndz (n = 1,850) during the study period were included. The overall mean age was 55 years, 87.4% were female, 42.3% were White, and 76.6% had breast cancer. Severe neutropenia occurred in 1.8% and 1.7% of patients initiated on filgrastim-aafi and filgrastim-sndz, respectively (<i>P</i> < .01 for noninferiority). The adjusted odds ratio for severe neutropenia with filgrastim-aafi compared with filgrastim-sndz was 0.91 (95% CI, 0.49 to 1.68; <i>P</i> = .76). Noninferiority was met for all secondary outcomes (<i>P</i> < .01), and there were no adjusted statistically significant differences between the groups (all <i>P</i> > .05).</p><p><strong>Conclusion: </strong>Among patients with select solid tumors receiving myelosuppressive chemotherapy, severe neutropenia outcomes were comparable between filgrastim-aafi and filgrastim-sndz biosimilars. Findings from this study may support utilization of different filgrastim biosimilars in clinical practice.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Risk Without Reward: Differing Patterns of Chemotherapy Use Do Not Improve Outcomes in Stage II Early-Onset Colon Cancer. 没有回报的风险:化疗的不同使用模式并不能改善 II 期早发结肠癌的预后。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-24 DOI: 10.1200/OP.24.00159
Jacob B Leary, Junxiao Hu, Alexis Leal, S Lindsey Davis, Sunnie Kim, Robert Lentz, Tyler Friedrich, Whitney Herter, Wells A Messersmith, Christopher H Lieu

Purpose: Rising rates of early-onset colon cancer (EOCC) present challenges in deciding how to optimally treat patients. Although standard of care for stage II CC is surgical resection, adding chemotherapy for high-risk disease, evidence suggests treatment selection may differ by age. We investigated whether adjuvant chemotherapy (AC) administration rates differ between patients with early- and later-onset stage II CC.

Methods: Data originated from the nationwide Flatiron Health electronic health record (EHR)-derived deidentified database spanning January 1, 2003, to August 1, 2021. Adults with stage II CC were grouped as age 18-49 years (EOCC) and those age 50 years or older (later-onset colon cancer [LOCC]). Demographics, Eastern Cooperative Oncology Group score, tumor stage and site, and chemotherapy were included. Primary outcomes included rates of AC administration by age and ethnicity; secondary outcomes included overall survival (OS) and time to metastatic disease (TTMD). Univariate and multivariable logistic regression models evaluated relationships between chemotherapy administration, age, and ethnicity, adjusting for significant covariates.

Results: One thousand sixty-five patients were included. Median age of patients with EOCC was 45.0 years versus 69.0 years for patients with LOCC. Adjusted multivariate analysis showed patients with EOCC received AC significantly more often than patients with LOCC. Non-Hispanic patients received AC at significantly lower rates than Hispanic patients in both cohorts. Subanalysis of stage IIA patients showed that patients with EOCC were more likely to receive AC than patients with LOCC. No significant differences in OS or TTMD were observed by age regardless of AC administration in stage II overall; however, patients with stage IIA EOCC receiving AC had significantly longer TTMD than those not receiving AC.

Conclusion: AC was given preferentially in stage II EOCC, even in stage IIA, despite deviation from guidelines. This may expose low-risk patients to unnecessary toxicities and suggests bias toward treating younger patients more aggressively, despite unclear evidence for better outcomes.

目的:早发性结肠癌(EOCC)发病率的上升给决定如何对患者进行最佳治疗带来了挑战。虽然II期结肠癌的标准治疗方法是手术切除,并对高风险疾病进行化疗,但有证据表明,不同年龄段的患者选择的治疗方法可能不同。我们研究了早期和晚期II期CC患者的辅助化疗(AC)使用率是否存在差异:数据来源于全国性的 Flatiron Health 电子健康记录(EHR)衍生的去标识数据库,时间跨度为 2003 年 1 月 1 日至 2021 年 8 月 1 日。II期结肠癌患者分为18-49岁(EOCC)和50岁或以上(晚发结肠癌[LOCC])两组。研究对象包括人口统计学、东部合作肿瘤学组评分、肿瘤分期和部位以及化疗。主要结果包括不同年龄和种族的 AC 使用率;次要结果包括总生存期 (OS) 和转移性疾病发生时间 (TTMD)。单变量和多变量逻辑回归模型评估了化疗用药、年龄和种族之间的关系,并对重要的协变量进行了调整:共纳入 165 名患者。EOCC患者的中位年龄为45.0岁,而LOCC患者的中位年龄为69.0岁。调整后的多变量分析显示,EOCC 患者接受 AC 治疗的频率明显高于 LOCC 患者。在两个队列中,非西班牙裔患者接受 AC 治疗的比例明显低于西班牙裔患者。对 IIA 期患者进行的子分析显示,EOCC 患者比 LOCC 患者更有可能接受 AC 治疗。在II期患者中,无论是否接受AC治疗,按年龄划分的OS或TTMD均无明显差异;但接受AC治疗的IIA期EOCC患者的TTMD明显长于未接受AC治疗的患者:结论:尽管偏离了指南,但在 II 期 EOCC 中,即使是 IIA 期,也优先给予 AC。这可能会使低风险患者遭受不必要的毒副作用,并表明对年轻患者的治疗偏向于更积极,尽管没有明确的证据表明这样做能获得更好的疗效。
{"title":"Risk Without Reward: Differing Patterns of Chemotherapy Use Do Not Improve Outcomes in Stage II Early-Onset Colon Cancer.","authors":"Jacob B Leary, Junxiao Hu, Alexis Leal, S Lindsey Davis, Sunnie Kim, Robert Lentz, Tyler Friedrich, Whitney Herter, Wells A Messersmith, Christopher H Lieu","doi":"10.1200/OP.24.00159","DOIUrl":"https://doi.org/10.1200/OP.24.00159","url":null,"abstract":"<p><strong>Purpose: </strong>Rising rates of early-onset colon cancer (EOCC) present challenges in deciding how to optimally treat patients. Although standard of care for stage II CC is surgical resection, adding chemotherapy for high-risk disease, evidence suggests treatment selection may differ by age. We investigated whether adjuvant chemotherapy (AC) administration rates differ between patients with early- and later-onset stage II CC.</p><p><strong>Methods: </strong>Data originated from the nationwide Flatiron Health electronic health record (EHR)-derived deidentified database spanning January 1, 2003, to August 1, 2021. Adults with stage II CC were grouped as age 18-49 years (EOCC) and those age 50 years or older (later-onset colon cancer [LOCC]). Demographics, Eastern Cooperative Oncology Group score, tumor stage and site, and chemotherapy were included. Primary outcomes included rates of AC administration by age and ethnicity; secondary outcomes included overall survival (OS) and time to metastatic disease (TTMD). Univariate and multivariable logistic regression models evaluated relationships between chemotherapy administration, age, and ethnicity, adjusting for significant covariates.</p><p><strong>Results: </strong>One thousand sixty-five patients were included. Median age of patients with EOCC was 45.0 years versus 69.0 years for patients with LOCC. Adjusted multivariate analysis showed patients with EOCC received AC significantly more often than patients with LOCC. Non-Hispanic patients received AC at significantly lower rates than Hispanic patients in both cohorts. Subanalysis of stage IIA patients showed that patients with EOCC were more likely to receive AC than patients with LOCC. No significant differences in OS or TTMD were observed by age regardless of AC administration in stage II overall; however, patients with stage IIA EOCC receiving AC had significantly longer TTMD than those not receiving AC.</p><p><strong>Conclusion: </strong>AC was given preferentially in stage II EOCC, even in stage IIA, despite deviation from guidelines. This may expose low-risk patients to unnecessary toxicities and suggests bias toward treating younger patients more aggressively, despite unclear evidence for better outcomes.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Evolving Practices in Immune-Related Adverse Event Management: Insights From the IMMUCARE Multidisciplinary Board. 免疫相关不良事件管理实践的演变:IMMUCARE 多学科委员会的见解。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-22 DOI: 10.1200/OP.24.00042
Romain Varnier, Clara Fontaine-Delaruelle, Nathalie Freymond, Aurore Essongue, Anissa Bouali, Gilles Boschetti, Fanny Lebosse, Sophie Tartas, Sarah Milley, Christine Cugnet-Anceau, Etienne Novel-Catin, Bastien Joubert, Emmanuel Massy, Stéphane Dalle, Denis Maillet

Purpose: The management of immune-related adverse events (irAEs) requires multidisciplinary boards to handle complex cases. This study aimed to examine the evolving practices of the IMMUCARE board and to evaluate its impact on clinical practices.

Materials and methods: The IMMUCARE board gathers oncologists and organ specialists from the Cancerology Institute of the Lyon University Hospital since 2018. We conducted a retrospective analysis of its activity (participants' specialty, referred cases, and recommendations) from 2018 to 2021, coupled with a survey among the physicians who participated.

Results: Across 68 board meetings, 245 cases from 195 patients were discussed. Each board had a median of six participants (IQR, 5-8). Participation rates varied across specialties and also over time (participation of nephrologists and rheumatologists significantly increased over time, whereas it decreased for endocrinologists). Most of the referred patients (89%) were treated at our center. Only 4% of referrals concerned eligibility for immune checkpoint inhibitor (ICI), whereas the majority pertained to irAEs. The board recommended ICI interruption for 56% and steroids for 41% of them. Immunosuppressants were recommended in 17% of cases, with a notable increase over time. ICI reintroduction was debated in 50% of cases, and the board identified a definitive contraindication in 26% of them. The survey of 49 of 98 physicians showed that the board significantly affected immunosuppressant introduction and ICI rechallenge decisions. The board's educational and collaborative benefits were highlighted, but time constraints posed challenges.

Conclusion: Our 4-year analysis of irAE management practices reveals changing patterns in the distribution of cases presented and in specialists' involvement. Dedicated multidisciplinary boards remain essential, particularly for intricate cases. Expanding access to these boards is crucial to ensure comprehensive care for all patients.

目的:免疫相关不良事件(irAEs)的管理需要多学科委员会来处理复杂病例。本研究旨在考察IMMUCARE委员会不断发展的实践,并评估其对临床实践的影响:自2018年起,IMMUCARE委员会聚集了里昂大学医院癌症研究所的肿瘤专家和器官专家。我们对其2018年至2021年的活动(参与者的专业、转诊病例和建议)进行了回顾性分析,并对参与的医生进行了调查:在 68 次委员会会议上,讨论了来自 195 名患者的 245 个病例。每个委员会的参与者中位数为 6 人(IQR,5-8)。各专科的参与率不尽相同,而且随时间推移而变化(肾病学家和风湿病学家的参与率随时间推移显著增加,而内分泌学家的参与率则有所下降)。大多数转诊患者(89%)都在本中心接受了治疗。仅有 4% 的转诊患者符合使用免疫检查点抑制剂 (ICI) 的条件,而大多数患者则与虹膜不良反应有关。委员会建议56%的患者中断使用ICI,41%的患者使用类固醇。17%的病例被建议使用免疫抑制剂,随着时间的推移,比例明显增加。50%的病例对重新使用 ICI 进行了辩论,委员会确定了其中 26% 的病例有明确的禁忌症。对 98 名医生中的 49 名医生进行的调查显示,委员会对免疫抑制剂的引入和 ICI 重新挑战的决定有重大影响。委员会在教育和合作方面的优势得到了强调,但时间限制带来了挑战:我们对irAE管理实践进行的4年分析表明,提交病例的分布和专家参与的模式正在发生变化。专门的多学科委员会仍然至关重要,尤其是对于复杂的病例。要确保为所有患者提供全面的治疗,扩大这些委员会的服务范围至关重要。
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引用次数: 0
Patient and Caregiver Experience With the Hope and Prognostic Uncertainty of Immunotherapy: A Qualitative Study. 患者和护理人员对免疫疗法的希望和预后不确定性的体验:定性研究。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-22 DOI: 10.1200/OP.24.00299
Mary C Boulanger, Ayo S Falade, Kelly Hsu, Robert K Sommer, Ashley Zhou, Roshni Sarathy, Donald Lawrence, Ryan J Sullivan, Lara Traeger, Joseph A Greer, Jennifer S Temel, Laura A Petrillo

Purpose: Immunotherapy has improved survival for patients with melanoma and non-small cell lung cancer (NSCLC). Yet, as responses vary widely, immunotherapy also introduces challenges in prognostic communication. In this study, we sought to explore how patients and caregivers learned about the goal of immunotherapy and their experience of living with uncertainty.

Materials and methods: We conducted a qualitative study of patients with stage III or IV melanoma or stage IV NSCLC within 12 weeks of initiating or 12 months of discontinuing immunotherapy, and their caregivers. We conducted in-depth interviews with participants to explore how they learned about immunotherapy from oncology clinicians and how they experienced uncertainty. We used a framework approach to analyze interview transcripts and synthesized concepts into themes.

Results: Forty-two patients and 10 caregivers participated; median age was 67 years and most were male (68%), white (95%), married (61%), and had melanoma (62%). We identified four themes: (1) the oncology team shaped participants' hopeful expectations of immunotherapy, including as a potential cure among those with melanoma; (2) distress related to prognostic uncertainty particularly affected patients who experienced toxicity or progressive disease; (3) patients who did not have long-term responses experienced overwhelming disappointment; and (4) some patients and caregivers had conflicting preferences for prognostic information. Participants provided suggestions to improve education and underscored unmet psychosocial needs.

Conclusion: Patients and caregivers held optimistic expectations of immunotherapy, which resulted in heightened disappointment among the subset with progression or toxicity. Clinicians should elicit information preferences of both patients and caregivers, as these may be disparate. Our results highlight the need to optimize prognostic communication and support for living with uncertainty among patients receiving immunotherapy.

目的:免疫疗法提高了黑色素瘤和非小细胞肺癌(NSCLC)患者的生存率。然而,由于反应差异很大,免疫疗法也给预后交流带来了挑战。在这项研究中,我们试图探讨患者和护理人员如何了解免疫疗法的目标以及他们在不确定情况下的生活体验:我们对开始免疫治疗 12 周内或停止免疫治疗 12 个月内的 III 期或 IV 期黑色素瘤或 IV 期 NSCLC 患者及其护理人员进行了定性研究。我们对参与者进行了深入访谈,探讨他们是如何从肿瘤临床医生那里了解免疫疗法的,以及他们是如何经历不确定性的。我们采用框架法分析访谈记录,并将概念归纳为主题:42名患者和10名护理人员参加了访谈;年龄中位数为67岁,大多数患者为男性(68%)、白人(95%)、已婚(61%)和黑色素瘤患者(62%)。我们确定了四个主题:(1)肿瘤团队塑造了参与者对免疫疗法的希望,包括将其作为黑色素瘤患者的一种潜在治愈方法;(2)与预后不确定性相关的痛苦尤其影响到出现毒性或疾病进展的患者;(3)没有长期反应的患者经历了难以承受的失望;以及(4)一些患者和护理人员对预后信息的偏好相互矛盾。参与者提出了改进教育的建议,并强调了尚未满足的社会心理需求:结论:患者和护理人员对免疫疗法抱有乐观的期望,结果导致病情恶化或出现毒性反应的患者更加失望。临床医生应了解患者和护理人员的信息偏好,因为他们的偏好可能各不相同。我们的研究结果突出表明,有必要优化预后沟通,并为接受免疫疗法的患者提供生活不确定性方面的支持。
{"title":"Patient and Caregiver Experience With the Hope and Prognostic Uncertainty of Immunotherapy: A Qualitative Study.","authors":"Mary C Boulanger, Ayo S Falade, Kelly Hsu, Robert K Sommer, Ashley Zhou, Roshni Sarathy, Donald Lawrence, Ryan J Sullivan, Lara Traeger, Joseph A Greer, Jennifer S Temel, Laura A Petrillo","doi":"10.1200/OP.24.00299","DOIUrl":"https://doi.org/10.1200/OP.24.00299","url":null,"abstract":"<p><strong>Purpose: </strong>Immunotherapy has improved survival for patients with melanoma and non-small cell lung cancer (NSCLC). Yet, as responses vary widely, immunotherapy also introduces challenges in prognostic communication. In this study, we sought to explore how patients and caregivers learned about the goal of immunotherapy and their experience of living with uncertainty.</p><p><strong>Materials and methods: </strong>We conducted a qualitative study of patients with stage III or IV melanoma or stage IV NSCLC within 12 weeks of initiating or 12 months of discontinuing immunotherapy, and their caregivers. We conducted in-depth interviews with participants to explore how they learned about immunotherapy from oncology clinicians and how they experienced uncertainty. We used a framework approach to analyze interview transcripts and synthesized concepts into themes.</p><p><strong>Results: </strong>Forty-two patients and 10 caregivers participated; median age was 67 years and most were male (68%), white (95%), married (61%), and had melanoma (62%). We identified four themes: (1) the oncology team shaped participants' hopeful expectations of immunotherapy, including as a potential cure among those with melanoma; (2) distress related to prognostic uncertainty particularly affected patients who experienced toxicity or progressive disease; (3) patients who did not have long-term responses experienced overwhelming disappointment; and (4) some patients and caregivers had conflicting preferences for prognostic information. Participants provided suggestions to improve education and underscored unmet psychosocial needs.</p><p><strong>Conclusion: </strong>Patients and caregivers held optimistic expectations of immunotherapy, which resulted in heightened disappointment among the subset with progression or toxicity. Clinicians should elicit information preferences of both patients and caregivers, as these may be disparate. Our results highlight the need to optimize prognostic communication and support for living with uncertainty among patients receiving immunotherapy.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Assessing the Validity of the Centers for Medicare & Medicaid Services Measure in Identifying Potentially Preventable Emergency Department Visits by Patients With Cancer. 评估美国医疗保险与医疗补助服务中心的衡量标准在识别癌症患者到急诊就诊的潜在可预防性方面的有效性。
IF 4.7 3区 医学 Q1 ONCOLOGY Pub Date : 2024-07-22 DOI: 10.1200/OP.24.00160
Amir Alishahi Tabriz, Kea Turner, Homa Hemati, Christopher Baugh, Jennifer Elston Lafata

Purpose: The Centers for Medicare & Medicaid Services (CMS) implemented chemotherapy measures (OP-35) to reduce potentially preventable emergency department visits (PPEDVs) and hospitalizations. This study evaluated the validity of the OP-35 measure in identifying PPEDVs among patients with cancer.

Methods: This is a cross-sectional study, which used data from the 2012-2022 National Hospital Ambulatory Medical Care Survey. ED visits are assessed and compared on the basis of three measures: immediacy using Emergency Severity Index (ESI), disposition (discharge v hospitalization), and OP-35 criteria.

Results: Between 2012 and 2022, a weighted sample of 46,723,524 ED visits were made by patients with cancer. Among reported ESI cases, 25.2% (8,346,443) was high urgency. In addition, 30.3% (14,135,496) of ED visits among patients with cancer led to hospitalizations. Using the OP-35 measure, it was found that 20.85% (9,743,977) was PPEDVs. A 21.9% (10,232,102) discrepancy between discharge diagnosis (CMS billing codes) and chief complaints was identified. Further analysis showed that 19.2% (1,872,556) of potentially preventable ED visits (CMS OP-35) were high urgency and 32.6% (3,181,280) resulted in hospitalization.

Conclusion: The CMS approach to identifying PPEDVs has limitations. First, it may overcount preventable visits by including high-urgency or hospitalization-requiring cases. Second, relying on final diagnoses for retrospective preventability judgment can be misleading as they may not reflect the initial reason for the visit. In addition, differentiating causes for ED visits in patients with cancer undergoing various treatments is challenging as the approach does not distinguish between chemotherapy-related complications and others. Identification inconsistencies arise because of varying coding practices and chosen preventable conditions, lacking consensus and alignment with specific hospital or patient needs. Finally, the model fails to consider crucial nonclinical factors like social support, economic barriers, and alternative care access, potentially unfairly penalizing hospitals serving underserved populations.

目的:美国医疗保险与医疗补助服务中心(CMS)实施了化疗措施(OP-35),以减少潜在可预防的急诊就诊率(PPEDV)和住院率。本研究评估了 OP-35 措施在确定癌症患者 PPEDV 方面的有效性:这是一项横断面研究,使用的数据来自 2012-2022 年全国医院非住院医疗护理调查。对急诊室就诊进行评估,并根据三项指标进行比较:使用急诊严重程度指数(ESI)的即时性、处置(出院与住院)和 OP-35 标准:结果:2012 年至 2022 年间,癌症患者在急诊室就诊的加权样本为 46,723,524 人次。在报告的ESI病例中,25.2%(834643例)为高度紧急病例。此外,30.3%(14,135,496 人次)的急诊就诊者因癌症住院。使用 OP-35 测量法发现,20.85%(9,743,977 人次)为 PPEDV。发现出院诊断(CMS 账单代码)与主诉之间存在 21.9%(10,232,102 例)的差异。进一步的分析表明,19.2%(1,872,556 人次)的潜在可预防急诊就诊(CMS OP-35)属于急诊,32.6%(3,181,280 人次)导致住院:CMS 识别 PPEDV 的方法存在局限性。结论:CMS 识别 PPEDV 的方法有其局限性。首先,它可能会因包括高急诊或需要住院的病例而过多计算可预防性就诊。其次,依靠最终诊断来进行可预防性回顾性判断可能会产生误导,因为最终诊断可能无法反映就诊的最初原因。此外,区分接受各种治疗的癌症患者的急诊就诊原因也很有难度,因为这种方法无法区分化疗相关并发症和其他并发症。由于编码实践和所选可预防疾病各不相同,缺乏共识,也不符合特定医院或患者的需求,因此会出现识别不一致的情况。最后,该模型没有考虑社会支持、经济障碍和替代治疗途径等重要的非临床因素,可能会对服务不足人群的医院造成不公平的惩罚。
{"title":"Assessing the Validity of the Centers for Medicare & Medicaid Services Measure in Identifying Potentially Preventable Emergency Department Visits by Patients With Cancer.","authors":"Amir Alishahi Tabriz, Kea Turner, Homa Hemati, Christopher Baugh, Jennifer Elston Lafata","doi":"10.1200/OP.24.00160","DOIUrl":"https://doi.org/10.1200/OP.24.00160","url":null,"abstract":"<p><strong>Purpose: </strong>The Centers for Medicare & Medicaid Services (CMS) implemented chemotherapy measures (OP-35) to reduce potentially preventable emergency department visits (PPEDVs) and hospitalizations. This study evaluated the validity of the OP-35 measure in identifying PPEDVs among patients with cancer.</p><p><strong>Methods: </strong>This is a cross-sectional study, which used data from the 2012-2022 National Hospital Ambulatory Medical Care Survey. ED visits are assessed and compared on the basis of three measures: immediacy using Emergency Severity Index (ESI), disposition (discharge <i>v</i> hospitalization), and OP-35 criteria.</p><p><strong>Results: </strong>Between 2012 and 2022, a weighted sample of 46,723,524 ED visits were made by patients with cancer. Among reported ESI cases, 25.2% (8,346,443) was high urgency. In addition, 30.3% (14,135,496) of ED visits among patients with cancer led to hospitalizations. Using the OP-35 measure, it was found that 20.85% (9,743,977) was PPEDVs. A 21.9% (10,232,102) discrepancy between discharge diagnosis (CMS billing codes) and chief complaints was identified. Further analysis showed that 19.2% (1,872,556) of potentially preventable ED visits (CMS OP-35) were high urgency and 32.6% (3,181,280) resulted in hospitalization.</p><p><strong>Conclusion: </strong>The CMS approach to identifying PPEDVs has limitations. First, it may overcount preventable visits by including high-urgency or hospitalization-requiring cases. Second, relying on final diagnoses for retrospective preventability judgment can be misleading as they may not reflect the initial reason for the visit. In addition, differentiating causes for ED visits in patients with cancer undergoing various treatments is challenging as the approach does not distinguish between chemotherapy-related complications and others. Identification inconsistencies arise because of varying coding practices and chosen preventable conditions, lacking consensus and alignment with specific hospital or patient needs. Finally, the model fails to consider crucial nonclinical factors like social support, economic barriers, and alternative care access, potentially unfairly penalizing hospitals serving underserved populations.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":null,"pages":null},"PeriodicalIF":4.7,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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