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Expanding Coverage of Oncology Drugs in an Aging, Upper-Middle-Income Country: Analyses of Public and Private Expenditures in Chile. 在老龄化的中高收入国家扩大肿瘤药物的覆盖范围:智利公共和私人支出分析。
Pub Date : 2019-12-01 DOI: 10.1200/JGO.19.00223
Veronica Vargas, Christine Leopold, Marianela Castillo-Riquelme, Jonathan J Darrow

Purpose: The population of Chile has aged, and in 2017, cancer became the leading cause of death. Since 2005, a national health program has expanded coverage of drugs for 13 types of cancer and related palliative care. We describe the trends in public and private oncology drug expenditures in Chile and consider how increasing expenditures might be addressed.

Methods: We analyzed total quarterly drug expenditures for 131 oncology drugs from quarter (Q)3 2012 until Q1 2017, including public and private insurance payments and patient out-of-pocket spending. The data were analyzed by drug-mix, sources of funding, growth, and intellectual property status. The Laspeyres Price Index was used to analyze expenditure growth.

Results: We found 131 oncology drugs associated with 87,129 observations. Spending on drugs rose 120% from the first period, spanning from the first 3 quarters (Q3, Q4, Q1 2012-2013) to the last period (Q3, Q4, Q1 2016-2017), corresponding to an annualized rate of 19.2% and totaling US$398 million (in 2017 dollars). The public sector accounted for 84.2% of spending, which included 50 drugs in the official treatment protocols, whereas private insurance accounted for 7.3% in on-protocol drugs. The remaining 8.5% was paid out of pocket. In the public sector, more than 90% of growth resulted from increased use. Seven drugs, including 3 with nonexpired patents, accounted for 50% of total expenditures.

Conclusion: Increased use and access enabled by expanded public expenditures drove most of the growth in oncology drug expenditures. However, the rate of public expenditure growth may be fiscally unsustainable. Policies are urgently needed to promote the use of generic drugs, the appropriate mix of on-protocol versus off-protocol drugs, and the curbing of off-label prescribing.

目的:智利人口老龄化,2017年,癌症成为死亡的主要原因。自2005年以来,一项国家卫生方案扩大了13种癌症和相关姑息治疗药物的覆盖范围。我们描述了智利公共和私人肿瘤药物支出的趋势,并考虑如何增加支出。方法:我们分析了从2012年第三季度到2017年第一季度131种肿瘤药物的季度总药物支出,包括公共和私人保险支付以及患者自付费用。数据按药物组合、资金来源、增长和知识产权状况进行分析。拉斯佩尔价格指数被用来分析支出增长。结果:共发现131种肿瘤药物与87,129条观察结果相关。从前三个季度(2012-2013年第一季度的第三季度、第四季度)到最后一个季度(2016-2017年第一季度的第三季度、第四季度),药品支出较第一季度增长了120%,相当于年化增长率为19.2%,总计3.98亿美元(以2017年美元计算)。公共部门占支出的84.2%,其中包括官方治疗方案中的50种药物,而私人保险占方案外药物的7.3%。剩下的8.5%是自掏腰包。在公共部门,超过90%的增长来自使用量的增加。7种药物占总费用的50%,其中包括3种专利未到期的药物。结论:由于公共支出的扩大,肿瘤药物的使用和可及性的增加是肿瘤药物支出增长的主要原因。然而,公共支出的增长速度在财政上可能是不可持续的。迫切需要政策来促进仿制药的使用,适当混合方案内药物和非方案药物,并遏制超说明书处方。
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引用次数: 4
Outcomes of Refractory and Relapsed Hodgkin Lymphoma With Autologous Stem-Cell Transplantation: A Single Institution Experience 自体干细胞移植治疗难治性和复发性霍奇金淋巴瘤的疗效:单一机构的经验
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00051
R. Wali, H. Saeed, Naveed Patrus, S. Javed, Saadiya Khan
PURPOSE Hodgkin lymphoma is the most common cancer in children, adolescents, and young adults. Overall survival is approximately 80% to 90%. A subset of these patients has refractory disease or experience disease relapse. Conventional salvage therapies and autologous stem-cell transplantation is usually considered the standard of care for these patients. Our analysis reports outcomes in these patients. PATIENTS AND METHODS After institutional review board approval, a retrospective analysis of patients with Hodgkin lymphoma who were up to 18 years of age and who had refractory or relapsed disease at Shaukat Khanum Memorial Cancer Hospital and Research Centre from September 2009 to December 2013 was performed. Patients who underwent high-dose chemotherapy followed by stem-cell rescue were included in this analysis. RESULTS A total of 567 patients with Hodgkin lymphoma registered at the hospital. Sixty of the patients (10.6%) had either primary progressive or refractory disease or relapse after finishing with first-line chemotherapy. High-dose chemotherapy followed by stem cell was administered to 25 of these patients (42%). Thirteen patients (40%) had progressive disease (PD), five (22%) had early relapse, and seven (38%) had late relapse. A number of salvage regimens were used, including etoposide, prednisolone, ifosfamide, and cisplatin; dexamethasone, cytarabine, and carboplatin; and gemcitabine plus vinorelbine. Re-evaluation was performed before taking patients to a high dose, and it showed complete response in 17 patients (68%), partial response in six patients (24%), and PD in two patients (8%). Twenty-one patients (84%) are in remission after transplantation, with two patients (8%) having died as a result of disease progression and two patients (2%) having relapsed after treatment. Overall survival is 92% at 4 years, with event-free survival of 80% at 4 years. CONCLUSION Our retrospective analysis shows good outcomes in patients who had PD or refractory disease. Disease response before transplantation is important in predicting outcomes.
霍奇金淋巴瘤是儿童、青少年和年轻人中最常见的癌症。总生存率约为80%至90%。这些患者中有一部分患有难治性疾病或经历疾病复发。传统的挽救疗法和自体干细胞移植通常被认为是这些患者的标准护理。我们的分析报告了这些患者的结果。患者和方法在机构审查委员会批准后,对2009年9月至2013年12月在Shaukat Khanum纪念癌症医院和研究中心患有难治性或复发性疾病的18岁以下霍奇金淋巴瘤患者进行回顾性分析。接受大剂量化疗后进行干细胞挽救的患者被纳入本分析。结果医院共登记了567例霍奇金淋巴瘤患者。60名患者(10.6%)患有原发性进行性或难治性疾病,或在完成一线化疗后复发。其中25名患者(42%)接受了高剂量化疗,然后进行干细胞治疗。13名患者(40%)患有进行性疾病(PD),5名患者(22%)早期复发,7名患者(38%)晚期复发。使用了许多挽救方案,包括依托泊苷、泼尼松、异环磷酰胺和顺铂;地塞米松、阿糖胞苷和卡铂;吉西他滨加长春瑞滨。在给患者服用高剂量之前进行了重新评估,结果显示17名患者(68%)完全缓解,6名患者(24%)部分缓解,2名患者(8%)出现PD。21名患者(84%)在移植后病情缓解,其中2名患者(8%)因疾病进展而死亡,2名患者在治疗后复发(2%)。4年时总生存率为92%,4年时无事件生存率为80%。结论我们的回顾性分析显示PD或难治性疾病患者的预后良好。移植前的疾病反应对预测结果很重要。
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引用次数: 7
Epidemiology of Hematologic Malignancies in Real-World Settings: Findings From the Hemato-Oncology Latin America Observational Registry Study 现实世界中血液系统恶性肿瘤的流行病学:来自拉丁美洲血液肿瘤观察注册研究的发现
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00025
Vania Tietsche de Moraes Hungría, C. Chiattone, M. Pavlovsky, Lina Abenoza, Gladys P Agreda, Jorge Armenta, C. Arrais, Oscar Avendaño Flores, F. Barroso, A. Basquiera, C. Cao, M. Cugliari, A. Enrico, Laura M Foggliatto, K. Gálvez, D. Gomez, A. Gomez, Daniel de Iracema, Danielle Farias, L. López, W. Mantilla, D. Martínez, M. Mela, Carlos E. Miguel, R. Ovilla, L. Palmer, C. Pavlovsky, C. Ramos, G. Remaggi, R. Santucci, S. Schusterschitz, C. Sossa, Elena Tuna-Aguilar, J. Vela, T. Santos, Odin de la Mora, G. Machnicki, Mariana Fernandez, Paula Barreyro
PURPOSE Limited information is available on multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and non-Hodgkin lymphoma (NHL) management in Latin America. The primary objective of the Hemato-Oncology Latin America (HOLA) study was to describe patient characteristics and treatment patterns of Latin American patients with MM, CLL, and NHL. METHODS This study was a multicenter, retrospective, medical chart review of patients with MM, CLL, and NHL in Latin America identified between January 1, 2006, and December 31, 2015. Included were adults with at least 1 year of follow-up (except in cases of death within 1 year of diagnosis) treated at 30 oncology hospitals (Argentina, 5; Brazil, 9; Chile, 1; Colombia, 5; Mexico, 6; Panama/Guatemala, 4). RESULTS Of 5,140 patients, 2,967 (57.7%) had NHL, 1,518 (29.5%) MM, and 655 (12.7%) CLL. Median follow-up was 2.2 years for MM, 3.0 years for CLL, and 2.2 years for NHL, and approximately 26% died during the study observation period. Most patients had at least one comorbidity at diagnosis. The most frequent induction regimen was thalidomide-based chemotherapy for MM and chlorambucil with or without prednisone for CLL. Most patients with NHL had diffuse large B-cell lymphoma (DLBCL; 49.1%) or follicular lymphoma (FL; 19.5%). The majority of patients with DLBCL or FL received rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. CONCLUSION The HOLA study generated an unprecedented level of high-quality, real-world evidence on characteristics and treatment patterns of patients with hematologic malignancies. Regional disparities in patient characteristics may reflect differences in ethnoracial identity and level of access to care. These data provide needed real-world evidence to understand the disease landscape in Latin America and may be used to inform clinical and health policy decision making.
关于拉丁美洲多发性骨髓瘤(MM)、慢性淋巴细胞白血病(CLL)和非霍奇金淋巴瘤(NHL)治疗的信息有限。拉丁美洲血液肿瘤(HOLA)研究的主要目的是描述拉丁美洲MM、CLL和NHL患者的特征和治疗模式。方法本研究是对2006年1月1日至2015年12月31日期间在拉丁美洲发现的MM、CLL和NHL患者的多中心、回顾性医学图表回顾。包括在30家肿瘤医院(阿根廷5家;巴西9家;智利1家;哥伦比亚5家;墨西哥6家;巴拿马/危地马拉4家)接受至少1年随访的成年人(确诊后1年内死亡的除外)。结果5140例患者中,2967例(57.7%)为NHL,1518例(29.5%)为MM,655例(12.7%)为CLL。MM的中位随访时间为2.2年,CLL为3.0年,NHL为2.2年。在研究观察期内,约26%的患者死亡。大多数患者在诊断时至少有一种合并症。最常见的诱导方案是以沙利度胺为基础的MM化疗和苯甲氯胺加或不加泼尼松治疗CLL。大多数NHL患者患有弥漫性大B细胞淋巴瘤(DLBCL;49.1%)或滤泡性淋巴瘤(FL;19.5%)。大多数DLBCL或FL患者接受利妥昔单抗加环磷酰胺、阿霉素、长春新碱和泼尼松治疗。结论HOLA研究为血液系统恶性肿瘤患者的特征和治疗模式提供了前所未有的高质量、真实的证据。患者特征的区域差异可能反映了种族认同和获得护理水平的差异。这些数据提供了了解拉丁美洲疾病状况所需的真实世界证据,并可用于为临床和卫生政策决策提供信息。
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引用次数: 40
Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma DRL-Rituximab与MabThera治疗弥漫性大B细胞淋巴瘤的随机双盲药代动力学等效性试验
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00248
A. Viswabandya, Sandip Shah, A. Mukhopadhyay, R. Nagarkar, Sonica Sachdeva Batra, L. López-Lázaro, S. Kankanwadi, A. Srivastava
PURPOSE We sought to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in patients with diffuse large B-cell lymphoma (DLBCL). Efficacy, pharmacodynamics (PDs), safety, and immunogenicity were also compared. PATIENTS AND METHODS We conducted a double-blind, parallel-group study in patients with untreated DLBCL who were eligible to receive cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Patients were randomly assigned at a one-to-one ratio to receive DRL_RI or RMP for six 21-day cycles of rituximab plus CHOP, with 18 months of follow-up after day 1, cycle 6 (C6). Primary end point was C1 PKs, measured as area under the plasma concentration–time curve from day 0 to 21 (AUC0-21 days) and maximum plasma concentration (Cmax). Equivalence was defined as 90% CIs for the DRL_RI/RMP geometric mean ratios (GMRs) within 80% and 125%. Secondary end points included efficacy noninferiority measured by objective response rate (ORR) at C6 and event-free survival and overall survival at 87 weeks, PK equivalence at C6 and PD equivalence (rate of B-cell depletion and repletion), safety, and immunogenicity. The trial was stopped after sufficient patients for primary end point evaluation were enrolled. Secondary end points are reported as observed. RESULTS A total of 151 patients were randomly assigned (DRL_RI, n = 76; RMP, n = 75). DRL_RI/RMP GMRs for AUC0-21 days and Cmax in C1 were 99.77 (90% CI, 87.60 to 113.63) and 96.19 (90% CI, 88.65 to 104.38), respectively. ORR at C6 for DRL_RI and RMP were 82.0% and 84.8%, respectively. Rates of B-cell depletion/repletion, immunogenicity, and adverse events were comparable in both groups. CONCLUSION DRL_RI and RMP had equivalent PKs, with comparable efficacy, PDs, safety, and immunogenicity.
我们试图比较DRL利妥昔单抗(DRL_RI;潜在生物仿制药)和创新药物利妥昔mab MabThera(Roche,Grenzach Wyhlen,德国;参考药品[RMP])在弥漫性大B细胞淋巴瘤(DLBCL)患者中的药代动力学(PKs)。还比较了疗效、药效学、安全性和免疫原性。患者和方法我们对未经治疗的DLBCL患者进行了一项双盲、平行组研究,这些患者有资格接受环磷酰胺、阿霉素、长春新碱和泼尼松(CHOP)治疗。患者以一对一的比例被随机分配接受DRL_RI或RMP,为期6个21天的利妥昔单抗加CHOP周期,第1天,第6周期(C6)后随访18个月。主要终点为C1 PKs,测量为第0天至第21天(AUC0-21天)的血浆浓度-时间曲线下面积和最大血浆浓度(Cmax)。等效性定义为DRL_RI/RMP几何平均比(GMR)在80%和125%之间的90%CI。次要终点包括通过C6时的客观反应率(ORR)、87周时的无事件生存率和总生存率、C6时的PK等效性和PD等效性(B细胞耗竭和充满率)、安全性和免疫原性测量的疗效非劣效性。在招募了足够多的患者进行主要终点评估后,试验停止。次要终点报告为观察到的终点。结果共151例患者被随机分配(DRL_RI,n=76;RMP,n=75)。AUC0-21天的DRL_RI/RMP GMRs和C1的Cmax分别为99.77(90%CI,87.60-113.63)和96.19(90%CI,88.65-104.38)。DRL_RI和RMP在C6的ORR分别为82.0%和84.8%。两组的B细胞耗竭/补充率、免疫原性和不良事件具有可比性。结论DRL_RI和RMP具有等效的PKs,具有相当的疗效、PDs、安全性和免疫原性。
{"title":"Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma","authors":"A. Viswabandya, Sandip Shah, A. Mukhopadhyay, R. Nagarkar, Sonica Sachdeva Batra, L. López-Lázaro, S. Kankanwadi, A. Srivastava","doi":"10.1200/JGO.19.00248","DOIUrl":"https://doi.org/10.1200/JGO.19.00248","url":null,"abstract":"PURPOSE We sought to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in patients with diffuse large B-cell lymphoma (DLBCL). Efficacy, pharmacodynamics (PDs), safety, and immunogenicity were also compared. PATIENTS AND METHODS We conducted a double-blind, parallel-group study in patients with untreated DLBCL who were eligible to receive cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Patients were randomly assigned at a one-to-one ratio to receive DRL_RI or RMP for six 21-day cycles of rituximab plus CHOP, with 18 months of follow-up after day 1, cycle 6 (C6). Primary end point was C1 PKs, measured as area under the plasma concentration–time curve from day 0 to 21 (AUC0-21 days) and maximum plasma concentration (Cmax). Equivalence was defined as 90% CIs for the DRL_RI/RMP geometric mean ratios (GMRs) within 80% and 125%. Secondary end points included efficacy noninferiority measured by objective response rate (ORR) at C6 and event-free survival and overall survival at 87 weeks, PK equivalence at C6 and PD equivalence (rate of B-cell depletion and repletion), safety, and immunogenicity. The trial was stopped after sufficient patients for primary end point evaluation were enrolled. Secondary end points are reported as observed. RESULTS A total of 151 patients were randomly assigned (DRL_RI, n = 76; RMP, n = 75). DRL_RI/RMP GMRs for AUC0-21 days and Cmax in C1 were 99.77 (90% CI, 87.60 to 113.63) and 96.19 (90% CI, 88.65 to 104.38), respectively. ORR at C6 for DRL_RI and RMP were 82.0% and 84.8%, respectively. Rates of B-cell depletion/repletion, immunogenicity, and adverse events were comparable in both groups. CONCLUSION DRL_RI and RMP had equivalent PKs, with comparable efficacy, PDs, safety, and immunogenicity.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1200/JGO.19.00248","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49152182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 17
Cluster Randomized Trial to Facilitate Breast Cancer Early Diagnosis in a Rural District of Rwanda 卢旺达农村地区促进癌症早期诊断的整群随机试验
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00209
L. Pace, J. Dusengimana, L. Shulman, L. E. Schleimer, C. Shyirambere, C. Rusangwa, G. Muvugabigwi, P. Park, Chuan-Chin Huang, J. B. Bigirimana, V. Hategekimana, Vestine Rugema, A. Umwizerwa, N. Keating, T. Mpunga
PURPOSE Feasible and effective strategies are needed to facilitate earlier diagnosis of breast cancer in low-income countries. The goal of this study was to examine the impact of health worker breast health training on health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district. METHODS We conducted a cluster randomized trial of a training intervention at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases. We evaluated the trainings’ impact on the volume of patient visits for breast concerns using difference-in-difference models. We used generalized estimating equations to evaluate incidence of HC and hospital visits for breast concerns, biopsies, benign breast diagnoses, breast cancer, and early-stage disease in catchment areas served by intervention versus control HCs. RESULTS From April 2015 to April 2017, 1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns. The intervention led to an increase of 4.7 visits/month for phase 1 HCs (P = .001) and 7.9 visits/month for phase 2 HCs (P = .007) compared with control HCs. The population served by intervention HCs had more hospital visits (115.1 v 20.5/100,000 person-years, P < .001) and biopsies (36.6 v 8.9/100,000 person-years, P < .001) and higher breast cancer incidence (6.9 v 3.3/100,000 person-years; P = .28). The incidence of early-stage breast cancer was 3.3 per 100,000 in intervention areas and 0.7 per 100,000 in control areas (P = .048). CONCLUSION In this cluster randomized trial in rural Rwanda, the training of health workers and establishment of regular breast clinics were associated with increased numbers of patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers.
为促进低收入国家乳腺癌症的早期诊断,需要可行、有效的策略。本研究的目的是研究卢旺达农村地区卫生工作者乳房健康培训对医疗保健利用、患者诊断和癌症分期的影响。方法我们在卢旺达Burera区19个卫生中心中的12个进行了一项训练干预的集群随机试验,分为两个阶段。我们使用差异模型评估了培训对乳腺问题患者就诊量的影响。我们使用广义估计方程来评估HC的发病率和乳腺问题、活组织检查、良性乳腺诊断、乳腺癌症和早期疾病在干预和对照HC服务的集水区的就诊情况。结果从2015年4月到2017年4月,1484名患者因乳腺问题就诊于干预性HC,308名患者就诊于对照性HC。与对照HC相比,干预导致1期HC每月就诊4.7次(P=0.001),2期HC每月访问7.9次(P=0.007)。接受干预HC服务的人群有更多的医院就诊(115.1比20.5/10万人年,P<0.001)和活组织检查(36.6比8.9/10万人岁,P<001),乳腺癌症发病率更高(6.9比3.3/万人年;P=.28)。干预区早期癌症的发病率为3.3/10万,对照区为0.7/10万(P=.048)这项在卢旺达农村进行的集群随机试验、卫生工作者的培训和定期乳腺诊所的建立,与在卫生机构出现乳腺问题的患者数量增加、更多的乳腺活检以及更高的良性乳腺诊断和早期乳腺癌发生率有关。
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引用次数: 18
Breast Cancer Care Quality in South Africa’s Public Health System: An Evaluation Using American Society of Clinical Oncology/National Quality Forum Measures 南非公共卫生系统癌症乳腺癌护理质量:美国临床肿瘤学会/国家质量论坛衡量标准的评估
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00171
Daniel S. O'Neil, W. Chen, O. Ayeni, S. Nietz, I. Buccimazza, U. Singh, S. Čačala, L. Stopforth, M. Joffe, K. Crew, J. Jacobson, A. Neugut, P. Ruff, H. Cubasch
PURPOSE The quality of breast cancer care in sub-Saharan Africa contributes to the region’s dismal breast cancer mortality. ASCO has issued quality measures focusing on delivery of adjuvant chemotherapy, radiotherapy, and endocrine therapy. We applied these measures in five South African public hospitals and analyzed factors associated with care concordance. MATERIALS AND METHODS Among 1,736 women with breast cancer who were enrolled in the South African Breast Cancer and HIV Outcomes study over 24 months, we evaluated care using ASCO’s three measures. We also evaluated adjuvant chemotherapy receipt in 957 women with an indication. We used logistic regression to estimate associations between measure-concordant care and patient factors. RESULTS Of 235 women with hormone receptor–negative cancer, 173 (74%) began adjuvant chemotherapy within 120 days from diagnosis. Of 194 patients who received breast-conserving surgery, 73 (37%) began radiotherapy within 365 days from diagnosis. Of 999 women with hormone receptor–positive cancer, 719 (72%) initiated endocrine therapy within 365 days from diagnosis. Chemotherapy and radiotherapy measure-concordant care were more common among women residing < 20 km from the hospital (odds ratio [OR], 1.79; 95% CI, 1.32 to 2.44 and OR, 3.17; 95% CI, 1.57 to 6.42). Endocrine therapy measure-concordant care was more common among English-speaking women (OR, 2.12; 95% CI, 1.12 to 4.02). Participating hospitals varied in care concordance. HIV infection did not affect care quality. CONCLUSION More timely delivery of chemotherapy, radiotherapy, and endocrine therapy is needed in South Africa, particularly for women living > 20 km from the hospital or not speaking English. Focused quality improvement efforts could support that goal.
目的:撒哈拉以南非洲地区乳腺癌护理的质量是该地区乳腺癌死亡率低的原因之一。ASCO发布了质量措施,重点关注辅助化疗、放疗和内分泌治疗的提供。我们在五家南非公立医院应用了这些措施,并分析了与护理一致性相关的因素。材料和方法在南非乳腺癌和艾滋病毒结局研究中招募了1736名乳腺癌妇女,研究时间超过24个月,我们使用ASCO的三个指标来评估护理。我们还评估了957名有适应症的女性接受辅助化疗的情况。我们使用逻辑回归来估计测量一致性护理与患者因素之间的关联。结果在235例激素受体阴性的女性癌症患者中,173例(74%)在诊断后120天内开始辅助化疗。在194例接受保乳手术的患者中,73例(37%)在确诊后365天内开始放疗。在999名激素受体阳性癌症患者中,719名(72%)在确诊后365天内开始接受内分泌治疗。在距离医院< 20 km的妇女中,化疗和放疗措施-协调护理更为常见(优势比[OR], 1.79;95% CI, 1.32 ~ 2.44, OR, 3.17;95% CI, 1.57 ~ 6.42)。内分泌治疗措施-和谐护理在英语女性中更为常见(OR, 2.12;95% CI, 1.12 - 4.02)。参与调查的医院在护理一致性方面存在差异。HIV感染不影响护理质量。结论南非需要更及时地提供化疗、放疗和内分泌治疗,特别是那些居住在距离医院20公里或不会说英语的妇女。集中的质量改进工作可以支持这一目标。
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引用次数: 13
Improving Cancer Outcomes In Low- and Middle-Income Countries 改善低收入和中等收入国家的癌症预后
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00297
R. Love
The common high-income country framework for improving cancer care that is applied globally leads to calls for workforce development (or capacity building), national cancer control plans, medical professional education, well-defined quality care, clinical practice guidelines, multidisciplinary care, certification programs for outpatient care, research (generally, and not specifically implementation research), and registries. The challenges are responded to by technology transfer interventions—most commonly educational activities— with very limited and hardly rigorous evaluations of their impacts. It is hard not to compare these approaches with those of advocates for economic development generally for the past half century that were found by many to have been so wanting. As we have written, “We believe that, in fact, the major issues are broader than these and that, in any event, these current dominant framework foci can hardly be successfully addressed without attention to bigger ecological issues and themes, such as weak, dysfunctional, and underfinanced health systems, overall, dominated by operational business/money making models; governance, corruption and transparency; human rights shortcomings; incomplete knowledge about diseases, patient/host factors; and cost-effective interventions” applicable in lowand middle-income country settings.
在全球范围内应用的改善癌症治疗的高收入国家共同框架要求劳动力发展(或能力建设)、国家癌症控制计划、医疗专业教育、明确定义的优质护理、临床实践指南、多学科护理、门诊护理认证计划、研究(一般而非具体的实施研究)和登记。应对这些挑战的办法是技术转让干预措施- -最常见的是教育活动- -对其影响的评价非常有限而且几乎没有严格的评价。人们很难不将这些方法与过去半个世纪以来倡导经济发展的人所采取的方法进行比较,许多人发现这些方法是如此的欠缺。正如我们所写的,“我们认为,事实上,主要问题比这些更广泛,而且,无论如何,如果不关注更大的生态问题和主题,例如总体上由运营业务/赚钱模式主导的薄弱、功能失调和资金不足的卫生系统,这些目前占主导地位的框架焦点很难成功解决;治理、腐败和透明度;人权不足;对疾病、患者/宿主因素了解不全;以及适用于中低收入国家环境的具有成本效益的干预措施。
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引用次数: 0
Dermatology-Driven Quality Improvement Interventions to Decrease Diagnostic Delays for Kaposi Sarcoma in Botswana. 皮肤病学驱动的质量改进干预措施减少博茨瓦纳卡波西肉瘤的诊断延误
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00181
Victoria L Williams, Mohan Narasimhamurthy, Olaf Rodriguez, Karen Mosojane, Thapelo Bale, Koorileng Kesalopa, Mukendi A Kayembe, Surbhi Grover

Purpose: Kaposi sarcoma (KS) is an HIV-associated skin cancer that is highly prevalent in Botswana and associated with significant morbidity and mortality. Histopathology-confirmed diagnosis is required for chemotherapeutic interventions in Botswana, which creates barriers to care because of limited biopsy and pathology services. We sought to understand the role a dermatology specialist can play in improving KS care through quality improvement (QI) initiatives to reduce histologic turnaround times (TATs) for KS.

Methods: Employment of a dermatology specialist within a public health care system that previously lacked a local dermatologist generated quality improvements in KS care. Retrospective review identified patients diagnosed with KS by skin biopsy in the predermatology QI interval (January 1, 2015, to December 31, 2015) versus the postdermatology QI interval (January 1, 2016, to November 31, 2017). Histology TATs and clinical characteristics were recorded. A t test compared the median histology TATs in the pre- and post-QI intervals.

Results: A total of 192 cases of KS were diagnosed by skin biopsy. Nearly all (98.4%) were HIV-positive; and 52.8% of patients were male with a median age of 39 years. Median TAT in the postdermatology QI interval was 11 days (interquartile range, 12-23 days) compared with 32 days in the predermatology QI interval (interquartile range, 24-56 days; P < .00).

Conclusion: Dermatology-led QI initiatives to improve multispecialty care coordination can significantly decrease histology TATs for KS. The reduction of diagnostic delays is a key first step to decreasing the morbidity and mortality associated with this cancer in resource-limited settings.

卡波西肉瘤(KS)是一种与HIV相关的癌症,在博茨瓦纳高度流行,并与显著的发病率和死亡率相关。博茨瓦纳的化疗干预需要组织病理学确诊,由于活检和病理学服务有限,这给护理带来了障碍。我们试图了解皮肤科专家通过质量改进(QI)举措来减少KS的组织学周转时间(TAT),在改善KS护理方面可以发挥的作用。方法在以前缺乏当地皮肤科医生的公共卫生保健系统中雇佣皮肤科专家,提高了KS护理的质量。回顾性审查确定了在皮肤病学前QI间期(2015年1月1日至2015年12月31日)和皮肤病学后QI间期(2016年1月31日至2017年11月31日的)通过皮肤活检诊断为KS的患者。记录组织学TATs和临床特征。t检验比较了QI前和QI后间期的组织学TAT中位数。结果皮肤活检共诊断出192例KS。几乎所有人(98.4%)都是艾滋病毒阳性;52.8%的患者为男性,中位年龄39岁。皮肤病学后QI间期的中位TAT为11天(四分位间距,12-23天),而皮肤病学前QI间期为32天(四位间距,24-56天;P<.00)。结论皮肤病学领导的QI改善多专业护理协调的举措可以显著降低KS的组织学TAT。在资源有限的环境中,减少诊断延误是降低与这种癌症相关的发病率和死亡率的关键第一步。
{"title":"Dermatology-Driven Quality Improvement Interventions to Decrease Diagnostic Delays for Kaposi Sarcoma in Botswana.","authors":"Victoria L Williams, Mohan Narasimhamurthy, Olaf Rodriguez, Karen Mosojane, Thapelo Bale, Koorileng Kesalopa, Mukendi A Kayembe, Surbhi Grover","doi":"10.1200/JGO.19.00181","DOIUrl":"10.1200/JGO.19.00181","url":null,"abstract":"<p><strong>Purpose: </strong>Kaposi sarcoma (KS) is an HIV-associated skin cancer that is highly prevalent in Botswana and associated with significant morbidity and mortality. Histopathology-confirmed diagnosis is required for chemotherapeutic interventions in Botswana, which creates barriers to care because of limited biopsy and pathology services. We sought to understand the role a dermatology specialist can play in improving KS care through quality improvement (QI) initiatives to reduce histologic turnaround times (TATs) for KS.</p><p><strong>Methods: </strong>Employment of a dermatology specialist within a public health care system that previously lacked a local dermatologist generated quality improvements in KS care. Retrospective review identified patients diagnosed with KS by skin biopsy in the predermatology QI interval (January 1, 2015, to December 31, 2015) versus the postdermatology QI interval (January 1, 2016, to November 31, 2017). Histology TATs and clinical characteristics were recorded. A <i>t</i> test compared the median histology TATs in the pre- and post-QI intervals.</p><p><strong>Results: </strong>A total of 192 cases of KS were diagnosed by skin biopsy. Nearly all (98.4%) were HIV-positive; and 52.8% of patients were male with a median age of 39 years. Median TAT in the postdermatology QI interval was 11 days (interquartile range, 12-23 days) compared with 32 days in the predermatology QI interval (interquartile range, 24-56 days; <i>P</i> < .00).</p><p><strong>Conclusion: </strong>Dermatology-led QI initiatives to improve multispecialty care coordination can significantly decrease histology TATs for KS. The reduction of diagnostic delays is a key first step to decreasing the morbidity and mortality associated with this cancer in resource-limited settings.</p>","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6882519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42055951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Identifying and Prioritizing Family Education Needs at Pediatric Oncology Centers in Central America and Mexico. 中美洲和墨西哥儿科肿瘤中心家庭教育需求的识别和优先排序。
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00272
Erin McCann, Soad Fuentes-Alabí, Federico Antillón, Lourdes Vega-Vega, Maria Sabina Sanchez, Irini Albanti

Methods: A qualitative study involving 72 in-person interviews and 4 focus groups was conducted using a semistructured interview guide. Key informants included family members, physicians, nurses, psychosocial providers, foundation leadership, volunteers, and communication professionals. The study sites included pediatric oncology centers in El Salvador, Guatemala, Mexico, and Panama. NVivo was used for thematic analysis.

Results: Across all sites, parents had common questions and educational needs. Questions from families focused on their child's likelihood of dying from cancer and feelings of guilt that were based on their perception that they caused the disease. The origin of cancer, nutrition, and psychosocial support were the most important educational themes. However, the prioritization of different educational themes varied on the basis of cultural or social influences unique to each site. Some of these differences included a need for education surrounding amputations, sibling support, and alternative or traditional healers.

Conclusion: This study demonstrates that although many educational needs were consistent across hospitals, some of the educational priorities differed by site despite geographic proximity and shared language. Developing an educational program in resource-limited settings can be challenging, but it is an important contributor to improving childhood cancer outcomes that should be tailored to the specific needs of a site. This study can be used as a guide for other programs with limited resources wanting to develop relevant educational materials for families.

方法:采用半结构化访谈指南进行72次面对面访谈和4个焦点小组的定性研究。主要信息提供者包括家庭成员、医生、护士、社会心理提供者、基金会领导、志愿者和通信专业人员。研究地点包括萨尔瓦多、危地马拉、墨西哥和巴拿马的儿科肿瘤中心。使用NVivo进行专题分析。结果:在所有站点中,家长都有共同的问题和教育需求。来自家庭的问题集中在他们的孩子死于癌症的可能性,以及基于他们认为是自己导致了这种疾病的负罪感。癌症的起源、营养和社会心理支持是最重要的教育主题。然而,不同教育主题的优先顺序根据每个地点独特的文化或社会影响而有所不同。其中一些差异包括截肢教育的需要、兄弟姐妹的支持、替代疗法或传统疗法。结论:本研究表明,尽管各医院的许多教育需求是一致的,但不同地点的一些教育重点却存在差异,尽管地理位置接近且语言相同。在资源有限的环境中制定教育计划可能具有挑战性,但它是改善儿童癌症治疗结果的重要贡献者,应该根据具体需要进行调整。本研究可作为其他资源有限的项目开发相关家庭教材的参考。
{"title":"Identifying and Prioritizing Family Education Needs at Pediatric Oncology Centers in Central America and Mexico.","authors":"Erin McCann,&nbsp;Soad Fuentes-Alabí,&nbsp;Federico Antillón,&nbsp;Lourdes Vega-Vega,&nbsp;Maria Sabina Sanchez,&nbsp;Irini Albanti","doi":"10.1200/JGO.19.00272","DOIUrl":"https://doi.org/10.1200/JGO.19.00272","url":null,"abstract":"<p><strong>Methods: </strong>A qualitative study involving 72 in-person interviews and 4 focus groups was conducted using a semistructured interview guide. Key informants included family members, physicians, nurses, psychosocial providers, foundation leadership, volunteers, and communication professionals. The study sites included pediatric oncology centers in El Salvador, Guatemala, Mexico, and Panama. NVivo was used for thematic analysis.</p><p><strong>Results: </strong>Across all sites, parents had common questions and educational needs. Questions from families focused on their child's likelihood of dying from cancer and feelings of guilt that were based on their perception that they caused the disease. The origin of cancer, nutrition, and psychosocial support were the most important educational themes. However, the prioritization of different educational themes varied on the basis of cultural or social influences unique to each site. Some of these differences included a need for education surrounding amputations, sibling support, and alternative or traditional healers.</p><p><strong>Conclusion: </strong>This study demonstrates that although many educational needs were consistent across hospitals, some of the educational priorities differed by site despite geographic proximity and shared language. Developing an educational program in resource-limited settings can be challenging, but it is an important contributor to improving childhood cancer outcomes that should be tailored to the specific needs of a site. This study can be used as a guide for other programs with limited resources wanting to develop relevant educational materials for families.</p>","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":"5 ","pages":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1200/JGO.19.00272","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37455224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Does Interim PET Scan After 2 Cycles of ABVD Predict Outcome in Hodgkin Lymphoma? Real-World Evidence. ABVD 2周期后中期PET扫描能否预测霍奇金淋巴瘤的预后?真实的证据。
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00179
Arun Seshachalam, Shashidhar V Karpurmath, Krishnakumar Rathnam, S Ganapathi Raman, Murugesan Janarthinakani, Krishna Prasad, Channappa Patil, Parameswaran Anoop, Neelesh Reddy, Satish Kumar Anumula, Sirigeri Prabhakar Roopa, Krishna Reddy Golamari, Madhav Danthala, Prasad Gunari, Basawantrao Malipatil, Bharath Rangarajan, Karthik S Udupa, Manjunath Nandennavar, Kesavan Niraimathi, Hemant Deepak Shewade

Purpose: Escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) improves overall survival (OS) in patients with Hodgkin lymphoma (HL) relative to ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) therapy. However, the associated higher cost and toxicity discourage clinicians from prescribing it. Identifying high-risk patients and administering escalated BEACOPP remains an effective strategy. We assessed the significance of interim positron emission tomography (iPET) scan after 2 cycles (iPET2) in identifying this high-risk subset.

Patients and methods: This cohort study used secondary data from 12 tertiary care centers in South India gathered over 10 years (2008-2018). OS, event-free survival (EFS), determinants of EFS, and complete response (CR) in iPET2 were assessed.

Results: The study included 409 patients with HL (mean age, 34.5 years; male/female ratio, 1.4:1). The median duration of follow-up was 2.8 years. Of 409 patients, 63% underwent PET-based staging and 37% underwent computerized tomography (CT) staging. Stage IV (28.9%) and bone involvement (9.2%) were seen more often with PET than with CT staging (9.2% and 2%, respectively). Among 171 patients with iPET2 results, 24% did not achieve CR, and no factors were significantly associated. The 5-year EFS and OS rates of the entire cohort were 78% and 97%, respectively. The 5-year EFS and OS rates of patients with CR on iPET2 were 90% and 99%, respectively, whereas these were 65% and 100%, respectively, for patients not achieving CR. On univariable analysis, sex, stage, and iPET2 response significantly predicted inferior EFS. On multivariate analysis, only iPET2 response significantly predicted EFS (P < .000).

Conclusion: Our study supports the use of PET for staging and iPET2 for response assessment. Nonachievement of CR on iPET2 indicates unfavorable outcome, and such patients may benefit from more intensive treatment.

目的:与ABVD(多柔比星、博来霉素、博来霉素、多柔比星、环磷酰胺、长春新碱、丙卡嗪和泼尼松)治疗相比,逐步升级的BEACOPP(博来霉素、依托泊苷、多柔比星、长春碱和达卡巴嗪)治疗可改善霍奇金淋巴瘤(HL)患者的总生存率(OS)。然而,相关的高成本和毒性使临床医生不愿开处方。确定高危患者并给予逐步升级的BEACOPP仍然是有效的策略。我们评估了2个周期后中期正电子发射断层扫描(iPET)扫描(iPET2)在识别这一高危亚群中的意义。患者和方法:本队列研究使用了印度南部12个三级医疗中心10年来(2008-2018年)收集的二次数据。评估iPET2患者的OS、无事件生存期(EFS)、EFS的决定因素和完全缓解(CR)。结果:纳入409例HL患者(平均年龄34.5岁;男女比例为1.4:1)。中位随访时间为2.8年。在409例患者中,63%接受了基于pet的分期,37%接受了计算机断层扫描(CT)分期。IV期(28.9%)和骨骼受累(9.2%)在PET分期中比在CT分期中更常见(分别为9.2%和2%)。171例iPET2结果患者中,24%未达到CR,无显著相关因素。整个队列的5年EFS和OS率分别为78%和97%。接受iPET2治疗的CR患者的5年EFS和OS率分别为90%和99%,而未达到CR的患者的5年EFS和OS率分别为65%和100%。在单变量分析中,性别、分期和iPET2反应显著预测了较差的EFS。在多变量分析中,只有iPET2反应能显著预测EFS (P < .000)。结论:我们的研究支持使用PET进行分期,iPET2进行疗效评估。iPET2未达到CR表明预后不良,这类患者可能受益于更强化的治疗。
{"title":"Does Interim PET Scan After 2 Cycles of ABVD Predict Outcome in Hodgkin Lymphoma? Real-World Evidence.","authors":"Arun Seshachalam,&nbsp;Shashidhar V Karpurmath,&nbsp;Krishnakumar Rathnam,&nbsp;S Ganapathi Raman,&nbsp;Murugesan Janarthinakani,&nbsp;Krishna Prasad,&nbsp;Channappa Patil,&nbsp;Parameswaran Anoop,&nbsp;Neelesh Reddy,&nbsp;Satish Kumar Anumula,&nbsp;Sirigeri Prabhakar Roopa,&nbsp;Krishna Reddy Golamari,&nbsp;Madhav Danthala,&nbsp;Prasad Gunari,&nbsp;Basawantrao Malipatil,&nbsp;Bharath Rangarajan,&nbsp;Karthik S Udupa,&nbsp;Manjunath Nandennavar,&nbsp;Kesavan Niraimathi,&nbsp;Hemant Deepak Shewade","doi":"10.1200/JGO.19.00179","DOIUrl":"https://doi.org/10.1200/JGO.19.00179","url":null,"abstract":"<p><strong>Purpose: </strong>Escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) improves overall survival (OS) in patients with Hodgkin lymphoma (HL) relative to ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) therapy. However, the associated higher cost and toxicity discourage clinicians from prescribing it. Identifying high-risk patients and administering escalated BEACOPP remains an effective strategy. We assessed the significance of interim positron emission tomography (iPET) scan after 2 cycles (iPET2) in identifying this high-risk subset.</p><p><strong>Patients and methods: </strong>This cohort study used secondary data from 12 tertiary care centers in South India gathered over 10 years (2008-2018). OS, event-free survival (EFS), determinants of EFS, and complete response (CR) in iPET2 were assessed.</p><p><strong>Results: </strong>The study included 409 patients with HL (mean age, 34.5 years; male/female ratio, 1.4:1). The median duration of follow-up was 2.8 years. Of 409 patients, 63% underwent PET-based staging and 37% underwent computerized tomography (CT) staging. Stage IV (28.9%) and bone involvement (9.2%) were seen more often with PET than with CT staging (9.2% and 2%, respectively). Among 171 patients with iPET2 results, 24% did not achieve CR, and no factors were significantly associated. The 5-year EFS and OS rates of the entire cohort were 78% and 97%, respectively. The 5-year EFS and OS rates of patients with CR on iPET2 were 90% and 99%, respectively, whereas these were 65% and 100%, respectively, for patients not achieving CR. On univariable analysis, sex, stage, and iPET2 response significantly predicted inferior EFS. On multivariate analysis, only iPET2 response significantly predicted EFS (<i>P</i> < .000).</p><p><strong>Conclusion: </strong>Our study supports the use of PET for staging and iPET2 for response assessment. Nonachievement of CR on iPET2 indicates unfavorable outcome, and such patients may benefit from more intensive treatment.</p>","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":"5 ","pages":"1-13"},"PeriodicalIF":0.0,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1200/JGO.19.00179","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37455576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 9
期刊
Journal of global oncology
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