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Cross-Cultural Validity Study of a Medical Education Leadership Competencies Instrument in Latin American Physicians: A Multinational Study 拉丁美洲医师医学教育领导能力工具的跨文化效度研究:一项跨国研究
Pub Date : 2019-11-01 DOI: 10.1200/JGO.19.00243
M. Mano, R. Gomes, G. Werutsky, C. Barrios, G. Marta, C. Villarreal-Garza, A. Frasson, C. Sternberg, Renan O Clara, S. Simon, Fadil T Çitaku, Marianne S. Waldrop, C. Violato, Don Zillioux, Yawar H Khan
PURPOSE Physicians rarely receive formal training in leadership skills. Çitaku and colleagues have identified a set of leadership competencies (LCs) providing validity evidence in North American (NA) and European Union (EU) medical education institutions. We aim to apply this same survey to a sample of Latin American (LA) medical leaders from the oncology community and related areas, compare the results with those of the previous survey, and perform subgroup analyses within the LA cohort. METHODS The survey was sent to nearly 8,000 physicians of participating professional organizations. In addition to the 63 questions, we also collected data on the type of institution, country, specialty, sex, age, years of experience in oncology, and leadership position. RESULTS The 217 LA respondents placed the highest value on task management competencies (91.37% reported these as important or very important v 87.0% of NA/EU respondents; P < .0001), followed by self-management (87.45% of LA respondents v 87.55% of NA/EU respondents; P = not significant [NS]), social responsibility (86.83% of LA respondents v 87.48% of NA/EU respondents; P = NS), innovation (86.69% of LA respondents v 85.31% of NA/EU respondents; P = NS), and leading others (83.31% of LA respondents v 84.71% of NA/EU respondents; P = NS). Social responsibility, which was first in importance in the NA/EU survey, was only third in the LA survey. Subgroup analyses showed significant variations in the ratings of specific LCs within the LA population. CONCLUSION LCs valued by LA leaders somewhat differ from those valued by their NA and EU counterparts, implying that cultural aspects might influence the perception of desired LCs. We also detected variations in the responses within the LA population. Our data indicate that current physician leadership training programs should be tailored to suit specific needs and cultural aspects of each region. Further validity studies of this instrument with other samples and cultures are warranted.
医生很少接受领导技能方面的正式培训。Çitaku及其同事已经确定了一套领导能力(LC),为北美(NA)和欧盟(EU)医学教育机构提供了有效性证据。我们的目标是将这项相同的调查应用于来自肿瘤学界和相关领域的拉丁美洲(LA)医学领袖的样本,将结果与之前的调查结果进行比较,并在LA队列中进行亚组分析。方法调查对象为参与调查的专业机构的近8000名医生。除了63个问题外,我们还收集了关于机构类型、国家、专业、性别、年龄、肿瘤学经验年限和领导职位的数据。结果217名LA受访者对任务管理能力的评价最高(91.37%的受访者认为这些能力很重要或非常重要,而NA/EU受访者的评价为87.0%;P<0.0001),其次是自我管理(87.45%的LA受访者对87.55%的NA/EU访问者;P=不显著[NS])、社会责任,创新(86.69%的LA受访者对85.31%的NA/EU受访者;P=NS),以及领先他人(83.31%的LA受访者和84.71%的NA/EU受访者;P=NS.)。社会责任在NA/EU调查中排名第一,在LA调查中排名第三。亚组分析显示,LA人群中特定LC的评分存在显著差异。结论LA领导人重视的LC与NA和欧盟领导人重视的LCs有所不同,这意味着文化方面可能会影响对所需LC的看法。我们还检测到LA人群中反应的变化。我们的数据表明,目前的医生领导力培训计划应该根据每个地区的具体需求和文化方面进行调整。有必要对该仪器与其他样本和培养物进行进一步的有效性研究。
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引用次数: 4
OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma OSSMAR:描述舒尼替尼在实际生活中治疗转移性肾细胞癌的观察研究
Pub Date : 2019-10-28 DOI: 10.1200/JGO.18.00238
M. Ghosn, R. Eid, E. Hamada, Hamdy Abdel Azim, J. Zekri, M. Al-Mansour, M. Jaloudi, F. Nasr, H. Errihani, A. Bounedjar, A. Mezlini, H. Boussen, J. Kattan, F. el Karak, F. Farhat
PURPOSE Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS Patients diagnosed with mRCC and started on sunitinib between 2006 and 2016 from 10 centers in Africa and the Middle East region were studied in this regional, multicenter, observational, retrospective trial to obtain routine clinical practice data on the usage patterns and outcomes of sunitinib in mRCC in real-life practice. RESULTS A total of 289 patients were enrolled. Median age at diagnosis was 58.7 years. The patient characteristics were as follows: 73.6% of patients were males; 85.8% had clear-cell renal cell carcinoma (RCC); 97.5% had unilateral RCC; 66.3% had metastatic disease at initial diagnosis; 56.3% received previous treatment for RCC, among which 98.7% had undergone surgery; and 15.2% and 31.4% were classified in the favorable and poor-risk groups (expanded Memorial Sloan Kettering Cancer Center criteria), respectively. On treatment initiation, the mean total sunitinib dose was 48.1 mg, and 87.6% of patients were started on a sunitinib dose of 50 mg. The mean duration of sunitinib treatment was 9.6 months. Overall response rate was 20.8%, with a median duration of 8.2 months. Median time to progression was 5.7 months. Median follow-up time was 7.8 months. By months 12 and 24, 34.3% and 11.4% of patients, respectively, were still alive. Seventy-six patients (60.9%) experienced 314 adverse events. Twenty-three patients (8.0%) experienced 28 serious adverse events. Overall, 83 patients (28.7%) discontinued their sunitinib treatment. CONCLUSION The results are indicative of the general treatment outcomes of patients with mRCC in the Middle East using sunitinib in routine clinical practice. Reported adverse events are similar to those described in the literature but at lower frequencies.
舒尼替尼可改善转移性肾细胞癌(mRCC)患者的疗效。为了在中东提供更好的疾病管理,我们研究了它在该地区现实生活中的应用。材料和方法在这项区域性、多中心、观察性、回顾性试验中,对2006年至2016年间来自非洲和中东地区10个中心的被诊断为mRCC并开始服用舒尼替尼的患者进行了研究,以获得关于舒尼替尼在mRCC中的实际使用模式和结果的常规临床实践数据。结果共有289名患者入选。诊断时的中位年龄为58.7岁。患者特征如下:男性占73.6%;肾透明细胞癌(RCC)占85.8%;97.5%为单侧RCC;66.3%的患者在初次诊断时有转移性疾病;56.3%曾接受过RCC治疗,其中98.7%曾接受过手术治疗;15.2%和31.4%分别被分为有利和低风险组(扩展了纪念斯隆-凯特琳癌症中心的标准)。在治疗开始时,舒尼替尼的平均总剂量为48.1 mg,87.6%的患者开始服用50 mg的舒尼替尼来治疗。舒尼替尼治疗的平均持续时间为9.6个月。总有效率为20.8%,中位持续时间为8.2个月。中位进展时间为5.7个月。中位随访时间为7.8个月。到第12个月和第24个月,分别有34.3%和11.4%的患者仍然活着。76名患者(60.9%)经历了314次不良事件。23名患者(8.0%)经历了28次严重不良事件。总的来说,83名患者(28.7%)停止了舒尼替尼的治疗。结论该结果可作为中东地区mRCC患者在常规临床实践中使用舒尼替尼的一般治疗结果的指标。报告的不良事件与文献中描述的类似,但发生频率较低。
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引用次数: 4
African School of Pediatric Oncology Initiative: Implementation of a Pediatric Oncology Diploma Program to Address Critical Workforce Shortages in French-Speaking Africa 非洲儿科肿瘤学院倡议:实施儿科肿瘤文凭课程,以解决法语非洲的严重劳动力短缺问题
Pub Date : 2019-10-28 DOI: 10.1200/JGO.19.00161
L. Hessissen, C. Patte, Hélène Martelli, C. Coze, S. Howard, A. Kili, A. Gagnepain-Lacheteau, M. Harif
PURPOSE In 2012, the French African Pediatric Oncology Group established the African School of Pediatric Oncology (EAOP), a training program supported by the Sanofi Espoir Foundation’s My Child Matters program. As part of the EAOP, the pediatric oncology training diploma is a 1-year intensive training program. We present this training and certification program as a model for subspecialty training for low- and middle-income countries. METHODS A 14-member committee of multidisciplinary experts finalized a curriculum patterned on the French model Diplôme Inter-Universitaire d’Oncologie Pédiatrique. The program trained per year 15 to 25 physician participants committed to returning to their home country to work at their parent institutions. Training included didactic lectures, both in person and online; an onsite practicum; and a research project. Evaluation included participant evaluation and feedback on the effectiveness and quality of training. RESULTS The first cohort began in October 2014, and by January 2019, 72 participants from three cohorts had been trained. Of the first 72 trainees from 19 French-speaking African countries, 55 (76%) graduated and returned to their countries of origin. Four new pediatric oncology units have been established in Niger, Benin, Central African Republic, and Gabon by the graduates. Sixty-six participants registered on the e-learning platform and continue their education through the EAOP Web site. CONCLUSION This training model rapidly increased the pool of qualified pediatric oncology professionals in French-speaking countries of Africa. It is feasible and scalable but requires sustained funding and ongoing mentoring of graduates to maximize its impact.
目的2012年,法国非洲儿科肿瘤集团成立了非洲儿科肿瘤学院(EAOP),这是一个由赛诺菲Espoir基金会的“我的孩子很重要”项目支持的培训项目。作为EAOP的一部分,儿科肿瘤学培训文凭是一项为期一年的强化培训计划。我们将这一培训和认证计划作为中低收入国家亚专业培训的典范。方法一个由14名成员组成的多学科专家委员会最终确定了一个以法国肿瘤国际大学为模式的课程。该项目每年培训15至25名医生参与者,他们承诺返回祖国在母机构工作。培训包括亲自授课和在线授课;现场实习;以及一个研究项目。评价包括对参与者的评价以及对培训的有效性和质量的反馈。结果第一个队列于2014年10月开始,到2019年1月,来自三个队列的72名参与者已经接受了培训。在来自19个非洲法语国家的首批72名学员中,有55人(76%)毕业并返回原籍国。毕业生们在尼日尔、贝宁、中非共和国和加蓬建立了四个新的儿科肿瘤科。66名参与者在电子学习平台上注册,并通过EAOP网站继续接受教育。结论这种培训模式迅速增加了非洲法语国家合格的儿科肿瘤学专业人才库。它是可行和可扩展的,但需要持续的资金和对毕业生的持续指导,以最大限度地发挥其影响。
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引用次数: 15
The Colombian Medical Oncologists Workforce 哥伦比亚医疗肿瘤学家队伍
Pub Date : 2019-10-28 DOI: 10.1200/JGO.19.00221
R. Murillo, Kelman Ojeda, J. Solano, M. V. Herrera, Oswaldo Sánchez
As a result of population aging, the absolute number of new cancer cases will increase in Colombia during the next decades from about 101,893 per year in 2018 (excluding nonmelanoma skin cancer) to about 136,246 per year in 2040, still with an average annual percentage change of −1.5%.1 The country shows an epidemiologic transition with breast and prostate cancers as leading causes of cancer incidence and mortality, and a mortality reduction from infection and tobacco-associated cancers such as those from the cervix, liver, stomach, larynx, esophagus, and lung.2,3 However, the latter remain highly prevalent and, with a few exceptions, population-based survival shows a relative reduction for most types of cancer and with significant differences when compared with high-income countries.4 Despite the reduced survival, the 5-year prevalence for all cancer types was 466.4 per 100,000 in 2018 corresponding to approximately 230,726 prevalent cases.1 The relative reduction in survival may indicate scarce progress in cancer early detection or proper timely treatment. In this regard, some analyses show a variable number of visits to the oncologist depending upon the stage of the disease, with higher rates at the beginning of treatment (particularly if neoadjuvant protocols are used), lower rates among survivors with controlled disease, and higher rates again toward the end of life.5 Thus, a high proportion of advanced cases at diagnosis, as may be the case in Colombia,6 would require greater oncologist time to meet the demand. In addition to cancer incidence and stage at diagnosis, technologies used for cancer treatment also determine the demand of medical oncology. Currently target and immune therapies represent the highest investment in research and development by pharmaceutical companies,7 thus inducing permanent licensing of new oncology drugs and delivery of associated knowledge, which demands careful analysis by the medical oncologist workforce. Moreover, new technologies lead to relevant changes in oncology practice; for instance, trastuzumab combined with cytotoxic drugs for the management of HER2-positive breast cancer patients (approximately 20% of cases) reduces relapse in 50% of cases and increases survival rates.8 Furthermore, the addition of trastuzumab increases treatment adverse effects and modifies the treatment schedule from approximately 8 to 27 sessions during the first year of treatment compared to chemotherapy alone.5 Similarly, systemic therapy combined with other treatment modalities, such as in the case of neoadjuvant and adjuvant protocols or concomitant chemo-radiation, the administration of several lines of treatment, and consolidation with bone marrow transplantation, have also shown better disease control and longer survival for different types of cancer, thus resulting in increased medical oncologist time for cancer care. All factors described challenge the planning and supply of medical oncologist workforce, a
由于人口老龄化,未来几十年,哥伦比亚新增癌症病例的绝对数量将从2018年的每年101893例(不包括癌症非黑色素瘤)增加到2040年的每年136246例,仍然平均每年百分比变化-1.5%。1该国表现出流行病学转变,乳腺癌和前列腺癌是癌症发病率和死亡率的主要原因,感染和烟草相关癌症(如宫颈癌、肝癌、胃癌、喉癌、食道癌和肺癌)的死亡率下降。2,3然而,后者仍然高度流行,除少数例外,大多数癌症类型的人群生存率相对降低,与高收入国家相比有显著差异。4尽管生存率降低,2018年,所有癌症类型的5年患病率为466.4/10万,相当于约230726例流行病例。1生存率的相对降低可能表明癌症早期检测或适当及时治疗进展缓慢。在这方面,一些分析显示,根据疾病的阶段,肿瘤医生的就诊次数各不相同,在治疗开始时的就诊率较高(特别是在使用新辅助方案的情况下),在疾病得到控制的幸存者中的就诊率较低,在生命结束时再次就诊的比率较高,正如哥伦比亚的情况一样,6需要更多的肿瘤学家时间来满足需求。除了癌症的发病率和诊断阶段外,用于癌症治疗的技术也决定了医学肿瘤学的需求。目前,靶向和免疫疗法代表了制药公司对研发的最高投资,7因此导致了肿瘤新药的永久许可和相关知识的提供,这需要医学肿瘤学家的仔细分析。此外,新技术导致肿瘤学实践的相关变化;例如,曲妥珠单抗与细胞毒性药物联合治疗HER2阳性乳腺癌症患者(约20%的病例)可减少50%的病例的复发并提高存活率。8此外,与单独化疗相比,曲妥珠单抗的加入增加了治疗的不良反应,并在治疗的第一年将治疗计划从大约8个疗程修改为27个疗程。5类似地,与其他治疗模式相结合的全身治疗,例如在新辅助和辅助方案或伴随化疗放疗的情况下,多种治疗方法的实施,以及骨髓移植的巩固,也显示了不同类型癌症更好的疾病控制和更长的生存期,从而增加了癌症医学肿瘤学家的治疗时间。所描述的所有因素都对医学肿瘤学家劳动力的规划和供应构成挑战,这对中等收入国家至关重要,因为这些国家可能会更好地获得新的癌症护理技术,但协调技术开发与癌症护理的资源并不常见。因此,在这篇文章中,我们使用经认可的信息来源和国际标准来审查哥伦比亚肿瘤学家劳动力的供需情况。
{"title":"The Colombian Medical Oncologists Workforce","authors":"R. Murillo, Kelman Ojeda, J. Solano, M. V. Herrera, Oswaldo Sánchez","doi":"10.1200/JGO.19.00221","DOIUrl":"https://doi.org/10.1200/JGO.19.00221","url":null,"abstract":"As a result of population aging, the absolute number of new cancer cases will increase in Colombia during the next decades from about 101,893 per year in 2018 (excluding nonmelanoma skin cancer) to about 136,246 per year in 2040, still with an average annual percentage change of −1.5%.1 \u0000 \u0000The country shows an epidemiologic transition with breast and prostate cancers as leading causes of cancer incidence and mortality, and a mortality reduction from infection and tobacco-associated cancers such as those from the cervix, liver, stomach, larynx, esophagus, and lung.2,3 However, the latter remain highly prevalent and, with a few exceptions, population-based survival shows a relative reduction for most types of cancer and with significant differences when compared with high-income countries.4 Despite the reduced survival, the 5-year prevalence for all cancer types was 466.4 per 100,000 in 2018 corresponding to approximately 230,726 prevalent cases.1 \u0000 \u0000The relative reduction in survival may indicate scarce progress in cancer early detection or proper timely treatment. In this regard, some analyses show a variable number of visits to the oncologist depending upon the stage of the disease, with higher rates at the beginning of treatment (particularly if neoadjuvant protocols are used), lower rates among survivors with controlled disease, and higher rates again toward the end of life.5 Thus, a high proportion of advanced cases at diagnosis, as may be the case in Colombia,6 would require greater oncologist time to meet the demand. \u0000 \u0000In addition to cancer incidence and stage at diagnosis, technologies used for cancer treatment also determine the demand of medical oncology. Currently target and immune therapies represent the highest investment in research and development by pharmaceutical companies,7 thus inducing permanent licensing of new oncology drugs and delivery of associated knowledge, which demands careful analysis by the medical oncologist workforce. \u0000 \u0000Moreover, new technologies lead to relevant changes in oncology practice; for instance, trastuzumab combined with cytotoxic drugs for the management of HER2-positive breast cancer patients (approximately 20% of cases) reduces relapse in 50% of cases and increases survival rates.8 Furthermore, the addition of trastuzumab increases treatment adverse effects and modifies the treatment schedule from approximately 8 to 27 sessions during the first year of treatment compared to chemotherapy alone.5 Similarly, systemic therapy combined with other treatment modalities, such as in the case of neoadjuvant and adjuvant protocols or concomitant chemo-radiation, the administration of several lines of treatment, and consolidation with bone marrow transplantation, have also shown better disease control and longer survival for different types of cancer, thus resulting in increased medical oncologist time for cancer care. \u0000 \u0000All factors described challenge the planning and supply of medical oncologist workforce, a","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1200/JGO.19.00221","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42908191","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: 3
Mapping Geospatial Access to Comprehensive Cancer Care in Nigeria 绘制尼日利亚癌症综合护理的地理空间获取情况
Pub Date : 2019-10-21 DOI: 10.1200/JGO.19.00283
G. Knapp, G. Tansley, O. Olasehinde, O. Alatise, F. Wuraola, M. Olawole, O. Arije, B. M. Gali, T. Kingham
PURPOSE To address the increasing burden of cancer in Nigeria, the National Cancer Control Plan outlines the development of 8 public comprehensive cancer centers. We map population-level geospatial access to these eight centers and explore equity of access and the impact of future development. METHODS Geospatial methods were used to estimate population-level travel times to the 8 cancer centers. A cost distance model was built using open source road infrastructure data with verified speed limits. Geolocated population estimates were amalgamated with this model to calculate travel times to cancer centers at a national and regional level for both the entire population and the population living on < US$2 per day. RESULTS Overall, 68.9% of Nigerians have access to a comprehensive cancer center at 4 hours of continuous vehicular travel. However, there is significant variability in access between geopolitical zones (P < .001). The North East has the lowest access at 4 hours (31.4%) and the highest mean travel times (268 minutes); this is significantly lower than the proportion with 4-hour access in the South East (31.4% v 85.0%, respectively; P < .001). The addition of a second comprehensive cancer center in the North East, in either Bauchi or Gombe, would significantly improve access to this underserved region. CONCLUSION The Federal Ministry of Health endorses investment in 8 public comprehensive cancer centers. Strengthening these centers will allow the majority of Nigerians to access the full complement of multidisciplinary care within a reasonable time frame. However, geospatial access remains inequitable, and the impact on outcomes is unclear. This must be considered as the cancer control system matures and expands.
为了解决尼日利亚癌症日益加重的负担,国家癌症控制计划概述了8个公共综合癌症中心的发展。我们绘制了这八个中心的人口级地理空间访问地图,并探讨访问的公平性和未来发展的影响。方法采用地理空间方法估计8个癌症中心的人群出行时间。使用已验证限速的开源道路基础设施数据建立了成本-距离模型。将地理定位的人口估计与该模型合并,以计算整个人口和每日生活费<2美元的人口前往国家和地区癌症中心的旅行时间。结果总体而言,68.9%的尼日利亚人可以在连续4小时的车辆旅行中进入综合癌症中心。然而,地缘政治区域之间的访问存在显著差异(P<.001)。东北部的访问时间最低,为4小时(31.4%),平均旅行时间最高(268分钟);这显著低于东南部4小时访问的比例(分别为31.4%和85.0%;P<.001)。在东北部增加第二个综合癌症中心,无论是包奇还是贡贝,都将显著改善对这一服务不足地区的访问。结论联邦卫生部批准投资8个公共综合癌症中心。加强这些中心将使大多数尼日利亚人能够在合理的时间内获得全面的多学科护理。然而,地理空间访问仍然不公平,对结果的影响尚不清楚。这必须考虑到癌症控制系统的成熟和扩展。
{"title":"Mapping Geospatial Access to Comprehensive Cancer Care in Nigeria","authors":"G. Knapp, G. Tansley, O. Olasehinde, O. Alatise, F. Wuraola, M. Olawole, O. Arije, B. M. Gali, T. Kingham","doi":"10.1200/JGO.19.00283","DOIUrl":"https://doi.org/10.1200/JGO.19.00283","url":null,"abstract":"PURPOSE To address the increasing burden of cancer in Nigeria, the National Cancer Control Plan outlines the development of 8 public comprehensive cancer centers. We map population-level geospatial access to these eight centers and explore equity of access and the impact of future development. METHODS Geospatial methods were used to estimate population-level travel times to the 8 cancer centers. A cost distance model was built using open source road infrastructure data with verified speed limits. Geolocated population estimates were amalgamated with this model to calculate travel times to cancer centers at a national and regional level for both the entire population and the population living on < US$2 per day. RESULTS Overall, 68.9% of Nigerians have access to a comprehensive cancer center at 4 hours of continuous vehicular travel. However, there is significant variability in access between geopolitical zones (P < .001). The North East has the lowest access at 4 hours (31.4%) and the highest mean travel times (268 minutes); this is significantly lower than the proportion with 4-hour access in the South East (31.4% v 85.0%, respectively; P < .001). The addition of a second comprehensive cancer center in the North East, in either Bauchi or Gombe, would significantly improve access to this underserved region. CONCLUSION The Federal Ministry of Health endorses investment in 8 public comprehensive cancer centers. Strengthening these centers will allow the majority of Nigerians to access the full complement of multidisciplinary care within a reasonable time frame. However, geospatial access remains inequitable, and the impact on outcomes is unclear. This must be considered as the cancer control system matures and expands.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1200/JGO.19.00283","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47966820","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: 13
Subsequent Cancer Prevention and Control Activities Among Low- and Middle-Income Country Participants in the US National Cancer Institute’s Summer Curriculum in Cancer Prevention 美国国家癌症研究所癌症预防暑期课程中低收入和中等收入国家参与者的后续癌症预防和控制活动
Pub Date : 2019-10-18 DOI: 10.1200/JGO.19.00231
Amanda L. Vogel, C. Morgan, K. Duncan, Makeda J Williams
PURPOSE A dramatic shift in the burden of cancer from high-income countries to low- and middle-income countries (LMICs) is predicted to occur over the next few decades. An effective response requires a range of approaches to capacity building in cancer prevention and control in LMICs, including training of cancer prevention and control professionals. Toward this end, the US National Cancer Institute includes LMIC-based participants in its Summer Curriculum in Cancer Prevention, which is an annual, short-term in-person training program. METHODS In 2015 and 2016, the US National Cancer Institute fielded a survey to all Summer Curriculum alumni who were based in LMICs when they participated in the program, between 1998 and 2015. Its aims were to learn about subsequent engagement in cancer prevention and control in LMICs and attribution of activities/accomplishments to participation in the Summer Curriculum in Cancer Prevention. RESULTS Respondents (N = 138) worked in academia/research (n = 61), health care (n = 41), and health policy/Ministries of Health (n = 36) in all six world regions. Most respondents (90.6%) worked in the same LMIC as when they participated in the Summer Curriculum in Cancer Prevention. When asked about activities/accomplishments completed as a result of participation, 92.8% reported at least one cancer prevention and control practice activity/accomplishment, 81.2% reported at least one cancer research activity/accomplishment, and 44.2% reported authoring one or more peer-reviewed publications. Reported ways that the Summer Curriculum in Cancer Prevention contributed to these activities/accomplishments were emphasizing a public health approach; focusing on research priorities, methods, and scientific writing; and highlighting the importance of research and publications. Finally, 79.7% of respondents reported using Summer Curriculum in Cancer Prevention materials to train others. CONCLUSION These findings have implications for the design of future training initiatives for LMIC-based cancer prevention and control professionals.
癌症负担将在未来几十年内从高收入国家急剧转移到低收入和中等收入国家(LMIC)。一项有效的应对措施需要采取一系列方法,在低成本医疗中心开展癌症预防和控制方面的能力建设,包括培训癌症预防和控制专业人员。为此,美国国家癌症研究所将LMIC的参与者纳入其癌症预防夏季课程,这是一项年度短期住院培训计划。方法2015年和2016年,美国国家癌症研究所对1998年至2015年间参加该项目的所有LMIC暑期课程校友进行了调查。其目的是了解随后在LMIC中参与癌症预防和控制的情况,以及将活动/成就归因于参与癌症预防暑期课程的情况。结果受访者(N=138)在世界所有六个地区的学术界/研究(N=61)、卫生保健(N=41)和卫生政策/卫生部(N=36)工作。大多数受访者(90.6%)与参加癌症预防暑期课程时在同一LMIC工作。当被问及因参与而完成的活动/成就时,92.8%的人报告至少有一项癌症预防和控制实践活动/成就,81.2%的人报告了至少一项癌症研究活动/成就;44.2%的人表示撰写了一份或多份同行评议的出版物。据报告,癌症预防暑期课程有助于这些活动/成就的方式是强调公共卫生方法;关注研究重点、方法和科学写作;强调研究和出版物的重要性。最后,79.7%的受访者报告使用癌症预防材料中的暑期课程来培训他人。结论这些发现对基于LMIC的癌症预防和控制专业人员未来培训计划的设计具有指导意义。
{"title":"Subsequent Cancer Prevention and Control Activities Among Low- and Middle-Income Country Participants in the US National Cancer Institute’s Summer Curriculum in Cancer Prevention","authors":"Amanda L. Vogel, C. Morgan, K. Duncan, Makeda J Williams","doi":"10.1200/JGO.19.00231","DOIUrl":"https://doi.org/10.1200/JGO.19.00231","url":null,"abstract":"PURPOSE A dramatic shift in the burden of cancer from high-income countries to low- and middle-income countries (LMICs) is predicted to occur over the next few decades. An effective response requires a range of approaches to capacity building in cancer prevention and control in LMICs, including training of cancer prevention and control professionals. Toward this end, the US National Cancer Institute includes LMIC-based participants in its Summer Curriculum in Cancer Prevention, which is an annual, short-term in-person training program. METHODS In 2015 and 2016, the US National Cancer Institute fielded a survey to all Summer Curriculum alumni who were based in LMICs when they participated in the program, between 1998 and 2015. Its aims were to learn about subsequent engagement in cancer prevention and control in LMICs and attribution of activities/accomplishments to participation in the Summer Curriculum in Cancer Prevention. RESULTS Respondents (N = 138) worked in academia/research (n = 61), health care (n = 41), and health policy/Ministries of Health (n = 36) in all six world regions. Most respondents (90.6%) worked in the same LMIC as when they participated in the Summer Curriculum in Cancer Prevention. When asked about activities/accomplishments completed as a result of participation, 92.8% reported at least one cancer prevention and control practice activity/accomplishment, 81.2% reported at least one cancer research activity/accomplishment, and 44.2% reported authoring one or more peer-reviewed publications. Reported ways that the Summer Curriculum in Cancer Prevention contributed to these activities/accomplishments were emphasizing a public health approach; focusing on research priorities, methods, and scientific writing; and highlighting the importance of research and publications. Finally, 79.7% of respondents reported using Summer Curriculum in Cancer Prevention materials to train others. CONCLUSION These findings have implications for the design of future training initiatives for LMIC-based cancer prevention and control professionals.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1200/JGO.19.00231","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48543787","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: 2
Intraoperative radiotherapy (IORT) for surgically resected brain metastases: Local control and dosimetric analysis. 手术切除脑转移瘤的术中放疗:局部控制和剂量分析。
Pub Date : 2019-10-15 DOI: 10.1200/jgo.2019.5.suppl.114
Christopher P. Cifarelli, J. Vargo, Joshua D. Hack, P. Renz, L. Poplawski, G. Jacobson, K. Kahl, S. Brehmer, G. Sarria, F. Giordano
114 Background: The optimal use of adjuvant radiation following surgical resection of large brain metastases (BM) remains undetermined. Time to initiation following surgery and target delineation both impact local control (LC). Intraoperative radiotherapy (IORT) allows for elimination of lag time between surgery and radiation, direct cavity targeting, and safe dose escalation beyond traditional stereotactic radiosurgery (SRS). The current study provides an analysis of local disease control and dosimetric parameters related to intracranial IORT. Methods: Retrospective data was collected on patients treated with IORT immediately following surgical resection of BMs at three institutions according to the approval of individual IRBs. All patients were treated with the Zeiss Intrabeam device (Carl Zeiss Meditech, Germany) using spherical applicators ranging from 1.5 to 4.0cm with 50kV output. Statistical analyses were performed using SPSS (IBM) with endpoints of LC and incidence of RN, with p < 0.05 considered significant. Dosimetric comparisons between IORT and SRS were made based on V10, V12, and dose homogeneity based on percent of GTV receiving greater than 20Gy or 30Gy. Results: 54 patients were treated with IORT with a median age of 64 years. The most common primary diagnosis was non-small cell lung cancer (40%) with the most common location in the frontal lobe (38%). Median follow-up was 7.2 months and 1-year LC rate was 88% with radiation necrosis (RN) present in 4 patients (7%). The dosimetric comparison of a single IORT case revealed non-target V10 and V12 volumes as 24.75cm3 and 14.76cm3, respectively, for the SRS treatment plan of 16Gy to the margin. The V10 and V12 for the IORT treatment plan were 20.83cm3 and 9.93cm3 with a surface dose of 30Gy. The volumes exceeding 20Gy and 30Gy in the SRS plan were 14.73cm3 and 0.328cm3, respectively, while the corresponding volumes in the IORT plan were 9.8cm3 and 0cm3. Conclusions: IORT is a safe and effective means of delivering adjuvant radiation to the BM resection cavities with a high rate of LC, low incidence of RN, increased homogeneity of target dose and ability to escalate dose beyond traditional SRS plans.
114背景:大面积脑转移瘤(BM)手术切除后辅助放射的最佳使用尚不确定。手术后的起始时间和靶点划定都会影响局部控制(LC)。术中放疗(IORT)可以消除手术和放疗之间的滞后时间,直接腔靶向,并在传统的立体定向放射外科(SRS)之外安全地增加剂量。目前的研究提供了与颅内IORT相关的局部疾病控制和剂量测定参数的分析。方法:根据个别IRB的批准,在三个机构收集BMs手术切除后立即接受IORT治疗的患者的回顾性数据。所有患者均使用蔡司Intrabem设备(德国卡尔蔡司Meditech)进行治疗,使用1.5至4.0cm的球形施加器,输出50kV。使用SPSS(IBM)对LC终点和RN发生率进行统计分析,p<0.05被认为是显著的。IORT和SRS之间的剂量测定比较基于V10、V12,剂量均匀性基于GTV接收大于20Gy或30Gy的百分比。结果:54例患者接受IORT治疗,中位年龄64岁。最常见的原发诊断是非小细胞肺癌癌症(40%),最常见的位置在额叶(38%)。中位随访时间为7.2个月,1年LC发生率为88%,4名患者(7%)出现放射性坏死(RN)。单个IORT病例的剂量测定比较显示,对于16Gy至边缘的SRS治疗计划,非目标V10和V12体积分别为24.75cm3和14.76cm3。IORT治疗方案的V10和V12分别为20.83cm3和9.93cm3,表面剂量为30Gy。SRS计划中超过20Gy和30Gy的体积分别为14.73立方厘米和0.328立方厘米,而IORT计划中的相应体积分别为9.8立方厘米和0立方厘米。结论:IORT是一种安全有效的向BM切除腔提供辅助辐射的方法,具有LC发生率高、RN发生率低、靶剂量均匀性增加以及将剂量增加到传统SRS计划之外的能力。
{"title":"Intraoperative radiotherapy (IORT) for surgically resected brain metastases: Local control and dosimetric analysis.","authors":"Christopher P. Cifarelli, J. Vargo, Joshua D. Hack, P. Renz, L. Poplawski, G. Jacobson, K. Kahl, S. Brehmer, G. Sarria, F. Giordano","doi":"10.1200/jgo.2019.5.suppl.114","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.114","url":null,"abstract":"114 Background: The optimal use of adjuvant radiation following surgical resection of large brain metastases (BM) remains undetermined. Time to initiation following surgery and target delineation both impact local control (LC). Intraoperative radiotherapy (IORT) allows for elimination of lag time between surgery and radiation, direct cavity targeting, and safe dose escalation beyond traditional stereotactic radiosurgery (SRS). The current study provides an analysis of local disease control and dosimetric parameters related to intracranial IORT. Methods: Retrospective data was collected on patients treated with IORT immediately following surgical resection of BMs at three institutions according to the approval of individual IRBs. All patients were treated with the Zeiss Intrabeam device (Carl Zeiss Meditech, Germany) using spherical applicators ranging from 1.5 to 4.0cm with 50kV output. Statistical analyses were performed using SPSS (IBM) with endpoints of LC and incidence of RN, with p < 0.05 considered significant. Dosimetric comparisons between IORT and SRS were made based on V10, V12, and dose homogeneity based on percent of GTV receiving greater than 20Gy or 30Gy. Results: 54 patients were treated with IORT with a median age of 64 years. The most common primary diagnosis was non-small cell lung cancer (40%) with the most common location in the frontal lobe (38%). Median follow-up was 7.2 months and 1-year LC rate was 88% with radiation necrosis (RN) present in 4 patients (7%). The dosimetric comparison of a single IORT case revealed non-target V10 and V12 volumes as 24.75cm3 and 14.76cm3, respectively, for the SRS treatment plan of 16Gy to the margin. The V10 and V12 for the IORT treatment plan were 20.83cm3 and 9.93cm3 with a surface dose of 30Gy. The volumes exceeding 20Gy and 30Gy in the SRS plan were 14.73cm3 and 0.328cm3, respectively, while the corresponding volumes in the IORT plan were 9.8cm3 and 0cm3. Conclusions: IORT is a safe and effective means of delivering adjuvant radiation to the BM resection cavities with a high rate of LC, low incidence of RN, increased homogeneity of target dose and ability to escalate dose beyond traditional SRS plans.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47763880","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: 0
Clinical efficacy of combination therapies with androgen receptor antagonists for treatment of multiple refractory cancers. 雄激素受体拮抗剂联合治疗多发性难治性癌症的临床疗效观察。
Pub Date : 2019-10-15 DOI: 10.1200/jgo.2019.5.suppl.115
D. Akolkar, D. Patil, V. Datta, A. Srinivasan, R. Datar
115 Background: Androgen Receptor (AR) antagonists have been the mainstay of prostate cancer treatments. However, there is increasing interest in the use of anti-AR agents in treatment of other cancers such as Triple Negative Breast Cancer and Lung Cancer. AR antagonists are usually administered as single agents and rarely in combination with other cytotoxic or targeted agents. We hypothesized that administration of AR antagonists indicated by Encyclopedic Tumor Analysis (ETA) in synergistic combination with cytotoxic, targeted or other endocrine agents may afford clinical benefit for refractory cancers. Methods: We evaluated treatment response in a basket of 18 patients with various advanced refractory solid organ malignancies, who received personalized treatments based on ETA investigations. As part of ETA, freshly biopsied tumor tissue and blood samples were evaluated for various markers such as gene mutations (DNA), gene expression (RNA) and receptor proteins (immunohistochemistry). Finally, viable tumor cells from the freshly biopsied tissue were used in in vitro chemosensitivity analysis with a panel of cytotoxic and targeted therapy agents. Radiological disease status was evaluated retrospectively and treatment response as well as Progression Free Survival (PFS) was determined. Results: Among the 18 patients, there were 8 males (44%) and 10 females (56%) with median age of 58 years (range 28 – 79). Patients had received a median of 3 prior lines of treatment (range 1 – 14). All 18 patients received ETA guided combination treatments which included an AR blockade. 9 patients showed Partial Response ( PR) with an Objective Response Rate (ORR) of 50%. 5 patients (28%) showed stable disease for ≥3 months (Clinical Benefit Rate = 77.8%), while 4 patients (22%) showed disease progression. In 2 patients (11%) disease progressed at ~60 days and in the remaining 2 patients (11%) progression was seen at > 120 days. Treatments were well tolerated without severe adverse events. Conclusions: Androgen addicted, refractory solid organ tumors respond to combinations of cytotoxic, targeted and endocrine agents along with AR antagonists guided by ETA.
115背景:雄激素受体(AR)拮抗剂已成为癌症治疗的主要药物。然而,抗AR药物在治疗其他癌症(如三阴性乳腺癌癌症和癌症)中的应用越来越引起人们的兴趣。AR拮抗剂通常作为单一药物给药,很少与其他细胞毒性或靶向药物联合给药。我们假设,百科全书肿瘤分析(ETA)指示的AR拮抗剂与细胞毒性、靶向或其他内分泌药物协同联合给药可能为难治性癌症提供临床益处。方法:我们评估了一篮子18名患有各种晚期难治性实体器官恶性肿瘤的患者的治疗反应,这些患者根据ETA调查接受了个性化治疗。作为ETA的一部分,对新鲜活检的肿瘤组织和血液样本进行各种标记物的评估,如基因突变(DNA)、基因表达(RNA)和受体蛋白(免疫组织化学)。最后,使用一组细胞毒性和靶向治疗剂,将来自新鲜活检组织的活肿瘤细胞用于体外化学敏感性分析。回顾性评估放射疾病状态,确定治疗反应和无进展生存期(PFS)。结果:在18名患者中,有8名男性(44%)和10名女性(56%),中位年龄为58岁(28-79岁)。患者之前接受过3次治疗(范围1-14)。所有18名患者均接受ETA指导的联合治疗,其中包括AR阻断。9例患者出现部分缓解(PR),客观缓解率(ORR)为50%。5名患者(28%)病情稳定≥3个月(临床获益率=77.8%),4名患者(22%)病情进展。在2名患者(11%)中,疾病在约60天时进展,在其余2名患者中(11%),疾病在>120天时进展。治疗耐受性良好,无严重不良事件。结论:雄激素成瘾、难治性实体器官肿瘤对细胞毒性、靶向和内分泌药物以及ETA引导的AR拮抗剂的组合有反应。
{"title":"Clinical efficacy of combination therapies with androgen receptor antagonists for treatment of multiple refractory cancers.","authors":"D. Akolkar, D. Patil, V. Datta, A. Srinivasan, R. Datar","doi":"10.1200/jgo.2019.5.suppl.115","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.115","url":null,"abstract":"115 Background: Androgen Receptor (AR) antagonists have been the mainstay of prostate cancer treatments. However, there is increasing interest in the use of anti-AR agents in treatment of other cancers such as Triple Negative Breast Cancer and Lung Cancer. AR antagonists are usually administered as single agents and rarely in combination with other cytotoxic or targeted agents. We hypothesized that administration of AR antagonists indicated by Encyclopedic Tumor Analysis (ETA) in synergistic combination with cytotoxic, targeted or other endocrine agents may afford clinical benefit for refractory cancers. Methods: We evaluated treatment response in a basket of 18 patients with various advanced refractory solid organ malignancies, who received personalized treatments based on ETA investigations. As part of ETA, freshly biopsied tumor tissue and blood samples were evaluated for various markers such as gene mutations (DNA), gene expression (RNA) and receptor proteins (immunohistochemistry). Finally, viable tumor cells from the freshly biopsied tissue were used in in vitro chemosensitivity analysis with a panel of cytotoxic and targeted therapy agents. Radiological disease status was evaluated retrospectively and treatment response as well as Progression Free Survival (PFS) was determined. Results: Among the 18 patients, there were 8 males (44%) and 10 females (56%) with median age of 58 years (range 28 – 79). Patients had received a median of 3 prior lines of treatment (range 1 – 14). All 18 patients received ETA guided combination treatments which included an AR blockade. 9 patients showed Partial Response ( PR) with an Objective Response Rate (ORR) of 50%. 5 patients (28%) showed stable disease for ≥3 months (Clinical Benefit Rate = 77.8%), while 4 patients (22%) showed disease progression. In 2 patients (11%) disease progressed at ~60 days and in the remaining 2 patients (11%) progression was seen at > 120 days. Treatments were well tolerated without severe adverse events. Conclusions: Androgen addicted, refractory solid organ tumors respond to combinations of cytotoxic, targeted and endocrine agents along with AR antagonists guided by ETA.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47827198","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: 0
Randomized phase II clinical trial of pioglitazone plus chemotherapy versus chemotherapy alone in patients with metastatic breast cancer. 转移性乳腺癌患者吡格列酮联合化疗与单独化疗的随机II期临床试验。
Pub Date : 2019-10-15 DOI: 10.1200/jgo.2019.5.suppl.83
Reza Moghareabed, S. Hemati, A. Akhavan, H. Emami, M. Farghadani, M. Roayaei, Saeideh Tavajoh, A. Feizi
83 Background: Breast carcinoma is the second cause of mortality between female cancers and metastasis is the main contributing factor to the mortality in patients with breast cancer. Optimal management for visceral metastatic breast cancer (MBC) remains unknown. In this study we aimed to assess if adding pioglitazone to chemotherapy regimen can improve response in patients with MBC. Methods: This double-blind randomized clinical trial enrolled women 18 years or older with visceral MBC either previously treated with adjuvant therapy or currently are undergoing different lines of endocrine and chemotherapy regimens. The main objective of this study is to compare treatment efficacy in patients with visceral MBC taking chemotherapy plus Pioglitazone (n = 30) versus chemotherapy in addition to placebo (n = 30) over three months. The efficacy evaluated by change in radiologic response defined by the proportion of patients with stable or partial/complete radiologic response to those experienced disease progression based on Revised Recist Guideline ver (1.1). Results: Combination of pioglitazone and chemotherapy led to higher complete radiologic response (7.4% vs.0%) stable disease status (66·7% vs. 53·6%) and lower progression (22·2% vs. 35·7%) rates, however the differences were not statistically significant (P = 0.24). Clinical benefit rate (CBR, proportion of patients with complete response, partial response, or stable disease) was 77.8% in pioglitazone group vs. 64.3% in control group (p = 0.27). Subgroup analysis revealed higher efficacy but not statistically significant among diabetic woman, who had hormone-receptor–positive tumor. Furthermore, patients treated with Taxan +/-Carboplatin agents had significantly higher stable disease status, lower progression rate and higher complete response rate than the placebo group (P = 0·03). Conclusions: This is the first reported randomized clinical trial on the efficacy of pioglitazone in patients with visceral MBC which demonstrated safety and improvement of response in the subgroup of Taxan / Carboplatin chemotherapy regimen. These findings are in agreement with previous results of in vitro preclinical studies. Clinical trial information: IRCT20180124038493N1.
83背景:乳腺癌是女性癌症死亡的第二大原因,转移是导致乳腺癌患者死亡的主要因素。内脏转移性乳腺癌(MBC)的最佳治疗方法尚不清楚。在这项研究中,我们旨在评估在化疗方案中加入吡格列酮是否可以改善MBC患者的反应。方法:这项双盲随机临床试验招募了18岁或以上的内脏MBC患者,这些患者要么以前接受过辅助治疗,要么目前正在接受不同的内分泌和化疗方案。本研究的主要目的是比较三个月内化疗加吡格列酮(n = 30)与化疗加安慰剂(n = 30)的内脏MBC患者的治疗效果。疗效通过放射反应的变化来评估,放射反应的变化由稳定或部分/完全放射反应的患者与经历疾病进展的患者的比例定义,该比例基于修订的Recist指南ver(1.1)。结果:吡格列酮联合化疗的完全放射反应率(7.4% vs.0%)较高,病情稳定(66.7% vs. 53.6%),进展率(22.2% vs. 35.7%)较低,但差异无统计学意义(P = 0.24)。吡格列酮组的临床获益率(CBR,完全缓解、部分缓解或疾病稳定的患者比例)为77.8%,对照组为64.3% (p = 0.27)。亚组分析显示,在患有激素受体阳性肿瘤的糖尿病女性患者中,疗效更高,但无统计学意义。与安慰剂组相比,Taxan +/-Carboplatin治疗组患者的疾病稳定状态更高,进展率更低,完全缓解率更高(P = 0.03)。结论:这是首个报道的吡格列酮治疗内脏性MBC患者疗效的随机临床试验,在Taxan / Carboplatin化疗方案亚组中证明了安全性和疗效的改善。这些发现与之前体外临床前研究的结果一致。临床试验信息:IRCT20180124038493N1。
{"title":"Randomized phase II clinical trial of pioglitazone plus chemotherapy versus chemotherapy alone in patients with metastatic breast cancer.","authors":"Reza Moghareabed, S. Hemati, A. Akhavan, H. Emami, M. Farghadani, M. Roayaei, Saeideh Tavajoh, A. Feizi","doi":"10.1200/jgo.2019.5.suppl.83","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.83","url":null,"abstract":"83 Background: Breast carcinoma is the second cause of mortality between female cancers and metastasis is the main contributing factor to the mortality in patients with breast cancer. Optimal management for visceral metastatic breast cancer (MBC) remains unknown. In this study we aimed to assess if adding pioglitazone to chemotherapy regimen can improve response in patients with MBC. Methods: This double-blind randomized clinical trial enrolled women 18 years or older with visceral MBC either previously treated with adjuvant therapy or currently are undergoing different lines of endocrine and chemotherapy regimens. The main objective of this study is to compare treatment efficacy in patients with visceral MBC taking chemotherapy plus Pioglitazone (n = 30) versus chemotherapy in addition to placebo (n = 30) over three months. The efficacy evaluated by change in radiologic response defined by the proportion of patients with stable or partial/complete radiologic response to those experienced disease progression based on Revised Recist Guideline ver (1.1). Results: Combination of pioglitazone and chemotherapy led to higher complete radiologic response (7.4% vs.0%) stable disease status (66·7% vs. 53·6%) and lower progression (22·2% vs. 35·7%) rates, however the differences were not statistically significant (P = 0.24). Clinical benefit rate (CBR, proportion of patients with complete response, partial response, or stable disease) was 77.8% in pioglitazone group vs. 64.3% in control group (p = 0.27). Subgroup analysis revealed higher efficacy but not statistically significant among diabetic woman, who had hormone-receptor–positive tumor. Furthermore, patients treated with Taxan +/-Carboplatin agents had significantly higher stable disease status, lower progression rate and higher complete response rate than the placebo group (P = 0·03). Conclusions: This is the first reported randomized clinical trial on the efficacy of pioglitazone in patients with visceral MBC which demonstrated safety and improvement of response in the subgroup of Taxan / Carboplatin chemotherapy regimen. These findings are in agreement with previous results of in vitro preclinical studies. Clinical trial information: IRCT20180124038493N1.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47781480","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: 1
Carcinoembryonic antigen (CEA) as a candidate prognostic marker of nonmucinous pneumonic adenocarcinoma (P-ADC) of the lung. 癌胚抗原(CEA)作为肺非黏液性肺腺癌(P-ADC)的候选预后标志物。
Pub Date : 2019-10-15 DOI: 10.1200/jgo.2019.5.suppl.28
Satoru Nakamura, M. Fukuda
28 Background: Serum level of CEA as a prognostic marker in NSCLC is well known. In patients with non-mucinous P-ADC, there were some paradoxical cases with high CEA, in spite of improved symptom and chest X-ray after chemotherapy including first-generation EGFR-TKI. Methods: We retrospectively comfirmed serum level of CEA of five patients, including four patients with non-mucinous P-ADC and one patient with mucinous P-ADC, between 2001-2007, all Japanese female without smoking history, 66-78 years old (mean 73.6 y.o.). All of them revealed abnormal pneumonic shadow on chest X-ray, and were diagnosed by TBLB or cytology. These cases were all stage IIIB or IV, and were applied to chemotherapy including first-generation EGFR-TKI. We had measured serum CEA as possible from initial diagnosis and pre or post chemotherapy including first-generation EGFR-TKI to death. OS were between 25~66 months with four patients of non-mucinous P-ADC, and 9 month with one patient of mucinous P-ADC. Other tumor marker such as CYFRA and Pro GRP were all almost normal range. Results: CEA of three patients with non-mucinous P-ADC was elevated according to worsened symptom and X-ray, and were all highly maintained or increased in spite of improved symptom and X-ray after chemotherapy including first-generation EGFR-TKI. CEA of one patient with non-mucinous P-ADC was normal range in initial diagnosis, and no more measured. She has got symptom free and improved chest X-ray after chemotherapy. In one patient with mucinous P-ADC, serum CEA was normal range, so no longer measured. This patient was no effective for chemotherapy, and was dead 9 month after the initial diagnosis. Number of cases was quite few, so further examination is favorable. Furthermore, All cases were exaggerated finally, they might be resistant to first-generation EGFR-TKI. Conclusions: In three patients with non-mucinous P-ADC of the lung, serum CEA was paradoxically highly maintained or elevated in spite of improved symptom and chest X-ray after chemotherapy including first-generation EGFR-TKI. Therefore, serum CEA is a candidate for useful prognostic marker of non-mucimous P-ADC of the lung.
28背景:血清CEA水平作为非小细胞肺癌的预后指标是众所周知的。在非黏液性P-ADC患者中,尽管包括第一代EGFR-TKI化疗后症状和胸部x线片有所改善,但仍有一些矛盾的高CEA病例。方法:回顾性分析2001-2007年间5例日本女性无吸烟史(66-78岁,平均73.6岁)患者血清CEA水平,其中4例为非黏液性P-ADC, 1例为黏液性P-ADC。所有病例均在胸片上显示异常肺影,经TBLB或细胞学诊断。这些病例均为IIIB或IV期,并应用化疗包括第一代EGFR-TKI。我们从最初诊断和化疗前或化疗后(包括第一代EGFR-TKI)到死亡,尽可能地测量血清CEA。4例非黏液性P-ADC的总生存期为25~66个月,1例黏液性P-ADC的总生存期为9个月。其他肿瘤标志物CYFRA、Pro GRP基本在正常范围。结果:3例非黏液性P-ADC患者的CEA均根据症状加重及x线片表现升高,经包括第一代EGFR-TKI在内的化疗后,尽管症状及x线片改善,CEA均高度维持或升高。1例非黏液性P-ADC患者的CEA在初诊时为正常范围,再无测定。化疗后,她的症状消失了,胸部x光片也有所改善。1例黏液性P-ADC患者血清CEA为正常范围,故不再检测。该患者化疗无效,在初步诊断后9个月死亡。病例数较少,宜进一步检查。此外,所有病例最后都被夸大了,他们可能对第一代EGFR-TKI有耐药性。结论:在3例肺非黏液性P-ADC患者中,尽管包括第一代EGFR-TKI在内的化疗后症状和胸片改善,但血清CEA却矛盾地高度维持或升高。因此,血清CEA可作为肺非黏液性P-ADC的有效预后指标。
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Journal of global oncology
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