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
{"title":"Cross-Cultural Validity Study of a Medical Education Leadership Competencies Instrument in Latin American Physicians: A Multinational Study","authors":"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","doi":"10.1200/JGO.19.00243","DOIUrl":"https://doi.org/10.1200/JGO.19.00243","url":null,"abstract":"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.","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.19.00243","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43439694","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}
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
{"title":"OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma","authors":"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","doi":"10.1200/JGO.18.00238","DOIUrl":"https://doi.org/10.1200/JGO.18.00238","url":null,"abstract":"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.","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.18.00238","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43353910","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}
L. Hessissen, C. Patte, Hélène Martelli, C. Coze, S. Howard, A. Kili, A. Gagnepain-Lacheteau, M. Harif
{"title":"African School of Pediatric Oncology Initiative: Implementation of a Pediatric Oncology Diploma Program to Address Critical Workforce Shortages in French-Speaking Africa","authors":"L. Hessissen, C. Patte, Hélène Martelli, C. Coze, S. Howard, A. Kili, A. Gagnepain-Lacheteau, M. Harif","doi":"10.1200/JGO.19.00161","DOIUrl":"https://doi.org/10.1200/JGO.19.00161","url":null,"abstract":"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.","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.19.00161","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41759271","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}
R. Murillo, Kelman Ojeda, J. Solano, M. V. Herrera, Oswaldo Sánchez
{"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}
G. Knapp, G. Tansley, O. Olasehinde, O. Alatise, F. Wuraola, M. Olawole, O. Arije, B. M. Gali, T. Kingham
{"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}
Amanda L. Vogel, C. Morgan, K. Duncan, Makeda J Williams
{"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}
Christopher P. Cifarelli, J. Vargo, Joshua D. Hack, P. Renz, L. Poplawski, G. Jacobson, K. Kahl, S. Brehmer, G. Sarria, F. Giordano
{"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}
D. Akolkar, D. Patil, V. Datta, A. Srinivasan, R. Datar
{"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}
Reza Moghareabed, S. Hemati, A. Akhavan, H. Emami, M. Farghadani, M. Roayaei, Saeideh Tavajoh, A. Feizi
{"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}
{"title":"Carcinoembryonic antigen (CEA) as a candidate prognostic marker of nonmucinous pneumonic adenocarcinoma (P-ADC) of the lung.","authors":"Satoru Nakamura, M. Fukuda","doi":"10.1200/jgo.2019.5.suppl.28","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.28","url":null,"abstract":"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.","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":"47041207","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}