tbuckley/cabot-search huggingface dataset:
Number of sentinel lymph nodes (SLN) removed in breast cancer (BC) patients undergoing sentinel lymph node biopsy (SLNB) in the province of Saskatchewan, Canada: Real-world experience.
Authors: Tyrell Wees, Gopinath Narasimhan, Osama Souied, Muhammad Khan, Ayesha Bashir, Shahid Ahmed, Osama Ahmed, Muhammad Salim, Haji I. Chalchal
Journal: Journal of Clinical Oncology (2020)

e19240 Background: SLNB is considered standard of care for BC patient's undergoing surgery. This standard of care is based on several randomized, prospective clinical trials showing non inferiority of this procedure compared to full axillary lymph node dissection (FALND). Retrieval of less than 3 lymph nodes at the time of SLN biopsy has been shown to be associated with decrease in disease specific survival. In the NSABP B-32 study, removal of two SLN rather than one almost halved the false negative rate. SK has an area of 651,900 square kilometer, with a small population of 1,098,352. This population is widely distributed throughout the province with variable access to health care. This study provides us with a unique opportunity to see if data obtained in clinical trials can be replicated in community settings. Methods: After approval from SK Cancer Agency and research ethics board of University of SK. Female Patient’s with BC who underwent SLNB from Jan 2010 to Dec 2014, were identified using cancer registry. 529 charts were reviewed retrospectively. Exclusion criteria’s were Male BC, pathology other than invasive ductal or lobular, locally advanced or metastatic disease, T4 tumors, patients who received neo adjuvant therapy, patients who had declined or were unable to receive post-operative recommended adjuvant systemic or radiation therapy, patients with full axillary lymph node dissection. Data was analyzed using SAS 9.4 software. Results: Rate of 1, 2 and 3 or more SLN was 21, 35 and 44% respectively. The median number of lymph nodes retrieved were 2. 14% of patients had positive lymph nodes. 259/529 (48.9 %) of patients used both vital blue dye and radiotracer method for detection of SLN. In 510/529 (96.4%) radiotracer method was used to detect lymph nodes. Blue dye was used in 264/529 (49.9%). Median number of SLN retrieved using both methods were 2. No change in median number of SNL retrieved in different quadrants and central part of the breast were noted, the number remained 2. Conclusions: Our review showed that rate of single lymph node retrieval was lower than what is reported in US SEER data base study of 37%, however the number of median lymph node retrieval was 2 which is considered less than optimal with reported higher rate of false negative rate. We did not attempt to look at disease-specific survival as our sample size is small. Continued data evaluation of established practice is required to improve quality of care and replication of advances established in clinical trials.
Results of a phase Ib study investigating durvalumab in combination with eribulin in patients with metastatic HER2-negative breast cancer and recurrent ovarian cancer.
Authors: Chrystal Ann Landry, Meng Ru, Christopher Hickson, Paula Klein, Julie Fasano, Aarti Bhardwaj, Charles L. Shapiro, Hanna Irie, Theresa Shao, Isaiah Selkridge, Amy Tiersten
Journal: Journal of Clinical Oncology (2020)

e15120 Background: The release of tumor-associated antigens with cytotoxic chemotherapy treatment may enhance the response to immune checkpoint blockade. Eribulin is a novel microtubule inhibitor with proven overall survival (OS) benefit in metastatic breast cancer (MBC), which may also enhance intratumoral vascular remodeling. Durvalumab, a humanized monoclonal antibody, targets the programmed cell death ligand-1 (PD-L1) receptor. This study sought to determine the recommended phase II dose (RP2D) of eribulin in combination with durvalumab, as well as the safety and preliminary anti-tumor activity of the combination in patients with previously treated HER2-negative MBC and recurrent ovarian cancer (ROC). Methods: Cohorts of 3-6 patients with HER2-negative MBC and ROC were treated in a modified 3+3 design. Eligible patients received escalating doses of eribulin (1.1mg/m2 or 1.4 mg/m2 IV on day 1 and day 8) with durvalumab (1.12g IV on day 1) in 21-day cycles until dose-limiting toxicity (DLT), intolerable adverse events (AEs), disease progression, or other reasons for withdrawal. Primary endpoint: the rate of dose limiting toxicities (DLTs) during cycle 1 and 2 of therapy. Secondary endpoints: AE rate, Objective Response Rate (ORR), progression-free survival (PFS), and OS. Results: Nine patients [median age 63 (37-77)] with median 4 prior therapies for advanced disease were treated: 5 patients with HER2-negative MBC and 4 patients with ROC. The RP2D of eribulin was 1.4mg/m2 in combination with durvalumab. There were no DLTs experienced during the first two cycles of therapy. The most common treatment-related AEs ( &gt; 50%) were fatigue, neutropenia, decreased white blood cell count, anemia, AST and alkaline phosphatase elevation, hyperglycemia, and nausea; most were grade 1/2. There was one immune-related AE of grade ≥3 (hepatitis). Three patients discontinued study drug related to toxicity [neutropenia (n = 1), hepatic toxicity (n = 2)]. ORR was 55% (all partial response) and 4 additional patients experienced stable disease; all MBC patients experienced a response to therapy. Median PFS was 6.2 months. Median OS has not been reached. Conclusions: The combination of eribulin and durvalumab had a favorable AE profile in patients with previously treated HER2- MBC and ROC. The early anti-tumor activity observed in this study suggests that further investigation of this combination is warranted. Clinical trial information: NCT03430518 .
A case analysis of a patient with type 2 diabetes mellitus and a thyroid nodule
Authors: Xiuwen Fei, Jiatang Zheng, Yuxia Kong, Aimei Dong
Journal: BMJ (2019)

2型糖尿病和甲状腺结节是社区常见病和多发病。胰岛素抵抗是2型糖尿病主要的病理生理学机制，同时可能参与甲状腺结节的发生。本文以全科门诊1例初治2型糖尿病合并甲状腺结节案例为基础，结合最新文献和指南，对两者的诊治、评估及其可能关系进行分析和讨论，体现全科诊疗思维。
Biapenem in the treatment of bronchiectasis with Pseudomonas aeruginosa infection
Authors: Jiuwu Bai, Jinfu Xu, Huiping Li, Beilan Gao, Weijun Cao, Shuo Liang, Kebin Cheng, Haiwen Lu
Journal: BMJ (2014)

Objective
To explore the efficacies of biapenem in the treatment of bronchiectasis infected with Pseudomonas aeruginosa.


Methods
Symptoms, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), leukocytes and neutrophil percentage in peripheral blood and temperature changes before and after therapy of biapenem were retrospectively analyzed over the past 5 years. They were divided into three groups according to the pathogen in sputum culture, i. e. group A (P. aeruginosa in sputum culture and sensitive to imipenem), group B (P. aeruginosa in sputum culture and resistant to imipenem) and group C (negative in sputum culture).


Results
The post-treatment levels of cough total score (6.8±2.7), symptom total score (8.1±3.4), ESR (27.5±20.7) mm/1 h, CRP (6.6±8.8) mg/L and blood neutrophil percentage[(63.0±11.4)%] were significantly lower than those pre-treatment (14.7±3.6), (19.8±4.7), (53.8±32.0)mm/1 h, (32.1±40.2) mg/L, (68.1±12.4)% (all P<0.01). The cough total score[(15.2±3.2), (16.1±3.6)]and ESR[(58.0±30.3) mm/1 h, (66.7±33.0) mm/1 h]of groups A and B before treatment was significantly higher than group C[(13.8±3.8), (44.9±31.9)mm/1 h) ](all P<0.05). The post-treatment CRP of group B[(12.7±13.5) mg/L]was higher than that of groups A [(6.0±7.8) mg/L]and C[(5.5±7.4) mg/L](both P<0.05). The temperature of those patients after treatment for 3 days and end of treatment[(36.85±0.35), (36.79±0.37)℃]significantly decreased than pre-treatment (37.22±0.58)℃ (all P<0.05).


Conclusions
Symptoms of cough, sputum and ESR may be used for evaluating severity for bronchiectasis with P. aeruginosa infection. Remarkable efficacies can be achieved by using biapenem in the treatment of bronchiectasis complicated by P. aeruginosa infection.


Key words: 
Bronchiectasis; Pseudomonas aeruginosa; Biapenem
后颅窝开颅后局部积液的防治
Authors: 程得钧, 张建生, 丁永忠, 任海军, 侯博儒, 张新定
Journal: BMJ (2006)

回顾分析441例后颅窝开颅术后局部引流患者开颅后局部积液的防治.经硬膜外或者硬膜下放置引流管引流,尽量严密缝合硬膜、各层肌肉及皮肤,术后多次局部加压包扎处理后,发生术后局部积液20例(4.5%),通过局部穿刺、反复腰椎穿刺放液、局部加压包扎等综合治疗,19例治愈(95%),1例听神经瘤患者脑脊液耳漏感染后合并脑积水而未愈,行脑室-心房分流术后局部积液消失.说明后颅窝开颅术后严密缝合硬膜,多次的局部加压包扎可预防局部积液的发生.局部积液穿刺、反复腰椎穿刺放液、长时间局部加压包扎可治愈局部积液。
Transmission of West Nile Virus from an Organ Donor to Four Transplant Recipients
Authors: Martha Iwamoto, Daniel B. Jernigan, Antonio Guasch, Mary Jo Trepka, Carina G. Blackmore, Walter C. Hellinger, Si M. Pham, Sherif Zaki, Robert S. Lanciotti, Susan E. Lance-Parker, Carlos A. DiazGranados, Andrea G. Winquist, Carl A. Perlino, Steven Wiersma, Krista L. Hillyer, Jesse L. Goodman, Anthony A. Marfin, Mary E. Chamberland, Lyle R. Petersen
Journal: New England Journal of Medicine (2003)

In August 2002, fever and mental-status changes developed in recipients of organs from a common donor. Transmission of West Nile virus through organ transplantation was suspected.
An in vivo model to evaluate donor-dependent cytokine release in response to single-agent or combination immune-oncology therapies.
Authors: Kyle Draheim, Jing Jiao, Jiwon Yang, Danying Cai, Mingshan Cheng, James G. Keck
Journal: Journal of Clinical Oncology (2020)

3114 Background: Although immune-oncology therapies such as checkpoint inhibitor, bi-specific antibody and CAR-T cell therapies are successfully used for cancer therapy, they can have very severe adverse effects such as cytokine release syndrome (CRS). The animal models and in vitro human PBMC assays presently in use do not reliably predict CRS in patients. Currently, the only widely accepted predictors of CRS are cancer burden and therapeutic dose. Despite this, most pre-clinical assays that evaluate CRS do not incorporate cancer cells and the safety of drug combinations has not been widely explored. A predictive assay that identifies patient/cancer/therapy combinations at risk for developing CRS upfront in addition to treatment efficacy would improve the safety of immune-oncology drug development. Methods: We have developed sensitive in vivo humanized mouse models for quantitating CRS that are rapid, reproducible and able to show variation among PBMC donors. The NSG mouse and its derivatives are engrafted with cancer cells and human PBMCs. Mice are then dosed with checkpoint inhibitors or bi-specific antibodies as a single therapy or in combination. Cytokine release is evaluated 2-6 hours post dosing. This assay can be modified to also evaluate efficacy by using luciferase labeled cancer cells and monitoring tumor burden using the Xenogen IVIS imaging system. Results: For all therapy groups, each cytokine tested (including human IFN-γ, IL-2, IL-6, IL-10 and TNF) was upregulated 2-6 hours after drug treatment, but different PBMC donors had various cytokines release levels. Cytokine release levels correlated with a dose response, PBMC engraftment levels and tumor burden. We can demonstrate additive and synergistic cytokine release in the combination treated groups and compare efficacy versus single agents. Our in vivo method was able to determine CRS missed in the in vitro testing method. Conclusions: We have developed a rapid, sensitive and reproducible novel in vivo PBMC humanized mouse model that can differentiate human PBMC donors based on individual safety response to single agent and combination therapeutics of immune checkpoint inhibitors and bispecific T-cell-engaging antibodies. Additionally, this assay can utilize luciferase labelled cell lines to measure treatment efficacy. Using this assay, we can potentially evaluate both cytokine release and efficacy of current immune-oncology therapies as single agents and in combination. This assay has immediate utility in current and future drug development.
Clinical observations of metabolic disturbance in patients with obstructive sleep apnea-hypoventilation syndrome
Authors: Gui-juan Chang, Fei-ya Zu, De-lian Zhang, Nan-fang Li
Journal: BMJ (2008)

Objectives To investigate the relationship between obstructive sleep apnea hypoventilation syndrome (OSAHS), insulin resistance (IR) and metabolic syndrome (MS), as well as to explore the possible mechanism of MS caused by OSAHS. Methods We recruited 186 hospitalized patients with hypertensions, who were divided into four groups based on their nocturnal polygraphs recordings, 35 as controls (group Ⅰ), 61 with mild (group Ⅱ), 52 with moderate (group Ⅲ) and 38 with severe OSAHS (group Ⅳ). They all underwent measurements including body height, body weight, waist circumference (WC), systolic and diastolic blood pressure (SBP and DBP), serum uric acid, creatinine, fasting plasma glucose, fasting plasma insulin, serum total cholesterol, high-density lipoprotein-cholesterul, low-density lipoprotein-cholesterol and triglyceride. Results One hundred and two patients with OSAHS (67.6 percent) also suffered of MS, 33 (86.8 percent) of them with severe OSAHS. There was no significant difference in age, gender, fasting plasma glucose, total cholesterol, high-density lipoprutein-cholesterul, low-density lipoprotein-cholesterol and triglyceride among the four groups (P>0.05). Body mass index (BMI), WC, ratio of serum uric acid to creatinine and DBP were all significantly higher in patients with severe OSAHS than those in patients with mild and moderate OSAHS and controls (P<0.01). SBP was significantly higher in patients with severe OSAHS than that in those with mild and moderate OSAHS (P<0.01). Insulin resistance was significantly severer in patients with severe OSAHS than that in those with mild OSAHS and controls (P<0.01). Results of multivariate linear regression analysis showed that insulin resistance was correlated with BMI and reversely correlated with minimal blood oxygen saturation, and minimal blood oxygen saturation reversely correlated with WC and ratio of uric acid to creatinine. Condusions Hypoxemia and obesity may promote development of insulin resistance. Patients of hypertension complicated with OSAHS tend to develop MS, particularly in those with severe OSAHS.

Key words: 
Sleep apnea,obstructive;  Metabolic syndromeX;  Insulin resistance
Patient composition and morbidities of chronic internal diseases at Gaobeidian community health service stations in Chaoyang district, Beijing
Authors: Chan Meng, Yue Sha, Xiao-ming Huang, Xue-jun Zeng, He-ping Ji
Journal: BMJ (2013)

To explore the population composition and the morbidities and treatment of hypertension and diabetes mellitus among the patients at 4 community healthy service stations at Gaobeidian, Chaoyang District of Beijing during the period of February 2009 to October 2010. A cross-sectional survey was conducted by self-reporting questionnaires. Most patients were above 40 years old, had a lower income level and education status and their treatment costs were mainly covered by social health insurance. Their incidences of hypertension and diabetes mellitus were high. Though most of them could recognize and treat their illnesses, the control rate remained non-satisfactory. Targeting incoming patients, community health service stations should take its advantages of managing chronic diseases and enroll more patients from local communities.


Key words: 
Chronic disease; Questionnaire
解读发展中的循证医学
Authors: 郭航远, 李锺大
Journal: BMJ (2007)

循证医学(evidence-based medicine,EBM)是20世纪90年代发展起来的一种新兴临床医学模式,其学术思想、研究方法和结果对于指导政府的卫生决策和医学教育、指导临床实践和科学研究都有十分重要的意义[1].但在循证过程和临床实践中,可以发现在解读大样本临床试验和循证医学核心思想、理解循证理论和实践方面的偏差等方面存在不同的见解.作为循证医学的实践者,一方面,应准确把握循证医学的核心理念,在循证理论指导下开展临床工作;另一方面,应关注循证医学的和谐健康发展。
Management by objectives model of health promotion improves fitness level and overall health in community residents
Authors: Ye Zhang, Ming Pan, Hong-chang Wang, Li-li Cheng, Fang Wang
Journal: BMJ (2012)

Total 406 community residents entered in fitness improvement program with “management by objectives model of health promotion” from 2009 to 2011.The fitness status was monitored by Xuhui Physical Constitution Center before and after entering the program.The results showed that the level of fitness assessment,the composite score,lung capacity and reaction time were improved with the years (P ＜ 0.01) ; the step index and sitting-and-reach test in 2010 was better than those in 2009(P ＜ 0.01) ; the grip strength in 2010 and 2011 was better than that in 2009 (P ＜ 0.01); the test of single leg-standing with closing eyes in 2011 was better than that in 2009(P ＜ 0.05).There was no difference in body mass index before and after program (P ＞ 0.05).The results indicate that physical fitness and overall health can be improved by management by objectives model for health promotion.

Key words: 
Health planning;  Body constitution
以家庭为单位
Authors: 吴春容
Journal: BMJ (2004)

以家庭为单位是国外家庭医学的核心原则,也是确立家庭医学这门学科的基础.中国的全科医学虽然是在引进国外家庭医学的基础上建立起来的,但与国外的家庭医学有一定的区别.中国的全科医学更强调整体医学观、系统整体性的思维方式和以人为本、以病人为中心的理念.以家庭为单位虽然也是一个重要的原则,但不是一个基础性的核心原则.所以,把中国的全科医学改称为家庭医学可能会造成很多学术上的混乱,更可能使中国的全科医学失去自己的特色.我们不能盲目照搬照抄国外的理论和模式,而应该吸取国外家庭医学的精髓,根据中国的实际情况和需要进行创造。
Efficacy of continuous glucose monitoring system combined with insulin pump in diabetic pafients aged 60 years and over
Authors: Xiao-yan Zhang, Yuan Zhong, Ting-jun Hu
Journal: BMJ (2009)

Objective To observe hypoglycemic efficacy of continuous glucose monitoring system (CGMS)combined with continuous insulin infusion(CSII)in the elderly diabetic patients aged 60 years and over.Methods A total 0f 100 elderly diabetic patients were randomly divided into two groups.50 were treated with CGMS or self-monitoring blood glucose(SMBG)and CSII.and whose insulin dose was adjusted based on results of monitoring,and the other 50 with SMBG and insulin pump as controls.whose insulin dose was adiusted based on the results of SMBG for three days.After two weeks.all the patients were monitored by CGMS for blood glucose.Results Mean blood level of glucose and mean amplitude of glycemic excursions(MAGE)were significantly lower in CGMS+CSII group than those in controls[(6.6±2.3)mmol/L vs.(7.5±2.1)mmol/L,and(3.9±0.9)mmol/L vs.(5.1±0.6)mmol/L,respectively,P＜0.05 1.Average insulin dose used was significantly lower in CGMS+CSII group than that in controls [(0.64±0.21)U/kg vs.(0.82±0.41)U/kg,P＜0.05],and duration of hypoglycemia was less in the former than that in the latter[(20±3)min vs.(40± 9)min,P＜0.05 ].Conclnsions CGMS combined with CSII can decrease blood glucose.glucose excursions.average dose of insulin and duration of hypoglycemia in the elderly diabetic patients,as well as prevent occurrence of hypoglycemia.

Key words: 
Diabetes mellitus,type 2; Blood glucose self-monitoring; Insulin infusion system
急性肠系膜血管缺血性疾病早期诊断的探讨
Authors: 王强, 聂素林, 王宝云, 丁德祥, 郭金兰, 郎丰涛
Journal: BMJ (2010)

急性肠系膜血管缺血性疾病(acute mesenteric ischemia,AMI)是一种很少见的普外科急腹症,其早期缺乏典型临床表现,文献报道误诊率高达90%～95%~([1]),病死率60%～100%~([2]),预后较差。
CRS + HIPEC in stage IIIc epithelial ovarian cancer and comparison of oncological outcome only with CRS and IV chemotherapy and CRS + IP chemotherapy.
Authors: S.P. Somashekhar, Rohit Kumar C., Ashwin K. Rajgopal, Ramya Yethadka, Shabber Zaveri, Vijay Ahuja, Amit Rauthan, Poonam Patil
Journal: Journal of Clinical Oncology (2020)

e18054 Background: Our study aims to describe role of CRS &amp; HIPEC in stage IIIC epithelial ovarian malignancy &amp; compare the oncological outcome (DFS &amp; OS) of extensive CRS+ HIPEC in comparison with CRS &amp; IV chemotherapy &amp; CRS + IP chemotherapy. Methods: Patients diagnosed of stage IIIc EOC underwent extensive CRS + HIPEC. All data prospectively entered in the HIPEC registry was analysed. Outcome of CRS &amp; IV group (n = 50), CRS + IP group (n = 60) operated around same period was compared with the CRS &amp; HIPEC group. Results: Out of 135 patients, upfront, interval and secondary cytoreduction plus HIPEC was done in 29.6%, 44.4% &amp; 25.9% &amp; mean PCI was 14.1, 9.6 &amp; 13.0 respectively. Multi-visceral resection, diaphragmatic resection &amp; bowel resection was required in 12.7%, 50% &amp; 41.8% respectively. Overall G3- G5 morbidity was seen in 25.4% with major being electrolyte imbalance 16.3%, hematological 12.7% &amp; surgical 11.8%. Mean ICU &amp; hospital stay 1.5 &amp; 11 days respectively. Overall 30 day mortality was 4.5%. With a median follow up of 42 months DFS was 30, 33 &amp; 16 months and OS was 70%, 67% &amp; 51% at 4 year for upfront, interval and the recurrent settings respectively. Detailed description presented in Table. Most of the recurrences in CRS &amp; IV group were in peritoneum whereas the other two groups had lesser peritoneal &amp; systemic recurrence. Conclusions: Optimal cytoreduction &amp; some form of IP therapy is needed to improve outcomes. CRS+ HIPEC is feasible in all groups of ovarian cancer with acceptable morbidity &amp; mortality. However the role of single HIPEC in comparison to 6 cycles of IP chemotherapy needs to be evaluated with a well-designed multi-institutional randomised study. [Table: see text]
Wallenberg综合征31例临床分析
Authors: 石磊, 刘晓芳, 迟兰芹
Journal: BMJ (2010)

Wallenberg综合征又称延髓背外侧综合征,由Wallenberg于1895年首次报告,经尸体解剖证实为小脑后下动脉闭塞所致,故又称小脑后下动脉闭塞综合征.现对我院2004年10月至2007年10月收治的31例Wallenberg综合征患者的临床特点进行回顾性分析。
SIENDO/ENGOT-EN5: A randomized phase III trial of maintenance with selinexor/placebo after combination chemotherapy in patients with advanced or recurrent endometrial cancer.
Authors: Ignace Vergote, Erika Paige Hamilton, Ignacio Romero, Eva M. Guerra, Joseph Buscema, Annouschka Laenen, Tamar Perri, Purificación Estévez-García, Cesar Gomez Raposo, Tally Levy, Giorgio Valabrega, Jeronimo Martinez Garcia, Giorgia Mangili, Vicky Makker, Dayana Michel, Hongwei Wang, Mansoor Raza Mirza
Journal: Journal of Clinical Oncology (2020)

TPS6105 Background: Endometrial cancer is one of the most common gynecologic malignancies with increasing incidence and mortality. Patients with advanced disease that has relapsed or received prior platinum-based therapy or radiotherapy have limited options and the prognosis remains poor. Selinexor is a novel, oral selective inhibitor of nuclear export (SINE) which forces nuclear retention and activation of tumor suppressor proteins. Selinexor in combination with low dose dexamethasone was recently approved for patients with multiple myeloma. In addition, single agent selinexor has demonstrated broad activity in other hematologic malignancies and solid tumors. In a phase II study, 50 mg/m 2 (~80 mg) selinexor administered twice weekly demonstrated a disease control rate of 35% with 2 confirmed partial responses among 23 patients with heavily pretreated endometrial cancer (Vergote I et al. Gynecol Oncol 2020). In the absence of approved maintenance therapies, we conducted this study to evaluate the efficacy of selinexor compared with placebo as maintenance therapy in patients with advanced or recurrent endometrial cancer. Methods: This is a multicenter, double-blind, placebo-controlled, randomized phase III study in patients in partial or complete remission after completing at least 12 weeks of taxane-platinum combination therapy for primary Stage IV disease and recurrent disease (i.e., relapse after primary therapy for early stage disease including surgery and/or adjuvant therapy). A total of 192 patients will be enrolled at 80 sites in Europe, North America, and Israel. Patients will be randomized in a 2:1 ratio to either maintenance therapy with 80 mg oral selinexor once weekly or placebo. Stratification factors include primary Stage IV versus first recurrent disease at the time of taxane-platinum therapy and disease status after chemotherapy (partial versus complete response). Treatment will continue until disease progression. The primary endpoint is progression free survival (PFS) per RECIST v1.1. Secondary endpoints include disease-specific survival, overall survival, time to first subsequent therapy, time to second subsequent therapy, PFS on subsequent therapy and safety and tolerability. The study is currently open and enrolling patients. Clinical trial information: NCT03555422.