Progression-free survival (PFS) and overall survival (OS) across ethnicities for patients with metastatic renal cell carcinoma (mRCC) receiving targeted therapies (TT) as first-line (1L) treatment.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 645-645
Author(s):  
Nicholas Salgia ◽  
Nazli Dizman ◽  
Paulo Gustavo Bergerot ◽  
Cristiane Decat Bergerot ◽  
Joann Hsu ◽  
...  
Keyword(s):  
Ethnic Groups ◽  
Asian American ◽  
Survival Data ◽  
Survival Function ◽  
Progression Free Survival ◽  
Mtor Inhibitors ◽  
Caucasian American ◽  
Kaplan Meier ◽  
Significant Difference ◽  
The Relationship

645 Background: Recent efforts have sought to characterize differences in clinical and pathological characteristics across ethnicities in mRCC (Batai et al CGUC 2018), however, the relationship between ethnicity and treatment outcomes has yet to be explored. We sought to compare survival outcomes across ethnic groups for patients receiving 1L TT for treatment of mRCC. Methods: Patients receiving 1L systemic treatment for mRCC were retrospectively identified from a single institution database from 2009 to present. Patient ethnicity data were collected from electronic health records. Due to the demographics of the patient population, ethnicity was categorized as Non-Hispanic Caucasian American (CA), Hispanic American (HA), or Asian American (AsA). Patients prescribed tyrosine kinase and/or mTOR inhibitors as 1L therapy were included for analysis. PFS and OS were analyzed across ethnic groups and comparisons were performed using the Kaplan Meier Survival Function in SPSS. Results: Of 294 (77:217 F:M) patients with documented survival data, 183 (62%) were CA, 82 (28%) HA, and 29 (10%) AsA. The most frequently used TTs were sunitinib (63%), temsirolimus (10%), pazopanib (7%), sorafenib (5%), and cabozantinib (4%). Median PFS for CA was 5.6 months (95% Confidence Interval [CI]: 4.1-7.1) vs. 4.7 months (95% CI: 3.1-6.2) for HA vs. 4.7 months (95% CI: 2.1-7.3) for AsA. Median OS was 32.0 months (95% CI: 26.2-37.8) for CA vs. 31.7 months (95% CI: 21.1-42.4) for HA vs. 51.7 months (95% CI: 31.6-71.8) for AsA. No significant difference in PFS or OS was calculated across the three ethnic groups (p=0.652 and p=0.435, respectively). Conclusions: The lack of a statistically significant difference in both PFS and OS across ethnic groups is a promising assessment for the current landscape of health disparities in mRCC. As these data are distinct from recent findings identifying disparities in other malignancies (e.g., prostate cancer), multicenter collaborations should be encouraged to validate these findings.

Race/Ethnicity and Survival in Metastatic Renal Cell Carcinoma: Outcomes for Patients Receiving First Line Targeted Therapies

Kidney Cancer ◽  
2020 ◽  
Vol 4 (3) ◽  
pp. 159-166
Author(s):  
Nazli Dizman ◽  
Nicholas J. Salgia ◽  
Paulo G. Bergerot ◽  
JoAnn Hsu ◽  
Nora Ruel ◽  
...  
Keyword(s):  
Ethnic Groups ◽  
Asian American ◽  
Targeted Therapies ◽  
Survival Outcomes ◽  
Hispanic American ◽  
First Line ◽  
Caucasian American ◽  
Race Ethnicity ◽  
The Relationship ◽  
Racial Ethnic

BACKGROUND: No study to date has assessed the relationship between treatment-specific therapeutic outcomes and race/ethnicity in metastatic renal cell carcinoma (mRCC). As targeted therapies have formed the backbone of first-line treatment options for mRCC until very recently, we assessed the relationship between race/ethnicity and targeted therapy-related outcomes in mRCC. OBJECTIVE: To retrospectively compare response rates and survival outcomes across ethnicities in patients who received first-line targeted therapies for mRCC. METHODS: Patients with mRCC receiving a first-line targeted therapy were identified from an institutional database encompassing consecutive patients treated between 2009 and 2019. Patient demographics, clinical characteristics and survival outcomes were recorded. The racial/ethnic groups included for analysis were Caucasian American, Hispanic American, and Asian American. Survival and response outcomes including progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) were calculated and compared across ethnic groups using Kaplan-Meier method and Chi-square test, respectively. RESULTS: In total, 295 patients were included for analysis. There were 184 (62.4%) Caucasian American patients, 82 (27.8%) Hispanic American patients, and 29 (9.8%) Asian American patients. No statistically significant differences in PFS nor OS were found between groups (PFS: 5.6 vs. 4.7 vs. 4.7 months, respectively) (OS: 32 vs. 31.7 vs. 51.7 months, respectively). No significant difference was found in ORR nor DCR across groups. Univariate cox regression analyses demonstrated no independent effect of race/ethnicity on PFS or OS. CONCLUSIONS: The apparent lack of differences in treatment-related outcomes across racial/ethnic groups is encouraging. However, further validation is required in larger series.

scholarly journals The relationship between CD204 M2-polarized tumour-associated macrophages (TAMs), tumour-infiltrating lymphocytes (TILs), and microglial activation in glioblastoma microenvironment: a novel immune checkpoint receptor target

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Maher Kurdi ◽  
Badrah Alghamdi ◽  
Nadeem Shafique Butt ◽  
Saleh Baeesa
Keyword(s):  
Microglial Activation ◽  
Inverse Correlation ◽  
Idh1 Mutation ◽  
High Expression ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Tumour Infiltrating Lymphocytes ◽  
Infiltrating Lymphocytes ◽  
The Relationship ◽  
Low Expression

Abstract Background Tumour associated macrophages (TAMs) and tumour infiltrating lymphocytes (TILs) are considered dominant cells in glioblastoma microenvironment. Aim The purpose of this study was to assess the expression of CD204+ M2-polarized TAMs in glioblastomas and their relationship with CD4+TILs, Iba+microglia, and IDH1 mutation. We also exploreed the prognostic value of these markers on the recurrence-free interval (RFI). Methods The expressions of CD204+TAMs, CD4+TILs, and Iba1+microglia were quantitively assessed in 45 glioblastomas using immunohistochemistry. Kaplan–Meier analysis and Cox hazards were used to examine the relationship between these factors. Results CD204+TAMs were highly expressed in 32 tumours (71%) and the remaining 13 tumours (29%) had reduced expression. CD4+TILs were highly expressed in 10 cases (22%) and 35 cases (77.8%) had low expression. There was an inverse correlation between CD204+TAMs and CD4+TILs, in which 85% of tumours had a high expression of CD204+TAMs and a low expression of CD4+TILs. Nevertheless, there was no significant difference in IDH1 mutation status between the two groups (p = 0.779). There was a significant difference in Iba1+microglial activation between IDH1mutant and IDH1wildtype groups (p = 0.031). For cases with a high expression of CD204+TAMs and a low expression of CD4+TILs, there was a significant difference in RFI after treatment with chemoradiotherapy or radiotherapy (p = 0.030). Conclusion Glioblastoma with a dense CD204+TAMs and few CD4+TILs is associated with IDH1wildtype. These findings suggest that TAMs masks tumour cell and suppress T-cell tumoricidal functions via immunomodulatory mechanisms. Blockade of the CD204-TAM receptor may prevent this mechanism and allow the evolution of TILs.

Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis

2021 ◽  
pp. jrheum.200154
Author(s):  
Nicolino Ruperto ◽  
Hermine I. Brunner ◽  
Nikolay Tzaribachev ◽  
Gabriel Vega-Cornejo ◽  
Ingrid Louw ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Pediatric Patients ◽  
Opportunistic Infections ◽  
Infection Risk ◽  
Rank Tests ◽  
Link Type ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Exposure Levels ◽  
The Relationship

Objective To assess the relationship between infection risk and abatacept exposure levels in patients with polyarticular-course juvenile idiopathic arthritis (pJIA) following treatment with subcutaneous and intravenous abatacept. Methods Data from two published studies (NCT01844518, NCT00095173) of abatacept treatment in pediatric patients were analyzed. One study treated patients aged 2–17 years with subcutaneous abatacept and the other treated patients aged 6–17 years with intravenous abatacept. Association between serum abatacept exposure measures and infection was evaluated using Kaplan–Meier plots of probability of first infection versus time on treatment by abatacept exposure quartiles and log-rank tests. Number of infections by abatacept exposure quartiles was investigated. Results Overall, 343 patients were included in this analysis: 219 patients received subcutaneous abatacept and 124 patients received intravenous abatacept. Overall, 237/343 (69.1%) patients had ≥1 infection over 24 months. No significant difference in time to first infection across four quartiles of abatacept exposure levels was observed in the pooled (p = 0.4458), subcutaneous (2–5 years p = 0.9305; 6–17 years p = 0.4787), or intravenous (p = 0.4999) analyses. Concomitant use of methotrexate and glucocorticoids (at baseline and throughout) with abatacept did not increase infection risk across the abatacept exposure quartiles. There was no evidence of association between number of infections and abatacept exposure quartiles. No opportunistic infections related to abatacept were reported. Conclusion In patients aged 2–17 years with pJIA, no evidence of association between higher levels of exposure to intravenous or subcutaneous abatacept and incidence of infection was observed.

scholarly journals Integrated analysis identifies AQP9 correlates with immune infiltration and acts as a prognosticator in multiple cancers

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Xiaohong Liu ◽  
Qian Xu ◽  
Zijing Li ◽  
Bin Xiong
Keyword(s):  
Survival Data ◽  
Integrated Analysis ◽  
Immune Gene ◽  
Gene Markers ◽  
Lung Cancers ◽  
Immune Infiltration ◽  
Kaplan Meier ◽  
Aquaporin 9 ◽  
Infiltrating Cells ◽  
The Relationship

AbstractAquaporin 9 (AQP9), as an aquaglyceroporin, is expressed in many immune cells and plays important role in tumor initiation and progression. However, the relationship between AQP9 and tumor-infiltrating cells, and its prognostic value in cancers still require comprehensive understanding. Herein, we aimed to elucidate the correlations of AQP9 with prognosis and immune infiltration levels in diverse cancers. We detected the expression and survival data of AQP9 through Oncomine, TIMER, Kaplan–Meier Plotter and PrognoScan databases. The correlations between AQP9 and immune infiltrates were analyzed in TIMER database. Our results found that high AQP9 expression was significantly correlated with worse prognosis in breast, colon and lung cancers, while predicted better prognosis in gastric cancer. Moreover, AQP9 had significant association with various immune infiltrating cells including CD8+ and CD4+ T cells, neutrophils, macrophages and dendritic cells (DCs), and diverse immune gene markers in BRCA, COAD, LUAD, LUSC and STAD. AQP9 was also significantly correlated with the regulation of tumor associated macrophages (TAM). These results indicate that AQP9 can play as a significant biomarker to determine the prognosis and the immune infiltrating levels in different cancers. It might also contribute to the development of the immunotherapy in breast, colon, lung and gastric cancers.

scholarly journals Hidden Imputations and the Kaplan-Meier Estimator

2020 ◽  
Vol 189 (11) ◽  
pp. 1408-1411 ◽  
Author(s):  
Stephen R Cole ◽  
Jessie K Edwards ◽  
Ashley I Naimi ◽  
Alvaro Muñoz
Keyword(s):  
Survival Data ◽  
Survival Function ◽  
Data Set ◽  
Kaplan Meier ◽  
Event Times

Abstract The Kaplan-Meier (KM) estimator of the survival function imputes event times for right-censored and left-truncated observations, but these imputations are hidden and therefore sometimes unrecognized by applied health scientists. Using a simple example data set and the redistribution algorithm, we illustrate how imputations are made by the KM estimator. We also discuss the assumptions necessary for valid analyses of survival data. Illustrating imputations hidden by the KM estimator helps to clarify these assumptions and therefore may reduce inappropriate inferences.

scholarly journals Lenalidomide and Low Dose Dexamethasone Plus Elotuzumab or Carfilzomib for Relapsed or Refractory Multiple Myeloma: A Comparison of Progression-Free Survival with Reconstructed Individual Participant Data

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Shuo Li ◽  
Xiang-Yu Meng ◽  
Souraka Tapara Dramani Maman ◽  
Yong-Nong Xiao ◽  
Sheng Li
Keyword(s):  
Multiple Myeloma ◽  
Survival Analysis ◽  
Low Dose ◽  
Progression Free Survival ◽  
Disease Stage ◽  
Free Survival ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Baseline Status ◽  
Individual Participant

Background. Refractory and relapsed multiple myeloma (RRMM) remains a clinical challenge. We compared the progression-free survival (PFS) of RRMM patients treated with lenalidomide and low dose dexamethasone plus elotuzumab or carfilzomib (ELD vs. CLD), using reconstructed individual patient data (IPD) based on two published trials reports. Methods. We extracted data of study-level characteristics from original trial reports. We evaluated the comparability between the two treatment groups in terms of baseline status. Digitization of PFS Kaplan-Meier curves, reconstruction of IPD data, and subsequent survival analysis were performed. Distribution of progression and death events over time was visualized as histograms and corresponding kernel density lines, and Kaplan-Meier survival curves were plotted. Hazard ratio (HR) and corresponding 95% confidence interval (95% CI) were calculated. Results. Significant difference in race and disease stage distribution was found (P < 0.0001). Higher proportion of white patients and patients with advanced disease in the carfilzomib group was identified. Survival analysis revealed better PFS in the carfilzomib group (elotuzumab group vs. carfilzomib group: HR = 1.36, 95% CI = [1.11-1.67]). Conclusion. The CLD regimen may result in better PFS as compared with the ELD regimen in RRMM patients.

scholarly journals MNG-03 PD-L1 EXPRESSION, PATIENT PROGNOSIS AND INITIAL WHO GRADE IN GRADE II/III MENINGIOMA

2019 ◽  
Vol 1 (Supplement_2) ◽  
pp. ii36-ii36
Author(s):  
Dai Kamamoto ◽  
Hikaru Sasaki ◽  
Ryota Sasao ◽  
Takumi Fujiyama ◽  
Kazunari Yoshida
Keyword(s):  
Radiation Therapy ◽  
Progression Free Survival ◽  
Who Grade ◽  
Free Survival ◽  
Specific Data ◽  
Tumor Immune Evasion ◽  
Significant Difference ◽  
Grade Ii ◽  
Patient Prognosis ◽  
The Relationship

Abstract The optimal treatment for grade II/III meningioma is operation with or without radiation therapy. However, their natural course is sometimes aggressive with high recurrent rate. There is no effective treatment other than operation and radiation therapy, therefore, a new therapeutic strategy for grade II/III meningioma is urgently required.PD-1 and PD-L1 play important roles as immune-checkpoint mediators within tumor microenvironment and the antibodies to these molecules are now approved for the treatment of various kinds of cancers. In Japan, anti-PD-1 antibody and anti-CTLA-4 antibody are approved for unresectable melanoma or advanced / recurrent non-small cell lung cancer and their high effectiveness has been reported. We investigated the expression of PD-L1 (clone:28-8) in 51 cases of grade II/III meningioma by immunohistochemistry and analyzed the relationship between the expression with overall survival, progression free survival and initial WHO grade. For now, we have evaluated 25 cases of PD-L1 immunohistochemistry and PD-L1 showed positivity in 15 cases. There is no correlation observed between PD-L1 expression and patients’ prognosis. Although it does not reach a significant difference, the WHO grade at the time of initial operation tends to be high in those with high PD-L1 staining rate.Similar studies that were previously reported did not use antibodies targeting clone 28-8, which was used as a companion diagnosis for nivolumab administration, but “Correlation between PD-L1 expression and WHO grade”, or “PD-L1 expression is an independent prognostic factor” have been reported. In our investigation, which was using antibodies for companion diagnosis, PD-L1 was positive in more than half of Grade II / III meningiomas and it also related to WHO grade. These results suggest the possibility that tumor immune evasion mechanisms are also working in meningiomas. At the conference, we will report it with the specific data from all cases with a literature review.

Association between intratumoral HER2 heterogeneity (IHH) and trastuzumab (T-mab) efficacy in HER2 positive–gastric cancer (GC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 92-92
Author(s):  
Takeru Wakatsuki ◽  
Noriko Yamamoto ◽  
Keisho Chin ◽  
Mariko Ogura ◽  
Eiji Shinozaki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Statistical Tests ◽  
Progression Free Survival ◽  
Clinical Impact ◽  
Heterogeneous Group ◽  
Rank Test ◽  
Her2 Positive ◽  
Kaplan Meier ◽  
Significant Difference ◽  
The Difference

92 Background: ToGA study showed superiority of adding T-mab to standard chemotherapy and a positive correlation between HER2 expression levels and the T-mab efficacy. In gastric cancer IHH is frequently recognized but its clinical impact on T-mab efficacy is unclear. Methods: Patients who were treated with T-mab and had surgical specimens available for IHC test were retrospectively examined. When all tumor cells overexpressed HER2 protein by IHC, the tumor was defined as non-HER2-heterogeneous. The others were defined as HER2-heterogeneous. Progression-free survival (PFS) and overall survival (OS) were estimated using by Kaplan-Meier methods and compared by the log-rank test. The level of significance was set to p<0.05 and all statistical tests were two-sided. Results: 23 patients were enrolled. Their median age was 68 years and 83% were male. PS 0, GEJ cancer, intestinal type histology, visceral metastasis (lung or liver), and previous chemotherapy were found in 57%, 35%, 83%, 57%, and 57% of them, respectively. After a median follow-up of 11.3 months, the median OS, PFS, and overall response rate were 14.4 months, 10.8 months, and 62.5%, respectively. All tumors were IHC3+, and 13 were non-HER2-heterogeneous and 10 were HER2-heterogeneous. There was no significant difference in clinicopathological features between the two groups. Median PFS in non-HER2-heterogeneous group (21.9 months) was significantly longer than that in HER2-heterogeneous group (8.6 months), (HR: 0.24 [0.06-0.91], P=0.024). Median OS in non-HER2-heterogeneous group was not reached while that in HER2-heterogeneous group was 12.9 months (HR: 0.29 [0.06-1.42], P=0.102). A higher rate of response to T-mab was seen in non-HER2-heterogeneous group than in HER2-heterogeneous group, though the difference was not statistically significant (75% vs. 50%, p=0.608). Conclusions: IHH might have robust clinical impact on T-mab efficacy for HER2 positive GC. These findings should be validated by independent large cohorts and further molecular correlative analyses are warranted.

Updated predictive analysis of the WHO-defined molecular subgroups of low-grade gliomas within the high-risk treatment arms of NRG Oncology/RTOG 9802.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2002-2002 ◽  
Author(s):  
Erica Hlavin Bell ◽  
Minhee Won ◽  
Jessica L. Fleming ◽  
Aline P. Becker ◽  
Joseph P. McElroy ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Survival Data ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Rank Test ◽  
Low Grade ◽  
Low Grade Gliomas ◽  
Significant Difference ◽  
Post Hoc

2002 Background: This study sought to update the predictive significance of the three WHO-defined molecular glioma subgroups ( IDHwt, IDHmt/noncodel, and IDHmt/codel) in the subset of specimens available for analysis in NRG Oncology/RTOG 9802, a phase III trial of high-risk low-grade gliomas (LGGs) treated with radiation (RT) with and without PCV after biopsy/surgical resection. Notably, this is the first phase III study to evaluate the predictive value of the WHO subgroups in LGGs using prospectively-collected, well-annotated long-term overall survival data, in a post-hoc analysis. Methods: IDH1/2 mutation status was determined by immunohistochemistry and/or next-generation sequencing. 1p/19q status was determined by Oncoscan and/or 450K methylation data. Treatment effects on overall survival (OS) and progression-free survival (PFS) by marker status were determined by the Cox proportional hazard model and tested using the log-rank test in a secondary and exploratory analysis. Results: Of all the randomized eligible high-risk G2 patients (N = 251) in NRG Oncology/RTOG 9802, 106(42%) patients had tissue available with sufficient quality DNA for profiling. Of these, 80(75%) were IDHmut; 43(41%) were IDHmut/non-co-deleted, 37(35%) were IDHmut/co-deleted, and 26(24%) were IDHwt. Upon univariate analyses, no significant difference in either PFS or OS was observed with the addition of PCV in the IDHwt subgroup. Both the IDHmut/non-co-deleted and IDHmut/co-deleted subgroups were significantly correlated with longer PFS (HR = 0.32; p = 0.003; HR = 0.13; p < 0.001) and OS (HR = 0.38; p = 0.013; HR = 0.21; p = 0.029) in the RT plus PCV arm, respectively. Conclusions: Our analyses suggest that both IDHmut/non-co-deleted and IDHmut/co-deleted subgroups received benefit from treatment with PCV although sample size is limited and analyses are post-hoc. Our results also support the notion that IDHwt high-risk LGG patients do not benefit from the addition of PCV to RT. Funding: U10CA180868, U10CA180822, and U24CA196067. Also, R01CA108633, R01CA169368, RC2CA148190, U10CA180850-01, BTFC, OSU-CCC (all to AC). Clinical trial information: NCT00003375.

Clinical outcome of local treatment in synchronous oligometastatic non-small cell lung cancer (NSCLC): A preliminary analysis of prospective data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21698-e21698
Author(s):  
Shangbiao Li ◽  
Xiaoxia Zhu ◽  
Zhihao Zheng
Keyword(s):  
Clinical Trial ◽  
Local Treatment ◽  
Progression Free Survival ◽  
Untreated Group ◽  
First Line ◽  
Term Survival ◽  
Nccn Guidelines ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Nsclc Patients

e21698 Background: Advanced NSCLC is a heterogeneous disease, a large number of retrospective studies suggested that patients with oligometastases may achieve long-term survival from aggressive local treatment. However, relevant prospective studies were limited. Therefore, we prospectively evaluated the role of local treatment in synchronous oligometastatic NSCLC. Methods: We prospectively identified 50 NSCLC patients newly diagnosed with synchronous oligometastases (≤5)in two centers between 11/2017 and 12/2019, among whom there were 24 patients from a randomized clinical trial NCT03119519. Patients were given first-line systemic therapy according to the latest NCCN guidelines with either local radiotherapy or surgery to thoracic primary tumor and/or radiotherapy to metastases. They were divided into combined therapies (Tx), systemic Tx and untreated groups. Kaplan Meier Survival analysis was used to compare progression free survival (PFS) and overall survival (OS) among the groups. Results: Median age of all patients was 61 years old (range: 27-80 years) and median follow up was 5.7 months (range: 0.5-23.3 months). A total of 10 deaths were observed. In the combined Tx group, 23 patients received radiotherapy, and 2 patients received primary surgical resection. The median OS of the combined Tx group (n = 25), the systemic Tx group (n = 19) and the untreated group (n = 6) was 18.47 months, not reached, 3.27 months, respectively. Compared with the untreated group, the combined group and the systemic Tx group had better OS (hazard ratio [HR] = 0.1047, p = 0.0001; HR = 0.1125, p= 0.0006). However, the patients in the combined group did not show significant OS advantage compared with those in the systemic Tx group (HR = 1.376, p= 0.667). In addition, we conducted an ITT analysis in clinical trial NCT03119519, in which 8 progression events were observed. There was no significant difference in PFS between the combined group (n = 13) and the systemic Tx group (n = 11) (13.2 months vs. not reached, HR = 1.317, p= 0.7015; 1-year PFS: 74% vs. 54%, p = 0.7015, respectively). Conclusions: Current analysis shows that the addition of local treatment to first-line systemic Tx does not improve PFS and OS. More samples, further updated data and selection of potential beneficer are necessary. Funding: 81972853, 81572279, 2016J004, LC2019ZD009, 2018CR033. Clinical trial information: NCT03119519.

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