Factors associated with clinical trial participation for patients with renal cell carcinoma.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 670-670
Author(s):  
Brian Shinder ◽  
Sinae Kim ◽  
Arnav Srivastava ◽  
Hiren V. Patel ◽  
Tina M. Mayer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Clinical Stage ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Factors Associated ◽  
Trial Participants

670 Background: Clinical trials are critical for the development of new treatment paradigms for renal cell carcinoma (RCC). The primary objective of this study was to characterize the factors associated with clinical trial participation for patients with RCC. The secondary objective was to examine survival outcomes in the clinical trial and control cohorts. Methods: The National Cancer Database (NCDB) was queried for patients with RCC who were coded as having enrolled in a clinical trial. Trial patients were matched in a 1:5 ratio to controls from the same institution based on clinical stage. Sociodemographic variables were compared between the two groups and univariate and multivariate logistic regression models evaluated factors associated with clinical trial participation. Kaplan-Meier product limit estimate was used to compare overall survival (OS) between the groups. Results: From 2004-2015, 681 patients enrolled in clinical trials were included for analysis. The mean age of trial patients was 56.4 compared to 62 in the matched cohort (p<0.0001). More patients in the trial group had a Charlson-Deyo comorbidity score of 0 (81.6% vs. 73.9%, p<0.0001). On multivariate analysis, male patients (OR 1.27; 95%CI 1.06-1.54, p=0.012) and white patients (OR 1.88, 95%CI 1.23-2.87; p=0.003) were more likely to participate in a trial. Having Medicaid (OR 0.42; 95%CI 0.27-0.64; p<0.0001) or Medicare (OR 0.6; 95%CI 0.46-0.77; p<0.0001) was negatively associated with clinical trial participation. Median OS was greater among clinical trial participants than that the control cohort (106.61 vs 87.62 months, p<0.0001). Conclusions: In this contemporary analysis of RCC patients from a national hospital registry database, we found that patient sociodemographic factors remain associated with clinical trial participation and that clinical trial participants experienced superior OS. Further work, both qualitative and quantitative, is necessary to identify clinical and non-clinical barriers to research participation in order to improve the validity of RCC trials.

Factors associated with clinical trial participation for patients with prostate cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 96-96
Author(s):  
Brian Shinder ◽  
Sinae Kim ◽  
Hiren V. Patel ◽  
Arnav Srivastava ◽  
Tina M. Mayer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Stage ◽  
Research Participation ◽  
Sociodemographic Factors ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Factors Associated ◽  
Trial Participants

96 Background: Clinical trials are critical for the development of new treatment paradigms for Prostate Cancer (PCa). The primary aim of this study was to characterize the factors associated with clinical trial participation for patients with PCa. The secondary objective was to examine survival outcomes in the clinical trial and control cohorts. Methods: The National Cancer Database (NCDB) was queried for patients with PCa who were coded as having enrolled in a clinical trial. Trial patients were matched in a 1:8 ratio to controls based on clinical stage. Sociodemographic variables were compared between the two groups and univariate and multivariate logistic regression models evaluated factors associated with clinical trial participation. Kaplan-Meier product limit estimate was used to compare overall survival (OS) between the groups. Results: From 2004-2015, 495 patients enrolled in clinical trials were included for analysis. The mean age of trial patients was 63.2 compared to 66.4 in the matched cohort (p < 0.0001). More patients in the trial group had a Charlson-Deyo comorbidity score of 0 (89.3% vs. 82.1%, p = 0.0002). On multivariate analysis, patients who traveled between 50-250 miles (OR 1.59; 95%CI 1.15-2.19, p = 0.005) or came from a zip code where greater than 93% of the population has a high school degree (OR 4.97; 95%CI 2.89-8.54, p < 0.0001) were more likely to participate in a clinical trial. There was no association between race and insurance status on clinical trial participation. Median OS was not significantly different among clinical trial participants than the control cohort (120.9 months vs. not reached, p = 0.928). Conclusions: In this contemporary analysis of PCa patients from a national hospital registry database, we found that certain patient sociodemographic factors remain associated with clinical trial participation, though clinical trial participants do not seem to experience a difference in OS. Further work, both qualitative and quantitative, is necessary to identify clinical and non-clinical barriers to research participation in order to improve the validity of PCa trials.

Is there a "trial effect" on outcome of patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib?

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 453-453
Author(s):  
Daniel Keizman ◽  
Maya Ish-Shalom ◽  
Natalie Maimon ◽  
Maya Gottfried ◽  
Roberto Pili ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Renal Cell ◽  
Progression Free Survival ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Free Survival ◽  
Trial Effect ◽  
Trial Participants

453 Background: Several studies have suggested the existence of a trial effect, in which for a given treatment, participation in a clinical trial is associated with a better outcome of cancer patients. The VEGFR inhibitor sunitinib is a standard treatment for mRCC. The effect of clinical trial participation on the outcome of sunitinib treatment in mRCC is poorly defined. We aimed to study the effect of clinical trial participation on outcome of mRCC patients treated with sunitinib. Methods: Records from 275 mRCC patients treated with sunitinib from 2004 to 2012 in 7 centers across 2 countries were reviewed. We compared the response rate, progression free survival, and overall survival, between clinical trial participants (n=49) and a matched cohort of non participants (n=49) who received standard therapy. Each patient participating in a clinical trial was individually matched with a non-participant by clinicopathologic factors. Progression free survival and overall survival were determined by Cox regression. Results: The groups were matched by age (median 64), gender (male 67%), Heng risk (favorable 24%, intermediate 60%, poor 16%), ECOG performance status (0-1 92%), prior nephrectomy (92%), renal cell carcinoma histology (clear cell 80%), sunitinib induced hypertension (56%), and sunitinib dose reduction/treatment interruption (41%). In clinical trial participants vs. non participants, objective response was partial response/stable disease 80% (n=39) vs. 73% (n=36), and progressive disease at first imaging evaluation within the first 3 months (mos) 20% (n=10) vs. 27% (n=13) (p = 0.63, OR 1.2). Median progression free survival was 10 vs. 11 mos (HR=0.96, p = 0.84), and median overall survival 23 vs. 24 mos (HR=0.97, p=0.89). Conclusions: In mRCC patient treated with sunitinib, the outcome of clinical trial participants was similar to matched non participants who received standard therapy.

scholarly journals Clinical Trial Participants With Metastatic Renal Cell Carcinoma Differ From Patients Treated in Real-World Practice

2015 ◽  
Vol 11 (6) ◽  
pp. 491-497 ◽  
Author(s):  
Aaron P. Mitchell ◽  
Michael R. Harrison ◽  
Mark S. Walker ◽  
Daniel J. George ◽  
Amy P. Abernethy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Tyrosine Kinase ◽  
Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Kinase Inhibitors ◽  
Trial Participants

Patients with mRCC treated with tyrosine kinase inhibitors in real-world clinical practice are sicker than those enrolled onto pivotal clinical trials, and more than one third are trial ineligible.

scholarly journals MP19-08 DISPARITIES IN CLINICAL TRIAL PARTICIPATION FOR PATIENTS WITH RENAL CELL CARCINOMA AND PROSTATE CANCER

2021 ◽  
Vol 206 (Supplement 3) ◽  
Author(s):  
Brian Shinder ◽  
Sinae Kim ◽  
Hiren Patel ◽  
Tina Mayer ◽  
Biren Saraiya ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Trial Participation ◽  
Clinical Trial Participation

Safety and efficacy outcomes with nivolumab plus ipilimumab in patients with advanced renal cell carcinoma and brain metastases: results from the CheckMate 920 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4515-4515
Author(s):  
Hamid Emamekhoo ◽  
Mark R Olsen ◽  
Bradley Curtis Carthon ◽  
Alexandra Drakaki ◽  
Ivor John Percent ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Brain Metastases ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Safety And Efficacy ◽  
Medical Need ◽  
Grade 3

4515 Background: Combination therapy with nivolumab plus ipilimumab (NIVO+IPI) has demonstrated long-term efficacy and tolerability in patients with previously untreated advanced renal cell carcinoma (aRCC). Previous phase 3 clinical trials of patients with advanced or metastatic cancers have mostly excluded patients with brain metastases. CheckMate 920 is an ongoing, phase 3b/4 clinical trial of NIVO+IPI treatment in patients with aRCC with a high unmet medical need. We present updated safety and efficacy results for the cohort of patients with aRCC of any histology and brain metastases from CheckMate 920 (NCT02982954). Methods: Patients with previously untreated advanced/metastatic aRCC of any histology, with asymptomatic brain metastases (not currently receiving corticosteroids or radiation), and Karnofsky performance status ≥ 70% were assigned to treatment with NIVO 3 mg/kg + IPI 1 mg/kg every 3 weeks × 4 doses followed by NIVO 480 mg every 4 weeks for ≤ 2 years or until disease progression/unacceptable toxicity. The primary endpoint was incidence of grade ≥ 3 immune-mediated adverse events (imAEs) within 100 days of last dose of study drug. Key secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by RECIST v1.1 (both per investigator). Exploratory endpoints included overall survival (OS). Results: Of 28 treated patients with brain metastases, 85.7% were men; median (range) age was 60 (38–87) years, and 14.3% had sarcomatoid features. With 24.5 months minimum follow-up of the 28 patients enrolled, median duration of therapy (range) was 3.4 (0.0–23.3) months for NIVO and 2.1 (0.0–3.3) months for IPI. No grade 5 imAEs occurred. Grade 3–4 imAEs by category were diarrhea/colitis (7.1%), hypophysitis (3.6%), rash (3.6%), hepatitis (3.6%), and diabetes mellitus (3.6%). Of the 25 patients who were evaluable for ORR, the ORR was 32.0% (95% CI, 14.9–53.5). No patients achieved complete response, 8 achieved partial response, and 10 patients had stable disease. Median time to response (range) was 2.8 (2.4–3.0) months. Median duration (range) of response was 24.0 (3.9–not estimable [NE]) months; 4 of 8 responders remain without reported progression. Of 28 patients, 7 (25%) had intracranial progression. Median PFS (n = 28) was 9.0 (95% CI, 2.9–12.0) months. Median OS (n = 28) was still not reached (95% CI, 14.1 months–NE). Conclusions: In patients with previously untreated aRCC and brain metastases, a population with high unmet medical need that is often underrepresented in clinical trials, the approved treatment regimen of NIVO+IPI followed by NIVO for aRCC showed no new safety signals and continues to show encouraging antitumor activity with longer follow-up. Clinical trial information: NCT02982954.

Clinical factors associated with outcome in metastatic renal cell carcinoma patients treated with VEGF-targeted therapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5046-5046 ◽  
Author(s):  
A. Golshayan ◽  
T. K. Choueiri ◽  
P. Elson ◽  
J. A. Garcia ◽  
M. Khaswneh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Clinical Features ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Clinical Trial Results ◽  
Metastatic Rcc

5046 Background: Therapy targeted against the vascular endothelial growth factor (VEGF) pathway is a standard of care in metastatic renal cell carcinoma (RCC). Identification of clinical features of patients more likely to benefit from these agents would aid in patient selection and interpretation of clinical trial results. Methods: We reviewed 120 metastatic RCC patients receiving bevacizumab, sorafenib, sunitinib or axitinib on one of eight prospective clinical trials at the Cleveland Clinic Taussig Cancer Center. Clinical features associated with outcome were identified by univariate analysis, and then a stepwise modeling approach based on Cox proportional hazards regression was used to identify independent prognostic factors and form a model for progression-free survival (PFS). A bootstrap algorithm was used to provide internal validation. Results: Forty-one patients (34%) achieved an objective response by RECIST criteria (95% C.I. 27–44%). The median PFS for the entire group was 13.8 months (m) (95% C.I. 10.7–19.0 m). Multivariate analysis identified the following independent adverse prognostic factors (PF) for PFS: time from diagnosis to current treatment <2 years, baseline platelet count >300 K/μL, baseline neutrophil count >4.5 K/μL, baseline corrected serum calcium <8.5 or >10.0 mg/dL and initial ECOG performance status >0. Using these factors three prognostic subgroups were formed based on the number of adverse PF present . Median PFS in patients with 0 or 1 adverse PF was 20.1 m (95% C.I. 19.0–22.3 m) compared to 13 m (95% C.I. 8.6–17.6 m) in patients with 2 adverse PF and 3.9 m (95% C.I. 1.8–7.2 m) in patients with >2 adverse PF. Conclusions: Five independent prognostic factors for predicting PFS were identified and used to categorize patients with metastatic RCC receiving VEGF-targeted therapies into three risk groups. These factors can be readily incorporated to clinical patient care, stratification schema for clinical trials utilizing these novel agents and for interpretation of clinical trial results using VEGF-targeted agents therapy. No significant financial relationships to disclose.

Overall survival of men with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy according to their participation (or not) in clinical trials.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 148-148
Author(s):  
Jatinder Goyal ◽  
Peng Huang ◽  
Prachi Tyagi ◽  
Daniel Oh ◽  
Michael Anthony Carducci ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Characteristics ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
First Line ◽  
Trial Participants ◽  
Baseline Hemoglobin

148 Background: There is insufficient evidence to determine whether clinical trial participation can itself lead to improved clinical outcomes in patients with mCRPC treated with docetaxel chemotherapy. We compared clinical characteristics and survival outcomes of patients with mCRPC receiving first-line docetaxel-containing therapy on a clinical study (trial participants) or outside of a clinical trial (non-participants). Methods: We retrospectively reviewed the records of 245 consecutive chemotherapy-naïve patients with mCRPC who received docetaxel-containing therapy between 1/1/1998 and 1/1/2010, either as trial participants (n=142; 11 separate studies) or as non-participants (n=103). Patient demographics, baseline clinical characteristics, treatment details and follow-up data were recorded. Results: In unadjusted analysis, trial participants were more likely to be white (83 vs 70%, p=0.005), to have better ECOG performance status (p=0.01), higher baseline hemoglobin (12.4 vs 11.6 g/dL, p=0.0003), higher albumin (4.3 vs 4.0 g/dL, p=0.009), lower creatinine (0.90 vs 1.04 mg/dL, p=0.01), and to have received a higher number of chemotherapy cycles (6.6 vs 5.1, p=0.001) than non-participants. In Kaplan-Meier analysis, median overall survival was significantly longer among trial participants vs non-participants (21.3 vs 17.1 months, p=0.024). In multivariable analysis, trial participation (HR 0.53, p=0.013), more chemotherapy cycles (HR 0.87; p=0.0002), baseline hemoglobin >12 g/dL (HR 0.67, p=0.016), lower ECOG score (HR 0.57, p=0.026) and lower baseline (log) PSA (HR 0.85, p=0.012) were all found to be independent predictors of survival. Conclusions: Clinical trial participation is an independent positive predictor of overall survival in men undergoing first-line docetaxel-containing chemotherapy for mCRPC. Improved survival in trial participants may reflect better medical oversight typically seen in patients enrolled in clinical trials, more regimented follow-up schedules, or a positive effect on caregivers’ attitudes due to greater contact with medical services.

Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma

2011 ◽  
Vol 18 (0) ◽  
Author(s):  
Sebastien J. Hotte ◽  
G.A. Bjarnason ◽  
D.Y.C. Heng ◽  
M.A.S. Jewett ◽  
A. Kapoor ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Progression Free Survival ◽  
Advanced Renal Cell Carcinoma ◽  
Free Survival ◽  
Clinical Trial Endpoint ◽  
Trial Endpoint

scholarly journals Low intratumor heterogeneity correlates with increased response to PD-1 blockade in renal cell carcinoma

2020 ◽  
Vol 12 ◽  
pp. 175883592097711
Author(s):  
Xia Ran ◽  
Jinyuan Xiao ◽  
Yi Zhang ◽  
Huajing Teng ◽  
Fang Cheng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Checkpoint Inhibitors ◽  
Simulated Data ◽  
The Cancer Genome Atlas ◽  
Intratumor Heterogeneity ◽  
Cell Renal Cell Carcinoma ◽  
Immune Activity

Background: Intratumor heterogeneity (ITH) has been shown to be inversely associated with immune infiltration in several cancers including clear cell renal cell carcinoma (ccRCC), but it remains unclear whether ITH is associated with response to immunotherapy (e.g. PD-1 blockade) in ccRCC. Methods: We quantified ITH using mutant-allele tumor heterogeneity, investigated the association of ITH with immune parameters in patients with ccRCC ( n = 336) as well as those with papillary RCC (pRCC, n = 280) from The Cancer Genome Atlas, and validations were conducted in patients with ccRCC from an independent cohort ( n = 152). The relationship between ITH and response to anti-PD-1 immunotherapy was explored in patients with metastatic ccRCC from a clinical trial of anti-PD-1 therapy ( n = 35), and validated in three equal-size simulated data sets ( n = 60) generated by random sampling with replacement based on this clinical trial cohort. Results: In ccRCC, low ITH was associated with better survival, more reductions in tumor burden, and clinical benefit of anti-PD-1 immunotherapy through modulating immune activity involving more neoantigens, elevated expression of HLA class I genes, and higher abundance of dendritic cells. Furthermore, we found that the association between the level of ITH and response to PD-1 blockade was independent of the mutation status of PBRM1 and that integrating both factors performed better than the individual predictors in predicting the benefit of anti-PD-1 immunotherapy in ccRCC patients. In pRCC, increased immune activity was also observed in low- versus high-ITH tumors, including higher neoantigen counts, increased abundance of monocytes, and decreased expression of PD-L1 and PD-L2. Conclusions: ITH may be helpful in the identification of patients who could benefit from PD-1 blockade in ccRCC, and even in pRCC where no genomic metrics has been found to correlate with response to immune checkpoint inhibitors.

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