Real world experience of immuno-oncology agents in metastatic renal cell carcinoma: Results from the IMDC.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 492-492 ◽  
Author(s):  
Steven Yip ◽  
Connor Wells ◽  
Raphael Brandao Moreira ◽  
Alex Wong ◽  
Sandy Srinivas ◽  
...  
Keyword(s):  
Real World ◽  
Survival Data ◽  
Renal Cell ◽  
Treatment Duration ◽  
Checkpoint Inhibitors ◽  
Cell Cancer ◽  
Response Rates ◽  
Line Treatment ◽  
Second Line ◽  
Poor Risk

492 Background: Immuno-oncology (IO) checkpoint inhibitors have demonstrated efficacy in metastatic renal cell cancer (mRCC) treatment. Real world data is required to assess outcomes when applied to the general population. Methods: A retrospective analysis was performed using the IMDC database. It included mRCC patients treated with IO agents, including atezolizumab (Atezo), avelumab, ipilimumab, nivolumab (Nivo), and pembrolizumab (Pembro). Some patients were treated with combination therapy with a targeted agent. Patients may have received IO therapy as first-, second-, third-, or fourth-line treatment. Overall survival (OS), treatment duration, and overall response rates (ORR) were calculated. Results: 255 patients with mRCC treated with IO therapy were included. The ORR to IO therapy in those patients who were evaluable was 29% (32% first-, 22% second-, 33% third-, and 32% fourth-line therapy). Patients treated with second-line IO therapy were divided into favorable, intermediate, and poor risk using IMDC criteria; the corresponding median OS rates were not reached, 26.7 mo, and 12.1 mo, respectively (p<0.0001). Conclusions: Response rates to IO therapies appear to remain consistent no matter which line of therapy it is used in. Within second-line treatment, IMDC criteria appear to stratify patients appropriately into favorable, intermediate, and poor risk groups. Survival data are premature and will be updated. In contrast to Nivo clinical trial data, where median treatment duration was 5.5 mo, longer treatment length is observed in real world practice. [Table: see text]

scholarly journals Real-world experience of everolimus as second-line treatment in metastatic renal cell cancer after failure of pazopanib

2017 ◽  
Vol Volume 10 ◽  
pp. 4885-4893 ◽  
Author(s):  
Konstantinos Koutsoukos ◽  
Aristotelis Bamias ◽  
Kimon Tzannis ◽  
Marta Espinosa Montaño ◽  
Vasiliki Bozionelou ◽  
...  
Keyword(s):  
Renal Cell Cancer ◽  
Real World ◽  
Renal Cell ◽  
Cell Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Renal Cell Cancer

Checkpoint inhibitors in metastatic renal cell carcinoma patients including elderly subgroups: Results from the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4580-4580
Author(s):  
Steven Yip ◽  
Connor Wells ◽  
Raphael Brandao Moreira ◽  
Alex Wong ◽  
Sandy Srinivas ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Cox Regression ◽  
Cell Cancer ◽  
Second Line ◽  
Cox Regression Analysis ◽  
Poor Risk

4580 Background: Immuno-oncology (IO) checkpoint inhibitor treatment outcomes are poorly characterized in the real world metastatic renal cell cancer (mRCC) patient population, including geriatric patients. Methods: Using the IMDC database, a retrospective analysis was performed on mRCC patients treated with IO, as listed below. Patients received one or more lines of IO therapy, with or without a targeted agent. Duration of treatment (DOT) and overall response rates (ORR) were calculated. Cox regression analysis was performed to examine the association between age as a continuous variable and DOT. Results: 312 mRCC patients treated with IO were included. In patients who were evaluable, ORR to IO therapy was 29% (32% first-, 22% second-, 33% third-, and 32% fourth-line treatment (Tx)). Patients treated with second-line IO therapy were divided into favorable, intermediate, and poor risk using IMDC criteria; the corresponding median DOT rates were not reached (NR), 8.6 mo, and 1.9 mo, respectively (p<0.0001). Based upon age, hazard ratios were calculated in the first- through fourth-line therapy setting, ranging from 1.03 to 0.97. Conclusions: The ORR to IO appears to remain consistent, regardless of line of therapy. In the second-line, IMDC criteria appear to appropriately stratify patients into favorable, intermediate, and poor risk groups for DOT. Premature OS data will be updated. In contrast to clinical trial data, longer DOT is observed in real world practice. Age may not be a factor influencing DOT. [Table: see text]

scholarly journals Individualizing Systemic Therapies in First Line Treatment and beyond for Advanced Renal Cell Carcinoma

Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3750
Author(s):  
Yasir Khan ◽  
Timothy D. Slattery ◽  
Lisa M. Pickering
Keyword(s):  
Renal Cell ◽  
Checkpoint Inhibitors ◽  
Cell Cancer ◽  
Predictive Biomarkers ◽  
Therapeutic Options ◽  
Current Status ◽  
Vegf Receptor ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Therapeutic options for treating advanced renal cell cancer (RCC) are rapidly evolving. Vascular endothelial growth factor (VEGF)-directed therapy, predominantly VEGF receptor (VEGFr) tyrosine kinase inhibitors (TKIs) had been the most effective first line treatment since 2005 irrespective of International Metastatic RCC Database Consortium (IMDC) risk stratification. However, immune checkpoint inhibitors (ICI) have recently changed the treatment paradigm for advanced RCC particularly as the first-line systemic treatment modality. The combination of Ipilimumab and Nivolumab provides better disease control and long-term outcomes compared with the anti-VEGFr TKI Sunitinib for IMDC intermediate- to poor-risk patients and we now have the option of using ICI with TKI upfront for all IMDC risk groups. This poses a challenge for physicians, both to select the most suitable first line regimen and the most suitable subsequent therapy given the lack of data about sequencing in this setting. This treatment landscape is expected to become more complex with the emerging treatment options. Moreover, these therapeutic options cannot be generalized as significant variability exists between individual’s disease biologies and their physiologies for handling treatment adverse effects. Notable efforts are being made to identify promising predictive biomarkers ranging from neo-antigen load to gene expression profiling. These biomarkers need prospective validation to justify their utility in clinical practice and in treatment decision making. This review article discusses various clinicopathological characteristics that should be carefully evaluated to help select appropriate treatment and discusses the current status of biomarker-based selection.

Second-line treatment for metastatic clear cell renal cell cancer: experts’ consensus algorithms

2016 ◽  
Vol 35 (4) ◽  
pp. 641-648 ◽  
Author(s):  
C. Rothermundt ◽  
J. von Rappard ◽  
T. Eisen ◽  
B. Escudier ◽  
V. Grünwald ◽  
...  
Keyword(s):  
Renal Cell Cancer ◽  
Renal Cell ◽  
Clear Cell ◽  
Cell Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Consensus Algorithms

scholarly journals Second-line treatment for renal cell cancer

2012 ◽  
Vol 106 (4) ◽  
pp. 617-618 ◽  
Author(s):  
G Di Lorenzo ◽  
S De Placido ◽  
C Buonerba
Keyword(s):  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cell Cancer ◽  
Line Treatment ◽  
Second Line

scholarly journals PCN101 Cost Effectiveness of Everolimus for Second Line Treatment of Metastatic Renal Cell Cancer in Serbia

2012 ◽  
Vol 15 (7) ◽  
pp. A427
Author(s):  
J. Mihajlović ◽  
P. Pechlivanoglou ◽  
A. Sabo ◽  
Z. Tomić ◽  
M.J. Postma
Keyword(s):  
Cost Effectiveness ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cell Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Metastatic Renal Cell Cancer

Demographics, response, and overall survival of patients with advanced renal cell cancer to sunitinib in a cohort of minority patient population

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16164-e16164
Author(s):  
M. Shah ◽  
S. Sreenivasappa ◽  
R. Kouz ◽  
B. Ciobanu ◽  
M. Mullane ◽  
...  
Keyword(s):  
Median Survival ◽  
Renal Cell Cancer ◽  
Survival Data ◽  
Renal Cell ◽  
Kinase Inhibitor ◽  
Performance Status ◽  
Cell Cancer ◽  
Minority Population ◽  
Ecog Performance Status ◽  
Poor Risk

e16164 Background: Sunitinib is a tyrosine kinase inhibitor active in renal cell cancer (RCC). There is scanty literature of its efficacy in minority population. Methods: 21 patients (pts) with RCC who received sunitinib between February 2006-September 2007 were identified and studied as a retrospective cohort. Clinical and survival data were analyzed using fisher's test, chi square test, Kaplan Meier analyses. Results: Of the 21 patients, 11 (52%) were female and 10 (47%) male, 7 (33.3%) African American, 7 (33.3%) Hispanic, and 5 (23.8%) Caucasian. Median age at diagnosis was 59 years (32–74). 7 (33.3%) had clear cell and 3 (14.3%) sarcomatoid pathology. Mixed, poorly differentiated, papillary and unknown histology were 2 (9.5%) each. 12 (57%) pts had stage 4 disease at diagnosis, stage 3 in 3 (14.3%), stage 2 in 1 (4.8%) and 5 (23%) had missing data. 14(66.7%) pts underwent nephrectomy while 7 (33.3%) did not. 6 (28.6%) pts has good MSKCC risk score, 11 (52.4%) intermediate risk and 3 (14.3%) poor risk. Sunitinib was given at a dose of 50 mg daily for 4 wks followed by 2 wks off. Median duration of treatment was 2.5 months (0–9 mts) and median follow up was 13 mts (1–21 mts). Common grade 3–4 toxicities observed were hand foot syndrome (n = 2), hypertension (n = 2) and thrombocytopenia (n = 1). 4 pts discontinued therapy due to adverse events. 5 (23.8%) has stable disease and 13 (61.9%) had progressive disease. Response to sunitinib was not influenced by sex, race, performance status, MSKCC Score, serum calcium level, LDH and hemoglobin level. Median survival of the group was 4 mts with no difference based on gender (p = 0.8), ethnicity (p = 0.8) or histologic type (p = 0.7). Survival of pts with ECOG performance status (PS) 1 was 8 mts, PS 2 was 4 mts, PS 3 was 2 mts (p = 0.001), MSKCC good risk was 9.4 mts, intermediate score was 9.4 mts and poor risk was 2 mts (p = 0.18). Hemoglobin (p = 0.6), LDH (p = 0.6), calcium (p = 0.2) did not affect the survival. Conclusions: In this minority cohort of pts with RCC treated with sunitinib, response and median survival is much lower than the historical controls. Tolerability and side effect profile are similar to reported literature. Prospective studies are warranted in the treatment of RCC with sunitinib in ethnic minority population. No significant financial relationships to disclose.

scholarly journals Evaluation of Treatment Outcomes after Second-Line Treatment Among Adult Patients with Immune Thrombocytopenia

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3765-3765 ◽  
Author(s):  
Qayyim Said ◽  
Lincy S Lal ◽  
Brigette Nezami ◽  
Katherine Andrade ◽  
J. Anthony Graves ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Immune Globulin ◽  
Real World ◽  
Treatment Duration ◽  
Immune Thrombocytopenia ◽  
Treatment Patterns ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Index Treatment

Abstract Introduction: Immune Thrombocytopenia (ITP) is a disease of immune-mediated destruction of platelets and suppression of platelet production. ITP has been historically treated with corticosteroids and/or immune globulins as first-line agents. There are several second-line treatments available, should patients fail to respond to initial therapy or relapse after it is tapered. These include eltrombopag, romiplostim, rituximab and splenectomy. This study utilized a national electronic health record (EHR) database to begin to explore the real world treatment patterns of the aforementioned second-line (index) therapies. Methods: Utilizing the Optum EHR database, we identified patients who initiated their first second-line treatment (i.e. the index treatment) with eltrombopag, romiplostim, rituximab or splenectomy from Jan. 1, 2009 to Sep. 30, 2016 for primary or unspecified ITP. Patients included in the analysis had the following characteristics: 18 years or older; previous treatment with corticosteroids and/or immune globulin products; active in the database for at least 6 months prior to and 12 months post initiation of the index treatment. Outcomes that were evaluated after initiation of the index treatment included: (1) Duration of therapy for eltrombopag and romiplostim; (2) Proportion of patients who started a subsequent line of treatment after their index treatment; (3) Treatment free duration between the end of the index treatment and start of a subsequent line of treatment; and (4) Proportion of patients using a first-line medication (corticosteroids and/or immune globulin) during treatment with eltrombopag and romiplostim. Chi-square and t-tests were used for statistical analysis. Results: 2,047 patients met the inclusion criteria and used an index treatment as follows: eltrombopag, N=110 (5.4%); romiplostim, N=189 (9.2%); rituximab, N=1488 (72.7%); splenectomy, N=260 (12.7%). The mean age was 60.8 years (standard deviation [SD]: 17.4), with 52.4% female and mean Charlson comorbidity score of 2.1 (SD: 2.1). Treatment duration was 481 days for eltrombopag versus 346 days for romiplostim (p=0.033). The proportion of patients who started a subsequent line of treatment after their index treatment ranged from 41% for rituximab to 49% for splenectomy (p=0.071). Treatment free duration between the end of the index treatment and start of a subsequent treatment ranged from a mean of 248 days for romiplostim to 575 days for splenectomy (p<0.001). The proportion of patients who did not use first-line medications during treatment with eltrombopag and romiplostim were similar (24% vs. 17%, p=0.157). See Table 1 below for details. Conclusions: In this dataset, rituximab was the predominant second-line treatment. Patients receiving eltrombopag had a greater treatment duration compared to romiplostim. As expected, a greater treatment free duration was observed with splenectomy and rituximab, though mean treatment free duration after treatment with romiplostim and eltrombopag was surprisingly long (248-270 days). Despite the longer duration off treatment following splenectomy and rituximab, a similar percentage of patients across all index treatments ultimately required a subsequent line of therapy. Further research is required to better understand the differences in real world treatment patterns among these cohorts. Disclosures Said: Novartis: Employment. Lal:Optum: Employment. Nezami:Novartis Pharmaceuticals: Employment. Andrade:Optum: Employment. Graves:Novartis: Employment. Roy:Novartis: Employment. Cuker:Spark Therapeutics: Research Funding; Kedrion: Membership on an entity's Board of Directors or advisory committees; Synergy: Consultancy; Genzyme: Consultancy.

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