Real-world treatment patterns and overall survival in previously treated advanced renal cell carcinoma patients receiving nivolumab in the UK.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16561-e16561
Author(s):  
Tom Waddell ◽  
Kate Fife ◽  
Richard Griffiths ◽  
Anand Sharma ◽  
Poonam Dhokia ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Treatment Patterns ◽  
Case Report Form ◽  
Real World Evidence ◽  
Previously Treated

e16561 Background: CheckMate 025 demonstrated favorable efficacy and safety results for nivolumab monotherapy in previously treated advanced or metastatic renal cell carcinoma (aRCC). However, real-world evidence on treatment patterns and clinical outcomes is limited. Methods: This multi-centre, retrospective cohort study examined treatment patterns and overall survival (OS) in aRCC patients treated with nivolumab monotherapy. Eligible patients who initiated nivolumab at second-line (2L) or beyond (index) between 01 March 2016 and 30 June 2018 were sampled from four UK centers. Data were extracted using an electronic case report form from index to earliest of: most recent visit; death; end of follow up (31 May 2019). Results: Overall , 151 patients were included in analyses (mean age at index 66.9 years, 72.2% male, median follow-up from index 15.2 months), with 109 (72.2%) and 42 (27.8%) receiving nivolumab at 2L and ≥ third-line (3L+), respectively. Key clinical characteristics are outlined in Table 1. All 2L nivolumab patients had received first-line (1L) tyrosine kinase inhibitors (TKI), pazopanib (57.8%), sunitinib (30.3%), or both in sequence (10.1%). After 2L nivolumab, 3L cabozantinib (36/52, 69.2%) was most common. Most 3L nivolumab patients received 2L TKI (31/36, 86.1%) - commonly axitinib (70.9%). After 3L nivolumab, most patients received fourth-line cabozantinib (8/12, 66.7%). Median time on line of therapy (LOT) decreased with LOT progression: from 7.8 months at 1L to 4.6 months at fifth-line (5L). The proportion of patients who discontinued treatment due to adverse events decreased by LOT, (28.6%, 22.7%, 16.0% and 0%, and 34.7%, 28.1%, 0% and 0% from 2L to 5L, overall and for nivolumab treatment, respectively). Overall, median OS from nivolumab initiation was 19.2 months [95% CI, 16.9-27.0]. Patients who received 2L nivolumab had longest median OS (23.0 months [95% CI, 17.2, not reached]), comparable to CheckMate 025 (25.8 months [95% CI, 22.2-29.8]). Median OS for 3L+ nivolumab patients was 12.4 months [95% CI, 8.8, 23.2]. Among 2L nivolumab patients, 73.9%, 46.2%, and 33.6% survived 12, 24, and 36 months, respectively. For the same respective timeframes, 52.4%, 24.7%, and 18.6% of 3L+ nivolumab patients survived. Conclusions: This study provides real-world evidence on the characteristics, treatment patterns and effectiveness of 2L or ≥ 3L nivolumab monotherapy in previously treated aRCC patients. OS results from UK routine clinical care were comparable to those found in CheckMate 025.[Table: see text]

scholarly journals Real-World Treatment Patterns and Costs for Patients with Renal Cell Carcinoma Initiating Treatment with Sunitinib and Pazopanib

2016 ◽  
Vol 22 (8) ◽  
pp. 979-990 ◽  
Author(s):  
Elizabeth MacLean ◽  
Jack Mardekian ◽  
Laura A. Cisar ◽  
Caroline J. Hoang ◽  
James Harnett
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Treatment Patterns

Sarcomatoid Renal Cell Carcinoma: Biologic Behavior, Prognosis, and Response to Combined Surgical Resection and Immunotherapy

1999 ◽  
Vol 17 (2) ◽  
pp. 523-523 ◽  
Author(s):  
Thomas Cangiano ◽  
Joseph Liao ◽  
John Naitoh ◽  
Frederick Dorey ◽  
Robert Figlin ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Cell Carcinoma ◽  
Surgical Resection ◽  
Median Duration ◽  
Renal Cell ◽  
High Dose ◽  
Risk Of Death

PURPOSE: Sarcomatoid variants of renal cell carcinoma (RCC) are aggressive tumors that respond poorly to immunotherapy. We report the outcomes of 31 patients with sarcomatoid RCC treated with a combination of surgical resection and immunotherapy. PATIENTS AND METHODS: Patients were identified from the database of the University of California Los Angeles Kidney Cancer Program. We retrospectively reviewed the cases of 31 consecutive patients in whom sarcomatoid RCC was diagnosed between 1990 and 1997. Clinical stage, sites of metastasis, pathologic stage, and type of immunotherapy were abstracted from the medical records. The primary end point analyzed was overall survival, and a multivariate analysis was performed to distinguish any factors conferring an improved survivorship. RESULTS: Twenty-six percent of patients were male and 74% were female, and the median age was 59 years (range, 34 to 73 years). Length of follow-up ranged from 2 to 77 months (mean, 21.4 months). Twenty-eight patients (84%) had known metastases at the time of radical nephrectomy (67% had lung metastases and 40% had bone, 21% had liver, 33% had lymphatic, and 15% had brain metastases). Twenty-five patients (81%) received immunotherapy, including low-dose interleukin (IL)-2–based therapy (five patients), tumor-infiltrating lymphocyte–based therapy plus IL-2 (nine patients), high-dose IL-2–based therapy (nine patients), dendritic cell vaccine–based therapy (one patient), and interferon alpha–based therapy alone (one patient). Two patients (6%) achieved complete responses (median duration, 46+ months) and five patients (15%) achieved partial responses (median duration, 36 months). One- and 2-year overall survival rates were 48% and 37%, respectively. Using a multivariate analysis, age, sex, and percentage of sarcomatoid tumor (< or > 50%) did not significantly correlate with survival. Improved survival was found in patients receiving high-dose IL-2 therapy compared with patients treated with surgery alone or any other form of immunotherapy (P = .025). Adjusting for age, sex, and percentage of sarcomatoid tumor, the relative risk of death was 10.4 times higher in patients not receiving high-dose IL-2 therapy. Final pathologic T stage did not correlate significantly with outcome, but node-positive patients had a higher death rate per year of follow-up than did the rest of the population (1.26 v 0.76, Cox regression analysis). CONCLUSION: Surgical resection and high-dose IL-2–based immunotherapy may play a role in the treatment of sarcomatoid RCCs in select patients.

Does obesity affect the outcome of renal cell carcinoma?

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 444-444
Author(s):  
Mohammad Mozayen ◽  
Anteneh Tesfaye ◽  
Khalil Katato
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Community Hospital ◽  
Prognostic Significance ◽  
Disease Stage ◽  
Increased Risk ◽  
Study Population

444 Background: Obesity has been associated with increased risk of renal cell carcinoma (RCC). However the prognostic significance of obesity in the survival of patients with RCC is still undefined. Our study examined prognostic significance of obesity on the overall survival of patients (pts) with RCC in community hospital settings. Methods: A retrospective review of pts diagnosed with RCC between 1995 and 2008 in a community hospital setting was done. Pts with additional malignancies, lymphoma of the kidneys and no follow up data were excluded from the study. Demographics, body mass index(BMI) at diagnoses, pathology, disease stage, operative note, and subsequent follow up data were reviewed. The WHO BMI classification was used to group pts into Underweight (UW) < 18.5; Normal (NL): 18.5-24.99; Pre-obese (PO): 25-29.99; Obese I (Ob I): 30-34.99; Obese II (Ob II): 35-39.99; Obese III (Ob III): ≥40. The primary outcome was 3 years overall survival. Results: A total Of 205 pts reviewed, 127 (62.3%) were males, 176 (85.9%) were Caucasians. The median age of the study population was 65 (22-91). The prevalence of obesity was 42.3% in the study population; 46.2% in females and 39% in males (p=0.19). The median BMI was 28.8 (16-54.6). Pts were categorized based on their BMI as: UW (1.5%), NL (21.4%), PO (34.7%), Ob I (26%), Ob II (8.2%), and Ob III (8.2%). Clear Cell was the commonest histology (79%). Stage I was seen in 53.9%, II in 23.5%, III in 13.7% and IV in 8.8% of the study population. The 3 year overall survival for the study population was 67.3% (95% CI: 60.4-73.7). The 3-year overall survival of obese and non obese pts with RCC were 66.4% and 69.5% respectively (p=0.34). There was no difference in the 3-year overall survival of patient in the BMI groupings: (UW: 66.7%, NW: 59%, Pre-Ob: 70.6%, Obese I: 70%, II: 75%, III: 62.5%; p=0.8). Conclusions: Our study didn’t find any association between BMI and 3 year overall survival in pts with RCC. Larger randomized trials are warranted before excluding the negative impact of obesity in the overall survival of pts with renal cell carcinoma.

Treatment patterns: Targeted therapies indicated for first-line management of metastatic renal cell carcinoma in a real-world setting.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 416-416
Author(s):  
Gregory P. Hess ◽  
Rohit Borker ◽  
Eileen Fonseca
Keyword(s):  
Renal Cell Carcinoma ◽  
Clinical Practice ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Treatment Duration ◽  
Treatment Patterns ◽  
Targeted Agents ◽  
Line Therapy

416 Background: Limited information about real-world treatment patterns of targeted agents for metastatic renal cell carcinoma (mRCC) is available to inform their use in clinical practice. Methods: This retrospective, observational study employed US claims data (January 2007-November 2010) to identify treatment patterns, including treatment duration and dosing, for targeted agents (sunitinib, sorafenib, pazopanib, bevacizumab, and temsirolimus) indicated in 1st line management of advanced/mRCC. The study included adult mRCC patients who were observed for ≥3 months after initiation of their 1st line therapy with a targeted agent. Descriptive analyses were conducted for the observed treatment patterns. Results: A total of 273 patients on 1st line therapy were identified and included in the study sample out of which 235 patients were treated with sunitinib, 16 patients with sorafenib, and 15 patients with temsirolimus. Pazopanib and bevacizumab were excluded from further analysis due to their small samples; n<10. The median observed treatment durations were: sunitinib 3.3 months, sorafenib 4.0 months, and temsirolimus 2.6 months. Patients initiating therapy on sorafenib (n=16) and temsirolimus (n=15) in the study sample were insufficient for meaningful dosing analyses. In sum, of the n=235 sunitinib patients, 178 (approximately 76%) initiated therapy at the indicated dose of 50 mg. Sixty-five percent of these patients were not observed filling a 4th script (the average number observed), while 26% maintained their starting dose and 9% experienced a dose reduction at their fourth fill. (See table). Conclusions: This study suggests that opportunities exist to improve treatment duration in real-world clinical practice and to better understand possible influences, other than disease progression, on treatment and dose changes. [Table: see text]

Lymphopenia as a prognostic factor in renal cell carcinoma.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 470-470
Author(s):  
Mohammad Mozayen ◽  
Anteneh Tesfaye ◽  
Khalil Katato
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
African Americans ◽  
Prognostic Factor ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Blood Count ◽  
Complete Blood Count ◽  
Study Population

470 Background: Lymphopenia is known to be a negative prognostic marker for NHL and hematological malignancies, recent observational studies evaluated the presence of lymphopenia and its impact in solid tumor like colon, lung and pancreatic cancer. We aim to assess the effect of Lymphopenia at the renal cell carcinoma (RCC) survival. Methods: A retrospective review of 207 patients diagnosed with RCC between 1995 and 2008 in a community hospital setting was done. Patients with additional malignancies, lymphoma of the kidneys, with no follow up data or no preoperative complete blood count test were excluded. Demographics, preoperative complete blood count, pathology, disease stage, operative note, and subsequent follow up data were reviewed. Lymphopenia was defined as absolute lymphocytic count < 1200/µl. Last follow up date was used to calculate the 3 year overall survival. The primary outcome was 3 year overall survival. Results: A total of 207 patients were included in the study. Caucasians were 176(85.9%), African Americans were 13.7% and Asians were 1(0.5%). Males (M) were 127 (62.3%) and females (F) were 77(37.7%). The median age of the study population was 65 (22-91. Clear cell histology was seen in 79%. Stage I was seen in 53.9%, II in 23.5%, III in 13.7% and IV in 8.8% of the study population. Lymphopenia was seen in 81 (40%) patients (95 CI 34-48). Lymphopenia was seen in 31.8% of stage I; 50% of stage II, 41.4% of stage III, and 65% of stage IV patients (p=0.017). Lymphopenia was seen in 28.6% of African Americans and 42.7% of Caucasians (p=0.11). Lymphopenia was seen in 32.1% of females and 45.7% of males (p=0.03). The 3 year overall survival for the study population was 67.3% (95% CI: 60.4-73.7). The 3-year overall survival for patients with lymphopenia was 60.5%, compared to 73.6% in non-lymphopenic patients (p=0.04). Conclusions: Lymphopenia was seen to be higher among males and Caucasians, more frequently at advanced stage at diagnosis. Patients with lymphopenia were observed to have significantly worse survival when compared to patients with normal lymphocytic count in RCC. We conclude that lymphopenia is considered as a negative prognostic factor for RCC, and needed to be studied in the correlation of other known prognostic factors.

Overall survival results from a phase III study of tivozanib hydrochloride versus sorafenib in patients with renal cell carcinoma.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 350-350 ◽  
Author(s):  
Robert John Motzer ◽  
Timothy Eisen ◽  
Thomas E. Hutson ◽  
Cezary Szczylik ◽  
Mizue Krygowski ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Phase Iii ◽  
Extension Study ◽  
Standards Of Care ◽  
Rank Test ◽  
Significant Difference

350 Background: Tivozanib hydrochloride (tivozanib) is a potent, selective, tyrosine kinase inhibitor targeting all three vascular endothelial growth factor receptors, with a long half-life. Tivozanib has shown tolerability and superior progression-free survival and overall response rate versus sorafenib in a phase III trial (TIVO-1) in patients with advanced renal cell carcinoma. Final overall survival (OS) data (August 27, 2012) from TIVO-1 and its open-label, multicenter extension study are reported. Methods: A total of 517 patients were randomized 1:1 to tivozanib 1.5 mg/d (3 weeks on, 1 week off) or sorafenib 400 mg/d (twice a day, continuously) (J Clin Oncol2012;30[suppl]:Abstract 4501). In the extension study, patients who progressed (PD) on sorafenib based on investigator assessment were eligible to receive tivozanib, and patients with PD on tivozanib received subsequent treatment according to regional standards of care. Final OS analysis was planned to be conducted after all patients had died or were lost to follow-up, or when all patients in follow-up had been on study for at least 2 years, whichever occurred first. OS was compared using the stratified log-rank test. OS distribution was estimated using the Kaplan-Meier method. Hazard ratio (HR) was estimated using the Cox proportional hazard regression model. Results: At the time of final OS analysis (2 years after last patient was enrolled), 219 deaths had occurred (tivozanib, n=118 [45.4%]; sorafenib, n=101 [39.3%]) (stratified HR=1.245; 95% confidence interval [CI] 0.954–1.624; p=0.105), trending in favor of the sorafenib arm. Median OS (95% CI) was 28.8 months (22.5–NA) for tivozanib and 29.3 months (29.3–NA) for sorafenib. Of the 257 patients on sorafenib, 155 (60.3%) had started next-line tivozanib at the time of the analysis. Conclusions: There was no significant difference in OS between the two treatment arms. The high rate of utilization of second-line tivozanib in patients following PD on sorafenib may have affected the OS outcome. Clinical trial information: NCT01030783.

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