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.

Prognostic significance of degree of anemia in renal cell carcinoma.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 469-469
Author(s):  
Mohammad Mozayen ◽  
Anteneh Tesfaye ◽  
Khalil Katato
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Prognostic Significance ◽  
Hospital Setting ◽  
Disease Stage ◽  
Study Population ◽  
The Impact

469 Background: Anemia can precede the diagnosis of renal cell carcinoma (RCC). It has been well studied that it has a negative effect on the outcome of RCC. The impact of the severity of anemia on the overall all survival of patients with RCC is not well known. Our study examined the impact of severity of anemia on the overall survival of patients with RCC. Methods: We retrospectively reviewed 204 patients diagnosed with RCC between 1995 and 2008 in a community hospital setting. Patients with additional malignancies, lymphoma of the kidneys, with no follow up data or no preoperative Hemoglobin levels (Hg) measurement were excluded from the study. Demographics, preoperative complete blood count (CBC), pathology, disease stage, operative note, and subsequent follow up data were reviewed. Patients were grouped based on their preoperative Hg. Anemia was defined as Hg <12g/dl for females and <13g/dl for males. Patients were divided based on Hg to Group A (females with Hg<10 g/dl, males with Hg<11g/dl), group B (females with Hg 10-12 g/dl, males with Hg 11-13 g/dl), group C (females with Hg >12 g/dl, males with Hg >13g/dl). Last follow up date was used to calculate the 3 year overall survival for patients. The primary outcome was 3 year overall survival. Results: A total of 204 patients were reviewed, 127 (62.3%) were males, 176 (85.9%) were Caucasians. The median age of the study population was 65 (22-91). Clear Cell was the commonest histology (79%). Anemia was found in 90 (44.1%) patients. The median Hg was 12.8 g/dl (Range: 7.2-18.2). Anemia was present in 41.8% of females and 46.2% of males. The median Hg level for stages I, II, III, IV were (13.05, 12.45, 12.45, 11.45) respectively. The 3 year overall survival for the study population was 67.3% (95% CI: 60.4-73.7). The 3-year overall survival for anemic patients was 51.2% (95% CI: 40-61) compared to 81.6% (95% CI: 72-87) in non anemic (p<0.0001). The 3-year overall survival significantly decreased with Hg levels, as shown by the Groups A (33.3%), B (60.7%), and C (81.6%) (p<0.0001). Conclusions: Our finding was consistent with other studies in portraying anemia as a negative prognostic factor in patients with renal cell carcinoma. Our study also showed that the severity of anemia corresponds to poorer overall patients survival.

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.

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.

scholarly journals Age at diagnosis is a determinant factor of renal cell carcinoma– specific survival in patients treated with nephrectomy

2008 ◽  
Vol 2 (6) ◽  
pp. 610 ◽  
Author(s):  
Pierre I. Karakiewicz ◽  
Claudio Jeldres ◽  
Nazareno Suardi ◽  
George C. Hutterer ◽  
Paul Perrotte ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Cox Regression ◽  
Prognostic Significance ◽  
Cubic Spline ◽  
Age At Diagnosis ◽  
Fuhrman Grade ◽  
Effect Of Age

Objective: Based on combined data for 4880 patients, 2 previous studies reported that advanced age is a predictor of increased renal cell carcinoma–specific mortality (RCC-SM). We explored the effect of age in cubic spline analyses to identify the age groups with the most elevated risk for renal cell carcinoma (RCC).Methods: Our study included 3595 patients from 14 European centres who had partial or radical nephrectomies. We used the Kaplan–Meier method to compile life tables, and we performed Cox regression analyses to assess RCC-SM. Covariates included age at diagnosis, sex, TNM (tumour, node, metastasis) stage, tumour size, Fuhrman grade, symptom classification and histological subtype.Results: Age ranged from 10 to 89 (mean 63, median 67) years. The median duration of follow-up was 2.9 years. The median survival for the cohort was 13.4 years. Stage distribution was as follows: 1915 patients (53.3%) had stage I disease, 388 (10.8%) had stage II, 895 (24.9%) had stage III and 397 (11.0%) had stage IV disease. In multivariate analyses, we coded age at diagnosis as a cubic spline, and it achieved independent predictor status (p < 0.001). The risk of RCC-SM was lowest among patients younger than 50 years. We observed an increase in RCC-SM until the age of 50, at which point the level of risk reached a plateau. We observed a second increase among patients aged 75–89 years. We found similar patterns when we stratified patients according to the 2002 American Joint Committee on Cancer (AJCC) stages.Conclusion: The effect of age shows prognostic significance and indicates that follow-up and possibly secondary treatments might need to be adjusted according to the age of the patient.

scholarly journals Significance of Chromosome 9p Status in Renal Cell Carcinoma: A Systematic Review and Quality of the Reported Studies

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
Ismail El-Mokadem ◽  
John Fitzpatrick ◽  
Bhavan Rai ◽  
J. Cunningham ◽  
Norman Pratt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Clinical Decision Making ◽  
Cell Cancer ◽  
Prognostic Significance ◽  
Clinical Applicability ◽  
Genetic Techniques

Defining the prognosis of renal cell carcinoma (RCC) using genetic tests is an evolving area. The prognostic significance of 9p status in RCC, although described in the literature, remains underutilised in clinical practice. The study explored the causes of this translational gap. A systematic review on the significance of 9p status in RCC was performed to assess its clinical applicability and impact on clinical decision-making. Medline, Embase, and other electronic searches were made for studies reporting on 9p status in RCC. We collected data on: genetic techniques, pathological parameters, clinical outcomes, and completeness of follow-up assessment. Eleven studies reporting on 1,431 patients using different genetic techniques were included. The most commonly used genetic technique for the assessment of 9p status in RCC was fluorescence in situ hybridization. Combined genomic hybridisation (CGH), microsatellite analysis, karyotyping, and sequencing were other reported techniques. Various thresholds and cut-off values were used for the diagnosis of 9p deletion in different studies. Standardization, interobserver agreement, and consensus on the interpretation of test remained poor. The studies lacked validation and had high risk of bias and poor clinical applicability as assessed by two independent reviewers using a modified quality assessment tool. Further protocol driven studies with standardised methodology including use of appropriate positive and negative controls, assessment of interobserver variations, and evidenced based follow-up protocols are needed to clarify the role of 9p status in predicting oncological outcomes in renal cell cancer.

Prognostic factors for the recurrence of renal cell carcinoma after radical nephrectomy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14629-14629
Author(s):  
C. H. Ohlmann ◽  
T. Schneider ◽  
S. Wille ◽  
U. Engelmann ◽  
A. Heidenreich
Keyword(s):  
Renal Cell Carcinoma ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Radical Nephrectomy ◽  
Prognostic Significance ◽  
Flank Pain ◽  
Time Of Surgery ◽  
Asymptomatic Patients

14629 Background: Recurrence of renal cell carcinoma depends mainly on tumor stage at the time of radical nephrectomy and increases with increasing T-stage. Up to 30% of patients with T1–2 tumors will experience local or distant recurrence. Recommendations for the follow-up include chest x-ray every 6 months for stages T1–4 and abdominal CT-scan for pT3–4 for the first 3 years. The aim of our study was to identify prognostic factors predicting recurrence of RCC in order to individualize follow up strategies. Methods: We retrospectively analyzed the charts of 177 patients with RCC who underwent radical nephrectomy. In 163/177 (92%) of the patients the histology revealed renal cell carcinoma. The median-follow up was 4.5 (1–6) years. The prognostic significance of histology, gender, age, c-reactive protein, hemoglobin, hematuria, gross hematuria, weight loss, flank pain and metastases at the time of surgery for risk of recurrence was calculated by uni- and multivariate analysis. Cancer specific survival (CSS) was analyzed by the Kaplan-Meir method. Results: Logistic regression analysis identified presence of metastases at time of surgery (p ≤ 0.0005), hematuria (p ≤ 0.0005) and flank pain (p = 0.011) as independent prognostic factors for the recurrence of RCC. The risk of recurrent disease is 33.5% with one, 70 to 83% with two and 95.6% with the presence of all 3 markers. 3-year CSS is 69% vs. 82% in symptomatic vs. asymptomatic patients (p = 0.1352), 45% vs. 90% in M1/N1 vs. M0/N0 (p = 0.0001) and 78% vs. 88% in pT3b vs. <pT3b (p = 0.0102). Conclusions: In our study we were able to identify prognostic factors for the recurrence of renal cell carcinoma. Based on this model the follow-up of patients can be individualized according to the risk for recurrence after radical nephrectomy. No significant financial relationships to disclose.

scholarly journals Variation in gene encoding the co-inhibitory molecule BTLA is associated with survival in patients treated for clear cell renal carcinoma – results of a prospective cohort study

2021 ◽  
Author(s):  
Krzysztof Tupikowski ◽  
Anna Partyka ◽  
Edyta Pawlak ◽  
Kuba Ptaszkowski ◽  
Romuald Zdrojowy ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Clear Cell ◽  
T Cell Response ◽  
Disease Stage ◽  
Tumor Diameter ◽  
Gene Encoding ◽  
Cell Renal Cell Carcinoma

IntroductionThe successful introduction of immune checkpoint blockade approaches to renal-cell carcinoma (RCC) treatment indicates the importance of molecules regulating the T cell response to RCC risk and progression.Material and methodsIn this study, we evaluate the association of variations in the CTLA-4, BTLA and CD28 genes with overall survival (OS) of RCC patients and specifically clear cell RCC (ccRCC) patients. The following previously genotyped using RFLP method or TaqManSNP Genotyping Assays single nucleotide polymorphisms (SNPs) were analyzed: CTLA-4 gene: c.49A>G (rs231775), g.319C>T (rs5742909), g.*6230G>A (CT60; rs3087243), g.*10223G>T (Jo31; rs11571302); CD28 gene: c.17+3T>C (rs3116496), c.-1042G>A (rs3181098); BTLA gene: rs2705511, rs1982809, rs9288952, rs9288953, rs2705535 and rs1844089.ResultsDuring long term observation (6.5 years) we discovered that possessing of A allele at BTLA rs1844089 SNP, together with advanced disease (stage >3, tumor grade >3, tumor diameter ≥70mm), is an independent risk factor of death which increases the HR (hazard ratio) of death by more than two-fold (HR=2.21, 95%CI 1.28-3.83). Furthermore, the OS of patients bearing this allele is 6 months shorter than for homozygous [GG] patients (42.5 vs. 48.2 months).ConclusionsOur results indicate for the first time that genetic variation within the gene encoding the BTLA is significantly associated with overall survival in clear cell renal cell carcinoma patients.

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.

Who could be appropriate candidates for partial nephrectomy in localized renal cell carcinoma? Selection by preoperative factors.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 542-542
Author(s):  
Kazuhiro Nagao ◽  
Shigeru Sakano ◽  
Nakanori Fujii ◽  
Keita Kobayashi ◽  
Ryo Inoue ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
High Risk ◽  
Cell Carcinoma ◽  
Partial Nephrectomy ◽  
Renal Cell ◽  
Odds Ratio ◽  
Significant Difference ◽  
Localized Renal Cell Carcinoma

542 Background: Chronic kidney disease (CKD) is a risk factor for the cardiovascular disease, which affect to the patients’ survival, while an EORTC randomized control trial did not show superiority of partial nephrectomy (PN) against localized renal cell carcinoma (RCC) in overall survival compared to radical nephrectomy (RN). We aimed to evaluate the role of operative methods affecting the survival and tried to estimate a predictive model for high risk CKD after surgery. Methods: We reviewed the data of 357 cases with clinical T1 RCC treated by RN (292 cases, RN group) or PN (65 cases, PN group) at Yamaguchi University Hospital or its related hospitals. We supposed the cases with CKD stage 3b or higher after surgery as high risk CKD. And we set the primary endpoints as the ratio of the cases with high risk CKD and overall survival after surgery. Results: Median follow-up period after surgery was 70 months (3-161). Statistically significant difference in performance status and clinical T stage were observed between the groups, but not in other patients’ characteristics. Mean values of preoperative eGFR were 69.2 and 65.5 ml/min/1.73m2 in RN and PN group, which decreased to 46.0 and 57.9 at 5 years after surgery, respectively. There was a significant difference in the incidence of high risk CKD between RN (39.3%) and PN group (2.2%) at 5 years after surgery. During follow up period, 17 cases (4.4%) were inducted to dialysis, there was no difference in the incidence between the RN and PN group. Multivariate analysis showed that eGFR ( < 72 ml/min/1.73m2; Odds ratio 15.3), proteinuria (Odds ratio 3.84), smoking (Odds ratio 2.76), BMI ( > 23; Odds ratio 2.66) and age ( > 67 years old; Odds ratio 2.47) could be significant predictive factors for high risk CKD at 5years after surgery. Our predicting model for high risk CKD showed 86.8% of sensitivity and 74.8% of specificity. But there was no significant difference in overall survival between the RN and PN group. Conclusions: Although there was a significant difference in the incidence of high risk CKD between RN and PN group, operative methods did not affect to the survival. Postoperative high risk CKD could be predictable by preoperative clinical factors.

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]

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