The role of cytoreductive nephrectomy (CN) in treatment of locally advanced or metastatic renal cell carcinoma (mRCC) in the era of targeted therapies (TT) is still not clearly defined. The study population consisted of 730 patients with synchronous mRCC. The RenIS (Renal carcinoma Information System) registry was used as the data source. The CN/TT cohort included patients having CN within 3 months from the mRCC diagnosis and subsequently being treated with TT, while the TT cohort included patients receiving TT upfront. Median progression-free survival from the first intervention was 6.7 months in the TT arm and 9.3 months in the CN/TT patients (p < 0.001). Median overall survival was 14.2 and 27.2 months, respectively (p < 0.001). Liver metastasis, high-grade tumor, absence of CN, non-clear cell histology, and MSKCC (Memorial Sloan-Kettering Cancer Center) poor prognosis status were associated with adverse treatment outcomes. According to the results of this retrospective study, patients who underwent CN and subsequently were treated with TT had better outcomes compared to patients treated with upfront TT. The results of the study support the use of CN in the treatment algorithm for mRCC.

• Keywords
• cytoreductive nephrectomy, metastatic renal cell carcinoma, overall survival, targeted therapy,
• Publication type
• Journal Article MeSH

BACKGROUND: It is well known that patient characteristics and survival outcomes in randomized trials may not necessarily be similar to those in real-life clinical practice. The aim of the present study was to analyse second line treatment strategies in the real-world practice and to estimate the outcomes of patients treated with second-line targeted therapy for metastatic renal cell carcinoma (mRCC). METHODS: This is a retrospective, registry-based study using data from the national registry of targeted therapies for mRCC. The RENIS registry contains data on 3049 patients who started the therapy with at least one targeted agent before 31 December, 2014. Of these patients, 1029 had a record of at least two different targeted therapies and sufficient data for analysis. Survival analysis was carried out using the Kaplan-Meier method. Statistical significance of differences in survival between subgroups was assessed using the log-rank test. RESULTS: The median overall survival from the start of second-line treatment was 17.0 months (95% confidence interval [CI] 14.5-19.5 months), 17.1 months (95% CI 14.5-19.8), and 15.4 months (95% CI 11.0-19.7) for second-line everolimus, sorafenib, and sunitinib, respectively. Patients receiving second-line everolimus were older at the start of second-line treatment, more likely to have metachronous disease, and less likely to be previously treated with cytokines or to continue to third-line treatment than patients treated with second-line sunitinib or sorafenib. Progression-free survival (PFS) correlated with PFS on first-line treatment only for everolimus. CONCLUSIONS: In this retrospective study, no significant differences in survival were observed between the cohorts treated with different second-line agents including everolimus, sorafenib, and sunitinib.

• Keywords
• Everolimus, Pazopanib, Renal cell carcinoma, Sorafenib, Sunitinib, Therapy,
• MeSH
• Molecular Targeted Therapy * MeSH
• Adult MeSH
• Carcinoma, Renal Cell drug therapy   pathology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Lymphatic Metastasis MeSH
• Survival Rate MeSH
• Kidney Neoplasms drug therapy   secondary   MeSH
• Follow-Up Studies MeSH
• Carcinoma, Papillary drug therapy   secondary   MeSH
• Prognosis MeSH
• Antineoplastic Combined Chemotherapy Protocols therapeutic use   MeSH
• Registries statistics & numerical data   MeSH
• Retrospective Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Salvage Therapy * MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

BACKGROUND: Although a significant proportion of patients with metastatic renal cell carcinoma (mRCC) are elderly, the data on the outcomes of targeted therapies in this population are limited. The aim of the present retrospective registry-based study was to analyse efficacy and toxicity of sunitinib as the first-line targeted therapy of elderly mRCC patients. PATIENTS AND METHODS: The national RENal information system registry of mRCC patients treated with targeted agents in the Czech Republic was used as the data source. Of the 1315 patients treated with sunitinib as first-line targeted therapy, 1016 and 299 patients were aged <70 and ≥70 years, respectively. RESULTS: Elderly patients had a significantly longer interval from diagnosis to the initiation of therapy. Median progression-free survival was 10.8 months (95 % confidence interval 9.8-11.8) and 8.8 months (7.2-10.4) for patients aged <70 and ≥70 years, respectively (p = 0.321). Median overall survival was 31.9 months (27.9-35.9) and 26.3 months (21.3-31.2), respectively (p = 0.044). Significantly more elderly patients started on a reduced dose of sunitinib or discontinued the treatment prior to progression because of adverse events. CONCLUSIONS: The differences in patient profile and dose-reduction rates point to a different approach in the management of older and younger patients in daily clinical practice. The lower dose intensity of sunitinib in the elderly population may have translated into inferior survival.

• MeSH
• Time-to-Treatment MeSH
• Indoles administration & dosage   adverse effects   therapeutic use   MeSH
• Carcinoma, Renal Cell drug therapy   pathology   MeSH
• Humans MeSH
• Neoplasm Metastasis MeSH
• Kidney Neoplasms drug therapy   pathology   MeSH
• Disease-Free Survival MeSH
• Disease Progression MeSH
• Antineoplastic Agents administration & dosage   adverse effects   therapeutic use   MeSH
• Pyrroles administration & dosage   adverse effects   therapeutic use   MeSH
• Registries MeSH
• Retrospective Studies MeSH
• Aged MeSH
• Sunitinib MeSH
• Age Factors MeSH
• Dose-Response Relationship, Drug MeSH
• Check Tag
• Humans MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Czech Republic MeSH
• Names of Substances
• Indoles MeSH
• Antineoplastic Agents MeSH
• Pyrroles MeSH
• Sunitinib MeSH

BACKGROUND: The study aimed to compare two prognostic models in terms of progression-free survival (PFS), median overall survival (OS), and 1-year survival in patients treated first-line with sunitinib for metastatic renal cell carcinoma (mRCC). METHODS: Data from patients who met prognostic model criteria for recording of baseline parameters and outcomes in the Czech Patient Registry RENal Information System (RENIS) were included in the retrospective analysis (n = 495). Performance of the modified Memorial Sloan Kettering Cancer Center (MSKCC) model and International Database Consortium (IDC) model was compared. PFS and OS were estimated using the Kaplan-Meier method. The statistical significance of differences in Kaplan-Meier estimates was assessed using the log-rank test. RESULTS: Median OS for prognostic groups according to MSKCC and IDC criteria, respectively, was 39.5 months (95 % confidence interval [CI]: 23.9-55.2) versus 44.3 months (95 % CI: 31.6-56.9) for favourable-risk patients (no adverse factors), 28.5 months (95 % CI: 20.1-36.8) versus 24.8 months (95 % CI: 19.8-29.8) for intermediate-risk patients (1-2 adverse factors), and 10.6 months (95 % CI: 6.3-14.8) versus 9.3 months (95 % CI: 5.1-13.5) for poor-risk patients (≥3 adverse factors). The majority of MSKCC poor-risk patients (54.1 %, n = 72) were reclassified as intermediate-risk using IDC criteria, and 20.2 % (n = 61) of MSKCC intermediate-risk patients were reclassified to the IDC favourable-risk group. CONCLUSIONS: Both prognostic models were validated in the present cohort. Use of the IDC model resulted in an upward shift in prognostic assessment compared to the MSKCC model.

• MeSH
• Adult MeSH
• Indoles therapeutic use   MeSH
• Carcinoma, Renal Cell drug therapy   pathology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Neoplasm Metastasis MeSH
• Kidney Neoplasms drug therapy   pathology   MeSH
• Disease-Free Survival MeSH
• Prognosis MeSH
• Antineoplastic Agents therapeutic use   MeSH
• Pyrroles therapeutic use   MeSH
• Registries MeSH
• Retrospective Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Models, Statistical * MeSH
• Sunitinib MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Comparative Study MeSH
• Names of Substances
• Indoles MeSH
• Antineoplastic Agents MeSH
• Pyrroles MeSH
• Sunitinib MeSH

The aim of this study was to describe the characteristics and outcomes of a large cohort of patients treated with sorafenib in clinical practice and to identify predictive factors associated with prognosis. Patient data were obtained from the national Czech registry (RenIS). Data of virtually all Czech patients receiving targeted therapies are entered into this non-interventional post-registration database. Demographics and clinical data, as well as all treatment sequences and clinical outcomes, are reported in this registry. A total of 836 patients treated with sorafenib before March 2013 were included in the analysis. Median age was 63 years and 70% were men. Most patients had received prior treatment with cytokines, sunitinib or both. Sorafenib was the first-line treatment in 15% of patients. Median overall survival and progression-free survival were 21.7 months and 7.5 months, respectively. Median overall survival and progression-free survival was 26.3 and 8.3 months, respectively, in patients receiving sorafenib as first-line therapy. Cox proportional models identified several parameters associated with poor outcome including time ≤1 year from diagnosis to first-line systemic treatment, performance status ≥2, low hemoglobin, and LDH >1.5 times the upper limit of normal. Our data demonstrate that the outcomes of real-life patients are comparable to those enrolled in clinical trials. Prognostic factors identified in the present study were consistent with previously reported models.

• MeSH
• Databases, Factual MeSH
• Adult MeSH
• Phenylurea Compounds therapeutic use   MeSH
• Kaplan-Meier Estimate MeSH
• Carcinoma, Renal Cell diagnosis   drug therapy   MeSH
• Middle Aged MeSH
• Humans MeSH
• Neoplasm Metastasis MeSH
• Young Adult MeSH
• Multivariate Analysis MeSH
• Kidney Neoplasms diagnosis   drug therapy   MeSH
• Niacinamide analogs & derivatives   therapeutic use   MeSH
• Disease-Free Survival MeSH
• Prognosis MeSH
• Proportional Hazards Models MeSH
• Antineoplastic Agents therapeutic use   MeSH
• Registries MeSH
• Retrospective Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Sorafenib MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Young Adult MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Czech Republic MeSH
• Names of Substances
• Phenylurea Compounds MeSH
• Niacinamide MeSH
• Antineoplastic Agents MeSH
• Sorafenib MeSH