Influence of access on survival of renal cancer in a Brazilian center.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 644-644
Author(s):  
Luciana de Moura Leite ◽  
Aldo A. Dettino ◽  
José Augusto Rinck ◽  
Stenio Cassio Zequi ◽  
Simone Loose ◽  
...  

644 Background: The introduction of tyrosine kinase inhibitors (TKI) and recently immunotherapy has brought major survival benefits for metastatic renal cancer (mRCC) patients (pts). In Brazil, there is no approved 2nd line treatment for mRCC in the Public Health System (PHS). Our center is unique, because it provides care for both PHS and Private System (PrS) population, enabling us to make the comparison of overall survival (OS) of these pts. Methods: We retrospectively reviewed medical records of all mRCC pts treated with 1st line TKI at our service from 2007 to 2018. Categorial variables were compared by Fisher’s exact test and continuous by Mann–Whitney. Survival was estimated by Kaplan-Maier method, prognostic factors adjusted by Cox regression model. Results: 171 pts were eligible, 37 (21.6%) PHS and 134 (78.4%) PrS pts. Between the two groups, there was no differences in age, gender, number and sites of metastasis (mets). PHS pts had worst ECOG (≥2, in 35.1 vs 13.5%, p .007), a trend towards more poor IMDC risk (IMDC favorable 16.2 vs 26.6%, intermediate 51.4 vs 57%, poor 32.4 vs 16.4%, p.09), had less nephrectomies (73 vs 92.5%, p.008) and more non clear cell histology (32.4 vs 12.7%, p.01). Median lines of therapy were 1 for PHS vs 2 for PrS pts (p.03). Sunitinib was the 1st line agent for 91.9 vs 67.2%, and pazopanib 8.1 vs 29.9%, of the PHS and PrS pts, respectively. Median time from diagnosis of mets to treatment start was 2.29 vs 1.79 m (p.59). Median OS was 16.5 vs 26.5 m (p.0002) and progression free survival, 8.4 vs 11 m (p.01), for the PHS vs PrS. On multivariate analysis, after adjusting for factors that were present before the beginning of treatment and were statistically significant for OS in the univariate model, PHS pts still had higher risk of death (HR 1.85, IC 95 1.2-2.9, p.01), probably due to having received fewer lines of therapy (≥2 lines of therapy vs 1, HR 0.51, IC95 0.4-0.7, p .001). Conclusions: Brazilian PHS pts had significant worse OS compared to PrS pts, in part due to less access to drugs. Access to cancer drugs is a challenge worldwide, and in Brazil effort has to be done to change this reality.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 588-588 ◽  
Author(s):  
Luciana de Moura Leite ◽  
Jose A. Rinck ◽  
Aldo A. Dettino ◽  
Stenio Cassio Zequi ◽  
Alexandre Andre B. A. Da Costa ◽  
...  

588 Background: Data on 1st line treatment with tyrosine kinase inhibitors (TKI) in elderly patients(pts) with metastatic renal cell carcinoma (mRCC) is controversial, and there is rationale for inferior outcomes due to multiple comorbidities and polypharmacy. We aimed to compare the efficacy and safety between the elderly (E) and non-elderly (NE) in 1st line therapy, and to explore factors influencing survival and toxicity. Methods: We retrospectively reviewed all medical records of mRCC pts treated with 1st line TKI at our institution (2007 – 2018). Categorial variables were compared by Fisher’s exact test and continuous, Mann–Whitney. Survival was estimated by Kaplan-Maier method, prognostic factors adjusted by Cox regression model. Results: From 171 eligible pts, 64 (37.4%) had ≥ 65years old, with median age of 70.5 for E and 56 for NE. In both groups most were male, had clear cell histology, good/intermediate IMDC risk, prior nephrectomy and > 1 metastatic (mets) site. Sites of mets were evenly distributed. E pts had more diabetes (35.9 vs16.8%, p.009) , hypertension (67.2 vs 46.7%, p.01), cardiovascular disease (15.6 vs 6.5%, p.06), moderate/severe renal dysfunction (62.5 vs 28.8%, p < 0001), high Charlson Comorbidities Index (CCI≥3, 48.4% vs 20.8%, p < .0001), polypharmacy (34.4 vs15.9%, p.008), worst ECOG (≥2, 28.2 vs 12.3%, p.01), and a trend to worst nutrition (weight loss 35.9 vs 22.5%, p.07). Sunitinib was used for 60.9 vs 79.4%, Pazopanib 35.9 vs 18.7%, Sorafenib 3.1 vs 1.9%, comparing E and NE pts. Median overall survival (OS) and progression free survival (PFS) was 23.7 vs 25.6m (p.8) and 9.3 vs 10.9m (p.7), respectively. After adjusting for prognostic factors, age continues not to influence OS (HR 1.17, IC95 0.77-1.78, p.45). Grade (G) 3/4 toxicity was seen in 59.4 vs 53.3%, dose reduction in 54.7 vs 53.3% and suspension due to toxicity 25 vs 13.3% for E and NE, respectively. In the E, none of the comorbidities, CCI or polypharmacy impaired OS or toxicity, but pts using sunitinibe had greater G3/4 toxicity than with pazopanib (71.8 vs 39.1%, p.02). Conclusions: Elderly had similar outcomes to NE pts, despite greater comorbidities and polypharmacy, hence efficacious therapies shouldn’t avoided. Pazopanib seems to be safer in this subgroup.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 379-379
Author(s):  
L. Riesenbeck ◽  
S. Bierer ◽  
I. Hoffmeister ◽  
T. Koepke ◽  
L. Hertle ◽  
...  

379 Background: To investigate prognostic markers in patients with metastatic renal cell carcinoma (mRCC) undergoing treatment with the tyrosine kinase inhibitors (TKIs) sorafenib (So) or sunitinib (Su). Methods: Eighty-three patients with mRCC, who were treated at our institution between 2006 and 2009, were evaluated prospectively. Clinical and laboratory parameters were investigated, as well as, treatment-related adverse events. Subclinical hypothyroidism was characterized by serum TSH above the upper limit of normal and both total triiodtyronine (T3) and thyroxine (T4) within normal limits. Clinical hypothyroidism was defined as low serum T3 and T4 together with elevated TSH. Results: Thirty-one (37.3%) patients received So, and 52 (62.7%) were treated with Su. In univariate analyses, a poor ECOG status was associated with an unfavorable progression-free survival (PFS) (p<0.0001); similarly high risk MSKCC criteria correlated with a worse PFS (p=0.003). Furthermore, response to therapy was a surrogate parameter (p<0.0001). Twenty-one of 66 (31.8%) patients developed hypothyroidism during treatment, which was associated with a positive prognosis (p=0.032). In multivariate analyses, only the ECOG status (ECOG 0/1 vs. ECOG 2, p=0.018) and hypothyroidism (p=0.01) were independent prognostic parameters. Conclusions: The development of hypothyroidism during treatment might be useful as a clinical predictor of PFS for mRCC patients undergoing treatment with targeted agents. No significant financial relationships to disclose.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16117-e16117
Author(s):  
Rixci Ramirez ◽  
Daniel Estuardo Rosales Lopez ◽  
Francisco Godinez Jerez ◽  
Alfredo Mansilla ◽  
Carolina Camey ◽  
...  

e16117 Background: Lymphopenia is associated with toxicity and clinical outcomes in several types of cancer. Decrease in absolute lymphocyte count (ALC) has been observed in the treatment with sunitinib. Objective: characterize lymphopenia ( < 1000/µL) associated with tyrosine kinase inhibitors in patients with metastatic renal cell carcinoma (mRCC) and its relation to progression free survival (PFS). Methods: A retrospective review of the charts was performed in patients with sunitinib and/or sorafenib between April 2000 and May 2017 in Guatemalan Social Security Institute (IGSS). The Kaplan-Meier models, the Cox regression and the log-rank test are within the groups for progression-free survival. Results: Eighty-nine patients were analyzed, 56 men and 33 women. The age groups < 50 from 51 to 75 and > 75 being these 19, 34 and 34 respectively. Regarding treatment received 56 patients received sunitinib and 47 sorafenib. Lymphopenia was found in 55% and 8% of the treated with sunitinib and sorafenib, respectively (p < 0.001). Focusing on patients treated with sunitinib for all subsequent analyzes, the median PFS was 11 months (95% CI, 6-19). The median PFS was 21 months (95% CI, 11-25) for patients who will not develop lymphopenia compared to 4 months (95% CI, 3-8) in patients with lymphopenia (p = 0, 0001). Conclusions: Lymphopenia related to sunitinib is associated with a decrease in PFS in mRCC. The decrease in lymphocytes can be used as a prognostic biomarker for patients treated with sunitinib in this context. [Table: see text]


2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi225-vi226
Author(s):  
Simone Frandsen ◽  
Helle Broholm ◽  
Vibeke A Larsen ◽  
Kirsten Grunnet ◽  
Søren Møller ◽  
...  

Abstract INTRODUCTION Gliosarcoma (GS) is a rare histopathologic variant of glioblastoma (GBM) characterized by a biphasic growth pattern consisting of both glial and sarcomatous components. Reports regarding its relative prognosis compared to conventional GBM are conflicting and although GS is treated as conventional GBM, supporting evidence is lacking. The aim of this study was to characterize demographic trends, clinical outcomes and prognostic variables of GS patients receiving standardized therapy and compare these to conventional GBM. METHODS 680 GBM patients, treated with maximal safe resection followed by Stupp’s regimen (radiotherapy with concomitant and adjuvant temozolomide) at a single institution, were retrospective reevaluated by reviewing histopathological records and tumor tissue for identification of GS patients. Clinicohistopathological characteristics obtained via assessment of medical records and imaging analysis were compared between the GS and GBM cohorts. Kaplan-Meier survival estimates were compared with log-rank testing, while cox-regression modeling tested for prognostic factors in GS patients. RESULTS The cohort revealed 26 primary gliosarcoma (PGS) patients (3.8 %) and 7 secondary gliosarcoma (SGS) patients (1.0 %). Compared to conventional GBM tumors, PGS tumors were significantly more often located in the temporal lobe (53.8 %, p = 0.006) and MGMT-unmethylated (73.9 %, p = 0.009). No significant differences were found between PGS and conventional GBM in progression-free-survival (6.8 and 7.6 months respectively, p = 0.105) and in overall survival (13.4 and 15.7 months respectively, p = 0.201). Also, survival from recurrence was not significant different between PGS, SGS and GBM (5.8, 8.6 and 7.4 months respectively, p = 0.694). MGMT status was the only factor prognostic for PGS survival (p = 0.022). CONCLUSION Despite tumor difference between GS and GBM, the patients present similar survival outcome from standardized treatment. This support continues practice of radiation and temozolomide for GS patients.


2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
D. Milonas ◽  
G. Smailyte ◽  
M. Jievaltas

Aim. The aim of this study is to present the oncologic outcomes and to determine the prognostic factors of overall survival (OS), cancer-specific survival (CSS), disease-progression-free survival (DPFS), and biochemical-progression-free survival (BPFS) after surgery for pT3 prostate cancer (PCa).Methods. Between 2002 and 2007, a pT3 stage after radical prostatectomy was detected in 182 patients at our institution. The Kaplan-Meier analysis was used to calculate OS, CSS, DPFS, and BPFS. Cox regression was used to identify predictive factors of survival.Results. pT3a was detected in 126 (69%) and pT3b in 56 (31%) of cases. Five-year OS, CSS, DPFS, and BPFS rates were 90.7%, 94%, 91.8%, and 48.4%, respectively. Survival was significantly different when comparing pT3a to pT3b groups. The 5-year OS, CSS, DPFS, and BPFS were 96% versus 72%, 98% versus 77%, 97.3% versus 79.3%, and 60% versus 24.2%, respectively. Specimen Gleason score was the most significant predictor of OS, CSS, DPFS, and BPFS. The risk of death increased up to 3-fold when a Gleason score 8–10 was present at the final pathology.Conclusions. Radical prostatectomy may offer very good CSS, OS, DPFS, and BPFS rates in pT3a PCa. However, outcomes in patients with pT3b or specimen Gleason ≥8 were significantly worse, suggesting the need for multimodality treatment in those cases.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 401-401
Author(s):  
I. Hoffmeister ◽  
L. Riesenbeck ◽  
S. Bierer ◽  
T. Koepke ◽  
L. Hertle ◽  
...  

401 Background: To validate the Memorial Sloan-Kettering Cancer Center (MSKCC) criteria as a prognostic factor in patients with metastatic renal cell carcinoma (mRCC) treated with the tyrosine kinase inhibitors (TKIs) sorafenib (So) or sunitinib (Su). Methods: Clinical and laboratory parameters from 83 patients with mRCC were investigated. All patients were treated at our institution between 2006 and 2009. Specifically, the MSKCC criteria (Karnofsky performance status <80%, time between diagnosis and treatment < 1 year, baseline anemia, elevated LDH > 1.5 times upper limit of normal, and elevated serum calcium) were evaluated as surrogate parameters for progression-free survival (PFS). Results: 34 (41.0%) patients were treated as first-line, and 49 (59.0%) patients were treated as second-line treatments, respectively. In univariate analyses, a poor ECOG status was associated with an unfavorable progression-free survival (p<0.0001); similarly high risk MSKCC criteria correlated with a worse PFS (p=0.003). Furthermore, response to therapy was a surrogate parameter (p<0.0001). Albeit statistically not significant, prior nephrectomy (p=0.056), histologic subtype (p=0.052) as well as baseline anemia (p=0.079) tended to be associated with PFS. In multivariate analyses, only the ECOG status (ECOG 0/1 vs. ECOG 2, p=0.001) and best treatment response (p<0.001) were independent prognostic markers, but not MSKCC criteria. Conclusions: In this patient cohort, MSKCC criteria did not show prognostic relevance in terms of PFS. The role of risk group stratification according to MSKCC in patients with mRCC and treatment with TKIs must be questioned. No significant financial relationships to disclose.


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 536-536
Author(s):  
Paolo Grassi ◽  
Elena Verzoni ◽  
Luca Porcu ◽  
Isabella Testa ◽  
Roberto Iacovelli ◽  
...  

536 Background: The predictive role of metastatic sites in RCC pts treated with tyrosine kinase inhibitors (TKIs) is unclear. Aim of this study was to investigate whether first line SU and SO was associated to metastatic sites in terms of progression-free survival (PFS) and overall survival (OS). Methods: A retrospective cohort of consecutive metastatic RCC (mRCC) pts treated with TKIs at Istituto Nazionale Tumori of Milan was analyzed. All pts received at least one targeted therapy including: SO, SU, bevacizumab plus interferon-alfa, pazopanib or temsirolimus. The product limit method was used to estimate survival functions and Cox regression to estimate hazard ratios (HRs) and to test statistical interaction between sub-groups identified by different metastatic sites. Results: 358 mRCC pts receiving first line TKIs between January 2005 and October 2012 were evaluated. Overall 206 pts (58%) received SO while 103 pts (29%) SU. Median duration of treatment for SU and SO groups was 16 (95%CI 12.0-20.1) and 9 months (mo) respectively (95%CI 7.0-12.0). After a median follow-up of 56.1 mo (range: 1.0-93.2) median OS for SO group was 19.9 mo (95%CI 16.0-25.1) while OS for SU group was not yet defined. Noteworthy 142 pts (69%) treated with SO received SU at disease progression (PD) while 36 pts (35%) received SO at SU failure. A statistically significant interaction between first line treatment and metastatic sites was found for the liver site in terms of PFS and OS (PFS p=0.034; OS p=0.004). SU was associated with a 18% [95%CI (-37%)- 123%] higher risk of PD as compared to SO in pts with liver mets while pts without liver mets showed a 46% [95%CI (-61%)-(-24%)] decreased risk of PD as compared to SO. SU was associated with a 40% [95%CI (-32%)-187%] higher risk of death as compared to SO in pts with liver mets while pts without liver mets showed a 62% [95%CI (-76%)-(-40%)] decreased risk of death as compared to SO. The predictive role of liver mets was confirmed introducing the Motzer score (PFS p=0.084; OS p=0.009). Conclusions: mRCC pts with liver mets treated with first line SO showed a better outcome as compared to SU while pts without liver mets treated with first line SO showed a worse outcome as compared to SU.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5016-5016
Author(s):  
Enrique Grande ◽  
Albert Font Pous ◽  
Natalia Fernández Núñez ◽  
Aranzazu Gonzalez del Alba ◽  
Begoña Mellado ◽  
...  

5016 Background: Building on previous discoveries studying AR status in plasma (Carreira S, Sci Transl Med 2014, Romanel A, Sci Transl Med 2015) and following a road-map for biomarker development, we aimed to clinically qualify AR status in chemotherapy-naïve mCRPC using an optimized multiplex droplet digital PCR (ddPCR) assay (Condeduca et al.;ASCO2017;Abstract#). Methods: Between February and November 2015, 98 asymptomatic or oligo-symptomatic chemotherapy-naïve mCRPC patients were recruited in 16 Spanish hospitals. Tissue and blood samples were required at study entry. Although initially designed to study the predictive value of TMPRSS2-ETS, data emerging after the trial was initiated led the group to prioritize alternative predefined exploratory biomarkers, including plasma ARand CTC characterization (Grande E. ESMO 2016 & Font A. et al; ASCO2017; Abstract #). Outcome measures included PSA-progression-free survival (sPFS), radiographic progression-free survival (rPFS) and overall survival (OS). Cox regression was used for survival analyses and Fisher’s exact test for PSA response. Results: Ninety-four patients had plasma DNA available for analysis. At baseline, AR gain was present in 11 pts (12%) and CTCs in 35 (37%). AR gain in CTC-positive and negative patients was 20% and 7%, respectively. At first interim analysis and with a median follow-up of 10.6 months, detection of AR gain was associated with worse sPFS (median, 3.60 versus 15.5 m, HR, 4.33; 95% CI 1.94-9.68; P < 0.001), rPFS (median, 3.90 m versus not reached HR, 8.06; 95% CI, 3.26-19.93; P < 0.001) and OS (medians not reached, HR, 11.08; 95% CI, 2.16-56.95; P = 0.004). These results were independently associated in multivariate analysis including cfDNA and CTCs for all described endpoints. AR gain patients were less likely to have a ≥50% decline in PSA (OR, 4.93; 95% CI, 1.30-18.75; P = 0.025). Conclusions: Detection of AR gain in plasma using a robust multiplex ddPCR method predicts an adverse outcome in chemotherapy-naïve mCRPC. Further prospective randomized studies are warranted. Clinical trial information: NCT02288936.


Sign in / Sign up

Export Citation Format

Share Document