Lymphopenia and clinical outcome of elderly patients treated with sunitinib for metastatic renal cell cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15615-e15615
Author(s):  
Ugo De Giorgi ◽  
Karim Rihawi ◽  
Michele Aieta ◽  
Giovanni Lo Re ◽  
Teodoro Sava ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Elderly Patients ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Performance Status ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Metastatic Renal Cell Cancer ◽  
Grade 3

e15615 Background: Lymphopenia is associated with toxicity and outcome in several cancer types. We assessed the association of pre-treatment lymphopenia with toxicity and clinical outcome of elderly patients with metastatic renal cell cancer treated with first-line sunitinib. We evaluated the prognostic factors in these patients. Methods: We reviewed the clinical files of 181 patients aged >70 years with mRCC treated with first-line sunitinib in seventeen Italian Oncology Units from February 2006 to September 2011. Baseline lymphopenia was defined as lymphocyte counts <1,000/µL. Results: Twenty–nine patients (16.0%) had a baseline lymphocyte counts <1,000/µL, and 152 (84%) ≥1,000/µL. No difference between the two groups was reported in overall response rate (p = 0.207), dose reductions (p = 0.740); discontinuations due to adverse events (p = 0.175), overall incidence of grade 3-4 toxicities (p = 0.112) even if more patients in the group with lymphopenia had grade 3-4 neutropenia (p = 0.017), grade 3-4 thrombocytopenia (p = 0.017) and grade 3-4 diarrhea (p = 0.006). In multivariate analysis, performance status and Heng score were predictors of progression-free survival (p = 0.015 and p = 0.0006, respectively), while performance status, Heng score, and lymphopenia were found to be significantly associated with overall survival (p = 0.007, p < 0.0001 and p = 0.023, respectively). Conclusions: Sunitinib appeared safe and active in elderly patients with lymphopenia. Lymphocyte counts is an independent prognostic factor for OS in elderly patients with mRCC treated with first-line sunitinib.

An Italian, multicenter, real-world, retrospective study of first-line pazopanib in unselected metastatic renal-cell carcinoma patients: the ‘Pamerit’ study

2020 ◽  
Author(s):  
Alessandra Mosca ◽  
Ugo De Giorgi ◽  
Giuseppe Procopio ◽  
Umberto Basso ◽  
Giacomo Cartenì ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Renal Cell Cancer ◽  
Real World ◽  
Renal Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival ◽  
Metastatic Renal Cell Cancer ◽  
Metastatic Rcc

Abstract Objective Despite the current immunotherapy era, VEGFR inhibitors maintain effectiveness in metastatic renal cell cancer. Real-world data concerning pazopanib are limited. The aim of this study is to add information about efficacy and safety of pazopanib as first-line treatment in metastatic renal cell cancer patients not enrolled into clinical trials. Methods Retrospective analysis (the PAMERIT study) of first-line pazopanib in real-world metastatic renal cell cancer patients among 39 Centers in Italy. Outcomes were progression-free survival, overall survival, objective response rate and treatment-related adverse events. Kaplan–Meier curves, log-rank test and multivariable Cox’s models were used and adjusted for age, histology, previous renal surgery, International Metastatic RCC Database Consortium score and pazopanib initial dose. Results Among 474 patients, 87.3% had clear cell metastatic renal cell cancer histology. Most of them (84.6%) had upfront renal surgery. Median progression-free survival and overall survival were 15.8 and 34.4 months, respectively, significantly correlating with International Metastatic RCC Database Consortium’s good prognosis (P &lt; 0.001), ECOG PS 0 (P &lt; 0.001), age (&lt;75 years, P = 0.005), surgery (P &lt; 0.001) and response to pazopanib (P &lt; 0.001). After 3 months of pazopanib, overall disease control rate have been observed in 76.6% patients. Among International Metastatic RCC Database Consortium’s favorable group patients, 57/121 (47%) showed complete/partial response. No unexpected AEs emerged. Conclusions In this real-world study, metastatic renal cell cancer patients treated with first-line pazopanib reached greater progression-free survival and overall survival than in pivotal studies and had high response rates when belonging to International Metastatic RCC Database Consortium’s favorable group, without new toxicities. Pazopanib has been confirmed a valid first-line option for International Metastatic RCC Database Consortium’s good prognosis metastatic renal cell cancer patients who cannot be submitted to immunotherapy.

Systemic immune-inflammation index to predict the clinical outcome in patients with metastatic renal cell cancer treated with sunitinib.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 547-547
Author(s):  
Cristian Lolli ◽  
Marco Maruzzo ◽  
Lisa Derosa ◽  
Teodoro Sava ◽  
Matteo Santoni ◽  
...  
Keyword(s):  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cox Regression ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Bioinformatic Analysis ◽  
First Line ◽  
Logrank Test ◽  
Metastatic Renal Cell Cancer ◽  
The Impact

547 Background: A systemic immune-inflammatory index (SII) based on lymphocyte (L), neutrophil (N), and platelet (P) counts has been recently developed. In this retrospective analysis, we explored its prognostic and predictive value at baseline and changes at week 6 during first-line sunitinib in patients (pts) with metastatic renal cell cancer (mRCC). Methods: We included 335 consecutive pts mRCC treated with first-line sunitinib for which P,N, and L data were available at start of therapy, and 6 weeks thereafter. The SII was defined as follows: SII = P x N/L. The X-tile 3.6.1 software (Yale University, New Haven, CT) was used for bioinformatic analysis of the baseline data to determine the cutoff value of SII. Progression-free survival (PFS), overall survival (OS) and their 95% confidence interval (95% CI) were estimated by Kaplan-Meier method and compared with logrank test. The impact of SII conversion on PFS and OS was evaluated by Cox regression analyses. Results: An optimal cutoff point for the SII of 730 x 109stratified these pts into high (≥ 730) and low SII (<730) groups. Median age was 63 years (range, 27 to 88); histotype clear cell carcinoma was reported in 94% of cases; 29.6%, 59.4% and 11% were classified in the favorable, intermediate and poor Motzer prognostic groups, respectively. The median PFS was 6.2 months (mo) (95% CI=5.5-9.5) in pts with baseline SII ≥730 and 17.7 mo (14.3-21.8) in those with SII <730, P<0.0001. The median OS was 13.7 mo (95% CI=9.6-20.3) in pts with baseline SII ≥730 and 41.8 mo (95% CI=34.5-51.8) in those with baseline SII <730, P<0.0001. Data for SII at baseline and change in SII by week 6 using a cut-off of 730 are shown in the table. Conclusions: The SII is a powerful prognostic and predictive indicator of poor outcome in pts with mRCC. A validation study from prospective data is warranted. [Table: see text]

Lymphopenia and clinical outcome of elderly patients treated with sunitinib for metastatic renal cell cancer

2014 ◽  
Vol 5 (2) ◽  
pp. 156-163 ◽  
Author(s):  
Ugo De Giorgi ◽  
Karim Rihawi ◽  
Michele Aieta ◽  
Giovanni Lo Re ◽  
Teodoro Sava ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Elderly Patients ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cell Cancer ◽  
Metastatic Renal Cell Cancer

Toxicities of axitinib, sunitinib and temsirolimus: implications for progression-free and overall survival in metastatic renal cell cancer

2020 ◽  
Author(s):  
Annemarie Uhlig ◽  
Johannes Uhlig ◽  
Lutz Trojan ◽  
Michael Woike ◽  
Marianne Leitsmann ◽  
...  
Keyword(s):  
Overall Survival ◽  
Cancer Patients ◽  
Skin Reaction ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Cox Models ◽  
Metastatic Renal Cell Cancer ◽  
Hand Foot Skin Reaction

The aim of this study was to evaluate the association between axitinib, sunitinib and temsirolimus toxicities and patient survival in metastatic renal cell cancer patients. Overall survival (OS) and progression-free survival (PFS) of metastatic renal cell cancer patients from the prospective multicenter STAR-TOR study were assessed using multivariable Cox models. A total of 1195 patients were included (n = 149 axitinib; n = 546 sunitinib; n = 500 temsirolimus). The following toxicities significantly predicted outcomes: hand–foot skin reaction (hazard ratio [HR] = 0.29) for PFS with axitinib; stomatitis (HR = 0.62) and pneumonitis (HR = 0.23) for PFS with temsirolimus; stomatitis (HR = 0.52) and thrombocytopenia (HR = 0.6) for OS with temsirolimus; fatigue (HR = 0.71) for PFS with sunitinib; hand–foot skin reaction (HR = 0.56) and fatigue (HR = 0.58) for OS with sunitinib. In conclusion, in metastatic renal cell cancer, axitinib, sunitinib and temsirolimus demonstrate specific toxicities that are protective OS/PFS predictors.

scholarly journals Phase II study of individualized sunitinib (SUN) as first-line therapy for metastatic renal cell cancer: Pharmacokinetic data

2017 ◽  
Vol 28 ◽  
pp. v319
Author(s):  
G.A. Bjarnason ◽  
J. Knox ◽  
C.K. Kollmannsberger ◽  
D. Soulieres ◽  
D.S. Ernst ◽  
...  
Keyword(s):  
Phase Ii ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Phase Ii Study ◽  
Cell Cancer ◽  
Pharmacokinetic Data ◽  
First Line ◽  
Metastatic Renal Cell Cancer ◽  
First Line Therapy ◽  
Line Therapy

Phase II study of individualized sunitinib as first-line therapy for metastatic renal cell cancer (mRCC).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 4555-4555 ◽  
Author(s):  
Georg A. Bjarnason ◽  
Jennifer J. Knox ◽  
Christian K. Kollmannsberger ◽  
Denis Soulieres ◽  
D. Scott Ernst ◽  
...  
Keyword(s):  
Phase Ii ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Phase Ii Study ◽  
Cell Cancer ◽  
First Line ◽  
Metastatic Renal Cell Cancer ◽  
First Line Therapy ◽  
Line Therapy

Clinical outcomes model in renal cell cancer patients treated with modified vaccinia Ankara plus tumor-associated antigen 5T4

2015 ◽  
Vol 30 (1) ◽  
pp. 111-121 ◽  
Author(s):  
Robert J. Amato ◽  
Youxin Xiong ◽  
Hui Peng ◽  
Virginia Mohlere
Keyword(s):  
Renal Cell Cancer ◽  
Renal Cell ◽  
Kinase Inhibitors ◽  
Performance Status ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Elispot Response ◽  
Ecog Performance Status ◽  
Fuhrman Grade ◽  
Phase Ii Studies

Aims We developed an outcomes model to select patients for renal cell cancer vaccine immunotherapy. Materials and methods We examined clinical data from 2 phase II studies of modified vaccinia Ankara as vector to express 5T4 (MVA-5T4), calculated progression-free survival (PFS) and overall survival (OS), and created risk groups based on the number of factors involved. Results Median OS was 12.4 months; median PFS was 3.6 months. Significant factors (p<0.05) included neutrophils (both), bone metastases (OS), ECOG performance status (OS), lactate dehydrogenase levels (both), prior therapy with tyrosine kinase inhibitors plus immunotherapy (OS), Fuhrman grade (OS), and 5T4-specific ELISPOT response (PFS). By group, median OS was not reached in patients with favorable risk (censored at cutoff), was 13.7 months in those with intermediate risk and 4.0 months in those with poor risk. Conclusions Further validation of this model will identify the patients most likely to respond to MVA-5T4 and provide a framework for outcomes models for other vaccine therapies.

Choi response criteria for prediction of clinical outcome in patients with metastatic renal cell cancer treated with sunitinib

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5044-5044
Author(s):  
A. van der Veldt ◽  
M. R. Meijerink ◽  
A. J. van den Eertwegh ◽  
J. B. Haanen ◽  
E. Boven
Keyword(s):  
Clinical Outcome ◽  
Renal Cell Cancer ◽  
Clinical Benefit ◽  
Predictive Value ◽  
Renal Cell ◽  
Cell Cancer ◽  
Ct Scans ◽  
Metastatic Renal Cell Cancer ◽  
Contrast Enhanced Ct ◽  
Choi Criteria

5044 Background: Sunitinib (SU) has been approved for the treatment of metastatic renal cell cancer (mRCC). Since SU can induce extensive necrosis, RECIST may be inappropriate for tumor response evaluation. We evaluated whether the new Choi criteria (J Clin Oncol. 2007;25:1753–1759) are of additional value to predict outcome in mRCC patients (pts) treated with SU. Methods: 56 mRCC pts treated with SU were included. Imaging data consisted of thoracic and abdominal helical CT scans at baseline, after a median of 2 months and were repeated during treatment. For Choi criteria the longest diameter was ≥15 mm. Density of these lesions was determined in Hounsfield units. According to Choi criteria partial response (PR) was defined as ≥10% decrease in size or ≥15% decrease in density, while progressive disease (PD) was defined as ≥10% increase in size without meeting PR criteria by density. Progression-free survival (PFS) and overall survival (OS) were calculated according to Kaplan-Meier. Log rank test was used to test the statistical difference between survival curves. Results: For RECIST and Choi criteria, respectively, 230 and 156 tumor lesions were eligible. At first evaluation, according to RECIST 7 pts had PR, 39 stable disease (SD), and 10 PD, while according to Choi criteria 33 pts had PR, 8 SD and 15 PD. The median tumor density decreased significantly (Wilcoxon Signed Ranks test, p ≤ 0.001). At first evaluation in patients with PR, Choi criteria had a significantly better predictive value for PFS and OS (p < 0.001 and p < 0.001, respectively) than RECIST (p = 0.384 and p = 0.392, respectively). When best response during treatment was analyzed according to RECIST, the predictive value of RECIST increased for both PFS and OS (p = 0.004 and p = 0.002, respectively). For clinical benefit (PR+SD), the predictive value of RECIST and Choi criteria for PFS and OS were comparable (both p < 0.001). Conclusions: Choi criteria can be easily applied on contrast-enhanced CT scans. RECIST and Choi criteria have similar predictive value for outcome in pts with clinical benefit. Choi criteria, however, are more useful to early define a large pt population with favourable clinical outcome. [Table: see text]

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