Comprehensive geriatric assessment is an independent prognostic factor in older patients with metastatic renal cell cancer treated with first-line Sunitinib or Pazopanib: a single center experience

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 < 0.001), ECOG PS 0 (P < 0.001), age (<75 years, P = 0.005), surgery (P < 0.001) and response to pazopanib (P < 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.

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Phase Ii Study of Individualized Sunitinib As First-Line Therapy for Metastatic Clear Cell Renal Cell Cancer (Mrcc)

Annals of Oncology ◽

10.1093/annonc/mdu337.32 ◽

2014 ◽

Vol 25 ◽

pp. iv292 ◽

Cited By ~ 2

Author(s):

G.A. Bjarnason ◽

B. Naveen ◽

E. Winquist ◽

C.K. Kollmannsberger ◽

C. Canil ◽

...

Keyword(s):

Phase Ii ◽

Renal Cell Cancer ◽

Renal Cell ◽

Clear Cell ◽

Phase Ii Study ◽

Cell Cancer ◽

First Line ◽

First Line Therapy ◽

Line Therapy

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

Annals of Oncology ◽

10.1093/annonc/mdx371.054 ◽

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

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

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e15615 ◽

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.

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

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.15_suppl.4555 ◽

2015 ◽

Vol 33 (15_suppl) ◽

pp. 4555-4555 ◽

Cited By ~ 3

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

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Does the time before starting first-line treatment influences the survival of patients with metastatic renal cell cancer in favorable-risk groups?

European Urology ◽

10.1016/s0302-2838(21)01014-9 ◽

2021 ◽

Vol 79 ◽

pp. S875

Author(s):

C. Rolley ◽

M. Cruz ◽

F.X. Nouhaud ◽

A. Villiers ◽

K. Bensalah ◽

...

Keyword(s):

Renal Cell Cancer ◽

Renal Cell ◽

Cell Cancer ◽

Risk Groups ◽

Line Treatment ◽

First Line ◽

Metastatic Renal Cell Cancer ◽

First Line Treatment

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

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.2_suppl.547 ◽

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]

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