scholarly journals MP21-10 A URINARY PROTEOMICS ANALYSIS OF PATIENTS TREATED WITH NEOADJUVANT AXITINIB FOR NON-METASTATIC CLEAR-CELL RENAL-CELL CARCINOMA: ANALYSIS FROM A PHASE II TRIAL

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Andrew McIntosh* ◽  
Hong Wang ◽  
Eric Umbreit ◽  
Chalairat Suk-Ouichai ◽  
Graciela Nogueras Gonzalez ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Trial ◽  
Proteomics Analysis ◽  
Cell Renal Cell Carcinoma ◽  
Urinary Proteomics

Phase II trial of neoadjuvant axitinib in patients with locally advanced nonmetastatic clear cell renal cell carcinoma.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 441-441
Author(s):  
Jose A. Karam ◽  
Catherine E Devine ◽  
Diana L Urbauer ◽  
Marisa Lozano ◽  
Kamran Ahrar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Cell Renal Cell Carcinoma

441^ Background: Previous studies have shown minimal impact of tyrosine kinase inhibitors on primary renal tumors. In this phase II trial, we investigate the safety and role of the axitinib in downsizing tumors in patients with non-metastatic clear cell renal cell carcinoma (RCC) prior to surgical resection. Methods: Patients with clinical stage T2-T3b N0 M0 biopsy-proven RCC were eligible for this study. Patients received axitinib daily for 12 weeks prior to surgery. The primary outcome was objective response rate. Secondary outcomes included safety, tolerability, feasibility of administration of axitinib and quality of life (using FKSI-15). A dedicated radiologist independently reviewed all CT scans to evaluate for response using RECIST. Results: Twenty-four patients were treated between 2011 and 2013. All patients had biopsy-proven clear cell RCC. Twenty-three patients continued axitinib for 12 weeks, and underwent surgery as planned without delay. One patient stopped treatment before 12 weeks due to adverse events (AEs) and was taken to surgery early. Median reduction of primary renal tumor size was 28.3% (range 5.3-42.9%). Eleven patients (45.8%) experienced a partial response by RECIST, and 13 patients had stable disease. There was no progression of disease while on axitinib. The most common AEs were hypertension, fatigue, oral mucositis, hypothyroidism, and hand-foot syndrome. No grade 4 AEs were observed. Intraoperatively, no complications or unusual bleeding were encountered. Postoperatively, 2 grade 3 and 13 grade 2 complications were noted, while no grade 4 or 5 complications occurred. FKSI-15 did change over time (p < 0.0001), with quality of life worsening in comparison to the screening assessment by week 7 (p = 0.0004). However, by week 19, quality of life was not found to be statistically different from screening (p = 0.3344). Conclusions: Axitinib was clinically active and well tolerated in the neoadjuvant setting in patients with locally advanced non-metastatic ccRCC. Clinical trial information: NCT01263769.

scholarly journals Phase II trial of sunitinib in patients with metastatic non-clear cell renal cell carcinoma

2010 ◽  
Vol 30 (1) ◽  
pp. 335-340 ◽  
Author(s):  
Ana M. Molina ◽  
Darren R. Feldman ◽  
Michelle S. Ginsberg ◽  
Glenn Kroog ◽  
Satish K. Tickoo ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Trial ◽  
Cell Renal Cell Carcinoma

A phase II trial of 17-(Allylamino)-17-demethoxygeldanamycin in patients with papillary and clear cell renal cell carcinoma

2006 ◽  
Vol 24 (6) ◽  
pp. 543-546 ◽  
Author(s):  
Ellen A. Ronnen ◽  
G. Varuni Kondagunta ◽  
Nicole Ishill ◽  
Suzanne M. Sweeney ◽  
John K. DeLuca ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Trial ◽  
Cell Renal Cell Carcinoma

scholarly journals Phase II Trial and Correlative Genomic Analysis of Everolimus Plus Bevacizumab in Advanced Non–Clear Cell Renal Cell Carcinoma

2016 ◽  
Vol 34 (32) ◽  
pp. 3846-3853 ◽  
Author(s):  
Martin H. Voss ◽  
Ana M. Molina ◽  
Ying-Bei Chen ◽  
Kaitlin M. Woo ◽  
Joshua L. Chaim ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Trial ◽  
Single Agent ◽  
Genetic Alterations ◽  
Cell Renal Cell Carcinoma

Purpose The decreased effectiveness of single-agent targeted therapies in advanced non–clear cell renal cell carcinoma (ncRCC) compared with clear cell renal cell carcinoma (RCC) supports the study of combination regimens. We evaluated the efficacy of everolimus plus bevacizumab in patients with metastatic ncRCC. Patients and Methods In this single-center phase II trial, treatment-naive patients received everolimus 10 mg oral once per day plus bevacizumab 10 mg/kg intravenously every 2 weeks. The primary end point was progression-free survival (PFS) at 6 months. Correlative analyses explored candidate tissue biomarkers through next-generation sequencing. Results Thirty-five patients were enrolled with the following histologic subtypes: chromophobe (n = 5), papillary (n = 5), and medullary (n = 2) RCC and unclassified RCC (uRCC, n = 23). The majority of patients had papillary growth as a major component (n = 14). For 34 evaluable patients, median PFS, overall survival, and objective response rate (ORR) were 11.0 months, 18.5 months, and 29%, respectively. PFS varied by histology ( P < .001), and ORR was higher in patients with significant papillary (seven of 18) or chromophobe (two of five) elements than for others (one of 11). Presence of papillary features were associated with benefit, including uRCC, where it correlated with ORR (43% v 11%), median PFS (12.9 v 1.9 months), and overall survival (28.2 v 9.3 months; P < .001). Several genetic alterations seemed to segregate by histology. In particular, somatic mutations in ARID1A were seen in five of 14 patients with papillary features but not in other RCC variants. All five patients achieved treatment benefit. Conclusion The study suggests efficacy for this combination in patients with ncRCC characterized by papillary features. Distinct mutational profiles among ncRCCs vary according to specific histology.

MP57-13 PHASE II TRIAL OF NEOADJUVANT AXITINIB IN PATIENTS WITH LOCALLY ADVANCED NON-METASTATIC CLEAR CELL RENAL CELL CARCINOMA

2014 ◽  
Vol 191 (4S) ◽  
Author(s):  
Jose Karam ◽  
Catherine Devine ◽  
Diana Urbauer ◽  
Marisa Lozano ◽  
Tapati Maity ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Cell Renal Cell Carcinoma

Circulating cytokines and angiogenic factors (CAFs) in patients with advanced non-clear cell renal cell carcinoma treated with sunitinib: Results from a phase II clinical trial.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 483-483
Author(s):  
Mehmet Asim Bilen ◽  
Amado J. Zurita ◽  
Nasreen A. Ilias-Khan ◽  
Hsiang-Chun Chen ◽  
Xuemei Wang ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Clear Cell ◽  
Phase Ii Trial ◽  
Collecting Duct ◽  
Medullary Carcinoma ◽  
Cell Renal Cell Carcinoma

483 Background: Development of hypertension (HTN) during VEGF-directed therapies is associated with improved overall survival (OS) in patients (pts) with clear-cell renal cell carcinoma. There is paucity of data about the molecular determinants of response and survival outcomes in non-clear cell renal cell carcinoma (nccRCC) pts treated with targeted therapies. We investigated CAFs and correlated them and HTN with outcomes of nccRCC pts treated with sunitinib in a phase II trial. Methods: Using a bead-based multiplex assay (Luminex), levels of 30 CAFs (including mediators of inflammation, angiogenesis, immunity, and metastasis) were measured prior to start of sunitinib therapy (baseline) and at 4 weeks after completion of cycle 1. Sunitinib benefit was defined as having partial response (PR) or stable disease (SD) by RECIST lasting ≥4 months. Cox proportional hazards regression models were used to assess the association between CAFs, HTN, and survival outcomes. The Kaplan-Meier method was used to estimate progression-free survival (PFS) and OS. Results: Fifty-seven pts [papillary (27), chromophobe (5), unclassified (8), collecting duct/medullary carcinoma (6), sarcomatoid (7), others (4)] were evaluable. Median follow up was 59.1 months (range, 30.6-82.6); 43 pts (75%) have died and 14 (25%) were alive at last follow up. Sunitinib benefit was seen in 21 pts (8 papillary, 4 chromophobe, 3 unclassified, 3 others, 2 collecting duct/medullary carcinoma, 1 sarcomatoid); 2 pts were not evaluable for response. Median PFS was 2.9 months (95% CI, 1.4-5.5) and median OS 16.8 months (95% CI, 10.7-27.4). 29 pts developed HTN during the first cycle, but there was no significant association between HTN and OS, PFS or sunitinib benefit. Elevated baseline levels of GRO, TGFα, sTNF-RI, sVEGF-R2 and IL-8 were correlated with higher risk of death. Conclusions: In this phase II trial in pts with advanced nccRCC, we found no significant association between HTN and PFS, OS, or sunitinib benefit. Candidate CAFs were identified that could be incorporated into prognostic and predictive models for validation in future studies in nccRCC.

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