scholarly journals Adherence to oral therapies among patients with renal cell carcinoma: Post hoc analysis of the ECOG‐ACRIN E2805 trial

2021 ◽  
Author(s):  
Caitlin C. Murphy ◽  
Hannah M. Fullington ◽  
David E. Gerber ◽  
Isaac Alex Bowman ◽  
Maneka Puligandla ◽  
...  
2019 ◽  
Vol 17 (6) ◽  
pp. 425-435.e4 ◽  
Author(s):  
Cora N. Sternberg ◽  
Robert J. Motzer ◽  
Thomas E. Hutson ◽  
Toni K. Choueiri ◽  
Christian Kollmannsberger ◽  
...  

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 582-582 ◽  
Author(s):  
Daniel J. George ◽  
Colin Hessel ◽  
Susan Halabi ◽  
Ben L. Sanford ◽  
M. Dror Michaelson ◽  
...  

582 Background: The randomized phase 2 CABOSUN trial (NCT01835158) compared cabozantinib (C) with sunitinib (S) as initial systemic therapy in patients (pts) with RCC of intermediate or poor risk. Compared with S, C improved both PFS and ORR as assessed by independent radiology review committee (IRC). Median PFS per IRC was 8.6 mo for C vs 5.3 mo for S (HR 0.48, 95% CI 0.31-0.74 two-sided p = 0.0008), and ORR per IRC was 20% vs 9%. Methods: 157 patients were randomized 1:1 to receive C (60 mg qd) or S (50 mg qd, 4 weeks on/2 weeks off) stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group and the presence of bone metastases. Subgroup analyses of PFS per IRC and ORR per IRC are presented based on stratification factors, age, sex, baseline ECOG status, and MET tumor expression by immunohistochemistry. The primary endpoint was investigator-assessed PFS. PFS and ORR were evaluated by IRC in a post-hoc analysis. Results: 45% of pts were ≥65 years, 78% were male, 54% were ECOG 1 or 2, 19% were poor risk, and 36% had bone metastases. MET status was determined in 131 pts; of these 47% were MET positive. The HR for PFS per IRC favored C over S across all subgroups analyzed (Table). Subgroups with poor prognostic characteristics (poor risk, ECOG 1 or 2, presence of bone metastases) had shorter median PFS for both C and S. Odds ratios for ORR also favored C over S, with the highest C ORR in the MET positive subgroup (34% C vs 10% S). Conclusions: C was associated with improved PFS and ORR compared with S in previously untreated pts with advanced RCC irrespective of baseline characteristics. Clinical trial information: NCT01835158. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4513-4513 ◽  
Author(s):  
David F. McDermott ◽  
Toni K. Choueiri ◽  
Robert J. Motzer ◽  
Osvaldo Rudy Aren ◽  
Saby George ◽  
...  

4513 Background: Patients (pts) with advanced renal cell carcinoma with sarcomatoid features (sRCC) have poor prognosis and suboptimal outcomes with anti-VEGF targeted therapy. Nivolumab plus ipilimumab (N+I) demonstrated superior objective response rate (ORR) and overall survival (OS) vs sunitinib (S) in previously untreated pts with International Metastatic RCC Database Consortium (IMDC) intermediate/poor (I/P)-risk, clear-cell, advanced RCC in the phase 3 CheckMate 214 trial. Methods: We performed a post-hoc exploratory analysis of N+I vs S in CheckMate 214 sRCC pts. The presence of sarcomatoid features was assessed by keyword search for “sarcomatoid” in pts with available local pathology reports accompanying pretreatment tumor samples. Results: 842 (77%) of 1096 intention-to-treat pts had local pathology reports available, including 112 randomized pts with I/P-risk sRCC (N+I, n = 60; S, n = 52). Baseline characteristics of sRCC pts were balanced between arms. Notably, 47% vs 53% of I/P-risk sRCC pts in the N+I and S arms had tumor PD-L1 expression ≥1% at baseline, which was higher than in all I/P-risk pts (N+I, 26% vs S, 29%). In descriptive analyses performed at a minimum follow-up of 30 months, confirmed ORR and complete response rate per investigator (RECIST v1.1), OS, and progression-free survival (PFS) per investigator were improved with N+I vs S in I/P-risk pts with sRCC (Table). No new safety signals were seen in sRCC pts. Conclusions: In this post-hoc descriptive subgroup analysis of CheckMate 214, N+I demonstrated promising efficacy and prolonged survival vs S, with consistent safety, in previously untreated, I/P-risk, advanced clear-cell RCC with sarcomatoid features. Prospective studies of N+I that include pts with sRCC are ongoing. Clinical trial information: NCT02231749. [Table: see text]


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