TY - JOUR
T1 - Impact of Prior Cytoreductive Nephrectomy on Efficacy in Patients with Synchronous Metastatic Renal Cell Carcinoma Treated with Avelumab plus Axitinib or Sunitinib
T2 - Post Hoc Analysis from the JAVELIN Renal 101 Phase 3 Trial
AU - Grimm, Marc Oliver
AU - Oya, Mototsugu
AU - Choueiri, Toni K.
AU - Motzer, Robert J.
AU - Schmidinger, Manuela
AU - Quinn, David I.
AU - Gravis-Mescam, Gwenaelle
AU - Verzoni, Elena
AU - Van den Eertwegh, Alfonsus J.M.
AU - di Pietro, Alessandra
AU - Mariani, Mariangela
AU - Wang, Jing
AU - Thomaidou, Despina
AU - Albiges, Laurence
N1 - Publisher Copyright:
© 2023 The Author(s)
PY - 2024/1/1
Y1 - 2024/1/1
N2 - Data on the effects of prior cytoreductive nephrectomy (CN) in patients with renal cell carcinoma (RCC) with synchronous metastases (M1 disease) before immune checkpoint inhibitor (ICI) treatment are limited. In this post hoc analysis of treatment-naive patients with advanced RCC from the phase 3 JAVELIN Renal 101 trial, we assessed efficacy outcomes in the avelumab + axitinib and sunitinib arms in patients who were initially diagnosed with M1 disease (n = 412) grouped by prior CN (yes vs no). Progression-free survival (PFS) and overall survival (OS) were analyzed using multivariable Cox regression, and objective response rates (ORRs) were analyzed using logistic regression. After adjusting for imbalances in baseline variables, the hazard ratio (HR) for PFS in the prior CN versus no prior CN subgroup was 0.79 (95% confidence interval [CI] 0.53–1.16) in the avelumab + axitinib arm, and 1.15 (95% CI 0.77–1.70) in the sunitinib arm. The corresponding HRs for OS were 0.59 (95% CI 0.38–0.93) and 0.86 (95% CI, 0.55–1.34), and the odds ratios for ORR were 2.67 (95% CI 1.32–5.41) and 2.02 (95% CI 0.82–4.94), respectively. Prospective studies of the potential benefits of CN and its appropriate timing in patients receiving first-line treatment with ICI-containing combinations are warranted. Patient summary: This study looked at patients with kidney cancer whose disease had already spread outside the kidneys when it was first detected. We found that patients whose kidney had been removed before starting treatment with avelumab + axitinib had better outcomes than those whose kidney had not been removed. For patients treated with sunitinib, the results were more similar between the groups with and without prior kidney removal. However, statistical tests did not find any significant differences. The JAVELIN Renal 101 trial is registered on ClinicalTrials.gov as NCT02684006.
AB - Data on the effects of prior cytoreductive nephrectomy (CN) in patients with renal cell carcinoma (RCC) with synchronous metastases (M1 disease) before immune checkpoint inhibitor (ICI) treatment are limited. In this post hoc analysis of treatment-naive patients with advanced RCC from the phase 3 JAVELIN Renal 101 trial, we assessed efficacy outcomes in the avelumab + axitinib and sunitinib arms in patients who were initially diagnosed with M1 disease (n = 412) grouped by prior CN (yes vs no). Progression-free survival (PFS) and overall survival (OS) were analyzed using multivariable Cox regression, and objective response rates (ORRs) were analyzed using logistic regression. After adjusting for imbalances in baseline variables, the hazard ratio (HR) for PFS in the prior CN versus no prior CN subgroup was 0.79 (95% confidence interval [CI] 0.53–1.16) in the avelumab + axitinib arm, and 1.15 (95% CI 0.77–1.70) in the sunitinib arm. The corresponding HRs for OS were 0.59 (95% CI 0.38–0.93) and 0.86 (95% CI, 0.55–1.34), and the odds ratios for ORR were 2.67 (95% CI 1.32–5.41) and 2.02 (95% CI 0.82–4.94), respectively. Prospective studies of the potential benefits of CN and its appropriate timing in patients receiving first-line treatment with ICI-containing combinations are warranted. Patient summary: This study looked at patients with kidney cancer whose disease had already spread outside the kidneys when it was first detected. We found that patients whose kidney had been removed before starting treatment with avelumab + axitinib had better outcomes than those whose kidney had not been removed. For patients treated with sunitinib, the results were more similar between the groups with and without prior kidney removal. However, statistical tests did not find any significant differences. The JAVELIN Renal 101 trial is registered on ClinicalTrials.gov as NCT02684006.
KW - Avelumab plus axitinib
KW - Nephrectomy
KW - Renal cell carcinoma
KW - Sunitinib
KW - Synchronous metastases
UR - http://www.scopus.com/inward/record.url?scp=85174353224&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2023.09.016
DO - 10.1016/j.eururo.2023.09.016
M3 - Article
AN - SCOPUS:85174353224
SN - 0302-2838
VL - 85
SP - 8
EP - 12
JO - European Urology
JF - European Urology
IS - 1
ER -