Sunitinib Versus Sorafenib as Initial Targeted Therapy for mCC-RCC With Favorable/Intermediate Risk: Multicenter Randomized Trial CROSS-J-RCC
Yoshihiko Tomita, Sei Naito, Naoto Sassa, Atsushi Takahashi, Tsunenori Kondo, Takuya Koie, Wataru Obara, Yasuyuki Kobayashi, Jun Teishima, Masayuki Takahashi, Hideyasu Matsuyama, Takeshi Ueda, Kenya Yamaguchi, Takeshi Kishida, Ryoichi Shiroki, Takashi Saika, Nobuo Shinohara, Mototsugu Oya, Hiro-Omi Kanayama, Yoshihiko Tomita, Sei Naito, Naoto Sassa, Atsushi Takahashi, Tsunenori Kondo, Takuya Koie, Wataru Obara, Yasuyuki Kobayashi, Jun Teishima, Masayuki Takahashi, Hideyasu Matsuyama, Takeshi Ueda, Kenya Yamaguchi, Takeshi Kishida, Ryoichi Shiroki, Takashi Saika, Nobuo Shinohara, Mototsugu Oya, Hiro-Omi Kanayama
Abstract
Purpose: The present study compared the efficacy of sunitinib and sorafenib as first-line treatment of metastatic clear cell renal cell carcinoma (mCC-RCC) with favorable or intermediate Memorial Sloan Kettering Cancer Center (MSKCC) risk.
Patients and methods: Treatment-naive patients with mCC-RCC were randomized to receive open-label sunitinib followed by sorafenib (SU/SO) or sorafenib followed by sunitinib (SO/SU). The primary endpoint was first-line progression-free survival (PFS). The secondary endpoints were total PFS and overall survival (OS).
Results: Of the 124 patients enrolled at 39 institutions from February 2010 to July 2012, 120 were evaluated. The median first-line PFS duration was 8.7 and 7.0 months in the SU/SO and SO/SU groups, respectively (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.42-1.08). The total PFS and OS were not significantly different between the SU/SO and SO/SU groups (27.8 and 22.6 months; HR, 0.73; 95% CI, 0.428-1.246; and 38.4 and 30.9 months; HR, 0.934; 95% CI, 0.588-1.485, respectively). The subgroup analysis revealed that the total PFS with SU/SO was superior to the total PFS with SO/SU in the patients with favorable MSKCC risk and those with < 5 metastatic sites). SO/SU was superior to SU/SO for patients without previous nephrectomy.
Conclusions: No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).
Keywords: PFS; RCT; Renal cell carcinoma; SO/SU; SU/SO.
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed