The Efficacy and Safety of Immune Checkpoint Inhibitor and Tyrosine Kinase Inhibitor Combination Therapy for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Real-World Cohort Study

Abstract

We evaluated the efficacy and safety of combination therapy with immune checkpoint inhibitors (ICIs) and tyrosine kinase inhibitors (TKI) as first-line therapy for patients diagnosed as having advanced or metastatic renal cell carcinoma (mRCC). We enrolled 51 patients to receive ICI+TKI therapy for mRCC at 9 Japanese institutions. The overall survival (OS) of the patients treated with ICI+TKI was the primary endpoint., and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Furthermore, we analyzed the clinical prognostic and predictive factors in patients with mRCC treated with ICI+TKI therapy. Seven months was the median follow-up period. The OS rates at 6, 12, and 18 months were 93.1, 82.5, and 68.8%, respectively. The median PFS for patients who received ICI+TKI was 19.0 months, ORR was 68.6%, and DCR was 88.2%. ICI+TKI-related adverse events occurred in 43 patients (84.3%) with any grade and in 22 patients (43.1%) with grade ≥3. Treatment selection with poor prognostic factors may be prudent, even though ICI+TKI is an efficacious and safe first-line treatment in patients with mRCC.

Comparative efficacy and safety of anti-PD-1/L1 antibody plus anti-VEGF antibody and anti-PD-1/L1 antibody plus VEGFR-targeted tyrosine kinase inhibitor as first-line therapy for unresectable hepatocellular carcinoma (uHCC): a systematic review and network meta- analysis

“…Another study also indicated that this conversion therapy strategy can be effective and safe for hepatectomy after careful preparation and patient evaluation [23]. At the same time, A + T combination treatment of renal cell carcinoma and non-small cell lung cancer also has an excellent tumour reduction effect with a high ORR [24,25].…”

Real‐world outcomes of avelumab plus axitinib as first‐line therapy in patients with advanced renal cell carcinoma in Japan: A multicenter, retrospective, observational study (J‐DART)

“…In the JAVELIN Renal 101 trial, 33 Japanese patients were randomized to receive avelumab plus axitinib 12 ; however, only a few studies have been reported for real-world treatment with avelumab plus axitinib in Japan. 13,14 The J-DART study reports real-world baseline characteristics and treatment outcomes of patients with aRCC treated with first-line avelumab plus axitinib 1 year after its approval in Japan.…”