AI Article Synopsis

  • Combined treatment of lenvatinib and pembrolizumab is a standard first-line therapy for advanced renal cell carcinoma (aRCC) patients, and this study aimed to evaluate its effectiveness and safety in Japanese patients who hadn't received prior treatment.
  • A total of 50 treatment-naïve aRCC patients were analyzed, revealing a 66% overall response rate, with 14% achieving complete responses and 52% having partial responses; the patients were classified into risk groups showing varied response rates.
  • The study concluded that the combined regimen's real-world efficacy and safety profiles are comparable to those seen in previous randomized clinical trials, with a notable incidence of adverse events in the patient population.

Article Abstract

Background: Combined treatment with lenvatinib and pembrolizumab is currently regarded as one of the standard first-line therapies for advanced renal cell carcinoma (aRCC) patients. The objective of this study was to assess the efficacy and safety of this combined regimen in treatment-naïve Japanese aRCC patients.

Methods: This study included a total of 50 consecutive aRCC patients receiving combined lenvatinib plus pembrolizumab in routine clinical practice in Japan, and comprehensively analyzed clinical outcomes of this treatment.

Results: Of these 50, 7 (14.0%), 23 (46.0%) and 20 (40.0%) were classified into favorable, intermediate and poor risk groups, respectively, according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) system. Responses to this combined therapy in the 50 patients were as follows: complete response, 7 (14.0%); partial response, 26 (52.0%); stable disease, 15 (30%) and progressive disease, 2 (4%); thus, the objective response rate (ORR) was 66%. ORRs in favorable, intermediate and poor risk groups were 57.1, 69.6 and 65.0%, respectively. During the observation period, disease progression and death occurred in 14 (28.0%) and 6 (12.0%) patients, respectively, and neither the median PFS nor OS was reached. Adverse events and those corresponding to grade ≥ 3 were observed in all (100%) and 33 (66.0%) patients, respectively.

Conclusions: To our knowledge, this is the first study focusing on real-world outcomes of lenvatinib and pembrolizumab for treatment-naïve aRCC patients, showing that the efficacy and safety of this combined regimen are similar to those noted in randomized clinical trial.

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Source
http://dx.doi.org/10.1007/s10147-024-02633-wDOI Listing

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