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Safety and Efficacy of Second-Line TKI Plus Anti-PD1 Following Targeted Therapy in Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma: A Real-World Study
20 Pages Posted: 17 May 2022
More...Abstract
Background: Immunotherapy combined with tyrosine kinase inhibitor (TKI) has shown promising results as a first-line treatment regimen in non-clear cell renal carcinoma (nccRCC), but little is known about the efficacy and safety of this treatment regimen as second-line treatment. This study aimed to evaluate the efficacy and safety of immune-targeted combination therapy as the second-line regimen in nccRCC.
Methods: We conducted a retrospective analysis of metastatic nccRCC patients who failed first-line TKI therapy between October 2011 and September 2020. The baseline characteristics of the patients and adverse events (AEs) were collected. Efficacy measures included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).
Findings: The current study enrolled 65 patients, with a median age of 48 (interquartile 37–60) years. Among all patients, 21 received TKI monotherapy while 44 patients received combination therapy (TKI plus anti-PD1). The overall ORR and DCR were 38.5% and 56.9%, respectively. The overall second-line PFS was 7.7 (95% CI: 6.1–9.3) months and OS was 25.2 (19.5–30.8) months. Patients receiving combination therapy had a significantly longer PFS compared with those receiving single TKI [median PFS (95% CI): 9.2 (5.9–12.4) vs 5.4 (2.6–8.2) m, Log-rank P =0.002]. Similarly, ORR (50.0% vs 14.3%, P=0.006) and DCR (70.5% vs 28.6%, P=0.001) were remarkably improved in the combination group compared with the TKI group. The incidence of treatment-related AEs of any grade was comparable between the two groups (95.2% vs 95.5%).
Interpretation: Immune-targeted combination therapy appeared effective and safe in the treatment of metastatic nccRCC who failed first-line TKIs.
Funding: This study was supported by the National Natural Science Foundation of China (No. 82102988 and 81772483) and the Medical Research Foundation of Guangdong Province (No. A2022492).
Declaration of Interest: The authors declare that they have no competing interests.
Ethical Approval: This study has been approved by the institutional review board (IRB) and
the ethical committee of Sun Yat-sen University Cancer Center
Keywords: Immunotherapy, tyrosine kinase inhibitor, safety, efficacy, non clear cell renal cell carcinoma
Suggested Citation: Suggested Citation