真实世界证据表明目前一线治疗策略在乳头状肾细胞癌中并未带来生存优势：呼吁开展随机试验.pdf

1、Real-World Evidence Shows No Survival Advantage with Contemporary First-Line Strategies in Papillary Renal Cell Carcinoma:A Call for Randomized TrialsMiguel Zugman,MDCity of HopePurpose To evaluate comparative effectiveness of VEGFR-TKIs,MET inhibitors,and IO-based regimens in a large US real-world

2、cohort.EXCLUSION ZONEMethods Data Source:ConcertAI Patient360 dataset:De-identified,human-curated real-world data from U.S.academic and community oncology practices,integrating EMRs,claims,and mortality data.Population:Metastatic pRCC,first-line systemic therapy,20162024(N=216).Treatment Groups:VEGF

3、R-TKIs,MET inhibitors,IO(monotherapy or IO/IO),IO+TKI/METi combinations,mTOR inhibitors.Outcomes:Real-world PFS and OS by KaplanMeier and Cox regression.CharacteristicsMetastatic Papillary Renal Cell Carcinoma(N=216)METi(N=33)(%)TKIs(N=107)(%)IO(N=47)(%)TKI+IO(N=10)(%)METi+IO(N=13)(%)mTORi(N=6)(%)Pr

4、actice Type Academic9.19.48.510.015.433.3Community90.990.791.590.084.666.7GenderFemale12.116.827.720.069.20.0Male87.983.272.380.030.8100.0Age(yr)Median 68.865.96471.767.765EthnicityHispanic or Latino12.14.76.410.0Not Hispanic or Latino72.769.266.060.076.966.7Unknown15.226.227.730.023.133.3Conclusion

5、s Real-world PFS and OS by KaplanMeier and Cox regression show no clear survival advantage across regimens in real-world practice.Findings underscore clinical equipoise and justify randomized phase trials PAPMET2(NCT05411081),SAMETA(NCT05043090),and STELLAR-304(NCT05678673).Takeaway message:Despite enthusiasm for IO and METi combinations,definitive evidence is lacking.