Armando Orlandi, Medical Director at the Agostino Gemelli University Hospital Foundation IRCCS, shared on LinkedIn:
“Real-World Evidence vs. Head-to-Head Comparisons: Lessons from CDK4/6 Inhibitor Studies
The recent publication of contrasting real-world studies on CDK4/6 inhibitors (PALMARES-2 vs. P-VERIFY) offers an important lesson for oncology research.
The Dilemma
- PALMARES-2 (🇮🇹 study): Found significant differences favoring abemaciclib/ribociclib over palbociclib
- P-VERIFY (🇺🇸 study): No significant differences between the three CDK4/6 inhibitors
The Issue
Despite sophisticated statistical adjustments (propensity scores, IPTW, multivariable analyses), observational studies cannot fully address selection bias and population heterogeneity when comparing active treatments.
The Solution
Real-world evidence should focus on its true strengths:
- Validating efficacy in underrepresented populations
- Long-term safety in diverse cohorts
- Treatment patterns in clinical practice
Bottom Line
Let’s use RWE for what it does best – complementing RCTs by addressing questions trials can’t answer, rather than attempting inferior head-to-head comparisons.”
Title: Real-world progression-free survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR-positive/HER2-negative metastatic breast cancer in United States routine clinical practice
Authors: H.S. Rugo, R.M. Layman, F. Lynce, X. Liu, B. Li, L. McRoy, A.B. Cohen, M. Estevez, G. Curigliano, A. Brufsky
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