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September 12, 2025Epidemiology Biostatistics and Public HealthOpen Access

Informative Censoring in CDK4/6 Inhibitor Adjuvant Therapy for Early Breast Cancer: A Sensitivity Analysis of Invasive Disease-Free Survival in the monarchE Trial

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Authors

FMFederico MerloFCFabio ConfortiVBVincenzo Bagnardi

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Overview

Sensitivity analysis reveals potential bias in IDFS estimates for early breast cancer treatment, indicating informative censoring may not explain outcomes.

Key Points

  • The IDFS hazard ratio estimates were influenced by potential informative censoring, showing a plausible adjustment to 0.72.
  • Censoring rates were similar between treatment arms, yet 80 patients needed reclassification to observe less relevant effect in the 24-month window.
  • Reverse Kaplan–Meier curves helped visualize censoring patterns, revealing increasing rates from 48 months due to administrative censoring.
  • Findings suggest the IDFS benefit is robust against potential biases, with prolonged survival post-recurrence complicating overall survival measurements.

Cite This Study

Merlo et al. (2025) studied this question.

synapsesocial.com/papers/68d41dae713b0b5dfea673d0https://doi.org/10.54103/2282-0930/29562
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Censoring in trials testing immunotherapy in advanced cancers: a systematic review and a meta-research study2025 · 1 citations
  2. 2Real-World Predictors of Survival in CDK4/6 Inhibitor-Treated Metastatic Breast Cancer: The Significance of ER Expression Level and Treatment Naivety2025 · 1 citations
  3. 3Chemotherapy-Free Survival of CDK4/6 Inhibitor Combination Therapy or Endocrine Monotherapy as First-Line Treatment for HR+/HER2–Advanced Breast Cancer2025
  4. 4Intermediate endpoints as surrogates for long-term outcomes in breast cancer adjuvant chemotherapy trials2025
  5. 5Treatment consequence and adverse events of cyclin-dependent kinase 4/6 inhibitors on patients with hormone receptor-positive, HER2-negative metastatic breast cancer: a systematic review and meta-analysis2025 · 2 citations