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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryP-REALITY X OverviewP-REALITY X OS and rwPFSP-REALITY X Subgroup analysis OverviewP-REALITY X:OS and rwPFS in Subgroup(Lung & Liver metastasisTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryMADELINE ASIA OverviewMADELINE ASIA Patient Reported OutcomesMADELINE ASIA SafetyMADELINE ASIA Study LimitationsDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

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P-REALITY X Overview

P-REALITY X (Palbociclib REAL-world 1st-LIne ComparaTive Effectiveness Study eXtended) is a comparative effectiveness study of 1st-line Palbace in combination with AI vs AI alone1

   

P-REALITY X Study Design1

   

*   OS was defined as the number of months from start of study treatment until death.
†   rwPFS was defined as the number of months from the start of study treatment to the date of the first         
     documentation of real-world progressive disease or death, whichever occurred first.


A total of 2888 patients received PALBACE® in combination with AI or AI alone in the 1st-line setting1

   

sIPTW was the primary analysis performed to balance baseline demographic and clinical characteristics, and to adjust for differences in observed potential confounders between the two groups.¹ 1:1 PSM was conducted as a sensitivity analysis.¹

   

The study included a heterogeneous population in terms of age, performance status and disease site1

    

Select baseline patient characteristics after sIPTW adjustment (n=2709)*1

  

Adapted from Rugo H, et al. 2022.1
Median follow-up (IQR) was 23.9 (12.8–38.0) months with PALBACE® + AI and 24.5 (12.0–42.9) months with AI alone. Patient characteristics were generally well balanced across groups after sIPTW and PSM adjustment.
*    sIPTW was applied to balance patient demographic and baseline clinical characteristics. This approach was used
      as the primary analysis.
†    Visceral disease was defined as metastatic disease in the lung and/or liver; patients could have had other sites     
      of metastases. No visceral disease was defined as no lung or liver metastases.
‡    Bone-only disease was defined as metastatic disease in the bone only.

    

 
  • 34.0% of patients after sIPTW presented with de novo mBC at baseline1                    
  • 30.3% of patients after sIPTW had an ECOG performance status score of 0; 22.9% a score of 1 and 15.5% a score of 2, 3 or 41


 

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.2,3 


 

AI = aromatase inhibitor; CI = confidence interval; HR = hazard ratio; N/n = number of patients; PFS = progression-free survival; PSM = propensity score matching; rwPFS = real-world progression-free survival; sIPTW = stabilized inverse probability treatment weighting.
 

   

References:

Rugo HS, et al. NPJ Breast Cancer. 2022;8(1):114.

Gerstein HC, et al. Lancet. 2019;393(10168):210-211. 

Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
All images used are for representation purposes only
(®)Trademark Proprietor: Pfizer Inc.USA Licensed User: Pfizer Products India Private Limited.India

    

PP-IBR-IND-0626  September 2023

Effectiveness

   

Clinical Efficacy & Safety

PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC

 Learn more

   

Dosing

Recommended dosing schedule and dose modifications for AEs

 Learn more

   

Monitoring One scheduled monitoring provision Learn more
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