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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 SummaryTolerability/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 SummaryDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

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P-REALITY Overall Survival

Median OS (secondary endpoint) was not reached with PALBACE® in combination with letrozole versus 43.1 months with letrozole alone.1,

  • Although median OS was reached in the LET alone group, significant censoring in the OS analysis highlights the need for subsequent evaluation with longer follow-up1
  • At 2 years’ follow-up, OS rate was 78.3% with IBRANCE + LET vs 68.0% with LET alone1
Adapted from DeMichele A, et al. 2021.1OS was defined as the number of months from the start of treatment with IBRANCE in combination with letrozole or letrozole alone to death due to any cause as recorded by Flatiron in the data extract. The date of death was acquired from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. Patients who did not die were censored at the study cut-off date (May 31, 2019).OS was defined as the number of months from the start of treatment with IBRANCE in combination with letrozole or letrozole alone to death due to any cause as recorded by Flatiron in the data extract. The date of death was acquired from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. Patients who did not die were censored at the study cut-off date (May 31, 2019).

After sIPTW adjustment, median follow-up was 24.2 and 23.3 months for PALBACE® in combination with letrozole and letrozole alone, respectively​​​​​​​.

In an exploratory analysis, a consistent OS benefit with PALBACE® in combination with letrozole versus letrozole alone was generally observed across examined subgroups, except race (after sIPTW) adjustments.1,*

​​​​​​​

   

  • Although median OS was reached in the LET alone group, significant censoring in the OS analysis highlights the need for subsequent evaluation with longer follow-up1
  • At 2 years' follow-up, OS rate was 78.3% with PALBACE® + LET versus 68.0% with LET alone1

    

Adapted from DeMichele A, et al. 2021.1

    

After sIPTW adjustment, median follow-up was 24.2 and 23.3 months for PALBACE® in combination with letrozole and letrozole alone, respectively.

    

In an exploratory analysis, a consistent OS benefit with PALBACE® in combination with letrozole versus letrozole alone was generally observed across examined subgroups, except race (after sIPTW) adjustments.1,†

    

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Adapted from DeMichele A, et al. 2021.1

   

Small patient numbers can be a limitation of subgroup analyses. These analyses are considered exploratory. No adjustments were made for multiple testing in the subgroup analyses.

   

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 

The PALOMA-2 randomised clinical trial (first-line trial of PALBACE® in combination with letrozole vs. placebo + letrozole) began in February 2013 and includes OS as a secondary endpoint.4 The planned number of events required for a final OS analysis has not been reached. Patients will continue to be followed for the final analysis.

   

   

*OS was defined as the number of months from the start of treatment with PALBACE® in combination with letrozole or letrozole alone to death due to any cause as recorded by Flatiron in the data extract. The date of death was acquired from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. Patients who did not die were censored at the study cut-off date (31 May 2019).

   

Race by cohort interaction and metastatic sites by cohort interaction were the only subgroup variable-by-treatment cohort interaction that were significant (P<0.0001 and P = 0.0050, respectively). However, race data were not present in the 'other/unknown' race group. Similar subgroup results were observed in the propensity score matching analysis.
Bone-only disease was defined as metastatic disease in the bone only.
§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.

   

CI, confidence interval; Dx, diagnosis; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; LET, letrozole; N, total number of patients; ND, not determined; NE, not estimable; NR, not reached; OS, overall survival; sIPTW, stabilised inverse probability treatment weighting

   

References:

DeMichele A, Cristofanilli M, Brufsky A, et al. Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice. Breast Cancer Res. 2021;23(1):37. 

Gerstein HC, McMurray J, Holman RR. Real-world studies no substitute for RCTs in establishing efficacy. Lancet. 2019;393(10168):210-211. 

Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and real-world data for evaluating drug safety and effectiveness. JAMA. 2018;320(9):867-868.

Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.

   

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.

    

PP-IBR-IND-0462 27 July 2022

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

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Dosing

Recommended dosing schedule and dose modifications for AEs

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