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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

Monitoring

One Scheduled Monitoring Provision
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Summary of Prescibing Information

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Safety Overview

PALBACE® has a well-characterised and consistent safety profile.1-6

   

PALOMA Trials

   

Dose reductions or modifications and discontinuation rates across the PALOMA trials are as follows1,5:

  • In an early pooled analysis of PALOMA trials, 38.4% of patients receiving PALBACE® had dose reductions or modifications due to any ARs and 5.2% permanently discontinued treatment, regardless of the combination¹
  • In an updated pooled safety analysis of PALOMA trials up to 5 years, 40.6% of patients receiving PALBACE® had ≥1 dose reduction and 11.1% permanently discontinued treatment due to ARs5

Neutropenia

   

Limited or no correlation between neutropenia and viral infections

   

In a long-term pooled analysis, overlapping of viral infections (all grades) and Grade ≥3 neutropenia occurred in 10.5% of patients treated with PALBACE®, with 99.8% of viral infections being Grade 1 or 2. Overlapping of Grade ≥3 viral infections occurred in only 0.2% of patients with Grade ≥3 neutropenia.5,*

   

Febrile neutropenia

   

Febrile neutropenia has been reported in about 2% of patients exposed to PALBACE® in a pooled analysis of the PALOMA trials.1

   

Discontinuation rates due to neutropenia

   

In a pooled analysis of the PALOMA trials up to 5 years5, 1.7% of patients permanently discontinued treatment due to neutropenia.

   

Neutropenia can be managed by dose delay or modification without an apparent effect on efficacy

   

 In 2 exploratory analyses from PALOMA-2 and -3, dose reductions did not appear to have an effect on efficacy.4,5

   

   

*Patients who have additional risk factors that make them susceptible to infection (e.g. elderly or patients with weakened immune systems) should be carefully monitored for the signs of infection.⁵ As per the PALBACE® LPD, patients should be monitored for the signs and symptoms of infection and treated as medically appropriate.¹

AR, adverse reaction; ALT, alanine aminotransferase; AST, aspartate aminotransferase; LPD, local product document; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer.

   

References:

Palbace. Local product document. Pfizer; 2021. Version LPDPAB102021.

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

Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [published correction appears in Lancet Oncol. 2016;17(4):e136] [published correction appears in Lancet Oncol. 2016;17(7):e270]. Lancet Oncol. 2016;17(4):425-439.

Verma S, Bartlett CH, Schnell P, et al. Palbociclib in combination with fulvestrant in women with hormone receptor-positive/HER2-negative advanced metastatic breast cancer: detailed safety analysis from a multicenter, randomized, placebo-controlled, phase III study (PALOMA-3). Oncologist. 2016;21(10):1165-1175.

Finn RS, Rugo HS, Gelmon KA, et al. Long-term pooled safety analysis of palbociclib in combination with endocrine therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: updated analysis with up to 5 years of follow-up. Oncologist. 2021;26(5):e749-e755.

Diéras V, Harbeck N, Joy AA, et al. Palbociclib with letrozole in postmenopausal women with ER+/HER2- advanced breast cancer: hematologic safety analysis of the randomized PALOMA-2 trial. Oncologist. 2019;24(12):1514-1525.

   

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

Safety

Real-world Evidence

With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose modifications for AEs

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Monitoring

One scheduled monitoring provision

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