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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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Summary of Prescibing Information

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Elderly Patients

In an exploratory, pooled analysis of patients aged ≥65 years in the PALOMA trials, the TEAEs reported were generally consistent with the known AE profile of PALBACE®.1

   

PALOMA Pooled Analysis: TEAEs Occurring in ≥10% of Patients ≥65 years in Either Treatment Group1

   

   

Download table

   

Adapted from Rugo HS, et al. 2018.1

   

Up to 6% of patients aged 65 to ≥75 years discontinued because of TEAEs.1

   

Data cut-off dates: 2 January 2015 for PALOMA-1, 26 February 2016 for PALOMA-2 and 23 October 2015 for PALOMA-3.

   

   

*Patients in PALOMA-1 and PALOMA-2 received PALBACE® + LET; patients in PALOMA-3 had endocrine-resistant mBC and received PALBACE® + FUL. 
Includes LET alone in PALOMA-1, LET + PLA in PALOMA-2 and FUL + PLA in PALOMA-3. 
All-causality AEs occurring in ≥10% of patients aged ≥65 years in the as-treated populations were graded in accordance with the maximum grade per CTCAE, version 3.0 (PALOMA-1) or 4.0 (PALOMA-2 and -3) and classified according to MedDRA, version 19.0. 
§Clustered PTs defined as follows: anaemia includes the PTs anaemia, haematocrit decreased and haemoglobin decreased; infections includes any reported PTs of the System Organ Class Infections and infestations; leukopenia includes the PTs Leukopenia and White blood cell count decreased; neutropenia includes the PTs Neutropenia and Neutrophil count decreased; thrombocytopenia includes the PTs Platelet count decreased and Thrombocytopenia; stomatitis includes the PTs Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain and Stomatitis.

   

AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; ET, endocrine therapy; FUL, fulvestrant; LET, letrozole; mBC, metastatic breast cancer; MedDRA, Medical Dictionary for Regulatory Activities; n, number of patients; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer;  PLA, placebo; PT, preferred term; TEAE, treatment-emergent adverse event.

   

Reference:

Rugo HS, Turner NC, Finn RS, et al. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018;101:123-133.

   

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.

    

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Selected Safety Features

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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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