IBRANCE® (palbociclib)|P-REALITY OS and rwPFS | PfizerPro Ireland

This site is intended only for healthcare professionals resident in the Republic of Ireland

Log out

Our medicines

Therapy areas

Explore content

Materials

Videos

Podcasts

Let’s connect

Let's connect

Clinical efficacy & safety

PALOMA-2

Trial design overview

Patient baseline characteristics

Progression-free survival (primary endpoint)

Overall survival (secondary endpoint)

Tumour control (secondary endpoint)

PALOMA-2 summary

PALOMA-3

Trial design overview

Patient baseline characteristics

Progression-free survival (primary endpoint)

Overall survival (secondary endpoint)

Tumour control (secondary endpoint)

Safety

Safety overview

Pooled laboratory abnormalities

PALOMA-2 AEs

PALOMA-3 AEs

Selected safety features

IBRANCE long-term safety

GI and liver toxicities

Effect of IBRANCE on QTc interval

Elderly patients

Visceral disease patients

Dose reduction effect on efficacy

RW evidence

Value of RWE

What is real-world evidence?

What is the value of RWE?

P-REALITY and P-REALITY X

P-REALITY Overview

P-REALITY OS and rwPFS

P-REALITY X Overview

P-REALITY X OS and rwPFS

IRIS

IRIS Overview

IRIS PFS and OS

POLARIS

POLARIS Overview

POLARIS Patient-Reported Outcomes

MADELINE

MADELINE Overview

MADELINE Patient Characteristics

MADELINE Patient-Reported Outcomes

PalomAGE

PalomAGE Overview

RWE in Older Patients with mBC

P-VERIFY

P-VERIFY Study

Patient-reported outcomes

PALOMA-2: FACT-B scores

PALOMA-3: EORTC QLQ-C30 scores

PALOMA-3: Time to deterioration in pain symptoms

Dosing

Recommended dosing schedule

Recommended dose modifications for AEs

Monitoring

One scheduled monitoring provision

Prescribing Information

Resources

Materials

P-REALITY OS and rwPFS

Median OS (secondary endpoint) was not reached with IBRANCE in combination with letrozole vs 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. 2021.¹

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 IBRANCE in combination with letrozole and letrozole alone, respectively.

Median rwPFS (primary endpoint) was significantly longer among patients who received IBRANCE in combination with letrozole vs letrozole alone^*1

Adapted from DeMichele A, et al. 2021.¹

Real-world PFS was defined as the number of months from start of IBRANCE in combination with letrozole or letrozole alone to death or disease progression. Disease progression was determined by the record assessment of the treating clinician based on radiology, pathology, clinical assessment, or laboratory evidence. Patients who did not die or have disease progression were censored at the date of initiation of next line of therapy for those with 2 or more lines of therapy or their last visit during the study period (February 2015–May 2019) for patients with only one line of therapy.

After sIPTW adjustment, median follow-up was 24.2 and 23.3 months for IBRANCE in combination with letrozole and letrozole alone, respectively.¹

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

Explore More

P-REALITY X overview

Explore more

P-REALITY X OS and rwPFS

Explore more

CI = confidence interval; Dx = diagnosis; ECOG PS = Eastern Cooperative Oncology Group performance status; LET = letrozole; N/n = number of patients; ND = not determined; NE = not estimable; NR = not reached; OS = overall survival; sIPTW = stabilized inverse probability treatment weighting; y = year.

References:

DeMichele A, et al. Breast Cancer Res. 2021;23:37.

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

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

P-REALITY and P-REALITY X

IBRANCE Summary of Product Characteristics

Product Characteristics

Legal Category: S1A
Further information is available upon request

PP-IBR-IRL-0649. August 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

PfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Account

Log out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit https://www.medicines.ie

This website is brought to you by Pfizer Healthcare Ireland Unlimited Company, The Watermarque Building, Ringsend Road, Dublin 4, Dublin, Ireland, D04 K7N3. Registered in the Republic of Ireland No. 127002. Directors: D. Mangone (Managing), O. Gavan, D. Kennedy. Company Secretary: M.Byrne.

PP-UNP-IRL-0832. October 2024

You are now leaving PfizerPro

You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.

PP-UNP-IRL-0832. October 2024