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DosingDosingIBRANCE® Dosing
 
Monitoring RequirementsSafetySafetyIBRANCE® Safety ProfileNeutropeniaAdverse Event ManagementClinical Trials
Clinical TrialsIBRANCE® Clinical TrialsIBRANCE® PALOMA-2 Trial
 
IBRANCE® PALOMA-3 TrialReal World EvidenceReal World EvidenceIBRANCE® Real World EvidenceIRIS (UK) StudyROIS
 
P-REALITY XPatient ProfilesThe Ibrance® PatientPatient ProfilesAlison - >65 years with comorbiditiesBecky - Postmenopausal with bone-only diseaseSupport and ResourcesSupport and ResourcesIBRANCE Service SupportMaterials
 
Videos

The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here.  Adverse event reporting information can be found at the bottom of the page.

IBRANCE® (palbociclib) is indicated for the treatment of HR+ HER2- locally advanced or metastatic breast cancer in combination with an AI, or in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.1
Real Outcomes IBRANCE® Study (ROIS)

Confidence Through Experience1-34, 36, 37

There is a growing body of RWE for IBRANCE® in the UK and globally to complement PALOMA-2 and PALOMA-3 RCT data and to help support prescribing decisions for appropriate patients with HR+/HER2- ABC.1-34, 36, 37

Please note observational retrospective analyses are not intended for direct comparison with clinical trials due to differences in study design and settings.

Learn more about  IBRANCE® Real World Evidence.​​​​​​

ROIS Summary

Hear Professor Carlo Palmieri, the lead author of the ROIS publication, summarise the data from this IBRANCE® ROIS Real World Study.


​​​​

Professor Carlo Palmieri
Consultant in Medical Oncology
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

IBRANCE® ROIS Manuscript
Download the manuscript to read more about the IBRANCE® ROIS study
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Published July 2023

ROIS Study Summary

The IBRANCE® Patient Program (IPP) was initiated to provide patients with HR+/HER2– mBC with routine access to a CDK4/6 inhibitor for the first time within the NHS, prior to recommendations by NICE or the SMC.30,31 The IPP provided 843 patients with access to IBRANCE® plus ET free of charge; 4 years after the start of the IPP, 150 of these patients were still receiving IBRANCE®.*30-32

ROIS is an observational cohort study of 191 Patients who were enrolled in IPP.30,33

- In the overall population (N=191), 9 out of 10 patients achieved CR, PR or SD.† In the de novo ‡ (n=57) population this increased to 94%30
- Time to best response§ was 3.5 months in the overall population (n=185)30,33
- In the overall population (N=191), patients being treated with IBRANCE® plus ET achieved a mPFS of 20.2 months. In patients who received first-line IBRANCE® plus ET (n=137) this increased to 22.8 months, with an mPFS not reached in patients with de novo mBC‡ (n=57)30
- Median OS was not reached for patients in any population or subgroup.30

Selected adverse events (neutropenia, febrile neutropenia, and gastrointestinal toxicity) associated with IBRANCE® during the first 12 months after initiation were assessed in ROIS;** febrile neutropenia reported in 3% of patients (n=6).30,33

* Data from May 2021, 33
† CR, PR or SD: 2%, 40% and 48%, respectively,30
‡ Patients diagnosed with de novo mBC. This was a subgroup analysis of the overall population (patients with de novo vs non-de novo (relapsed) mBC) that included patients from all treatment lines.,30
§ Best overall response includes CR, PR, SD and PD,30
Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE® initiation. This was a subgroup analysis of the overall population (IBRANCE treatment line)​​​,30

**These selected AEs were assessed from medical records. AEs were selected based on common AEs observed in PALOMA-2 and -3, plus AEs which are likely to affect patient quality of life. AEs recorded for these patients were as a result of standard reporting to yellow card.30,33

 

 

ROIS Study Design

The overall study observation period for this analysis was from the date of breast cancer diagnosis until 24 months after initiation of IBRANCE®30

Example

During the evaluation of patients’ breast cancer treatment history, it became apparent that not all patients received IBRANCE plus AI in the first line according to the licensed UK indication; therefore, patients were grouped based on the treatment line as well as defined according to breast cancer treatment history.30

All endpoints were analysed in the overall population. Subgroup analyses were conducted to describe clinical outcomes in the following subgroups:

IBRANCE® Treatment Line30,33
  • First-line population
    • Patients with no previous treatments prescribed in the metastatic setting prior to IBRANCE initiation
  • First-line IBRANCE added to letrozole population
    • Patients who added first-line IBRANCE treatment to ongoing letrozole treatment; letrozole started >3 months prior to IBRANCE initiation
  • Second/subsequent-line population
    • Patients initiated IBRANCE in combination with ET after at least one other treatment for advanced/metastatic disease
Please note: The first-line IBRANCE added to letrozole subgroup population is part of the overall population. However, the definition for this population is not consistent with first-line use of IBRANCE plus AI according to the licensed UK indication, study protocol or the PALOMA-2 trial population.*

De novo and non-de novo (Relapsed) mBC30, 33
  • De novo population
    • Patients diagnosed with de novo mBC (all treatment lines)
  • Non-de novo population
    • Patients diagnosed with recurrent mBC (all treatment lines)
De novo mBC and non-de novo mBC groups are mutually exclusive.

Early Relapse and Late Relapse30,33
  • Early relapse
    • Patients with less than 12 months between last date of adjuvant ET and diagnosis of mBC
  • Late relapse
    • Patients with more than 12 months between last date of adjuvant ET and diagnosis of mBC
Early relapse (<12 months), late relapse (>12 months) and de novo MBC groups are mutually exclusive

The results presented herein will therefore focus on the results for the overall population, and the first-line, second-/subsequent-line and de novo subgroup populations.

* ROIS was a real-world study designed to enrol patients who would receive palbociclib in line with the approved label. However, some patients received palbociclib off label as a result of being deemed suitable for treatment by the treating clinicianKey Baseline Characteristics

Patient demographic and clinical characteristics in ROIS were reflective of a UK population of patients with HR+ HER2- metastatic breast cancer reported previously.30,35-36

  • The median age of patients treated with IBRANCE® was 57.0 years old30
  • A total of 30% of the patients were diagnosed de novo mBC and 32% of the patients had visceral disease30
  • The most common site of metastatic spread was bone30

  • The majority of the patients were postmenopausal by the time they were diagnosed with metastatic disease30

*First line (n=40), first-line IBRANCE® added (n=10), Second/subsequent-line (n=7);30
†Not available in the notes (n = 11);30
‡Not available in the notes due to time of initial BC diagnosis (n=11), not available in the notes (n=9);30
§Menopausal status not applicable for 1 male patient (1%) and not available for 4 patients (2%);30
¶Defined as time from last known date on (neo)adjuvant therapy (hormone therapy, chemotherapy or radiotherapy);30
**Treatment dates are not available due to time of initial BC diagnosis (n=3), patient previously treated at a different hospital and so treatment dates are not available (n = 2), patient had no (neo)adjuvant hormone therapy (n=4), no prior hormone therapy recorded (n=16);
††ROIS was a real-world study designed to enrol patients who would receive palbociclib in line with the approved label. However, some patients received palbociclib off label as a result of being deemed suitable for treatment by the treating clinician. Patients were not screened for progesterone-receptor status;
‡‡Not available in the notes (n=2);30
§§Not available in the notes (n=2);30
¶¶Includes any patient, regardless of treatment line group, with at least one hormone therapy recorded as being in the advanced/disease-modifying/metastatic setting.30

Table adapted from Palmieri C, et al. Br J Cancer 2023.30Response and Efficacy - Time and Best Response

In the overall population (N=191), 9 out of 10 patients achieved either CR, PR or SD.30

Best overall response*30,33

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.Figure adapted from Palmieri C, et all. Br J Cancer 2023. Supplementary material.33

The first‑line population† and patients with de novo disease‡ treated with IBRANCE® plus ET had a shorter median time to best response* of 3.4 months versus the overall population (3.5 months).30

Best overall response includes CR, PR, SD and PD.

Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE®  This was a subgroup analysis of the overall population (IBRANCE treatment line)

Patients diagnosed with de novo mBC. This was a subgroup analysis of the overall population (patients with de novo vs non-de novo (relapsed) mBC) that included patients from all treatment lines. 30

Response and Efficacy - Progression Free Survival

Patients had an mPFS of 20.2 months in the overall population. When used in the first-line setting*, the PFS benefit of IBRANCE® plus ET was extended to 22.8 months.30

PFS Probability†30

Figure adapted from Palmieri C et al. Br J Cancer 2023.30

* Patients with no previous treatments prescribed in the metastatic setting prior to IBRANCE initiation. This was a subgroup analysis of the overall population (IBRANCE treatment line);30
† Estimated via Kaplan–Meier analysis. PFS defined as the time from the date of IBRANCE initiation to the date of first documented disease progression or death as assessed during a clinic visit;30
‡ Patients receiving IBRANCE after at least 1 other treatment in the metastatic setting. This was a subgroup analysis of the overall population (IBRANCE treatment line);30
§ Patients diagnosed with de novo mBC (all treatment lines). This was a subgroup analysis of the overall population (patients with de novo vs non-de novo [relapsed] mBC) that included patients from all treatment lines;30
¶ Median (range) follow-up of 24 months (1.1–24.0) in the overall population.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.Response and Efficacy - Overall SurvivalLorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.

At 2 years, mOS was not reached in any patient population or subgroup in the ROIS study.30 

OS Probability*30

Figure adapted from Palmieri C, et al. Br J Cancer 2023.30

*Data collection is still ongoing. OS was defined as the time from the date of IBRANCE initiation until death from any cause as assessed by the individual centres;30
†Patients with no previous treatments prescribed in the metastatic setting prior to IBRANCE initiation. This was a subgroup analysis of the overall population (IBRANCE treatment line);30
§Patients receiving IBRANCE after at least 1 other treatment in the metastatic setting. This was a subgroup analysis of the overall population (IBRANCE treatment line);30
¶Patients diagnosed with de novo mBC. This was a subgroup analysis of the overall population (patients with de novo vs non-de novo (relapsed) mBC) that included patients from all treatment lines;30
**Median follow-up of 24 months (range: 1.1–24.0) in the overall population.30

Safety Profile

Selected adverse events (neutropenia, febrile neutropenia, and gastrointestinal toxicity) associated with IBRANCE® during the first 12 months after initiation were assessed in ROIS*; febrile neutropenia reported in 3% of patients (n=6).30,33

Selected haematological adverse events associated with IBRANCE during the first year after initiation*30,33

These selected AEs were assessed from medical records. AEs were selected based on common AEs observed in PALOMA-2 and 3, plus AEs which are likely to affect patient quality of life. AEs recorded for these patients was as a result of standard reporting to yellow card;Based on ANC values recorded in the 6 months following IBRANCE® initiation, represents the worst Grade of neutropenia experienced for each patient.

Selected non-haematological adverse events associated with IBRANCE during the first year after initiation*30,33

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.These selected AEs were assessed from medical records. AEs were selected based on common AEs observed in PALOMA-2 and 3, plus AEs which are likely to affect patient quality of life. AEs recorded for these patients was as a result of standard reporting to yellow card.Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.Treatment Patterns

In the overall population, median time to IBRANCE treatment discontinuation was 19.3 months (95% CI: 13.9–NR). When used as first-line* therapy, median time to discontinuation was 23.5 months (95% CI: 14.1–NR). On the other hand, patients diagnosed with de novo mBC† did not reach the median time to discontinuation.30,33

Proportion of patients who continued IBRANCE plus ET treatment at 12 and 24 months30,33

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.Figure adapted from Palmieri, et al. Br J Cancer 2023. Supplementary Material.33Patients with no prior treatments prescribed in the metastatic setting prior to IBRANCE® This was a subgroup analysis of the overall population (IBRANCE treatment line)Patients diagnosed with de novo mBC. This was a subgroup analysis of the overall population (patients with de novo vs non-de novo (relapsed) mBC) that included patients from all treatment lines30Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur neque tellus, elementum sit amet lectus id, congue varius elit. Fusce molestie urna id elit fermentum tincidunt. Proin vel nibh sed elit commodo efficitur nec nec ipsum. Aliquam erat volutpat. Suspendisse eu elit et nisi malesuada luctus. Phasellus nec velit dapibus, condimentum purus non, rutrum mi. In eros sem, pellentesque id congue mollis, vehicula sit amet neque. Quisque condimentum feugiat quam non rhoncus. Cras eget vestibulum urna. Nullam sodales ipsum elit, ac commodo odio fringilla at.
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ABC : Advanced British Cancer, AE : Adverse Events, AI : Aromatase Inhibitor, ANC : Absolute Neutrophil Count, BC : Breast Cancer, CDK4/6 : Cyclin-Dependent Kinase 4/6 CI : Confidence Interval, CR : Complete Response, ECOG PS : Eastern Cooperative Oncology Group Performance Status, ET : Endocrine Therapy, HR+/HER2− : Hormone Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative, IPP : IBRANCE® Patient Program, LHRH : Luteinising Hormone-Releasing Hormone, mBC : metasatic Breast Cancer, mPFS : Median Progression-Free Survival, mOS : Median Overall Survival, NICE : National Institute for Health and Care Excellence, NR : Not Reached, OS : Overall Survival, PFS : Progression-Free Survival, PR : Partial Response, RCT : Randomised Controlled Trial, ROIS : Real Outcomes IBRANCE® Study, RWE : Real World Evidence, SD : Stable Disease, SMC : Scottish Medicines Consortium, SmPC : Summary of Product Characteristics.

References

IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.Finn RS, et al. N Engl J Med 2016;375:1925-1936Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439. Turner NC, et al. N Engl J Med 2018;379:1926–1936. Mycock K, et al. Poster P510. Presented at the European Breast Cancer Conference, 2-3 October 2020, virtual.Ettl J, et al. Breast Cancer Res 2020;22:27.Taylor-Stokes G, et al. Poster 269P. Presented at the European Society for Medical Oncology Congress, 19-21 September 2020, virtual.Pfizer Ltd. Data on file. IBRANCE Real-World Insights (IRIS) UK results, 2020. REF-PLB0472;Taylor-Stokes G, et al. Breast 2019;43:22–27. Waller J, et al. J Glob Oncol 2019;5:JGO1800239. Mycock K, et al. Curr Oncol 2021;28:678-688Mycock K, et al. Future Oncol 2022;18:349-362Kish JK, et al. Breast Cancer Res 2018;20:37Mycock K, et al. Clin Ther 2022; 44:1588-1601.Richardson D, et al. Breast Cancer Res Treat 2021;187:113-124.De Laurentiis M, et al. Poster P3-11-25. Presented at San Antonio Breat Cancer Symposium, 14-10 December 2019, San Antonio, TX, USA.Caillet P, et al. Presentation 1012. Presented at ASCO, 4-8 June 2021, Virtual.NCT03280303. Available at: https://clinicaltrials.gov/ct2/show/NCT03280303 (accessed September 2023)Rugo HS, et al. NPJ Breast Cancer 2022;8:114.Goyal RK, et al. Cancer 2023; 129:1051-1063.Darden C, et al. Future Oncol 2019;15:141-150El Badri S, et al, Breat 2021;60:199-205Trocio J, et al. Poster P6-18-29. Presented at San Antonio Breast Cancer Symposium, 4–8 December 2018, San Antonio, TX, USA. Karuturi MS, et al. Poster PS7-19. Presented at the San Antonio Breast Cancer Symposium, 8–12 December 2020, virtual. Harbeck N, et al. Abstract 165P. Presented at ESMO, 2–4 May 2019, Berlin, Germany. Karuturi MS, et al. Poster P1-18-25. Presented at San Antonio Breast Cancer Symposium, 7–10 December 2021, San Antonio, TX, USA. Guarin A, et al. Poster 004. Presented at MBCC Conference, 7–8 August 2020, virtual symposium. Palumbo R, et al. Ther Adv Med Oncol 2021;13:1–18. Palmieri C, et al. Br J Cancer 2023; doi: 10.1038/s41416-023-02352-5 [online ahead of print].ClinicalTrials.gov. NCT03921866. Available at: https://clinicaltrials.gov/ct2/show/NCT03921866 (accessed September 2023).Pfizer Ltd. Data on file. UK IBRANCE Patient Program Study (ROIS) records. 2021. REF-IBR20062.Palmieri C, et al. Br J Cancer 2023; doi: 10.1038/s41416-023-02352-5 [online ahead of print]. Supplementary material.Diéras V, et al. J Natl Cancer Inst 2019;111:419–430.Cancer Research UK. Breast cancer incidence (invasive) statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/incidence-invasive (accessed September 2023).Kurosky S, et al. Poster #PCN352. Presented at International Society For Pharmacoeconomics and Outcomes Research 18th Annual European Congress 2015.Finn RS, et al. Presentation LBA1003. Presented at ASCO, 3–7 June 2022, Chicago, IL, USA.
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