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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.
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.
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
Published July 2023
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
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:
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 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
In the overall population (N=191), 9 out of 10 patients achieved either CR, PR or SD.30
Best overall response*30,33
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 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
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.
At 2 years, mOS was not reached in any patient population or subgroup in the ROIS study.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
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
Selected non-haematological adverse events associated with IBRANCE during the first year after initiation*30,33
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
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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
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