Ibrance is indicated for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy.1

Real-world Experience

What is RWD and RWE IBRANCE RWE Initiatives Flatiron IRIS

The IRIS (IBRANCE Real World Insights) study evaluated the demographics, clinical characteristics, patterns and outcomes of IBRANCE combinations in diverse real-world populations2

Go straight to a country cohort 

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Observational retrospective chart review in patients with HR+/HER2- ABC/mBC treated with IBRANCE combinations in the US and Argentina2​​​​​​​


US cohort

Study Design

*Index date as 60 days after the physician first prescribed IBRANCE with partner therapy following approval. 
ABC = advanced breast cancer; AI = aromatase inhibitor; eCRF = electronic case report form; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; = number of patients

Select baseline characteristics2

Adapted from Taylor-Stokes G, et al. 2019.2

Patient demographics were similar between the IBRANCE + aromatase inhibitor and IBRANCE + fulvestrant cohorts:1

  • Median age at IBRANCE initiation was 65 years (range: 30–90)
  • 64.3% of patients had comorbidities‡5
  • 60.0% were of white/caucasian ethnicity

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.3,4



*Data for patients with metastatic disease only.2 †Defined as having metastases to the lungs, brain, liver, or ovaries.2 ‡Patients were asked about their medical comorbidities diagnosed in the 12 months prior to IBRANCE initiation.5

ABC = advanced breast cancer; ECOG PS = Eastern Cooperative Oncology Group performance status; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; n = number of patients.

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Taylor-Stokes G, et al. Breast. 2019;43:22-27.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.
  5. Pfizer Data on File. New York, NY: Pfizer, Inc.

rwPFS rates

Progression-free survival rate in patients treated with IBRANCE + LET (n=360)2

Adapted from Taylor-Stokes G, et al. 2019.2

  • 64.3% of patients treated with 1st line IBRANCE + AI were progression free at 2 years2

Progression-free survival rate in patients treated with IBRANCE + FUL (n=292)*2

Adapted from Taylor-Stokes G, et al. 2019.2
  • 79.8% of patients treated with IBRANCE + FUL in 1st line or later were progression free at 1 year*2
  • Physician-assessed clinical benefit rate was >90% for both patients treated with IBRANCE + AI and IBRANCE + FUL.1 For the majority of patients, partial response or stable disease was reported as best response by the physician†2

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.3,4 

*Fulvestrant combination approved in the US in Feb 2016, therefore, 18- and 24- month data unavailable. Clinical response was based on physician assessment reported at any time and was not based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. In randomised clinical trials, RECIST criterion for a partial response is a ≥30% reduction in tumour size. In IRIS, complete response was defined as one where “complete response” has been recorded at any time (no 24-week minimum); partial response was defined as one where “partial response” has been recorded at any time (no 24-week minimum); clinical benefit rate was calculated by adding the percentages of patients who achieved complete response, partial response, and stable disease ≥24 weeks; stable disease ≥24 weeks was defined as patient remained on IBRANCE for a minimum of 24 weeks, without complete or partial response, death, treatment switch, or progression; stable disease <24 weeks was defined as stable disease recorded for initial response, with a subsequent progression recorded <24 weeks or treatment switch for reason other than progression <24 weeks or death without recorded progression <24 weeks; progressive disease was recorded for patients with initial response without a subsequent partial or complete response recorded.2
AI = aromatase inhibitor; FUL = fulvestrant; LET = letrozole; n = number of patients.

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021Taylor-Stokes G, et al. Breast. 2019;43:22-27.
  2. Taylor-Stokes G, et al. Breast. 2019;43:22-27.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.

rwOS rates

Survival rate in patients treated with IBRANCE + LET (n=360)2

Adapted from Taylor-Stokes G, et al. 2019.2

  • 95.1% and 90.1% of patients treated with 1st line IBRANCE + AI were alive at 12 and 24 months, respectively2

Survival rate in patients treated with IBRANCE + FUL (n=292)*2

Adapted from Taylor-Stokes G, et al. 2019.2
  • 87.9% of patients treated with IBRANCE + FUL in 1st line or later were alive at 1 year*1
  • Physician-assessed clinical benefit rate was >90% for both patients treated with IBRANCE + AI and IBRANCE + FUL.1 For the majority of patients, partial response or stable disease was reported as best response by the physician†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



*Fulvestrant combination approved in the US in Feb 2016, therefore, 18- and 24- month data unavailable. Clinical response was based on physician assessment reported at any time and was not based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. In randomised clinical trials, RECIST criterion for a partial response is a ≥30% reduction in tumour size. In IRIS, complete response was defined as one where “complete response” has been recorded at any time (no 24-week minimum); partial response was defined as one where “partial response” has been recorded at any time (no 24-week minimum); clinical benefit rate was calculated by adding the percentages of patients who achieved complete response, partial response, and stable disease ≥24 weeks; stable disease ≥24 weeks was defined as patient remained on IBRANCE for a minimum of 24 weeks, without complete or partial response, death, treatment switch, or progression; stable disease <24 weeks was defined as stable disease recorded for initial response, with a subsequent progression recorded <24 weeks or treatment switch for reason other than progression <24 weeks or death without recorded progression <24 weeks; progressive disease was recorded for patients with initial response without a subsequent partial or complete response recorded.1

AI = aromatase inhibitor; FUL = fulvestrant; LET = letrozole; n = number of patients. 

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Taylor-Stokes G, et al. Breast. 2019;43:22-27.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868. 

Dose Adjustments

The majority of US patients did not require dose adjustment for the duration of therapy, regardless of starting dose1

The recommended starting dose of IBRANCE per the approved EU Summary of Product Characteristics is 125 mg taken daily, 3 weeks on, 1 week off2


Dose adjustment rates (percent of patients)​​​​​​​

Adapted from Taylor-Stokes G, et al. 2019.1

  • 77.5% and 72.9% of patients initiated IBRANCE at the 125 mg/day dose in combination with an aromatase inhibitor and fulvestrant, respectively*1
  • 5.6% of patients receiving IBRANCE + aromatase inhibitor in 1st line and 10.3% of those receiving IBRANCE + fulvestrant in 1st or later line discontinued treatment for reasons other than disease progression*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.3,4 



*Rates of dose adjustment or discontinuation may differ from those in clinical trials or other real-world data studies partly due to differences in the percentage of patients that started at doses other than 125 mg/day.1
AI = aromatase inhibitor; FUL = fulvestrant; n = number of patients.

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Taylor-Stokes G, et al. Breast. 2019;43:22-27.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868. 

Study Limitations

  • Data were only collected by physicians willing to participate in the study, introducing a potential selection bias1
  • Data were only collected for patients initiating treatment ≥6 months before chart abstraction for IBRANCE + AI and ≥ 3 months for IBRANCE + fulvestrant1
  • The IBRANCE + fulvestrant combination was only approved in the US in February 2016; consequently, 18- and 24- month data were not available for Kaplan-Meier analysis for this group1
  • To eliminate potential selection bias, physicians were asked to select consecutive patients in line with the index date1


AI = aromatase inhibitor. 

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Taylor-Stokes G, et al. Breast. 2019;43:22-27. 

Argentina cohort

Study Design

*The index date was defined as 60 days after the physician first prescribed IBRANCE + letrozole or fulvestrant after regulatory approval in Argentina. Data were extracted from the index date until the last available medical record, death, or date of record abstraction, whichever was earliest. 
ABC = advanced breast cancer; AI = aromatase inhibitor; ET = endocrine therapy; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; = number of patients.

Select baseline characteristics1

  • Median age at IBRANCE initiation was 64 years (range: 29–84)
  • 39% had de novo metastatic disease

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



​​​​​​​Adapted from Waller J, et al. 2019.1
*There were two pre-menopausal patients for whom induction status was not available.1
AI = aromatase inhibitor; ECOG PS = Eastern Cooperative Oncology Group performance status; = number of patients. 

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Waller J, et al. J Glob Oncol. 2019;5:JGO1800239.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868. 

rwPFS rates

Progression-free survival rate in patients treated  with IBRANCE + LET (n=105)1

Adapted from Waller J, et al. 2019.1

  • 85% and 80% of patients treated with 1st line IBRANCE + AI were progression free at 12 and 18 months, respectively1

Progression-free survival rate in patients treated with IBRANCE + FUL (n=57)1

Adapted from Waller J, et al. 2019.1
  • 95% of patients treated with IBRANCE + fulvestrant were progression free at 6 months1
  • Physician-assessed clinical benefit rate was >90% for both patients treated with IBRANCE + AI and IBRANCE + fulvestrant. For the majority of patients, partial response or stable disease was reported as best response by the physician*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


*Includes patients censored for having stable disease. Clinical response was based on physician assessment reported at any time and was not based on RECIST criteria. In randomised clinical trials, RECIST criterion for a partial response is a ≥30% reduction in tumour size. CBR was defined as the proportion of patients with a complete response (CR), partial response (PR), or stable disease lasting 24 weeks or longer. CBR data were censored for patients with less than 24 weeks of data who were still receiving IBRANCE with no evidence of CR, PR, or disease progression. Missing data were not imputed. The >90% CBR includes patients censored for having stable disease.1


AI = aromatase inhibitor; CBR = clinical benefit response; FUL = fulvestrant; LET = letrozole; n = number of patients;
RECIST = Response Evaluation Criteria in Solid Tumors.

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Waller J, et al. J Glob Oncol. 2019;5:JGO1800239.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.

rwOS rates

Survival rate in patients treated with IBRANCE + LET (n=105)​​​​​​​

Adapted from Waller J, et al. 2019.1

  • 93% and 89% of patients treated with 1st line IBRANCE + AI were alive at 12 and 18 months, respectively1

Survival rate in patients treated with IBRANCE + FUL (n=57)1

Adapted from Waller J, et al. 2019.1
  • 98% of patients treated with IBRANCE + fulvestrant were still alive at 6 months1
  • Physician-assessed clinical benefit rate was >90% for both patients treated with IBRANCE + AI and IBRANCE + fulvestrant. For the majority of patients, partial response or stable disease was reported as best response by the physician*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 



*Includes patients censored for having stable disease. Clinical response was based on physician assessment reported at any time and was not based on RECIST criteria. In randomised clinical trials, RECIST criterion for a partial response is a ≥30% reduction in tumour size. CBR was defined as the proportion of patients with a complete response (CR), partial response (PR), or stable disease lasting 24 weeks or longer. CBR data were censored for patients with less than 24 weeks of data who were still receiving IBRANCE with no evidence of CR, PR, or disease progression. Missing data were not imputed. The >90% CBR includes patients censored for having stable disease.1


AI = aromatase inhibitor; CBR = clinical benefit response; FUL = fulvestrant; LET = letrozole; n = number of patients;
RECIST = Response Evaluation Criteria in Solid Tumors.

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Waller J, et al. J Glob Oncol. 2019;5:JGO1800239.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868. 

Dose Adjustments

The majority of Argentinian patients did not require dose adjustment for the duration of therapy, regardless of starting dose1

The recommended starting dose of IBRANCE per the approved EU Summary of Product Characteristics is 125 mg taken daily, 3 weeks on, 1 week off2


Dose adjustment rates (percent of patients)​​​​​​​

Adapted from Waller J, et al. 2019.1

  • 85% and 90% of patients initiated IBRANCE at the 125 mg/day dose in combination with an AI and FUL, respectively*1
  • 8.6% of patients receiving IBRANCE + AI and 8.8% of those receiving IBRANCE + FUL discontinued treatment for reasons other than disease progression*1
  • Dose adjustments were more common in patients aged >65 years and those with visceral disease1


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.3,4 


*Rates of dose adjustment or discontinuation may differ from those in clinical trials or other real-world data studies partly due to differences in the percentage of patients that started at doses other than 125 mg/day.1
AI = aromatase inhibitor; FUL = fulvestrant; LET = letrozole; n = number of patients.


References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Waller J, et al. J Glob Oncol. 2019;5:JGO1800239.
  3. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  4. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868. 

Study Limitations

  • Data were only collected by physicians willing to participate in the study, introducing a potential selection bias, although physicians were asked to select consecutive patients in line with the index date to mitigate this1
  • Data were only collected for patients initiating treatment ≥6 months before chart abstraction for IBRANCE plus letrozole and ≥3 months before chart abstraction for IBRANCE plus fulvestrant because the latter combination was not approved in Argentina until August 20161
  • Consequently, progression and survival data at 12 months and beyond were not available for patients undergoing treatment with IBRANCE plus fulvestrant

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Waller J, et al. J Glob Oncol. 2019;5:JGO1800239. 

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Taylor-Stokes G, et al. Breast. 2019;43:22-27.

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All rights reserved. Date of preparation: June 2020 PP-IBR-GLB-0254

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