Palbociclib Pfizer

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HomeAboutMode of actionEfficacyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)Real World EvidenceP-REALITY study designP-REALITY patients characteristicsP-REALITY real-world progression-free survivalP-REALITY overall survivalP-REALITY strengthsSafetyImportant Safety InformationSafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresPalbociclib long-term safetyGI and liver toxicitiesEffect of Palbociclib on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyDosingRecommended dosing scheduleRecommended dose modifications for AEsOne scheduled monitoring provisionMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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P-REALITY overall survivalMedian OS (secondary endpoint) was not reached with Palbociclib Pfizer 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 Palbociclib Pfizer + LET vs 68.0% with LET alone1
Adapted from DeMichele A, et al. 2021.1OS was defined as the number of months from the start of treatment with Palbociclib Pfizer 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 Palbociclib Pfizer in combination with letrozole and letrozole alone, respectively

In an exploratory analysis, a consistent OS benefit with Palbociclib Pfizer in combination with letrozole vs letrozole alone was generally observed across examined subgroups, except race (after sIPTW) adjustments*1 Download figure Adapted from DeMichele A, et al. 2021.1Race by Cohort interaction and Metastatic Sites by Cohort interaction were the only subgroup variable-by-treatment cohort interaction that were significant (P<0.0001 and P=0.0050, respectively). However, race data were not present in the “other/unknown” race group. Similar subgroup results were observed in the propensity score matching analysis.Bone-only disease was defined as metastatic disease in the bone only. Visceral disease was defined as metastatic disease in the lung and/or liver; patients could have had other sites of metastases. No visceral disease was defined as no lung or liver metastases.

Small patient numbers can be a limitation of subgroup analyses. These analyses are considered exploratory. No adjustments were made for multiple testing in the subgroup analyses.

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 

The PALOMA-2 randomised clinical trial (1st-line trial of Palbociclib Pfizer in combination with letrozole vs placebo + letrozole) began in February 2013 and includes OS as a secondary endpoint.4 The planned number of events required for a final OS analysis has not been reached. Patients will continue to be followed for the final analysis.

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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 = stabilised 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.Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 
Effectiveness PALOMA-2

Overall survival

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