Efficacy
PALOMA-2
The PALOMA-2 study met its primary end point by showing an improved progression free survival of 24.8 months (95% CI, 22.1 to not estimable) compared to 14.5 months (95% CI, 12.9 to 17.1) in the letrozole-placebo group with a hazard ratio for disease progression or death, 0.58, 95% CI, 0.46 to 0.72; two sided P<0.001.
Data on overall survival were immature at the time of analysis of the primary end point and final overall survival analysis will be performed when a total of 390 deaths occur per protocol.
Kaplan-meier analysis of progression-free survival
© NEJM 2016
Subgroup analyses of progression-free survival according to baseline characteristics and stratification factors, showed a consistent benefit of palbociclib plus letrozole across all subgroups..
Best overall response (in the intention-to-treat population)
© NEJM 2016
PALOMA-3
In the PALOMA-3 study the median progression free survival was 9.5 months (95% CI, 9.2 - 11.0) in the palbociclib plus fulvestrant group compared with 4.6 months (95% CI, 3.5 - 5.6) in the fulvestrant plus placebo group (HR 0.46, 95% CI, 0.36 – 0.59, two sided p<0.0001).
Kaplan-meier analysis of progression free survival
A) intention to treat population, B) patients who had received neoadjuvant or adjuvant therapy but no previous systemic therapy for metastatic breast cancer, C) patients who received at least one previous systemic therapy for metastatic breast cancer.
Note: previous systemic therapy means chemotherapy or endocrine therapy, or both. HR = hazard ratio, NE = not estimable
© Lancet Oncol 2016
Subgroup analyses of progression-free survival were generally consistent with the results from the overall population.
Best overall tumour response by treatment and according to PIK3CA mutation status in the intention-to-treat populationr
© Lancet Oncol 2016
Median overall survival was 34.9 months (95% CI, 28.8-40.0) in the palbociclib plus fulvestrant group and 28.0 months (95% CI, 23.6-34.6) in the fulvestrant plus placebo group (HR 0.81, 95% CI 0.64-1.03, P=0.09).r
Kaplan-meier analysis of overall survival in the intention-to-treat populationr
© N Engl J Med 2018