Outcomes in Stage IIA vs. Stage IIB/III in the PALLAS Trial
Background
The PALLAS trial studied whether adding palbociclib to standard hormone therapy could lower the chances of breast cancer returning. This analysis focused on patients with lower risk stage IIA compared to those with higher stage diseases.
Methods
PALLAS was a large, international study involving multiple centers. It was a phase III trial that included a partnership between Pfizer and other organizations. Patients with stage II-III, hormone-receptor-positive, HER2-negative breast cancer were eligible if they had completed most of their treatment. They were randomly assigned to receive either standard hormone therapy alone or hormone therapy plus palbociclib for two years.
Results
A total of 5,796 patients participated, including 1,010 with stage IIA. The follow-up period was about 50 months for stage IIA patients. The results showed:
- In the stage IIA group, the 4-year invasive disease-free survival (iDFS) was 92.9% with palbociclib and 92.1% without it.
- No significant benefits were found for palbociclib in terms of other survival measures.
- For stage IIB/III patients, the 4-year iDFS was 85.3% with palbociclib and 83.6% without it.
Conclusions
Despite differences in outcomes between stage IIA and IIB/III patients, adding palbociclib did not improve results for any stage.
Trial Registration
ClinicalTrials.gov number NCT02513394, registered on July 30, 2015.
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