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Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]).

A DeMichele1,2, A C Dueck3, D Hlauschek4

  • 1Department of Hematology and Oncology, Perelman Center for Advanced Medicine, University of Pennsylvania, Room 10-153, 3400 Civic Center Blvd., Philadelphia, PA, 19104, USA. Angela.demichele@pennmedicine.upenn.edu.

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The PALLAS trial found that adding palbociclib to endocrine therapy did not improve outcomes for early breast cancer patients. This includes those with lower-risk stage IIA disease compared to higher-risk stages.

Keywords:
AdjuvantCDK4/6 inhibitorEndocrineStage II breast cancer

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Area of Science:

  • Oncology
  • Clinical Trials
  • Breast Cancer Research

Background:

  • The PALLAS trial evaluated palbociclib plus standard adjuvant endocrine therapy (ET) for early breast cancer to reduce recurrence.
  • A specific analysis focused on whether palbociclib benefited patients with lower-risk stage IIA disease compared to higher-stage disease.

Purpose of the Study:

  • To determine the efficacy of adjuvant palbociclib in patients with stage IIA early breast cancer.
  • To compare outcomes between patients receiving standard ET alone versus ET plus palbociclib.

Main Methods:

  • A randomized, open-label, phase III trial (PALLAS, NCT02513394) involving 5,796 patients with hormone receptor-positive, HER2-negative early breast cancer (stage II-III).
  • Patients received standard ET for at least 5 years, with or without 2 years of oral palbociclib (125 mg daily for 21 days on/7 days off).
  • Tumor blocks were required, and patients were stratified by stage (IIA vs. IIB/III) and other risk factors.

Main Results:

  • In the stage IIA cohort (1,010 patients), 4-year invasive disease-free survival (iDFS) was 92.9% with palbociclib + ET versus 92.1% with ET alone (HR 0.75, p=0.23).
  • No significant benefit of palbociclib was observed in stage IIA patients across various endpoints, including invasive breast cancer-free survival (iBCFS), locoregional relapse-free survival (LRFS), distant relapse-free survival (DRFS), or overall survival (OS).
  • For stage IIB/III patients, 4-year iDFS was 85.3% with palbociclib + ET versus 83.6% with ET alone (HR 0.91, p=0.24).

Conclusions:

  • Despite differences in outcomes between stage IIA and IIB/III patients, the addition of palbociclib did not improve outcomes for either group.
  • Adjuvant palbociclib is not recommended for patients with stage IIA hormone receptor-positive, HER2-negative early breast cancer.