Outcomes in Stage IIA vs. Stage IIB/III in the PALLAS Trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13])

Author:

DeMichele Angela1,Dueck Amylou2,Hlauschek Dominik3,Martin Miguel4,Burstein Hal5,Pfeiler Georg6,Zdenkowski Nick7,Wolff Antonio8,Bellet-Ezquerra Meritxell9,Winer Eric10,Balic Marija11,Miller Kathy12,Colleoni Marco13,Lake Diana14,Rubovsky Gabor15,Cameron David16,Balko Justin17,Singer Christian6,Nowecki Zbigniew18,Iwata Hiroji19,Wolmark Norman20,Parraga Kepa Amilano21,Rugo Hope22,Steger Guenther G6,Traina Tiffany14,Werutsky Gustavo23,Czajkowska Dorota3,Metzger Otto5,El-Abed Sarra24,Theall Kathy Puyana25,Lu Ray Dongrui25,O’Brien Patrick26,Fesl Christian3,Mayer Erica5,Gnant Michael6

Affiliation:

1. University of Pennsylvania

2. Mayo Clinic

3. Austrian Breast & Colorectal Cancer Study Group

4. Hospital General Universitario Gregorio Marañón

5. Dana-Farber Cancer Institute

6. Medical University of Vienna

7. Calvary Mater Newcastle Hospital

8. Johns Hopkins University

9. Vall d'Hebron Hospital Universitari

10. Yale Cancer Center

11. Medical University of Graz

12. Indiana University

13. European Institute of Oncology

14. Memorial Sloan Kettering Cancer Center

15. National Institute of Oncology

16. The Edinburgh Cancer Research Centre

17. Vanderbilt University

18. The Maria Sklodowska-Curie National Research Institute of Oncology

19. Aichi Cancer Center

20. NSABP Foundation

21. Hospital Universitari Sant Joan de Reus

22. University of California, San Francisco

23. Hospital São Lucas da PUCRS

24. Breast International Group

25. Pfizer (United States)

26. Alliance Foundation Trials

Abstract

Abstract

Background The PALLAS trial investigated the addition of palbociclib to standard adjuvant endocrine therapy reduces breast cancer recurrence. This pre-specified analysis was conducted to determine whether adjuvant palbociclib benefited patients diagnosed with lower risk stage IIA disease compared to those with higher stage disease. Methods PALLAS was an international, multicenter, randomized, open-label, phase III trial, representing a public-private partnership between Pfizer, the Austrian Breast Cancer Study Group and, the U.S. ALLIANCE Foundation. Patients diagnosed with stage II-III, hormone-receptor-positive, HER2/neu negative breast cancer who were within 12 months of diagnosis, and had completed all definitive therapy aside from endocrine therapy, which was started within 6 months prior to study entry. All patients were required to submit a formalin-fixed paraffin-embedded (FFPE) tumor block. Patients were randomly assigned 1:1 to receive standard adjuvant endocrine therapy (of physicians’ choice) for at least 5 years with or without 2 years of Palbociclib, administered orally at a starting dose of 125 mg daily, given for 21 days followed by a 7-day break. Results A total of 5,796 patients with HR+/HER2- early breast cancer (including 1,010 with stage IIA) were enrolled. Median follow-up was 50 months for stage IIA patients and 43.1 months overall. In the stage IIA cohort, four-year iDFS in the palbociclib arm was 92.9% versus 92.1% for ET alone (HR 0.75, 95%CI 0.48–1.19, p = 0.23). There was no differential benefit by histologic grade, chemotherapy receipt, age, or anatomic/clinical risk. Additionally, no benefit to palbociclib was seen in this cohort in invasive breast cancer-free survival (iBCFS), locoregional relapse-free survival (LRFS), distant relapse-free survival (DRFS), or overall survival (OS). For the stage IIB/III patients, 4-year iDFS was 85.3% for palbociclib + ET versus 83.6% for ET alone (HR 0.91, 95% CI 0.77–1.07, p = 0.24). Conclusions and Relevance: While there were substantial differences in outcome for stage IIA versus IIB/III patients at 4 years of follow-up, the addition of 2 years of palbociclib did not improve outcomes for patients, regardless of stage. Trial Registration: The study was registered on Clinicaltrials.gov on July 31, 2015, and was assigned the clinical trial number (NCT02513394).

Publisher

Springer Science and Business Media LLC

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