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Published in: Journal of Cancer Research and Clinical Oncology 9/2023

21-01-2023 | Breast Cancer | Research

Neoadjuvant endocrine therapy with or without palbociclib in low-risk patients: a phase III randomized double-blind SAFIA trial

Authors: K. Alsaleh, H. Al Zahwahry, A. Bounedjar, M. Oukkal, A. Saadeddine, H. Mahfouf, K. Bouzid, A. Bensalem, T. Filali, H. Abdel-Razeq, B. Larbaoui, A. Kandil, O. Abulkhair, M. Al Foheidi, M. Ghosn, H. Rasool, H. Boussen, A. Mezlini, A. Haddaoui, J. Ayari, M. Al Ghamdi, H. Errihani, N. Abdel-Aziz, M. Arafah, F. Dabouz, M. Bahadoor, S. Kullab, J. M. Nabholtz, King Saud University, Riyadh, Kingdom of Saudi Arabia, and the International Cancer Research Group (ICRG), Sharjah, Unites Arab Emirates

Published in: Journal of Cancer Research and Clinical Oncology | Issue 9/2023

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Abstract

Background

The most prevalent subtype of breast cancer (BC) is luminal hormonal-positive breast cancer. The neoadjuvant chemotherapy regimens have side effects, emphasizing the need to identify new startegies.

Objective

Analyze the complete pathologic response (pCR) rate and overall response in a low-risk hormone-positive subset of patients receiving neoadjuvant hormone treatment (NAHT) with or without Palbociclib (a CDK4/CDK6 inhibitor) to boost NAHT effectiveness.

Materials and methods

Based on the upfront 21-gene Oncotype DX or low-risk Breast Recurrence Score assay (RS™), the SAFIA trial is designed as a prospective multicenter international, double-blind neoadjuvant phase-III trial that selects operable with luminal BC patients that are HER2-negative for the induction hormonal therapy with Fulvestrant 500 mg ± Goserelin (F/G) followed by randomization of responding patients to palbociclib versus placebo. The pCR rate served as the study’s main outcome, while the secondary endpoint was a clinical benefit.

Results

Of the 354 patients enrolled, 253 initially responded and were randomized to either F/G fulvestrant with palbociclib or placebo. Two hundred twenty-nine were eligible for the evaluation of the pathologic response. No statistically significant changes were observed in the pCR rates for the patients treated with the F/G therapy with placebo or palbociclib (7% versus 2%, respectively) per the Chevallier classification (Class1 + Class2) (p = 0.1464) and 3% versus 10% assessed per Sataloff Classification (TA, NA/NB) (p = 0.3108). Palbociclib did not increase the rate of complete pathological response.

Conclusion

Neoadjuvant hormonal therapy is feasible in a selected population with a low RS score of < 31

Clinical trial

NCT03447132.
Appendix
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Metadata
Title
Neoadjuvant endocrine therapy with or without palbociclib in low-risk patients: a phase III randomized double-blind SAFIA trial
Authors
K. Alsaleh
H. Al Zahwahry
A. Bounedjar
M. Oukkal
A. Saadeddine
H. Mahfouf
K. Bouzid
A. Bensalem
T. Filali
H. Abdel-Razeq
B. Larbaoui
A. Kandil
O. Abulkhair
M. Al Foheidi
M. Ghosn
H. Rasool
H. Boussen
A. Mezlini
A. Haddaoui
J. Ayari
M. Al Ghamdi
H. Errihani
N. Abdel-Aziz
M. Arafah
F. Dabouz
M. Bahadoor
S. Kullab
J. M. Nabholtz
King Saud University, Riyadh, Kingdom of Saudi Arabia, and the International Cancer Research Group (ICRG), Sharjah, Unites Arab Emirates
Publication date
21-01-2023
Publisher
Springer Berlin Heidelberg
Published in
Journal of Cancer Research and Clinical Oncology / Issue 9/2023
Print ISSN: 0171-5216
Electronic ISSN: 1432-1335
DOI
https://doi.org/10.1007/s00432-023-04588-3

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