by Federica
Miglietta, Michela Cinquini, Maria Vittoria Dieci, Laura Cortesi, Carmen
Criscitiello, Filippo Montemurro, Lucia Del Mastro, Alberto Zambelli, Laura
Biganzoli, Alessia Levaggi, Chiara Delle Piane, Caterina Marchiò, Massimo
Calabrese, Lucio Fortunato, Pierfrancesco Franco, Bruno Meduri, Veronica Andrea
Fittipaldo, Stefania Gori
The Breast: VOLUME 66, P293-304, DECEMBER
01, 2022
Background
Approximately 5–10%
of unselected breast cancer (BC) patients retain a hereditary predisposition
related to a germline mutation in BRCA1/2 genes. The poly-ADP ribose polymerase
(PARP)-inhibitors olaparib and talazoparib have been granted marketing authorization
by both FDA and EMA for adults with BRCA1/2 germline mutations and
HER2-negative (HER2-) advanced BC based on the results from the phase III
OlympiAd and EMBRACA trials.
Methods
The panel of the
Italian Association of Medical Oncology (AIOM) Clinical Practice Guidelines on
Breast Cancer addressed two critical clinical questions, adopting the Grades of
Recommendation, Assessment, Development and Evaluation (GRADE) approach and the
Evidence to Decision framework (EtD), to develop recommendations on the use of
PARP-inhibitors, with respect to single-agent chemotherapy, in patients with
BRCA-related triple-negative (clinical question 1) and hormone
receptor-positive (HR+)/HER2- (clinical question 2) advanced BC.
Results
Two studies were
eligible (OlympiAd and EMBRACA). For both clinical questions, the Panel judged
the benefit/harm balance probably in favor of the intervention, given the
favorable impact in terms of PFS, ORR, and QoL at an acceptable cost in terms
of toxicity; the overall certainty of the evidence was low. The panel's final
recommendations were conditional in favor of PARP-inhibitors over single-agent
chemotherapy in both HR+/HER2-and triple-negative BC. Finally, the Panel
identified and discussed areas of uncertainty calling for further exploration.
Conclusions
The Panel of AIOM
BC Clinical Practice Guideline provided clinical recommendations on the use of
PARP-inhibitors, with respect to single-agent chemotherapy, in patients with
BRCA-related HER2-advanced BC by adopting the GRADE methodology.
