Real-world use of multigene signatures in early breast cancer: differences to clinical trials.

Autor: Licata L; Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy. licata.luca@hsr.it.; School of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy. licata.luca@hsr.it., De Sanctis R; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.; Medical Oncology and Hematology Unit, IRCCS - Humanitas Research Hospital, Rozzano, Milan, Italy., Vingiani A; Deparment of Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.; School of Medicine, University of Milan, Milan, Italy., Cosentini D; Medical Oncology Unit, ASST Spedali Civili of Brescia, Brescia, Italy., Iorfida M; Division of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy., Caremoli ER; Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy., Sassi I; Pathology Unit, IRCCS Ospedale San Raffaele, Milan, Italy., Fernandes B; Department of Pathology, IRCCS - Humanitas Research Hospital, Rozzano - Milan, Italy., Gianatti A; Department of Pathology, ASST Papa Giovanni XXIII, Bergamo, Italy., Guerini-Rocco E; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy.; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy., Zambelli C; Pathology Unit, ASST Spedali Civili of Brescia, Brescia, Italy., Munzone E; Division of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy., Simoncini EL; SSVD Breast Unit, ASST Spedali Civili of Brescia, Brescia, Italy., Tondini C; Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy., Gentilini OD; School of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy.; Breast Surgery Unit, San Raffaele Hospital, Milan, Italy., Zambelli A; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.; Medical Oncology and Hematology Unit, IRCCS - Humanitas Research Hospital, Rozzano, Milan, Italy., Pruneri G; Deparment of Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.; School of Medicine, University of Milan, Milan, Italy., Bianchini G; Department of Medical Oncology, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy.; School of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2024 May; Vol. 205 (1), pp. 39-48. Date of Electronic Publication: 2024 Jan 24.
DOI: 10.1007/s10549-023-07227-0
Abstrakt: Purpose: In Italy, Lombardy was the first region to reimburse multigene assays (MGAs) for patients otherwise candidates for chemotherapy. This is a real-world experience of MGAs usage in six referral cancer centers in Lombardy.
Methods: Among MGAs, Oncotype DX (RS) was used in 97% of cases. Consecutive patients tested with Oncotype DX from July 2020 to July 2022 were selected. The distribution of clinicopathologic features by RS groups (low RS: 0-25, high RS: 26-100) was assessed using chi-square and compared with those of the TAILORx and RxPONDER trials.
Results: Out of 1,098 patients identified, 73% had low RS. Grade and Ki67 were associated with RS (p < 0.001). In patients with both G3 and Ki67 > 30%, 39% had low RS, while in patients with both G1 and Ki67 < 20%, 7% had high RS. The proportion of low RS in node-positive patients was similar to that in RxPONDER (82% vs 83%), while node-negative patients with low RS were significantly less than in TAILORx (66% vs 86%, p < 0.001). The distribution of Grade was different from registration trials, with more G3 and fewer G1 (38% and 3%) than in TAILORx (18% and 27%) and RxPONDER (10% and 24%) (p < 0.001). Patients ≤ 50 years were overrepresented in this series (41%) than in TAILORx and RxPONDER (31% and 24%, respectively) (p < 0.001) and, among them, 42% were node positive.
Conclusions: In this real-world series, Oncotype DX was the test almost exclusively used. Despite reimbursement being linked to pre-test chemotherapy recommendation, almost 3/4 patients resulted in the low-RS group. The significant proportion of node-positive patients ≤ 50 years tested indicates that oncologists considered Oncotype DX informative also in this population.
(© 2024. The Author(s).)
Databáze: MEDLINE
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