Real-world use of multigene signatures in early breast cancer : differences to clinical trials
© 2024. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Breast cancer research and treatment - (2024) vom: 24. Jan. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Licata, Luca [VerfasserIn] |
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| Links: |
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| Themen: |
Adjuvant therapy |
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| Anmerkungen: |
Date Revised 24.01.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1007/s10549-023-07227-0 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367559935 |
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| 245 | 1 | 0 | |a Real-world use of multigene signatures in early breast cancer |b differences to clinical trials |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Adjuvant therapy | |
| 650 | 4 | |a ER+/HER2− early breast cancer | |
| 650 | 4 | |a Multigene assays | |
| 650 | 4 | |a Oncotype DX | |
| 700 | 1 | |a De Sanctis, Rita |e verfasserin |4 aut | |
| 700 | 1 | |a Vingiani, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Cosentini, Deborah |e verfasserin |4 aut | |
| 700 | 1 | |a Iorfida, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Caremoli, Elena Rota |e verfasserin |4 aut | |
| 700 | 1 | |a Sassi, Isabella |e verfasserin |4 aut | |
| 700 | 1 | |a Fernandes, Bethania |e verfasserin |4 aut | |
| 700 | 1 | |a Gianatti, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Guerini-Rocco, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Zambelli, Claudia |e verfasserin |4 aut | |
| 700 | 1 | |a Munzone, Elisabetta |e verfasserin |4 aut | |
| 700 | 1 | |a Simoncini, Edda Lucia |e verfasserin |4 aut | |
| 700 | 1 | |a Tondini, Carlo |e verfasserin |4 aut | |
| 700 | 1 | |a Gentilini, Oreste Davide |e verfasserin |4 aut | |
| 700 | 1 | |a Zambelli, Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Pruneri, Giancarlo |e verfasserin |4 aut | |
| 700 | 1 | |a Bianchini, Giampaolo |e verfasserin |4 aut | |
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