Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial
In: Breast Cancer Research and Treatment, Jg. 165 (2017-06-29), S. 573-583
Online
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Zugriff:
The prospective phase 3 PlanB trial used the Oncotype DX® Recurrence Score® (RS) to define a genomically low-risk subset of clinically high-risk pN0-1 early breast cancer (EBC) patients for treatment with adjuvant endocrine therapy (ET) alone. Here, we report five-year data evaluating the prognostic value of RS, Ki-67, and other traditional clinicopathological parameters. A central tumour bank was prospectively established within PlanB. Following an early amendment, hormone receptor (HR)+ , pN0-1 RS ≤ 11 patients were recommended to omit chemotherapy. Patients with RS ≥ 12, pN2-3, or HR-negative/HER2-negative disease were randomised to anthracycline-containing or anthracycline-free chemotherapy. Primary endpoint: disease-free survival (DFS). PlanB Clinicaltrials.gov identifier: NCT01049425. From 2009 to 2011, PlanB enrolled 3198 patients (central tumour bank, n = 3073) with the median age of 56 years, 41.1% pN+, and 32.5% grade 3 EBC. Chemotherapy was omitted in 348/404 (86.1%) eligible RS ≤ 11 patients. After 55 months of median follow-up, five-year DFS in ET-treated RS ≤ 11 patients was 94% (in both pN0 and pN1) versus 94% (RS 12–25) and 84% (RS > 25) in chemotherapy-treated patients (p 2 cm, and RS, but not IHC4 or Ki-67 were independent adverse factors. If RS was excluded, IHC4 or both Ki-67 and PR entered the model. The impact of RS was particularly pronounced in patients with intermediate Ki-67 (>10%
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Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial
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Autor/in / Beteiligte Person: | Wuerstlein, Rachel ; Augustin, Doris ; Aktas, Bahriye ; Kates, Ronald E. ; Lorenz-Salehi, F ; Krabisch, Petra ; Nuding, Benno ; Malter, Wolfram ; Harbeck, Nadia ; Nitz, Ulrike ; Clemens, Michael R. ; Kreipe, Hans ; Just, Marianne ; Gluz, Oleg ; Reimer, Toralf ; Stefek, Andrea ; Chao, Calvin ; Christgen, Matthias ; Liedtke, Cornelia ; Kuemmel, Sherko ; Shak, Steven |
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Zeitschrift: | Breast Cancer Research and Treatment, Jg. 165 (2017-06-29), S. 573-583 |
Veröffentlichung: | Springer Science and Business Media LLC, 2017 |
Medientyp: | unknown |
ISSN: | 1573-7217 (print) ; 0167-6806 (print) |
DOI: | 10.1007/s10549-017-4358-6 |
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