Universität zu Köln

Nitz, Ulrike, Gluz, Oleg, Christgen, Matthias, Kates, Ronald E., Clemens, Michael, Malter, Wolfram, Nuding, Benno, Aktas, Bahriye, Kuemmel, Sherko, Reimer, Toralf, Stefek, Andrea, Lorenz-Salehi, Fatemeh, Krabisch, Petra, Just, Marianne, Augustin, Doris, Liedtke, Cornelia, Chao, Calvin, Shak, Steven, Wuerstlein, Rachel, Kreipe, Hans H. and Harbeck, Nadia (2017). 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. Breast Cancer Res. Treat., 165 (3). S. 573 - 584. NEW YORK: SPRINGER. ISSN 1573-7217

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Abstract

The prospective phase 3 PlanB trial used the Oncotype DXA (R) Recurrence Score(A (R)) (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 ae<currency> 11 patients were recommended to omit chemotherapy. Patients with RS ae<yen> 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 ae<currency> 11 patients. After 55 months of median follow-up, five-year DFS in ET-treated RS ae<currency> 11 patients was 94% (in both pN0 and pN1) versus 94% (RS 12-25) and 84% (RS > 25) in chemotherapy-treated patients (p < 0.001); five-year overall survival (OS) was 99 versus 97% and 93%, respectively (p < 0.001). Nodal status, central/local grade, tumour size, continuous Ki-67, progesterone receptor (PR), IHC4, and RS were univariate prognostic factors for DFS. In a multivariate analysis including all univariate prognostic markers, only pN2-3, central and local grade 3, tumour size > 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%, < 40%) tumours. The excellent five-year outcomes in clinically high-risk, genomically low-risk (RS ae<currency> 11) pN0-1 patients without adjuvant chemotherapy support using RS with standardised pathology for treatment decisions in HR+ HER2-negative EBC. Ki-67 has the potential to support patient selection for genomic testing.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Nitz, Ulrike UNSPECIFIED UNSPECIFIED UNSPECIFIED Gluz, Oleg UNSPECIFIED UNSPECIFIED UNSPECIFIED Christgen, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Kates, Ronald E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Clemens, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Malter, Wolfram UNSPECIFIED UNSPECIFIED UNSPECIFIED Nuding, Benno UNSPECIFIED UNSPECIFIED UNSPECIFIED Aktas, Bahriye UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuemmel, Sherko UNSPECIFIED UNSPECIFIED UNSPECIFIED Reimer, Toralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Stefek, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Lorenz-Salehi, Fatemeh UNSPECIFIED UNSPECIFIED UNSPECIFIED Krabisch, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Just, Marianne UNSPECIFIED UNSPECIFIED UNSPECIFIED Augustin, Doris UNSPECIFIED UNSPECIFIED UNSPECIFIED Liedtke, Cornelia UNSPECIFIED UNSPECIFIED UNSPECIFIED Chao, Calvin UNSPECIFIED UNSPECIFIED UNSPECIFIED Shak, Steven UNSPECIFIED UNSPECIFIED UNSPECIFIED Wuerstlein, Rachel UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreipe, Hans H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harbeck, Nadia UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-217009
DOI:	10.1007/s10549-017-4358-6
Journal or Publication Title:	Breast Cancer Res. Treat.
Volume:	165
Number:	3
Page Range:	S. 573 - 584
Date:	2017
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1573-7217
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DX RECURRENCE SCORE; DISTANT RECURRENCE; ESTROGEN-RECEPTOR; POSTMENOPAUSAL PATIENTS; PROGESTERONE-RECEPTOR; INTERNATIONAL KI67; GENE-EXPRESSION; ASSAY; RECOMMENDATIONS; VALIDATION Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/21700