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

Nitz, Ulrike; Gluz, Oleg; Christgen, Matthias; Kates, Ronald; Clemens, Michael; Malter, Wolfram; Nuding, Benno; Aktas, Bahriye; Küemmel, Sherko; Reimer, Toralf; Stefek, Andrea; Lorenz-Salehi, Fatemeh; Krabisch, Petra; Just, Marianne; Augustin, Doris; Liedtke, Cornelia; Chao, Calvin; Shak, Steven; Wuerstlein, Rachel; Kreipe, Hans; Harbeck, Nadia

doi:10.1007/s10549-017-4358-6

Cited by 161 publications

(174 citation statements)

References 33 publications

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“…Patients should be assessed periodically to confirm the absence of tumor progression. Patients with Stage 1 or limited Stage 2 disease (including those with N1 nodal involvement), and those with low-intermediate grade tumors, lobular BCs, low-risk genomic assays (especially the recurrence score, which may be sent from a core biopsy [26]), or "luminal A" signatures, do not benefit substantially from neoadjuvant or adjuvant chemotherapy [27,28]. These patients may receive endocrine therapy alone.…”

Section: Invasive Bc-early Stagementioning

confidence: 99%

Recommendations for prioritization, treatment, and triage of breast cancer patients during the COVID-19 pandemic. the COVID-19 pandemic breast cancer consortium

Dietz

Moran²,

Isakoff

et al. 2020

Breast Cancer Res Treat

320

409

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The COVID-19 pandemic presents clinicians a unique set of challenges in managing breast cancer (BC) patients. As hospital resources and staff become more limited during the COVID-19 pandemic, it becomes critically important to define which BC patients require more urgent care and which patients can wait for treatment until the pandemic is over. In this Special Communication, we use expert opinion of representatives from multiple cancer care organizations to categorize BC patients into priority levels (A, B, C) for urgency of care across all specialties. Additionally, we provide treatment recommendations for each of these patient scenarios. Priority A patients have conditions that are immediately life threatening or symptomatic requiring urgent treatment. Priority B patients have conditions that do not require immediate treatment but should start treatment before the pandemic is over. Priority C patients have conditions that can be safely deferred until the pandemic is over. The implementation of these recommendations for patient triage, which are based on the highest level available evidence, must be adapted to current availability of hospital resources and severity of the COVID-19 pandemic in each region of the country. Additionally, the risk of disease progression and worse outcomes for patients need to be weighed against the risk of patient and staff exposure to SARS CoV-2 (virus associated with the COVID-19 pandemic). Physicians should use these recommendations to prioritize care for their BC patients and adapt treatment recommendations to the local context at their hospital.

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Section: Invasive Bc-early Stagementioning

confidence: 99%

Recommendations for prioritization, treatment, and triage of breast cancer patients during the COVID-19 pandemic. the COVID-19 pandemic breast cancer consortium

Dietz

Moran²,

Isakoff

et al. 2020

Breast Cancer Res Treat

320

409

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“…The trial is ongoing to accrue patients with intermediate risk (RS 11-25), and we await the next interim analysis to be published. PlanB, a trial using the RS as a key tool in decision-making for chemotherapy, has already demonstrated disease-free survival rates of 94% in women with RS between 11 and 25, treated with hormone therapy alone [17]. …”

Section: Discussionmentioning

confidence: 99%

The Warwick Experience of the Oncotype DX® Breast Recurrence Score® Assay as a Predictor of Chemotherapy Administration

et al. 2018

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Introduction: Oncotype DX® analyses the expression of 21 genes within tumour tissue to determine a Recurrence Score® (RS). RS is a marker of risk for distant recurrence in oestrogen receptor-positive early breast cancer, allowing patient-specific benefit of chemotherapy to be evaluated. Our aim was to determine whether the introduction of Oncotype DX led to a net reduction in chemotherapy use. Methods: Consecutive patients that underwent Oncotype DX at Warwick Hospital were reviewed. Patients were anonymised and re-discussed at a multidisciplinary team meeting (MDM; without RS), and treatment recommendations were recorded. This was compared to the original MDM outcome (recommendations made with RS). Differences were analysed using Wilcoxon signed-rank test. Results: 67 patients were identified. Proportions of high, intermediate and low risk were 28, 33 and 39% (n = 19/22/26), respectively. Without RS, 56 (84%) patients were recommended for chemotherapy and 3 were not. The remaining 8 patients were deemed borderline for requiring chemotherapy and referred for discussion with an oncologist. With availability of RS, 34 (50%) patients were recommended for chemotherapy, and 24 (43%) patients were spared chemotherapy (p < 0.0005). The net reduction in chemotherapy was 33%. Conclusion: There has been a significant reduction in chemotherapy usage in patients at Warwick since the introduction of Oncotype DX.

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“…The authors emphasized on the one hand that patients with a low RS had a very good prognosis with purely endocrine therapy, and on the other that the substantial discordance between traditional pathological parameters and the RS makes further standardization necessary and that wellstandardized and validated gene expression tests ought to be taken into account in the choice of treatment. In another recent analysis from the PlanB study, Nitz et al also investigated clinical and pathological prognostic factors such as nodal status, grading, tumor size, Ki-67, PR, and four immunohistochemical markers (IHC4) alongside the recurrence score [21]. The prognostic significance of the RS was particularly marked with tumors that had moderate Ki-67 values (> 10 %, < 40 %).…”

Section: Comparison Of Different Multigene Testsmentioning

confidence: 99%

Gene Expression Analyses in Early Breast Carcinoma — Quo Vadis?

Almstedt

Denkert

Schmidt

2017

Senologie - Zeitschrift für Mammadiagnostik und -therapie

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In order to establish whether adjuvant therapy should be administered in patients with breast carcinoma, it is decisive to have as precise as possible an assessment of the risk of recurrence. In this context, gene expression — and thus gene expression signatures as well — have become a focus of attention as prognostic factors. For practical application, it is important to be able to analyze gene expression signatures in formalin-fixed, paraffin-embedded tumor tissue. Careful analytic and clinical validations and a high level of evidence (LoE) are required in order to avoid imprecise risk classification and thus potential overtreatment or undertreatment of the patients. Among the commercially available gene expression signatures, the Working Group on Gynecological Oncology (Arbeitsgemeinschaft Gynäkologische Onkologie, AGO) currently grades MammaPrint® and Oncotype DX® as having LoE IA, with prospective study results; and Endopredict® and Prosigna® as having LoE IB. The panel members at this year’s St. Gallen consensus conference also voted by a majority in favor of the possible usage of Oncotype DX®, MammaPrint®, Prosigna®, EndoPredict®, and Breast Cancer Index®. These multigene tests can be used in selected patients with hormone receptor–positive and HER2-negative findings if none of the other criteria allow a treatment decision to be made.

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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

Cited by 161 publications

References 33 publications

Recommendations for prioritization, treatment, and triage of breast cancer patients during the COVID-19 pandemic. the COVID-19 pandemic breast cancer consortium

Recommendations for prioritization, treatment, and triage of breast cancer patients during the COVID-19 pandemic. the COVID-19 pandemic breast cancer consortium

The Warwick Experience of the Oncotype DX® Breast Recurrence Score® Assay as a Predictor of Chemotherapy Administration

Gene Expression Analyses in Early Breast Carcinoma — Quo Vadis?

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