70-Gene signature-guided adjuvant systemic treatment adjustments in early-stage ER+ breast cancer patients: 7-year follow-up of a prospective multicenter cohort study

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2024年9月30日

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Eline E. F. Verreck,
Anne Kuijer,
Julia E. C. van Steenhoven,
José H. Volders,
Annette W. G. van der Velden,
Sabine Siesling,
Anja N. H. Timmer-Bonte,
Tineke J. Smilde,
Alex L. T. Imholz,
Charlotte F. J. M. Blanken-Peeters,
Bart de Valk,
Suzan Vrijaldenhoven,
Willem B. Lastdrager,
Annebeth W. Haringhuizen,
Jarmo C. B. Hunting,
Sjoerd Hovenga,
Peter Nieboer,
Hanneke M. Zuetenhorst,
Geert W. M. Tetteroo,
Carolien H. Smorenburg,
Marissa C. van Maaren,
Thijs van Dalen

摘要

Background

A previous prospective multicenter study revealed the change of the oncologists’ chemotherapy advice due to the 70-Gene signature (GS) test result in half of the estrogen receptor-positive (ER+) invasive early-stage breast cancer patients with disputable chemotherapy indication. This resulted in less patients receiving chemotherapy. This study aims to complement these results by the 7-year oncological outcomes according to the 70-GS test result and the oncologists’ pre-test advice.

Methods

Patients operated for early-stage ER+ breast cancer with disputable chemotherapy indication, had been prospectively included between 2013 and 2015. Oncologists were asked whether they intended to administer adjuvant chemotherapy before deployment of the 70-GS test. Information on adjuvant systemic treatment and oncological outcome was obtained through active follow-up by data managers of the Netherlands Cancer Registry. The primary endpoint of this study was distant metastasis-free survival (DMFS) according to the genomic risk. Exploratory analyses were done to evaluate DMFS in relation to the oncologists’ pre-test advice.

Results

After a median follow-up of 7 years, distant metastases were diagnosed in 23 of the 606 patients (3.8%) and 36 (5.9%) patients had died. The DMFS rate for the 357 70-GS genomic low-risk patients was 94.2% (95% CI 91.2–96.2) and 89.1% for the 249 genomic high-risk patients (95% CI 84.3–92.4). Of the low-risk patients 3% had received chemotherapy compared to 80% of the high-risk patients. For the subgroups based on the pre-test oncologists’ advice (no chemotherapy/chemotherapy/unsure) there were no clinically relevant differences in DMFS (89.8, 93.2 and 92.0%, respectively), while comparable proportions of patients had received chemotherapy.

Conclusions

In patients with early-stage ER+ breast cancer with a disputable chemotherapy indication it is sensible to deploy the 70-GS to better select patients for adjuvant chemotherapy.