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. 2023 Jun 2;9(1):49.
doi: 10.1038/s41523-023-00549-8.

Clinical outcomes in estrogen receptor-positive early-stage breast cancer patients with Recurrence Score 26-30: observational real-world cohort study

Ofer Rotem #  1 , Idit Peretz #  2 , Michelle Leviov  3 , Iryna Kuchuk  4 , Amit Itay  5 , Margarita Tokar  6 , Shani Paluch-Shimon  7   8 , Ofra Maimon  7 , Rinat Yerushalmi  2   9 , Karen Drumea  3 , Ella Evron  8   10 , Amir Sonnenblick  9   11 , Einav Gal-Yam  5   9 , Hadar Goldvaser  8   12 , Yosef Samih  13 , Rotem Merose  14 , Avital Bareket-Samish  15 , Lior Soussan-Gutman  16 , Salomon M Stemmer  2   9
Affiliations

Clinical outcomes in estrogen receptor-positive early-stage breast cancer patients with Recurrence Score 26-30: observational real-world cohort study

Ofer Rotem et al. NPJ Breast Cancer. .

Abstract

Data on adjuvant chemotherapy (CT) benefit in ER + HER2‒ early-stage breast cancer (EBC) patients with Recurrence Score (RS) 26-30 are limited. This real-world study evaluated the relationships between the RS, adjuvant treatments, and outcomes in 534 RS 26-30 patients tested through Clalit Health Services (N0: n = 394, 49% CT-treated; N1mi/N1: n = 140, 62% CT-treated). The CT-treated and untreated groups were imbalanced (more high-risk clinicopathologic characteristics in CT-treated patients). With median follow-up of 8 years, Kaplan-Meier estimates for overall survival (OS), distant recurrence-free survival (DRFS), and BC-specific mortality (BCSM) were not significantly different between CT-treated and untreated N0 patients. Seven-year rates (95% CI) in CT-treated vs untreated: OS, 97.9% (94.4-99.2%) vs 97.9% (94.6-99.2%); DRFS, 91.5% (86.6-94.7%) vs 91.2% (86.0-94.6%); BCSM, 0.5% (0.1-3.7%) vs 1.6% (0.5-4.7%). For N1mi/N1 patients, OS/DRFS did not differ significantly between treatment groups; whereas BCSM did (1.3% [0.2-8.6%] vs 6.2% [2.0-17.7%] for CT-treated and untreated patients, respectively, p = 0.024).

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Conflict of interest statement

The authors declared the following competing financial interests. O.R. reported being a consultant for Rhenium. S.P-S. reported being a speaker for Exact Sciences, and Nanostring, A.S. reported being a consultant for Progenetics, H.G. reported receiving honoraria from Rhenium Oncotest. A.B-S. reported being a consultant for Oncotest, and Exact Sciences. L.S-G. reported being employed at Rhenium Oncotest. The authors declared the following competing nonfinancial interests. O.R. reported being a speaker for AstraZeneca, Boehringer Ingelheim, BMS, MSD, Novartis, Pfizer, Roche, Takeda and Teva, and being a consultant for NucleaiMD and Edocate. I.K. reported being a speaker and receiving travel support for Roche, Pfizer, and Medison. S.P-S. reported being a speaker for Roche, Novartis, Pfizer, and AstraZeneca, being a consultant for Roche, Novartis, Eli Lilly, Gilead, MSD, Pfizer and AstraZeneca, and receiving travel support from Roche and Pfizer. R.Y. reported being a speaker for Roche, Novartis, MSD, AstraZeneca, and Eli Lilly, and being a consultant for Roche, Pfizer, Novartis, Medison, AstraZeneca, Gilead, and Eli Lilly. A.S. reported being a speaker for Teva, Roche, Pfizer, Novartis, and Eli Lilly; being a consultant for Eli Lilly, Pfizer, Novartis, Roche, Gilead, MSD, and AstraZeneca, receiving travels/accommodation support from Neopharm, Celgene, Medison, and Roche, and receiving a grant from Novartis and Roche. E.G-Y. reported receiving honoraria from Roche, Novartis, Eli Lilly, Pfizer, MSD, and AstraZeneca. H.G. reported receiving honoraria from Roche, Novartis, Pfizer, and MSD, and being a consultant for Novartis, Pfizer, Eli Lilly, and Gilead. A.B-S. reported being a consultant for Pfizer and Can-Fite. Dr. Stemmer reported receiving research grant from Can-Fite, AstraZeneca, Bioline RX, BMS, Halozyme, Clovis Oncology, CTG Pharma, Exelexis, Geicam, Halozyme, Incyte, Lilly, Moderna, Teva pharmaceuticals, and Roche, and owning stocks and options in CTG Pharma, DocBoxMD, Tyrnovo, VYPE, Cytora, and CAN-FITE. The remaining authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1. Patient disposition.
HER2 human epidermal growth factor receptor 2, RS Recurrence Score.
Fig. 2
Fig. 2. RS distribution in the N0 and N1mi/N1 patients (p = 0.804 for comparing RS distribution between N0 and N1mi/N1 patients, chi-square test).
RS Recurrence Score.
Fig. 3
Fig. 3. Proportion of patients undergoing CT use by RS result for N0 and N1mi/N1 patients.
Number of patients and rates of CT use (%) are displayed on the bar chart. CT chemotherapy, RS Recurrence Score.
Fig. 4
Fig. 4. Kaplan-Meier curves for N0 patients by treatment received.
a. Overall survival; b. Distant recurrence-free survival; c. Breast cancer-specific mortality. The box under each graph presents the number of patients at risk at each time point. One-degree of freedom log-rank p-values were calculated from all the data.
Fig. 5
Fig. 5. Kaplan-Meier curves for N1mi/N1 patients by treatment received.
a. Overall survival; b. Distant recurrence-free survival; c. Breast cancer-specific mortality The box under each graph presents the number of patients at risk at each time point. One-degree of freedom log-rank p-values were calculated from all the data.
See this image and copyright information in PMC

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