Yujing Tan,1,* Hanfang Jiang,2,* Xinzhu Tian,1,* Fei Ma,1 Jiayu Wang,1 Pin Zhang,1 Binghe Xu,1 Ying Fan,1 Weihong Zhao3 

1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, People’s Republic of China; 2Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, 100142, People’s Republic of China; 3Department of Medical Oncology, Chinese PLA General Hospital, Beijing, 100853, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Ying Fan; Weihong Zhao, Email fanying@cicams.ac.cn; zhaowh0818@163.com

Purpose: This study aims to explore the role of the non-luminal disease score (NOLUS) for everolimus in patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC).
Methods: NOLUS has previously been established as an algorithm: NOLUS (0– 100) = − 0.45 × ER(%) − 0.28 × PR(%) + 0.27 × Ki67(%) + 73. Information of cancer patients was retrospectively collected from three cancer centers in China.
Results: Totally, 198 HR+/HER2- ABC patients with complete records in expression rates (%) of ER, PR and Ki67 were enrolled in the study. The expression rates (%) of ER, PR, and Ki67 were 38.8 ± 27.9 versus 80.9 ± 14.2 (p < 0.001), 13.9 ± 14.3 versus 50.2 ± 30.4 (p < 0.001), and 37.8 ± 23.6 versus 28.7 ± 19.9 (p = 0.04), respectively, for NOLUS-positive patients and NOLUS-negative patients. For the overall population, the median PFS was 5.8 months versus 5.1 months in NOLUS-positive and NOLUS-negative patients (p = 0.16, HR = 0.75, 95% CI = 0.50, 1.12). The median 1L-, 2L, and 3L-PFS was 13.9 months versus 11.8 months (p = 0.22, HR = 1.63, 95% CI = 0.74, 3.62), 6.7 months versus 3.6 months (p = 0.08, HR = 0.34, 95% CI = 0.10, 1.18), and 4.6 months versus 4.0 months (p = 0.81, HR = 1.07, 95% CI = 0.63, 1.79) respectively, for NOLUS-positive patients and NOLUS-negative patients.
Conclusion: NOLUS-positive patients have a lower percentage of ER and PR, but a higher percentage of Ki67 index. The correlation between the benefits of everolimus and NOLUS failed to develop significance, suggesting that NOLUS may not be applicable in predicting everolimus efficacy in patients with HR+/HER2- ABC. Further research is expected.

Keywords: NOLUS, advanced breast cancer, everolimus, HR+/HER2- breast cancer, efficacy