Abstract P4-10-04: Health-related quality of life (HRQoL) in hormone receptor-positive, HER2-negative, luminal B breast cancer patients treated with ribociclib plus letrozole or chemotherapy
Authors: Villacampa Guillermo , Paré Laia , Hernando Cristina , Arumí Miriam , Muñoz Montserrat , Gil-Gil Miguel , Izarzugaza Yann , Ferrer Neus , Montaño Alvaro , Ciruelos Eva , González-Santiago Santiago , Falato Claudette , Villagrasa Patricia , Gavilá Joaquín , Prat Aleix , Pascual Tomás 
Published: March 2022

Background: Neoadjuvant ribociclib plus letrozole (R+L), was evaluated in the phase II Coralleen study (NCT03248427) in comparison with poli-chemotherapy (CT) in women with hormone receptor-positive (HR+), HER2-negative, luminal B breast cancer. In the primary efficacy analysis, both groups showed a similar proportion of pts with PAM50 low-risk risk of recurrence at surgery (46.9% vs 46.1%) (Prat. Lancet Oncol. 2020). Now we present patients (pts)-reported HRQoL results. Methods: In the CORALLEEN study, 106 postmenopausal women with stage I-IIIA HR+/HER2-negative Luminal B breast cancer by PAM50 were randomized 1:1 to receive six 28-days cycles of R+L (n=52) or four cycles of doxorubicin and cyclophosphamide followed by weekly paclitaxel (n=54). The primary efficacy endpoint was the proportion of patients with PAM50 Risk of Recurrence (ROR) low disease at surgery in each arm. Pts-reported HRQoL was evaluated at baseline (bl), day 1 of each subsequent cycle and before surgery, using i) the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) and ii) the breast cancer-specific EORTC QLQ-BR23 questionnaires. On-treatment comparison of mean change from bl in global health status (GHS), functioning and symptom scales was performed. Longitudinal linear mixed-effect models using a random intercept and random slope were fitted to estimated least squares (LS) mean change. The proportion of patients with clinically meaningful (10-point thereshold) deterioration was estimated in each group. Results: Completion and compliance rates of HRQoL questionaries at bl was 100% for R+L group and 98% for CT group, at week 12 completion rate was 92% and 87% and before surgery 80% in both groups. At bl, EORTC QLQ-C30 GHS scores were similar between R+L and CT groups (median 80.4 and 79.4, respectively). Before surgery, GHS scores presented a slight decrease in the R+L group while it considerably decreased in the CL group (mean change -5.2 vs. -23.6). The between-group difference in mean change from bl was 18.4 points (95% CI 9.8 - 26.9) showing a worsening in patients receiving CT. Overall, at the end of treatment 38% of patients in the R+L and 68% of patients in the CT group reported a clinically meaningful deterioration. R+L group presented better results in the mean change from bl in all functioning and symptom scales, specially in terms of fatigue and appetite loss (28.7 and 24 points difference between groups, respectively) (Table). Conclusions: R+L provided better outcomes in GHS HRQoL, functioning and symptoms in comparison with CT for the treatment of patient with high-risk breast cancer in the pre-operative setting. Together with the similar clinical efficacy and manageable safety profile, these results provide additional support for the development of clinical trials evaluating R+L in this patient population.

Estimated mean change from baseline to before surgery (95% CI)Estimated mean change from baseline to before surgery (95% CI)Difference in the mean change in R+L vs. CTR+LCTGlobal health status 1-5.2 (-11.3 ; 0.9)-23.6 (-29.6 ; -17.6)18.4 (9.8 ; 26.9)Functional scales• Physical1-4.3 ( -9.5 ; 0.8)-20.3 (-25.5 ; -15.1)16 (8.7 ; 23.2)• Social1-6.3 (-13 ; 0.4)-19.7 (-26.1 ; -13.4)13.4 (4.2 ; 22.6)• Emotional1-0.7 (-7.4 ; 6.0)-6.8 (-13.3 ; -0.2)6.1 (-3.3 ; 15.4)• Role1-4.8 (-11.8 ; 2.2)-26.7 (-33.7 ; -19.7)21.9 (12 ; 31.8)• Body imagine2-3.2 (-8.9 ; 2.5)-12.9 (-18.5 ; -7.3)9.7 (1.7 ; 17.7)• Sexual enjoymnet2-5.3 (-20.4 ; 9.9)-36.1 (-54.4 ; -17.8)30.8 (7.2 ; 54.5)Symptom scales• Fatigue15.7 (0.7 ; 10.9)35.1 (26.6 ; 43.7)-28.7 (-38.2 ; -19.1)• Pain15.5 (-1.2 ; 12.1)15.5 (9 ; 22.1)-10.1 (-19.4 ; -0.8)• Insomnia14.8 (-2.7 ; 12.4)10.6 (3.2 ; 18.0)-5.8 (-16.2 ; 4.6)• Appetite loss12.5 (-5.8 ; 10.8)26.5 (18.2 ; 34.9)-24 (-35.8 ; -12.3)• Upset by hair loss28.8 (-10.4 ; 27.9)27.7 (8.3 ; 47.2)-18.9 (-45.6 ; 7.7)• Breast symptoms2-2.6 (-6.3 ; 1.2)0.7 (-3.0 ; 4.3)-3.3 (-8.5 ; 1.9)Positive values favour R+L except for symptom scale where negative values favour R+L. Changes from baseline were estimated using a repeated-measures mixed-effect model. CI, confidence interval. 1 EORTC QLQ-C30, 2EORTC QLQ-BR23 questionnaires.

Citation Format: Guillermo Villacampa, Laia Paré, Cristina Hernando, Miriam Arumí, Montserrat Muñoz, Miguel Gil-Gil, Yann Izarzugaza, Neus Ferrer, Alvaro Montaño, Eva Ciruelos, Santiago González-Santiago, Claudette Falato, Patricia Villagrasa, Joaquín Gavilá, Aleix Prat, Tomás Pascual. Health-related quality of life (HRQoL) in hormone receptor-positive, HER2-negative, luminal B breast cancer patients treated with ribociclib plus letrozole or chemotherapy [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-10-04.