Abstract P4-01-03: Progression-free survival and patient-reported outcomes in HR+, HER2– ABC patients treated with first-line ribociclib + endocrine therapy (ET) or ET monotherapy or chemotherapy in real world setting: 5th interim analysis of RIBANNA
Authors: Fasching Peter A. , Brucker Cosima , Decker Thomas , Engel Anne , Göhler Thomas , Jackisch Christian , Janssen Jan , Köhler Andreas , Lüdtke-Heckenkamp Kerstin , Lüftner Diana , van Mackelenbergh Marion , Marmé Frederik , Nusch Arnd , Rautenberg Beate , Reimer Toralf , Schmidt Marcus , Weide Rudolf , Wimberger Pauline , Roos Christian , Wöckel Achim 
Published: March 2023

Abstract
Background: Ribociclib in combination with endocrine therapy (ET) has demonstrated survival benefits in a broad patient population with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC). RIBANNA (CLEE011ADE03) is an ongoing, prospective, noninterventional study assessing the efficacy and safety of first-line (1L) ribociclib in combination with ET in routine clinical practice in women with HR+, HER2– ABC. This study will provide insights into the use of ribociclib in combination with ET with regard to effectiveness and patient-reported outcomes (PRO) in the real-world setting in a large patient population.
Methods: Patients with HR+, HER2– ABC starting their 1L treatment with ribociclib + ET, or ET monotherapy, or chemotherapy (CT) were included. Data after disease progression to second-line (2L) and further lines of therapy are being collected too. The progression-free survival (PFS) in 1L, 2L and PFS2 (time from inclusion into the trial in the 1L setting until progression from 2L to third-line therapy) for individual treatment sequences will be analyzed using the Kaplan–Meier method. PRO for all the patients in the 1L and 2L treatment cohorts are being evaluated using the Morisky Medication Adherence Scale (MMAS-8), questionnaires related to quality-of-life (EORTC QLQ-C30) and its breast cancer–specific module (EORTC QLQ-BR23) as well as the Hospital Anxiety and Depression Scale (HADS). Data were collected at baseline and at every 3 months until the end of treatment.
Results: By the cutoff date (October 11, 2021) of the fourth interim analysis, data were available for 2187 patients (Table 1). Overall, 633 patients progressed after 1L therapy, including 27.6%, 30.6%, and 43.4% of patients from the 1L ribociclib + ET, ET monotherapy, and CT cohorts, respectively. A total of 286 patients received CDK4/6 inhibitors in 2L, which represents 48.3%, 37.3%, and 27.0% of patients from the 1L ribociclib + ET, ET monotherapy, and CT cohorts, respectively. The PFS in 1L, 2L and PFS2 results for individual treatment sequences will be presented at SABCS 2022. PRO compliance rates at baseline were 88.2%, 89.8%, and 89.4% for EORTC QLQ-C30 global health status, QLQ-BR23, and HADS-D/A, respectively, in the overall population, and 84.5% for MMAS-8 in the 1L ribociclib + ET cohort. Data for patient-reported adherence to 1L ribociclib + ET and for questionnaires related to global health-related quality of life, functioning, and symptoms from patients receiving treatment in 1L and 2L settings will be analyzed and presented at SABCS 2022.
Conclusion: The RIBANNA study has shown diverse population characteristics among patients who received ribociclib treatment in a real-world setting. The 5th interim analysis is planned in October 2022. Data on PFS, PFS2, specific therapy sequences and PRO from 1L and 2L that will provide insights on therapy sequencing strategy will be presented at SABCS 2022.
Table 1. Patient disposition at the data cutoff date (October 11, 2021).
Citation Format: Peter A. Fasching, Cosima Brucker, Thomas Decker, Anne Engel, Thomas Göhler, Christian Jackisch, Jan Janssen, Andreas Köhler, Kerstin Lüdtke-Heckenkamp, Diana Lüftner, Marion van Mackelenbergh, Frederik Marmé, Arnd Nusch, Beate Rautenberg, Toralf Reimer, Marcus Schmidt, Rudolf Weide, Pauline Wimberger, Christian Roos, Achim Wöckel. Progression-free survival and patient-reported outcomes in HR+, HER2– ABC patients treated with first-line ribociclib + endocrine therapy (ET) or ET monotherapy or chemotherapy in real world setting: 5th interim analysis of RIBANNA [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-01-03.