Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant
Abstract Background The phase III MONALEESA-3 trial included first- (1L) and second-line (2L) patients and demonstrated a significant overall survival (OS) benefit for ribociclib + fulvestrant in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) a...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-08-01
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| Series: | Breast Cancer Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13058-023-01701-9 |
| _version_ | 1797555552977420288 |
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| author | P. Neven P. A. Fasching S. Chia G. Jerusalem M. De Laurentiis S.-A. Im K. Petrakova G. V. Bianchi M. Martín A. Nusch G. S. Sonke L. De la Cruz-Merino J. T. Beck J. P. Zarate Y. Wang A. Chakravartty C. Wang D. J. Slamon |
| author_facet | P. Neven P. A. Fasching S. Chia G. Jerusalem M. De Laurentiis S.-A. Im K. Petrakova G. V. Bianchi M. Martín A. Nusch G. S. Sonke L. De la Cruz-Merino J. T. Beck J. P. Zarate Y. Wang A. Chakravartty C. Wang D. J. Slamon |
| author_sort | P. Neven |
| collection | DOAJ |
| description | Abstract Background The phase III MONALEESA-3 trial included first- (1L) and second-line (2L) patients and demonstrated a significant overall survival (OS) benefit for ribociclib + fulvestrant in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC) in the final protocol-specified and exploratory (longer follow-up) OS analyses. At the time of these analyses, the full OS benefit of 1L ribociclib was not completely characterized because the median OS (mOS) was not reached. As CDK4/6 inhibitor (CDK4/6i) + endocrine therapy (ET) is now a preferred option for 1L HR+/HER2− ABC, we report an exploratory analysis (median follow-up, 70.8 months; 14.5 months longer than the prior analysis) to fully elucidate the OS benefit in the MONALEESA-3 1L population. Methods Postmenopausal patients with HR+/HER2− ABC were randomized 2:1 to 1L/2L fulvestrant + ribociclib or placebo. OS in 1L patients (de novo disease or relapse > 12 months from completion of [neo]adjuvant ET) was assessed by Cox proportional hazards model and Kaplan–Meier methods. Progression-free survival 2 (PFS2) and chemotherapy-free survival (CFS) were analyzed. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615). Results At data cutoff (January 12, 2022; median follow-up time, 70.8 months), mOS was 67.6 versus 51.8 months with 1L ribociclib versus placebo (hazard ratio (HR) 0.67; 95% CI 0.50–0.90); 16.5% and 8.6% of ribociclib and placebo patients, respectively, were still receiving treatment. PFS2 (HR 0.64) and CFS (HR 0.62) favored ribociclib versus placebo. Among those who discontinued treatment, 16.7% and 35.0% on ribociclib or placebo, respectively, received a subsequent CDK4/6i. No new safety signals were observed. Conclusions This analysis of MONALEESA-3 reports the longest mOS thus far (67.6 months) for 1L patients in a phase III ABC trial. These results in a 1L population show that the OS benefit of ribociclib was maintained through extended follow-up, further supporting its use in HR+/HER2− ABC. |
| first_indexed | 2024-03-10T16:49:09Z |
| format | Article |
| id | doaj.art-d5a21e559a8a42ca8ba62ead0fa349e5 |
| institution | Directory Open Access Journal |
| issn | 1465-542X |
| language | English |
| last_indexed | 2024-03-10T16:49:09Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Breast Cancer Research |
| spelling | doaj.art-d5a21e559a8a42ca8ba62ead0fa349e52023-11-20T11:22:10ZengBMCBreast Cancer Research1465-542X2023-08-0125111010.1186/s13058-023-01701-9Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrantP. Neven0P. A. Fasching1S. Chia2G. Jerusalem3M. De Laurentiis4S.-A. Im5K. Petrakova6G. V. Bianchi7M. Martín8A. Nusch9G. S. Sonke10L. De la Cruz-Merino11J. T. Beck12J. P. Zarate13Y. Wang14A. Chakravartty15C. Wang16D. J. Slamon17Multidisciplinary Breast Centre, Universitair Ziekenhuis LeuvenUniversity Hospital Erlangen, Friedrich-Alexander University Erlangen-NurembergBritish Columbia Cancer AgencyCHU Liege and Liège UniversityIstituto Nazionale Tumori IRCCS “Fondazione G. Pascale”Cancer Research Institute, Seoul National University Hospital, Seoul National University College of MedicineMasaryk Memorial Cancer InstituteFondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei TumoriInstituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad ComplutensePractice for Hematology and Internal OncologyNetherlands Cancer Institute/Borstkanker Onderzoek Groep Study CenterHospital Universitario Virgen MacarenaHighlands OncologyNovartis Pharmaceuticals CorporationNovartis Pharmaceuticals CorporationNovartis Pharmaceuticals CorporationNovartis Pharma AGDavid Geffen School of Medicine at UCLAAbstract Background The phase III MONALEESA-3 trial included first- (1L) and second-line (2L) patients and demonstrated a significant overall survival (OS) benefit for ribociclib + fulvestrant in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC) in the final protocol-specified and exploratory (longer follow-up) OS analyses. At the time of these analyses, the full OS benefit of 1L ribociclib was not completely characterized because the median OS (mOS) was not reached. As CDK4/6 inhibitor (CDK4/6i) + endocrine therapy (ET) is now a preferred option for 1L HR+/HER2− ABC, we report an exploratory analysis (median follow-up, 70.8 months; 14.5 months longer than the prior analysis) to fully elucidate the OS benefit in the MONALEESA-3 1L population. Methods Postmenopausal patients with HR+/HER2− ABC were randomized 2:1 to 1L/2L fulvestrant + ribociclib or placebo. OS in 1L patients (de novo disease or relapse > 12 months from completion of [neo]adjuvant ET) was assessed by Cox proportional hazards model and Kaplan–Meier methods. Progression-free survival 2 (PFS2) and chemotherapy-free survival (CFS) were analyzed. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615). Results At data cutoff (January 12, 2022; median follow-up time, 70.8 months), mOS was 67.6 versus 51.8 months with 1L ribociclib versus placebo (hazard ratio (HR) 0.67; 95% CI 0.50–0.90); 16.5% and 8.6% of ribociclib and placebo patients, respectively, were still receiving treatment. PFS2 (HR 0.64) and CFS (HR 0.62) favored ribociclib versus placebo. Among those who discontinued treatment, 16.7% and 35.0% on ribociclib or placebo, respectively, received a subsequent CDK4/6i. No new safety signals were observed. Conclusions This analysis of MONALEESA-3 reports the longest mOS thus far (67.6 months) for 1L patients in a phase III ABC trial. These results in a 1L population show that the OS benefit of ribociclib was maintained through extended follow-up, further supporting its use in HR+/HER2− ABC.https://doi.org/10.1186/s13058-023-01701-9RibociclibCDK4/6 inhibitorAdvanced breast cancerOverall survivalFirst line |
| spellingShingle | P. Neven P. A. Fasching S. Chia G. Jerusalem M. De Laurentiis S.-A. Im K. Petrakova G. V. Bianchi M. Martín A. Nusch G. S. Sonke L. De la Cruz-Merino J. T. Beck J. P. Zarate Y. Wang A. Chakravartty C. Wang D. J. Slamon Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant Breast Cancer Research Ribociclib CDK4/6 inhibitor Advanced breast cancer Overall survival First line |
| title | Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant |
| title_full | Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant |
| title_fullStr | Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant |
| title_full_unstemmed | Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant |
| title_short | Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant |
| title_sort | updated overall survival from the monaleesa 3 trial in postmenopausal women with hr her2 advanced breast cancer receiving first line ribociclib plus fulvestrant |
| topic | Ribociclib CDK4/6 inhibitor Advanced breast cancer Overall survival First line |
| url | https://doi.org/10.1186/s13058-023-01701-9 |
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