Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population

Laurentiis, Michelino De; Borštnar, Simona; Campone, Mario; Warner, Ellen; Bofill, Javier Salvador; Jacot, William; Dent, Susan; Martín, Miguel; Ring, Alistair; Cottu, Paul; Lu, Janice; Ciruelos, Eva; Azim, Hamdy A.; Chatterjee, Sanjoy; Zhou, Katie; Wu, Jiwen; Menon-Singh, Lakshmi; Zamagni, Claudio

doi:10.1007/s10549-021-06334-0

Cited by 28 publications

(42 citation statements)

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“…A total of 3,246 patients were evaluated in the overall CompLEEment-1 study over a median follow-up duration of 25.4 months and a median duration of exposure to ribociclib of 17.5 months (range, 0.0– 33 months). 26 The median TTP was 27.1 months, and the ORR was 43.6% (95% CI 41.5–45.8%). The CBR (was 69.1% (95% CI 67.1–71.1%) for patients with measurable disease at baseline.…”

Section: Resultsmentioning

confidence: 95%

“…Results from the overall CompLEEment-1 patient population demonstrated the safety, tolerability, and efficacy of ribociclib plus letrozole in this large and diverse cohort of patients with HR+/ HER2− advanced breast cancer, with a safety profile consistent with the pivotal ribociclib trials and no new safety signals. 26 The median time to progression (TTP) was 27.1 months, and the clinical benefit rate (CBR) in patients with measurable disease at baseline was 69.1% and the median PFS was 26.7 months. 26 The quality of life of patients was maintained throughout treatment.…”

Section: Introductionmentioning

confidence: 99%

“… 26 The median time to progression (TTP) was 27.1 months, and the clinical benefit rate (CBR) in patients with measurable disease at baseline was 69.1% and the median PFS was 26.7 months. 26 The quality of life of patients was maintained throughout treatment.…”

Section: Introductionmentioning

confidence: 99%

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Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup safety analysis from the phase 3b CompLEEment-1 trial

Borštnar

Palácová

Łacko³

et al. 2022

Radiology and Oncology

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Background The CDK4/6 inhibitor, ribociclib in combination with endocrine therapy significantly improved progression-free survival in the first line setting in post-menopausal patients with HR+/HER2− advanced breast cancer (ABC) in a pivotal phase 3, placebo-controlled trial (MONALEESA-2) and demonstrated superior overall survival in premenopausal patients with HR+/HER2− ABC (MONALEESA-7). The multinational, phase 3b, CompLEEment-1 trial, which assessed the safety and efficacy of ribociclib plus letrozole in a broader population of patients who have not received prior endocrine therapy for advanced disease, is the largest phase 3 clinical trial to date to evaluate the safety and efficacy of a CDK4/6 inhibitor. We report a subanalysis of data from patients (N = 339) enrolled in the central and south European countries of the SERCE (Southern Europe, RUC, Central Europe) cluster of CompLEEment-1. Patients and methods Men and women of any menopausal status with HR+/HER2− ABC received once-daily oral ribociclib 600 mg (3-weeks on/1-week-off), plus letrozole 2.5 mg continuously. Men/premenopausal women also received a GnRH-agonist. The primary outcome was the number of patients with adverse events (AEs) over a timeframe of approximately 36 months. Time-to-progression, overall response rate, and clinical benefit rate were also measured. Results Safety results in the SERCE subgroup were consistent with those in the pivotal clinical trials of ribociclib in combination with endocrine therapy. Treatment-related AEs leading to dose adjustments/interruption occurred in 63.1% of patients but led to treatment discontinuation in only 10.6%. The most common treatment-related AEs of grade ≥ 3 were neutropenia and transaminase elevations. There were no fatal treatment-related events. Conclusions These findings from the SERCE subgroup support the safety and manageable tolerability of ribociclib in a broad range of patients with HR+/HER2− ABC more representative of patients in real-world clinical practice.

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Section: Resultsmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 99%

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Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup safety analysis from the phase 3b CompLEEment-1 trial

Borštnar

Palácová

Łacko³

et al. 2022

Radiology and Oncology

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“…Data were more frequently available for grade 3 or more fatigue than for any-grade fatigue; rates were very low (2%) for pertuzumab + trastuzumab + paclitaxel or nab-paclitaxel (PERUSE study [82]) and trastuzumab + docetaxel (CLEOPATRA study control arm [76]), but they reached more than 20% for 100 mg/m 2 of docetaxel (15 to 24%) and gemcitabine vinorelbine (24%); in the metastatic context and according to the 5th advanced breast cancer conference guidelines, this highlights the need to favor monotherapy in such patients [101], and, when considering docetaxel, to prefer a 3w-75 mg/m 2 schedule. For BALLET: sub-analysis by ages (<70 vs. ≥70, non-comparative) 29 vs. 21 6 vs. 3 Palbociclib letrozole (PALOMA-1 and PALOMA-2) [83,95] 37-40 (ctrl: 23-28) 2-4 (ctrl: 1) Palbociclib fulvestrant (PALOMA-3) [88] 44 (ctrl: 31) 3 (ctrl: 1) Palbociclib-ET (pooled analysis PALOMA 1, 2, 3) <65 [96] 40 (ctrl: 27) 2 (ctrl: 1) 65-74 [96] 41 (ctrl: 28) 3 (ctrl: 0) ≥75 [96] 37 (ctrl: 31) 6 (ctrl: 0) Ribociclib letrozole (MONALEESA-2, CompLEEment-1) [84,97] 23-42 (ctrl: 27) 1-2 (ctrl: 1) Ribociclib fulvestrant (MONALEESA-3) [ [99] 50 (ctrl: 43) 2 (ctrl: 3) Olaparib (OlympiaAD) [100] 29 (ctrl: 23) 3 (ctrl: 1) The colors refer to the hiher reported freuency of grade 3 or more fatiue for each regime [30-40%];…”

Section: Setting Treatment Regimen and Reference Fatigue Any-grade (%...mentioning

confidence: 99%

Oncological Treatment-Related Fatigue in Oncogeriatrics: A Scoping Review

André

Antherieu

Boinet

et al. 2022

Cancers

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Fatigue is a highly prevalent symptom in both cancer patients and the older population, and it contributes to quality-of-life impairment. Cancer treatment-related fatigue should thus be included in the risk/benefit assessment when introducing any treatment, but tools are lacking to a priori estimate such risk. This scoping review was designed to report the current evidence regarding the frequency of fatigue for the different treatment regimens proposed for the main cancer indications, with a specific focus on age-specific data, for the following tumors: breast, ovary, prostate, urothelium, colon, lung and lymphoma. Fatigue was most frequently reported using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) versions 3 to 5. A total of 324 regimens were analyzed; data on fatigue were available for 217 (67%) of them, and data specific to older patients were available for 35 (11%) of them; recent pivotal trials have generally reported more fatigue grades than older studies, illustrating increasing concern over time. This scoping review presents an easy-to-understand summary that is expected to provide helpful information for shared decisions with patients regarding the anticipation and prevention of fatigue during each cancer treatment.

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“…Recent results from the CompLEEment-1 trial (phase 3b trial in an expanded patient population with hormone receptor-positive, human epidermal growth factor receptor-2–negative advanced BC) confirmed that safety and efficacy data in this expanded population were consistent with the data from the MONALEESA-2 and MONALEESA-7 trials and support the use of RIBO plus LET in the first-line setting for patients with HR +, HER2– advanced BC. 16 …”

Section: Safety and Quality Of Lifementioning

confidence: 99%

Ribociclib in the Treatment of Hormone-Receptor Positive/HER2-Negative Advanced and Early Breast Cancer: Overview of Clinical Data and Patients Selection

Parati¹,

Pedersini²,

Perego³

et al. 2022

BCTT

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Among pre- and postmenopausal women with hormone receptor-positive (HR+) breast cancer (BC), combinations of an aromatase inhibitor (AI) or fulvestrant with a CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) have demonstrated improved progression-free survival (PFS) and overall survival (OS) compared to standard single-agent hormone therapy alone as first-line therapy for de novo metastatic disease or relapse during or after adjuvant therapy and no previous therapies in an advanced setting. We here reviewed clinical data about ribociclib in advanced and early BC. Also, we shed light on patient selection and special settings in which medical oncologists urgently await an advance in treatment. Ribociclib was FDA-approved in combination with letrozole based on a Phase III study in which 668 postmenopausal women with HR+, HER2-negative recurrent or metastatic BC were treated with first-line letrozole with or without ribociclib. For patients with metastatic disease at presentation or after a course of AIs, the results of the MONALEESA-3 trial suggest ribociclib’s efficacy in combination with fulvestrant, and this combination is FDA-approved for initial- and subsequent-line endocrine therapy for postmenopausal women with metastatic hormone receptor-positive, HER2-negative BC. In adjuvant and neoadjuvant settings, the use of CDK 4/6 inhibitors may be useful to boost outcomes in high-risk patients with HR+ BC, but data contrast with those of a phase III study, which produced positive results. New combinations are being explored in upfront disease (neoadjuvant) or in association with other targeted agents in metastatic disease. Compared to other CDK 4/6 available, ribociclib has a higher incidence of liver function test abnormalities than the other agents and can cause QTc prolongation, and therefore may be prudently avoided in patients with cardiac morbidities or other risk factors for QTc prolongation (drugs, interactions). In these cases, different agents (palbociclib or abemaciclib) may be used. In conclusion, ribociclib with letrozole or with fulvestrant is effective for the entire spectrum of patients with HR+ BC in the advanced setting. Ribociclib has all the characteristics of an innovative drug able to change the clinical practice and most BC patients’ prognoses.

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Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population

Cited by 28 publications

References 28 publications

Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup safety analysis from the phase 3b CompLEEment-1 trial

Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup safety analysis from the phase 3b CompLEEment-1 trial

Oncological Treatment-Related Fatigue in Oncogeriatrics: A Scoping Review

Ribociclib in the Treatment of Hormone-Receptor Positive/HER2-Negative Advanced and Early Breast Cancer: Overview of Clinical Data and Patients Selection

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