205P Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials

Yardley, Denise A.; Yap, Y-S; Azim, Hamdy A.; Boer, Richard H. De; Campone, M.; Ring, A.; Laurentiis, Michelino De; O’Shaughnessy, Joyce; Cortés, J.; Chattar, Y.; Thuerigen, A.; Zarate, Juan Pablo; Nusch, A.

doi:10.1016/j.annonc.2022.07.239

Cited by 6 publications

(10 citation statements)

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“…Both trials enrolled a similar proportion (18–22%) of patients with a TFI of ⩽12 months. 2,4,8,18 Although the inclusion and exclusion criteria for the two trials were generally similar, there were some differences that were reflected in a small subset of patients. These absolute differences were less than approximately 10% for most characteristics, except ECOG PS (Table 2).…”

Section: Methodsmentioning

confidence: 99%

“… b‘ TFI’ was defined as the time from the end of (neo)adjuvant treatment to recurrence and was referred to as a ‘disease-free interval’ in the PALOMA-2 trial. 18 …”

Section: Methodsmentioning

confidence: 99%

“…20 b‘ TFI’ was defined as the time from the end of (neo)adjuvant treatment to recurrence and was referred to as a ‘disease-free interval’ in the PALOMA-2 trial. 18 ABC, advanced breast cancer; PFS, progression-free survival; TFI, treatment-free interval. …”

Section: Methodsmentioning

confidence: 99%

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Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

Jhaveri,

O’Shaughnessy,

Fasching

et al. 2023

Ther Adv Med Oncol

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Background: Current standard-of-care first-line treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC) is cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + endocrine therapy. In the MONALEESA-2 trial, first-line ribociclib + letrozole demonstrated statistically significant overall survival (OS) benefit versus placebo + letrozole in postmenopausal patients with HR+/HER2− ABC. In the PALOMA-2 trial, first-line palbociclib + letrozole did not show OS benefit versus placebo + letrozole in a similar patient population. Understanding OS outcomes in the respective trials is critical for treatment decisions; however, there are no head-to-head clinical trial data comparing ribociclib and palbociclib. Objectives: To conduct a matching-adjusted indirect comparison (MAIC) to compare progression-free survival (PFS) and OS of first-line ribociclib + letrozole versus palbociclib + letrozole in postmenopausal patients with HR+/HER2− ABC. Design: Letrozole-anchored MAIC using individual patient data from MONALEESA-2 and published summary data from PALOMA-2. Methods: Using individual data, patients from MONALEESA-2 who matched inclusion criteria from PALOMA-2 were selected, and weighting was conducted to ensure baseline characteristics were similar to those in published aggregated data from PALOMA-2. The Bucher method was used to generate corresponding hazard ratios (HRs). Results: The final effective sample size compared n = 150 (ribociclib) and n = 112 (placebo) MONALEESA-2 patients with n = 444 (palbociclib) and n = 222 (placebo) PALOMA-2 patients. After matching and weighting, patient characteristics were well balanced. MAIC analysis showed a numerical PFS benefit [HR, 0.80; 95% confidence interval (CI), 0.58–1.11; p = 0.187] and significant OS benefit (HR, 0.68; 95% CI, 0.48–0.96; p = 0.031) with ribociclib + letrozole versus palbociclib + letrozole. Conclusion: Results of this cross-trial MAIC analysis showed a numerical PFS benefit and significantly greater OS benefit with first-line ribociclib + letrozole versus palbociclib + letrozole. These results support letrozole + ribociclib as the preferred first-line CDK4/6i for postmenopausal patients with HR+/HER2− ABC. Trial registration: NCT01958021; https://www.clinicaltrials.gov/study/NCT01958021 (MONALEESA-2) and NCT01740427; https://clinicaltrials.gov/study/NCT01740427 (PALOMA-2).

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Section: Methodsmentioning

confidence: 99%

“… b‘ TFI’ was defined as the time from the end of (neo)adjuvant treatment to recurrence and was referred to as a ‘disease-free interval’ in the PALOMA-2 trial. 18 …”

Section: Methodsmentioning

confidence: 99%

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Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

Jhaveri,

O’Shaughnessy,

Fasching

et al. 2023

Ther Adv Med Oncol

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“…Для оценки суммарной эффективности рибоциклиба проведен объединенный анализ ОВ и ВБП пациенток с висцеральными метастазами, которые получили терапию в рамках исследований ML-2, 3, 7. Результаты стали известны в 2022 г., опубликованы в печатном органе Европейского об-щества клинических онкологов (European Society for Medical Oncology) [25].…”

Section: подгрупповой анализ ов клинически неблагоприятных подгрупп в...unclassified

“…3. ОВ пациенток, получавших 1-ю линию терапии в исследованиях цикла ML, по данным объединенного анализа в подгруппах с клинически неблагоприятными прогностическими факторами: a -с висцеральными метастазами; b -с метастазами в печени; c -с 3 метастатическими очагами и больше [25]. Fig.…”

Section: заключениеunclassified

The effect of CDK4/6 inhibitors on the overall survival in patients with advanced HR+/HER2- BC in the entire population and in special clinical subgroups of unfavorable prognosis: A review

et al. 2023

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An increase in the median progression-free survival when using cyclin-dependent kinase 4/6 inhibitors in combination with aromatase inhibitors led to high expectations from the analysis of the overall survival of patients with HR+/HER2- metastatic breast cancer. Of the three drugs in the group, the final data were obtained in the MONALEESA-2 and PALOMA-2 studies, while a statistically significant difference in median overall survival was achieved only with the use of ribociclib. The review discusses possible factors that could affect the final results of the presented studies. The effect of ribociclib on the value of OS in clinically unfavorable prognostic subgroups (for example, patients with visceral metastases) and on progression-free survival depending on the expression of molecular genetic factors that worsen patient survival (such as Rb, p16, Ki-67, CDKN2A, CCND1, ESR1) was analyzed.The combination of ribociclib and aromatase inhibitors has proven to be an advantage in the treatment of patients with HR+/HER2- metastatic breast cancer in terms of increasing both progression-free survival and overall survival. Efficacy has been proven in subgroups with clinical and molecular adverse prognostic factors.

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Advances in medical treatment of breast cancer in 2022

Zhai

et al. 2023

Cancer Innovation

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Breast cancer has replaced lung cancer as the most common malignancy worldwide. The 5-year survival rate of breast cancer has reached 90%. Systemic treatment of breast cancer has developed into a mature system including chemotherapy, targeted therapy, endocrine therapy and immunotherapy. This article summarizes the annual progress of breast cancer chemotherapy, targeted therapy, endocrine therapy and immunotherapy in 2022, providing valuable information for future research to better guide individualized treatment of breast cancer, thereby improving the prognosis and quality of life of breast cancer patients.

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205P Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials

Cited by 6 publications

References 0 publications

Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer

The effect of CDK4/6 inhibitors on the overall survival in patients with advanced HR+/HER2- BC in the entire population and in special clinical subgroups of unfavorable prognosis: A review

Advances in medical treatment of breast cancer in 2022

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