MONALEESA-2: Ribociclib Extends OS >1 Year in Advanced BC

Theme

MONALEESA-2: First-Line Ribociclib Extension of Overall Survival Exceeds One Year

Source
Source: Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022;386:942-50. MONALEESA-2 Clinical Trial (NCT01958021).

Advanced HR+/HER2- Breast Cancer • Median Follow-up: 6.6 Years (Longest reported for CDK4/6i)

Population
N = 668
Postmenopausal
HR+/HER2- Advanced
Design
Phase 3
Randomized, Double-blind
Placebo-controlled
Intervention
Ribociclib + Letrozole
vs. Placebo + Letrozole
(1:1 Randomization)
Follow-Up
6.6 Years
Median (80 months)

Median Overall Survival

63.9
Months
+12.5 Months Gain

vs. 51.4 Months (Placebo)
HR 0.76 (P=0.008)

Efficacy Outcomes

Survival Advantage 24% relative reduction in risk of death. Absolute improvement of 12.5 months.
Long-Term Durability At 6 years, 44.2% of Ribociclib patients estimated alive vs. 32.0% (placebo).
Delayed Chemo Median time to first chemo extended to 50.6 months (vs 38.9), preserving QoL.
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Анаболическая защита (Тестостерон)

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Влияние приема Бромелаина на уровень свободного тестостерона
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\n Плацебо\n
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\n Бромелаин (Картилокс)\n
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AbbreviationsQuick
CDK4/6, cyclin-dependent kinases 4 and 6; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; NE, could not be estimated; PgR, progesterone receptor.
Bibliography8
  1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med 2022;386:942-50. (DOI: 10.1056/NEJMoa2114663)
  2. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016;375:1738-48.
  3. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16.
  4. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24.
  5. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016; 17:425-39.
  6. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol 2017;35:3638-46.
  7. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy — MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6:116-24.
  8. Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med 2018; 379:1926-36.
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