Otros Perfiles de pacientes
In HR+/HER2- mBC 1L KISQALI (ribociclib) + ET* may benefit your patients, regardless of age1,2
How can you help June achieve her goal?
* Including AI and fulvestrant.
KISQALI + TE logró consistentemente una mSG > 5 años, independientemente de la edad1
Pacientes de edad avanzada: análisis combinado de MONALEESA
Adaptado de Hart L, et al. 2023.1
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* HR = 0,69; IC de 95%: 0,56–0,84.1
† HR = 0,79; IC de 95%: 0,58–1,07.1
‡ HR = 0.75; IC de 95%: 0,46–1,21.1
Este fue un análisis exploratorio para evaluar la SLP, SG y TTC en diferentes grupos de edad (<65 años, 65-74 y ≥75 años) utilizando los métodos de Kaplan-Meier.1
KISQALI + TE logró consistentemente una mSG > 5 años, independientemente de la edad1
Pacientes de edad avanzada: análisis combinado de MONALEESA
Adaptado de Hart L, et al. 2023.1
|
* HR = 0,69; IC de 95%: 0,56–0,84.1
† HR = 0,79; IC de 95%: 0,58–1,07.1
‡ HR = 0.75; IC de 95%: 0,46–1,21.1
Este fue un análisis exploratorio para evaluar la SLP, SG y TTC en diferentes grupos de edad (<65 años, 65-74 y ≥75 años) utilizando los métodos de Kaplan-Meier.1
KISQALI + TE logró consistentemente una mSG > 5 años, independientemente de la edad1
Pacientes de edad avanzada: análisis combinado de MONALEESA
Adapted from Hart L, et al. 2023.1
|
* HR = 0,69; IC de 95%: 0,56–0,84.1
† HR = 0,79; IC de 95%: 0,58–1,07.1
‡ HR = 0.75; IC de 95%: 0,46–1,21.1
Este fue un análisis exploratorio para evaluar la SLP, SG y TTC en diferentes grupos de edad (<65 años, 65-74 y ≥75 años) utilizando los métodos de Kaplan-Meier.1
KISQALI + TE presentó un perfil de eficacia y seguridad consistente, independiente de la edad1,2
Pacientes de edad avanzada: análisis del mundo real y de la población diversa
Hombres y mujeres pre-/postmenopáusicas con cáncer de mama localmente avanzado o con RH+/HER2-, no aptos para terapia curativa sin TE previa para la enfermedad avanzada.2
1L KISQALI + ET delivered consistent PFS,* regardless of age2
RIBANNA Real-world cohort†2
Adapted from Decker T, et al. 2023.2
Cox proportional hazard regression compared to unadjusted Kaplan-Meier estimates for PFS in 1L KISQALI + ET Cohort (FAS‡). Type 3 Wald tests examine the significance of an effect with all the other effects in the model (global test). The Cox proportional hazard regression analysis included the effect of variables such as the age of the patient, ECOG score, metastasis site, and CCI.2
* Unadjusted PFS.2
† In this post hoc analysis, not all confounders that influence PFS outcome might have been included.2
‡ Excluding patients with missing data in some effects only.2
RIBANNA study design2
RIBANNA is a prospective, non-interventional study ongoing in Germany (from October 2017 to February 2025) involving treatment-naïve pre-/peri-menopausal and post-menopausal women with HR+/HER2- aBC treated with 1L KISQALI + ET, ET, or CT, in accordance with the German treatment guidelines and within the described label of the SmPC.
* The last patient first visit occurred in February 2021 and the LPLV is expected in February 2025.
KISQALI has a well-established safety profile in elderly patients1,2
MONALEESA pooled analysis1
Rates of AEs were generally consistent across all
age groups, including patients <65 years, 65–74
years and ≥75 years1
Similar proportions of patients required ≥1 dose
reduction due to AEs across all age groups1
Regardless of age, AEs were manageable using
existing guidance for dose modifications1
RIBANNA Real-world cohort2
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Choose 1L KISQALI to help improve outcomes for your HR+/HER2- mBC patients, regardless of age1,2
MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomised, multicentre, phase III trial in postmenopausal women with HR+/HER2− aBC. As 1L in advanced disease. No prior endocrine therapy for aBC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous). The primary endpoint was locally assessed PFS, and the key secondary endpoint was OS. Other secondary endpoints included the ORR (complete or partial response), the CBR (overall response plus stable disease lasting 24 weeks or more), safety, and QoL assessments.3,4
MONALEESA-3: N=726, double-blind, placebo-controlled, 2:1 randomised, phase III trial. As 1L and 2L in advanced disease plus those with early relapse in postmenopausal women with HR+/HER2– aBC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + 500 mg intramuscular fulvestrant. The primary endpoint was locally assessed PFS. Secondary endpoints included OS, ORR, CBR, and safety and tolerability. 1L defined as: newly diagnosed (de novo) aBC patients or patients with relapse >12 months from completion of (neo)adjuvant ET with no treatment for aBC or metastatic disease.5,6
MONALEESA-7: N=672, double-blind, placebo-controlled, 1:1 randomised, phase III trial in pre- or perimenopausal women with HR+/HER2− aBC. As 1L in advanced disease and in patients who received 1 or fewer lines of chemotherapy for aBC. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen* 20 mg orally once daily continuously + LHRH agonist (goserelin 3.6 mg subcutaneously on Day 1 of every cycle). The primary endpoint was investigator-assessed PFS. The key secondary endpoint was OS, defined as the time from randomisation to death from any cause.7
* KISQALI should not be co-administered with tamoxifen.8
Abbreviations: AEs, adverse events; AI, aromatase inhibitor; BC, breast cancer; CCI, Charlson Comorbidity Index; CI, confidence interval; combo CT; combination chemotherapy; CT, computerised tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; ER+, oestrogen receptor-positive; ET, endocrine therapy; FAS, full analysis set; GSH, global health score; HER2-, human epidermal growth factor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; LPLV, last patient last visit; mBC; metastatic breast cancer; mOS, median overall survival; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life.
References:
1. Hart L, et al. Poster presentation PS02-01. Presented at San Antonio Breast Cancer Symposium 2023, 5–9 December, San Antonio, USA.
2. Decker T, et al. Poster presentation 409P. Presented at European Society for Medical Oncology 2023, 20–24 October, Madrid, Spain.
3. Hortobagyi GN, et al. N Engl J Med. 2022;386(10):942–950.
4. Hortobagyi GN, et al. N Engl J Med. 2016;375(18):1738–1748.
5. Neven P, et al. Breast Cancer Res. 2023;25:103.
6. Slamon DJ, et al. J Clin Oncol. 2018;36(24):2465–2472.
7. Lu Y-S, et al. Clin Cancer Res. 2022;28:851–859.
8. KISQALI (ribociclib), Summary of Product Characteristics.
Click here for the KISQALI Summary of Product Characteristics. [Insert link to KISQALI SmPC]
Please refer to the Summary of Product Characteristics before prescribing KISQALI.
KISQALI is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.8
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.8
[Insert Prescribing Information here]
Adverse Event reporting:
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