 Home > Active Ingredient News > Antitumor Therapy > Clin Cancer Res: MONALEESA-7 study update results show that Ribociclib combined with endocrine therapy consistently improves the prognosis of patients with HR+/HER2- advanced breast cancer compared with endocrine monotherapy

Clin Cancer Res: MONALEESA-7 study update results show that Ribociclib combined with endocrine therapy consistently improves the prognosis of patients with HR+/HER2- advanced breast cancer compared with endocrine monotherapy

 Last Update: 2022-01-23
 Source: Internet
 Author: User

Tags

beta glucan cancer

benefit

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

Initial results from the phase III randomized clinical study MONALEESA-7 showed that Ribociclib plus endocrine therapy (ET) was significantly more effective than endocrine therapy (ET) in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) patients.
ET monotherapy significantly improved progression-free survival and overall survival (OS) in patients
.

Recently, updated results of the MONALEESA-7 study were published in the journal Clin Cancer Res

Between December 17, 2014, and August 1, 2016, 335 and 337 patients were randomly assigned to ribociclib and placebo
.

The median follow-up time was 53.

Between December 17, 2014, and August 1, 2016, 335 and 337 patients were randomly assigned to ribociclib and placebo

Differences in OS between the two treatment groups in the overall population

Among patients treated with NSAIs, 107 (43%) of 248 patients in the ribociclib group died and 120 (49%) of 247 patients in the placebo group died
.

Median OS was 58.

Among patients treated with NSAIs, 107 (43%) of 248 patients in the ribociclib group died and 120 (49%) of 247 patients in the placebo group died

Differences in OS between the two treatment groups receiving NSAI treatment

Among patients receiving tamoxifen, 34 (39%) of 87 patients in the ribociclib group died and 47 (52%) of 90 patients in the placebo group died
.

Median OS was not reached and 49.

Among patients receiving tamoxifen, 34 (39%) of 87 patients in the ribociclib group died and 47 (52%) of 90 patients in the placebo group died

Differences in OS between the two treatment groups receiving tamoxifen

Subgroup analysis

Similar proportions received subsequent antitumor therapy after progression: 204 patients (77%) in the ribociclib group and 239 patients (78%) in the placebo group
.

The most common subsequent treatments were chemotherapy alone (ribociclib, 22%; placebo, 28%) and hormone therapy alone (ribociclib, 28%; placebo, 18%)

Similar proportions received subsequent antitumor therapy after progression: 204 patients (77%) in the ribociclib group and 239 patients (78%) in the placebo group

After completion of the treatment regimen in this study, 144 patients (43%) in the ribociclib group and 173 patients (51%) in the placebo group received chemotherapy as follow-up therapy
.

The median time to first chemotherapy with ribociclib and placebo was 50.
9 months and 36.
8 months, respectively (HR, 0.
69; 95% CI, 0.
56-0.
87)
.
Median chemotherapy-free survival was 42.
4 months versus 26.
4 months for placebo (HR, 0.
67; 95% CI, 0.
55-0.
81)
.

After completion of the treatment regimen in this study, 144 patients (43%) in the ribociclib group and 173 patients (51%) in the placebo group received chemotherapy as follow-up therapy
.
The median time to first chemotherapy with ribociclib and placebo was 50.
9 months and 36.
8 months, respectively (HR, 0.
69; 95% CI, 0.
56-0.
87)
.
Median chemotherapy-free survival was 42.
4 months versus 26.
4 months for placebo (HR, 0.
67; 95% CI, 0.
55-0.
81)
.
The median time to first chemotherapy with ribociclib and placebo was 50.
9 months and 36.
8 months, respectively (HR, 0.
69; 95% CI, 0.
56-0.
87)
.
Median chemotherapy-free survival was 42.
4 months versus 26.
4 months for placebo (HR, 0.
67; 95% CI, 0.
55-0.
81)
.
The median time to first chemotherapy with ribociclib and placebo was 50.
9 months and 36.
8 months, respectively (HR, 0.
69; 95% CI, 0.
56-0.
87)
.
Median chemotherapy-free survival was 42.
4 months versus 26.
4 months for placebo (HR, 0.
67; 95% CI, 0.
55-0.
81)
.

TTC, time to chemotherapy and CFS, chemotherapy-free survival

TTC, time to chemotherapy TTC, time to chemotherapy and CFS, chemotherapy-free survival and CFS, chemotherapy-free survival

Overall, 177 (53%) and 221 (66%) patients receiving ribociclib and placebo, respectively, experienced disease progression or died of any cause on subsequent therapy
.
Median PFS2 was 44.
2 months in the ribociclib group and 31.
0 months in the placebo group (HR, 0.
68; 95% CI, 0.
56-0.
83); in subgroup analyses, the PFS2 benefit was generally consistent
.
Disease progression or death from any cause occurred in 177 (53%) and 221 (66%) patients receiving ribociclib and placebo, respectively, on subsequent therapy
.
Median PFS2 was 44.
2 months in the ribociclib group and 31.
0 months in the placebo group (HR, 0.
68; 95% CI, 0.
56-0.
83); in subgroup analyses, the PFS2 benefit was generally consistent
.
Disease progression or death from any cause occurred in 177 (53%) and 221 (66%) patients receiving ribociclib and placebo, respectively, on subsequent therapy
.
Median PFS2 was 44.
2 months in the ribociclib group and 31.
0 months in the placebo group (HR, 0.
68; 95% CI, 0.
56-0.
83); in subgroup analyses, the PFS2 benefit was generally consistent
.

PFS2

Grade 3 or 4 adverse events of particular concern were neutropenia (ribociclib, 65%; placebo, 6%), hepatobiliary toxicity (ribociclib, 12%; placebo, 7%), QT prolongation (ribociclib, 2%; placebo, 1%)
.

In conclusion, the updated results of the MONALEESA-7 study showed that Ribociclib combined with endocrine therapy continued to improve the prognosis of patients with HR+/HER2- advanced breast cancer compared with endocrine monotherapy
.
The updated results of the MONALEESA-7 study showed that Ribociclib combined with endocrine therapy continued to improve the prognosis of patients with HR+/HER2- advanced breast cancer compared with endocrine monotherapy
.
The updated results of the MONALEESA-7 study showed that Ribociclib combined with endocrine therapy continued to improve the prognosis of patients with HR+/HER2- advanced breast cancer compared with endocrine monotherapy
.

Original source:

Lu YS, Im SA, Colleoni M, et al .
Updated Overall Survival of Ribociclib Plus Endocrine Therapy vs Endocrine Therapy Alone in Pre- and Perimenopausal Patients With HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial.
Clin Cancer Res.
2021 Dec 29:clincanres.
3032.
2021.
doi: 10.
1158/1078-0432.
CCR-21-3032.
Epub ahead of print.
PMID: 34965945.
Lu YS, Im SA, Colleoni M, et al .
Updated Overall Survival of Ribociclib Plus Endocrine Therapy vs Endocrine Therapy Alone in Pre- and Perimenopausal Patients With HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial.
Clin Cancer Res.
2021 Dec 29:clincanres.
3032.
2021.
doi: 10.
1158 /1078-0432.
CCR-21-3032.
Epub ahead of print.
PMID: 34965945.
Leave a message here

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.