 Home > Active Ingredient News > Antitumor Therapy > Eur J Cancer: Palbociclib or placebo combined with fulvestrant in patients with HR+/HER2- advanced breast cancer

Eur J Cancer: Palbociclib or placebo combined with fulvestrant in patients with HR+/HER2- advanced breast cancer

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

Tags

1 5 crown

2 4 6 trinitrotoluene

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

The potential benefit of adding palbociclib to fulvestrant as first-line therapy in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive advanced breast cancer (ABC) is unclear
.

Therefore, Spanish scholars carried out a phase II clinical study GEICAM/2014-12 (FLIPPER) to evaluate the efficacy of fulvestrant combined with CDK4/6 inhibitor palbociclib in patients with HR+/HER2- advanced breast cancer

A total of 189 patients were included in the study, including 94 in the fulvestrant + palbociclib group and 95 in the fulvestrant + placebo group
.

The cutoff date (January 11, 2020), and the median follow-up time was 28.

A total of 189 patients were included in the study, including 94 in the fulvestrant + palbociclib group and 95 in the fulvestrant + placebo group

PFS

The ORR was 68.
3% in the fulvestrant + palbociclib group and 42.
2% in the fulvestrant + placebo group (OR 2.
9; 80% CI, 1.
8-4.
6, p=0.
004)
.

The 24-week CBR in the two groups was 90.

The ORR was 68.

Efficacy assessment

In subgroup analysis, among patients with visceral metastases, the median PFS in the fulvestrant + palbociclib group and fulvestrant + placebo group was 30.
9 and 19.
4 months, respectively (p=0.
003); Median PFS was 33.
4 and 25.
6 months in the strontium+palbociclib group and fulvestrant+placebo group, respectively (p=0.
176); among patients with newly diagnosed metastases, fulvestrant+palbociclib and fulvestrant+ The median PFS in the placebo group was 33.
4 and 16.
4 months, respectively (p<0.
001); among patients with recurrence and metastasis, the median PFS in the fulvestrant + palbociclib group and the fulvestrant + placebo group were 30.
5 and 27.
3, respectively months (p=0.
370)
.

In subgroup analysis, among patients with visceral metastases, the median PFS in the fulvestrant + palbociclib group and fulvestrant + placebo group was 30.

PFS subgroup analysis

In conclusion, the study showed that fulvestrant + palbociclib improved PFS in patients compared with fulvestrant + placebo
.

Studies have shown that fulvestrant + palbociclib improves patients' PFS compared to fulvestrant + placebo treatment

Original source:

Albanell J, Martínez MT, Ramos M, O'Connor M, de la Cruz-Merino L, Santaballa A, Martínez-Jañez N, Moreno F, Fernández I, Alarcón J, Virizuela JA, de la Haba-Rodríguez J, Sánchez- Rovira P, González-Cortijo L, Margelí M, Sánchez-Muñoz A, Antón A, Casas M, Bezares S, Rojo F.
Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2- advanced breast cancer: GEICAM/2014-12 (FLIPPER).
Eur J Cancer.
2022 Jan;161:26-37.
doi: 10.
1016/j.
ejca.
2021.
11.
010.
Epub 2021 Dec 11.
PMID: 34902765.
Leave a comment 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.