Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial
Purpose - The CDK4/6 inhibitor palbociclib inhibits cyclin A, which is overexpressed in endometrial cancer. Combining palbociclib with endocrine therapy improves efficacy in hormone receptor-positive breast cancer. We investigated palbociclib combined with endocrine therapy for estrogen receptor-pos...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
January 2025
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| In: |
Gynecologic oncology
Year: 2025, Volume: 192, Pages: 128-136 |
| ISSN: | 1095-6859 |
| DOI: | 10.1016/j.ygyno.2024.12.003 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.ygyno.2024.12.003 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0090825824012204 
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| Author Notes: | Mansoor R. Mirza, Line Bjørge, Frederik Marmé, René DePont Christensen, Marta Gil-Martin, Annika Auranen, Beyhan Ataseven, Maria Jesús Rubio, Vanda Salutari, Adam A. Luczak, Ingo B. Runnebaum, Andrés Redondo, Kristina Lindemann, Fabian Trillsch, M. Pilar Barretina Ginesta, Henrik Roed, Jean-Emmanuel Kurtz, Karen S. Petersson, Gitte-Bettina Nyvang, Jalid Sehouli |
MARC
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| 245 | 1 | 0 | |a Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer |b double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial |c Mansoor R. Mirza, Line Bjørge, Frederik Marmé, René DePont Christensen, Marta Gil-Martin, Annika Auranen, Beyhan Ataseven, Maria Jesús Rubio, Vanda Salutari, Adam A. Luczak, Ingo B. Runnebaum, Andrés Redondo, Kristina Lindemann, Fabian Trillsch, M. Pilar Barretina Ginesta, Henrik Roed, Jean-Emmanuel Kurtz, Karen S. Petersson, Gitte-Bettina Nyvang, Jalid Sehouli |
| 264 | 1 | |c January 2025 | |
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| 500 | |a Gesehen am 13.05.2025 | ||
| 520 | |a Purpose - The CDK4/6 inhibitor palbociclib inhibits cyclin A, which is overexpressed in endometrial cancer. Combining palbociclib with endocrine therapy improves efficacy in hormone receptor-positive breast cancer. We investigated palbociclib combined with endocrine therapy for estrogen receptor-positive advanced/recurrent endometrial cancer. - Patients and methods - This placebo-controlled double-blind, randomized phase II screening trial (NCT02730429) enrolled women with measurable/evaluable estrogen receptor-positive endometrioid endometrial cancer that was primary metastatic or had relapsed after ≥1 prior systemic therapy. Patients were randomized in a 1:1 ratio, stratified by number of prior chemotherapy lines, measurable versus evaluable non-measurable disease, and prior medroxyprogesterone/megestrol acetate treatment, to receive oral letrozole 2.5 mg on days 1-28 plus either oral palbociclib 125 mg or placebo on days 1-21, repeated every 28 days until disease progression or unacceptable toxicity. The primary end point was investigator-assessed progression-free survival (PFS). - Results - Among 77 patients randomized between February 16, 2017, and December 21, 2018, 73 were treated (36 with palbociclib-letrozole, 37 with placebo-letrozole). Median follow-up was 21.9 (95 % CI, 16.7 to 22.3) months. Median PFS was 8.3 (95 % CI, 4.6 to 11.2) versus 3.1 (95 % CI, 2.7 to 6.8) months, respectively. In a landmark analysis at 12 months the PFS hazard ratio was 0.57 (95 % CI, 0.32 to 0.99; P = .044). Grade ≥ 3 adverse events were more common with palbociclib-letrozole (67 %) than placebo-letrozole (30 %), most commonly neutropenia (44 % v 0 %, respectively). - Conclusion - These results support a potential role of the palbociclib-letrozole combination as treatment for hormone receptor-positive advanced/recurrent endometrial cancer. Based on these encouraging results, phase III evaluation of letrozole combined with a CDK4/6 inhibitor is planned. - Clinical trial information - NCT02730429 | ||
| 650 | 4 | |a CDK4/6 inhibitor | |
| 650 | 4 | |a Endometrial cancer | |
| 650 | 4 | |a Estrogen receptor-positive | |
| 650 | 4 | |a Hormonal therapy | |
| 650 | 4 | |a Letrozole | |
| 650 | 4 | |a Palbociclib | |
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| 700 | 1 | |a Rubio, Maria Jesús |e VerfasserIn |4 aut | |
| 700 | 1 | |a Salutari, Vanda |e VerfasserIn |4 aut | |
| 700 | 1 | |a Luczak, Adam A. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Runnebaum, Ingo B. |d 1960- |e VerfasserIn |0 (DE-588)1111567727 |0 (DE-627)865636184 |0 (DE-576)476172144 |4 aut | |
| 700 | 1 | |a Redondo, Andrés |e VerfasserIn |4 aut | |
| 700 | 1 | |a Lindemann, Kristina |e VerfasserIn |4 aut | |
| 700 | 1 | |a Trillsch, Fabian |e VerfasserIn |4 aut | |
| 700 | 1 | |a Ginesta, M. Pilar Barretina |e VerfasserIn |4 aut | |
| 700 | 1 | |a Roed, Henrik |e VerfasserIn |4 aut | |
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