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Proffered Paper - Gynaecological cancers 1

LBA28 - A randomised double-blind placebo-controlled phase II trial of palbociclib combined with letrozole (L) in patients (pts) with oestrogen receptor-positive (ER+) advanced/recurrent endometrial cancer (EC): NSGO-PALEO / ENGOT-EN3 trial


19 Sep 2020


Proffered Paper - Gynaecological cancers 1


Tumour Site

Endometrial Cancer


Mansoor Raza Mirza


Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325


M.R. Mirza1, L. Bjørge2, F. Marmé3, R. DePont Christensen4, M. Gil-Martin5, A. Auranen6, B. Ataseven7, M.J. Rubio8, V. Salutari9, B. Lund10, I. Runnebaum11, A. Redondo12, K. Lindemann13, F. Trillsch14, M.P. Barretina Ginesta15, H. Roed16, J. Løhndorf17, G. Nyvang18, J. Sehouli19

Author affiliations

  • 1 Department Of Oncology, Nordic Society of Gynaecological Oncology (NSGO) and Rigshospitalet, Copenhagen University Hospital, 2100 - Copenhagen/DK
  • 2 Department Of Gynaecological Oncology, Nordic Society of Gynaecological Oncology (NSGO-CTU) andHaukeland University Hospital and Center of Biomarkers CCBIO, University of Bergen, Norway, Bergen/NO
  • 3 Gynecologic Oncology Department, UMM - Universitaetsklinikum Mannheim - Medizinische Fakultaet, 68167 - Mannheim/DE
  • 4 Department Of Biostatistics, Nordic Society of Gynaecological Oncology (NSGO-CTU) and Institute of Public Health, University of Southern Denmark, Odense/DK
  • 5 Oncology, GEICO & Institut Català d'Oncologia-IDIBELL, L'Hospitalet-Barcelona, Spain, barcelona/ES
  • 6 Department Of Obstetrics And Gynecology, NSGO-CTU & Tampere University Hospital (Tays), 33521 - Tampere/FI
  • 7 Gynaecology, NOGGO & Kliniken Essen Mitte Evang. Huyssens-Stiftung, 45136 - Essen/DE
  • 8 Gynecology, GEICO & University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 9 Gynecologic Oncology Department, MITO & Policlinico Universitario A. Gemelli, 00168 - Rome/IT
  • 10 Department Of Oncology, Nordic Society of Gynaecological Oncology (NSGO-CTU) and Aalborg university hospital, Aalborg/DK
  • 11 Gynaecology, NOGGO & Klinik für Frauenheilkunde und Fortpflanzungsmedizin, Munich/DE
  • 12 Dept. Oncologia Medica, GEICO & Hospital Universitario La Paz, 28046 - Madrid/ES
  • 13 Department Of Gynecological Cancer, NSGO-CTU & Oslo University Hospital - The Norwegian Radium Hospital, 0424 - Oslo/NO
  • 14 Department Of Gynecology And Obstetrics, NOGGO & Klinikum der Universität München, 81377 - Munich/DE
  • 15 Dept. Medical Oncology, GEICO & ICO - Institut Català d'Oncologia Girona (Hospital Universitari Josep Trueta Hospital Universitari Josep Trueta), 17007 - Girona/ES
  • 16 Department Of Oncology 3994, NSGO-CTU & Rigshospitalet, DK-2100 - Copenhagen/DK
  • 17 Nsgo, NSGO-CTU Nordic Society of Gynaecological Oncology - Rigshospitalet, 2100 - Copenhagen/DK
  • 18 Department Of Oncology, NSGO-CTU & Odense University Hospital, Odense/DK
  • 19 Gynecology, NOGGO & Universitätsklinik Charité, Campus Virchow Klinikum, 13353 - Berlin/DE


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Abstract LBA28


Cyclins are proteins that activate cyclin-dependent kinases (CDKs) and are required for normal cell cycle transitions. Palbociclib is an oral selective inhibitor of the CDKs 4 and 6. EC endometrioid adenocarcinoma is hormone dependent and endocrine therapy with aromatase inhibitors is well established. This is the first randomised trial of a CDK4/6 inhibitor (P) vs placebo combined with L in pts with advanced or recurrent ER+ EC.


Eligible pts had ECOG PS 0/1, histologically confirmed endometrioid EC that was ER+ and measurable or evaluable per RECIST v1.1 and had received no prior CDK4/6 inhibitor therapy. Prior surgery, radiation therapy, chemotherapy or ≤1 line of endocrine therapy (MPA/megestrol acetate) was permitted. Pts were stratified according to number of prior chemotherapy lines, prior endocrine therapy and measurable vs evaluable disease. Pts were randomised 1:1 to receive L 2.5 mg OD orally d1–28 with either palbociclib 125 mg or placebo OD orally d1–21 in a 28-d cycle until progression. Tumours were assessed every 12 weeks. The primary endpoint was progression-free survival (PFS).


Of 77 enrolled pts, 73 were evaluable (2 received no trial drug; 1 had brain metastases; 1 withdrew consent before starting treatment): 37 randomised to L + placebo and 36 to L + palbociclib combination. Major comorbidity: diabetes in 12%, hypertension in 41%. 88% had relapsed disease and only 15% had prior MPA/megestrol acetate. Palbociclib/placebo was interrupted in 25/ 8 pts and in 14 pts the dose of palbociclib was reduced. L + palbociclib significantly improved PFS compared with L + placebo: median 8.3 vs. 3.0 months, respectively; hazard ratio 0.56 (95% CI 0.32 to 0.98; p0.041). Disease control rate at 24 weeks: 64% vs. 38%. Treatment-emergent grade 3/4 adverse events were significantly more frequent with L + palbociclib (anaemia 8% vs 3%; neutropenia 42% vs 0%). Patient-reported outcomes were similar in the two treatment arms.


The L + palbociclib combination demonstrated clinically meaningful improvement in PFS with manageable toxicity, meriting phase III investigation.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

NSGO-CTU (Nordic Society of Gynaecological Oncology - Clinical Trial Unit).




M.R. Mirza: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Biocad; Advisory/Consultancy, Research grant/Funding (institution): Clovis Oncology; Honoraria (self): Genmab; Advisory/Consultancy, Leadership role, Board of Directors: Karyopharm Therapeutics; Advisory/Consultancy: Merck; Advisory/Consultancy: Oncology Adventure; Research grant/Funding (institution): Pfizer; Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Seattle Genetics; Honoraria (self), Advisory/Consultancy: Sera Prognostics; Advisory/Consultancy: Sotio; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): GSK; Advisory/Consultancy: Zailab; Research grant/Funding (institution): Boehringer. All other authors have declared no conflicts of interest.

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