Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial

被引：15

作者：

Lorusso, Domenica ^{[1
,2
,3
]}

Mouret-Reynier, Marie-Ange ^{[4
,5
]}

Harter, Philipp ^{[6
,7
]}

Cropet, Claire ^{[8
]}

Caballero, Cristina ^{[9
,10
]}

Wolfrum-Ristau, Pia ^{[11
,12
]}

Satoh, Toyomi ^{[13
,14
]}

Vergote, Ignace ^{[15
,16
]}

Parma, Gabriella ^{[17
,18
]}

Nottrup, Trine J. ^{[19
,20
]}

Lebreton, Coriolan ^{[5
,21
]}

Fasching, Peter A. ^{[7
,22
]}

Pisano, Carmela ^{[3
,23
]}

Manso, Luis ^{[10
,24
]}

Bourgeois, Hugues ^{[5
,25
]}

Runnebaum, Ingo ^{[7
,26
]}

Zamagni, Claudio ^{[3
,27
]}

Hardy-Bessard, Anne-Claire ^{[5
,28
]}

Schnelzer, Andreas ^{[7
,29
,41
]}

Fabbro, Michel ^{[5
,30
]}

Schmalfeldt, Barbara ^{[7
,31
]}

Berton, Dominique ^{[5
,32
]}

Belau, Antje ^{[7
,33
,34
]}

Lotz, Jean-Pierre ^{[5
,35
]}

Gropp-Meier, Martina ^{[7
,36
]}

Gladieff, Laurence ^{[5
,37
]}

Lueck, Hans-Joachim ^{[7
]}

Abadie-Lacourtoisie, Sophie ^{[5
,38
]}

Pujade-Lauraine, Eric ^{[5
,39
]}

Ray-Coquard, Isabelle ^{[5
,40
]}

机构：

[1] Fdn Policlin Univ A Gemelli IRCCS, Ist Tumori Milano, Rome, Italy

[2] Univ Cattolica Sacro Cuore, Milan, Italy

[3] Multictr Italian Trials Ovarian Canc & Gynecol Ma, Rome, Italy

[4] Ctr Jean Perrin, Dept Med Oncol, Clermont Ferrand, France

[5] Grp Investigateurs Nationaux Etud Canc Ovariens G, Villejuif, France

[6] Ev Kliniken Essen Mitte, Dept Gynaecol & Gynaecol Oncol, Essen, Germany

[7] Arbeitsgemeinschaft Gynakol Onkol Studiengrp AGO, Greifswald, Germany

[8] Ctr Leon Berard, Dept Biostat, Lyon, France

[9] Hosp Gen Univ Valencia, Serv Oncol Med, Valencia, Spain

[10] GEICO, Madrid, Spain

[11] Paracelsus Med Univ Salzburg, Dept Obstet & Gynecol, Salzburg, Austria

[12] Arbeitsgemeinschaft Gynaekol Onkol Study Grp AGO, Graz, Austria

[13] Univ Tsukuba, Fac Med, Dept Obstet & Gynecol, Tsukuba, Ibaraki, Japan

[14] GOTIC, Hidaka, Japan

[15] Univ Hosp Leuven, Dept Obstet & Gynaecol, Leuven Canc Inst, Leuven, Belgium

[16] Belgium & Luxembourg Gynaecol Oncol Grp BGOG, Leuven, Belgium

[17] European Inst Oncol IRCCS, Gynecol Oncol Program, Milan, Italy

[18] Mario Negri Gynecol Oncol Grp MANGO, Milan, Italy

[19] Copenhagen Univ Hosp, Rigshosp, Dept Oncol, Copenhagen, Denmark

[20] Nord Soc Gynecol Oncol NSGO, Copenhagen, Denmark

[21] Inst Bergonie, Dept Med Oncol, Bordeaux, France

[22] Univ Frauenklin Erlangen, Gynecol & Obstet Translat Med, Erlangen, Germany

[23] IRCCS Fdn G Pascale Napoli, Dept Urol & Gynecol, Ist Nazl Tumori, Naples, Italy

[24] Hosp 12 Octubre, Dept Med Oncol, Madrid, Spain

[25] Ctr Jean Bernard Clin Victor Hugo, Med Oncol Dept, Le Mans, France

[26] Friedrich Schiller Univ, Jena Univ Hosp, Dept Gynecol & Reprod Med, Jena, Germany

[27] IRCCS Azienda Osped Univ Bologna, Bologna, Italy

[28] Ctr CARIO HPCA, Oncol Med, Plerin Sur Mer, Plerin, France

[29] Tech Univ Munich, Klinikum Rechts Isar, Frauenklin & Poliklin, Munich, Germany

[30] Inst Canc Montpellier, Montpellier, France

[31] Univ Klinikum Hamburg Eppendorf, Hamburg, Germany

[32] Ctr Rene Gauducheau, ICO, St Herblain, France

[33] Univ Med Greifswald, Frauenklin, Greifswald, Germany

[34] Univ Med Greifswald, Frauenarztpraxis, Greifswald, Germany

[35] Hop Tenon, AP HP, Paris, France

[36] Onkol Ravensburg, Ravensburg, Germany

[37] Oncopole CLAUDIUS REGAUD IUCT Oncopole, Toulouse, France

[38] ICO Paul Papin, Angers, France

[39] ARCAGY Res, Med Oncol Dept, Paris, France

[40] Ctr Leon Berard, Dept Med Oncol, Lyon, France

[41] RoMed Klinikum Rosenheim, Gynakol & Geburtshilfe, Rosenheim, Germany

来源：

INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER | 2024年 / 34卷 / 04期

关键词：

Ovarian Cancer; GROUPS REQUIREMENTS; EUROPEAN NETWORK; ACADEMIC GROUPS; CHEMOTHERAPY; DISEASE;

D O I：

10.1136/ijgc-2023-004995

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

ObjectiveIn the PAOLA-1/ENGOT-ov25 trial (NCT02477644), adding maintenance olaparib to bevacizumab provided a substantial progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and homologous recombination deficiency (HRD)-positive tumors, irrespective of clinical risk. Subsequently, a clinically meaningful improvement in overall survival was reported with olaparib plus bevacizumab in the HRD-positive subgroup. We report updated progression-free survival and overall survival by clinical risk and HRD status.MethodsPatients in clinical response after first-line platinum-based chemotherapy plus bevacizumab received maintenance olaparib (up to 24 months) plus bevacizumab (up to 15 months in total) or placebo plus bevacizumab. This post hoc analysis evaluated 5-year progression-free survival and mature overall survival in patients classified by clinical risk and HRD status.ResultsOf 806 randomized patients, 74% were higher-risk and 26% were lower-risk. In higher-risk HRD-positive patients, the hazard ratio (HR) for progression-free survival was 0.46 (95% confidence interval (95% CI) 0.34 to 0.61), with 5-year progression-free survival of 35% with olaparib plus bevacizumab versus 15% with bevacizumab alone; and the HR for overall survival was 0.70 (95% CI 0.50 to 1.00), with 5-year overall survival of 55% versus 42%, respectively. In lower-risk HRD-positive patients, the HR for progression-free survival was 0.26 (95% CI 0.15 to 0.45), with 5-year progression-free survival of 72% with olaparib plus bevacizumab versus 28% with bevacizumab alone; and the HR for overall survival was 0.31 (95% CI 0.14 to 0.66), with 5-year overall survival of 88% versus 61%, respectively. No benefit was seen in HRD-negative patients regardless of clinical risk.ConclusionThis post hoc analysis indicates that in patients with newly diagnosed advanced HRD-positive ovarian cancer, maintenance olaparib plus bevacizumab should not be limited to those considered at higher risk of disease progression. Five-year progression-free survival rates support long-term remission and suggest an increased potential for cure with particular benefit suggested in lower-risk HRD-positive patients.

引用

页码：550 / 558

页数：9

共 23 条

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