INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line

被引：18

作者：

Colombo, N. ^{[1
,2
]}

Gadducci, A. ^{[3
]}

Sehouli, J. ^{[4
]}

Rulli, E. ^{[5
]}

Maenpaa, J. ^{[6
,7
,8
,9
]}

Sessa, C. ^{[10
,11
]}

Montes, A. ^{[12
]}

Ottevanger, N. B. ^{[13
]}

Berger, R. ^{[14
,15
]}

Vergote, I. ^{[16
,17
]}

D'Incalci, M. ^{[5
,18
]}

Galaz, C. Churruca ^{[19
,20
]}

Chekerov, R. ^{[4
]}

Nyvang, G. B. ^{[21
,22
]}

Riniker, S. ^{[23
,24
]}

Herbertson, R. ^{[25
]}

Fossati, R. ^{[5
]}

Barretina-Ginesta, M. P. ^{[26
,27
]}

Deryal, M. ^{[28
,29
]}

Mirza, M. R. ^{[30
,31
]}

Biagioli, E. ^{[5
]}

Iglesias, M. ^{[32
,33
]}

Funari, G. ^{[5
]}

Romeo, M. ^{[34
,35
]}

Tasca, G. ^{[36
,37
]}

Pardo, B. ^{[38
]}

Tognon, G. ^{[39
,40
]}

Rubio-Perez, M. J. ^{[41
]}

DeCensi, A. ^{[42
]}

De Giorgi, U. ^{[43
]}

Zola, P. ^{[44
]}

Panici, P. Benedetti ^{[45
,46
]}

Aglietta, M. ^{[47
]}

Arcangeli, V. ^{[48
]}

Zamagni, C. ^{[49
]}

Bologna, A. ^{[50
]}

Westermann, A. ^{[51
]}

Heinzelmann-Schwarz, V. ^{[52
,53
]}

Tsibulak, I. ^{[14
,15
]}

Wimberger, P. ^{[54
,55
,56
,57
,58
]}

Poveda, A. ^{[59
,60
]}

机构：

[1] IRCCS, European Inst Oncol, Gynecol Canc Program, Milan, Italy

[2] Univ Milano Bicocca, Milan, Italy

[3] Univ Pisa, Div Obstet & Gynecol, Clin & Expt Med, Pisa, Italy

[4] Charite Berlin Univ Med, European Competence Ctr Ovarian Canc, North Eastern German Soc Gynecol Oncol NOGGO, Study Grp & Gynecol,Ctr Oncol Surg, Berlin, Germany

[5] Ist Ric Farmacol Mario Negri IRCCS, Milan, Italy

[6] Tampere Univ, Nord Soc Gynecol Oncol Clin Trial Unit NSGOCTU, Tampere, Finland

[7] Tampere Univ, Dept Obstet & Gynaecol, Tampere, Finland

[8] Tampere Univ, Tays Canc Ctr, Tampere, Finland

[9] Univ Hosp, Tampere, Finland

[10] Ist Oncol Svizzera Italiana, IOSI, Bellinzona, Switzerland

[11] Swiss Grp Clin Canc Res SAKK, Bellinzona, Switzerland

[12] Guys & St Thomas NHS Fdn Trust, London, England

[13] Radboud Univ Nijmegen, Med Ctr, Med Oncol, Nijmegen, Netherlands

[14] Med Univ Innsbruck, Dept Gynecol & Obstet, Innsbruck, Austria

[15] AGO, Innsbruck, Austria

[16] Univ Hosp Leuven, Leuven Canc Inst, Gynecol Oncol, Leuven, Belgium

[17] European Union, Belgian Gynaecol Oncol Grp BGOG, Leuven, Belgium

[18] Humanitas Univ, Dept Biomed Sci, Pieve Emanuele, Italy

[19] Hosp Donosti San Sebastian, De Donosti San, Spain

[20] Grp Espanol Canc Ovario GEICO, De Donosti San, Spain

[21] Odense Univ Hosp, Nord Soc Gynecol Oncol Clin Trial Unit NSGO CTU, Odense, Denmark

[22] Odense Univ Hosp, Dept Oncol, Odense, Denmark

[23] Kantonsspital St Gallen, Oncol, St Gallen, Switzerland

[24] Swiss Grp Clin Canc Res SAKK, St Gallen, Switzerland

[25] Brighton & Sussex Univ Hosp NHS Trust, Brighton, E Sussex, England

[26] Inst Catala Oncologia Girona, De Donosti San, Spain

[27] Girona & Grp Espanol Canc Ovario GEICO, De Donosti San, Spain

[28] North Eastern German Soc Gynecol Oncol NOGGO, Study Grp, Saarbrucken, Germany

[29] CaritasKlinikum St Theresia Saarbruecken, Saarbrucken, Germany

[30] Copenhagen Univ Hosp, Nord Soc Gynecol Oncol Clin Trial Unit NSGO CTU, Copenhagen, Denmark

[31] Copenhagen Univ Hosp, Dept Canc Treatment, Copenhagen, Denmark

[32] Hosp Son Llazter, Palma De Mallorca, Spain

[33] Grupo Espanol Canc Ovario GEICO, Palma De Mallorca, Spain

[34] Inst Catala Oncologia Badalona, De Donosti San, Spain

[35] Grp Espanol Canc Ovario GEICO, De Donosti San, Spain

[36] Inst Catala Oncol Hosp, Barcelona, Spain

[37] Grp Espanol Canc Ovario GEICO, Barcelona, Spain

[38] ASST Spedali Civili Univ Brescia, Obstetr & Gynaecol, Brescia, Italy

[39] Hosp Reina Sofia Cordoba, De Donosti San, Spain

[40] Grp Espanol Canc Ovario GEICO, De Donosti San, Spain

[41] EO Ospedali Galliera, SC Oncol Med, Genoa, Italy

[42] IRCCS Ist Romagnolo Studio Tumori IRST Dino Amado, Meldola, Italy

[43] AOU Citta Salute & Scienza OIRM S Anna, Turin, Italy

[44] AOU Policlin I Umberto Roma, Rome, Italy

[45] Univ Torino, Ist Candiolo, FPO IRCCS, Turin, Italy

[46] Univ Torino, Turin, Italy

[47] Ospedale Infermi, Rimini, Italy

[48] Univ Bologna, IRCCS Azienda Ospedaliero, Bologna, Italy

[49] IRCCS, Azienda Unita Sanit Locale Reggio Emilia, Reggio Emilia, Italy

[50] Amsterdam UMC, Amsterdam, Netherlands

来源：

BRITISH JOURNAL OF CANCER | 2023年 / 128卷 / 08期

关键词：

QUALITY-OF-LIFE; OPEN-LABEL; TRIAL; EFFICACY; MULTICENTER; SAFETY; SENSITIVITY; COMBINATION; EVALUATE; THERAPY;

D O I：

10.1038/s41416-022-02108-7

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

BACKGROUND: This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC). METHODS: Patients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75). RESULTS: The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP). CONCLUSIONS: This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities.

引用

页码：1503 / 1513

页数：11

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