Trabectedin plus pegylated liposomal doxorubicin (PLD) for patients with platinum-sensitive recurrent ovarian cancer: a prospective, observational, multicenter study

被引:9
作者
Runnebaum, Ingo B. [1 ]
Reichert, Dietmar [2 ,3 ]
Ringsdorf, Uta [4 ]
Kuther, Markus [5 ]
Hesse, Tobias [6 ]
Sehouli, Jalid [7 ,8 ,9 ]
Wimberger, Pauline [10 ]
机构
[1] Univ Womens Hosp, Jena Univ Hosp, Dept Gynecol & Reprod Med, Klinikum 1, D-07747 Jena, Germany
[2] Univ Womens Hosp, Jena Univ Hosp, ESGO Training Ctr Gynecol Oncol, Klinikum 1, D-07747 Jena, Germany
[3] Med Studiengesellsch NORD W GmbH, Med Oncol, Kuhlenstr 53d, D-26655 Westerstede, Germany
[4] Lahn Dill Kliniken GmbH, Gynecol & Obstet, Forsthausstr 1, D-35578 Wetzlar, Germany
[5] Municipal Hosp Kiel, Med oncol, Chemnitzstr 33, D-24116 Kiel, Germany
[6] Agaples Diakonieklinikum Rotenburg GmbH, Dept Gynecol & Obstet, Elise Averdieck Str 17, D-27356 Rotenburg, Germany
[7] Med Univ Berlin, Benjamin Franklin Charite Comprehens Canc Ctr, Augustenburger Pl 1, D-13353 Berlin, Germany
[8] Med Univ Berlin, European Competence Ctr Ovarian Canc, Augustenburger Pl 1, D-13353 Berlin, Germany
[9] Tech Univ Dresden, Fac Med, Fetscherstr 74, D-01397 Dresden, Germany
[10] Tech Univ Dresden, Hosp Carl Gustav Carus Gynecol & Obstet, Fetscherstr 74, D-01397 Dresden, Germany
关键词
Trabectedin; Observational trial; Pegylated liposomal doxorubicin (PLD); PHASE-II; MECHANISM; SAFETY;
D O I
10.1007/s00432-018-2637-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose The OVA-YOND study is the first prospective, non-interventional trial designed to evaluate trabectedin (1.1 mg/m(2)) plus PLD (30 mg/m(2)) in patients with platinum-sensitive recurrent ovarian cancer (ROC), given according to the marketing authorization in real-life clinical practice across Germany. Methods Eligible patients were adults with platinum-sensitive ROC, pretreated with >= 1 platinum-containing regimen/s. The primary endpoint was to assess safety/tolerability of the combination. Results Seventy-seven patients with platinum-sensitive relapse from 31 sites were evaluated. Patients received a median of 6 cycles (range 1-21) with 39 patients (50.6%) receiving >= 6 cycles. Median treatment duration was 4.2 months (range 0.7-18.8), mostly on an outpatient basis (88.3% of patients). Most common grade 3/4 trabectedin-related adverse events (AEs) were leukopenia (18.2%), neutropenia (15.6%), thrombocytopenia (9.1%), alanine (7.8%) and aspartate aminotransferase (6.5%) increase, and nausea/vomiting (5.2% each). Neutropenia (18.2%), leukopenia (15.6%), thrombocytopenia (10.4%), and nausea/vomiting (5.2% each) were the most frequent grade 3/4 PLD-related AEs. No deaths attributed to drug-related AEs or unexpected AEs occurred. Five patients (6.5%) had a complete response and 19 patients (24.7%) achieved a partial response for an objective response rate of 31.2% with median response duration of 6.25 months. Sixteen patients (20.8%) had disease stabilization for a disease control rate of 51.9%. Median progression-free survival was 6.3 months and median overall survival was 16.4 months. Conclusion Trabectedin plus PLD confer clinically meaningful benefit to pre-treated patients with platinum-sensitive ROC, being comparable to those previously observed in selected populations from clinical trials and with a manageable safety profile.
引用
收藏
页码:1185 / 1195
页数:11
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