Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial

被引：7

作者：

Gruenwald, Viktor ^{[1
,2
]}

Pink, Daniel ^{[3
,4
]}

Egerer, Gerlinde ^{[5
]}

Schalk, Enrico ^{[6
]}

Augustin, Marinela ^{[7
]}

Deinzer, Christoph K. W. ^{[8
]}

Kob, Viola ^{[9
]}

Reichert, Dietmar ^{[10
]}

Kebenko, Maxim ^{[11
]}

Brandl, Stephan ^{[12
]}

Hahn, Dennis ^{[13
]}

Lindner, Lars H. ^{[14
]}

Hoiczyk, Mathias ^{[15
]}

Ringsdorf, Uta ^{[16
]}

Hanker, Lars C. ^{[17
]}

Hempel, Dirk ^{[18
]}

De Rivas, Beatriz ^{[19
]}

Wismann, Tobias ^{[20
]}

Ivanyi, Philipp ^{[21
]}

机构：

[1] Univ Klinikum Essen, Innere Klin Tumorforsch, D-45147 Essen, Germany

[2] Univ Klinikum Essen, Klin Urol, D-45147 Essen, Germany

[3] Sarkomzentrum Berlin Brandenburg, Klin Onkol & Palliat Med, Helios Klinikum Bad Saarow, D-15526 Bad Saarow Pieskow, Germany

[4] Univ Med Greifswald, Innere Med C, D-17489 Greifswald, Germany

[5] Univ Klinikum Heidelberg, Klin Hamatol Onkol Rheumatol, D-69120 Heidelberg, Germany

[6] Otto von Guericke Univ, Med Ctr, D-39106 Magdeburg, Germany

[7] Paracelsus Med Privatuniv, Klin Innere Med 5, Schwerpunkt Onkol Hamatol, Klinikum Nurnberg Nord, D-90419 Nurnberg, Germany

[8] Univ Klinikum Wurzburg, Med Klin & Poliklin 2, Hamatol & Internist Onkol, D-97078 Wurzburg, Germany

[9] MVZ Immunol Lokstedt GmbH, Schwerpunktpraxis Hamatol Onkol Volksdorf, D-20251 Hamburg, Germany

[10] Gemeinschaftspraxis Hamatol & Onkol, Kuhlenstr 53d, D-26655 Westerstede, Germany

[11] Univ Klinikum Schleswig Holstein, Klin Hamatol & Onkol, D-23538 Lubeck, Germany

[12] Uberortl Gemeinschaftspraxis Bergedorf, D-21029 Hamburg, Germany

[13] Klinikum Stuttgart, Klin Hamatol Onkol & Palliat Med, D-70174 Stuttgart, Germany

[14] LMU Klinikum, Med Klin & Poliklin 3, Campus Grosshadern, D-81377 Munich, Germany

[15] Marien Hosp Wesel gGmbH, Med Klin 2, D-46483 Wesel, Germany

[16] Lahn Dill Kliniken GmbH, Gynakol Tumorzentrums Lahn Dill, D-35578 Wetzlar, Germany

[17] Univ Klinikum Schleswig Holstein, Klin Frauenheilkunde & Geburtshilfe Gynakol, D-23538 Lubeck, Germany

[18] Onkol Zentrum, D-86609 Donauworth, Germany

[19] PharmaMar SA, Med Affairs, Madrid 28770, Spain

[20] Praxis Onkol & Urol, D-26389 Wilhelmshaven, Germany

[21] Hannover Med Sch, Claudia von Schilling Zentrum, Hamostaseol Onkol & Stammzelltransplantat, Klin Hamatol,Comprehens Canc Ctr, D-30625 Hannover, Germany

来源：

CANCERS | 2022年 / 14卷 / 21期

关键词：

trabectedin; STS; sarcoma; non-interventional; prospective; CLINICAL-PRACTICE GUIDELINES; METASTATIC LIPOSARCOMA; SUPPORTIVE CARE; CHEMOTHERAPY; MECHANISM; EFFICACY; SAFETY; LEIOMYOSARCOMA; DIAGNOSIS; FAILURE;

D O I：

10.3390/cancers14215234

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

This non-interventional, prospective phase IV trial evaluated trabectedin in patients with soft tissue sarcoma (STS) in real-life clinical practice across Germany. The primary endpoints were progression-free survival (PFS) rates at 3 and 6 months, as defined by investigators. Overall, 128 patients from 19 German sites were evaluated for efficacy and 130 for safety. Median age was 58.5 years (range: 23-84) and leiomyosarcoma was the most frequent histotype (n = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (n = 91; 71.1%). Median PFS was 5.2 months (95% CI: 3.3-6.7), with 60.7% and 44.5% of patients free from progression at 3 and 6 months, respectively. Median overall survival was 15.2 months (95% CI: 9.6-21.4). One patient achieved a complete and 14 patients a partial response, conferring an objective response rate of 11.7%. Decreases in white blood cells (27.0% of patients), platelets (16.2%) and neutrophils (13.1%) and increased alanine aminotransferase (10.8%) were the most common trabectedin-related grade 3/4 adverse drug reactions. Two deaths due to pneumonia and sepsis were considered trabectedin-related. Trabectedin confers clinically meaningful activity in patients with multiple STS histotypes, comparable to that previously observed in clinical trials and other non-interventional studies, and with a manageable safety profile.

引用

页数：15

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