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

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 f...
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Autor*in:	Viktor Grünwald [verfasserIn] Daniel Pink [verfasserIn] Gerlinde Egerer [verfasserIn] Enrico Schalk [verfasserIn] Marinela Augustin [verfasserIn] Christoph K. W. Deinzer [verfasserIn] Viola Kob [verfasserIn] Dietmar Reichert [verfasserIn] Maxim Kebenko [verfasserIn] Stephan Brandl [verfasserIn] Dennis Hahn [verfasserIn] Lars H. Lindner [verfasserIn] Mathias Hoiczyk [verfasserIn] Uta Ringsdorf [verfasserIn] Lars C. Hanker [verfasserIn] Dirk Hempel [verfasserIn] Beatriz De Rivas [verfasserIn] Tobias Wismann [verfasserIn] Philipp Ivanyi [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	trabectedin STS sarcoma non-interventional prospective

Übergeordnetes Werk:	In: Cancers - MDPI AG, 2010, 14(2022), 21, p 5234
Übergeordnetes Werk:	volume:14 ; year:2022 ; number:21, p 5234

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3390/cancers14215234

Katalog-ID:	DOAJ020729790

Internformat


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allfields	10.3390/cancers14215234 doi (DE-627)DOAJ020729790 (DE-599)DOAJd4d17da928394b7caec7844af4db59f2 DE-627 ger DE-627 rakwb eng RC254-282 Viktor Grünwald verfasserin aut Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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. trabectedin STS sarcoma non-interventional prospective Neoplasms. Tumors. Oncology. Including cancer and carcinogens Daniel Pink verfasserin aut Gerlinde Egerer verfasserin aut Enrico Schalk verfasserin aut Marinela Augustin verfasserin aut Christoph K. W. Deinzer verfasserin aut Viola Kob verfasserin aut Dietmar Reichert verfasserin aut Maxim Kebenko verfasserin aut Stephan Brandl verfasserin aut Dennis Hahn verfasserin aut Lars H. Lindner verfasserin aut Mathias Hoiczyk verfasserin aut Uta Ringsdorf verfasserin aut Lars C. Hanker verfasserin aut Dirk Hempel verfasserin aut Beatriz De Rivas verfasserin aut Tobias Wismann verfasserin aut Philipp Ivanyi verfasserin aut In Cancers MDPI AG, 2010 14(2022), 21, p 5234 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:21, p 5234 https://doi.org/10.3390/cancers14215234 kostenfrei https://doaj.org/article/d4d17da928394b7caec7844af4db59f2 kostenfrei https://www.mdpi.com/2072-6694/14/21/5234 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 5234
spelling	10.3390/cancers14215234 doi (DE-627)DOAJ020729790 (DE-599)DOAJd4d17da928394b7caec7844af4db59f2 DE-627 ger DE-627 rakwb eng RC254-282 Viktor Grünwald verfasserin aut Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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. trabectedin STS sarcoma non-interventional prospective Neoplasms. Tumors. Oncology. Including cancer and carcinogens Daniel Pink verfasserin aut Gerlinde Egerer verfasserin aut Enrico Schalk verfasserin aut Marinela Augustin verfasserin aut Christoph K. W. Deinzer verfasserin aut Viola Kob verfasserin aut Dietmar Reichert verfasserin aut Maxim Kebenko verfasserin aut Stephan Brandl verfasserin aut Dennis Hahn verfasserin aut Lars H. Lindner verfasserin aut Mathias Hoiczyk verfasserin aut Uta Ringsdorf verfasserin aut Lars C. Hanker verfasserin aut Dirk Hempel verfasserin aut Beatriz De Rivas verfasserin aut Tobias Wismann verfasserin aut Philipp Ivanyi verfasserin aut In Cancers MDPI AG, 2010 14(2022), 21, p 5234 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:21, p 5234 https://doi.org/10.3390/cancers14215234 kostenfrei https://doaj.org/article/d4d17da928394b7caec7844af4db59f2 kostenfrei https://www.mdpi.com/2072-6694/14/21/5234 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 5234
allfields_unstemmed	10.3390/cancers14215234 doi (DE-627)DOAJ020729790 (DE-599)DOAJd4d17da928394b7caec7844af4db59f2 DE-627 ger DE-627 rakwb eng RC254-282 Viktor Grünwald verfasserin aut Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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. trabectedin STS sarcoma non-interventional prospective Neoplasms. Tumors. Oncology. Including cancer and carcinogens Daniel Pink verfasserin aut Gerlinde Egerer verfasserin aut Enrico Schalk verfasserin aut Marinela Augustin verfasserin aut Christoph K. W. Deinzer verfasserin aut Viola Kob verfasserin aut Dietmar Reichert verfasserin aut Maxim Kebenko verfasserin aut Stephan Brandl verfasserin aut Dennis Hahn verfasserin aut Lars H. Lindner verfasserin aut Mathias Hoiczyk verfasserin aut Uta Ringsdorf verfasserin aut Lars C. Hanker verfasserin aut Dirk Hempel verfasserin aut Beatriz De Rivas verfasserin aut Tobias Wismann verfasserin aut Philipp Ivanyi verfasserin aut In Cancers MDPI AG, 2010 14(2022), 21, p 5234 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:21, p 5234 https://doi.org/10.3390/cancers14215234 kostenfrei https://doaj.org/article/d4d17da928394b7caec7844af4db59f2 kostenfrei https://www.mdpi.com/2072-6694/14/21/5234 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 5234
allfieldsGer	10.3390/cancers14215234 doi (DE-627)DOAJ020729790 (DE-599)DOAJd4d17da928394b7caec7844af4db59f2 DE-627 ger DE-627 rakwb eng RC254-282 Viktor Grünwald verfasserin aut Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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. trabectedin STS sarcoma non-interventional prospective Neoplasms. Tumors. Oncology. Including cancer and carcinogens Daniel Pink verfasserin aut Gerlinde Egerer verfasserin aut Enrico Schalk verfasserin aut Marinela Augustin verfasserin aut Christoph K. W. Deinzer verfasserin aut Viola Kob verfasserin aut Dietmar Reichert verfasserin aut Maxim Kebenko verfasserin aut Stephan Brandl verfasserin aut Dennis Hahn verfasserin aut Lars H. Lindner verfasserin aut Mathias Hoiczyk verfasserin aut Uta Ringsdorf verfasserin aut Lars C. Hanker verfasserin aut Dirk Hempel verfasserin aut Beatriz De Rivas verfasserin aut Tobias Wismann verfasserin aut Philipp Ivanyi verfasserin aut In Cancers MDPI AG, 2010 14(2022), 21, p 5234 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:21, p 5234 https://doi.org/10.3390/cancers14215234 kostenfrei https://doaj.org/article/d4d17da928394b7caec7844af4db59f2 kostenfrei https://www.mdpi.com/2072-6694/14/21/5234 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 5234
allfieldsSound	10.3390/cancers14215234 doi (DE-627)DOAJ020729790 (DE-599)DOAJd4d17da928394b7caec7844af4db59f2 DE-627 ger DE-627 rakwb eng RC254-282 Viktor Grünwald verfasserin aut Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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. trabectedin STS sarcoma non-interventional prospective Neoplasms. Tumors. Oncology. Including cancer and carcinogens Daniel Pink verfasserin aut Gerlinde Egerer verfasserin aut Enrico Schalk verfasserin aut Marinela Augustin verfasserin aut Christoph K. W. Deinzer verfasserin aut Viola Kob verfasserin aut Dietmar Reichert verfasserin aut Maxim Kebenko verfasserin aut Stephan Brandl verfasserin aut Dennis Hahn verfasserin aut Lars H. Lindner verfasserin aut Mathias Hoiczyk verfasserin aut Uta Ringsdorf verfasserin aut Lars C. Hanker verfasserin aut Dirk Hempel verfasserin aut Beatriz De Rivas verfasserin aut Tobias Wismann verfasserin aut Philipp Ivanyi verfasserin aut In Cancers MDPI AG, 2010 14(2022), 21, p 5234 (DE-627)614095670 (DE-600)2527080-1 20726694 nnns volume:14 year:2022 number:21, p 5234 https://doi.org/10.3390/cancers14215234 kostenfrei https://doaj.org/article/d4d17da928394b7caec7844af4db59f2 kostenfrei https://www.mdpi.com/2072-6694/14/21/5234 kostenfrei https://doaj.org/toc/2072-6694 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2022 21, p 5234
language	English
source	In Cancers 14(2022), 21, p 5234 volume:14 year:2022 number:21, p 5234
sourceStr	In Cancers 14(2022), 21, p 5234 volume:14 year:2022 number:21, p 5234
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	trabectedin STS sarcoma non-interventional prospective Neoplasms. Tumors. Oncology. Including cancer and carcinogens
isfreeaccess_bool	true
container_title	Cancers
authorswithroles_txt_mv	Viktor Grünwald @@aut@@ Daniel Pink @@aut@@ Gerlinde Egerer @@aut@@ Enrico Schalk @@aut@@ Marinela Augustin @@aut@@ Christoph K. W. Deinzer @@aut@@ Viola Kob @@aut@@ Dietmar Reichert @@aut@@ Maxim Kebenko @@aut@@ Stephan Brandl @@aut@@ Dennis Hahn @@aut@@ Lars H. Lindner @@aut@@ Mathias Hoiczyk @@aut@@ Uta Ringsdorf @@aut@@ Lars C. Hanker @@aut@@ Dirk Hempel @@aut@@ Beatriz De Rivas @@aut@@ Tobias Wismann @@aut@@ Philipp Ivanyi @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	614095670
id	DOAJ020729790
language_de	englisch
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callnumber-first	R - Medicine
author	Viktor Grünwald
spellingShingle	Viktor Grünwald misc RC254-282 misc trabectedin misc STS misc sarcoma misc non-interventional misc prospective misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial
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topic_title	RC254-282 Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial trabectedin STS sarcoma non-interventional prospective
topic	misc RC254-282 misc trabectedin misc STS misc sarcoma misc non-interventional misc prospective misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
topic_unstemmed	misc RC254-282 misc trabectedin misc STS misc sarcoma misc non-interventional misc prospective misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
topic_browse	misc RC254-282 misc trabectedin misc STS misc sarcoma misc non-interventional misc prospective misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens
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title	Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial
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title_full	Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial
author_sort	Viktor Grünwald
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author_browse	Viktor Grünwald Daniel Pink Gerlinde Egerer Enrico Schalk Marinela Augustin Christoph K. W. Deinzer Viola Kob Dietmar Reichert Maxim Kebenko Stephan Brandl Dennis Hahn Lars H. Lindner Mathias Hoiczyk Uta Ringsdorf Lars C. Hanker Dirk Hempel Beatriz De Rivas Tobias Wismann Philipp Ivanyi
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title_sort	trabectedin for patients with advanced soft tissue sarcoma: a non-interventional, prospective, multicenter, phase iv trial
callnumber	RC254-282
title_auth	Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial
abstract	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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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.
abstractGer	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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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.
abstract_unstemmed	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 (<i<n</i< = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (<i<n</i< = 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.
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title_short	Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Prospective, Multicenter, Phase IV Trial
url	https://doi.org/10.3390/cancers14215234 https://doaj.org/article/d4d17da928394b7caec7844af4db59f2 https://www.mdpi.com/2072-6694/14/21/5234 https://doaj.org/toc/2072-6694
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up_date	2024-07-03T16:38:46.930Z
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