Lack of Correlation between Liver Tests Abnormalities and Trabectedin Efficacy in the Treatment of Soft Tissue Sarcoma: A Retrospective Study

Bruno Vincenzi; Luciano Stumbo; Giuseppina Maltese; Linda Cerbone; Mariella Spalato Ceruso; Giuseppe Badalamenti; Daniele Santini; Giuseppe Tonini; Anna Maria Frezza; Delia De Lisi; Marianna Silletta

doi:10.1038/srep12077

Lack of Correlation between Liver Tests Abnormalities and Trabectedin Efficacy in the Treatment of Soft Tissue Sarcoma: A Retrospective Study

Bruno Vincenzi, Luciano Stumbo, Giuseppina Maltese, Linda Cerbone, Mariella Spalato Ceruso, Giuseppe Badalamenti, Daniele Santini, Giuseppe Tonini, Anna Maria Frezza, Delia De Lisi, Marianna Silletta

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Abstract

Elevation in liver transaminases is common in patients treated with the marine antitumor agent trabectedin. However, the impact of trabectedin-related transaminase elevations on treatment outcomes is unclear. This retrospective study investigated the correlation between liver tests abnormalities and treatment outcomes in patients with unresectable advanced or metastatic soft tissue sarcomas (STS) treated with trabectedin 1.5 mg/m² once every 3 weeks at three reference centers in Italy. The effect of grade 3/4 elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) during the first two cycles and at any time during trabectedin treatment on progression-free survival (PFS) and overall survival (OS) were analyzed. Liver tests abnormalities during the first two cycles of chemotherapy or at any time during trabectedin treatment did not significantly affect PFS or OS. Nor were survival outcomes significantly different in the subgroups of patients with or without ALT/AST increases or with ALT/AST elevations ≥15 × the upper limit of normal (ULN) versus those with ALT/AST elevation

Original language	English
Article number	12077
Journal	Scientific Reports
Volume	5
DOIs	https://doi.org/10.1038/srep12077
Publication status	Published - Aug 3 2015

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Vincenzi, B., Stumbo, L., Maltese, G., Cerbone, L., Spalato Ceruso, M., Badalamenti, G., Santini, D., Tonini, G., Frezza, A. M., De Lisi, D., & Silletta, M. (2015). Lack of Correlation between Liver Tests Abnormalities and Trabectedin Efficacy in the Treatment of Soft Tissue Sarcoma: A Retrospective Study. Scientific Reports, 5, [12077]. https://doi.org/10.1038/srep12077

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title = "Lack of Correlation between Liver Tests Abnormalities and Trabectedin Efficacy in the Treatment of Soft Tissue Sarcoma: A Retrospective Study",

abstract = "Elevation in liver transaminases is common in patients treated with the marine antitumor agent trabectedin. However, the impact of trabectedin-related transaminase elevations on treatment outcomes is unclear. This retrospective study investigated the correlation between liver tests abnormalities and treatment outcomes in patients with unresectable advanced or metastatic soft tissue sarcomas (STS) treated with trabectedin 1.5 mg/m2 once every 3 weeks at three reference centers in Italy. The effect of grade 3/4 elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) during the first two cycles and at any time during trabectedin treatment on progression-free survival (PFS) and overall survival (OS) were analyzed. Liver tests abnormalities during the first two cycles of chemotherapy or at any time during trabectedin treatment did not significantly affect PFS or OS. Nor were survival outcomes significantly different in the subgroups of patients with or without ALT/AST increases or with ALT/AST elevations ≥15 × the upper limit of normal (ULN) versus those with ALT/AST elevation ",

author = "Bruno Vincenzi and Luciano Stumbo and Giuseppina Maltese and Linda Cerbone and {Spalato Ceruso}, Mariella and Giuseppe Badalamenti and Daniele Santini and Giuseppe Tonini and Frezza, {Anna Maria} and {De Lisi}, Delia and Marianna Silletta",

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doi = "10.1038/srep12077",

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AU - Vincenzi, Bruno

AU - Stumbo, Luciano

AU - Maltese, Giuseppina

AU - Cerbone, Linda

AU - Spalato Ceruso, Mariella

AU - Badalamenti, Giuseppe

AU - Santini, Daniele

AU - Tonini, Giuseppe

AU - Frezza, Anna Maria

AU - De Lisi, Delia

AU - Silletta, Marianna

PY - 2015/8/3

Y1 - 2015/8/3

N2 - Elevation in liver transaminases is common in patients treated with the marine antitumor agent trabectedin. However, the impact of trabectedin-related transaminase elevations on treatment outcomes is unclear. This retrospective study investigated the correlation between liver tests abnormalities and treatment outcomes in patients with unresectable advanced or metastatic soft tissue sarcomas (STS) treated with trabectedin 1.5 mg/m2 once every 3 weeks at three reference centers in Italy. The effect of grade 3/4 elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) during the first two cycles and at any time during trabectedin treatment on progression-free survival (PFS) and overall survival (OS) were analyzed. Liver tests abnormalities during the first two cycles of chemotherapy or at any time during trabectedin treatment did not significantly affect PFS or OS. Nor were survival outcomes significantly different in the subgroups of patients with or without ALT/AST increases or with ALT/AST elevations ≥15 × the upper limit of normal (ULN) versus those with ALT/AST elevation

AB - Elevation in liver transaminases is common in patients treated with the marine antitumor agent trabectedin. However, the impact of trabectedin-related transaminase elevations on treatment outcomes is unclear. This retrospective study investigated the correlation between liver tests abnormalities and treatment outcomes in patients with unresectable advanced or metastatic soft tissue sarcomas (STS) treated with trabectedin 1.5 mg/m2 once every 3 weeks at three reference centers in Italy. The effect of grade 3/4 elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) during the first two cycles and at any time during trabectedin treatment on progression-free survival (PFS) and overall survival (OS) were analyzed. Liver tests abnormalities during the first two cycles of chemotherapy or at any time during trabectedin treatment did not significantly affect PFS or OS. Nor were survival outcomes significantly different in the subgroups of patients with or without ALT/AST increases or with ALT/AST elevations ≥15 × the upper limit of normal (ULN) versus those with ALT/AST elevation

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Lack of Correlation between Liver Tests Abnormalities and Trabectedin Efficacy in the Treatment of Soft Tissue Sarcoma: A Retrospective Study

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