The Danish experience with trabectedin treatment for metastatic sarcoma: Importance of hyponatremia

TY - JOUR

T1 - The Danish experience with trabectedin treatment for metastatic sarcoma

T2 - Importance of hyponatremia

AU - Schack, Line H

AU - Mouritsen, Lene S

AU - Elowsson, Charlotte

AU - Krarup-Hansen, Anders

AU - Safwat, Akmal

PY - 2015/1/1

Y1 - 2015/1/1

N2 - BACKGROUND: Trabectedin was in Europe approved for treatment of metastatic soft tissue sarcoma (STS) in 2007 based on results of a phase II study with relatively few patients. The purpose of this nationwide retrospective study was to assess efficacy and safety of using trabectedin in the entire unselected cohort of patients with metastatic sarcoma and to test known, as well as new prognostic factors that may affect overall survival (OS).PATIENTS AND METHODS: Between January 2008 and April 2013, 117 patients were treated with trabectedin for metastatic sarcoma in the three specialized sarcoma centers in Denmark. Known prognostic factors such as age, gender and performance status, the histopathology as well as other new factors such as response to previous chemotherapy and hyponatremia were tested.RESULTS: Median age was 59 years. Lipo- and leiomysosarcomas (L-sarcomas) represented 43% of the cases and 18% had hyponatremia before the start of trabectedin. The median number of previous lines of chemotherapy was two (range 0-6) and the median number of chemotherapy cycles given before trabectedin was nine (range 0-85). The median number of trabectedin cycles was three (range 1-17). The median OS for the whole cohort was seven months. Poor performance status, non-L-sarcomas, and hyponatremia were statistically significant adverse prognostic factors with median survival of: 4, 5, and 2 months compared to 9, 12 and 13 months, respectively. Moreover, having achieved clinical benefit [complete response (CR), partial response (PR) or stable disease (SD)] from previous chemotherapy was a favorable prognostic factor for response to trabectedin. In multivariate analysis hyponatremia was the only independent significant poor prognostic factor affecting OS.CONCLUSIONS: This retrospective study confirmed the previously published safety and efficacy of trabectedin in patients with metastatic sarcoma and showed hyponatremia to be a strong independent statistically significant poor prognostic factor.

AB - BACKGROUND: Trabectedin was in Europe approved for treatment of metastatic soft tissue sarcoma (STS) in 2007 based on results of a phase II study with relatively few patients. The purpose of this nationwide retrospective study was to assess efficacy and safety of using trabectedin in the entire unselected cohort of patients with metastatic sarcoma and to test known, as well as new prognostic factors that may affect overall survival (OS).PATIENTS AND METHODS: Between January 2008 and April 2013, 117 patients were treated with trabectedin for metastatic sarcoma in the three specialized sarcoma centers in Denmark. Known prognostic factors such as age, gender and performance status, the histopathology as well as other new factors such as response to previous chemotherapy and hyponatremia were tested.RESULTS: Median age was 59 years. Lipo- and leiomysosarcomas (L-sarcomas) represented 43% of the cases and 18% had hyponatremia before the start of trabectedin. The median number of previous lines of chemotherapy was two (range 0-6) and the median number of chemotherapy cycles given before trabectedin was nine (range 0-85). The median number of trabectedin cycles was three (range 1-17). The median OS for the whole cohort was seven months. Poor performance status, non-L-sarcomas, and hyponatremia were statistically significant adverse prognostic factors with median survival of: 4, 5, and 2 months compared to 9, 12 and 13 months, respectively. Moreover, having achieved clinical benefit [complete response (CR), partial response (PR) or stable disease (SD)] from previous chemotherapy was a favorable prognostic factor for response to trabectedin. In multivariate analysis hyponatremia was the only independent significant poor prognostic factor affecting OS.CONCLUSIONS: This retrospective study confirmed the previously published safety and efficacy of trabectedin in patients with metastatic sarcoma and showed hyponatremia to be a strong independent statistically significant poor prognostic factor.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Agents, Alkylating

KW - Chondrosarcoma

KW - Denmark

KW - Dioxoles

KW - Female

KW - Humans

KW - Hyponatremia

KW - Karnofsky Performance Status

KW - Leiomyosarcoma

KW - Liposarcoma

KW - Middle Aged

KW - Multivariate Analysis

KW - Retrospective Studies

KW - Sarcoma

KW - Tetrahydroisoquinolines

KW - Young Adult

U2 - 10.3109/0284186x.2014.958530

DO - 10.3109/0284186x.2014.958530

M3 - Journal article

C2 - 25263179

SN - 0284-186X

VL - 54

SP - 34

EP - 40

JO - Acta Oncologica

JF - Acta Oncologica

IS - 1

ER -