Trabectedin and its potential in the treatment of soft tissue sarcoma

Figures & data

Table 1 Main toxicities observed in phase II trials in patients with soft tissue sarcoma

Reference	Study type	N	Grade 3–4 neutropenia	Febrile neutropenia	Grade 3–4 thrombocytopenia	Grade 3–4 transaminitis
Delaloge et al 2001	Phase I + compassionate-use program	29	48.4%	10.3%	20.6%	52.0%
Yovine et al 2004	Phase II, second line	54	61%	7%	19%	48% ALT 57% ALT
Garcia-Carbonero et al 2004	Phase II, second line	36	34%	6%	17%	26% AST 20%ALT
Le Cesne et al 2005	Phase II, second line	104	52.5%	9.1%	18.2%	35.3% AST 44.5% ALT
Garcia-Carbonero et al 2005	Phase II, first line	36	33%	0%	0%	34% AST 36% ALT
Huygh et al 2006	Phase II + compassionate-use program	89	35.9%	7.9%	17.9%	34.9%

Table 2 Main efficacy outcomes of trabectedin in phase II trials in patients with non-GIST soft tissue sarcoma

Reference	Study type	N	Response rate	Median PFS (months)	6-month PFS	Median OS (months)
Delaloge et al 2001	phase I + compassionate-use program	29	14.0%	2.8	28.0%	NR
Yovine et al 2004	Phase II, second line	54	3.7%	1.9	24.1%	12.8
Garcia-Carbonero et al 2004	Phase II, second line	36	8.0%	1.7	20.0%	12.1
Le Cesne et al 2005	Phase II, second line	104	8.0%	3.4	29.0%	9.2
Garcia-Carbonero et al 2005	Phase II, first line	36	17.1%	1.6	24.4	15.8
Huygh et al 2006	Phase II + compassionate-use program	89	7.0%	2.0	NR	8.2

NR, not reported.

DelalogeSYovineATaammaAEcteinascidin-743: a marine-derived compound in advanced, pretreated sarcoma patients – preliminary evidence of activityJ Clin Oncol20011912485511230465

 PubMed Web of Science ®Google Scholar

YovineARiofrioMBlayJYPhase II study of ecteinascidin-743 in advanced pretreated soft tissue sarcoma patientsJ Clin Oncol200422890914990645

 PubMed Web of Science ®Google Scholar

Garcia-CarboneroRSupkoJGManolaJPhase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapyJ Clin Oncol20042214809015084621

 PubMed Web of Science ®Google Scholar

Garcia-CarboneroRSupkoJGMakiRGEcteinascidin-743 (ET-743) for chemotherapy-naive patients with advanced soft tissue sarcomas: multicenter phase II and pharmacokinetic studyJ Clin Oncol20052354849216110008

 PubMed Web of Science ®Google Scholar

HuyghGClementPMDumezHEcteinascidin-743: evidence of activity in advanced, pretreated soft tissue and bone sarcoma patientsSarcoma200620065628217496996

 PubMedGoogle Scholar