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Trabectedin
Source: Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 21, 2025 · Captured 2026-09-09.
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Trabectedin is an FDA-approved option for second-line treatment of patients with advanced liposarcoma and leiomyosarcoma.
Evidence (trabectedin):
The approval of trabectedin was based on a phase III randomized study (NCT01343277) of 518 patients who received trabectedin (1.5 mg/m2 over 24 hours on day 1 every 21 days) or dacarbazine (1,000 mg/m2 on day 1 every 21 days).[19]
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The approval of trabectedin was based on a phase III randomized study (NCT01343277) of 518 patients who received trabectedin (1.5 mg/m2 over 24 hours on day 1 every 21 days) or dacarbazine (1,000 mg/m2 on day 1 every 21 days).[19]
Treatment with trabectedin significantly improved median PFS (4.2 months for patients who received trabectedin vs. 1.5 months for patients who received dacarbazine).
The approval of trabectedin was based on a phase III randomized study (NCT01343277) of 518 patients who received trabectedin (1.5 mg/m2 over 24 hours on day 1 every 21 days) or dacarbazine (1,000 mg/m2 on day 1 every 21 days).[19]
OS, the primary end point, was not statistically different (12.4 months for patients who received trabectedin vs. 12.9 months for patients who received dacarbazine).
The approval of trabectedin was based on a phase III randomized study (NCT01343277) of 518 patients who received trabectedin (1.5 mg/m2 over 24 hours on day 1 every 21 days) or dacarbazine (1,000 mg/m2 on day 1 every 21 days).[19]
Response rates were low in both arms (10% for patients who received trabectedin vs. 7% for patients who received dacarbazine), but clinical benefit (that included both response rates and stable disease) was higher for the trabectedin group (34%) than for the dacarbazine group (19%).
The approval of trabectedin was based on a phase III randomized study (NCT01343277) of 518 patients who received trabectedin (1.5 mg/m2 over 24 hours on day 1 every 21 days) or dacarbazine (1,000 mg/m2 on day 1 every 21 days).[19]
The most common grade 3 and 4 adverse events in the trabectedin group were myelosuppression and transient elevation of liver function test results.
Phase II studies have shown a particularly high response rate to trabectedin in patients with myxoid/round cell liposarcoma, with overall response rates up to 51%, and a 6-month PFS rate of 88%.[20]
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Preserved source evidence · Not medical advice