Inadequacy of size-based response criteria to assess the efficacy of trabectedin among metastatic sarcoma patients

Excerpt

Trabectedin is a tetrahydro-isoquinoline alkaloid isolated from a tunicate (Ecteinascidia turbinata) that binds and alkylates N2 of guanines located in the 5′-PuGC-3′ or 5'-PyrGG-3' sequences of the minor groove of DNA. It is currently in phase II/III clinical evaluation for ovarian and breast cancers, and has been approved by the European Medicines Agency (EMEA) for the treatment of soft tissue sarcomas (STS) after failure of standard therapy [1]. According to the Response Evaluation Criteria In Solid Tumours (RECIST), the response rate in STS is about 8% and the non-progression-rate is about 40%, including 25% of stable diseases lasting more than 6 months [1]. However, we herein report a case that demonstrates the difficulty assessing the efficacy of trabectedin using only RECIST. …