VIENNA, AUSTRIA—A large prospective postcommercialization study in patients with advanced soft tissue sarcoma (STS) in Europe confirmed the long-term anticancer activity of trabectedin (Yondelis) in different subtypes of sarcoma. This data was shared at the European Cancer Congress 2015 (ECC2015).
“The results from this interim analysis are in line with the efficacy demonstrated in clinical trials and, more important, are consistent with what we find in clinical practice,” said lead author Nicolas Penel, MD, PhD, of the Department of Medical Oncology at the Centre Oscar Lambret in France. “Patients with soft tissue sarcoma are certainly benefiting from this treatment, and studies such as this one continue adding value to the management of patients treated with trabectedin.”
The noninterventional, multicenter, prospective phase IV study enrolled 217 patients from 41 European centers. Among the patients, there were 27 different subtypes of soft tissue sarcoma with leiomyosarcoma and liposarcoma being the two most common ones (41.9% and 23.5%, respectively). Although most of the patients received chemotherapy before enrollment, 10% of the patients received trabectedin as first-line therapy.
The median progression-free survival was 5.5 months at the time of this analysis measured by RECIST, Choi, or clinical evaluation. The data also showed some durable response with 18 patients still on treatment when this analysis was performed.
“It was interesting to see how more than half of the patients received six cycles or more of this treatment and 16.1% of the patients received the drug for 1 year or more,” pointed out Penel, who added that “given the manageable safety profile of trabectedin, the data underscore the clinical benefit for these patients.”
Retrospective Choi criteria showed a different pattern of response compared to RECIST in 44 patients, in which median PFS was 15.3 months versus 8.1 months when measured by Choi and RECIST, respectively.
The most frequent grade 3 and 4 adverse events were neutropenia (17.9%) and transaminase elevation (7.9%). Febrile neutropenia occurred in 2.7% of patients. Most commonly occurring grade 3 adverse events included fatigue (3.7%), nausea (1.4%), and vomiting (1.4%). A fatal case was recorded as well.
Soft tissue sarcoma is a type of cancer originating in the soft tissues that connect, support, and surround other body structures such as muscle, fat, blood vessels, nerves, tendons and the lining of joints. In the United States, nearly 12,000 people will develop soft tissue sarcomas and approximately 4,870 are expected to die of their disease in 2015.
Trabectedin (Yondelis)) is a novel, multimodal, synthetically produced antitumor agent, originally derived from a sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair.
The study was sponsored by PharmaMar, which develops and commercializes trabectedin. PharmaMar is headquartered in Madrid, Spain.