Adding Trabectedin to Doxorubicin Not Superior to Doxorubicin Alone for STS

Share this content:
The addition of trabectedin to doxorubicin did not demonstrate superiority over doxorubicin alone as first-line treatment.
The addition of trabectedin to doxorubicin did not demonstrate superiority over doxorubicin alone as first-line treatment.

The addition of trabectedin to doxorubicin did not demonstrate superiority over doxorubicin alone as first-line treatment for patients with advanced soft tissue sarcoma, a study published in the Journal of Clinical Oncology has shown.1

Doxorubicin has been considered an active drug in soft tissue sarcoma for many years; trabectedin was approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of 2 types of advanced soft tissue sarcoma. Because findings from a phase 1 trial showed that the combination is safe and preclinical research has suggested that it may be advantageous, researchers sought to compare the clinical outcome of trabectedin plus doxorubicin vs doxorubicin alone as first-line treatment of advanced soft tissue sarcoma.

For the open-label, phase 2 trial, researchers enrolled 115 patients and randomly assigned them to receive trabectedin 1.1 mg/m2 administered intravenously over 3 hours plus doxorubicin 60 mg/m2 intravenously or doxorubicin 75 mg/m2 alone. Participants received treatment for up to 6 cycles. Investigators also conducted translational research to identify correlates between apoptotic and DNA repair gene expression and clinical outcome.

Results showed that median progression-free survival was 5.7 with trabectedin plus doxorubicin compared with 5.5 months with single-agent doxorubicin (HR, 1.16; 95% CI, 0.79-1.71; P = .45). The trial was ultimately stopped early due to futility.

RELATED: FDA Grants Priority Review to Olaratumab for Advanced Soft Tissue Sarcoma

Researchers also found that significantly more patients in the combination arm experienced grade 3 or 4 thrombocytopenia, asthenia, and hepatotoxicity than those in the monotherapy group.

In regard to biomarkers, apoptic key genes FAS and p53 were prognostic factors for progression-free survival and overall survival.                        

Reference

  1. Martin-Broto J, Pousa AL, de las Peñas R, et al. Randomized phase II study of trabectedin and doxorubicin compared with doxorubicin alone as first-line treatment in patients with advanced soft tissue sarcomas: A Spanish Group for Research on Sarcoma study [published online ahead of print May 16, 2016]. J Clin Oncol. doi: 10.1200/JCO.2015.65.3329.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs