Researchers compared a combination regimen with the current standard of care for first-line treatment of advanced soft-tissue sarcoma.
Doxorubicin has been considered the standard of care first-line treatment for locally advanced or metastatic soft-tissue sarcoma for many years. However, with the treatment landscape for soft-tissue sarcoma evolving, further research is needed to determine the optimal treatment for patients with such disease.
Beatrice Seddon, PhD, University College London Hospitals NHS Foundation Trust, and colleagues conducted a study to compare the effects of gemcitabine plus docetaxel vs doxorubicin as first-line treatment for advanced or metastatic soft-tissue sarcoma. The randomized phase III trial (GeDDiS) enrolled 257 patients with histologically confirmed locally advanced or metastatic disease of Trojani grade 2 or 3, disease progression before enrollment, and no previous chemotherapy for sarcoma or previous doxorubicin for any cancer. Patients were assigned (1:1) to receive either six cycles of intravenous doxorubicin (75 mg/m2) on day 1 every 3 weeks, or intravenous gemcitabine (675 mg, m2) on days 1 and 8 and intravenous docetaxel (75 mg/m2) on day 8 every 3 weeks.
The primary endpoint of the study was the proportion of patients alive and progression-free at 24 weeks. A separate safety population was used to measure adherence to treatment and toxicity. Results of the study were published in The LANCET Oncology (online September 4, 2017; doi:10.1016/S1470-2045(17)30622-8).
After a median follow-up of 22 months, the proportion of patients alive and progression-free at 24 weeks did not differ significantly between either treatment group (23.3 weeks vs 23.7 weeks, respectively).
Common adverse events in both arms were febrile neutropenia, fever, and neutropenia.
A total of 154 patients died in the intention-to-treat population (74 in the doxorubicin, 80 in the combination group).
Researchers concluded that doxorubicin should remain the standard of care in the first-line setting for most patients with advanced soft-tissue sarcoma. “These results provide evidence for clinicians to consider with their patients when selecting first-line treatment for locally advanced or metastatic soft-tissue sarcoma,” they wrote.—Zachary Bessette