In a phase II EORTC Soft-Tissue and Bone Sarcoma Group trial reported in JAMA Oncology, Sanfilippo et al found that cabazitaxel showed activity in locally advanced, inoperable, or metastatic dedifferentiated liposarcoma.
Study Details
In the trial, 38 evaluable patients who had received no more than one prior line of chemotherapy were enrolled from sites in four European countries between March 2015 and March 2019. Cabazitaxel was given at 25 mg/m2 every 21 days until disease progression or intolerance. The primary endpoint was the progression-free survival rate at 12 weeks, with the endpoint being met if at least 11 of the first 37 evaluable patients were free of disease progression at 12 weeks.
Key Findings
Progression-free survival at 12 weeks was observed in 21 (55%) of 38 patients, with the study endpoint thus being met. At a median follow-up of 21.6 months, median progression-free survival was 6.5 months (95% confidence interval [CI] = 2.8–10.3 months), median time to progression was 7.4 months (95% CI = 2.8–12.1 months), and median overall survival was 21.1 months (95% CI = 14.8–33.5 months).
Objective response was observed in three patients (8%), with complete response in one. An additional 23 patients (60.5%) had stable disease; the disease control rate was 68%.
The most common cabazitaxel-related adverse events of any grade among 40 patients who received at least one dose of study treatment were decreased neutrophils (52.5%), diarrhea (42.5%), fatigue (40%), anorexia (32.5%), and anemia (30%). The most common grade 3 or 4 adverse events, irrespective of causality attribution, included decreased neutrophils (50%), decreased white blood cell count (42.5%), febrile neutropenia (25%), fatigue (12.5%), and anemia (10%). There were no deaths due to adverse events.
The investigators concluded, “This nonrandomized phase II clinical trial met its primary endpoint, with 21 of 38 patients (55%) being progression-free at 12 weeks. These results suggest important activity of cabazitaxel in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma. The drug is worth being further studied in these tumors in a phase III setting.”
Roberta Sanfilippo, MD, of the Fondazione IRCCS Istituto Nazionale Tumori, Milan, is the corresponding author for the JAMA Oncology article.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
