Cabazitaxel exhibits antitumor activity in patients with previously treated, advanced dedifferentiated liposarcoma (DDLPS), according to research published in JAMA Oncology.
More than half of patients treated with cabazitaxel in a phase 2 trial were progression-free at 12 weeks. Based on this result, researchers recommended the drug be studied further in a phase 3 setting.
The researchers conducted this phase 2 study (ClinicalTrials.gov Identifier: NCT01913652) in 38 patients with locally advanced or metastatic DDLPS. The median age at baseline was 65 (range, 31-74) years, 52.6% of patients were men, and 84.2% had grade 2 disease.
Patients started treatment within 72 hours of trial registration and received cabazitaxel at 25 mg/m2 IV every 21 days until progression, intolerance, or consent withdrawal. Patients received a median of 5 (range, 1-30) cycles, with the majority (65%) receiving at least 4 cycles.
There were 3 patients who achieved a response to treatment, including 1 complete response and 2 partial responses. Twenty-three patients had stable disease.
The progression-free survival rate at 12 weeks was 55%, which met the study’s primary endpoint. At a median follow-up of 21.6 months, the median progression-free survival was 6.5 months, and the median overall survival was 21.1 months.
“In essence, the activity of cabazitaxel as assessed in this phase 2 study compares favorably with the other drugs currently used in second- or further-line therapy for DDLPS,” the researchers wrote.
“Overall, treatment options for patients with advanced DDLPS remain limited, with a strong need for more effective and tolerable treatment options. Given the positive findings of this open-label, single-arm, phase 2 trial, a further phase 3 study of cabazitaxel is strongly recommended to assess the efficacy of this drug in patients with DDLPS, hopefully improving the armamentarium of the medical oncologist and outcomes for these patients.”
Disclosures: This research was supported by Sanofi. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Sanfilippo R, Hayward RL, Musoro J, et al. Activity of cabazitaxel in metastatic or inoperable locally advanced dedifferentiated liposarcoma. A phase 2 study of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG).JAMA Oncol. Published online August 18, 2022. doi:10.1001/jamaoncol.2022.3218