Utidelone-based therapy in advanced or metastatic solid tumors after failure of standard therapies: a prospective,...

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Limited treatment options exist for advanced or metastatic solid tumors post-standard therapy failure.
• Utidelone (UTD1), a novel microtubule stabilizer, showed efficacy in metastatic breast cancer but its use in other advanced cancers was unclear.
• Peripheral neuropathy is a significant adverse event associated with UTD1.

Purpose of the Study:

• To evaluate the efficacy and safety of Utidelone (UTD1) using a modified administration schedule in patients with advanced or metastatic solid tumors.
• To assess the tolerability of UTD1 administered via 120-hour continuous intravenous infusion.
• To explore the anti-tumor activity of UTD1 in a broader range of advanced solid tumors.

Main Methods:

• A prospective, multicenter, single-arm clinical trial (ChiCTR2300074299) involving 50 patients with advanced or metastatic solid tumors.
• Utidelone (UTD1) was administered at 150 mg/m² every 21 days via 120-hour continuous intravenous infusion, alone or in combination.
• Patients were treated until disease progression or intolerable toxicity.

Main Results:

• The overall median progression-free survival (PFS) was 4 months.
• The objective response rate (ORR) was 20%, and the disease control rate (DCR) was 66%.
• Grade ≥3 adverse events, including peripheral neuropathy, occurred in only 4% of patients, indicating improved tolerability with the continuous infusion method.

Conclusions:

• Utidelone (UTD1) demonstrates promising anti-tumor activity in patients with advanced or metastatic solid tumors refractory to standard therapies.
• The 120-hour continuous intravenous infusion of UTD1 is a more tolerable administration mode compared to intermittent infusion.
• This modified administration of UTD1 warrants further investigation in clinical studies for various advanced solid tumors.