Talactoferrin improved survival for patients with metastatic renal cell carcinoma

Talactoferrin, a unique recombinant form of human lactoferrin, demonstrated clinical activity in a recent multicenter, phase-2 trial.

Researchers from The University of Texas M.D. Anderson Cancer Center, the University of Chicago Medical Center and other institutions administered patients an oral dose of 1.5 g of talactoferrin twice daily for 12 weeks, followed by a two-week break. All 44 patients in the trial had progressive advanced or metastatic renal cell carcinoma, and all of them did not respond to prior systemic therapy.

Twenty-nine patients completed one cycle, and 20 completed two. Patients could go through up to three cycles.

The researchers set primary endpoints for the trial of a progression-free survival of at least 40% after 14 weeks or a response rate of 12.5%.

Patients in the trial reached a progression-free survival of 59% after 14 weeks. The response rate was 4.5%, with 70.5% of patients demonstrating stable disease for eight weeks.

The median progression-free survival was 6.4 months, the median overall survival was 21.1 months and the median one-year survival rate was 77%.

The researchers observed at least one adverse event in 42 patients. Twenty-three patients reported at least one related adverse event, though none more severe than grade 2. The researchers concluded that one case of grade-3 dyspnea was possibly related to talactoferrin. – by Jason Harris

Cancer. 2008;113:72-77.

This paper supports continued investigation into immunotherapy with metastatic renal cell carcinoma. Talactoferrin demonstrates modest antitumor effects similar to other immunotherapeutics, but the optimal approach for maximizing the benefit of immunotherapy in renal cell carcinoma remains elusive.

– Brian Rini, MD

Associate Director for Clinical Research, Cleveland Clinic Taussig Cancer Institute