Systemic chemotherapy is the current standard of care for patients with non–small cell lung cancer (NSCLC), but in the United States, the five-year survival rate in patients with advanced disease is less than 3%. Clinicians from the National Cancer Institute, Bethesda, Maryland, recently presented results of a phase 2 trial of talactoferrin alfa for treating NSCLC that provided some optimism.

In this double-blind, placebo-controlled trial, 100 patients with stage IIIB/IV NSCLC whose disease was refractory to previous chemotherapy were enrolled. Forty seven were randomly assigned to receive oral talactoferrin 1.5 g bid, and 53 were given a placebo twice daily. Although supportive care was given, no one received any other anticancer treatment while participating in the study. Treatment was given in 14-week cycles (12 wk receiving treatment, 2 wk without treatment) for up to three cycles or until the disease progressed.

Median overall survival for the intent-to-treat population was found to be 65% higher in the talactoferrin group compared with the placebo group (6.1 vs. 3.7 mo; hazard ratio, 0.68; P = .04). A significant difference in six-month survival for the full intent-to-treat population was noted in the talactoferrin group (49%) compared with the placebo group (28%) (P = .03).

Oral talactoferrin was well tolerated in the study group, the researchers noted, with generally mild adverse events. Patients in the talactoferrin group had 26% fewer adverse events and registered 48% fewer grade 3–5 adverse events compared with the placebo group (P = .004 and P = .002, respectively), they added.

Giaccone G: Oral talactoferrin alfa improves overall survival in patients with refractory non-small cell lung cancer: Final phase 2 study results presented at the 8th annual Targeted Therapies for the Treatment of Lung Cancer meeting. Santa Monica,California February 26, 2008.