Back to Search
Start Over
Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)
- Source :
- Annals of Oncology. 24:2875-2880
- Publication Year :
- 2013
- Publisher :
- Elsevier BV, 2013.
-
Abstract
- Background Talactoferrin alfa is an oral dendritic cell (DC)-mediated immunotherapy (DCMI). We tested whether talactoferrin was superior to placebo in advanced non-small-cell lung cancer (NSCLC). Patients and methods An FORTIS-M trial was an international, multicenter, randomized, double-blind comparison of talactoferrin (1.5g p.o. BID) versus placebo BID, in patients with stage IIIB/IV NSCLC whose disease had failed two or more prior regimens. Treatment was administered for a maximum of five 14-week cycles. The primary efficacy end point was overall survival (OS); secondary end points included 6- and 12-month survival, progression-free survival (PFS), and disease control rate (DCR). Results Seven hundred and forty-two patients were randomly assigned (2:1) to talactoferrin (497) or placebo (245). The median OS in the intent-to-treat (ITT) population was 7.66 months in the placebo arm and 7.49 months in the talactoferrin arm [hazard ratio (HR), 1.04; 95% CI, 0.873–1.24; P = 0.6602]. The 6-month survival rates were 59.9% (95% CI, 53.4% to 65.8%) and 55.7% (95% CI, 51.1% to 59.9%), respectively. The 12-month survival rates were 32.2% (95% CI, 26.3% to 38.2%) and 30.9% (95% CI, 26.8% to 35%), respectively. The median PFS rates were 1.64 months and 1.68 months, respectively (HR, 0.99; 95% CI, 0.835–1.16; P = 0.8073). The DCRs were 38.4 and 37.6%, respectively [stratified odds ratio (OR), 0.96; 95% CI, 0.698–1.33; P = 0.8336]. The safety profiles were comparable between arms. Conclusions There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.
- Subjects :
- Male
medicine.medical_specialty
Population
Kaplan-Meier Estimate
Placebo
Gastroenterology
Disease-Free Survival
Drug Administration Schedule
Placebos
Double-Blind Method
Talactoferrin Alfa
Carcinoma, Non-Small-Cell Lung
Internal medicine
Talactoferrin
Humans
Medicine
Phase III study
Progression-free survival
education
Lung cancer
Survival rate
Aged
Neoplasm Staging
education.field_of_study
business.industry
Surrogate endpoint
Hazard ratio
Hematology
Middle Aged
medicine.disease
Surgery
oral dendritic cell (DC)-mediated immunotherapy
Lactoferrin
Treatment Outcome
Oncology
Female
Immunotherapy
Immunotherapy, Non-small-cell lung cancer, Phase III study, Talactoferrin
business
Non-small-cell lung cancer
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 24
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....279f128904fe8fc09b31972c2bf65519