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Lung Cancer treatment details. Biologic therapy. Chemotherapy. Doce de Octobre University Hospital, Madrid, Spain

Survival: 10.0 months
Toxicity Grade: 5
Treatments: Biologic therapy
Drugs: Gemzar
Country: Spain
City/State/Province: Madrid
Hospital: Doce de Octobre University Hospital
Journal: Link
Date: 3/2006

Patients: This Phase III study involved 670 patients with advanced non-small-cell lung cancer. None of the patients had received treatment before the study. The patients were randomly divided into two groups. Group B had 342 patients (222 men, 120 women, median age 59) with the following demographics: 51 Asian, 13 Hispanic, 276 Caucasian).

Treatment: Treatment consisted of two chemotherapeutic agents: gemcitabine and cisplatin. In addition, Group B received aprinocarsen, which is an antisense oligonucleotide targetting the enzyme protein kinase C.

Toxicity: For Group B, two patients died due to adverse toxicity. In addition, grade 3-4 toxicities included neutropenia, thrombocytopenia, leukopenia, anemia, vomiting, fatigue, nausea, thrombosis and embolism.

Results: The median overall survival was 10.4 months for Group A and 10.0 months for Group B; this difference was not statistically significant. The authors concluded, "Adding aprinocarsen to gemcitabine and cisplatin regimen did not enhance survival and other efficacy measures in patients with advanced NSCLC."

Support: Eli Lilly and Company financially supported this study. Eli Lilly manufactures and/or markets gemcitabine and aprinocarsen.

Correspondence: Luis Paz-Ares

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