May 27th, 2010

Tarceva Maintenance Therapy Prolongs Survival in Advanced NSCLC


Maintenance therapy with the targeted agent Tarceva® (erlotinib) modestly prolongs progression-free and overall survival in patients with advanced non-small cell lung cancer compared with placebo, according to the results of a phase III study published in The Lancet Oncology.1

Lung cancer remains the leading cause of cancer death in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. The first-line of treatment in advanced NSCLC is typically platinum-based chemotherapy.

Tarceva is a targeted therapy that works by blocking a biological pathway referred to as the epidermal growth factor receptor (EGFR) pathway. The EGFR pathway is involved in cell growth and replication. Tarceva may be used for treatment of NSCLC after failure of initial chemotherapy, and more recently was approved for NSCLC maintenance therapy. Maintenance therapy refers to treatment that is given after initial treatment but before cancer progression

The safety and effectiveness of Tarceva maintenance therapy was evaluated in a Phase III clinical trial known as SATURN. The study enrolled 884 patients with advanced NSCLC that had not progressed following initial, platinum-based chemotherapy. Half the patients received Tarceva maintenance therapy and half received a placebo.

  • Median progression-free survival was 12.3 weeks among patients in the Tarceva group and 11.1 weeks among patients in the placebo group.
  • Overall survival was prolonged with Tarceva (12 months) compared with placebo (11 months).
  • The most commonly reported adverse events with Tarceva were rash (60%) and diarrhea (18%). These were predominantly grade 1-2 in severity.

The researchers concluded that maintenance therapy with Tarceva is well tolerated and prolongs survival in patients with locally advanced or metastatic NSCLC that has not progressed after four cycles of platinum-based first-line chemotherapy. They assert that first-line maintenance with Tarceva could be considered in patients that do not progress after four cycles of chemotherapy.


1 Cappuzo F, Ciuleanu T, Stelmakh L, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: A multi-center, randomized, placebo-controlled phase 3 study. The Lancet Oncology. Published early online May 20, 2010.


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