Tarceva.net

Tarceva first-line for EGFR Mut+ NSCLC

Trial designs of the EURTAC and OPTIMAL trials, the two key trials of Tarceva first-line in EGFR Mut+ NSCLC patients were similar. EURTAC investigated the efficacy of Tarceva in a Caucasian population, OPTIMAL in an Asian population.^1–4

 

EURTAC^1,2

• A phase III randomized controlled trial of Tarceva versus chemotherapy for the first-line treatment of advanced NSCLC in an EGFR Mut+ Caucasian population
  
  Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial

OPTIMAL^3,4

• A phase III randomized controlled trial of Tarceva versus chemotherapy for the first-line treatment of advanced NSCLC in an EGFR Mut+ Asian population
  
  Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study

Tarceva post-platinum in advanced NSCLC

Tarceva is indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic NSCLC with stable disease after 4 cycles of standard platinum-based first-line chemotherapy.

Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

SATURN⁵

• A phase III multicenter randomized placebo-controlled trial of Tarceva as maintenance therapy versus best supportive care in patients with stage IIIb or IV NSCLC who had no progressed following 1L platinum-based chemotherapy
  
  Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study.

TITAN⁶

• A phase III open-label study of Tarceva as 2L therapy versus docetaxel or pemetrexed in patients with advanced, recurrent or metastatic NSCLC with disease progression after failure of platinum-based chemotherapy
  
  Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. 

HORG⁷

• A phase III randomized trial of Tarceva versus pemetrexed as 2L and 3L therapy, conducted by the Hellenic Oncology Research Group
  
  Pemetrexed (MTA) compared with erlotinib (ERL) in pretreated patients with advanced non-small-cell lung cancer (NSCLC): Results of a randomized phase III Hellenic Oncology Research Group Trial. 

BR.21⁸

• An international phase III randomized double-blind placebo-controlled trial of Tarceva as 2L and 3L therapy versus best supportive care in patients with stage IIIb or IV NSCLC
  
  Erlotinib in previously treated non-small-cell lung cancer.

References

1. Tarceva^® (erlotinib) Summary of Product Characteristics, F. Hoffmann-La Roche Ltd, 2011.
2. Rosell R, et al. Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: interim results of the European erlotinib versus chemotherapy (EURTAC) phase III randomized trial. The Lancet Oncology - 1 March 2012 ( Vol. 13, Issue 3, Pages 239-246 )
3. Zhou C, Wu Y-L, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. [published online ahead of print July 22, 2011.] Lancet Oncol. doi:10.1016/S1470-2045(11)70184-X.
4. Zhou C, Wu Y-L, Chen G, et al. Updated efficacy and quality of life (QoL) analyses in OPTIMAL, a phase III, randomized, open-label study of first-line erlotinib versus gemcitabine/carboplatin in patients with EGFR activating-mutation positive (EGFR Act Mut+) advanced non-small-cell lung cancer (NSCLC). J Clin Oncol. 2011;29:Abstract 7520.
5. Cappuzzo F, Ciuleanu T, Stelmakh L, et al. Erlotinib as maintenance treatment in advanced non-small cell lung cancer: a muticentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 2010; 11(6): 521–9.
6. Ciuleanu T, et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. The Lancet Oncology - 1 March 2012 ( Vol. 13, Issue 3, Pages 300-308 )
7. Vamvakas L, Agelaki S, Kentepozidis NK, et al. Pemetrexed (MTA) compared with erlotinib (ERL) in pretreated patients with advanced non-small cell lung cancer (NSCLC): Results of a randomized phase III Hellenic Oncology Research Group trial. J Clin Oncol 2010; 28: 15s (Suppl. Abstr 7519).
8. Shepherd FA, Rodrigues PJ, Ciuleanu T, et al. Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 2005; 353(2): 123–32.