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Maintenance therapy with Tarceva

  • A randomized, placebo-controlled Phase III trial to evaluate the efficacy of Tarceva 150 mg monotherapy vs placebo in patients with Stage IIIB or IV NSCLC who had not progressed following first-line platinum-based chemotherapy.6,12
  • Primary endpoints: progression-free survival in all patients and in patients with EGFR overexpression measured by IHC (immunohistochemistry–positive [IHC+] tumors).6,12
    • Secondary endpoints: including overall survival in all patients and in patients with EGFR IHC tumors, biomarker analyses, safety, time to symptom progression and quality of life.

Tarceva is an EGFR tyrosine kinase inhibitor with the benefits of:6-11

  • Proven second-line survival, disease control and symptom control, and improvement in quality of life.6-9
  • A well-established and predictable safety profile, without dose-limiting cytopenias.6
  • Convenient and flexible once-daily oral dosing.6
  • A targeted mechanism of action different from conventional chemotherapies.6,10
  • An extensive record of clinical experience in more than 400,000 patients worldwide.11

References:

  1. Stinchcombe TE, Socinski MA. Current treatments for advanced stage non–small cell lung cancer. Proc Am Thorac Soc. 2009;6:233-241.
  2. Sandler A, Gray R, Perry MC, et al. Paclitaxel–carboplatin alone or with bevacizumab for non–small-cell lung cancer. N Engl J Med. 2006;355:2542-2550.
  3. Socinski MA, Schell MJ, Peterman A, et al. Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non–small-cell lung cancer. J Clin Oncol. 2002;20:1335-1343.
  4. Mok TSK, Ramalingam SS. Maintenance therapy in nonsmall cell lung cancer: a new treatment paradigm. Cancer. 2009;115:5143-5154.
  5. Sun J-M, Park JO, Won Y-W, et al. Who are less likely to receive subsequent chemotherapy beyond first-line therapy for advanced non-small cell lung cancer? Implications for selection of patients for maintenance therapy. J Thorac Oncol. 2010;5:540-545.
  6. Draft Tarceva® (erlotinib) summary of product characteristics, F. Hoffmann-La Roche Ltd., 2010.
  7. Shepherd FA, Pereira JR, Ciuleanu T, et al; for the National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non–small-cell lung cancer. N Engl J Med. 2005;353:123-132.
  8. Bezjak A, Tu D, Seymour L, et al. Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol. 2006;24:3831-3837.
  9. Data on file, OSI Pharmaceuticals, Inc.
  10. Harari PM. Epidermal growth factor receptor inhibition strategies in oncology. Endocr Relat Cancer. 2004;11:689-708.
  11. Data on file, F. Hoffmann-La Roche Ltd.
  12. Cappuzzo F, Coudert B, Wierzbicki R, et al; on behalf of the SATURN Investigators. Overall survival analyses from the SATURN phase III placebo-controlled study of erlotinib as first-line maintenance therapy in advanced non-small-cell lung cancer (NSCLC). Presented at: European CanCer Organisation (ECCO) 15–34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress; September 20-24, 2009; Berlin, Germany. Abstract 22LBA.

Mechanism of action

How Tarceva® works

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This site is only intended for use by healthcare professionals outside of the US. If you are a US resident, please visit www.tarceva.com.

New indication for Tarceva

Tarceva in maintenance NSCLC therapy