Rationale for treatment and study design of tailor: A randomized phase iii trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor receptor mutations

Gabriella Farina, Flavia Longo, Olga Martelli, Ida Pavese, Andrea Mancuso, Luca Moscetti, Roberto Labianca, Alessandro Bertolini, Enrico Cortesi, Antonio Farris, Daniele Fagnani, Maria Cristina Locatelli, Giuseppe Valmadre, Antonio Ardizzoia, Maurizio Tomirotti, Eliana Rulli, Marina Chiara Garassino, Alberto Scanni

Research output: Contribution to journalArticlepeer-review

Abstract

We present the rationale and study design of the Tarceva Italian Lung Optimization trial phase III, multicenter, open-label, randomized trial on efficacy of second-line therapies in different subgroups of non-small-cell lung cancer (NSCLC) patients identified using molecular and clinical evaluations. To date, we can assume that advanced NSCLC epidermal growth factor receptor (EGFR)-mutated patients benefit from EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, whereas their role in the treatment of patients who do not have EGFR mutations is controversial. The aim of this study is to assess whether it is possible to optimize second-line treatment in NSCLC patients with absence of EGFR mutations. Moreover, the predictive value of the K-ras mutation, EGFR protein expression, and EGFR gene copy number, as well as a smoking habit and histotype for determining a different effect of erlotinib compared with chemotherapy will be assessed in patients who do not have EGFR mutations. The primary endpoint is overall survival; the secondary endpoints are progression-free survival, response rate, quality of life, and toxicity. We have planned to collect blood samples to identify different prognosis-related polymorphisms and to assess their sensitivity and specificity in the detection of EGFR and K-ras mutations with respect to histologic samples.

Original languageEnglish
Pages (from-to)138-141
Number of pages4
JournalClinical Lung Cancer
Volume12
Issue number2
DOIs
Publication statusPublished - Mar 2011

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pulmonary and Respiratory Medicine

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