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¨CSmall-Cell Lung Cancer With the Absence of Epidermal Growth Factor Receptor

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• 作者：Gabriella Farina¹ ; Flavia Longo² ; Olga Martelli³ ; ^{olga.martelli@fastwebnet.it} ; Ida Pavese⁴ ; Andrea Mancuso⁵ ; Luca Moscetti⁶ ; Roberto Labianca⁷ ; Alessandro Bertolini⁸ ; Enrico Cortesi⁹ ; Antonio Farris¹⁰ ; Daniele Fagnani¹¹ ; Maria Cristina Locatelli¹² ; Giuseppe Valmadre¹³ ; Antonio Ardizzoia¹⁴ ; Maurizio Tomirotti¹⁵ ; Eliana Rulli¹⁶ ; Marina Chiara Garassino¹ ; Alberto Scanni¹⁷
• 刊名：Clinical Lung Cancer
• 出版年：2011
• 出版时间：March 2011
• 年：2011
• 卷：12
• 期：2
• 页码：138-141
• 全文大小：524 K

文摘

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¨Csmall-cell lung cancer (NSCLC) patients identified using molecular and clinical evaluations. To date, we can assume that advanced NSCLC epidermal growth factor receptor (EGFR)¨Cmutated 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.