Fluorescence in situ hybridization subgroup analysis of TRIBUTE, a phase III trial of erlotinib plus carboplatin and paclitaxel in non-small cell lung cancer.

摘要: Purpose: TRIBUTE was a phase III trial evaluating the addition of erlotinib to carboplatin and paclitaxel as first-line treatment for advanced non–small cell lung cancer that did not meet its primary end point improving overall survival. Here, we assess value using epidermal growth factor receptor (EGFR) gene copy number in tumor biopsy samples, determined by fluorescence situ hybridization (FISH), predictor outcome. Methods: EGFR FISH analysis done LSI SpectrumOrange/CEP7 SpectrumGreen probe. Results: Of 275 245 (89.1%) were successfully analyzed FISH. One hundred (40.8%) patients FISH(+). Median survival different between FISH(+) FISH(−) either chemotherapy+erlotinib arm or chemotherapy+placebo arm. In patients, median time progression (TTP) 6.3 months versus 5.8 placebo (hazard ratio, 0.59; 95% confidence interval, 0.35-0.99; P = 0.0430); TTP 4.6 6.0 1.42; 0.95-2.14; 0.0895; interaction test, 0.007). After 6 treatment, notable separation curves favor emerged. Objective response rates 11.6% 29.8% (chemotherapy+erlotinib arm; 0.0495) 21.8% 25.4%, respectively, ( 0.6954). Conclusions: predict benefit. However, among longer who received continued receive it after completing therapy.