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Patients
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Patients

Of 1060 patients screened from 13 countries, 1033 (97.5%) provided baseline tumor samples. Of these, EGFR mutation status could be determined for 859 patients (81.0%), and 118 patients (11.1%) were assigned an eligible EGFR mutation-positive status (mutation frequency, 13.7%) and enrolled in the study from September 8, 2010, to February 15, 2012; gefitinib treatment was started in 106 of these patients (FAS population) (Fig. ​(Fig.1).1). One additional patient of EGFR mutation-positive ineligible status was treated with gefitinib in error. Of the 201 patients (19%) for whom tumor EGFR mutation status could not be determined (unevaluable/unavailable), tissue was not provided from 27 patients (2.6%) who consented, and 174 patients (16.4%) could not be evaluated for EGFR mutation status (100 [9.4%] failed histopathology, 42 [4.0%] yielded insufficient DNA, 2 [0.2%] failed EGFR mutation analysis, and 30 [2.8%] were not shipped from the study site in time). A flow diagram of the accountability of tumor samples is presented in Figure ​Figure22.
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J Thorac Oncol. 2014 Sep; 9(9): 1345–1353.
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