ABSTRACT
Objective To evaluate the diagnostic value and safety of domestic electromagnetic navigation bronchoscopy (ENB) guided transbronchial lung biopsy (TBLB) for peripheral pulmonary lesions.Methods Sixty-four patients with peripheral pulmonary lesions shown by thoracic CT in Zhongshan Hospital,Fudan University between Jul.and Dec.,2014 were collected.The patients were randomly assigned to test group (underwent ENB in combination with X-ray guided TBLB) and control group (underwent X-ray guided TBLB).The final diagnosis was confirmed by pathologic examination of surgically removed lesions or by 24 months clinical follow-up.The operative time as well as the intraoperative and postoperative complications were also recorded.Results Sixty-four patients had 70 peripheral pulmonary lesions.There was no difference in age,sex,the lesion size or location between the two groups.Pathology results showed that the diagnostic yield of test group and control group were 88.6％ and 62.9％,respectively,with statistical significance (P =0.012).Subgroup analysis showed that if the lesion's diameter was ≤2 cm,the diagnosis yield of test group was higher than control group (66.7％ vs.20.0％,P =0.266);if the lesion was ＞2 and ≤3 cm,the diagnosis yield of test group and control group were 100 ％ and 81.8 ％,respectively (P =0.485).But if the lesion was＞3 cm,the diagnostic yield of the 2 group was significantly different (94.4 ％ in test group,63.1％ in control group,P =0.042).Mean operation duration of the 2 group was (966 ± 372)s and (1 040 ± 470) s,respectively,with no statistical difference (P =0.600).However,there was statistical difference between the 2 groups on the X-ray time needed to find the pulmonary lessions [(7.0 ± 4.8)s vs.(37.0 ± 37.5) s,P =0.008).There was no pneumothoraxes and excessive bleeding in patients undergoing ENB.Conclusions Compared with X-ray guide TBLB,ENB guided TBLB for peripheral pulmonary lesions has a certain degree of security,and has superiority in reducing the X-ray time required to find the lesion and improving diagnostic yield especially when the lesion's diameter was ＞3 cm.
ABSTRACT
Background and purpose:Epidermal growth factor receptor (EGFR) gene mutation is the most important predictive factor for determining the effectiveness of EGFR tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer (NSCLC). This study aimed to determine the clinical application value of mutation-speciifc immu-nohistochemistry forEGFR mutation detection in NSCLC.Methods:Mutation-specific immunohistochemistry and ampliifcation refractory mutation system (ARMS) were used simultaneously to detectEGFR gene mutation status in 290 lung cancer specimens. The sensitivity, speciifcity, positive predictive value (PPV) and negative predictive value (NPV) of mutation-speciifc immunohistochemistry for detectingEGFR gene mutations were evaluated. The consistency was analyzed between mutation-speciifc immunohistochemistry results and ARMS results.Results:With ARMS testing as the gold standard, when a cutoff value of score 1+ was used as positive by immunohistochemistry, the sensitivity of mutation-speciifc immunohistochemistry forEGFR gene mutation was 72.92%, speciifcity 95.20%, positive predictive value 93.75% and negative predictive value 78.08%. The accuracy of immunohistochemistry was obviously different when variousEGFR gene mutations were detected. The sensitivity of immunohistochemistry for exon 19 deletion was only 55.55%, but speciifcity was above 99%. When immunohistochemistry score was 1+, the sensitivity for L858R mu-tation was 90.27%, whereas speciifcity was 95.86%. When immunohistochemistry score was 2+ or 3+, the speciifcity for L858R mutation was 98.63%-100%. The results of mutation-speciifc immunohistochemistry were ifnely correlated with mutation status determined by ARMS assay (P<0.001, Kappa value: 0.612-0.864). Mutation-speciifc immunohis-tochemistry can directly determineEGFR gene mutation abundance at the cellular level.Conclusion:Mutation-speciifc immunohistochemistry could be an effective supplemental method toEGFR molecular tests.