© 2008 American Thoracic Society
A Guide to Staging in Lung Cancer, but Potentially Misleading without Attention to the DetailsFrom the Authors:We appreciate the comments by Dr. Detterbeck regarding our article (1). Diagnostic as well as treatment issues need evidence-based guidelines with a solid scientific basis. The best way to achieve this is the randomized trial (2, 3) instead of the uncontrolled series (4). Unfortunately, the guidelines for invasive lung cancer staging are virtually devoid of randomized trials that compare innovative techniques with standard approaches (5). Our trial was designed to show that transesophageal endoscopic ultrasound with fine needle aspiration (EUS-FNA) can eliminate surgical staging, assuming that the demonstration of lymph node invasion by EUS-FNA makes further surgical mediastinal investigation redundant. If EUS-FNA is helpful only to obtain a diagnosis in otherwise inoperable patients or irresectable tumors, the question underlying our trial becomes very relevant and doesn't have an a priori answer. A related issue is the fraction of patients with bulky disease. First, there is no uniform definition for bulky disease. Second, at the time the trial was designed, the new ACCP guidelines that propose a pragmatic classification of mediastinal involvement in non–small cell lung cancer (NSCLC) were not available (5). Nevertheless, we anticipated this by clear eligibility criteria stating that the tumor had to be otherwise resectable. So, none of the patients included had "bulky" mediastinal disease. Therefore, there was no inherent bias in favor of EUS-FNA. We also stratified for size to offer each arm a similar "set" of suspicious nodes, regardless of their localization, and with the surgeon free to choose the staging procedure. The fact that we included patients with proven or suspected NSCLC has no relevance with regard to the primary endpoint of the trial. We are aware that a hospital stay for mediastinoscopy reflects only European practice. That is why we explicitly mention the relativity of this (even in the abstract). Whether the cost of a negative EUS-FNA plus "confirmatory" mediastinoscopy (in 32%) compensates the gain made by positive EUS-FNAs remains controversial. Esophageal perforation upon mediastinoscopy is certainly a rare event, as are bleeding or hoarseness. Though statistically of limited value, it is relevant for the rare patient who experiences a complication, and for the clinicians. Table 5 was meant to provide reliable test characteristics, since they are calculated for each separate study group. We also presented the data for surgical staging to include those patients who had a negative prior EUS-FNA, and we show that the sensitivity does not change. We hope these comments further clarify our data.
Ghent University Hospital FOOTNOTES Conflict of Interest Statement: None of the authors has a financial relationship with a commercial entity that has an interest in the subject of this manuscript. REFERENCES
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