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| Randomized Trial of Mediastinal Lymph Node Sampling versus Complete Lymphadenectomy During Pulmonary Resection in Patients with N0 or N1 (Less than Hilar) Non-Small Cell Carcinoma: Results of the ACOSOG Z0030 Trial |
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Gail E. Darling1, Mark S. Allen2, Paul Decker3, Karla V. Ballman3, Rodney J. Landreneau4, Robert J. McKenna5, David R. Jones7, Richard I. Inculet8, Valerie W. Rusch9, Joe B. Putnam6 1 Surgery, University of Toronto, Toronto, ON, Canada; 2 Surgery, Mayo Clinic, Rochester, MN; 3 Biostatistics, Mayo Clinic, Rochester, MN; 4 Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA; 5 Thoracic Surgery, Cedars Sinai Medical Center, Los Angeles, CA; 6 Thoracic Surgery, Vanderbilt University, Memphis, TN; 7 Thoracic and Cardiovascular Surgery, University of Virginia, Charlottesville, VA; 8 Surgery, University of Western Ontario, London, ON, Canada; 9 Thoracic Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. Objective: To evaluate whether mediastinal lymph node dissection (MLND) improves overall survival compared to mediastinal lymph node sampling (MLNS) in patients undergoing pulmonary resection for N0 or non-hilar N1, T1 or T2 NSCLC. Methods: : Patients with proven NSCLC underwent sampling of lymph node stations 2R, 4R, 7 and 10R for right sided tumors; and 5, 6, 7 and 10L for left sided tumors. If these lymph node stations were negative for malignancy, patients were randomized to no further lymph node resection (MLNS) or complete MLND. All surgeons were required to adhere to the technique described in written instructions and demonstrated in an approved instructional video. Following surgery, patients were followed for a minimum of 5 years. Results: A total of 1,111 patients were randomized (555 MLNS and 556 MLND). After final eligibility review, 1,023 (498 MLNS and 525 MLND) patients were classified as eligible/evaluable. There were no significant differences between the two groups in terms of gender, race, age or ECOG performance status. The right upper lobe was the most common tumor location (MLNS: 213 vs MLND: 205) and adenocarcinoma was the most common histologic type in both arms (MLNS: 210 vs MLND: 235). There was no significant difference between the two arms in terms of type or extent of resection, stage, length of stay, morbidity or mortality. In the MLND group 20 patients (3.8%) were found to have occult N2 disease in the lymphadenectomy specimen. At a median follow-up of 6.3 years, 431 (42.1%) patients have died: 214 (42.9%) in the MLNS arm and 217 (41.3%) in the MLND arm. The median survival was 8.1 years (MLNS) versus 8.5 (MLND) (p=0.531). There were 493 recurrences including deaths: 54 local; 73 regional; and 224 distant. The median time to recurrence was 5.7 years in the MLNS group (243 recurrences; 24 local; 42 regional; and 110 distant) versus 6.1 years in the MLND group (250 recurrences; 30 local; 31 regional; and 114 distant) (p=0.655). There also was no difference for local (p=0.527) or regional recurrence (p=0.126) between the two groups. Conclusion: MLND does not improve survival in patients with early stage NSCLC when a thorough preresection sampling of the mediastinal lymph nodes is negative. MLND also does not decrease the incidence of local or distant recurrences. These results are not generalizable to higher stage tumors. Back to 2010 Annual Meeting Back to Program Outline Back to Main Program |
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Copyright © 2012 American Association for Thoracic Surgery
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.