Randomized trial of mediastinal lymph node sampling versus complete lymphadenectomy during pulmonary resection in the patient with N0 or N1 (less than hilar) non–small cell carcinoma: Results of the American College of Surgery Oncology Group Z0030 Trial

Abstract

Objective To determine if mediastinal lymph node dissection (MLND) improves survival compared to mediastinal lymph node sampling (MLNS) in patients undergoing resection for N0 or non-hilar N1, T1 or T2 non-small cell lung cancer (NSCLC). Methods Patients with NSCLC underwent sampling of 2R, 4R, 7 and 10R for right sided tumors, and 5, 6, 7 and 10L for left sided tumors. If all were negative for malignancy, patients were randomized to no further lymph node sampling (MLNS) or complete MLND. Results Of 1,111 patients randomized, 1,023 (498 MLNS, 525 MLND) were eligible/evaluable. There were no significant differences between the two groups in terms of demographics, ECOG status, histology, location of the cancer, type or extent of resection, or pathological stage. Occult N2 disease was found in 21 patients in the MLND group. At median follow-up of 6.5 years, 435 (43%) patients have died; (MLNS: 217 (44%);MLND:218 (42%)). The median survival for MLNS is8.1 years, and 8.5 years for MLND (p=0.25). The 5-year disease free survival rate was 69% (95% CI: 64%-74%) in the MLNS group versus 68%(95% CI: 64%-73%) years in the MLND group (p=0.92). There was no difference for local (p=0.52), regional (p=0.10), or distant (p=0.76) recurrence between the two groups. Conclusions If systematic, thorough presection sampling of the mediastinal and hilar lymph nodes is negative, MLND does not improve survival in patients with early stage NSCLC but these results are not generalizable to patients staged radiographically or those with higher stage tumors.

Transcervical Extended Mediastinal Lymphadenectomy – Indications and Technique

“…It is important to keep in mind that no benefit has been demonstrated with routine lymphadenectomy in early stage NSCLC (ACOSOG Z0030) [7]. Thus, we perform TEMLA in situations with a high likelihood of occult N2 disease and for restaging the mediastinum after neoadjuvant therapy; in the latter situation, other modalities of restaging such as PET/CT and EBUS are not very accurate.…”

Selective lymph node dissection in early-stage non-small cell lung cancer

“…Nowadays, the standard surgical treatment of early-stage NSCLC is lobectomy with systematic lymph node dissection (LND) as recommended by the guidelines (3,4), which capable of providing accurate staging (5,6), detecting occult metastasis (7) and improving survival (5,8,9). However, randomized trials have not demonstrated that LND has more survival benefit than sampling (7,10). Since advanced radiographic techniques become available and regular medical examination grows popular, early-stage NSCLC patients have occupied a larger proportion.…”

Mediastinal lymphadenectomy fulfilling NCCN criteria may improve the outcome of clinical N0–1 and pathological N2 non-small cell lung cancer

“…The extent of lymph node removal (dissection versus sampling) and its impact on survival has been addressed by several randomized trials (2,3). The biggest randomized trial Z0030 demonstrated that mediastinal lymph node dissection did not improve survival in patients with early stage non-small…”