Adjuvant vinorelbine plus cisplatin has an acceptable level of toxicity and prolongs disease-free and overall survival among patients with completely resected early-stage non-small-cell lung cancer.
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.
Patients undergoing video-assisted lobectomy had fewer respiratory complications and shorter length of stay. These data suggest video-assisted thoracoscopic lobectomy is safe in patients with resectable lung cancer. Longer follow-up is needed to determine the oncologic equivalency of video-assisted versus open lobectomy.
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