Radomized multicenter trial to compare standard lobectomy versus anatomical segmentectomy each plus radical lymphadenectomy in patients with Non-Small Cell Lung Cancer (NSCLC) pT1a pN0 cM0, Stage IA
Final Report Abstract
The oncologic significance equivalence of anatomic segment resection in the treatment of early-stage NSCLC remains controversial today. A randomized, controlled, multicenter trial (trial No. DRKS00004897) comparing patients with stage Ia NSCLC (up to 2 cm in size) after anatomic segment resection and after lobectomy was initiated. The objective was noninferiority of segmentectomy versus lobectomy in terms of overall survival and quality of life (primary endpoints), as well as perioperative lethality and complications and tumor-free survival (secondary endpoints). The 5-year hazard ratio comparing lobectomy versus segmental resection was prescribed not to fall below the value of 0.5. In the period from October 2013 to June 2016, 108 patients underwent surgery, 54 received lobectomy and 54 received segmental resection. Postoperative and 90-day lethality was 0% in both groups. Morbidity during inpatient stay was 13.2% in segment resection group and 13.0% in lobectomy group (p value 0.563). Twelve months after surgery, we found statistically significant worsening from baseline values in quality of life parameters in lobectomy group, namely physical function (p<0.001), cognitive function (p=0.025, dyspnea (p<0.001) and fatigue (p=0.003). Patients with dyspnea recovered faster after segmental resection than after lobectomy (p=0.016). Overall survival at 5 years was 86.5% after lobectomy and 78.2% after segmental resection (HR=0.61, (95% CI 0.23-1.66), p value 0.687). Tumor-free survival at 5 years was 77.29% after lobectomy and 77.96% after segmental resection (HR=1.50, (95% CI 0.60-3.76); p value =.019). After an observation period of 5 years, we found no difference in either loco-regional or distant recurrences (9.4% vs. 7.4%, p value 0.506). In patients with stage Ia NSCLC, overall survival, loco-regional, and distant recurrences were not significantly different after segmental resection and lobectomy.
Publications
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„Perioperative course and quality of life in a prospective randomized multicenter phase III trial, comparing standard lobectomy versus anatomical segmentectomy in patients with nonsmall cell lung cancer up to 2 cm, stage IA (7th edition of TNM staging system)”, Lung Cancer 138 (2019) 19-26
Stamatis G, Leschber G, Schwarz B, Brintrup DL, Ose C, Weinreich G, Passlick B, Hecker E, Kugler C, Dienemann H, Krbek T, Eggeling S, Hatz R, Müller MR, Weder W, Aigner C, Jöckel KH
