Perioperative course and quality of life in a prospective randomized multicenter phase III trial, comparing standard lobectomy versus anatomical segmentectomy in patients with non-small cell lung cancer up to 2 cm, stage IA (7th edition of TNM staging system).


Journal

Lung cancer (Amsterdam, Netherlands)
ISSN: 1872-8332
Titre abrégé: Lung Cancer
Pays: Ireland
ID NLM: 8800805

Informations de publication

Date de publication:
12 2019
Historique:
received: 25 04 2019
revised: 30 08 2019
accepted: 26 09 2019
pubmed: 14 10 2019
medline: 2 9 2020
entrez: 14 10 2019
Statut: ppublish

Résumé

For early stage non-small cell lung cancer (NSCLC) retrospective data of functionally compromised patients undergoing segmentectomy showed equal outcomes for perioperative complications and quality of life (QoL) compared with lobectomy patients. However no prospectively randomized data comparing patients eligible for both procedures are available. We conducted a prospective, randomized, multicenter phase III trial and investigated perioperative complications and QoL in patients with NSCLC stage IA (7th edition) undergoing segmentectomy versus lobectomy. The EORTC Questionnaire Core-30 (QLQ C-30) supplemented by thirteen-item lung cancer-specific module (LC13) was assessed before surgery, at discharge, 6 weeks, 3, 6 and 12 months post-surgery. 108 patients with verified or suspected NSCLC up to 2 cm diameter were enrolled, whereby 54 were assigned to lobectomy and 54 to segmentectomy. Due to nodal disease, tumor size and surgical reasons estimated during the operation, eight patients of the segmentectomy group received a lobectomy. In hospital and 90 days mortality was 0% in both groups. Perioperative complications were observed in 6 (11.3%) patients after segmentectomy and in 8 patients (14.8%) after lobectomy (p = 0.563), while the 90-day morbidity were 17% and 25.9% (9 and 14 patients), respectively (p = 0.452). Twelve months after surgery, there was a significant deterioration to the baselines of physical (p < 0.001) and cognitive functioning (p = 0.025), dyspnea (p < 0.001) and fatigue (p = 0.003) in the lobectomy group. Dyspnea showed a faster recovery in the segmentectomy compared to lobectomy group with statistical significance (p = 0.016 after 12 months). In patients with early-stage NSCLC, segmentectomy is associated with a statistically not significant lower perioperative morbidity and appears to provide a superior recovery in QoL compared with lobectomy patients.

Identifiants

pubmed: 31606521
pii: S0169-5002(19)30666-X
doi: 10.1016/j.lungcan.2019.09.021
pii:
doi:

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

19-26

Informations de copyright

Copyright © 2019 Elsevier B.V. All rights reserved.

Auteurs

Georgios Stamatis (G)

Thoracic Surgery and Endoscopy, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany. Electronic address: georgios.stamatis@uk-essen.de.

Gunda Leschber (G)

Departement of Thoracic Surgery, Evangelische Lungenklinik ELK Chest Hospital, Berlin, Germany.

Birte Schwarz (B)

Thoracic Surgery and Endoscopy, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.

Diana Lütke Brintrup (DL)

Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University of Duisburg-Essen, Essen, Germany.

Claudia Ose (C)

Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University of Duisburg-Essen, Essen, Germany.

Gerhard Weinreich (G)

Pneumology, Ruhrlandklinik, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.

Bernward Passlick (B)

Departement of Thoracic Surgery, University Freiburg, Germany.

Erich Hecker (E)

Departement of Thoracic Surgery, Evangelisches Krankenhaus Herne, Germany.

Christian Kugler (C)

Departement of Thoracic Surgery, LungenClinic Grosshansdorf, Germany.

Hendrik Dienemann (H)

Departement of Thoracic Surgery, Heidelberg University, Germany.

Thomas Krbek (T)

Departement of Thoracic Surgery, Krankenhaus Bethanien Moers, Germany.

Stephan Eggeling (S)

Departement of Thoracic Surgery, Vivantes Klinikum Neukölln, Berlin, Germany.

Rudolf Hatz (R)

Departement of Thoracic Surgery, Asklepios Fachkliniken München-Gauting, Germany.

Michael Rolf Müller (MR)

Departement of Thoracic Surgery, Otto Wagner Spital Wien, Austria.

Walter Weder (W)

Departement of Thoracic Surgery, UniversitätsSpital Zürich, Switzerland.

Clemens Aigner (C)

Thoracic Surgery and Endoscopy, University Medicine Essen- Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.

Karl-Heinz Jöckel (KH)

Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University of Duisburg-Essen, Essen, Germany.

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