Perioperative Outcome of Robotic Approach Versus Manual Videothoracoscopic Major Resection in Patients Affected by Early Lung Cancer: Results of a Randomized Multicentric Study (ROMAN Study)

The IASLC Staging and Prognostic Factors Committee has collected a new database of 94,708 cases donated from 35 sources in 16 countries around the globe. This has now been analysed by our statistical partners at Cancer Research And Biostatistics and, in close collaboration with the members of the committee proposals have been developed for the T, N, and M categories of the 8th edition of the TNM Classification for lung cancer due to be published late 2016. In this publication we describe the methods used to evaluate the resultant Stage groupings and the proposals put forward for the 8th edition.

The European Society of Thoracic Surgeons (ESTS) organized a workshop dealing with lymph node staging in non-small cell lung cancer. The objective of this workshop was to develop guidelines for definitions and the surgical procedures of intraoperative lymph node staging, and the pathologic evaluation of resected lymph nodes in patients with non-small cell lung cancer (NSCLC). Relevant peer-reviewed publications on the subjects, the experience of the participants, and the opinion of the ESTS members contributing on line, were used to reach a consensus. Systematic nodal dissection is recommended in all cases to ensure complete resection. Lobe-specific systematic nodal dissection is acceptable for peripheral squamous T1 tumors, if hilar and interlobar nodes are negative on frozen section studies; it implies removal of, at least, three hilar and interlobar nodes and three mediastinal nodes from three stations in which the subcarinal is always included. Selected lymph node biopsies and sampling are justified to prove nodal involvement when resection is not possible. Pathologic evaluation includes all lymph nodes resected separately and those remaining in the lung specimen. Sections are done at the site of gross abnormalities. If macroscopic inspection does not detect any abnormal site, 2-mm slices of the nodes in the longitudinal plane are recommended. Routine search for micrometastases or isolated tumor cells in hematoxylin-eosin negative nodes would be desirable. Randomized controlled trials to evaluate adjuvant therapies for patients with these conditions are recommended. The adherence to these guidelines will standardize the intraoperative lymph node staging and pathologic evaluation, and improve pathologic staging, which will help decide on the best adjuvant therapy.

To propose an internationally accepted definition of complete resection in lung cancer surgery. The International Association for the Study of Lung Cancer (IASLC) Staging Committee created the Complete Resection Subcommittee in 2001 to work on an international definition of complete resection in lung cancer surgery. The previous definitions of complete resection and the rules of the International Union Against Cancer regarding the TNM residual tumor classification, together with a thorough review of the pertinent literature, and the input of the members of the IASLC Staging Committee were considered in order to get an international consensus on the definition of complete resection in lung cancer surgery. Complete resection requires all of the following: free resection margins proved microscopically; systematic nodal dissection or lobe-specific systematic nodal dissection; no extracapsular nodal extension of the tumor; and the highest mediastinal node removed must be negative. Whenever there is involvement of resection margins, extracapsular nodal extension, unremoved positive lymph nodes or positive pleural or pericardial effusions, the resection is defined as incomplete. When the resection margins are free and no residual tumor is left, but the resection does not fulfill the criteria for complete resection, there is carcinoma in situ at the bronchial margin or positive pleural lavage cytology, the term uncertain resection is proposed. The proposed definitions of complete, incomplete and uncertain resections are clear and reproducible in an international setting to study their prognostic impact prospectively.