The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groups in the Forthcoming (Ninth) Edition of the TNM Classification for Lung Cancer.

Introduction: The TNM classification of lung cancer is periodically revised. The International Association for the Study of Lung Cancer collected and analyzed a new database to inform the forthcoming ninth edition of the TNM classification. The results are herewith presented.
Methods: After exclusions, 76,518 patients from a total of 124,581 registered patients were available for analyses: 58,193 with clinical stage, 39,192 with pathologic stage, and 62,611 with best stage NSCLC. The proposed new N2 subcategories (N2a, involvement of single ipsilateral mediastinal or subcarinal nodal station, and N2b, involvement of multiple ipsilateral mediastinal nodal stations with or without involvement of the subcarinal nodal station) and the new M1c subcategories (M1c1, multiple extrathoracic metastases in one organ system, and M1c2, multiple extrathoracic metastases in multiple organ systems) were considered in the survival analyses. Several potential stage groupings were evaluated, using multiple analyses, including recursive partitioning, assessment of homogeneity within and discrimination between potential groups, clinical and statistical significance of survival differences, multivariable regression, and broad assessment of generalizability.
Results: T1N1, T1N2a, and T3N2a subgroups are assigned to IIA, IIB, and IIIA stage groups, respectively. T2aN2b and T2bN2b subgroups are assigned to IIIB. M1c1 and M1c2 remain in stage group IVB. Analyses reveal consistent ordering, discrimination of prognosis, and broad generalizability of the proposed ninth edition stage classification of lung cancer.
Conclusions: The proposed stages for the ninth edition TNM improve the granularity of nomenclature about anatomic extent that has benefits as treatment approaches become increasingly differentiated and complex.
Competing Interests: Disclosure Dr. Nishimura and Ms. Giroux report that statistical consulting by Cancer Research And Biostatistics (CRAB) employees for data collection, analysis, and manuscript preparation in the Staging Project is funded by the International Association for the Study of Lung Cancer (IASLC). Dr. Fong reports payments made to his institution by Competitive Research Grant, MRFF EPCDR Improving Diagnosis in Cancers Low Survival Rates; Competitive Research Grant, NHMRC Ideas grant: Early lung cancer biomarkers; Competitive Research Grant, MRFF Next Generation Clinical Researchers Program - Practitioner Fellowship; Competitive Research Grant, NHMRC Project: Novel biomarkers for lung cancer; Competitive Research Grant, NHMRC Low dose computed tomography (LDCT) to diagnose lung cancer; payments to himself by UpToDate Reviewer and Cochrane Clinical Answers Reviewer; payment for travel support to WCLC, ATS in 2022 and PCCP in 2023; payments for travel support by the 2023 Asia Pacific Coalition Against Lung Cancer; and payments from the Asia Pacific Society of Respirology former President and EXCO member; support with loan bronchoscopes for the purpose of a research study—no financial funding from Olympus; and software licensing for Computer Aided Diagnosis research in the International Lung Screen Trial (ILST) from Mevis Veolity. Dr. Giuliani reports receiving payments for Advisory Board member from AstraZeneca and Bristol Myers Squibb; and being Section Editor, of the International Journal of Radiation Oncology, Biology and Physics. Dr. Marom reports receiving honorarium for lectures from Boehringer Ingelheim, Merck Sharp & Dohme, and AstraZeneca. Dr. Nicholson reports receiving personal fees from Merck, Boehringer Ingelheim, Novartis, AstraZeneca, Bristol-Myers Squibb, Roche, AbbVie, Oncologica, UpToDate, the European Society of Oncology, and Liberum; and grants and personal fees from Pfizer, outside of the submitted work. Dr. Van Schil reports receiving lecture and consulting institutional fees from AstraZeneca and Janssen and lecture and consulting personal fees from Bristol Myers Squibb, Merck Sharp & Dohme, and Roche; and having leadership positions in BACTS (Belgian Association for Cardiothoracic Surgery) as treasurer and IASLC (International Association for the Study of Lung Cancer) as president with no fees. Dr. Travis reports receiving a grant from the National Cancer Institute: MSKCC Core Grant: P30 CA008748. Dr. Rusch reports receiving support for the present manuscript from NIH Cancer Support Grant P30-CA008748; institutional funding for a clinical trail from Genentech; and miscellaneous honoraria for lectures of no commercial interest at various universities; funding for meeting preparation and attendance by NIH Thoracic Malignancy Steering Committee (Co-Chair); and reports being a committee member of MARS II and RAMON trials (Cancer Research UK). Dr. Asamura reports receiving funding for analyses of results and manuscript preparation and support from the IASLC for attending meetings. The remaining authors report no conflict of interest.
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