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.

Background Concurrent chemotherapy plus radiation therapy (chemoRT) is the standard treatment for stage IIIA(N2) non-small cell lung cancer (NSCLC), a common disease entity. Phase II studies demonstrated feasibility of resection after chemoRT with encouraging survival rates. This phase III trial compared both approaches. Methods Patients with stage T1-3pN2M0 NSCLC were randomized before induction chemoRT (2 cycles of cisplatin and etoposide [PE] concurrent with 45 Gy RT). If no progression, arm 1 underwent resection, and arm 2 continued RT uninterrupted to 61 Gy. Two additional cycles of PE were given. The primary endpoint was overall survival (OS). Findings Progression-free survival for 396 eligible patients was superior in arm 1: median 12.8 versus 10.5 months, p=0.017, hazard ratio (HR) 0.77 (0.62,0.96); 5-yr 22.4% versus 11.1%. Median OS was 23.6 versus 22.2 months, p=0.24, HR 0.87 (0.70,1.10). Five-year survivals were arm 1, 27.2% and arm 2, 20.3%; odds ratio 0.63 (0.36,1.10, p=0.10). N0 status at thoracotomy predicted median OS of 33.5 months (5-year, 41.8%). Major chemoRT toxicities were neutropenia and esophagitis. Treatment-related death occurred in 16 (7.9%) patients on arm 1, of which 14 were post-pneumonectomy; and in 4 (2.1%) on arm 2. An exploratory analysis showed improved OS for patients who underwent lobectomy versus a matched cohort on chemoRT alone, but not for those undergoing pneumonectomy (matched similarly). Interpretation There was no significant survival advantage to surgery after chemoRT, despite improved PFS. Both chemoRT with definitive RT and chemoRT followed by resection (preferably lobectomy) are options for patients with stage IIIA(N2) NSCLC.

Four cycles of cisplatin plus etoposide and a course of radiotherapy (45 Gy, given either once or twice daily) beginning with cycle 1 of the chemotherapy resulted in overall two- and five-year survival rates of 44 percent and 23 percent, a considerable improvement in survival rates over previous results in patients with limited small-cell lung cancer.

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