Phase III Study of Surgery Versus Definitive Concurrent Chemoradiotherapy Boost in Patients With Resectable Stage IIIA(N2) and Selected IIIB Non–Small-Cell Lung Cancer After Induction Chemotherapy and Concurrent Chemoradiotherapy (ESPATUE)

• DOI: 10.1200/jco.2015.62.6812
• Publication Date: 2015-11-03T03:24:17Z
• Authors: Wilfried Ernst Er...; Christoph Pöttgen; Thomas Christoph ...; Godehard Friedel; Stefanie Veit; Vanessa Heinrich; Stefan Welter; Wilfried Budach; Werner Spengler; Martin Kimmich; Berthold Fischer; Heinz Schmidberger; Dirk De Ruysscher; Claus Belka; Sebastian Cordes; Rodrigo Hepp; Diana Lütke-Brintrup; Nils Lehmann; Martin Schuler; Karl-Heinz Jöckel; Georgios Stamatis; Martin Stuschke
• Keywords: Chemoradiotherapy; Induction chemotherapy; Vinorelbine; Interim analysis; Clinical endpoint; Surgical oncology

Purpose Concurrent chemoradiotherapy with or without surgery are options for stage IIIA(N2) non–small-cell lung cancer. Our previous phase II study had shown the efficacy of induction chemotherapy followed by and in patients disease selected IIIB disease. Here, we compared definitive resectable III after induction. Patients Methods pathologically proven that medical/functional operability received chemotherapy, which consisted three cycles cisplatin 50 mg/m 2 on days 1 8 paclitaxel 175 day every 21 days, as well concurrent to 45 Gy given 1.5 twice daily, 9, vinorelbine 20 9. Those whose tumors were reevaluated deemed last week radiotherapy randomly assigned receive a boost was risk adapted between 65 71 arm A undergo (arm B). The primary end point overall survival (OS). Results After 246 500 planned enrolled, trial closed second scheduled interim analysis because slow accrual funding, left underpowered relative its point. Seventy-five IIIA 171 according Union International Cancer Control TNM classification, sixth edition. median age 59 years (range, 33 74 years). induction, 161 (65.4%) assigned; strata tumor-node group, prophylactic cranial irradiation policy, region. Patient characteristics balanced arms, 81 80 boost. In B, 81% underwent R0 resection. With follow-up random assignment 78 months, 5-year OS progression-free (PFS) did not differ arms. rates 44% B 40% (log-rank P = .34) PFS 32% 35% .75). at 5 34.1% (95% CI, 27.6% 40.8%) all patients, 216 (87.8%) local treatment. Conclusion cancer excellent both treatments. Both acceptable strategies this good-prognosis group.