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10-year long-term survival (LTS) of induction chemotherapy with three cycles cisplatin/paclitaxel followed by concurrent chemoradiation cisplatin/etoposide/45 Gy (1.5 Gy bid) plus surgery in locally advanced non-small-cell lung cancer (NSCLC)-a multicenter phase-II trial (CISTAXOL).

Author(s): Georgios Stamatis, Wilfried Eberhardt, Stefan Welter, C Poettgen, Berthold Fischer, T Krbek, Stephan Bildat, S Seeber, T. C. Gauler, T. Chevalier, D Grunenwald, Hepp de Los Rios Rodrigo, Dirk Theegarten, Martin Stuschke, C Lepechoux

Publication date: 2013-09-30

Journal: Lung cancer (Amsterdam, Netherlands)

Keywords: Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, therapeutic use, Carcinoma, Non-Small-Cell Lung, mortality, therapy, Chemoradiotherapy, Cisplatin, administration & dosage, Etoposide, Female, Follow-Up Studies, Humans, Induction Chemotherapy, Kaplan-Meier Estimate, Lung Neoplasms, Male, Middle Aged, Paclitaxel, Prospective Studies, Survivors, Treatment Outcome

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Abstract

Induction chemoradiotherapy plus surgery remains an option to study in IIIA(N2) and selected IIIB NSCLC. Here we report ten-year long-term survival of a prospective multicenter German-French phase-II trial with trimodality. Mediastinoscopically proven IIIA(N2)/selected IIIB NSCLC received three cycles cisplatin (50 mg/m(2) day 1+8) and paclitaxel (175 mg/m(2)d1) qd 22. Concurrent CTx/RTx followed: 45 Gy (1.5 Gy bid) with cisplatin 50 mg/m(2) day 2+9 and etoposide 100 mg/m(2) d 4-6. Surgery was planned three to five weeks after RTx. If evaluated inoperable/irresectable at the end of RTx, definitive RTx-boost (20 Gy; 2 Gy qd) followed. Here we report 10-year-LTS for this cohort. All 64 patients were accrued 3/99 to 2/02. Patients characteristics: IIIA(N2)/IIIB 25/39; m/f 48/16; adeno/squamous/large-cell/adenosquamous/NOS 15/26/18/3/2; age: median 52.5 (range 33-69). 36 operated: R0 32/36 (89%); pCR 16/36 (44%). 10-year-LTS%; all 26.0; IIIA(N2) 37.1; IIIB 17.9; relevant prognostic factors (exploratory): pretreatment - histopathology (squamous/adeno) - age (<50/≥50) - Charlson-CI: 1/>1 - BMI (≥25/<25) - pack years smoking (≥10/<10); treatment-dependent - R0/no-R0. This regimen achieves substantial LTS. Interestingly, adenocarcinomas, older patients, unfavorable comorbidity scores, higher BMI and light smokers demonstrate poor long-term outcome even with aggressive trimodality. This dataset defines the rationale for our ongoing randomized trial with surgery after induction therapy in IIIA(N2)/selected IIIB (ESPATÜ). Copyright © 2013. Published by Elsevier Ireland Ltd.