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)

• Published in: Lung cancer (Amsterdam, Netherlands) Vol. 82; no. 1; pp. 83 - 89
• Main Authors: Eberhardt, Wilfried Ernst Erich, Gauler, Thomas Christoph, LePechoux, Cecile, Stamatis, Georgios, Bildat, Stephan, Krbek, Thomas, Welter, Stefan, Grunenwald, Dominique, Fischer, Berthold, Rodrigo, Hepp de los Rios, Theegarten, Dirk, Le Chevalier, Thierry, Seeber, Siegfried, Stuschke, Martin, Poettgen, Christoph
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier 01.10.2013
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - therapy; Chemoradiotherapy; Cisplatin - administration & dosage; Etoposide - administration & dosage; Female; Follow-Up Studies; Hematology, Oncology and Palliative Medicine; Humans; Induction Chemotherapy; Kaplan-Meier Estimate; Lung Neoplasms - mortality; Lung Neoplasms - therapy; Male; Medical sciences; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Paclitaxel - administration & dosage; Pneumology; Prospective Studies; Pulmonary/Respiratory; Survivors; Treatment Outcome; Tumors; Tumors of the respiratory system and mediastinum; Trimodality treatment; 10-Year survival; Lung cancer; Surgery; Induction chemoradiotherapy; Prognostic factors; Antineoplastic agent; Prognosis; Multicenter study; Concurrent; non-small cell lung carcinoma; Chemoradiotherapy; Phase II trial; Paclitaxel; Bronchus disease; Advanced stage; Non small cell carcinoma; Lung disease; Drug combination; Induction; Respiratory disease; Etoposide; Malignant tumor; Long term; Survival; Induction treatment; Cisplatin; Cycle; Concomitant disease; Cancer
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2013.06.007

Abstract Background 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. Patients and methods Mediastinoscopically proven IIIA(N2)/selected IIIB NSCLC received three cycles cisplatin (50 mg/m2 day 1 + 8) and paclitaxel (175 mg/m2 d1) qd 22. Concurrent CTx/RTx followed: 45 Gy (1.5 Gy bid) with cisplatin 50 mg/m2 day 2 + 9 and etoposide 100 mg/m2 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. Results 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. Conclusions 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).