title: Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study.
abstract: The optimal schedule and regimen of chemotherapy (CT) in association with chemoradiation has not been established in stage III non-small-cell lung cancer (NSCLC). We have compared three schedules of non-platinum-based CT plus either radiotherapy or chemoradiation. From May 2001 to June 2006, 158 patients with unresectable stage III NSCLC were enrolled in a randomized phase II trial with overall response rate (ORR) as the primary endpoint. The initial design included three arms: sequential CT followed by thoracic radiation (TRT); concurrent CT/TRT followed by consolidation CT; and induction CT followed by concurrent CT/TRT. However, based on the preliminary results of the RTOG 9410 trial, the sequential arm was closed when 19 patients had been enrolled. All patients received two cycles of docetaxel 40 mg/m(2) days 1 and 8 plus gemcitabine 1200 mg/m(2) days 1 and 8, as either induction or consolidation therapy. Concurrent CT/TRT consisted of docetaxel 20 mg/m(2) and carboplatin AUC 2 weekly plus 60 Gy TRT. No differences were found in ORR between the two arms (56% and 57%). Hematological toxicity was mild but significantly superior with consolidation CT; the esophagitis rate was similar in both arms (16% and 15%). With a median follow-up of 57 months, no differences were found in median survival (13.07 and 13.8 months) or 5-year survival (16.4% and 22%). This regimen cannot be recommended as an alternative to platinum-based CT/TRT although it has an acceptable toxicity profile and encouraging long-term survival data (ClinicalTrials.gov NCT01652820).
authors.affiliation: Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Hospital Universitario Ramón y Cajal, Madrid, Spain. pilargarridol@gmail.com
authors.forename: Pilar
authors.initials: P
authors.lastname: Garrido
authors.forename: Rafael
authors.initials: R
authors.lastname: Rosell
authors.forename: Antonio
authors.initials: A
authors.lastname: Arellano
authors.forename: Francisco
authors.initials: F
authors.lastname: Andreu
authors.forename: Manuel
authors.initials: M
authors.lastname: Dómine
authors.forename: Ana
authors.initials: A
authors.lastname: Perez-Casas
authors.forename: Felipe
authors.initials: F
authors.lastname: Cardenal
authors.forename: María Del Mar
authors.initials: Mdel M
authors.lastname: Arnaiz
authors.forename: Teresa
authors.initials: T
authors.lastname: Morán
authors.forename: Rosa
authors.initials: R
authors.lastname: Morera
authors.forename: Dolores
authors.initials: D
authors.lastname: Isla
authors.forename: Javier
authors.initials: J
authors.lastname: Valencia
authors.forename: Manuel
authors.initials: M
authors.lastname: Cobo
authors.forename: Raquel
authors.initials: R
authors.lastname: Delgado
authors.forename: Ramón
authors.initials: R
authors.lastname: García-Gómez
authors.forename: Felipe
authors.initials: F
authors.lastname: Calvo
authors.forename: Javier
authors.initials: J
authors.lastname: Zamora
authors.forename: Alfredo
authors.initials: A
authors.lastname: Ramos
authors.forename: Bartomeu
authors.initials: B
authors.lastname: Massutí
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D059248:Chemoradiotherapy; D060830:Consolidation Chemotherapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D016190:Carboplatin; D000093542:Gemcitabine