학술논문
Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer.
Document Type
Academic Journal
Author
Bajetta E; Istituto di Oncologia, Policlinico di Monza, Monza.; Floriani I; Laboratory of Clinical Research, IRCCS-Istituto di Ricerche Farmacologiche 'Mario Negri', Milano. Electronic address: irene.floriani@marionegri.it.; Di Bartolomeo M; Struttura Complessa di Medicina Oncologica 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.; Labianca R; Unità di Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo.; Falcone A; Dipartimento di Ricerca Traslazionale, Università di Pisa, Istituto Toscano Tumori, Pisa.; Di Costanzo F; S.C. Oncologia Medica, Azienda Ospedaliero-Universitaria Careggi, Firenze.; Comella G; Oncologia Medica A, Fondazione Pascale, Istituto Nazionale dei Tumori, Napoli.; Amadori D; I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola.; Pinto C; U.O. di Oncologia Medica, Policlinico S.Orsola Malpighi, Bologna.; Carlomagno C; Dipartimento di Medicina Clinica e Chirurgia, Università Federico II, Napoli.; Nitti D; Clinica Chiurgica 1, Dipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche, Padova.; Daniele B; Dipartimento di Oncologia, A.O.G. Rummo, Benevento.; Mini E; Dipartimento di Scienze Della Salute, Sezione di Farmacologia Clinica e Oncologia, Università degli Studi di Firenze, Firenze.; Poli D; Laboratory of Clinical Research, IRCCS-Istituto di Ricerche Farmacologiche 'Mario Negri', Milano.; Santoro A; U.O. Oncologia e Ematologia, Humanitas Cancer Center, Istituto Clinico Humanitas-I.R.C.C.S., Rozzano.; Mosconi S; Unità di Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo.; Casaretti R; S.C. di Oncologia Medica Addominale, dell'Istituto Tumori di Napoli, Napoli.; Boni C; Oncologia, Arcispedale Santa Maria Nuova-I.R.C.C.S., Reggio Emilia, Reggio Emilia.; Pinotti G; Divisione di Oncologia Medica, A.O. Ospedale di Circolo, Varese.; Bidoli P; S.C. Oncologia Medica, A.O.S. Gerardo, Monza.; Landi L; U.O. Oncologia Medica, Azienda USL6 di Livorno, Istituto Toscano Tumori, Livorno.; Rosati G; Unità Oncologia Medica, Ospedale S. Carlo, Potenza.; Ravaioli A; U.O. di Oncologia, Ospedale Infermi Rimini, Ospedale Cervesi, Azienda USL di Rimini, Rimini, Cattolica.; Cantore M; Oncologia Medica, USL 1, Massa Carrara.; Di Fabio F; U.O. di Oncologia Medica, Policlinico S.Orsola Malpighi, Bologna.; Aitini E; Ospedale Carlo Poma, Mantova, Italy.; Marchet A; Clinica Chiurgica 1, Dipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche, Padova.
Source
Publisher: Elsevier Country of Publication: England NLM ID: 9007735 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1569-8041 (Electronic) Linking ISSN: 09237534 NLM ISO Abbreviation: Ann Oncol Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Some trial have demonstrated a benefit of adjuvant fluoropirimidine with or without platinum compounds compared with surgery alone. ITACA-S study was designed to evaluate whether a sequential treatment of FOLFIRI [irinotecan plus 5-fluorouracil/folinic acid (5-FU/LV)] followed by docetaxel plus cisplatin improves disease-free survival in comparison with 5-FU/LV in patients with radically resected gastric cancer.
Patients and Methods: Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m(2) day 1, LV 100 mg/m(2) as 2 h infusion and 5-FU 400 mg/m(2) as bolus, days 1 and 2 followed by 600 mg/m(2)/day as 22 h continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m(2) day 1, cisplatin 75 mg/m(2) day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm).
Results: From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis: 562 in the sequential arm and 538 in the 5-FU/LV arm. With a median follow-up of 57.4 months, 581 patients recurred or died (297 sequential arm and 284 5-FU/LV arm), and 483 died (243 and 240, respectively). No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85-1.17; P = 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82-1.18; P = 0.865). Five-year disease-free and OS rates were 44.6% and 44.6%, 51.0% and 50.6% in the sequential and 5-FU/LV arm, respectively.
Conclusions: A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy.
Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01640782.
(© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Patients and Methods: Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m(2) day 1, LV 100 mg/m(2) as 2 h infusion and 5-FU 400 mg/m(2) as bolus, days 1 and 2 followed by 600 mg/m(2)/day as 22 h continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m(2) day 1, cisplatin 75 mg/m(2) day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm).
Results: From February 2005 to August 2009, 1106 patients were enrolled, and 1100 included in the analysis: 562 in the sequential arm and 538 in the 5-FU/LV arm. With a median follow-up of 57.4 months, 581 patients recurred or died (297 sequential arm and 284 5-FU/LV arm), and 483 died (243 and 240, respectively). No statistically significant difference was detected for both disease-free [hazard ratio (HR) 1.00; 95% confidence interval (CI): 0.85-1.17; P = 0.974] and overall survival (OS) (HR 0.98; 95% CI: 0.82-1.18; P = 0.865). Five-year disease-free and OS rates were 44.6% and 44.6%, 51.0% and 50.6% in the sequential and 5-FU/LV arm, respectively.
Conclusions: A more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy.
Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01640782.
(© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)