Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer |
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| Institution: | 1. Istituto di Oncologia, Policlinico di Monza, Monza;2. Laboratory of Clinical Research, IRCCS—Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milano;3. Struttura Complessa di Medicina Oncologica 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano;4. Unità di Oncologia Medica, Ospedale Papa Giovanni XXIII, Bergamo;5. Dipartimento di Ricerca Traslazionale, Università di Pisa, Istituto Toscano Tumori, Pisa;6. S.C. Oncologia Medica, Azienda Ospedaliero-Universitaria Careggi, Firenze;7. Oncologia Medica A, Fondazione Pascale, Istituto Nazionale dei Tumori, Napoli;8. I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola;9. U.O. di Oncologia Medica, Policlinico S.Orsola Malpighi, Bologna;10. Dipartimento di Medicina Clinica e Chirurgia, Università Federico II, Napoli;11. Clinica Chiurgica 1, Dipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche, Padova;12. Dipartimento di Oncologia, A.O.G. Rummo, Benevento;13. Dipartimento di Scienze Della Salute, Sezione di Farmacologia Clinica e Oncologia, Università degli Studi di Firenze, Firenze;14. U.O. Oncologia e Ematologia, Humanitas Cancer Center, Istituto Clinico Humanitas—I.R.C.C.S., Rozzano;15. S.C. di Oncologia Medica Addominale, dell''Istituto Tumori di Napoli, Napoli;16. Oncologia, Arcispedale Santa Maria Nuova-I.R.C.C.S., Reggio Emilia, Reggio Emilia;17. Divisione di Oncologia Medica, A.O. Ospedale di Circolo, Varese;18. S.C. Oncologia Medica, A.O.S. Gerardo, Monza;19. U.O. Oncologia Medica, Azienda USL6 di Livorno, Istituto Toscano Tumori, Livorno;20. Unità Oncologia Medica, Ospedale S. Carlo, Potenza;21. U.O. di Oncologia, Ospedale Infermi Rimini, Ospedale Cervesi, Azienda USL di Rimini, Rimini, Cattolica;22. Oncologia Medica, USL 1, Massa Carrara;23. Ospedale Carlo Poma, Mantova, Italy |
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| Abstract: | BackgroundSome 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 methodsPatients with resectable adenocarcinoma of the stomach or gastroesophageal junction were randomly assigned to either FOLFIRI (irinotecan 180 mg/m2 day 1, LV 100 mg/m2 as 2 h infusion and 5-FU 400 mg/m2 as bolus, days 1 and 2 followed by 600 mg/m2/day as 22 h continuous infusion, q14 for four cycles) followed by docetaxel 75 mg/m2 day 1, cisplatin 75 mg/m2 day 1, q21 for three cycles (sequential arm) or De Gramont regimen (5-FU/LV arm).ResultsFrom 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.ConclusionsA more intensive regimen failed to show any benefit in disease-free and OS versus monotherapy.Clinical trial registrationClinicalTrials.gov Identifier: NCT01640782. |
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