E Bajetta1, I Floriani2, M Di Bartolomeo3, R Labianca4, A Falcone5, F Di Costanzo6, G Comella7, D Amadori8, C Pinto9, C Carlomagno10, D Nitti11, B Daniele12, E Mini13, D Poli14, A Santoro15, S Mosconi4, R Casaretti16, C Boni17, G Pinotti18, P Bidoli19, L Landi20, G Rosati21, A Ravaioli22, M Cantore23, F Di Fabio9, E Aitini24, A Marchet11. 1. Istituto di Oncologia, Policlinico di Monza, Monza. 2. Laboratory of Clinical Research, IRCCS-Istituto di Ricerche Farmacologiche 'Mario Negri', Milano irene.floriani@marionegri.it. 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. Laboratory of Clinical Research, IRCCS-Istituto di Ricerche Farmacologiche 'Mario Negri', Milano. 15. U.O. Oncologia e Ematologia, Humanitas Cancer Center, Istituto Clinico Humanitas-I.R.C.C.S., Rozzano. 16. S.C. di Oncologia Medica Addominale, dell'Istituto Tumori di Napoli, Napoli. 17. Oncologia, Arcispedale Santa Maria Nuova-I.R.C.C.S., Reggio Emilia, Reggio Emilia. 18. Divisione di Oncologia Medica, A.O. Ospedale di Circolo, Varese. 19. S.C. Oncologia Medica, A.O.S. Gerardo, Monza. 20. U.O. Oncologia Medica, Azienda USL6 di Livorno, Istituto Toscano Tumori, Livorno. 21. Unità Oncologia Medica, Ospedale S. Carlo, Potenza. 22. U.O. di Oncologia, Ospedale Infermi Rimini, Ospedale Cervesi, Azienda USL di Rimini, Rimini, Cattolica. 23. Oncologia Medica, USL 1, Massa Carrara. 24. Ospedale Carlo Poma, Mantova, Italy.
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.
RCT Entities:
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.
Authors: Nelson Adami Andreollo; Eric Drizlionoks; Valdir Tercioti-Junior; João de Souza Coelho-Neto; José Antonio Possato Ferrer; José Barreto Campello Carvalheira; Luiz Roberto Lopes Journal: Arq Bras Cir Dig Date: 2019-12-20
Authors: Maria Di Bartolomeo; Filippo Pietrantonio; Alessandro Pellegrinelli; Antonia Martinetti; Luigi Mariani; Maria Grazia Daidone; Emilio Bajetta; Giuseppe Pelosi; Filippo de Braud; Irene Floriani; Rosalba Miceli Journal: Gastric Cancer Date: 2015-04-11 Impact factor: 7.370