1. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer
- Author
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E. Bajetta, I. Floriani, M. Di Bartolomeo, R. Labianca, A. Falcone, F. Di Costanzo, G. Comella, D. Amadori, C. Pinto, C. Carlomagno, D. Nitti, B. Daniele, E. Mini, D. Poli, A. Santoro, S. Mosconi, R. Casaretti, C. Boni, G. Pinotti, P. Bidoli, L. Landi, G. Rosati, A. Ravaioli, M. Cantore, F. Di Fabio, E. Aitini, A. Marchet, E. Rulli, M. Cropalato Di Tullio, F. Galli, E. Biagioli, I. De Simone, S. Mangano, M. Tonato, E. Zucca, M.G. Valsecchi, S. De Placido, L. Catena, M. Schiavo, I. Proserpio, R. Bordonaro, S. Cordio, G. Burrafato, A.M. Bochicchio, M. Aieta, N. Fazio, F. Spada, V. Amoroso, G. Marini, H. Soto Parra, G. Novello, B. Massidda, M.T. Ionta, M. Comandè, R. Venezia, A. Bertolini, E. Menatti, L. Zanlorenzi, A. Colombo, A. Iop, S. Bonura, E. Mazza, M. Viganò, A. Ardizzoia, S. Dell'Oro, G. Lo Re, D. Santeufemia, A. Buonadonna, D. Luisi, G. Ucci, G. Di Lucca, A. Bonetti, F. Bergamo, M. Alù, F. Vastola, P. Marchetti, D.C. Corsi, E. Massa, G. Di Pinto, M. Duro, C. Oliani, M. Franchini, A. Inzoli, N. Gebbia, L. Repetto, S. Rota, L. Frontini, A. Quadri, S. De Grossi, M.E. Cazzaniga, F. Villa, P. Foa, D. Ferrari, C. Rabbi, S. Barni, F. Petrelli, M. Giordano, G. Luchena, M. Pirovano, A. Nasisi, V. Catalano, P. Giordani, A. Zaniboni, F. Leone, S. Ferrario, G.D. Beretta, E.T. Menichetti, D. Conte, D. Mari, R. Giannicola, C. Pierantoni, A.G. Luporini, D. Tassinari, M. Nicolini, G.L. Frassineti, D. Turci, F. Zumaglini, S. Tamberi, A. Piancastelli, G. Cruciani, G. Minuti, M. Orlandi, A. Mambrini, A. Ciarlo, D. Cavaciocchi, F. Del Monte, S. Ricci, M.I. Brunetti, M. Lencioni, M. Sisani, P. Sozzi, C. Granetto, S. Chiara, A.S. Galetto, A.S. Ribecco, A. DeCensi, L. Ciuffreda, E.E. Baldini, R. Camisa, R. Todeschini, L. Rimassa, C. Carnaghi, T. Pressiani, E. Rondini, R. Gnoni, S. Gasperoni, L. Cavanna, M.A. Palladino, R. Mattioli, G. Laici, F. Pucci, M.D. Alessio, I. Bernardini, G. Tomasello, G. Baldino, R. Rossetti, S. Giaquinta, F.L. Rijas Llimpe, A.A. Brandes, M. Marzola, V. Montesarchio, A. Rea, G. Genua, L. Silvestro, M. Montano, M.G. Sarobba, G. Sanna, G. Filippelli, G. Dima, E. Greco, M. Roselli, D. Natale, G. Condemi, G. Fumi, S. Tafuto, P. Masullo, G. Tiberio, G. de Manzoni, G. Fiorentini, R. Mazzanti, A. De Stefano, G. Cartenì, M. Otero, Bajetta, E, Floriani, I, Di Bartolomeo, M, Labianca, R, Falcone, A, Di Costanzo, F, Comella, G, Amadori, D, Pinto, C, Carlomagno, Chiara, Nitti, D, Daniele, B, Mini, E, Poli, D, Santoro, A, Mosconi, S, Casaretti, R, Boni, C, Pinotti, G, Bidoli, P, Landi, L, Rosati, G, Ravaioli, A, Cantore, M, Di Fabio, F, Marchet, A, for the ITACA S., Study Group, Carlomagno, C, Aitini, E, and Valsecchi, M
- Subjects
medicine.medical_specialty ,SURGERY ,Settore MED/06 - Oncologia Medica ,adjuvant treatment ,Docetaxel ,Gastroenterology ,LEUCOVORIN ,adjuvant chemotherapy ,gastric cancer ,Folinic acid ,Bolus (medicine) ,Stomach Neoplasms ,randomized clinical trial ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Humans ,GASTRECTOMY ,business.industry ,Hazard ratio ,gastric cancer, adjuvant treatment, adjuvant chemotherapy, randomized clinical trial ,PHASE-III TRIAL, CHEMOTHERAPY, SURGERY, S-1, ADENOCARCINOMA, GASTRECTOMY, LEUCOVORIN ,PHASE-III TRIAL ,ADENOCARCINOMA ,Hematology ,S-1 ,CHEMOTHERAPY ,Combined Modality Therapy ,Surgery ,Irinotecan ,Regimen ,Oncology ,Fluorouracil ,Chemotherapy, Adjuvant ,FOLFIRI ,Camptothecin ,Taxoids ,Cisplatin ,business ,medicine.drug - 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.
- Published
- 2014