Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer
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, ITACA-S (Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach Trial) Study Group, I Floriani, E Rulli, M Cropalato Di Tullio, D Poli, F Galli, E Biagioli, I De Simone, D Poli, S Mangano, M Tonato, E Zucca, M G Valsecchi, I Floriani, E Bajetta, M Di Bartolomeo, R Labianca, D Amadori, A Falcone, F Di Costanzo, B Daniele, C Pinto, G Comella, D Nitti, E Mini, S De Placido, A Marchet, E Bajetta, M Di Bartolomeo, L Catena, M Schiavo, G Pinotti, I Proserpio, G Rosati, 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, R Labianca, S Mosconi, A Quadri, S De Grossi, P Bidoli, M E Cazzaniga, F Villa, P Foa, D Ferrari, E Aitini, 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, A Ravaioli, D Tassinari, M Nicolini, D Amadori, G L Frassineti, D Turci, F Zumaglini, S Tamberi, A Piancastelli, G Cruciani, A Falcone, L Landi, G Minuti, M Cantore, 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, A Santoro, L Rimassa, C Carnaghi, T Pressiani, C Boni, E Rondini, R Gnoni, F Di Costanzo, 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, C Pinto, F Di Fabio, F L Rijas Llimpe, A A Brandes, M Marzola, V Montesarchio, A Rea, B Daniele, G Genua, R Casaretti, 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, D Nitti, A Marchet, G Tiberio, G de Manzoni, G Fiorentini, R Mazzanti, C Carlomagno, A De Stefano, G Cartenì, M Otero, 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, ITACA-S (Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach Trial) Study Group, I Floriani, E Rulli, M Cropalato Di Tullio, D Poli, F Galli, E Biagioli, I De Simone, D Poli, S Mangano, M Tonato, E Zucca, M G Valsecchi, I Floriani, E Bajetta, M Di Bartolomeo, R Labianca, D Amadori, A Falcone, F Di Costanzo, B Daniele, C Pinto, G Comella, D Nitti, E Mini, S De Placido, A Marchet, E Bajetta, M Di Bartolomeo, L Catena, M Schiavo, G Pinotti, I Proserpio, G Rosati, 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, R Labianca, S Mosconi, A Quadri, S De Grossi, P Bidoli, M E Cazzaniga, F Villa, P Foa, D Ferrari, E Aitini, 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, A Ravaioli, D Tassinari, M Nicolini, D Amadori, G L Frassineti, D Turci, F Zumaglini, S Tamberi, A Piancastelli, G Cruciani, A Falcone, L Landi, G Minuti, M Cantore, 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, A Santoro, L Rimassa, C Carnaghi, T Pressiani, C Boni, E Rondini, R Gnoni, F Di Costanzo, 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, C Pinto, F Di Fabio, F L Rijas Llimpe, A A Brandes, M Marzola, V Montesarchio, A Rea, B Daniele, G Genua, R Casaretti, 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, D Nitti, A Marchet, G Tiberio, G de Manzoni, G Fiorentini, R Mazzanti, C Carlomagno, A De Stefano, G Cartenì, M Otero
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.
Keywords: adjuvant chemotherapy; adjuvant treatment; gastric cancer; randomized clinical trial.
© 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.
Source: PubMed