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1. Impact on Survival of Timing and Duration of Adjuvant Chemotherapy in Radically Resected Gastric Cancer

Author

Maria Di Bartolomeo, Filippo Pietrantonio, Eliana Rulli, Davide Poli, Rosa Berenato, Marta Caporale, Emilio Bajetta, Irene Floriani, 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. Ragazzini, A. Ravaioli, D. Tassinari, M. Nicolini, D. Amadori, G.L. Frassineti, D. Turci, F. Zumaglini, S. Tamberi, A. Piancastelli, G. Cruciani, E. Bejtja, A. Falcone, L. Landi, G. Minuti, M. Cantore, M. Orlandi, A. Mambrini, A. Ciarlo, D. Cavaciocchi, F. Del Monte, S. Ricci, I.M. 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, A.O.G. Rummo Benevento, S. Competiello, V. Montesarchio, A. Rea, B. Daniele, G. Genua, M. Licenziato, 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, S. Nobili, G. Fiorentini, R. Mazzanti, E. Perrotta, C. Carlomagno, A. De Stefano, G. Cartenì, and M. Otero

Subjects
Male, Oncology, Cancer Research, medicine.medical_specialty, Adjuvant chemotherapy, medicine.medical_treatment, Time-to-Treatment, 03 medical and health sciences, 0302 clinical medicine, Stomach Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Combined Modality Therapy, Aged, Neoplasm Staging, Proportional Hazards Models, Postoperative Care, Chemotherapy, Proportional hazards model, business.industry, Stomach, Cancer, General Medicine, Middle Aged, medicine.disease, medicine.anatomical_structure, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Adenocarcinoma, Female, 030211 gastroenterology & hepatology, business, Adjuvant
Abstract

Purpose Adjuvant chemotherapy improves survival of patients with gastric cancer. Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S) was a phase III study comparing sequential FOLFIRI followed by docetaxel/cisplatin versus 5-fluorouracil monotherapy. The intensive regimen was not superior in terms of disease-free survival (DFS) and overall survival (OS). Methods The treatment was to be started within 8 weeks from surgery. This analysis evaluates the impact of time from surgery to chemotherapy start (TSC) on outcomes. Results Out of 1,106 randomized, 1,072 patients without major violations of eligibility criteria and receiving at least one treatment cycle were analyzed. Median TSC was 50 days. Chemotherapy was interrupted in 201 (18.8%) cases, whereas it was completed without or with modifications in 277 (25.8%) and 594 (55.4%), respectively. At a median follow-up of 56.9 months, 513 progressions and 472 deaths occurred. A longer TSC was significantly associated with longer DFS (hazard ratio [HR] 0.95; 95% confidence interval [CI] 0.89-1.00; p = 0.05) and OS (HR 0.91; 95% CI 0.86-0.97; p = 0.004), after adjustment for treatment arm, age, sex, primary tumor site, number of resected nodes, and tumor stage. Better treatment compliance was associated with improved survival. Conclusions Our findings suggest that longer TSC had at least no detrimental effect on DFS and OS, whereas treatment completion had a protective effect. Our findings need to be confirmed prospectively.

Published
2016
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2. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

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

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