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

Bajetta, Emilio; Floriani, Irene; Bartolomeo, Maria Di; Labianca, Roberto; Falcone, Alfredo; Costanzo, F. Di; Comella, G.; Amadori, Dino; Pinto, Carmine; Carlomagno, Chiara; Nitti, D.; Daniele, Bruno; Mini, Enrico; Poli, Davide; Santoro, Armando; Mosconi, S.; Casaretti, R.; Boni, C.; Pinotti, Graziella; Bidoli, Paolo; Landi, Lorenza; Rosati, Gerardo; Ravaioli, Alberto; Cantore, Maurizio; Fabio, Francesca Di; Aitini, Enrico; Marchet, Alberto; Rulli, Eliana; Tullio, Mattia; Galli, Federica; Biagioli, Elena; Simone, Irene De; Mangano, Stefano; Tonato, Maurizio; Zucca, Emanuele; Valsecchi, M.G.; Placido, Sabino De; Catena, Laura; Schiavo, Marcello; Proserpio, Ilaria; Bordonaro, Roberto; Cordio, S.; Burrafato, Giovanni; Bochicchio, Anna Maria; Aieta, Michele; Fazio, Nicola; Spada, Francesca; Amoroso, Vito; Marini, G; Parra, Héctor Soto; Novello, G.; Massidda, B.; Ionta, M. T.; Comandè, Mario; Venezia, Rachel; Bertolini, A.; Menatti, E.; Zanlorenzi, Laura; Colombo, Anna; Iop, Aldo; Bonura, Salvatore; Mazza, Elena; Viganò, Maria Grazia; Ardizzoia, A; Dell’Oro, Stefania; Re, Giuseppe Lo; Santeufemia, Davide Adriano; Buonadonna, Angela; Luisi, Dimitri; Ucci, G.; Lucca, Giuseppe Di; Bonetti, Andrea; Bergamo, Francesca; Alù, Massimiliano; Vastola, Francesca; Marchetti, Paolo; Corsi, D.C.; Massa, Elena; Pinto, Gama; Duro, Mary; Oliani, Cristina; Franchini, Massimo; Inzoli, Alessandro; Gebbia, N.; Repetto, L; Rota, Silvia; Frontini, L.; Quadri, Antonello; Grossi, S.; Cazzaniga, M.; Villa, Francesco; Foa, Paolo; Ferrari, Debora; Rabbi, C.; Barni, Sandro; Petrelli, Fabio; Giordano, Monica; Luchena, Giovanna; Pirovano, M; Nasisi, A.; Catalano, Vincenzo; Giordani, Paolo; Zaniboni, Alberto; Leone, Francesco; Ferrario, S.; Beretta, Giordano Domenico; Menichetti, Ettore Tito; Conte, D.; Mari, D.; Giannicola, Rocco; Pierantoni, Chiara; Luporini, Alberto; Tassinari, Davide; Nicolini, M.; Frassineti, Giovanni Luca; Turci, D.; Zumaglini, F.; Tamberi, Stefano; Piancastelli, A; Cruciani, Giorgio; Minuti, Gabriele; Orlandi, Maurizio; Mambrini, Andrea; Ciarlo, A.; Cavaciocchi, D.; Monte, Francesca Del; Ricci, Sergio; Brunetti, Maurizio; Lencioni, Monica; Sisani, Michele; Sozzi, Pietro; Granetto, Cristina; Chiara, Silvana; Galetto, Alessandra; Ribecco, Angela Stefania; DeCensi, Andrea; Ciuffreda, Lucia; Baldini, Editta; Camisa, Roberta; Todeschini, Renata; Rimassa, Lorenza; Carnaghi, Carlo; Pressiani, Tiziana; Rondini, Ermanno; Gnoni, R.; Gasperoni, Silvia; Cavanna, Luigi; Palladino, M A; Mattioli, Rodolfo; Laici, G.; Pucci, Francesca; Alessio, Manuela; Bernardini, Ilaria; Tomasello, Gianluca; Baldino, Giovanni; Rossetti, Riccardo; Giaquinta, S.; Llimpe, F.L. Rijas; Brandes, Alba Ariela; Marzola, Marina; Montesarchio, Vincenzo; Rea, Antonio; Genua, Geppino; Silvestro, Lucrezia; Montano, Massimo; Sarobba, Maria Giuseppa; Sanna, G.; Filippelli, Gianfranco; Dima, G.; Greco, Ettore; Roselli, Mario; Natale, D.; Condemi, G.; Fumi, Guglielmo; Tafuto, Salvatore; Masullo, P.; Tiberio, Guido Alberto Massimo; Manzoni, Giovanni De; Fiorentini, G.; Mazzanti, Roberto; Stefano, Alfonso De; Cartenì, Giacomo; Otero, M. J.

doi:10.1093/annonc/mdu146

Cited by 82 publications

(53 citation statements)

References 19 publications

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“…The use of more intensive chemotherapy to improve the efficacy of existing regimens for adjuvant chemotherapy has already been investigated in previous randomized phase 3 trials for overall stages of gastric cancer patients, but all of those studies failed to demonstrate a survival benefit for this strategy [17,18,20]. The AMC 0201 trial in Korea compared mitomycin, cisplatin, and 12 months of oral doxifluridine (MFP) with mitomycin plus 3 months of oral doxifluridine (Mf) in patients with D2-resected stage II-IV (M0) gastric cancer [18].…”

Section: Discussionmentioning

confidence: 99%

“…There was no difference between the two groups in RFS [20]. In the ITACA-S trial from Italy, four cycles of FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) followed by three cycles of docetaxel and cisplatin were tested for comparison with 5-fluorouracil/leucovorin (p = 0.97 for RFS and p = 0.87 for OS) [17]. These might represent evidence against the potential role of intensive chemotherapy in patients with curatively resected gastric cancer.…”

Section: Discussionmentioning

confidence: 99%

“…Eligibility criteria included histologically documented adenocarcinoma of the stomach or esophagogastric junction; curative D2 resection; stage IIIB or IV without distant metastasis (pT3N2, pT4N1-2M0 or pTanyN3M0) according to the AJCC staging system, 6 th edition; an age of between 18 and 70 years; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; adequate bone marrow function (absolute neutrophil count [17] [1,500/lL, hemoglobin [9.0 g/dL, and platelets [100,000/lL); adequate renal function (serum creatinine \1.5 mg/dL); adequate liver function [total serum bilirubin less than the upper normal limit (UNL)], aspartate aminotransferase and alanine aminotransferase \2.5 9 UNL, alkaline phosphatase \5 9 UNL); and no prior chemotherapy or radiotherapy.…”

Section: Study Design and Patientsmentioning

confidence: 99%

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Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB–IV gastric cancer

et al. 2015

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Objective Postoperative chemotherapy with S-1 or capecitabine plus oxaliplatin is a standard treatment for resectable gastric cancer (GC). However, survival outcomes of stage IIIB-IV (M0) GC cases are still poor. We investigated the efficacy and safety of docetaxel, capecitabine, and cisplatin (DXP) in patients with stage IIIB-IV GC. Methods This was a single-arm phase 2 study that included patients with stage IIIB-IV GC who underwent D2 gastrectomy. Patients received six cycles of docetaxel [60 mg/m 2 on day 1 (D1)], capecitabine (1,875 mg/m 2 /day on D1-14), and cisplatin (60 mg/m 2 on D1) every 3 weeks. The primary end-point was recurrence-free survival (RFS).Results A total of 46 GC patients between January 2007 and August 2008 were included. After a median follow-up of 56.1 months (range 52.2-64.1), the median RFS and overall survival (OS) were 26.9 months (95 % CI 7.5-46.4) and 43.9 months (95 % CI 29.2-58.7), respectively. The 5-year RFS and OS rates were 39.1 and 41.3 %, respectively. The most common grade 3/4 toxicities were neutropenia (40 %), anorexia (22 %), and febrile neutropenia (15 %). Conclusions Adjuvant DXP is feasible and effective for patients with stage IIIB-IV GC. A phase 3 study comparing triplet and doublet regimens for these patients is ongoing.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Study Design and Patientsmentioning

confidence: 99%

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Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB–IV gastric cancer

et al. 2015

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“…The study population consisted of 1106 patients enrolled between 2005 and 2009 and with pathologically confirmed, radically resected, stage II/III adenocarcinoma involving the stomach or the gastroesophageal junction. The primary end point of disease-free survival, which may be considered as a surrogate for overall survival (OS) [13], was not significantly different among the two treatment arms [12].…”

Section: Patient Population and Study Designmentioning

confidence: 97%

“…To conduct our investigations, we used data from the ITACA-S study [12], a multicenter randomized, open-label, parallel group, superiority phase III trial which planned to evaluate a survival benefit with sequential use of infusional 5-fluorouracil (5-FU) and leucovorin (LV) plus irinotecan (FOLFIRI regimen) followed by cisplatin and docetaxel versus 5-FU and LV alone (De Gramont regimen). The study population consisted of 1106 patients enrolled between 2005 and 2009 and with pathologically confirmed, radically resected, stage II/III adenocarcinoma involving the stomach or the gastroesophageal junction.…”

Section: Patient Population and Study Designmentioning

confidence: 99%

Osteopontin, E-cadherin, and β-catenin expression as prognostic biomarkers in patients with radically resected gastric cancer

et al. 2015

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A correlation between osteopontin, E-cadherin, b-catenin, and cyclooxygenase 2 overexpression and poor clinicopathological features and prognosis has been previously suggested in gastric cancer. This translational study was aimed at assessing the correlation of these immunohistochemical biomarkers with outcome in patients with radically resected gastric cancer. We analyzed osteopontin, E-cadherin, b-catenin, and cyclooxygenase 2 expression by immunohistochemistry in 346 primary gastric tumor tissue samples from patients enrolled in the ITACA-S trial. This phase III study randomized patients with radically resected gastric cancer to receive adjuvant chemotherapy with either 5-fluorouracil and leucovorin or a sequential regimen of infusional 5-fluorouracil and leucovorin plus irinotecan followed by cisplatin and docetaxel. High expression of osteopontin was correlated with high histological grade, diffuse histotype, and peritoneal relapse, but not with TNM stage. Moreover, osteopontin overexpression was associated with higher risk of tumor recurrence and metastases, and was an independent prognostic factor for both relapsefree and overall survival of gastric cancer patients following adjuvant chemotherapy. Abnormal E-cadherin expression and abnormal b-catenin expression were correlated with more advanced disease stage, and as a consequence, with poor outcome. Our results suggest that osteopontin overexpression is a valuable independent predictor of tumor recurrence and survival in patients with radically resected gastric cancer.

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Neoadjuvant chemotherapy for locally advanced gastric cancer in Japan: Consensus meeting at the 77th general meeting of the Japanese Society of Gastroenterological Surgery

Tokunaga

Kurokawa

Fukagawa

et al. 2023

Annals of Gastroent Surgery

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Treatment strategy for locally advanced gastric cancer differs worldwide. Neoadjuvant chemotherapy (NAC) is considered one of the promising treatment options for locally advanced gastric cancer, even in Japan, and clinical trials have been conducted or are ongoing. A consensus meeting was organized at the 77th general meeting of the Japanese Society of Gastroenterological Surgery in 2022, in which the current status and future prospects of NAC for locally advanced gastric cancer were discussed. Participants at the meeting looked forward to the results of the JCOG1509 trial, providing solid evidence regarding NAC. The optimal indications and regimens for NAC were also debated. Patients with cStage III gastric cancer are the main targets of NAC in Japan, and a doublet regimen of S‐1 and oxaliplatin was preferred by the participants. However, the feasibility of a triplet regimen with S‐1, oxaliplatin, and docetaxel, and that with 5‐FU, leucovorin, oxaliplatin, and docetaxel has been demonstrated, and these could become treatment options in Japan. Other points of discussion include perioperative chemotherapy to avoid peritoneal recurrence and for patients with dMMR/MSI‐high tumors. The panel regarded NAC as a promising treatment option, and NAC will become the standard treatment for cStage III gastric cancer in Japan if an ongoing clinical trial successfully demonstrates its efficacy.

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

Cited by 82 publications

References 19 publications

Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB–IV gastric cancer

Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB–IV gastric cancer

Osteopontin, E-cadherin, and β-catenin expression as prognostic biomarkers in patients with radically resected gastric cancer

Neoadjuvant chemotherapy for locally advanced gastric cancer in Japan: Consensus meeting at the 77th general meeting of the Japanese Society of Gastroenterological Surgery

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