TY - JOUR
T1 - Preoperative or perioperative docetaxel, oxaliplatin, and capecitabine (GASTRODOC regimen) in patients with locally-advanced resectable gastric cancer
T2 - A randomized phase-II trial
AU - Monti, Manlio
AU - Morgagni, Paolo
AU - Nanni, Oriana
AU - Framarini, Massimo
AU - Saragoni, Luca
AU - Marrelli, Daniele
AU - Roviello, Franco
AU - Petrioli, Roberto
AU - Romario, Uberto Fumagalli
AU - Rimassa, Lorenza
AU - Bozzarelli, Silvia
AU - Donini, Annibale
AU - Graziosi, Luigina
AU - De Angelis, Verena
AU - De Manzoni, Giovanni
AU - Bencivenga, Maria
AU - Mengardo, Valentina
AU - Parma, Emilio
AU - Milandri, Carlo
AU - Mura, Gianni
AU - Signorini, Alessandra
AU - Baiocchi, Gianluca
AU - Molfino, Sarah
AU - Sgroi, Giovanni
AU - Steccanella, Francesca
AU - Rausei, Stefano
AU - Proserpio, Ilaria
AU - Viganò, Jacopo
AU - Brugnatelli, Silvia
AU - Rinnovati, Andrea
AU - Santi, Stefano
AU - Ercolani, Giorgio
AU - Foca, Flavia
AU - Valmorri, Linda
AU - Amadori, Dino
AU - Frassineti, Giovanni Luca
PY - 2020/10
Y1 - 2020/10
N2 - Docetaxel associated with oxaliplatin and 5-fluorouracil (FLOT) has been reported as the best perioperative treatment for gastric cancer. However, there is still some debate about the most appropriate number and timing of chemotherapy cycles. In this randomized multicenter phase II study, patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology, and randomly assigned (1:1) to either four cycles of neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B). The primary endpoint was to assess the percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles. Ninety-one patients were enrolled between September 2010 and August 2016. The treatment was well tolerated in both arms. Thirty-three (71.7%) and 24 (53.3%) patients completed the planned cycles in arms A and B, respectively (p = 0.066), reporting an odds ratio for early interruption of treatment of 0.45 (95% confidence interval (CI): 0.18–1.07). Resection was curative in 39 (88.6%) arm A patients and 35 (83.3%) arm B patients. Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2–65.8) in arm A and 40.3% (95% CI: 28.9–55.2) in arm B (p = 0.300). Five-year survival was 58.5% (95% CI: 41.3–72.2) and 53.9% (95% CI: 35.5–69.3) (p = 0.883) in arms A and B, respectively. The planned treatment was more frequently completed and was more active, albeit not significantly, in the neoadjuvant arm than in the perioperative group.
AB - Docetaxel associated with oxaliplatin and 5-fluorouracil (FLOT) has been reported as the best perioperative treatment for gastric cancer. However, there is still some debate about the most appropriate number and timing of chemotherapy cycles. In this randomized multicenter phase II study, patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology, and randomly assigned (1:1) to either four cycles of neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B). The primary endpoint was to assess the percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles. Ninety-one patients were enrolled between September 2010 and August 2016. The treatment was well tolerated in both arms. Thirty-three (71.7%) and 24 (53.3%) patients completed the planned cycles in arms A and B, respectively (p = 0.066), reporting an odds ratio for early interruption of treatment of 0.45 (95% confidence interval (CI): 0.18–1.07). Resection was curative in 39 (88.6%) arm A patients and 35 (83.3%) arm B patients. Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2–65.8) in arm A and 40.3% (95% CI: 28.9–55.2) in arm B (p = 0.300). Five-year survival was 58.5% (95% CI: 41.3–72.2) and 53.9% (95% CI: 35.5–69.3) (p = 0.883) in arms A and B, respectively. The planned treatment was more frequently completed and was more active, albeit not significantly, in the neoadjuvant arm than in the perioperative group.
KW - Chemotherapy
KW - Gastric cancer
KW - Perioperative
KW - Preoperative
UR - http://www.scopus.com/inward/record.url?scp=85088929261&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85088929261&partnerID=8YFLogxK
U2 - 10.3390/cancers12102790
DO - 10.3390/cancers12102790
M3 - Article
AN - SCOPUS:85088929261
VL - 12
SP - 1
EP - 13
JO - Cancers
JF - Cancers
SN - 2072-6694
IS - 10
M1 - 2790
ER -