Preoperative or perioperative docetaxel, oxaliplatin, and capecitabine (GASTRODOC regimen) in patients with locally-advanced resectable gastric cancer: A randomized phase-II trial

Manlio Monti, Paolo Morgagni, Oriana Nanni, Massimo Framarini, Luca Saragoni, Daniele Marrelli, Franco Roviello, Roberto Petrioli, Uberto Fumagalli Romario, Lorenza Rimassa, Silvia Bozzarelli, Annibale Donini, Luigina Graziosi, Verena De Angelis, Giovanni De Manzoni, Maria Bencivenga, Valentina Mengardo, Emilio Parma, Carlo Milandri, Gianni MuraAlessandra Signorini, Gianluca Baiocchi, Sarah Molfino, Giovanni Sgroi, Francesca Steccanella, Stefano Rausei, Ilaria Proserpio, Jacopo Viganò, Silvia Brugnatelli, Andrea Rinnovati, Stefano Santi, Giorgio Ercolani, Flavia Foca, Linda Valmorri, Dino Amadori, Giovanni Luca Frassineti

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Article number2790
Pages (from-to)1-13
Number of pages13
JournalCancers
Volume12
Issue number10
DOIs
Publication statusPublished - Oct 2020

Keywords

  • Chemotherapy
  • Gastric cancer
  • Perioperative
  • Preoperative

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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