Cancers (Sep 2020)
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 Mura,
- Alessandra 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
Affiliations
- Manlio Monti
- Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy
- Paolo Morgagni
- Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy
- Oriana Nanni
- Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy
- Massimo Framarini
- Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy
- Luca Saragoni
- Pathology Unit, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy
- Daniele Marrelli
- Unit of Surgical Oncology, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy
- Franco Roviello
- Unit of Surgical Oncology, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy
- Roberto Petrioli
- Unit of Medical Oncology, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy
- Uberto Fumagalli Romario
- European Institute of Oncology IRCCS, 20141 Milan, Italy
- Lorenza Rimassa
- Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, 20089 Rozzano (Milan), Italy
- Silvia Bozzarelli
- Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, 20089 Rozzano (Milan), Italy
- Annibale Donini
- General and Emergency Surgery, Santa Maria della Misericordia Hospital, University of Perugia, 06129 Perugia, Italy
- Luigina Graziosi
- General and Emergency Surgery, Santa Maria della Misericordia Hospital, University of Perugia, 06129 Perugia, Italy
- Verena De Angelis
- Clinical Oncology, Santa Maria della Misericordia Hospital, University of Perugia, 06129 Perugia, Italy
- Giovanni De Manzoni
- General and Upper GI Surgery Division, University of Verona, 37129 Verona, Italy
- Maria Bencivenga
- General and Upper GI Surgery Division, University of Verona, 37129 Verona, Italy
- Valentina Mengardo
- General and Upper GI Surgery Division, University of Verona, 37129 Verona, Italy
- Emilio Parma
- Department of Surgery, San Giuseppe Hospital, 50053 Empoli, Italy
- Carlo Milandri
- Department of Oncology, San Giuseppe Hospital, 50053 Empoli, Italy
- Gianni Mura
- Department of General Surgery, San Donato Hospital, 52100 Arezzo, Italy
- Alessandra Signorini
- Department of Oncology, Valdarno Hospital, 52025 Montevarchi, Italy
- Gianluca Baiocchi
- Department of Clinical and Experimental Sciences, Surgical Clinic, University of Brescia, 25121 Brescia, Italy
- Sarah Molfino
- Department of Clinical and Experimental Sciences, Surgical Clinic, University of Brescia, 25121 Brescia, Italy
- Giovanni Sgroi
- Surgical Oncology Unit, Surgery Department, ASST Bergamo Ovest, 24047 Treviglio, Italy
- Francesca Steccanella
- Surgical Oncology Unit, Surgery Department, ASST Bergamo Ovest, 24047 Treviglio, Italy
- Stefano Rausei
- First Division of Surgery, Senology Research Center, Department of Surgical and Morphological Sciences, University of Insubria, 21100 Varese, Italy
- Ilaria Proserpio
- Medical Oncology, Ospedale di Circolo e Fondazione Macchi, 21100 Varese, Italy
- Jacopo Viganò
- General Surgery, IRCCS San Matteo, 27100 Pavia, Italy
- Silvia Brugnatelli
- Medical Oncology Unit, IRCCS San Matteo, 27100 Pavia, Italy
- Andrea Rinnovati
- General Surgery Unit, Ospedale del Casentino, 52010 Bibbiena, Italy
- Stefano Santi
- Department of Gastroenterology, Esophageal Surgery Unit, Tuscany Regional Referral Center for the Diagnosis and Treatment of Esophageal Disease, 56126 Pisa, Italy
- Giorgio Ercolani
- Department of General Surgery, Morgagni-Pierantoni Hospital, 47121 Forlì, Italy
- Flavia Foca
- Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy
- Linda Valmorri
- Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy
- Dino Amadori
- Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy
- Giovanni Luca Frassineti
- Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy
- DOI
- https://doi.org/10.3390/cancers12102790
- Journal volume & issue
-
Vol. 12,
no. 10
p. 2790
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.
Keywords
