학술논문
Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer: Pathological Response as Primary Endpoint and FDG-PET Predictions.
Document Type
Article
Author
Berenato, Rosa; Morano, Federica; Pietrantonio, Filippo; Cotsoglou, Christian; Caporale, Marta; Infante, Gabriele; Pellegrinelli, alessandro; alessi, alessandra; Battiston, Carlo; Coppa, Jorgelina; Padovano, Barbara; Mennitto, alessia; Niger, Monica; Fucà, Giovanni; Lazzati, Silvia; Greco, Giorgio; Delconte, Gabriele; de Braud, Filippo; Mazzaferro, Vincenzo; Di Bartolomeo, Maria
Source
Subject
*ANTIMETABOLITES
*ANTINEOPLASTIC agents
*CLINICAL trials
*DEOXY sugars
*PREOPERATIVE care
*RADIOPHARMACEUTICALS
*STOMACH tumors
*TIME
*POSITRON emission tomography
*OXALIPLATIN
*IRINOTECAN
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Language
ISSN
0030-2414
Abstract
Objectives: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Methods: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al. [Cancer 2003; 98: 1521-1530]. The potential role of fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) as a predictive biomarker of pathological tumor response was assessed in a subgroup of 19 evaluable patients. Results: Between January 2011 and October 2015, a total of 40 patients were enrolled. After the preoperative phase, 36 out of 40 patients (90%) were considered eligible for surgery: 12 patients (30%) achieved a pathological response. The most frequent grade 3/4 adverse events were diarrhea (27%), nausea (25%), and fatigue (17%). Grade 3 neutropenia occurred in 7.5% of patients. A lower standard uptake value at baseline FDG-PET/CT was associated with pathological response. Conclusion: COI combination is active with a manageable toxicity profile in patients with resectable GC or GEJ cancer. FDG-PET/CT imaging as a surrogate biomarker of pathological response in this setting appears fascinating but should be further investigated. [ABSTRACT FROM AUTHOR]