-
Multicenter Study
Phase II trial of preoperative chemoradiotherapy with oxaliplatin, cisplatin, and 5-FU in locally advanced esophageal and gastric cancer.
- M Pera, R Gallego, C Montagut, M Martín-Richard, M Iglesias, C Conill, A Reig, C Balagué, L Pétriz, D Momblan, J Bellmunt, and J Maurel.
- Section of Gastrointestinal Surgery, Hospital Universitario del Mar and Institut de Recerca Hospital del Mar (IMIM), Universitat Autónoma de Barcelona, Barcelona. Electronic address: pera@parcdesalutmar.cat.
- Ann. Oncol. 2012 Mar 1; 23 (3): 664-670.
BackgroundBased on a phase I study showing the feasibility of combining of oxaliplatin, cisplatin, and 5-fluorouracil (5-FU) (OCF) with radiation therapy (RT) in esophageal cancer, the efficacy of this regimen in esophageal, gastroesophageal (GE), and gastric (G) cancer was assessed in this phase II multicenter study.Patients And MethodsPatients with resectable tumors were eligible. Treatment included two cycles of oxaliplatin 85 mg/m(2), cisplatin 55 mg/m(2), and continuously infused 5-FU 3 g/m(2) in 96 h and concurrent RT (45 Gy), followed by surgery after 6-8 weeks. Primary end point was complete pathologic response (pCR).ResultsForty-one patients were enrolled. Tumor location was esophagus 39% (squamous 10/adenocarcinoma 6), GE junction 32%, and stomach 29%. G3-G4 adverse events included asthenia (27%) and neutropenia (14%). One toxic death occurred. Thirty-one patients (75.6%) underwent surgery (R0 in 94%). Pathologic response was achieved in 58% of patients, with pCR in 50% and 16% of esophageal and GE/G cancer, respectively. pCR was achieved in 67% of squamous cell carcinoma. Survival: median follow-up, 50.4 months; median progression-free survival and overall survival were 23.2 and 28.4 months, respectively.ConclusionPreoperative OCF plus RT showed an acceptable toxicity and promising activity especially in squamous cell esophageal cancer.
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