Phase II trial of preoperative chemoradiotherapy with oxaliplatin, cisplatin, and 5-FU in locally advanced esophageal and gastric cancer
Mené sur 41 patients atteints d'un cancer localement avancé de l'œsophage ou de l'estomac, cet essai de phase II évalue une chimioradiothérapie préopératoire à base d'oxaliplatine, de cisplatine et de 5-FU
Background: Based 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 methods: Patients with resectable tumors were eligible. Treatment included two cycles of oxaliplatin 85 mg/m2, cisplatin 55 mg/m2, and continuously infused 5-FU 3 g/m2 in 96 h and concurrent RT (45 Gy), followed by surgery after 6–8 weeks. Primary end point was complete pathologic response (pCR).Results: Forty-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.Conclusion: Preoperative OCF plus RT showed an acceptable toxicity and promising activity especially in squamous cell esophageal cancer.
Annals of Oncology 2011