Phase II trial of preoperative chemoradiotherapy with oxaliplatin, cisplatin, and 5-FU in locally advanced esophageal and gastric cancer

• Published in: Annals of oncology Vol. 23; no. 3; pp. 664 - 670
• Main Authors: Pera, M., Gallego, R., Montagut, C., Martín-Richard, M., Iglesias, M., Conill, C., Reig, A., Balagué, C., Pétriz, L., Momblan, D., Bellmunt, J., Maurel, J.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.03.2012; Oxford University Press
• Subjects: Adenocarcinoma - pathology; Adenocarcinoma - therapy; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - therapy; chemoradiotherapy; Chemoradiotherapy - methods; Cisplatin - administration & dosage; Cisplatin - adverse effects; Disease-Free Survival; esophageal cancer; Esophageal Neoplasms - pathology; Esophageal Neoplasms - therapy; Esophagus; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; gastric cancer; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Kaplan-Meier Estimate; Male; Medical sciences; Middle Aged; Neoadjuvant Therapy - methods; Neoplasm Staging; Organoplatinum Compounds - administration & dosage; Organoplatinum Compounds - adverse effects; Oxaliplatin; pathologic response; Pharmacology. Drug treatments; preoperative therapy; Stomach Neoplasms - pathology; Stomach Neoplasms - therapy; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors; chemoradiotherapy; oxaliplatin; esophageal cancer; gastric cancer; preoperative therapy; pathologic response; Antineoplastic agent; Esophageal disease; Stomach cancer; Chemoradiotherapy; Esophagus cancer; Oxaliplatin; Phase II trial; Gastric disease; Platinum II Complexes; Fluorouracil; Human; Enzyme; Fluoropyrimidine derivatives; Transferases; Enzyme inhibitor; Malignant tumor; Thymidylate synthase; Cisplatin; Alkylating agent; Treatment; Antimetabolic; Methyltransferases; Pyrimidine derivatives; Digestive diseases; Locally advanced stage; Preoperative; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdr291

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 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). 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. Preoperative OCF plus RT showed an acceptable toxicity and promising activity especially in squamous cell esophageal cancer.