M Pera1, R Gallego2, C Montagut3, M Martín-Richard4, M Iglesias5, C Conill2, A Reig6, C Balagué7, L Pétriz8, D Momblan9, J Bellmunt3, J Maurel2. 1. 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. 2. Department of Medical Oncology and Radiation Therapy, Hospital Clínic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona Medical School, Barcelona. 3. Service of Medical Oncology, Hospital Universitario del Mar and Institut de Recerca Hospital del Mar (IMIM), Barcelona. 4. Service of Medical Oncology, Hospital de Sant Pau, Barcelona. 5. Services of Pathology. 6. Services of Radiotherapy, Hospital Universitario del Mar and Institut de Recerca Hospital del Mar (IMIM), Barcelona. 7. Services of Digestive Surgery. 8. Services of Radiation Therapy, Hospital de Sant Pau, Barcelona. 9. Service of Gastrointestinal Surgery, Hospital Clinic, Barcelona, Spain.
Abstract
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/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). 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.
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/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). 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.
Authors: M Orditura; G Galizia; N Di Martino; E Ancona; C Castoro; R Pacelli; F Morgillo; S Rossetti; V Gambardella; A Farella; M M Laterza; A Ruol; A Fabozzi; V Napolitano; F Iovino; E Lieto; L Fei; G Conzo; F Ciardiello; F De Vita Journal: Curr Oncol Date: 2014-06 Impact factor: 3.677