TY - JOUR
T1 - Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer
AU - Chiarion-Sileni, Vanna
AU - Innocente, Roberto
AU - Cavina, Raffaele
AU - Ruol, Alberto
AU - Corti, Luigi
AU - Pigozzo, Jacopo
AU - Del Bianco, Paola
AU - Fumagalli, Uberto
AU - Santoro, Armando
AU - Ancona, Ermanno
PY - 2009/5
Y1 - 2009/5
N2 - Purpose: The aim of this study was to evaluate the activity and safety of oxaliplatin/5-fluorouracil-based chemo-radiotherapy in patients with not radically resectable locally advanced esophageal cancer. Methods: Fifty-nine patients with adeno or squamous-cell carcinoma received oxaliplatin (60 mg/m2), and leucovorin (20 mg/m2 on days 1,8,15,29,36,43,50,57) followed by continuous infusion fluorouracil (200 mg/m2 per day on days 1-22 and 29-64) with radiotherapy (1.8 Gy daily fractions to a total dose of 45 Gy, from days 29 to 64). When feasible, surgery was scheduled 6-8 weeks after chemo-radiotherapy completion. The primary endpoint was 1-year progression-free survival. Results: Forty (68%) patients completed treatment without modifications. An objective clinical response was seen in 35 patients (59%). Esophagectomy was possible in 33 patients and a complete resection (R0) was achieved in 26 (79%) with 6 pathologic complete responses (pCR) and 3 near pCR. At a median follow-up of 39.7 months for the surviving patients, the median progression-free and overall survivals were 11 months (95% CI 6.5-14) and 18.5 months (95% CI 13-29). The 1-year progression-free and overall survivals were 47.5% (95% CI 34-59.5%) and 63% (95% CI 49-74%). Major toxicities were esophagitis (20% G3 and 5% G4) and diarrhea (8.5% G3 and 8.5% G4). Hematological toxicity (7% G3 and 3% G4) was less common; severe neurotoxicity (3% G3) was infrequent. Conclusions: Concurrent oxaliplatin, leucovorin, fluorouracil and radiotherapy followed or not by esophagectomy has a tolerable toxicity and promising activity in locally advanced esophageal cancer.
AB - Purpose: The aim of this study was to evaluate the activity and safety of oxaliplatin/5-fluorouracil-based chemo-radiotherapy in patients with not radically resectable locally advanced esophageal cancer. Methods: Fifty-nine patients with adeno or squamous-cell carcinoma received oxaliplatin (60 mg/m2), and leucovorin (20 mg/m2 on days 1,8,15,29,36,43,50,57) followed by continuous infusion fluorouracil (200 mg/m2 per day on days 1-22 and 29-64) with radiotherapy (1.8 Gy daily fractions to a total dose of 45 Gy, from days 29 to 64). When feasible, surgery was scheduled 6-8 weeks after chemo-radiotherapy completion. The primary endpoint was 1-year progression-free survival. Results: Forty (68%) patients completed treatment without modifications. An objective clinical response was seen in 35 patients (59%). Esophagectomy was possible in 33 patients and a complete resection (R0) was achieved in 26 (79%) with 6 pathologic complete responses (pCR) and 3 near pCR. At a median follow-up of 39.7 months for the surviving patients, the median progression-free and overall survivals were 11 months (95% CI 6.5-14) and 18.5 months (95% CI 13-29). The 1-year progression-free and overall survivals were 47.5% (95% CI 34-59.5%) and 63% (95% CI 49-74%). Major toxicities were esophagitis (20% G3 and 5% G4) and diarrhea (8.5% G3 and 8.5% G4). Hematological toxicity (7% G3 and 3% G4) was less common; severe neurotoxicity (3% G3) was infrequent. Conclusions: Concurrent oxaliplatin, leucovorin, fluorouracil and radiotherapy followed or not by esophagectomy has a tolerable toxicity and promising activity in locally advanced esophageal cancer.
KW - Chemo-radiotherapy
KW - Esophageal cancer
KW - Oxaliplatin
KW - Phase II study
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U2 - 10.1007/s00280-008-0834-3
DO - 10.1007/s00280-008-0834-3
M3 - Article
C2 - 18825381
AN - SCOPUS:63949084961
VL - 63
SP - 1111
EP - 1119
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 6
ER -