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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 6/2009

Open Access 01-05-2009 | Original Article

Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer

Authors: Vanna Chiarion-Sileni, Roberto Innocente, Raffaele Cavina, Alberto Ruol, Luigi Corti, Jacopo Pigozzo, Paola Del Bianco, Uberto Fumagalli, Armando Santoro, Ermanno Ancona

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2009

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Abstract

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.
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Metadata
Title
Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer
Authors
Vanna Chiarion-Sileni
Roberto Innocente
Raffaele Cavina
Alberto Ruol
Luigi Corti
Jacopo Pigozzo
Paola Del Bianco
Uberto Fumagalli
Armando Santoro
Ermanno Ancona
Publication date
01-05-2009
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 6/2009
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-008-0834-3

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