PMID- 18825381
OWN - NLM
STAT- MEDLINE
DCOM- 20090417
LR  - 20181201
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Linking)
VI  - 63
IP  - 6
DP  - 2009 May
TI  - Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin 
      and oxaliplatin in locally advanced esophageal cancer.
PG  - 1111-9
LID - 10.1007/s00280-008-0834-3 [doi]
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/m(2)), 
      and leucovorin (20 mg/m(2) on days 1,8,15,29,36,43,50,57) followed by continuous 
      infusion fluorouracil (200 mg/m(2) 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.
FAU - Chiarion-Sileni, Vanna
AU  - Chiarion-Sileni V
AD  - Medical Oncology Unit, Istituto Oncologico Veneto-IRCCS, Via Gattamelata, 
      6435128, Padova, Italy. mgaliz@tiscali.it
FAU - Innocente, Roberto
AU  - Innocente R
FAU - Cavina, Raffaele
AU  - Cavina R
FAU - Ruol, Alberto
AU  - Ruol A
FAU - Corti, Luigi
AU  - Corti L
FAU - Pigozzo, Jacopo
AU  - Pigozzo J
FAU - Del Bianco, Paola
AU  - Del Bianco P
FAU - Fumagalli, Uberto
AU  - Fumagalli U
FAU - Santoro, Armando
AU  - Santoro A
FAU - Ancona, Ermanno
AU  - Ancona E
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20080930
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Organoplatinum Compounds)
RN  - 04ZR38536J (Oxaliplatin)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/pathology/*radiotherapy/surgery
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Carcinoma, Squamous Cell/*drug therapy/pathology/*radiotherapy/surgery
MH  - Combined Modality Therapy
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Esophageal Neoplasms/*drug therapy/pathology/*radiotherapy/surgery
MH  - Esophagectomy
MH  - Female
MH  - Fluorouracil/administration & dosage/adverse effects/therapeutic use
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Leucovorin/administration & dosage/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Invasiveness
MH  - Organoplatinum Compounds/administration & dosage/adverse effects/therapeutic use
MH  - Oxaliplatin
MH  - Radiation Dosage
EDAT- 2008/10/01 09:00
MHDA- 2009/04/18 09:00
CRDT- 2008/10/01 09:00
PHST- 2008/06/18 00:00 [received]
PHST- 2008/09/08 00:00 [accepted]
PHST- 2008/10/01 09:00 [pubmed]
PHST- 2009/04/18 09:00 [medline]
PHST- 2008/10/01 09:00 [entrez]
AID - 10.1007/s00280-008-0834-3 [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2009 May;63(6):1111-9. doi: 
      10.1007/s00280-008-0834-3. Epub 2008 Sep 30.