PMID- 14998850
OWN - NLM
STAT- MEDLINE
DCOM- 20040712
LR  - 20220330
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 15
IP  - 3
DP  - 2004 Mar
TI  - Randomized phase II study evaluating oxaliplatin alone, oxaliplatin combined with 
      infusional 5-FU, and infusional 5-FU alone in advanced pancreatic carcinoma 
      patients.
PG  - 467-73
AB  - BACKGROUND: A randomized phase II, open-label multicenter study evaluating 
      oxaliplatin alone (OXA), infusional 5-fluorouracil alone (5-FU) and an 
      oxaliplatin/infusional 5-FU combination (OXFU) in untreated, advanced pancreatic 
      carcinoma (APC). PATIENTS AND METHODS: Chemotherapy-naive patients with advanced 
      or metastatic, histologically/cytologically proven pancreatic carcinoma with 
      measurable disease, received OXA [130 mg/m2, 2-h intravenous (i.v.) infusion] 
      alone, OXA combined with 5-FU (1000 mg/m2/day, continuous i.v., days 1-4), or 
      5-FU alone, every 3 weeks. RESULTS: Sixty-three patients (42 males/21 females) 
      were treated: 17 patients/52 cycles OXA, 31 patients/ 175 cycles OXFU, 15 
      patients/41 cycles 5-FU, with a median of three, six and two cycles/patient, 
      respectively. Patient characteristics were similar in all arms. Median age was 57 
      years (range 21-75), and 83% of patients had PS 0-1. Most patients (62%) had 
      moderate to well-differentiated tumors, 90% had metastatic disease, 81% with 
      liver metastases. All responses (three partial responses; WHO) occurred in the 
      OXFU arm (10% response rate). Five of 32 patients evaluable for clinical benefit 
      were responders (OXA, 14%; OXFU, 21%). Median time to progression and overall 
      survival were higher in the combination arm (4.2 and 9.0 months, respectively) 
      than either single-agent arm (OXA, 2.0 and 3.4 months; 5-FU, 1.5 and 2.4 months, 
      respectively). Moderate hematotoxicity without morbidity was seen in all arms. 
      Two OXFU patients had grade 3 oxaliplatin neurosensory toxicity. CONCLUSIONS: 
      With a 10% response rate, median overall survival of 9 months and an encouraging 
      safety profile, the OXFU combination is effective, appears superior to infusional 
      5-FU and warrants further studies in APC patients.
FAU - Ducreux, M
AU  - Ducreux M
AD  - Institut Gustave Roussy, Villejuif, France.
FAU - Mitry, E
AU  - Mitry E
FAU - Ould-Kaci, M
AU  - Ould-Kaci M
FAU - Boige, V
AU  - Boige V
FAU - Seitz, J F
AU  - Seitz JF
FAU - Bugat, R
AU  - Bugat R
FAU - Breau, J L
AU  - Breau JL
FAU - Bouche, O
AU  - Bouche O
FAU - Etienne, P L
AU  - Etienne PL
FAU - Tigaud, J M
AU  - Tigaud JM
FAU - Morvan, F
AU  - Morvan F
FAU - Cvitkovic, E
AU  - Cvitkovic E
FAU - Rougier, P
AU  - Rougier P
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Organoplatinum Compounds)
RN  - 04ZR38536J (Oxaliplatin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
CIN - Ann Oncol. 2004 Oct;15(10):1576-7; author reply 1577-8. PMID: 15367423
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Humans
MH  - Infusions, Intravenous
MH  - Liver Neoplasms/*drug therapy/secondary
MH  - Male
MH  - Middle Aged
MH  - Organoplatinum Compounds/administration & dosage
MH  - Oxaliplatin
MH  - Pancreatic Neoplasms/*drug therapy/pathology
MH  - Survival Rate
EDAT- 2004/03/05 05:00
MHDA- 2004/07/13 05:00
CRDT- 2004/03/05 05:00
PHST- 2004/03/05 05:00 [pubmed]
PHST- 2004/07/13 05:00 [medline]
PHST- 2004/03/05 05:00 [entrez]
AID - S0923-7534(19)64145-1 [pii]
AID - 10.1093/annonc/mdh098 [doi]
PST - ppublish
SO  - Ann Oncol. 2004 Mar;15(3):467-73. doi: 10.1093/annonc/mdh098.