PMID- 12881395
OWN - NLM
STAT- MEDLINE
DCOM- 20031017
LR  - 20200203
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 14
IP  - 8
DP  - 2003 Aug
TI  - Phase II study of oxaliplatin versus oxaliplatin combined with infusional 
      5-fluorouracil in hormone refractory metastatic prostate cancer patients.
PG  - 1291-8
AB  - BACKGROUND: A randomized, multicenter phase II study evaluating oxaliplatin alone 
      (OXA) and oxaliplatin-5-fluorouracil combination (OXFU) in advanced 
      hormone-refractory prostate cancer (HRPC) patients. PATIENTS AND METHODS: 
      Metastatic, pathologically proven prostate carcinoma patients, progressing 
      despite anti-androgen therapy, received intravenous OXA (130 mg/m(2 )over 2 h), 
      alone or with 5-FU (1000 mg/m(2)/day, continuous intravenous infusion, days 1-4), 
      every 3 weeks. OXA patients could receive OXFU after treatment failure. RESULTS: 
      Fifty-four patients (26 OXA, 28 OXFU) from nine centers received 269 treatment 
      cycles (106 OXA, 163 OXFU; median 3.5 OXA or 5 OXFU cycles per patient; range 
      1-10 or 1-14, respectively). Patient characteristics were similar in both arms. 
      Three partial responses (PR) occurred in 21 evaluable OXA patients [14%; 95% 
      confidence interval (CI) 1% to 30%], and in five of 26 evaluable OXFU patients 
      (19%; 95% CI 7% to 39%). Clinical benefit response (pain, performance status and 
      weight changes) was assessed in 20 OXA and 22 OXFU symptomatic patients, with 
      more responders in the OXFU arm (39% compared with 12%). Median time to 
      progression in the OXA and OXFU arms was 2.6 and 3.4 months, and median overall 
      survival was 9.4 and 11.4 months, respectively. Hematotoxicity was common, but 
      mostly mild to moderate. Neutropenia was more common in OXFU than OXA patients. 
      After oxaliplatin failure, 12 patients received 46 cycles of OXFU and one of 11 
      evaluable patients had a PR. CONCLUSION: The objective response rate, palliation 
      benefit, survival and manageable toxicity obtained in this heavily pretreated 
      HRPC population with OXFU merit further study.
FAU - Droz, J P
AU  - Droz JP
AD  - Leon Berard, Lyon, France.
FAU - Muracciole, X
AU  - Muracciole X
FAU - Mottet, N
AU  - Mottet N
FAU - Ould Kaci, M
AU  - Ould Kaci M
FAU - Vannetzel, J M
AU  - Vannetzel JM
FAU - Albin, N
AU  - Albin N
FAU - Culine, S
AU  - Culine S
FAU - Rodier, J-M
AU  - Rodier JM
FAU - Misset, J-L
AU  - Misset JL
FAU - Mackenzie, S
AU  - Mackenzie S
FAU - Cvitkovic, E
AU  - Cvitkovic E
FAU - Benoit, G
AU  - Benoit G
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Organoplatinum Compounds)
RN  - 0 (Pyridines)
RN  - 0 (oxiplatin)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents, Hormonal/administration & dosage
MH  - Disease-Free Survival
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Drug Resistance, Neoplasm
MH  - Fluorouracil/*administration & dosage
MH  - Follow-Up Studies
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Invasiveness/*pathology
MH  - Neoplasm Staging
MH  - Organoplatinum Compounds/*administration & dosage
MH  - Prostate-Specific Antigen/analysis
MH  - Prostatic Neoplasms/*drug therapy/mortality/*pathology
MH  - Pyridines/*administration & dosage
MH  - Risk Assessment
MH  - Salvage Therapy
MH  - Survival Rate
MH  - Treatment Outcome
EDAT- 2003/07/26 05:00
MHDA- 2003/10/18 05:00
CRDT- 2003/07/26 05:00
PHST- 2003/07/26 05:00 [pubmed]
PHST- 2003/10/18 05:00 [medline]
PHST- 2003/07/26 05:00 [entrez]
AID - S0923-7534(19)63598-2 [pii]
AID - 10.1093/annonc/mdg342 [doi]
PST - ppublish
SO  - Ann Oncol. 2003 Aug;14(8):1291-8. doi: 10.1093/annonc/mdg342.