PMID- 18436520
OWN - NLM
STAT- MEDLINE
DCOM- 20081027
LR  - 20200203
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 19
IP  - 9
DP  - 2008 Sep
TI  - A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 
      3 weeks in taxane-resistant metastatic breast cancer patients.
PG  - 1547-52
LID - 10.1093/annonc/mdn171 [doi]
AB  - BACKGROUND: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. 
      This multicenter phase II study assessed the activity of XRP6258 in the treatment 
      of taxane-resistant metastatic breast cancer (MBC). PATIENTS AND METHODS: XRP6258 
      was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m(2) (then, in the 
      absence of severe toxicity, at 25 mg/m(2) from cycle 2). The primary end point 
      was the objective response rate (ORR) assessed according to response evaluation 
      criteria in solid tumours (RECIST) guidelines. RESULTS: Seventy-one patients were 
      enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two 
      complete, eight partial responses). Eighteen patients (25%) had stable disease of 
      >3 months duration. At a median follow-up of 20.0 months, the median time to 
      progression was 2.7 months, and the median overall survival 12.3 months. The most 
      common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia 
      (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, 
      treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths 
      were reported, one related to study drug and one to unknown cause. CONCLUSIONS: 
      XRP6258 was active and well tolerated in this group of MBC patients with 
      taxane-resistant disease. These results support the further clinical development 
      of this agent.
FAU - Pivot, X
AU  - Pivot X
AD  - Department of Medical Oncology, University Hospital Jean Minjoz, Institut 
      National de la Sante et de la Recherche Medicale, Unit 645, Besancon, France. 
      Xavier.pivot@univ-fcomte.fr
FAU - Koralewski, P
AU  - Koralewski P
FAU - Hidalgo, J L
AU  - Hidalgo JL
FAU - Chan, A
AU  - Chan A
FAU - Goncalves, A
AU  - Goncalves A
FAU - Schwartsmann, G
AU  - Schwartsmann G
FAU - Assadourian, S
AU  - Assadourian S
FAU - Lotz, J P
AU  - Lotz JP
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20080423
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Bridged-Ring Compounds)
RN  - 0 (Taxoids)
RN  - 0 (XRP6258)
RN  - 1605-68-1 (taxane)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/mortality/pathology/*secondary
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*administration & dosage
MH  - Breast Neoplasms/*drug therapy/*mortality/pathology
MH  - Bridged-Ring Compounds/pharmacology
MH  - Confidence Intervals
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - *Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Kaplan-Meier Estimate
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Risk Assessment
MH  - Survival Analysis
MH  - Taxoids/*administration & dosage/pharmacology
MH  - Treatment Outcome
EDAT- 2008/04/26 09:00
MHDA- 2008/10/28 09:00
CRDT- 2008/04/26 09:00
PHST- 2008/04/26 09:00 [pubmed]
PHST- 2008/10/28 09:00 [medline]
PHST- 2008/04/26 09:00 [entrez]
AID - S0923-7534(19)40209-3 [pii]
AID - 10.1093/annonc/mdn171 [doi]
PST - ppublish
SO  - Ann Oncol. 2008 Sep;19(9):1547-52. doi: 10.1093/annonc/mdn171. Epub 2008 Apr 23.