Abstract | BACKGROUND: PATIENTS AND METHODS: In part I, we used a 3+3 dose-escalation scheme to assess the MTD of intravenous cabazitaxel (day 1) with oral capecitabine twice daily (days 1-14) every 3 weeks. In part II, we evaluated the objective response rate (ORR) at the MTD. RESULTS: Thirty-three patients were enrolled and treated (15 in part I; 18 in part II). Cabazitaxel 20mg/m(2) plus capecitabine 1000 mg/m(2) was the MTD. Pharmacokinetic analysis showed no apparent drug-drug interaction. In all patients, the main grade 3-4 toxicities were asthenia (n=5), hand-foot syndrome (n=5), neutropenia (n=21), neutropenic infection (n=1), and neutropenic colitis (n=1). One patient had febrile neutropenia. Antitumour activity was observed at all dose-levels with two complete responses, five partial responses (PRs), and 20 disease stabilisations (seven unconfirmed PR). At the MTD, 21 patients were evaluable for efficacy. The ORR was 23.8% (95% CI: 8.2-47.2%). The median response duration was 3.1 months (95% CI: 2.1-8.4 months), with four of five lasting for more than 3 months. Median time to progression was 4.9 months. CONCLUSIONS:
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Authors | C Villanueva, A Awada, M Campone, J P Machiels, T Besse, E Magherini, F Dubin, D Semiond, X Pivot |
Journal | European journal of cancer (Oxford, England : 1990)
(Eur J Cancer)
Vol. 47
Issue 7
Pg. 1037-45
(May 2011)
ISSN: 1879-0852 [Electronic] England |
PMID | 21339064
(Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 Elsevier Ltd. All rights reserved. |
Chemical References |
- Taxoids
- Deoxycytidine
- cabazitaxel
- Capecitabine
- Fluorouracil
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Area Under Curve
- Breast Neoplasms
(drug therapy)
- Capecitabine
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Drug Resistance, Neoplasm
- Female
- Fluorouracil
(administration & dosage, analogs & derivatives)
- Humans
- Maximum Tolerated Dose
- Middle Aged
- Neoplasm Metastasis
- Taxoids
(administration & dosage)
- Treatment Outcome
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