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Phase III study of N,N-diethyl-2-[4-(phenylmethyl) phenoxy]ethanamine (BMS-217380-01) combined with doxorubicin versus doxorubicin alone in metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA.19.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2004 Jan 15; Vol. 22 (2), pp. 269-76. - Publication Year :
- 2004
-
Abstract
- Purpose: N,N-diethyl-2-[4-(phenylmethyl)phenoxy]ethanamine (DPPE; tesmilifene) is a novel agent that augments chemotherapy cytotoxicity in vitro and in vivo. A phase II trial combining DPPE and doxorubicin (DOX) in metastatic breast carcinoma showed increased response over that expected with DOX. We report a phase III trial comparing DOX with DPPE plus DOX in metastatic or recurrent breast cancer.<br />Patients and Methods: Anthracycline-naive women with measurable metastatic disease were randomly assigned to receive, every 21 days, either DOX 60 mg/m(2) intravenously or DOX during the last 20 minutes of an 80-minute infusion of DPPE (5.3 mg/kg), in both cases to cumulative DOX doses of 450 mg/m(2). Patients receiving DPPE were aggressively premedicated to ameliorate toxicity. End points included progression-free survival (PFS), response rate (RR), and response duration (RD), quality of life (QOL), toxicity, and overall survival (OS).<br />Results: A planned interim analysis failed to detect an RR difference more than 5%. The study was closed to additional accrual and all DPPE was discontinued. The final analysis was conducted as planned after 256 progression events (median follow-up, 20.5 months). There was no significant difference in RR, RD, or PFS between arms. DPPE plus DOX was statistically superior to DOX in OS (hazard ratio, 0.66; 95% CI, 0.48 to 0.91; P =.021). DPPE plus DOX was associated with more gastrointestinal and CNS toxicity. No consistent influence on QOL was detected.<br />Conclusion: This study demonstrated no advantage in RR, RD, or PFS but significantly superior OS for DPPE plus DOX. Additional studies of DPPE are warranted.
- Subjects :
- Breast Neoplasms pathology
Disease-Free Survival
Female
Humans
Infusions, Intravenous
Middle Aged
Neoplasm Metastasis
Quality of Life
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms drug therapy
Doxorubicin administration & dosage
Phenyl Ethers administration & dosage
Phenyl Ethers pharmacology
Platelet Aggregation Inhibitors administration & dosage
Platelet Aggregation Inhibitors pharmacology
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 22
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 14722035
- Full Text :
- https://doi.org/10.1200/JCO.2003.04.075