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Phase II trial of N,N-diethyl,2-[4-(phenylmethyl)phenoxy]ethanamine.HCl and doxorubicin chemotherapy in metastatic breast cancer: A National Cancer Institute of Canada Clinical Trials Group study

Publication ,  Journal Article
Khoo, K; Brandes, L; Reyno, L; Arnold, A; Dent, S; Vandenberg, T; Lebwohl, D; Fisher, B; Eisenhauer, E
Published in: Journal of Clinical Oncology
January 1, 1999

Purpose: This multicenter phase II trial investigated the efficacy and toxicity of a combination of the novel intracellular histamine antagonist, N,N-diethyl-2-[4(phenylmethyl)phenoxy]ethanamine.HCl (DPPE), and doxorubicin in patients with anthracycline-naive metastatic breast cancer. Preclinical models and early single institutional studies suggested DPPE could potentiate the cytotoxicity of doxorubicin. Patients and Methods: Forty-two women, 32 to 77 years old (median, 59 years), with anthracycline-naive metastatic breast cancer were treated. Patients may have had one previous regimen of nonanthracycline chemotherapy, either in the adjuvant or metastatic disease treatment setting. DPPE (6 mg/kg) was administered as an 80 minute intravenous infusion with doxorubicin (60 mg/m2) given intravenously over the last 20 minutes of the DPPE infusion. Patients were premedicated with an antiemetic and sedating regimen. The DPPE/doxorubicin treatment was given every 21 days for a maximum of seven cycles. Results: All 42 patients were assessable. Overall, toxicity was comparable to that expected with doxorubicin alone, with the exception of DPPE-related motion sickness, mild hallucinations, and cerebellar signs at the time of the infusion. These CNS side effects were manageable in an ambulatory care setting, improved with subsequent cycles of treatment, and did not usually require hospitalization. Four patients developed febrile neutropenia. Thirty-five patients received four or more cycles of chemotherapy. The overall response rate was 52.5% (95% confidence interval, 36% to 68%), with 9.5% complete responses (n = 4), 43% partial responses (n = 18), and 38% of patients with stable disease (n = 16). Conclusion: The antitumour effects of DPPE/doxorubicin the 52.5% response rate seems encouraging, particularly in consideration of the fact that a recently reported randomized National Cancer Institute of Canada Clinical Trials Group trial using single-agent doxorubicin 60 mg/m2 in one of the treatment arms achieved a 31% response rate. Thus, a randomized phase III trial of doxorubicin versus doxorubicin plus DPPE is being conducted in this clinical setting.

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

ISSN

0732-183X

Publication Date

January 1, 1999

Volume

17

Issue

11

Start / End Page

3431 / 3437

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Khoo, K., Brandes, L., Reyno, L., Arnold, A., Dent, S., Vandenberg, T., … Eisenhauer, E. (1999). Phase II trial of N,N-diethyl,2-[4-(phenylmethyl)phenoxy]ethanamine.HCl and doxorubicin chemotherapy in metastatic breast cancer: A National Cancer Institute of Canada Clinical Trials Group study. Journal of Clinical Oncology, 17(11), 3431–3437. https://doi.org/10.1200/JCO.1999.17.11.3431
Khoo, K., L. Brandes, L. Reyno, A. Arnold, S. Dent, T. Vandenberg, D. Lebwohl, B. Fisher, and E. Eisenhauer. “Phase II trial of N,N-diethyl,2-[4-(phenylmethyl)phenoxy]ethanamine.HCl and doxorubicin chemotherapy in metastatic breast cancer: A National Cancer Institute of Canada Clinical Trials Group study.” Journal of Clinical Oncology 17, no. 11 (January 1, 1999): 3431–37. https://doi.org/10.1200/JCO.1999.17.11.3431.
Khoo, K., et al. “Phase II trial of N,N-diethyl,2-[4-(phenylmethyl)phenoxy]ethanamine.HCl and doxorubicin chemotherapy in metastatic breast cancer: A National Cancer Institute of Canada Clinical Trials Group study.” Journal of Clinical Oncology, vol. 17, no. 11, Jan. 1999, pp. 3431–37. Scopus, doi:10.1200/JCO.1999.17.11.3431.
Khoo K, Brandes L, Reyno L, Arnold A, Dent S, Vandenberg T, Lebwohl D, Fisher B, Eisenhauer E. Phase II trial of N,N-diethyl,2-[4-(phenylmethyl)phenoxy]ethanamine.HCl and doxorubicin chemotherapy in metastatic breast cancer: A National Cancer Institute of Canada Clinical Trials Group study. Journal of Clinical Oncology. 1999 Jan 1;17(11):3431–3437.

Published In

Journal of Clinical Oncology

DOI

ISSN

0732-183X

Publication Date

January 1, 1999

Volume

17

Issue

11

Start / End Page

3431 / 3437

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences