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Phase II feasibility and pharmacokinetic study of concurrent administration of trastuzumab and high-dose chemotherapy in advanced HER2+ breast cancer.

Publication ,  Journal Article
Nieto, Y; Vredenburgh, JJ; Shpall, EJ; Bearman, SI; McSweeney, PA; Chao, N; Rizzieri, D; Gasparetto, C; Matthes, S; Barón, AE; Jones, RB
Published in: Clin Cancer Res
November 1, 2004

PURPOSE: To evaluate the safety of concurrent treatment with trastuzumab and high-dose chemotherapy (HDC), using cyclophosphamide, cisplatin, and 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU), with autologous hematopoietic progenitor cells support, in patients with HER2+ advanced breast cancer. EXPERIMENTAL DESIGN: Patients with HER2-overexpressing high-risk primary breast cancer (HRPBC; defined as > or =4 involved nodes or inflammatory disease), or metastatic breast cancer (MBC) were eligible. Treatment consisted of a loading dose of trastuzumab at 4 mg/kg (day -5), HDC (days -5 to -2), autologous hematopoietic progenitor cells infusion on day 0, and weekly maintenance trastuzumab (2 mg/kg) from day +1 (minimum of 9 doses). Cardiac monitoring included serial left ventricular ejection fraction measurements before treatment and on days +20 and +65. RESULTS: Thirty-three patients were prospectively enrolled (13 HRPBC, 20 MBC). Toxicity seemed similar to that expected with this HDC regimen alone. Neutrophils and platelets engrafted promptly. There were no cases of grade 4 or 5 toxicity. One patient experienced symptomatic grade 3 acute cardiac failure on day -4, responsive to treatment. Trastuzumab did not alter the pharmacokinetics of HDC. Eleven of twelve MBC patients with measurable disease (nine of them refractory to previous chemotherapy) experienced an objective response (9 complete and 2 partial responses). At median follow-up of 34 (13-58) months, all HRPBC patients remain alive and free of disease; the MBC group has event-free survival and overall survival rates of 45 and 70%, respectively. CONCLUSIONS: Incorporation of trastuzumab into HDC (cyclophosphamide, cisplatin, and BCNU) is feasible, with no apparent increased toxicity or pharmacokinetic interactions.

Duke Scholars

Published In

Clin Cancer Res

DOI

ISSN

1078-0432

Publication Date

November 1, 2004

Volume

10

Issue

21

Start / End Page

7136 / 7143

Location

United States

Related Subject Headings

  • Trastuzumab
  • Time Factors
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Prospective Studies
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Nieto, Y., Vredenburgh, J. J., Shpall, E. J., Bearman, S. I., McSweeney, P. A., Chao, N., … Jones, R. B. (2004). Phase II feasibility and pharmacokinetic study of concurrent administration of trastuzumab and high-dose chemotherapy in advanced HER2+ breast cancer. Clin Cancer Res, 10(21), 7136–7143. https://doi.org/10.1158/1078-0432.CCR-04-0891
Nieto, Yago, James J. Vredenburgh, Elizabeth J. Shpall, Scott I. Bearman, Peter A. McSweeney, Nelson Chao, David Rizzieri, et al. “Phase II feasibility and pharmacokinetic study of concurrent administration of trastuzumab and high-dose chemotherapy in advanced HER2+ breast cancer.Clin Cancer Res 10, no. 21 (November 1, 2004): 7136–43. https://doi.org/10.1158/1078-0432.CCR-04-0891.
Nieto Y, Vredenburgh JJ, Shpall EJ, Bearman SI, McSweeney PA, Chao N, et al. Phase II feasibility and pharmacokinetic study of concurrent administration of trastuzumab and high-dose chemotherapy in advanced HER2+ breast cancer. Clin Cancer Res. 2004 Nov 1;10(21):7136–43.
Nieto, Yago, et al. “Phase II feasibility and pharmacokinetic study of concurrent administration of trastuzumab and high-dose chemotherapy in advanced HER2+ breast cancer.Clin Cancer Res, vol. 10, no. 21, Nov. 2004, pp. 7136–43. Pubmed, doi:10.1158/1078-0432.CCR-04-0891.
Nieto Y, Vredenburgh JJ, Shpall EJ, Bearman SI, McSweeney PA, Chao N, Rizzieri D, Gasparetto C, Matthes S, Barón AE, Jones RB. Phase II feasibility and pharmacokinetic study of concurrent administration of trastuzumab and high-dose chemotherapy in advanced HER2+ breast cancer. Clin Cancer Res. 2004 Nov 1;10(21):7136–7143.

Published In

Clin Cancer Res

DOI

ISSN

1078-0432

Publication Date

November 1, 2004

Volume

10

Issue

21

Start / End Page

7136 / 7143

Location

United States

Related Subject Headings

  • Trastuzumab
  • Time Factors
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Prospective Studies
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Female