A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer

Antonio Llombart-Cussac, Miguel Martin, Nadia Harbeck, Rodica M. Anghel, Alexandra E. Eniu, Mark W. Verrill, Patrick Neven, Jacques De Grève, Allen S. Melemed, Romnee Clark, Lorinda Simms, Christopher J. Kaiser, Doreen Ma

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Purpose: Pemetrexed has shown varied response rates in advanced breast cancer. This randomized, double-blind, phase II study was conducted to assess the efficacy and safety of two doses of pemetrexed in a homogeneous population. A secondary objective was to identify molecular biomarkers correlating with response and toxicity. Experimental Design: Patients with newly diagnosed metastatic breast cancer or locally recurrent breast cancer received 600mg/m2 (P600 arm) or 900mg/m2 (P900 arm) of pemetrexed on day1of a 21-day cycle. All patients received folic acid and vitamin B 12 supplementation. Results: The P600 (47 patients) and P900 (45 patients) arms had response rates of 17.0% (95% confidence interval, 7.7-30.8%) and 15.6% (95% confidence interval, 6.5-29.5%) with ∼50% stable disease per arm, median progression-free survival of 4.2 and 4.1 months, and median times to tumor progression of 4.2 and 4.6 months, respectively. Both arms exhibited minimal toxicity (grade 3/4 neutropenia

Original languageEnglish (US)
Pages (from-to)3652-3659
Number of pages8
JournalClinical Cancer Research
Volume13
Issue number12
DOIs
StatePublished - Jun 15 2007
Externally publishedYes

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Pemetrexed
Breast Neoplasms
Drug Therapy
Confidence Intervals
Vitamin B 12
Neutropenia
Folic Acid
Disease-Free Survival
Research Design
Biomarkers
Safety
Population
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Llombart-Cussac, A., Martin, M., Harbeck, N., Anghel, R. M., Eniu, A. E., Verrill, M. W., ... Ma, D. (2007). A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer. Clinical Cancer Research, 13(12), 3652-3659. https://doi.org/10.1158/1078-0432.CCR-06-2377

A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer. / Llombart-Cussac, Antonio; Martin, Miguel; Harbeck, Nadia; Anghel, Rodica M.; Eniu, Alexandra E.; Verrill, Mark W.; Neven, Patrick; De Grève, Jacques; Melemed, Allen S.; Clark, Romnee; Simms, Lorinda; Kaiser, Christopher J.; Ma, Doreen.

In: Clinical Cancer Research, Vol. 13, No. 12, 15.06.2007, p. 3652-3659.

Research output: Contribution to journalArticle

Llombart-Cussac, A, Martin, M, Harbeck, N, Anghel, RM, Eniu, AE, Verrill, MW, Neven, P, De Grève, J, Melemed, AS, Clark, R, Simms, L, Kaiser, CJ & Ma, D 2007, 'A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer', Clinical Cancer Research, vol. 13, no. 12, pp. 3652-3659. https://doi.org/10.1158/1078-0432.CCR-06-2377
Llombart-Cussac, Antonio ; Martin, Miguel ; Harbeck, Nadia ; Anghel, Rodica M. ; Eniu, Alexandra E. ; Verrill, Mark W. ; Neven, Patrick ; De Grève, Jacques ; Melemed, Allen S. ; Clark, Romnee ; Simms, Lorinda ; Kaiser, Christopher J. ; Ma, Doreen. / A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer. In: Clinical Cancer Research. 2007 ; Vol. 13, No. 12. pp. 3652-3659.
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AU - Neven, Patrick

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