Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer

V. Lorusso, E. Crucitta, N. Silvestris, A. Catino, L. Caporusso, A. Mazzei, M. Guida, A. Latorre, D. Sambiasi, C. D'Amico, F. Schittulli, P. Calabrese, M. De Lena

Research output: Contribution to journalArticlepeer-review


The purpose of this study was to determine the maximum-tolerated close of gemcitabine plus mitoxantrone in women with metastatic breast cancer (MBC) and to evaluate activity and toxicity of this combination in a phase II trial. Sixty-three patients with MBC, previously treated with chemotherapy including anthracycline and/or taxanes, were treated with mitoxantrone 10 or 12 mg m-2 intravenously on day 1 plus gemcitabine in escalating doses from 600 to 1200 mg m-2 intravenously on days 1 and 8, every 3 weeks. In phase I, on 23 patients entered on study, dose-limiting toxicity occurred at the dosage of 1200 mg m-2 gemcitabine and 10 mg m-2 mitoxantrone, with three out of five patients developing grade 4 neutropenia. In phase II, with gemcitabine administered at 1000 mg m-2 and mitoxantrone at 10 mg m-2, 12 (30%) out of 40 assessable patients responded, even if no complete response was obtained. Moreover, stable disease was observed in eight (20%) patients. The median time to treatment failure was 22 weeks (range, 2-33), and median survival was 42 weeks (range, 2-92). Grade 3 and 4 neutropenia were observed in 12 (30%) and one (2.5%) cases respectively; grade 3 thrombocytopenia was observed in two patients (5%), grade 2 mucositis in two patients (5%), grade 3 anaemia in two patients (5%), grade 3 alopecia in one patient (2.5%) and asymptomatic cardiotoxicity in three patients (8%), respectively. In conclusion, the doses of 10 mg m-2 (day 1) for mitoxantrone and 1000 mg m-2 for gemcitabine (days 1-8) every 3 weeks resulted active and safe in MBC. Further investigations in less heavily pretreated patients are warranted.

Original languageEnglish
Pages (from-to)491-495
Number of pages5
JournalBritish Journal of Cancer
Issue number4
Publication statusPublished - Feb 24 2003


  • Breast cancer
  • Chemotherapy
  • Gemcitabine
  • Metastatic disease
  • Mitoxantrone
  • Phase I/II study

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


Dive into the research topics of 'Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer'. Together they form a unique fingerprint.

Cite this