A phase II study of two cycles of high-dose chemotherapy with autologous stem cell support in patients with metastatic breast cancer who meet eligibility criteria for a single cycle

Bone Marrow Transplant. 2000 Mar;25(5):519-24. doi: 10.1038/sj.bmt.1702172.

Abstract

Multi-cycle high-dose chemotherapy with autologous stem cell support (HDC-ASCS) may improve the results obtained with single-cycle HDC-ASCS in metastatic breast cancer (MBC). However, the tolerability and efficacy of additional cycles of HDC-ASCS in patients selected using standard eligibility criteria for single cycle HDC-ASCS is uncertain. Twenty-nine patients with MBC and a CR or PR to induction chemotherapy were selected by standard institutional eligibility criteria for single-cycle HDC-ASCS. Cycle 1 HDC-ASCS (cyclophosphamide 6 g/m2; mitoxantrone 70 mg/m2; carboplatin 800 mg/m2) was followed by a planned second cycle (etoposide 1.6 g/m2; thiotepa 800 mg/m2; carboplatin 800 mg/m2 modulated by tamoxifen 120 mg/m2/day x 5 days) with a median interval of 3.2 months. CR rate was 20% after induction chemotherapy and 33% and 54% after HDC cycles I and II, respectively. Sixteen patients (55%) failed to complete HDC cycle II within 200 days because of disease progression, toxicity, inadequate stem cell collection, insurance denials or patient choice. Median progression-free survival (PFS) for all 29 patients entered is 301 days from date of HDC cycle I and actuarial PFS at 2 years is 35%. For the 13 patients who received the two cycles of HDC-ASCS, actuarial PFS at 2 years was 54% (P = NS compared to those receiving only one cycle). These data show that a second cycle of full-dose intensity HDC-ASCS may increase the proportion of patients with MBC that achieve CR and may increase PFS. However, a large proportion of patients that complete HDC-ASCS cycle I may fail to proceed to cycle II in a timely fashion. Bone Marrow Transplantation (2000) 25, 519-524.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / toxicity
  • Bone Neoplasms / secondary
  • Breast Neoplasms / pathology
  • Breast Neoplasms / secondary*
  • Breast Neoplasms / therapy*
  • Carboplatin / administration & dosage
  • Carboplatin / toxicity
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / toxicity
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Etoposide / administration & dosage
  • Etoposide / toxicity
  • Female
  • Graft Survival
  • Hematopoietic Stem Cell Transplantation* / adverse effects
  • Humans
  • Liver Neoplasms / secondary
  • Middle Aged
  • Mitoxantrone / administration & dosage
  • Mitoxantrone / toxicity
  • Platelet Count
  • Soft Tissue Neoplasms / secondary
  • Survival Rate
  • Tamoxifen / administration & dosage
  • Tamoxifen / toxicity
  • Thiotepa / administration & dosage
  • Thiotepa / toxicity
  • Transplantation, Autologous

Substances

  • Tamoxifen
  • Etoposide
  • Cyclophosphamide
  • Thiotepa
  • Carboplatin
  • Mitoxantrone