Journal of Clinical Oncology, Vol 14, 2984-2992, Copyright © 1996 by American Society of Clinical Oncology
Double dose-intensive chemotherapy with autologous stem-cell support for metastatic breast cancer: no improvement in progression-free survival by the sequence of high-dose melphalan followed by cyclophosphamide, thiotepa, and carboplatin
LJ Ayash, A Elias, G Schwartz, C Wheeler, J Ibrahim, BA Teicher, E Reich, D Warren, C Lynch, P Richardson, L Schnipper, E Frei 3rd and K Antman
Department of Cancer Pharmacology, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
PURPOSE: Twenty-one percent of responding metastatic breast cancer patients
remain progression-free a median 50 months following one intensification
cycle of cyclophosphamide (6,000 mg/m2), thiotepa (500 mg/ m2), and
carboplatin (800 mg/m2) (CTCb) with autologous bone marrow transplantation
(ABMT). This trial studied whether the sequence of high- dose melphalan
followed by CTCb resulted in improved disease response and duration.
METHODS: Women with at least partial responses (PRS) to induction received
melphalan (140 or 180 mg/ m2) with peripheral-blood progenitor cell (PBPC)
and granulocyte colony-stimulating factor (G- CSF) support. They were
monitored as outpatients. After recovery, patients were hospitalized for
CTCb with marrow, PBPC, and G-CSF support. RESULTS: Data on 67 women, at a
median of 25 months from CTCb, were examined. After melphalan, 49 (73%)
required admission for fever (89%), mucositis (35%), or infection (15%)
(median stay, 8 days). All received CTCb. For the first 33 patients, the
median days from start of melphalan to CTCb was 24. After liver toxicity
(one death from venoocclusive disease [VOD]) developed in 11 patients
during CTCb, the interval between intensifications was increased to 35 days
without incident. Twenty-three patients (34%) are progression-free a median
of 16 months post-CTCb. The median progression-free survival (PFS) and
survival times for the whole group are estimated at 11 and 20 months,
respectively. CONCLUSION: Treatment with this sequence of high-dose
melphalan followed by CTCb has not resulted in superior PFS to date, when
compared with single-intensification CTCb. This report discusses factors
related to patient selection, the role of induced drug resistance, and the
schedule of administration of alkylating agenting that may adversely
influence outcome.
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