autologous blood and marrow transplantation - Blog Science ...

308 Chapter 6: Breast Cancer
separate back-up collection was also obtained and cryopreserved unmanipulated
(i.e., three bags with >2X10 6
/kg CD34 +
cells in each). In this study, patients
received ifosfamide (10 g/m 2
/cycle), thiotepa (300 mg/m 2
/cycle), and paclitaxel
(175 mg/m 2
/cycle).
CTP study (n=3). This cohort of patients was treated immediately after
determining the MTD of the ITP study. As the major toxicities observed in the ITP
study were ifosfamide-related, cyclophosphamide was substituted for ifosfamide;
it was anticipated that this combination would be more acceptable in terms of
toxicity for the subsequent phase III multi-institutional study.
Consolidative radiotherapy
Indications for radiotherapy followed published practice for radiotherapy after
high-dose therapy. 19-21
Statistical analysis
To compare ANC and platelet recovery between the three cycles of high-dose
therapy (individual patient data sets), repeated measures analysis of variance
(ANOVA) was used. Kaplan-Meier estimates of platelet and ANC recovery were
performed, and recovery of the consecutive cycles was compared using the log-rank
test. Spearman correlation was used to compare autograft CD34 +
cell content and
platelet and ANC recovery. All results are expressed as two-sided P values.
Statistical analysis was performed using GraphPad Prism version 2.01 and GraphPad
StatMate version 1.00 for Windows 3.1 (GraphPad Software, San Diego, CA).
RESULTS
Patient characteristics
The characteristics of the 42 patients are summarized in Table 2. The median
age was 45 years, and the median time from initial diagnosis of breast cancer to
transplant was 15 months (range 2.6-53). The majority of patients had metastatic
disease (n=38) with a median of two sites involved. Ten patients underwent highdose
therapy as part of primary therapy for metastatic disease, and 32 patients had
relapsed/progressed after prior adjuvant chemotherapy. Of these, 16 (38%) were
refractory to, or had relapsed within 12 months of, their adjuvant therapy. Most
patients were heavily pretreated, and 14 (33%) were resistant to conventional-dose
chemotherapy. A third of patients had received a taxane-containing regimen before
entry into the study.