autologous blood and marrow transplantation - Blog Science ...

310 Chapter 6: Breast Cancer
Table 3. Mobilization characteristics
Regimen n (range)
Total number of collection sets
Ifosfamide + paclitaxel
Ifosfamide + doxorubicin
Cyclophosphamide + paclitaxel
Cyclophosphamide + doxorubicin
G-CSF alone
CD34 dose per cycle x 10 6
/kg
MNC dose per cycle x 10 8
/kg
CFU-GM dose per cycle x 10 4
/kg
*Four patients were collected twice.
46*
13
23
3
6
2.82 (0.41-9.6)
2.7 (0.69-9.7)
12.7 (2.2-82.5)
completed only one cycle (total cycles 4). Three patients are yet to complete their
planned therapy (two patients completed one of three and one patient two of
three3). The planned treatment interval was 28 days, and since rapid hematopoietic
recovery was observed after most cycles (see below), the subsequent cycle of high-
dose treatment was usually delivered 24 days following infusion of the PBPCs
(range 24-38).
Nonhematopoietic toxicity
Nonhematopoietic toxicity was closely examined in the Phase I study of ITP
and has previously been presented. 22
The dose-limiting toxicities were renal tubular
acidosis (grade 3) and mucositis (grade 4). There was one treatment-related death
due to intractable gastrointestinal hemorrhage. Other relevant but non-dose-
limiting toxicities were ifosfamide encephalopathy (grade 4) and grade 2 reversible
interstitial pneumonitis (IP). Both patients with IP responded to steroid treatment
and were retreated with high-dose therapy. The recommended dose for phase II
studies is ifosfamide (10 g/m 2
), thiotepa (350 mg/m 2
), and paclitaxel (175 mg/m 2
).
Hematopoietic recovery
Neutrophil recovery. Hematopoietic recovery after the high-dose treatment is
summarized in Table 4. For all 109 cycles, the median time to ANC >0.5X 10 9
/L
and 1.0X10 9
/L was 10 days (range 7-26) and 10 days (range 8-28), respectively.
There were no significant differences in neutrophil recovery over consecutive
cycles when comparing either recovery of consecutive cycles for individual
patients (i.e., for ANC >0.5; P=0.1081; repeated measures ANOVA) or mean
recoveries for the entire cohort (i.e., for ANC >0.5; P=0.5233; log-rank test) (Table