autologous blood and marrow transplantation - Blog Science ...

292 Chapter 6: Breast Cancer
Table 1. Levels of scientific evidence for therapeutic interventions
Evidence Description
Level V Case series
Level IV Formal comparison with historic controls
Level III Formal comparison with nonrandomized contemporaneous controls
Level II Randomized controlled trials that are too small
Level I Randomized controlled trials that are big enough and meta-analyses
disease was allowed. Adjuvant chemotherapy, if any, had to be at least 6 months
before metastatic disease. Patients were excluded if they had exposure to taxanes.
Karnofsky performance status was >60%, and cardiopulmonary and
hematopoietic functions were normal. When patients entered the study, met all
eligibility criteria, and signed the informed consent form, they received the initial
IDC consisting of 5-fluorouracil (5-FU) 750 mg/m 2
body surface area (BSA),
epirubicin 100 mg/m 2
BSA, cyclophosphamide 750 mg/m 2
BSA, all delivered on
day 1 as intravenous infusion. Starting on day 2, G-CSF (10 pg/kg subcuta-
neously) was administered daily for ~2 weeks until the total white blood cell
(WBC) count reached 2.5/nL. On that day, standard apheresis procedure (AP) was
performed using a double lumen catheter connected to a Baxter CS3000+. The
blood flow on average was 70 mL/min to a blood volume of 10 L. Our target was
to collect at least 5X10 8
2X10 6
CD34 +
cells/kg. 9
mononucleated cells per kilogram body weight and
After the first cycle of IDC, the patients obtained a further
two to three cycles of chemotherapy consisting of 5-FU 600 mg/m 2
BSA,
epirubicin 60 mg/m 2
BSA, cyclophosphamide 600 mg/m 2
BSA, all administered
intravenously. The treatment was delivered every 3 weeks if ANC was >1.5/nL
and platelets >100/nL. After IDC, all patients were restaged with a physical
examination, imaging studies, and blood work. Only patients who did not progress
on IDC and did not experience severe toxicity and/or organ damage proceeded to
HDCT. HDCT consisted of cyclophosphamide 6 g/m 2
intravenously delivered on
3 consecutive days; MXT 70 mg/m 2
intravenously delivered on the same 3
consecutive days. On day 4, the paclitaxel dose starting at 250 mg/m 2
delivered as a 3-hour infusion. The dose was increased by 50 mg/ m 2
+ XL if three
or more patients did not experience DCT. Usual premedication, including
antiemetics and dexamethasone, was delivered on each day. After 24^18 hours of
rest, the ABSC were reinfused and rhG-CSF was administered at the dose of 5
pg/kg daily until hematologic recovery (ANC >1.5/nL for 3 consecutive days).
The ABSC were cryopreserved in 10% DMSO as previously described. 9
The four
days of chemotherapy were delivered in the hospital. The patients were usually
discharged on the day after HDCT just before the reinfusion of the autograft. 3
was