VI Autologous Bone Marrow Transplantation.pdf - Blog Science ...

chest and upper abdominal computerized tomography (CT) scans, bone scan,
bilateral marrow aspirates and biopsies.
High dose "intensification" chemotherapy contained cyclophosphamide
(1875 mg/m2 as a two hour infusion daily for 3 days), cisplatin (55 mg/m2 per
day by continuous infusion over 72 hours) and carmustine (BCNTJ) (60 mg/m2/
dose given as a one hour infusion twice daily for 4 days). The total doses were
5625,165 and 480 mg/m2, respectively. Initially, bladder irrigation was employed,
but for the past two years, mesna at 375 mg/m2 q 3h for 3 days was
given for uroprotection. Hematopoietic support, reinfused 3 days after completion
of chemotherapy (day 0), consisted of marrow alone in 17, or marrow augmented
by GM-CSF-mobilized peripheral blood progenitor cells (PBPC) in 13
patients.
Consolidative chest (50-60 Gy/5-6 weeks) and prophylactic cranial radiotherapy
(30 Gy in 15 fractions) were administered after complete recovery from
the acute morbidity of intensification. Involved field radiotherapy to tissue tolerance
was given to isolated bulk areas of metastatic disease in the setting of
oligometastatic disease. Patients may have had chest radiotherapy prior to intensification
concurrent with induction therapy.
Statistical Methods: Standard response criteria were used for complete and
partial response, stable disease and disease progression. Near complete response
was defined as ~ 90% reduction with persistent radiographic abnormalities such
as residual parenchymal scarring without nodular characteristic, residual pleural
or pericardial thickening, residual mediastinal adenopathy less than 1.5 cm in
greatest diameter for at least four weeks. Event-free survival was calculated
from day 0 of intensification (unmaintained by further systemic therapy) to the
documentation of progression or death from any cause. Survival was calculated
from day 0 of intensification to the documentation of death from any cause.
Event-free and overall survival were estimated by the Kaplan-Meier method 5.
The logrank test 7 and proportional hazards regression 8 were used for
univariate and multivariate analysis. However, due to small sample sizes, a lack
of significance should not be interpreted as no association. A generalized
Wilcoxon statistic 6 was used to compare the time to granulocytes > 500/ul, to
platelets > 20,000/ul, and to RBC transfusion independence between patients
treated with and without PBPC.
RESULTS
From December 1985 to April 1992,30 patients were enrolled and have completed
high dose intensification (Table 1). All patients who were entered on the
protocol were treated and considered évaluable for toxicity and survival. Median
age was 49 (range 25-61) years; 60% had performance status 0 at initiation
of high dose therapy; and 67% were male. Except for chronic bronchitis or emphysema,
most patients had no active comorbid disease. One patient had
sequelae from childhood polio and three had previous vascular angioplasty. All
limited stage patients had stage III disease. Patients with extensive disease had a
median of 2 (1-7) metastatic sites, including three with marrow involvement.
A median of four cycles of various induction chemotherapy regimens was
given (range 2-6). Fourteen limited patients and seven of the ten extensive patients
achieved complete or near complete response. The remainder had partial
SIXTH INTERNATIONAL SYMPOSIUM ON AUTOLOGOUS BONE MARROW TRANSPLANTATION 163