autologous blood and marrow transplantation - Blog Science ...

282 Chapter 6: Breast Cancer
procedures in each center. Finally, patients who were menopausal at diagnosis and
with positive estrogen and/or progesterone receptors received tamoxifen 20 mg/d
for 3 years.
Response evaluation
Clinical. Clinical evaluation was performed on day 1 of each cycle of
chemotherapy and before local treatment. Complete clinical response was defined
as the clinical complete disappearance of breast inflammation as well as of the
underlying breast tumor mass. Partial response was at least a 50% decrease in
tumor diameter with disappearance of inflammation.
Pathologic. Two independent pathologists performed pathologic evaluation
using a blind study technique. Response in the breast was defined as described by
Chevallier et al. 15
: grade 1, disappearance of all tumor both on macroscopic and
microscopic examination; grade 2, presence of in situ carcinoma of the breast with
no invasive tumor; grade 3, presence of invasive carcinoma with stromal alterations
such as sclerosis or fibrosis; grade 4, no or few alterations in tumor appearance.
Lymph nodes were evaluated separately when available after chemotherapy and
classified in two categories: involved or not involved.
Statistical analysis
No interim analysis on efficacy was performed. However, it was planned to stop
the study if the toxic death rate was too high. To keep the toxic death rate under 3%
with a 5% a risk, only four or fewer toxic deaths among the first 30 patients were
deemed acceptable. 16
Medians are presented with their range and response rate with 95% confidence
intervals. Percentage differentials were tested by application of the x 2
test. When a
patient stopped her treatment, she was analyzed for received cycle toxicity, dose
intensity, and pathologic response if mastectomy was performed before beginning
another antineoplastic treatment and for follow-up.
RESULTS
Patients
Between December 1994 and September 1996, 100 patients from 17 participating
centers entered the study.
Five patients were withdrawn from the study: four had metastatic IBC at diagnosis
and were not eligible and one received another chemotherapy regimen before the first
cycle. As a result, a total of 95 patients were considered valid for analysis.