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296 Chapter 6: Breast Cancer<br />

of rest (day -1), ABSC were reinfused on day 0. Starting within 24 hours, rhG-CSF<br />

at the dose of 5 ug/kg was administered subcutaneously until hematologic recovery.<br />

RESULTS<br />

Ninety-two patients were enrolled into the study. Eighteen patients were<br />

withdrawn from the study after completion of the induction regimen because of PD or<br />

other reasons (increasing renal insufficiency, one patient; diagnosis of a second<br />

cancer, one patient; withdrawal of consent, one patient). Thus far, 74 have undergone<br />

the complete treatment <strong>and</strong> are évaluable for toxicity <strong>and</strong> efficacy. In general,<br />

treatment-related toxicity was rather rare <strong>and</strong> mild, except for hematotoxicity. None of<br />

our patients died from acute toxic complications within the first 6 weeks during <strong>and</strong><br />

after <strong>transplantation</strong>. Transfusion frequency for packed red <strong>blood</strong> cells after the highdose<br />

chemotherapy ranged between 0 <strong>and</strong> 26 units for a median of only two units.<br />

There were between 1 <strong>and</strong> 29 platelet transfusion encounters, for median of only two<br />

encounters. Median time of hematologic recovery to ANC >0.5/nL was 11.5 days<br />

(range 8-17), days to platelet recovery of >20/nL was 12 (range 0-17). The patients'<br />

age was 42 years (19-55). Those who did not fulfill the criteria of response <strong>and</strong> did<br />

not obtain the HDCT had a median survival of only 8 months. Patients who underwent<br />

HDCT <strong>and</strong> <strong>autologous</strong> BSC showed a median survival of 28.5 months. This is longer<br />

than the average for historical controls treated with st<strong>and</strong>ard-dose chemotherapy<br />

(SDCT). We performed univariate analysis. From all patients enrolled into the study<br />

(intent-to-treat analysis), the median survival was 28 months if liver was not involved<br />

by metastatic disease, <strong>and</strong> only 8 months with liver involvement. The hazard ratio of<br />

dying with metastatic breast cancer to the liver was 3.25. Adjuvant chemotherapy<br />

predicted a statistically significant difference in survival: median survival for patients<br />

without adjuvant chemotherapy is 28 months. Patients developing metastasis after<br />

adjuvant chemotherapy have a median survival probability of 13.5 months (difference<br />

significant; P=0.049, log-rank test; hazard ratio 0.54). Prior doxorubicin, bone <strong>marrow</strong><br />

involvement, <strong>and</strong> age did not reveal a significant difference. Figure 1 shows the<br />

probability of survival of all 74 transplanted patients as estimated by the Kapler-Meier<br />

method showing differences in survival in patients with bone metastases <strong>and</strong> visceral<br />

metastases, respectively (P

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