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Rodenhuis et al. 429<br />

Figure 2. Progression-free survival of patients who responded to FE mC. The progression<br />

free survival was calculated from the start of chemotherapy for all patients who had at least<br />

50% regression of measurable or évaluable disease after the two courses ofFE mC, <strong>and</strong> who<br />

were considered to have "chemosensitive disease. "<br />

the progression-free survival data of this highly selected patient group are<br />

immature. Nevertheless, some indication of the level of efficacy at this early time<br />

can be obtained from Figs. 1 <strong>and</strong> 2. Not surprisingly, patients responding to two<br />

courses of FEC with at least 50% regression of évaluable tumor appeared to have<br />

a better prognosis than those who did not. The 2-year progression-free survival for<br />

all patients was 22% (95% confidence interval[CI] 8^14%), <strong>and</strong> that for FECresponsive<br />

patients was 47% (95% CI 20-66%).<br />

Pharmacokinetic data<br />

For two patients, the plasma concentration vs. time curves of carboplatin,<br />

thiotepa, TEPA, cyclophosphamide, <strong>and</strong> 2-dechloroethyl cyclophosphamide are<br />

shown in Fig. 3A-D. This information establishes the suitability of the methods to<br />

obtain adequate curves in this patient group. Detailed analyses of more patients are<br />

in progress <strong>and</strong> will be published elsewhere.<br />

DISCUSSION<br />

Three subsequent courses of tCTC could be administered to most patients in this<br />

trial. As in the study with full-dose CTC, 7<br />

end-organ toxicity such as hemorrhagic<br />

cystitis <strong>and</strong> veno-occlusive disease occurred but were generally mild <strong>and</strong> did not

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