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Table 3. ICE toxicity (172 cycles)
Leyvraz et al. 399
WHO grade
0 / II III IV % III+IV
Mucositis 94 33 27 16 2 10.5
Diarrhea 80 37 30 21 4 14.5
Nausea/vomiting 38 47 51 34 2 21
Neurologic 150 14 3 4 1 3
Otological 162 4 5 — 1 0.5
Cardiac 162 4 2 4 — 2
Infection 119 7 24 17 5 13
platelets with no difference between cycles 1 and 3. The platelet or red cell
transfusion rate was similar when comparing cycle 1 and 3. Febrile neutropenia
occurred in 117 of the 172 cycles (68%). Overall, intravenous antibiotics were
prescribed during 9 days (range 0-62); the median duration of hospital stay was 20
days (5-75).
Response rate and survival
Sixty-seven patients were évaluable for response (two were too early). After
high-dose chemotherapy, 33 patients (49%; 95% confidence interval [CI]
37-62%), achieved a CR or near CR according to Dana Farber Cancer Institute
criteria. 11
Twenty-four patients achieved a PR, resulting in overall response rate of
85% (95% CI 74-93%). Response rate was also analyzed according to established
prognostic factors such as disease extension, performance status, sex, liver
metastases, and elevated LDH (Table 4). Disease extension was the only
significant predictive factor for response, with 68% of the patients with limited
disease achieving complete response compared with only 36% of the those with
extensive disease (P=0.01).
Median OS was analyzed according to disease extension. In limited-disease
patients, the OS was 19 months compared with 11 months in patients with
extensive disease (P=0.00l) (Fig. 1). Survival was also analyzed according to
established prognostic factors. Patients with LDH below normal values had a
significantly better overall survival compared with the patients with abnormal
values (median OS: 17 months vs. 11 months; F=0.001).
CONCLUSIONS
This phase II multicenter study supported by the EBMT demonstrated the
feasibility of administering sequential high-dose ICE chemotherapy with PBPC