Up to 9/95 54 patients (29 in stage IIIB) were enrolled. a multicenter phase II trial: after completion of two cycles of chemotherapy (Carboplatin 300 mg/m(2); dl/Ifosfamid 3 x 1,5 g/m(2); dl,3,5/Etoposid 3 x 120 mg/m(2); dl,3,5) a 3 week-period of hyperfractionated-accelerated radiotherapy (45 Gy; 2 x 1,5 Gy/d) with concurrent Carboplatin (100 mg/m(2); dl,8,15)/Vindesin (3 mg; dl,8,15) followed. Main toxicities turned out in esophagitis (5 x WHO III/IV0) and pneumonitis (5 x WHO III/IV 0). 5 treatment related deaths occured: 2 due to pneumonitis, 2 because of postoperative bronchopleural fistula and one due to postoperative pneumonia. For 40 of 54 (74%) a clinical response was achieved with 6/54 (11%) complete remissions. 40/54 (74%) patients went on to surgery with a RO-resection - rate of 34/40 (85%). Median survival rime (MST) for all patients is 20 months (IIIA 24 months; IIIB 16 months) with a median follow up of 21 months.

In an attempt to further improve on the encouraging results achieved by high-dose cytosine arabinoside (HD AraC) and mitoxantrone (HAM) in refractory acute leukemias, a timely modified sequential schedule of both drugs was developed (S-HAM) and applied to 13 patients with far advanced acute leukemias, 8 of whom had been treated with the original HAM protocol before. Based on the cell kinetic and pharmacokinetic rationale outlined by Capizzi et al., HD AraC 3 g/m2 was applied every 12 h on days 1 and 2 followed by mitoxantrone 10 mg/m2/day on days 3 and 4. After 3 days without therapy the identical sequence was repeated on days 8 and 9 (HD AraC) and 10 and 11 (mitoxantrone), respectively. Of the 13 patients 9 (69%) achieved a complete remission, 2 were resistant and 2 were early deaths. Six of the 8 patients with prior HAM treatment obtained a further complete remission with S-HAM. In 2 of these patients a longer remission was induced by S-HAM than by the preceding original HAM treatment. Although these data are preliminary and need confirmation on larger numbers of patients, they strongly suggest a high antileukemic activity of the S-HAM protocol which may even be superior to the previously used HAM regimen.

In a pilot study 16 patients with advanced inoperable stomach cancer were treated with Etoposide, Adriamycin, Cisplatin. The recommended dose for phase II studies was established and first therapy results are presented. Two of 16 patients responded with complete remissions and 8 with partial remissions. The recommended dose schedule for phase II studies is: Adriamycin 20 mg/m2 i.v. day 1 + 7; Cisplatin 40 mg/m2 i.v. day 2 + 8; Etoposide 120 mg/m2 i.v. day 4, 5, 6, every four weeks.