Abstract
17135 Background: In spite of the obvious chemosensitivity of SCLC only 10–15% of patients with limited disease (LD) live for 5 years and hardly any of those with extensive disease (ED). Intensification of treatment has not got a break-through, though there are studies demonstrating an improved survival from shortened intervals, three drugs instead of two and higher doses at first treatment. We have performed a study combining these three ways of treatment intensification. Methods: Patients with confirmed SCLC, in performance status 0–2, below 76 were included in a randomized phase II study. Randomisation was performed between standard treatment (S): Carboplatin 6 AUC day 1 and Etopside 100 mg/m2 day1–3, 6 courses with 3 weeks intervals. Radiotherapy was given with 1.5 Gy bid to 45 Gy in patients with LD starting simultaneously with course 2. And between intensified treatment (I): Ifosfamide 5000 mg/m2 day 1 at first course, 3000 mg/m2 at courses 2–6 and Carboplatin and Etoposide as in the S-group. Six courses were given with 2 weeks interval which was possible by giving G-CSF (Neupogen) day 4 of each course. A dose escalation schedule, if low effect on bone-marrow was applied in the I-group. Radiotherapy was given as in the S-group. Results: Forty-two patients were included during three years. Inclusion rate, however, decreased spontaneously, and the inclusion was stopped. Twenty-four patients had ED and 18 LD. After four years follow-up 4/7 (57%) LD patients are still alive without disease in the I group and 3/11 (27%) in the S group, of which 1 has relapsed. In the ED patients 1/11 (9%) is alive without disease in the I group and 0/13 in the S group. Conclusions: The low number of patients does not permit any firm conclusion concerning survival even if the results are promising. Intensified treatment in this way is feasible even if mainly thrombocytopenia and fatigue are problems in the I group. No significant financial relationships to disclose.
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