Combination therapy of pulmonary metastasised gynaecological cancer with inhalative IL-2 - Results of a feasibility study

Purpose: Additive inhalative IL-2 was evaluated for efficacy and safety in the treatment of pulmonary metastasised gynaecological cancer patients in c ombination with a chemotherapeutic regime. Material and Methods: 10 patients with pulmonary metastases of breast (n = 8) and ovarian cancer (n = 2) received in addition to different chemotherap y protocols inhalative rIL-2 (15-36 Mio I.U.) for 5 days a week during the interval of cytotoxic treatment. Results: Maximum toxicity per total treatment was tolerable. Toxicity was l imited to WHO I to II, mainly cough. Progressive pulmonary metastases respo nded in 7/10 patients with PR with a duration of 6.4 months (mean), 2/10 wi th NC (7.5 months) and in one patient with further progression under treatm ent. Conclusion: Inhalatory IL-2 treatment in pulmonary metastasised gynaecologi cal cancer patients implies an additive treatment under chemotherapy for fu rther tumour control. Based on the feasibility of inhalatory IL-2 treatment , a phase II study will be performed for pulmonary metastatic breast cancer patients in addition to standard chemotherapy in an outpatient trial which is already under way.