A new G-CSF-supported combination chemotherapy, LSG15, for adult T-cell leukaemia-lymphoma: Japan Clinical Oncology Group Study 9303

This phase II trial was performed to evaluate the efficacy of a new granulo cyte colony-stimulating factor (G-CSF)-supported multi-agent chemotherapy p rotocol, LSG15, for aggressive adult T-cell leukaemia-lymphoma (ATL), Ninet y-six previously untreated patients with aggressive ATL were enrolled and g rouped as: acute type (58), lymphoma type (28) and unfavourable chronic typ e (10). Therapy consisted of seven cycles of VCAP (vincristine, cyclophosph amide, doxorubicin and prednisone), AMP (doxorubicin, ranimustine and predn isone) and VECP (vindesine, etoposide, carboplatin and prednisone). G-CSF w as administered during the intervals between chemotherapy until neutrophil reconstitution was achieved. Eighty-one per cent of the 93 eligible patient s responded [95% confidence interval (CI), 71.1-8.81%], with 33 patients ob taining complete response (35.5%) and 42 obtaining partial response (45.2%) . The median survival time (MST) after registration was 13 months and the m edian follow-up duration of the 20 surviving patients was 42 years (range 2 .8-5.6). Overall survival at 2 years was estimated to be 31.3% (95% CI, 22. 0-40.5%). Grade 4 haematological toxicity of neutropenia and thrombocytopen ia were observed in 65.3% and 52.6% of the patients respectively, but grade 4 non-haematological toxicity was observed in only one patient. LSG15 is f easible with mild non-haematological toxicity and improved the clinical out come of ATL patients. MST and overall survival at 2 years were superior to those obtained by our previous trials.