Phase II study of Docetaxel-Ifosfamide-Carboplatin in Adv. NSCLC

In this continuing phase II study, researchers evaluated the tolerability and activity of the docetaxel-ifosfamide-carboplatin (DICb) combination on outpatients with advanced non-small-cell lung cancer (NSCLC).

To be eligible for this study, patients had advanced NSCLC (stages IIIB/IV) WHO performance status <2, and no prior chemotherapy. Fourty patients with median age 64 (range of 48-72) were involved in the study. There were 29 males and 11 females, with 13 (33%) at stage IIIB and 27 (67%) at stage IV. Patients were given chemotherapy drug doses of docetaxel 80mg/m2, ifosfamide 3.5g/m2, and carboplatin at a target area under the curve of 5 (based on Calvert's formula), all on day 1, followed by prophylactic G-CSF.All participants were evaluable for response and toxicity. Metastatic sites at diagnosis included: 25 lymph nodes, 7 bone, 4 liver, 5 brain, 13 lung nodules and 6 adrenals.22 of the patients responded to the treatment with 4 making a complete response, 18 making partial responses, 11 having stable disease and 7 having progressive disease. The median response duration was 7 months (range 2-14 months), with a median time to progression 9 months (range 2-18 months). The median overall survival was 11 months (range 3-46+ months). There was a 47.5% 1 year survival rate. Grade 3/4 toxicities included: neutropenia with 12 developing grade 4 and 12% febrile neutropenia, thrombocytopenia grade 3: occurring in 3 patients and grade 4: occurring in 1 patient, grade 1 CNS toxicity in 3 patients, grade 2 diarrhoea in 8 patients and grade 3 vomiting in 4 patients.Researchers concluded that based on findings from this present phase II study the docetaxel-ifosfamide-carboplatin combination yielded important activity and good tolerability in advanced non-small-cell lung cancer.(Source: Oncology 2005; 69:333-341.)