A Phase II Study of the Docetaxel- Ifosfamide-Carboplatin Combination in Advanced Non-Small-Cell Lung Cancer

Abstract

Purpose: In the present phase II study we evaluated the docetaxel-ifosfamide-carboplatin (DICb) combination in the outpatient setting in patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with advanced NSCLC (stages IIIB/IV), WHO performance status (PS) <2, and no prior chemotherapy were eligible. Chemotherapy drug doses were: docetaxel: 80 mg/m², ifosfamide: 3.5 g/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. Results: Fourty patients were entered and all are evaluable for response and toxicity: median age: 64 (48–72); PS: 1 (0–1); gender: 29 males/11 females; stages: IIIB: 13 (33%), IV: 27 (67%). Metastatic sites at diagnosis included: lymph nodes: 25; bone: 7; liver: 4; brain: 5; lung nodules: 13; adrenals: 6. Responses were as follows: 22/40 [55%; 95% confidence interval (CI), 54–81%] evaluable patients responded: 4 complete responses, 18 partial responses, 11 had stable disease, and 7 had progressive disease. The median response duration was 7 months (range 2–14 months), median time to progression 9 months (range 2–18 months) and median overall survival 11 months (range 3–46+ months). 1-year survival was 47.5%. Grade 3/4 toxicities included: neutropenia 28/40, with 12 developing grade 4 and 12% febrile neutropenia, thrombocytopenia grade 3: 3/40 and grade 4: 1/40, no grade 3 neuropathy, grade 1 CNS toxicity in 3, no renal toxicity, 8 grade 2 diarrhea and 4 grade 3 vomiting. Conclusion: In the present phase II study the DICb combination yielded important activity and good tolerability in advanced NSCLC.

Phase II study of liposomal cisplatin (Lipoplatin™) plus gemcitabine versus cisplatin plus gemcitabine as first line treatment in inoperable (stage IIIB/IV) non-small cell lung cancer

“…A number of chemotherapy regimens have been explored in clinical trials and in medical practice. For example, preferred regimens for first line treatment against NSCLC in EU include gemcitabine and cisplatin [3][4][5] and carboplatin-paclitaxel in USA [6,7]; second line treatments tested include single agents such as docetaxel [8,9], pemetrexed [10] and erlotinib [11] as well as combinations of gemcitabine plus docetaxel [12], gemcitabine and irrinotecan [13], docetaxel-ifosfamide-carboplatin [14].…”