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

Vol. 69, No. 4, 2005

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Clinical Study

A Phase II Study of the Docetaxel- Ifosfamide-Carboplatin Combination in Advanced Non-Small-Cell Lung Cancer
Christos Kosmas^a, Nicolas Tsavaris^b, Aggelos Koutras^c, Thomas Makatsoris^c, Nicolas Mylonakis^a, George Tzelepis^b, Antonis Dimitrakopoulos^b, Konstantinos Spyropoulos^b, Aristidis Polyzos^b, Athanasios Karabelis^a, Haralambos P. Kalofonos^c

^aDepartment of Medicine, Second Division of Medical Oncology, 'Metaxa' Memorial Hospital, Piraeus,
^bMedical Oncology Unit, Department of Pathophysiology, Laikon General Hospital, Athens University School of Medicine, Athens, and
^cDepartment of Medicine/Oncology/Pulmonary Medicine, Patras University School of Medicine, Rio, Patras, Greece

Address of Corresponding Author

Oncology 2005;69:333-341 (DOI: 10.1159/000089681)

Key Words

Docetaxel
Ifosfamide
Carboplatin
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.

Author Contacts

Christos Kosmas, MD
Department of Medicine, 2nd Division of Medical Oncology, 'Metaxa' Cancer Hospital
21 Apolloniou Street
GR-16341 Athens (Greece)
Tel. +30 1 991 8301, Fax +30 1 996 2917, E-Mail ckosm@ath.forthnet.gr

Article Information

Received: March 14, 2005
Accepted after revision: June 19, 2005
Published online: November 9, 2005
Number of Print Pages : 9
Number of Figures : 1, Number of Tables : 4, Number of References : 44

Medline Abstract (ID 16282711)

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