Docetaxel in combination with gemcitabine plus rhG-CSF support as second-line treatment in non-small cell lung cancer. A multicenter phase II study

• Published in: Lung cancer (Amsterdam, Netherlands) Vol. 32; no. 2; pp. 179 - 187
• Main Authors: Kakolyris, S., Papadakis, E., Tsiafaki, X., Kalofonos, C., Rapti, A., Toubis, M., Bania, E., Kouroussis, Ch, Chainis, K., Androulakis, N., Agelaki, S., Sarra, E., Vardakis, N., Georgoulias, V.
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 01.05.2001; Elsevier Science
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Cisplatin - pharmacology; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Disease Progression; Disease-Free Survival; Docetaxel; Drug Administration Schedule; Drug Resistance, Neoplasm; Female; Gemcitabine; Granulocyte Colony-Stimulating Factor - therapeutic use; Hematologic Diseases - chemically induced; Hematologic Diseases - prevention & control; Humans; Life Tables; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Male; Medical sciences; Middle Aged; Neutropenia - chemically induced; Neutropenia - prevention & control; NSCLC; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel - analogs & derivatives; Pneumology; Recombinant Proteins - therapeutic use; Salvage Therapy; Salvage treatment; Survival Analysis; Survival Rate; Taxoids; Treatment Outcome; Tumors of the respiratory system and mediastinum; Salvage treatment; Gemcitabine; NSCLC; Docetaxel; Antineoplastic agent; Human; Lung disease; Respiratory disease; Treatment efficiency; Multicenter study; Malignant tumor; Colony stimulating factor; Bronchopulmonary; Chemotherapy; Taxane derivatives; Phase II trial; Bronchus disease; Fluorine Organic compounds; Therapeutic protocol; Pyrimidine nucleoside; Non small cell carcinoma
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/S0169-5002(00)00212-9

Background: Docetaxel in combination with gemcitabine is an active front-line chemotherapy regimen against non-small cell lung cancer (NSCLC) with acceptable toxicity. A multicenter phase II study was conducted in order to determine the toxicity and efficacy of this combination, as salvage treatment in patients progressing after a cisplatin-based front line regimens. Patients and methods: Thirty-two patients with histologically confirmed, bidimensionally measurable NSCLC, who failed prior cisplatin-based chemotherapy were enrolled. The patients’ median age was 62.5 years, 29 (91%) were male, 23 (72%) had disease stage IV, and 22 (69%) had a performance status (WHO) 0–1. Gemcitabine (900 mg/m 2) was administered on days 1 and 8 and docetaxel (100 mg/m 2) on day 8, after appropriate premedication. rhG-CSF (150 μg/m 2) was given prophylactically from day 9 to 15. Treatment was repeated on an outpatient basis every three weeks. Results: A total of 127 chemotherapy cycles were administered. In an intention-to-treat analysis five patients (15.6%; 95% CI: 3.04–28.21%) achieved a partial response, 11 (34.4%) stable disease, and 16 (50%) progressive disease. The median duration of response was 9 months, the median TTP 7 months, and the overall median survival 6.5 months; the overall 1-year survival probability was 27.6%. Grade 3/4 neutropenia was observed in five (15.6%) patients and in two of them associated with fever. Grade 3 anemia and thrombocytopenia occurred in three (9%) and two (6.5%) patients, respectively. Non-hematologic toxicity was very mild with only one episode of grade 4 diarrhea and mucositis, respectively; two (6%) patients complained for grade 3 asthenia. Conclusion: The combination of gemcitabine and docetaxel with prophylactic use of rhG-CSF is a safe and well-tolerated regimen for the treatment of patients with advanced NSCLC, who failed front-line treatment with cisplatin-based regimens.