First-line treatment of advanced non-small-cell lung cancer with docetaxel and cisplatin: a multicenter phase II study
| Autor: | A.M. Dimopoulos, Stelios Kakolyris, E. Mavromanolakis, C. Kourousis, Dora Hatzidaki, V. Georgoulias, J. Vlachonicolis, Nikos Androulakis, S. Tzannes, A. Vossos, Christos Papadimitriou, F Apostolopoulou, E. Papadakis, P. Heras, M. Agelidou |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
Male medicine.medical_specialty Lung Neoplasms Paclitaxel medicine.medical_treatment Phases of clinical research Docetaxel Neutropenia Gastroenterology Severity of Illness Index Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor medicine Mucositis Humans Lung cancer Infusions Intravenous Survival rate Aged Chemotherapy Performance status business.industry Hematology Middle Aged medicine.disease Antineoplastic Agents Phytogenic Hematologic Diseases Surgery Survival Rate Treatment Outcome Oncology Female Taxoids Cisplatin business medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 9(3) |
| ISSN: | 0923-7534 |
| Popis: | Summary Purpose To evaluate the efficacy and safety of the docetaxel-cisplatin combination in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods Chemotherapy-naive patients with histologically confirmed, measurable stage IIIB or IV NSCLC, a World Health Organization (WHO) performance status of0-2 and adequate bone marrow, renal, hepatic and cardiac function were eligible for the study. Patients received docetaxel (100 mg/m2) as an one-hour infusion on day 1 and cisplatin (80 mg/m2) as a 30-min infusion with appropriate hydration on day 2. Granulocyte colony-stimulating factor (G-CSF; 150 μg/m2, SC) was given on days 3 to 13. Treatment was repeated every three weeks. Results Fifty-three patients were enrolled (28 with stage IIIB and 25 with stage IV). One complete and 23 partial responses were observed (overall response rate (OR): 45%; 95% CI: 34.1%–61.8%). The response rate was 57% and 32% in patients with stages IIIB and IV disease (P = NS). The median time to progression was 36 weeks and the median survival 48 weeks; the one-year survival was 48%. Grade 3–4 neutropenia occurred in 23 patients, 15 of whom were hospitalized for neutropenic fever; two patients died of sepsis. Grade 2 neurotoxicity was observed in six patients and grade 3 in five patients; grade 3 fatigue occurred in seven patients, grade 3–4 mucositis in four patients and grade 3–4 diarrhea in six patients. Mild allergic reactions and oedema were observed in five and four patients, respectively. The median dose intensity was 30 mg/m2/week for docetaxel and 24 mg/m2/week for cisplatin, corresponding to 91% and 89% of the specified protocol doses, respectively. Conclusions The docetaxel–cisplatin combination is an active regimen in advanced NSCLC, but hematologic toxicity remains high despite the prophylactic use of G-CSF. |
| Databáze: | OpenAIRE |
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