Reduction of chemotherapy-induced febrile leucopenia by prophylactic use of ciprofloxacin and roxithromycin in small-cell lung cancer patients: an EORTC double-blind placebo-controlled phase III study

Autor: V.C. Tjan-Heijnen, M. Mollers, E. Buchholz, G. Giaccone, Pieter E. Postmus, Christian Manegold, C. Debruyne, Catherine Legrand, Andrea Ardizzoni, Steven Gans, J. Van Meerbeeck, J.T.M. Burghouts, Bonne Biesma
Přispěvatelé: European Organisation for Research and Treatment of Cancer-Lung Cancer Group
Rok vydání: 2001
Předmět:
Male
Palliative care
Lung Neoplasms
medicine.medical_treatment
Antibiotics
Gastroenterology
Placebos
Anti-Infective Agents
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
Carcinoma
Small Cell
Infusions
Intravenous
Etoposide
Hematology
Middle Aged
Chemotherapy regimen
Anti-Bacterial Agents
Hospitalization
Treatment Outcome
Oncology
Female
Macrolides
medicine.drug
Fluoroquinolones
Adult
medicine.medical_specialty
Neutropenia
Fever
medicine.drug_class
Filgrastim
Placebo
Infections
Small-cell carcinoma
Experimental diagnostics and therapy of malignancies
Double-Blind Method
Internal medicine
medicine
Humans
Cyclophosphamide
Aged
Chemotherapy
business.industry
Roxithromycin
Antibiotic Prophylaxis
medicine.disease
Survival Analysis
Surgery
Doxorubicin
Human medicine
business
Zdroj: Annals of Oncology, 12, 10, pp. 1359-68
Annals of Oncology, 12, 1359-68
Annals of oncology
ISSN: 0923-7534
Popis: Item does not contain fulltext BACKGROUND: CDE (cyclophosphamide, doxorubicin, etoposide) is one of the standard chemotherapy regimens in the treatment of small-cell lung cancer (SCLC), with myelosuppression as dose-limiting toxicity. In this trial the impact of prophylactic antibiotics on incidence of febrile leucopenia (FL) during chemotherapy for SCLC was evaluated. PATIENTS AND METHODS: Patients with chemo-naive SCLC were randomized to standard-dose CDE (C 1,000 mg/m2 day 1, D 45 mg/m2 day 1, E 100 mg/m2 days 1-3. i.v., q 3 weeks, x5) or to intensified CDE chemotherapy (125% dose, q 2 weeks, x4, with filgrastim 5 microg/kg/day days 4-13) to assess the impact on survival (n = 240 patients). Patients were also randomized to prophylactic antibiotics (ciprofloxacin 750 mg plus roxithromycin 150 mg, bid. days 4-13) or to placebo in a 2 x 2 factorial design (first 163 patients). This manuscript focuses on the antibiotics question. RESULTS: The incidence of FL during the first cycle was 25% of patients in the placebo and 11% in the antibiotics arm (P = 0.010; 1-sided), with an overall incidence through all cycles of 43% vs. 24% respectively (P = 0.007; 1-sided). There were less Gram-positive (12 vs. 4), Gram-negative (20 vs. 5) and clinically documented (38 vs. 15) infections in the antibiotics arm. The use of therapeutic antibiotics was reduced (P = 0.013; 1-sided), with less hospitalizations due to FL (31 vs. 17 patients, P = 0.013: 1-sided). However, the overall number of days of hospitalization was not reduced (P = 0.05; 1-sided). The number of infectious deaths was nil in the antibiotics vs. five (6%) in the placebo arm (P = 0.022; 2-sided). CONCLUSIONS: Prophylactic ciprofloxacin plus roxithromycin during CDE chemotherapy reduced the incidence of FL, the number of infections, the use of therapeutic antibiotics and hospitalizations due to FL by approximately 50%, with reduced number of infectious deaths. For patients with similar risk for FL, the prophylactic use of antibiotics should be considered.
Databáze: OpenAIRE
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