Randomized Phase III Trial of Docetaxel Plus Carboplatin with or without Levofloxacin Prophylaxis in Elderly Patients with Advanced Non-small Cell Lung Cancer: The APRONTA Trial
| Autor: | Sylke Nagel, Burkhard Deuss, Katrin Roscher, Nicolas Dickgreber, Stefan Pabst, Christian Schumann, Wolfgang Schuette, Ludwig Fischer von Weikersthal, Thorsten Salm |
|---|---|
| Jazyk: | angličtina |
| Předmět: |
Male
Ofloxacin Lung Neoplasms medicine.medical_treatment Docetaxel Kaplan-Meier Estimate Levofloxacin NSCLC Gastroenterology Carboplatin chemistry.chemical_compound Elderly Anti-Infective Agents Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Antibiotic prophylaxis Aged 80 and over education.field_of_study Bacterial Infections Middle Aged Intention to Treat Analysis Oncology Anesthesia Female Taxoids medicine.drug Pulmonary and Respiratory Medicine medicine.medical_specialty Neutropenia Population Pain Placebo Disease-Free Survival Double-Blind Method Internal medicine medicine Humans Chemotherapy education Aged business.industry Prophylaxis Leukopenia Antibiotic Prophylaxis medicine.disease Dyspnea chemistry business |
| Zdroj: | Journal of Thoracic Oncology. (12):2090-2096 |
| ISSN: | 1556-0864 |
| DOI: | 10.1097/JTO.0b013e3182307e3c |
| Popis: | Purpose: To examine the effect of levofloxacin prophylaxis on infection rates during chemotherapy with docetaxel plus carboplatin in elderly patients with advanced non-small cell lung cancer. Methods: In a randomized, double-blind, phase III study, patients (≥65 years) with untreated, histologically/cytologically proven stage IIIB/IV non-small cell lung cancer received docetaxel (75 mg/m 2 ) plus carboplatin (area under the curve 6) on day 1 every 3 weeks, plus once-daily levofloxacin (500 mg orally) or placebo on days 5 to 11. The primary end point was the rate of grade 3/4 infections or grade 1/2 infections treated with additional antibiotics. Secondary end points included overall infection rate, toxicity, overall survival, and progression-free survival. Results: In total, 187 patients were randomized to levofloxacin ( n = 95) or placebo ( n = 92). The rate of grade 3/4 infections or grade 1/2 infections treated with additional antibiotics (intent-to-treat population) was 27.5% (95% confidence interval, 19.3–39.0%) for levofloxacin versus 36.7% (95% confidence interval, 27.1–48.0%) for placebo. Median time to first infection was 67 days for levofloxacin versus 46 days for placebo. Grade 3/4 infections occurred in 8.8% of patients in the levofloxacin group versus 26.7% for placebo. There was one grade 5 infection in each group. Grade ≥3 toxicities (levofloxacin versus placebo) included leukopenia (63.2 versus 52.2%), neutropenia (62.1 versus 51.1%), dyspnea (12.6 versus 8.7%), and pain (10.5 versus 9.8%). There was no significant difference in overall survival or progression-free survival between groups. Conclusions: Levofloxacin prophylaxis reduces the rate of infection compared with placebo and is well tolerated in elderly patients receiving docetaxel plus carboplatin. |
| Databáze: | OpenAIRE |
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