Randomized, multicenter, open-label phase II study of gemcitabine plus single-dose versus split-dose carboplatin in the treatment of patients with advanced-stage non-small-cell lung cancer
| Autor: | Thomas Blankenburg, Ludwig Fischer von Weikersthal, Gerhard Laier-Groeneveld, Claus-Peter Schneider, Martin Reck, Johann Christian Virchow, Sylvia Guetz, Assnad Chemaissani, Wolfgang Schuette |
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| Rok vydání: | 2006 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male Cancer Research medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions medicine.medical_treatment Phases of clinical research Antineoplastic Agents Gastroenterology Deoxycytidine Carboplatin chemistry.chemical_compound Internal medicine Carcinoma Non-Small-Cell Lung medicine Humans Lung cancer Aged Neoplasm Staging Chemotherapy Leukopenia business.industry Area under the curve Middle Aged medicine.disease Survival Analysis Gemcitabine Surgery Oncology chemistry Toxicity Female medicine.symptom business medicine.drug |
| Zdroj: | Clinical lung cancer. 8(2) |
| ISSN: | 1525-7304 |
| Popis: | Background Gemcitabine/carboplatin is a convenient and effective treatment for advanced-stage non– small-cell lung cancer (NSCLC), but modification of the schedule to diminish thrombocytopenia is worthwhile. Patients and Methods One hundred fifty-eight chemotherapy-naive patients with stage IIIB/IV NSCLC were randomized from 15 centers in Germany to receive gemcitabine 1250 mg/m 2 on days 1 and 8 plus carboplatin area under the curve 5 on day 1 (arm A) or carboplatin area under the curve 2.5 on days 1 and 8 (arm B), every 21 days for 4 cycles. Results The 2 arms (A vs. B) were well balanced with regard to patient baseline characteristics: stage IV 72.5% versus 69%, median Eastern Cooperative Oncology Group performance status 1 versus 1. The incidence of grade 3/4 hematologic toxicity was as follows (percentage of patients in arm A vs. B): leukopenia 37.5% versus 27% ( P = 0.075), granulocytopenia 36% versus 36%, and thrombocytopenia 51% versus 35% ( P = 0.017). Nonhematologic toxicity was modest and comparable with both schedules. The overall response rate was 46% versus 36% ( P = 0.12), and 24% versus 42% had stable disease. Median progression-free survival (5.8 months vs. 6.1 months) and overall survival (11.7 months vs. 10.7 months) were not significantly different between arms A and B. Conclusion Splitting the dose of carboplatin between days 1 and 8 on the same days as gemcitabine results in a significantly decreased incidence of severe thrombocytopenia, without compromising the activity of the combination. |
| Databáze: | OpenAIRE |
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