Randomized phase II study of carboplatin/gemcitabine versus vinorelbine/gemcitabine in patients with advanced nonsmall cell lung cancer
| Autor: | Kazuhiko Nakagawa, Hisao Uejima, Tatsuhiko Kashii, Minoru Takada, Kaoru Matsui, Y. Takada, Nobuyuki Yamamoto, Yoichi Nakanishi, Takahiko Sugiura, Terufumi Kato, Shun Ichi Negoro, Masahiro Fukuoka |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Lung Neoplasms Drug-Related Side Effects and Adverse Reactions Survival medicine.drug_class Phases of clinical research Vinblastine Vinorelbine Deoxycytidine Antimetabolite Gastroenterology Carboplatin chemistry.chemical_compound Japan Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Survival rate Aged Neoplasm Staging business.industry Patient Selection Middle Aged Gemcitabine Surgery Treatment Outcome Oncology chemistry Female business medicine.drug |
| Zdroj: | Cancer. 107:599-605 |
| ISSN: | 1097-0142 0008-543X |
| Popis: | BACKGROUND. Combined gemcitabine and carboplatin (GC) and combined gemcitabine and vinorelbine (GV) are active and well tolerated chemotherapeutic regimens for patients with advanced nonsmall cell lung cancer (NSCLC). The authors conducted a randomized Phase II study of GC versus GV to compare them in terms of efficacy and toxicity. METHODS. One hundred twenty-eight patients with Stage IIIB or IV NSCLC were randomized to receive either carboplatin at an area under the curve of 5 on Day 1 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) or vinorelbine 25 mg/m2 combined with gemcitabine 1000 mg/m2 on Days 1 and 8 (n = 64 patients) every 3 weeks. RESULTS. Response rates were 20.3% for the GC patients and 21.0% for the GV patients. In the GC arm, the median survival was 432 days, and the a 1-year survival rate was 57.6%; in the GV arm, the median survival was 385 days, and the 1-year survival rate was 53.3% in the GV arm. The median progression-free survival was 165 days in the GC arm and 137 days in the GV arm. Severe hematologic toxicity (Grade 4) was significantly more frequent in the GC arm (45.3% vs. 25.8% in the GV arm; P = .022). Most notably, the incidence of Grade 3 or 4 thrombocytopenia was significantly higher in the GC arm (81.3% vs. 6.5% in the GV arm; P < .001). Conversely, severe nonhematologic toxicity (Grade 3 or 4) was more common in the GV arm (7.8% vs. 19.4% in the GC arm; P = .057). CONCLUSIONS. Although the GV and GC regimens had different toxicity profiles, there was no significant difference in survival among patients with NSCLC in the current study. Cancer 2006. © 2006 American Cancer Society. |
| Databáze: | OpenAIRE |
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