Gemcitabine/docetaxel (GD) vs gemcitabine/cisplatin (GC) in stage IIIB/IV advanced non-small cell lung cancer (NSCLC)
| Autor: | M. Lázaro Quintela, E. Alvarez Gomez, F. Vázquez Rivera, M. Amenedo Gancedo, C. Grande Ventura, J. R. Mel Lorenzo, J.L. Firvida Perez, J. Casal Rubio, S. Vazquez Estevez, R. Lopez Lopez |
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| Rok vydání: | 2006 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 24:17017-17017 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2006.24.18_suppl.17017 |
| Popis: | 17017 Background: This trial was designed to compare, in terms of response rates, the standard regimen gemcitabine/cisplatin versus a non-platin regimen, gemcitabine-docetaxel in NSCLC. Methods: The chemotherapy regimens administered were: Arm A: gemcitabine 1250 mg/m2 d1 & 8 plus cisplatin 75 mg/m2 d1; Arm B: gemcitabine 1000 mg/m2 d1 & 8 plus docetaxel 85 mg/m2 d1 repeated every three weeks. Eligibility criteria were measurable stage IV or stage IIIB with pleural effusion NSCLC (brain metastases eligible if asymptomatic) and PS (ECOG Scale) = 0–2. Results: 108 patients (pts) were included between January 2001 and August 2004, 56 in arm A and 52 in arm B. For arm A median age was 59.9 (69.7–50.1); PS 0–1: 83.3%, PS 2: 16.7; Stage IIIB/IV: 18.2/81.8%, For arm B median age was 61.4 (70.4–52.4); PS 0–1: 84%, PS 2: 16%; Stage IIIB/IV: 14/86%. A median number of 5 cycles in arm A and 4 in arm B were administered. Response rates from the 105 eligible patients were: Arm A (55 pts): CR 3.8%, PR 32.1%, SD 32.1%; Arm B (50 pts): CR 2.3%, PR 44.2%, SD 20.9%. Median overall survival (OS) was the same in both arms, 8.9 months (6.3–10.5) in arm A and 8.9 months (3.9–10) in arm B (p = 0.525); median time to progression disease (TTPD) was 6 months (4.2–7.1) in arm A and 5.5 months (4.1–7.2) in arm B (p = 0.607). Toxicities include, in Arms A and B respectively: Grade 3–4 neutropenia 49.1% and 41.2%, with neutropenic fever in 1.8% and 2%; Grade 3/4 thrombocytopenia 30.9/0% and 3.9/0%; Grade 3/4 anemia 14.5/0% and 3.9/0%. Non-hematological toxicity grades 3–4 were similar in both arms, with the exception of nausea and vomiting, (16.3% and 2% in arm A and B respectively); renal and hepatic toxicity (hepatic 5.6% vs. 12.7% and renal 3.7% vs. 0%). Conclusions: The overall response rate was higher in the combination gemcitabine-docetaxel, although there are no significant differences in OS and TTPD. GD is an active non-platin regimen and a good first treatment option for advanced NSCLC. No significant financial relationships to disclose. |
| Databáze: | OpenAIRE |
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