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
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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