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A phase II randomized trial of gemcitabine-docetaxel versus gemcitabine-cisplatin in patients with advanced non-small cell lung carcinoma

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Abstract

Purpose

To test efficacy and tolerability of non-platinum regimens for advanced non-small-cell lung cancer (NSCLC).

Methods

Chemonaive patients with measurable stage IIIB/IV NSCLC treated with gemcitabine and cisplatin (GC), or gemcitabine and docetaxel (GD), maximumsix cycles in a phase IIB trial.

Results

A total of 108 patients were randomized. Response rates (GC vs. GD, respectively): complete 3.6/2.0%, Partial 30.9/38.0%. Median Overall Survival (OS): 8.9 months in both groups (P = 0.53); and median time to progression (TTP): 6.2/5.5 months respectively (P = 0.61). Toxicities included (GC vs. GD, respectively): grade 3–4 neutropenia 49.1/41.2%; grade 3 thrombocytopenia 30.9/3.9%; grade 3 anemia 14.5/3.9%. Non-haematological toxicity was similar, except for nausea and vomiting, (16.3/2%); renal toxicity (3.7/0%) and hepatic toxicity (5.6/12.7%).

Conclusions

With a higher overall response rate and lower toxicity, GD is a good first treatment option for advanced NSCLC.

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Acknowledgments

The authors would like to thank all members of the Galician Group of Lung Cancer (GGCP in the Spanish acronym) and the team members who participated in this study. They would also like to thank Dr. Ariadna Lloansí, Clinical Coordinator of the Oncology Business Unit of Sanofi-Aventis, and Dr. Carlos M Hortelano, Medical Writing Director of AAI Pharma for their technical contribution to this manuscript preparation. The authors would finally thank AAI Pharma, Madrid, Spain, for the data management and statistical analysis activities associated with this study. These results were in part presented at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GE, USA, 2–6 June 2006 and at the 31st Annual Meeting of the European Society of Medical Oncology, Istanbul, Turkey, 29 September–03 Oct 2006.

Funding and competing interest: This study was supported by the Galician Group of Lung Cancer (GGCP in the Spanish acronym).

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Authors and Affiliations

  1. Department of Medical Oncology, Hospital do Meixoeiro, C/Meixoeiro, s/n, 36200, Vigo (Pontevedra), Spain

    Joaquín Casal Rubio, G. Huidobro & M. Lázaro

  2. Complejo Hospitalario Xeral-Calde, Lugo, Spain

    S. Vázquez, J. R. Mel & E. Álvarez

  3. Hospital Arquitecto Marcide, Ferrol, Spain

    F. Vázquez

  4. Centro Oncológico de Galicia, A Coruña, Spain

    M. Amenedo

  5. Complejo Hospitalario, Ourense, Spain

    J. L. Fírvida

  6. Hospital Juan Canalejo, A Coruña, Spain

    G. Alonso

  7. Hospital Montecelo, Pontevedra, Spain

    I. Fernández

Authors
  1. Joaquín Casal Rubio
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  2. S. Vázquez
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  3. F. Vázquez
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  4. M. Amenedo
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  5. J. L. Fírvida
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  6. J. R. Mel
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  7. G. Huidobro
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  8. E. Álvarez
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  9. M. Lázaro
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As representatives of the Galician Group of Lung Cancer (GGCP in the Spanish acronym)

Corresponding author

Correspondence to Joaquín Casal Rubio.

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Rubio, J.C., Vázquez, S., Vázquez, F. et al. A phase II randomized trial of gemcitabine-docetaxel versus gemcitabine-cisplatin in patients with advanced non-small cell lung carcinoma. Cancer Chemother Pharmacol 64, 379–384 (2009). https://doi.org/10.1007/s00280-008-0884-6

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  • DOI: https://doi.org/10.1007/s00280-008-0884-6

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