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Investigational New Drugs

, Volume 26, Issue 1, pp 67–74 | Cite as

Pulmonary toxicity in patients treated with gemcitabine plus vinorelbine or docetaxel for advanced non-small cell lung cancer: outcome data on a randomized phase II study

  • Emilio EstebanEmail author
  • Noemi Villanueva
  • Isabel Muñiz
  • Yolanda Fernández
  • Joaquin Fra
  • Maria Luque
  • Paula Jiménez
  • Beatriz Llorente
  • Marta Capelan
  • José M. Vieitez
  • Enrique Estrada
  • José M. Buesa
  • Angel Jiménez-Lacave
PHASE II STUDIES

Summary

Studies with the gemcitabine/vinorelbine (GV) or the gemcitabine/docetaxel (GD) combinations have shown similar efficacy and less toxicity compared to platinum-based chemotherapies, in patients with advanced non-small-cell lung cancer (NSCLC). The present trial was designed to test the efficacy and safety of both, GV and GD, combinations. Chemotherapy-naïve patients (n = 39) ≤75 years of age, KPS ≥ 60% and adequate hematological, renal and hepatic function were randomly assigned to receive G 1,000 mg/m2 + either V 25 mg/m2 or D 35 mg/m2 (all of which were administered i.v.) on days 1 and 8 every 21 days. Baseline characteristics were comparable in GV (n = 20) and GD (n = 19) groups. Results indicated objective response of 7 (35%) vs 6 (31%) patients and median time-to-treatment failure of 120 versus 90 days in the GV and GD arms, respectively. The most common non-hematological toxicities were (GV vs GD): grade 2–4 pulmonary toxicity in 1 (5%) vs 7 (37%); grade 2–3 diarrhea 0 versus 4 (21%) and edema 1 (5%) vs 3 (16%); grade 3–4 hematological toxicities occurred in 3 (15%) vs 1 (5%) patients. Our results indicate that the combination of gemcitabine/docetaxel does not have a favorable safety profile with this schedule of administration, particularly in terms of pulmonary toxicity.

Keywords

Non-small-cell lung cancer Vinorelbine Gemcitabine Docetaxel Pulmonary toxicity 

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Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Emilio Esteban
    • 1
    Email author
  • Noemi Villanueva
    • 1
  • Isabel Muñiz
    • 1
  • Yolanda Fernández
    • 1
  • Joaquin Fra
    • 1
  • Maria Luque
    • 1
  • Paula Jiménez
    • 1
  • Beatriz Llorente
    • 1
  • Marta Capelan
    • 1
  • José M. Vieitez
    • 1
  • Enrique Estrada
    • 1
  • José M. Buesa
    • 1
  • Angel Jiménez-Lacave
    • 1
  1. 1.Servicio de Oncología MédicaHospital Central de AsturiasOviedoSpain

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