Cancer Chemotherapy and Pharmacology

, Volume 69, Issue 2, pp 369–375

A randomised phase II trial of two sequential schedules of docetaxel and cisplatin followed by gemcitabine in patients with advanced non-small-cell lung cancer

  • Francesco Grossi
  • Filippo de Marinis
  • Vittorio Gebbia
  • Ferdinando Riccardi
  • Orazio Caffo
  • Teresa Gamucci
  • Francesco Ferraù
  • Mario Nardi
  • Luca Moscetti
  • Luca Boni
  • Davide Dondi
  • Enzo Galligioni
Original Article

DOI: 10.1007/s00280-011-1710-0

Cite this article as:
Grossi, F., de Marinis, F., Gebbia, V. et al. Cancer Chemother Pharmacol (2012) 69: 369. doi:10.1007/s00280-011-1710-0

Abstract

Purpose

The aim of this study was to determine the activity and toxicity of two sequential chemotherapy regimens in the first-line treatment of advanced non-small-cell lung cancer (NSCLC).

Methods

Eighty-eight chemonaive patients with stage IIIB/IV NSCLC were randomised to receive either three cycles of 75 mg/m2 cisplatin plus 75 mg/m2 docetaxel, both administered on day 1 every 21 days, followed by three cycles of 1,200 mg/m2 gemcitabine on days 1 and 8 every 3 weeks (arm A), or three cycles of 25 mg/m2 cisplatin plus 25 mg/m2 docetaxel on days 1, 8 and 15 every 28 days, followed by three cycles of 1,200 mg/m2 gemcitabine on days 1 and 8 every 3 weeks (arm B).

Results

Of the evaluable patients, 61% in arm A (n = 41) and 36% (n = 44) in arm B completed treatment as per the protocol. The best tumour response rates were as follows (arm A and arm B): complete response: 2.4 and 2.3%; partial response: 39 and 20.4%; stable disease: 26.8 and 13.6%; and progressive disease: 31.8 and 45.4%. The median progression-free and overall survival were 3.9 and 12.3 months in arm A, respectively, 3.1 and 7.7 months in arm B. Grade 3–4 adverse events were more common in arm A. Grade 3–4 neutropenia was the main toxicity observed (56.1% in arm A and 11.4% in arm B).

Conclusions

Our data demonstrate the feasibility of a sequential approach of cisplatin plus docetaxel followed by single-agent gemcitabine. Weekly administration of platinum-docetaxel is associated with an improved safety profile but lower efficacy than the conventional three-weekly schedule (registration ID 2004-001044-72).

Keywords

Non-small-cell lung cancer Docetaxel Gemcitabine Cisplatin Sequential chemotherapy First-line chemotherapy 

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Francesco Grossi
    • 1
  • Filippo de Marinis
    • 2
  • Vittorio Gebbia
    • 3
  • Ferdinando Riccardi
    • 4
  • Orazio Caffo
    • 5
  • Teresa Gamucci
    • 6
  • Francesco Ferraù
    • 7
  • Mario Nardi
    • 8
  • Luca Moscetti
    • 9
  • Luca Boni
    • 10
  • Davide Dondi
    • 11
  • Enzo Galligioni
    • 5
  1. 1.Istituto Nazionale per la Ricerca sul CancroGenoaItaly
  2. 2.Ospedale S. Camillo ForlaniniRomeItaly
  3. 3.Casa di Cura La MaddalenaPalermoItaly
  4. 4.Ospedale CardarelliNaplesItaly
  5. 5.Ospedale S. ChiaraTrentoItaly
  6. 6.P.O. SS. TrinitàSora-FrosinoneItaly
  7. 7.Ospedale San VincenzoTaorminaItaly
  8. 8.Ospedali RiunitiReggio CalabriaItaly
  9. 9.Ospedale BelcolleViterboItaly
  10. 10.AOU Careggi and Istituto Toscano TumoriFlorenceItaly
  11. 11.Medical DepartmentSanofi-AventisItaly

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