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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

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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).

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Acknowledgments

The study was supported by Sanofi-Aventis Italy.

Conflict of interest

Francesco Grossi, Filippo de Marinis, Vittorio Gebbia, Ferdinando Riccardi, Orazio Caffo, Teresa Gamucci, Francesco Ferraù, Mario Nardi, Luca Moscetti, Luca Boni, Enzo Galligioni have no conflicts of interest. Davide Dondi is full employee of Sanofi-Aventis.

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Authors and Affiliations

  1. Istituto Nazionale per la Ricerca sul Cancro, S.S. Tumori Polmonari, Largo R. Benzi, 10, 16132, Genoa, Italy

    Francesco Grossi

  2. Ospedale S. Camillo Forlanini, Rome, Italy

    Filippo de Marinis

  3. Casa di Cura La Maddalena, Palermo, Italy

    Vittorio Gebbia

  4. Ospedale Cardarelli, Naples, Italy

    Ferdinando Riccardi

  5. Ospedale S. Chiara, Trento, Italy

    Orazio Caffo & Enzo Galligioni

  6. P.O. SS. Trinità, Sora-Frosinone, Italy

    Teresa Gamucci

  7. Ospedale San Vincenzo, Taormina, Italy

    Francesco Ferraù

  8. Ospedali Riuniti, Reggio Calabria, Italy

    Mario Nardi

  9. Ospedale Belcolle, Viterbo, Italy

    Luca Moscetti

  10. AOU Careggi and Istituto Toscano Tumori, Florence, Italy

    Luca Boni

  11. Medical Department, Sanofi-Aventis, Italy

    Davide Dondi

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  1. Francesco Grossi
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  2. Filippo de Marinis
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Corresponding author

Correspondence to Francesco Grossi.

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Grossi, F., de Marinis, F., Gebbia, V. et al. 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. Cancer Chemother Pharmacol 69, 369–375 (2012). https://doi.org/10.1007/s00280-011-1710-0

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  • DOI: https://doi.org/10.1007/s00280-011-1710-0

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