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Cisplatin plus gemcitabine on days 1 and 4 every 21 days for solid tumors: Result of a dose-intensity study

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Summary

Background: Three and 4-week cisplatin-gemcitabine schedules have shown similar dose-intensity (DI) and activity in non-small-cell lung cancer (NSCLC). The 3-week schedule is generally preferred because it enables better treatment compliance. To improve DI and compliance further, we delivered gemcitabine plus cisplatin over 4 days every 21 days.

Methods: Patients with any stage NSCLC or epithelial neoplasms and an ECOG PS ≤2 were given gemcitabine 1000 mg/m2 on days 1 and 4 plus cisplatin 70 mg/m2 on day 2 of a 21-day cycle. Minimax design was used and a received DI for gemcitabine of ≥580 mg/m2/wk was considered successful.

Results: Thirty-nine patients (34 NSCLC, 5 epithelial neoplasias) were enrolled. SWOG grade 3–4 neutropenia and thrombocytopenia were observed in 17.9% and 12.8% of patients, respectively. Nonhematological toxicity was minimal. Twenty-eight (18%) of 158 cycles required dose modifications and/or delays. Twenty-five patients received a gemcitabine dose intensity of ≥580 mg/m2/wk. The received DIs were 601.8 mg/m2/wk for gemcitabine and 21.0 for cisplatin, with a relative DIs of 90.3% and 90.1%, respectively. The response rate of 27 evaluable patients with NSCLC was 44% (95% confidence interval [CI], 25.3 to 62.7%).

Conclusions: The shorter schedule of gemcitabine on days 1 and 4 plus cisplatin on day 2 produces an effective DI and a toxicity profile comparable to that of weekly regimens.

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Authors and Affiliations

  1. Department of Medical Oncology and Hematology, Istituto Clinico Humanitas, Via Manzoni, 56 Rozzano-Milan, Rozzano, 20089, Italy

    Hector Soto Parra, Raffaele Cavina, Fiorenza Latteri, Elisabetta Campagnoli & Armando Santoro

  2. Clinical Sperimentation Office, Istituto Clinico Humanitas, Via Manzoni, 56 Rozzano-Milan, 20089, Rozzano, Italy

    Emanuela Morenghi

  3. Department of Oncology, Biometry Unit, Istituto di Ricerca Farmacologica, Mario Negri, Rozzano, Italy

    Walter Torri

  4. Division of Diagnostic Radiology, Istituto Clinico Humanitas, Via Manzoni, 56 Rozzano-Milan, Rozzano, 20089, Italy

    Giorgio Brambilla

  5. Division of Thoracic Surgery, Istituto Clinico Humanitas, Via Manzoni, 56 Rozzano-Milan, Rozzano, 20089, Italy

    Marco Alloisio

Authors
  1. Hector Soto Parra
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  2. Raffaele Cavina
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  3. Fiorenza Latteri
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  4. Elisabetta Campagnoli
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  5. Emanuela Morenghi
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  6. Walter Torri
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  7. Giorgio Brambilla
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  8. Marco Alloisio
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  9. Armando Santoro
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Correspondence to Hector Soto Parra.

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Parra, H.S., Cavina, R., Latteri, F. et al. Cisplatin plus gemcitabine on days 1 and 4 every 21 days for solid tumors: Result of a dose-intensity study. Invest New Drugs 25, 57–62 (2007). https://doi.org/10.1007/s10637-006-8220-7

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