Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas

Results of a phase II trial

Authors

  • Palma Dileo MD,

    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • Jeffrey A. Morgan MD,

    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • David Zahrieh MS,

    1. Department of Biostatistics and Computational Biology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • Jayesh Desai MD,

    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • Jeanine M. Salesi BSBA,

    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • David C. Harmon MD,

    1. Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts
    Search for more papers by this author
  • M. Travis Quigley RN,

    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • Kathleen Polson NP,

    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • George D. Demetri MD,

    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    Search for more papers by this author
  • Suzanne George MD

    Corresponding author
    1. Department of Medical Oncology, Center for Sarcoma and Bone Oncology and Ludwig Center for Cancer Research, Dana-Farber Cancer Institute, Boston, Massachusetts
    • Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115
    Search for more papers by this author
    • Fax: (617) 632-3408


  • All patients provided written informed consent in accordance with federal and institutional guidelines.

Abstract

BACKGROUND.

Single-agent gemcitabine and vinorelbine have activity in treatment of patients with soft-tissue sarcomas. The combination of gemcitabine plus vinorelbine has activity against several forms of metastatic carcinoma with acceptable toxicity. This study evaluated the efficacy and tolerability of gemcitabine plus vinorelbine in advanced soft-tissue sarcoma.

METHODS.

A single academic center performed this phase II trial. Eligible patients had unresectable or metastatic soft-tissue sarcomas, Eastern Cooperative Group performance status of 0–2, adequate organ function, and ≤1 prior regimen. Gemcitabine 800 mg/m2 was given over 90 minutes on Days 1 and 8 of a 21-day cycle after administration of vinorelbine 25 mg/m2. Dosing schedule was modified for toxicity (doses constant but administered on Days 1 and 15 of a 28-day cycle). Dose reductions were allowed if unacceptable toxicities recurred.

RESULTS.

The study accrued 40 patients, and 248 dosing cycles were administered (range, 1–32). No treatment-related deaths occurred. Of 9 episodes of grade 4 toxicities, 8 were hematologic. Of 38 episodes of grade 3 toxicity, 24 were hematologic. Clinical benefit was seen in 25% of patients and was defined as complete response (CR), partial response (PR), or stable disease (SD) at >4 months. There has been 1 CR lasting >1 year in a patient with high-grade pleomorphic spindle-cell sarcoma.

CONCLUSIONS.

Gemcitabine given by a fixed-dose rate of infusion combined with vinorelbine was associated with clinically meaningful rates of disease control in patients with advanced soft-tissue sarcoma. Toxicity was acceptable. This study contributed to data that have supported the administration of fixed-dose rate gemcitabine-based drug regimens in soft-tissue sarcomas. Cancer 2007. © 2007 American Cancer Society.

Ancillary