Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer

Authors

  • Henry Q. Xiong MD, PhD,

    1. Center for Cancer and Blood Disorders, Fort Worth, Texas
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    • The first 2 authors contributed equally to this work.

  • Gauri R. Varadhachary MD,

    Corresponding author
    1. Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
    • Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Box 426, Houston, TX 77030
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    • The first 2 authors contributed equally to this work.

    • Fax: (713) 745-1163

  • Joan C. Blais RN,

    1. Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Kenneth R. Hess PhD,

    1. Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • James L. Abbruzzese MD,

    1. Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Robert A. Wolff MD

    1. Department of Gastrointestinal Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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Abstract

BACKGROUND.

To the authors' knowledge, there is no established second-line chemotherapy for patients with pancreatic cancer who have received gemcitabine-based therapy. A phase 2 trial was conducted to explore the efficacy of capecitabine and oxaliplatin (XELOX) in patients with advanced pancreatic cancer previously who were treated with gemcitabine.

METHODS.

Patients aged ≤65 years who had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 received oxaliplatin at a dose of 130 mg/m2 given on Day 1 and capecitabine at a dose of 1000 mg/m2 twice daily for 14 days. For patients aged >65 years or with an ECOG PS of 2, the oxaliplatin dose was 110 mg/m2 on Day 1 and the capecitabine dose was 750 mg/m2 twice daily for 14 days. The treatment was repeated every 3 weeks. Tumor measurements were performed every 9 weeks and the primary study objective was 6-month overall survival.

RESULTS.

The study enrolled 41 patients. Of the 39 evaluable patients, 1 patient had a partial response and 10 patients demonstrated stable disease. The Kaplan-Meier estimate of the overall median survival was 23 weeks (95% confidence interval [95% CI], 17.0-31.0 weeks). Progression-free survival was 9.9 weeks (95% CI, 9.6-14.5 weeks). The 6-month and 1-year survival rates were 44% (95% CI, 31%-62%) and 21% (95% CI, 11%-38%), respectively. The most common grade 3-4 nonhematologic toxicity was fatigue (toxicity was graded using the National Cancer Institute Common Toxicity Criteria [version 2.0]).

CONCLUSIONS.

The combination of capecitabine and oxaliplatin is active in gemcitabine-pretreated patients with advanced pancreatic cancer, especially in patients with a good PS and those who have responded to first-line chemotherapy. Cancer 2008. © 2008 American Cancer Society.

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