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Prospective Phase I Study of Capecitabine and Oxaliplatin Concurrent with Radiation Therapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma, and Retrospective Comparison to Concurrent 5-Fluorouracil/Radiation and Gemcitabine/Radiation

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Abstract

Purpose

The aims of this study is to determine the maximum tolerated dose of capecitabine and oxaliplatin (CAPOX) delivered concurrent with radiation therapy (RT) in the treatment of locally advanced pancreatic adenocarcinoma and to retrospectively compare outcomes with this regimen to concurrent 5-fluorouracil or capecitabine with RT (5FU-RT) or concurrent gemcitabine-based chemotherapy with RT (GEM-RT).

Materials and Methods

Twelve patients were enrolled in a phase I study using 50.4 Gy RT concurrent with capecitabine chemotherapy (twice daily, 7 days per week) and oxaliplatin (once weekly during weeks 1, 2, 4, and 5). Capecitabine and oxaliplatin doses were 400 mg/m2 and 50 mg/m2, respectively, at dose level 1; 600 mg/m2 and 50 mg/m2 at level 2; and 600 mg/m2 and 60 mg/m2 at level 3. A standard dose of gemcitabine was recommended following RT or following surgery (if done). The outcomes of patients treated with this regimen were retrospectively compared to 20 patients treated with 5FU-RT and 30 patients treated with GEM-RT.

Results

Dose level 3 was tolerated with acceptable toxicity. Survival in patients receiving CAPOX-RT did not differ from GEM-RT or 5FU-RT. Response of the primary tumor was observed in 38% of patients treated with CAPOX-RT, 31% of patients treated with 5FU-RT, and 66% of patients treated with GEM-RT (p = 0.03 GEM-RT versus 5FU-RT).

Conclusions

CAPOX-RT has acceptable toxicity. A retrospective comparison shows higher response rate with GEM-RT versus 5FU-RT, but this difference did not translate into improvement in overall survival.

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Authors and Affiliations

  1. Department of Radiation Oncology, University of Arizona, 1501 N Campbell Ave., P.O. Box 245081, Tucson, AZ, 85724-5081, USA

    Lisa Hazard

  2. Department of Radiation Oncology, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA

    Christopher Anker

  3. Department of Medical Oncology, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA

    Kimberly Jones & John Weis

  4. Department of Surgery, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA

    Courtney Scaife & Sean Mulvihill

  5. Department of Radiology, University of Utah, Salt Lake City, UT, USA

    Akram Shaban

Authors
  1. Lisa Hazard
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  2. Kimberly Jones
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  3. Akram Shaban
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  4. Christopher Anker
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  5. Courtney Scaife
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  6. John Weis
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  7. Sean Mulvihill
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Correspondence to Lisa Hazard.

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Hazard, L., Jones, K., Shaban, A. et al. Prospective Phase I Study of Capecitabine and Oxaliplatin Concurrent with Radiation Therapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma, and Retrospective Comparison to Concurrent 5-Fluorouracil/Radiation and Gemcitabine/Radiation. J Gastrointest Canc 43, 258–266 (2012). https://doi.org/10.1007/s12029-011-9251-7

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  • DOI: https://doi.org/10.1007/s12029-011-9251-7

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