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The gemcitabine, docetaxel, and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis

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An Erratum to this article was published on 09 September 2007

Abstract

Purpose

We developed a laboratory based regimen called GTX which induces synergistic apoptosis in human pancreatic cancer cells. This retrospective review summarizes our clinical experience with GTX in an initial group of 35 patients; 66% untreated and 34% failed prior therapies.

Methods

All patients treated with GTX for metastatic pancreatic cancer, prior to initiation of a prospective phase II trial of GTX were assessed and followed until death. GTX consisted of capecitabine (X), 750 mg/m2 p.o. BID on days 1–14, gemcitabine (G) (750 mg/m2) over 75 min and docetaxel (T) (30 mg/m2) on days 4 and 11. Thus one cycle of GTX was 14 days with 7 days off for a 21 day cycle. Tumor assessments were repeated every 3 cycles.

Results

All 35 patients had metastatic pancreatic cancer (94% liver, 6% lung sites). Grade 3–4 hematological toxicities were: leukopenia and thrombocytopenia—both 14%, and anemia 9%, respectively. The overall response rate of all 35 patients treated with GTX (from 0.5 cycles onward) was 29% (CR/PR) by WHO criteria, and 31% had a minor response or stable disease (MR, SD). At the metastatic sites for the 35 patients, there were 9% complete (CR) and 31% partial (PR) responses (total 40%). For the 31 patients who had their primary tumor (4 patients had a prior Whipple resection), there were 13% CR and 19% PR for a response rate of 32% at the primary tumor site. Overall median progression free survival of responders was 6.3 months (95% C.I. 4.4–10.4 months) and median survival was 11.2 months (95% C.I. 8.1–15.1 months). Survival after initiation of GTX at 12, 18, 24 and 30 months was 43, 29, 20, and 11%, respectively.

Conclusion

Our retrospective review suggests that GTX has potential as a regimen for untreated and treated metastatic pancreatic cancer.

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Acknowledgments

We wish to thank the Marcove and Manelski Family Foundations, Susan Grant Kaplansky Memorial Fund and the Herbert Irving Scholar Award for support of these clinical and laboratory studies to RLF. The clinical expertise of our Data Collector, Cara DeRosa, and Research Nurse, Kyung Chu, was invaluable to this report. We also thank Susan Bronson and Gina Egan for their excellent assistance in the preparation of this manuscript. This paper is dedicated to the memory and courage of Denis Manelski who was one of the first patients to receive GTX and lived 3 years with metastatic (liver) pancreatic cancer.

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Authors and Affiliations

  1. Experimental Therapeutics Program, Division of Medical Oncology, Department of Medicine, New York Presbyterian Medical Center, Columbia University College of Physicians and Surgeons, and The Pancreas Center at Columbia, New York, NY, USA

    Robert L. Fine, David R. Fogelman & William Sherman

  2. Oncology and Hematology Specialists, Morristown Memorial Hospital, Morristown, NJ, USA

    Stephen M. Schreibman

  3. Department of Biostatistics, Mailman School of Public Health, New York Presbyterian Medical Center, Columbia University College of Physicians and Surgeons, and The Pancreas Center at Columbia, New York, NY, USA

    Manisha Desai

  4. U.S. Oncology Associates, Dallas, TX, USA

    James Strauss

  5. Texas Cancer Associates, Dallas, TX, USA

    Susan Guba

  6. Hematology-Oncology Associates, Poughkeepsie, NY, USA

    Riolan Andrade

  7. Whipple Service, Department of Surgery, New York Presbyterian Medical Center, Columbia University College of Physicians and Surgeons, and The Pancreas Center at Columbia, New York, NY, USA

    John Chabot

  8. Division of Medical Oncology, Columbia University Medical Center, 650 West 168th Street, Room 20-05, New York, NY, 10032, USA

    Robert L. Fine

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  1. Robert L. Fine
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  2. David R. Fogelman
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  7. Susan Guba
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Correspondence to Robert L. Fine.

Additional information

An erratum to this article can be found at http://dx.doi.org/10.1007/s00280-007-0569-6

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Fine, R.L., Fogelman, D.R., Schreibman, S.M. et al. The gemcitabine, docetaxel, and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis. Cancer Chemother Pharmacol 61, 167–175 (2008). https://doi.org/10.1007/s00280-007-0473-0

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