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Fixed dose-rate gemcitabine infusion as first-line treatment for advanced-stage carcinoma of the pancreas and biliary tree

  1. Alain Gelibter M.D.1,
  2. Paola Malaguti M.S.1,
  3. Serena Di Cosimo M.D.1,
  4. Emilio Bria M.D.2,
  5. Enzo Maria Ruggeri M.D.1,
  6. Paolo Carlini M.D.1,
  7. Fabio Carboni M.D., Ph.D.3,
  8. Giuseppe Maria Ettorre M.D.3,
  9. Mario Pellicciotta M.S.4,
  10. Diana Giannarelli M.S.4,
  11. Edmondo Terzoli M.D.2,
  12. Francesco Cognetti M.D.1,
  13. Michele Milella M.D.1,†,*

Article first published online: 2 AUG 2005

DOI: 10.1002/cncr.21286

Issue

Cancer

Cancer

Volume 104, Issue 6, pages 1237–1245, 15 September 2005

Additional Information

How to Cite

Gelibter, A., Malaguti, P., Di Cosimo, S., Bria, E., Ruggeri, E. M., Carlini, P., Carboni, F., Ettorre, G. M., Pellicciotta, M., Giannarelli, D., Terzoli, E., Cognetti, F. and Milella, M. (2005), Fixed dose-rate gemcitabine infusion as first-line treatment for advanced-stage carcinoma of the pancreas and biliary tree. Cancer, 104: 1237–1245. doi: 10.1002/cncr.21286

Author Information

  1. 1

    Division of Medical Oncology A, Regina Elena National Cancer Institute, Rome, Italy

  2. 2

    Division of Medical Oncology C, Regina Elena National Cancer Institute, Rome, Italy

  3. 3

    Division of Digestive Surgery and Liver Transplantation, Regina Elena National Cancer Institute, Rome, Italy

  4. 4

    Division of Biostatistics, Regina Elena National Cancer Institute, Rome, Italy

  1. †

    Fax: (011) 39-06-5266-5637

*Division of Medical Oncology A, Regina Elena National Cancer Institute, Via Elio Chianesi, 53, 00144 Rome, Italy

Publication History

  1. Issue published online: 31 AUG 2005
  2. Article first published online: 2 AUG 2005
  3. Manuscript Accepted: 11 MAY 2005
  4. Manuscript Revised: 26 FEB 2005
  5. Manuscript Received: 20 OCT 2004

Funded by

  • Italian Ministry of Health. Grant Number: R.F. 02/184

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Keywords:

  • fixed dose rate;
  • gemcitabine;
  • pancreatic carcinoma;
  • biliary tree carcinoma;
  • carbohydrate antigen 19-9

Abstract

BACKGROUND

Gemcitabine infusion at the fixed dose rate of 10 mg/m2 per minute (FDR-gemcitabine) has pharmacokinetic advantages and may result in improved therapeutic efficacy.

METHODS

Between April 2002 and September 2003, 40 patients with advanced-stage pancreatic adenocarcinoma (PDAC; n = 27) or biliary tree carcinoma (BTC; n = 13) were treated with weekly FDR-gemcitabine (1000 mg/m2). The primary end point was the response rate. The secondary end points were progression-free and overall survival (PFS and OS), tumor marker response, and clinical benefit response (CBR).

RESULTS

The overall response rate (ORR) on an intent-to-treat basis was 15% (95% confidence interval [95% CI], 4–26%). A positive CBR was obtained in 14 of 29 (48%) patients. Seventeen of 25 (68%) patients had a reduction in carbohydrate antigen 19-9 (CA 19-9) of > 25%. The median time to treatment failure and the median PFS were 17 weeks (95% CI, 13–22 weeks) and 19 weeks (95% CI, 15–23 weeks), respectively. The median OS was 40 weeks (95% CI, 36–45 weeks) and the 1-year actuarial survival rate was 25.8%. Multivariate analysis showed that a performance status score of 0–1 at study entry and locally advanced disease were the only independent predictors of longer PFS and OS, whereas a reduction in CA 19-9 serum levels > 75% was an independent predictor of longer PFS, but had no impact on OS. Toxicity was mild with Grade 3–4 neutropenia (according to the National Cancer Institute-Common Toxicity Criteria [version 2.0]) in 18 of 427 treatment weeks (4.2%), and Grade 3 anemia and thrombocytopenia in 6 of 427 treatment weeks (1.4%) and 9 of 427 treatment weeks (2.1%), respectively, and asymptomatic Grade 3–4 transaminase elevation in 21 of 427 treatment weeks (4.9%).

CONCLUSIONS

FDR-gemcitabine at the weekly dose of 1000 mg/m2 demonstrated promising activity, despite negligible toxicity, in patients with advanced-stage PDAC and BTC. Cancer 2005. © 2005 American Cancer Society.

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