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Vol. 72, No. 5-6, 2007
Issue release date: February 2008
Oncology 2007;72:279–284

Irinotecan plus Gemcitabine and 5-Fluorouracil in Advanced Pancreatic Cancer: A Phase II Study

Endlicher E. · Troppmann M. · Kullmann A. · Gölder S. · Herold T. · Herfarth H. · Grossmann J. · Schlottmann K. · Kullmann F.
aDepartment of Internal Medicine I and bInstitute of Radiology, University of Regensburg, Regensburg, Germany

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Aims: The aim of the present study was to evaluate the 6-month survival rate of patients with inoperable or metastatic pancreatic cancer treated with irinotecan and gemcitabine plus 5-fluorouracil. Secondary efficacy end points included response rate, time to progression (TTP), overall survival (OS) and toxicity. Patients and Methods: 30 patients with histologically proven pancreatic carcinoma and at least one bidimensionally measurable lesion were enrolled. Of the patients, 83% had metastatic and 17% locally advanced disease. One cycle, lasting 21 days, comprised treatment on days 1 and 8 consisting of 75 mg/m2 irinotecan i.v. for 90 min, 1,000 mg/m2 gemcitabine i.v. for 30 min and 2,000 mg/m2 fluorouracil (5-FU) for 24 h. A total of six cycles was planned for each patient. Results: 28 patients competed at least one treatment cycle and were therefore assessable for efficacy, and 75% of them achieved the primary end point of the study (survival after 6 months). One-year survival was 25%. Stabilization (partial response and stable disease) was observed in 35.7% (10/28) and partial remission in 7.1% (2/28). The objective response rate was 7.1% (2/28) after completion of the six cycles. Median TTP was 3.4 months (1.2–11.5), and median OS was 8.3 months (2.1–36.2). Regarding severe hematological toxicities, only neutropenia was observed (grade 3 20.7%, 6/29, and grade 4 3.5%, 1/29). In spite of anti-emetic supportive care, nausea affected most of the patients: 79.3% (23/29). Grade 3 vomiting was observed in 4 of the 29 patients (13.8%) and grade 4 in 1 patient (3.5%). Only 1 patient experienced diarrhea grade 3 (3.5%) and 1 patient (3.5%) suffered from a grade 3 peroneal nerve enervation. Conclusions: A combination of irinotecan, gemcitabine and 5-FU is feasible and shows considerable efficacy in patients with inoperable or metastatic pancreatic cancer. Due to its low toxicity, this combination might be an interesting cytotoxic regimen in addition to targeted therapies.

Copyright / Drug Dosage

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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  1. Jemal A, Tiwari RC, Murray T, et al: Cancer statistics, 2004. CA Cancer J Clin 2004;54:8–29.
  2. Mallinson CN, Rake MO, Cocking JB, et al: Chemotherapy in pancreatic cancer: results of a controlled, prospective, randomised, multicentre trial. Br Med J 1980;281:1589–1591.
  3. Palmer KR, Kerr M, Knowles G, et al: Chemotherapy prolongs survival in inoperable pancreatic carcinoma. Br J Surg 1994;81:882–885.
  4. Glimelius B, Hoffman K, Sjoden PO, et al: Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol 1996;7:593–600.
  5. Shore S, Raraty MGT, Ghaneh P, et al: Review article: chemotherapy for pancreatic cancer. Aliment Pharmacol Ther 2003;18:1049–1069.
  6. Burris HA, Moore MJ, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997;15:2403–2413.
  7. Rocha Lima CM, Savarese D, Bruckner H, et al: Irinotecan plus gemcitabine induces both radiographic and CA19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer J Clin Oncol 2002;20:1182–1191.
  8. Rocha Lima CM, Green MR, Rotche R, et al: Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate. J Clin Oncol 2004;22:3776–3786.
  9. Shiah HS, Cheng AL, Hsu C, et al: Phase I–II trial of weekly gemcitabine plus high-dose 5-fluorouracil and leucovorin in advanced pancreatic cancer. J Gastroenterol Hepatol 2006;21:531–536.
  10. Bahadori HR, Rocha Lima CM, Green MR, et al: Synergistic effect of gemcitabine and irinotecan (CPT-11) on breast and small cell lung cancer cell lines. Anticancer Res 1999;19:5423–5428.
  11. Schlottmann K, Friedrich A, Messmann H, et al: A phase I study of irinotecan (I), gemcitabine (G), and 5-fluorouracil (5-FU) in patients with advanced gastrointestinal cancers. Eur J Cancer 2001;37(suppl 6):A1066.
  12. Miller AB, Hoogstraten B, Staquet M, et al: Reporting results of cancer treatment. Cancer 1981;47:207–214.
  13. Van Cutsem E, van de Velde H, Karasek P, et al: Phase III trial of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in advanced pancreatic cancer. J Clin Oncol 2004;22:1430–1438.
  14. Moore MJ, Hamm J, Dancey J, et al: Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced or metastatic adenocarcinoma of the pancreas: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2003;21:3296–3302.
  15. Bramhall SR, Schulz J, Nemunaitis J, et al: A double-blind placebo controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. Br J Cancer 2002;87:161–167.
  16. Richards DA, Boehm KA, Waterhouse DM, et al: Gemcitabine plus CI-994 offers no advantage over gemcitabine alone in the treatment of patients with advanced pancreatic cancer: results of a phase II randomized, double-blind, placebo-controlled, multicenter study. Ann Oncol 2006;17:1096–1102.
  17. Heinemann V, Labianca R, Hinke A, Louvet C: Increased survival using platinum analog combined with gemcitabine as compared to single agent gemcitabine in advanced pancreatic cancer: pooled analysis of two randomized trials, the GERCOR/GISCAD Intergroup Study and a German multicenter study. Ann Oncol 2007;18:1652–1659.
  18. Storniolo AM, Enas MH, Brown CA, et al: An investigational new drug treatment program for patients with gemcitabine. Cancer 1999;85:1261–1268.
  19. Stathopoulos GP, Syrigos K, Aravantinos G, et al: A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer. Br J Cancer 2006;95:587–592.
  20. Abou-Alfa GK, Letourneau R, Harker G, et al: Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer. J Clin Oncol 2006;24:4441–4447.
  21. Cunningham D, Chau I, Stocken D, et al: Phase III randomized comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. Eur J Cancer 2005;3(suppl 4):PS11.

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