Endlicher, E. and Troppmann, M. and Kullmann, A. and Goelder, S. and Herold, T. and Herfarth, H. and Grossmann, J. and Schlottmann, K. and Kullmann, Frank (2007) Irinotecan plus gemcitabine and 5-fluorouracil in advanced pancreatic cancer: A phase II study. ONCOLOGY, 72 (5-6). pp. 279-284. ISSN 0030-2414,
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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/m(2) irinotecan i.v. for 90 min, 1,000 mg/m(2) gemcitabine i.v. for 30 min and 2,000 mg/m(2) 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 43.5%, 1/29). In spite of antiemetic 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 (C) 2008 S. Karger AG, Basel.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DOUBLE-BLIND; TRIAL; SURVIVAL; CHEMOTHERAPY; MULTICENTER; PLACEBO; MONOTHERAPY; ADVANTAGE; CARCINOMA; THERAPY; chemotherapy; 5-fluorouracil; gemcitabine; irinotecan; pancreatic cancer |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I Medicine > Lehrstuhl für Röntgendiagnostik |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 13 Jan 2021 11:05 |
| Last Modified: | 13 Jan 2021 11:05 |
| URI: | https://pred.uni-regensburg.de/id/eprint/33497 |
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