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24 April 2011

Palliative first-line therapy with weekly high-dose 5-fluorouracil and sodium folinic acid as a 24-hour infusion (AIO regimen) combined with weekly irinotecan in patients with metastatic adenocarcinoma of the stomach or esophagogastric junction followed by secondary metastatic resection after downsizing

Kathrin KouckyABCDEF, Axel WeinABCDEFG, Peter C. KonturekDE, Heinz AlbrechtB, Udo ReulbachCD, Gudrun MannleinE, Kerstin WolffB, Nicola OstermeierB, Dagmar BusseB, Henriette GolcherD, Claus SchildbergD, Rolf JankaB, Werner HohenbergerDE, Eckhart G. HahnD, Jurgen SieblerDE, Markus F. NeurathD, Frank BoxbergerABCDEFG

DOI: 10.12659/MSM.881764

Med Sci Monit 2011; 17(5): CR248-258

Abstract

Background: The aim of this retrospective study was to evaluate the efficacy and safety of weekly high-dose 5-fluorouracil (5-FU)/folinic acid (FA) as 24-h infusion (AIO regimen) plus irinotecan in patients with histologically proven metastatic gastroesophageal adenocarcinoma (UICC stage IV).
Material/Methods: From 08/1999 to 12/2008, 76 registered, previously untreated patients were evaluable. Treatment regimen: irinotecan (80 mg/m²) as 1-h infusion followed by 5-FU (2000 mg/m²) combined with FA (500 mg/m²) as 24-h infusion (d1, 8, 15, 22, 29, 36, qd 57).
Results: Median age: 59 years; male/female: 74%/26%; ECOG ≤1: 83%; response: CR: 1%, PR: 16%, SD: 61%, PD: 17%, not evaluable in terms of response: 5%; tumor control: 78%; median OS: 11.2 months; median time-to-progression: 5.3 months; 1-year survival rate: 49%; 2-year survival rate: 17%; no evidence of disease: 6.6%; higher grade toxicities (grade 3/4): anemia: 7%, leucopenia: 1%, ascites: 3%, nausea: 3%, infections: 12%, vomiting: 9%, GI bleeding of the primary tumor: 4%, diarrhea: 17%, thromboembolic events: 4%; secondary metastatic resection after downsizing: 16 patients (21%), R-classification of secondary resections: R0/R1/R2: 81%/6%/13%, median survival of the 16 patients with secondary resection: 23.7 months.
Conclusions: Combined 5-FU/FA as 24-h infusion plus irinotecan may be considered as an active palliative first-line treatment accompanied by tolerable toxicity; thus offering an alternative to cisplatin-based treatment regimens. Thanks to efficient interdisciplinary teamwork, secondary metastatic resections could be performed in 16 patients. In total, the patients who had undergone secondary resection had a median survival of 23.7 months, whereas the median survival of patients without secondary resection was 10.1 months (p≤0.001).

Keywords: Kaplan-Meier Estimate, Infusions, Intravenous, Fluorouracil - therapeutic use, Esophagogastric Junction - pathology, Esophageal Neoplasms - surgery, Drug Administration Schedule, Dose-Response Relationship, Drug, Camptothecin - therapeutic use, Antineoplastic Combined Chemotherapy Protocols - therapeutic use, Antineoplastic Agents - therapeutic use, Adenocarcinoma - surgery, Leucovorin - therapeutic use, Palliative Care, Prognosis, Stomach Neoplasms - surgery

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750