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KMID : 0880520090450020079
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Chonnam Medical Journal
2009 Volume.45 No. 2 p.79 ~ p.86
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Phase II Study of Irinotecan, High-dose 5-fluorouracil, and Leucovorin Combination Chemotherapy in Taxane and Cisplatin-based Chemotherapy-refractory Metastatic Gastric Cancer
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Yoon Ju-Young
Chung Ik-Joo
Cho Sang-Hee
Cho Dae-Ho
Bae Woo-Kyun
Lee Sung-Ji
Rew Sung-Yoon
Kim Dae-Eun
Hwang Jun-Eul
Shim Hyun-Jeong
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Abstract
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This phase II study evaluated the efficacy and safety of combination chemotherapy with irinotecan, highdose 5-fluorouracil (5-FU), and leucovorin as a second line of treatment in metastatic gastric cancer refractory to taxane and cisplatin-based chemotherapy. Eligible criteria were as follows: histologically confirmed adenocarcinoma of the stomach previously treated with taxane and cisplatin, age≥18 years, Eastern Clinical Oncology Group (ECOG) performance status of 1 or less, and adequate organ function. Irinotecan (150 mg/m2) and leucovorin (200 mg/m2) were given on day 1, followed by a 400-mg/m2 bolus infusion of 5-FU and then 2,400 mg/m2 5-FU as a 48-hour continuous infusion. This cycle was repeated
every 2 weeks until disease progression or unacceptable toxicities. Thirty-seven patients were enrolled. The patients’ median age was 55 years (range, 27∼73 years), and the ECOG performance status of all patients was 1. All patients were evaluable for safety and survival, and 29 patients (78.3%) were evaluable for tumor response. The overall response rate was 17.2% [95% confidence interval (CI): 3.5∼30.9%]. The median progression-free survival and overall survival were 4.3 months (95% CI: 2.1∼6.6) and 10.6 months (95% CI: 7.1∼14.1). Greater than grade 3 hematological toxicities were neutropenia in 9 (24.3%), febrile neutropenia in 1 (2.7%), and thrombocytopenia in 1 (2.7%) patient. The major nonhematological toxicity was asthenia, but most patients showed grade 1 or 2. Greater than grade 3 nonhematological toxicities were elevated AST/ALT in 4 (10.8%), hyperbilirubinemia in 2 (5.4%), and nausea in 2 (5.4%) patients. This
study showed that combination chemotherapy with irinotecan, high dose 5-FU, and leucovorin is well tolerated and active in patients with cancer refractory to taxane and cisplatin.
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KEYWORD
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Stomach neoplasms, Irinotecan, Chemotherapy
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