Chonnam Med J.  2009 Aug;45(2):79-86. 10.4068/cmj.2009.45.2.79.

Phase II Study of Irinotecan, High-dose 5-fluorouracil, and Leucovorin Combination Chemotherapy in Taxane and Cisplatin-based Chemotherapy-refractory Metastatic Gastric Cancer

• Yoon JY
• Lee SJ
• Cho DH
• Rew SY
• Kim DE
• Hwang JE
• Bae WK
• Shim HJ
• Cho SH
• Chung IJ

• KMID: 2172265
• DOI: http://doi.org/10.4068/cmj.2009.45.2.79

Abstract

This phase II study evaluated the efficacy and safety of combination chemotherapy with irinotecan, high-dose 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> or =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.

Keyword

Stomach neoplasms; Irinotecan; Chemotherapy

MeSH Terms

Adenocarcinoma
Asthenia
Bridged Compounds
Camptothecin
Cisplatin
Disease Progression
Disease-Free Survival
Drug Therapy, Combination
Fluorouracil
Humans
Hyperbilirubinemia
Leucovorin
Medical Oncology
Nausea
Neutropenia
Stomach
Stomach Neoplasms
Taxoids
Thrombocytopenia
Bridged Compounds
Camptothecin
Cisplatin
Fluorouracil
Leucovorin
Taxoids

Figure

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  Fig. 1 Survival probability of the 37 patients. The overall survival (OS, A) and progression-free survival (PFS, B) in the 37 patients were 10.6 months and 4.3 months, respectively.

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