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Simvastatin plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line chemotherapy in metastatic colorectal patients: a multicenter phase II study.

Authors
 Jeeyun Lee  ;  Kyung Hae Jung  ;  Young Suk Park  ;  Joong Bae Ahn  ;  Sang Jun Shin  ;  Seock-Ah Im  ;  Do Youn Oh  ;  Dong Bok Shin  ;  Tae Won Kim  ;  Namsu Lee  ;  Jae Ho Byun  ;  Yong Sang Hong  ;  Joon Oh Park  ;  Se Hoon Park  ;  Ho Yeong Lim  ;  Won Ki Kang 
Citation
 CANCER CHEMOTHERAPY AND PHARMACOLOGY, Vol.64(4) : 657-663, 2009 
Journal Title
 CANCER CHEMOTHERAPY AND PHARMACOLOGY 
ISSN
 0344-5704 
Issue Date
2009
MeSH
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Camptothecin/administration & dosage ; Camptothecin/analogs & derivatives ; Colorectal Neoplasms/drug therapy* ; Colorectal Neoplasms/pathology ; Female ; Fluorouracil/administration & dosage ; Humans ; Leucovorin/administration & dosage ; Male ; Middle Aged ; Neoplasm Metastasis ; Simvastatin/administration & dosage
Abstract
BACKGROUND: Simvastatin has demonstrated anti-tumor activity in preclinical studies via tumor cell senescence, anti-angiogenesis, and apoptosis. This phase II trial evaluated the efficacy and toxicity profile of conventional FOLFIRI chemotherapy plus simvastatin in metastatic colorectal cancer patients. METHODS: Patients received irinotecan 180 mg/m(2) as a 90-min infusion followed by leucovorin 200 mg/m(2) in a 2-h infusion, and then 5-FU 400 mg/m(2) bolus injection followed by 2,400 mg/m(2) as a 46-h continuous infusion. Treatment cycles were repeated every 2 weeks until documented disease progression, unacceptable toxicity, or patient's refusal. Simvastatin 40 mg tablet was given once daily per oral everyday during the period of chemotherapy without a rest. RESULTS: From October 2005 to June 2006, 49 patients were enrolled. The overall response rate (ORR) was 46.9% (95% CI, 31.0-58.8) by intent-to-treat analysis and 45.8% (95% CI, 33.3-62.8) by per-protocol analysis. There were one complete response (CR) and 22 partial responses (PRs). Both CR and PRs were confirmed at least 4 weeks later. The disease-control rate was 83.7% (95% CI, 73.4-94.0). The median follow-up duration was 25.6 months (range, 20.9-28.8 months). The median survival of all patients was 21.8 months (95% CI, 14.4, 29.2). The median TTP was 9.9 months (95% CI, 6.4, 13.3). No patients experienced additional adverse effect that was definitely caused by simvastatin drug therapy in this trial. CONCLUSION: The combination of simvastatin plus FOLFIRI was a feasible regimen with promising antitumor activity.
Full Text
http://link.springer.com/article/10.1007%2Fs00280-008-0913-5
DOI
10.1007/s00280-008-0913-5
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Neurosurgery (신경외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ahn, Jung Yong(안정용)
Ahn, Joong Bae(안중배) ORCID logo https://orcid.org/0000-0001-6787-1503
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/105157
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