S-Space College of Medicine/School of Medicine (의과대학/대학원) Internal Medicine (내과학전공) Journal Papers (저널논문_내과학전공)
Simvastatin plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line chemotherapy in metastatic colorectal patients: a multicenter phase II study
- Lee, Jeeyun; Jung, Kyung Hae; Park, Young Suk; Ahn, Joong Bae; Shin, Sang Jun; Im, Seock-Ah; Oh, Do Youn; Shin, Dong Bok; Kim, Tae Won; Lee, Namsu; Byun, Jae Ho; Hong, Yong Sang; Park, Joon Oh; Park, Se Hoon; Lim, Ho Yeong; Kang, Won Ki
- Issue Date
- Springer Verlag
- Cancer Chemother Pharmacol. 2009 Sep;64(4):657-63. Epub 2009 Jan 24.
- Adult; Aged; Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use; Female; Camptothecin/administration & dosage/analogs & derivatives; Fluorouracil/administration & dosage; Humans; Leucovorin/administration & dosage; Male; Middle Aged; Neoplasm Metastasis; Simvastatin/administration & dosage
- 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.
- 1432-0843 (Electronic)
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