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01.09.2009 | Original Article | Ausgabe 4/2009

Cancer Chemotherapy and Pharmacology 4/2009

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

Cancer Chemotherapy and Pharmacology > Ausgabe 4/2009
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



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.


Patients received irinotecan 180 mg/m2 as a 90-min infusion followed by leucovorin 200 mg/m2 in a 2-h infusion, and then 5-FU 400 mg/m2 bolus injection followed by 2,400 mg/m2 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.


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.


The combination of simvastatin plus FOLFIRI was a feasible regimen with promising antitumor activity.

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