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Plasma micro-RNA levels may predict response to cetuximab plus FOLFIRI
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PARIS — Plasma micro-RNA levels were predictive of response among patients with metastatic gastric cancer who were treated with cetuximab plus modified FOLFIRI chemotherapy, according to study results presented at the WIN Symposium.
Researchers in China conducted the phase 2 study to test cetuximab in combination with modified FOLFIRI as second-line treatment in 61 patients with metastatic gastric cancer.
Patients received an initial 400 mg/m2 dose of cetuximab (Erbitux, Eli Lilly) intravenously, followed by weekly doses of 250 mg/m2. On day 2 of each 14-day cycle, patients received IV irinotecan (180 mg/m2); leucovorin (200 mg/m2); and an initial IV bolus dose of 5-FU (400 mg/m2), followed by a continuous 46-hour infusion of 5-FU at 2,400 mg/m2.
Time to progression served as the primary endpoint.
Among 54 evaluable participants, the response rate was 33.3%.
Median time to progression in the intention-to-treat analysis was 4.6 months (95% CI, 3.6-5.6) and median OS was 8.6 months (95% CI, 7.3-9.9).
KRAS mutations were not detected in any patients.
Results of multivariate Cox regression analysis indicated levels of four plasma micro-RNA were associated with treatment outcome.
"The discriminant function composed of the four micro-RNAs can predict whether the time to progression of patients will be over 5 months, or less than or equal to 5 months," the researchers wrote.
The accurate rate of discrimination was as high as 87.04%,according to researchers.
"Plasma micro-RNA levels were identified as potential predictive biomarkers of prognosis, which warrants further investigation," the researchers wrote."Combination therapy comprising cetuximab and modified FOLFIRI was well tolerated, which could potentially be used as a second-line treatment for patients with advanced gastric cancer."
For more information:
Li J. Abstract #P1.09. Presented at: WIN Symposium; July 10-12, 2013; Paris.
Disclosure: The researchers report support from Fudan University Shanghai Cancer Center; Merck KGaA; and the "Eleventh Five-Year Plan," part of a series of social and economic development initiatives in the People's Republic of China.