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• W2054310270 abstract "Background: We conducted an open label, phase II trial, in order to evaluate the efficacy and safety of modified FOLFIRI plus bevacizumab as first-line treatment of fit and frail elderly (>70 years old) patients with metastatic colorectal cancer (CRC). Methods: Elderly (>70 years) patients with unresectable mCRC, categorized as fit or frail according to the complete geriatric assessment (CGA) were available for the study. The patients were treated with bevacizumab 5mg/kg in day one, followed by the administration of modified FOLFIRI (Irinotecan 130mg/m2 as iv 90min infusion on day 1, Leucovorin 400mg/m2 as 2h infusion, on day 1, 5-Fluorouracil 400mg/m2, as bolus iv infusion, on day 1 and 5-Fluorouracil 1.200 mg/m2, as ci 48h infusion). The sample size calculation was conducted according to an optimal Simon two-step design testing: The null hypothesis was that the ORR is ≤ 30% versus the alternative hypothesis that the ORR is ≥ 50% (&agr; = 0.05, power 90%). Here we described the results of the 1st part of the study. Results: Seventeen elderly fit or frail patients [median age 76 years (min-max: 71-84 years); male/female 15/3; PS (ECOG) 0 in 45% and 1 55% respectively] were included in the 1st step of the study. The median number of target lesions was 2. One hundred eighty-four cycles have been administered. Complete and partial responses were observed in one (5.9%) and 6 (35.3%) patients, respectively [overall response rate (ORR) = 41.2%; 95% CI, 27.8%-64.6%]; eight patients (47.1%) had stable disease and two (11.8%) progressive disease. After a follow-up of 11.2 months, the median time of response was 10.9 months, while the median time to tumor progression and the median overall survival have not been reached, with a probability of 1-year survival of 77%. Secondary R0 resection was performed in one (5.9%) patient. No grade 4 toxicity has been observed. Grade 3 neutropenia was recorded in three (16.7%) patients while grade 2 diarrhea was observed in 2 (11.6%) No treatment related death has been reported. Dose reduction was required in 4 (2.1%) of the cycles, while 5 (2.7%) cycles have been delayed due to toxicity. Conclusion: The mFOLFIRI-bevacizumab combination presented significant efficacy with excellent toxicity profile in fit or frail elderly with mCRC. The trial successfully meets the criterion of efficacy and is continued to complete the target accrual." @default.
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• W2054310270 date "2013-06-01" @default.
• W2054310270 modified "2023-09-27" @default.
• W2054310270 title "Phase II Trial of Mfoliri Plus Bevacizumab as 1st Line Treatment in Elderly Patients with Metastatic Colorectal Cancer" @default.
• W2054310270 doi "https://doi.org/10.1093/annonc/mdt203.277" @default.
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