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• W2257229045 abstract "13500 Background: Patients homozygous for the UGTA1A*28 allele are at risk for severe neutropenia (ANC) with irinotecan (IRI) chemotherapy. Among these pts, grade 4 ANC rates were 50% with IRI [Innocenti, JCO 2004] and 18.2% -54.5% with IFL & IROX in the N9741 study [Mcleod, ASCO 2006]. Higher doses of IRI are associated with a higher toxicity[Hoskins, ASCO 2007]. The FDA mandated a change in the IRI package insert regarding genotype-based dose modifications but the impact of these recommendations has not been prospectively validated. Methods: We conducted a prospective registry of pts treated with IRI. After informed consent, blood was collected to determine UGT1A1 genotype. For pts with UGT1A1 *28/*28, IRI doses were reduced to minimize toxicity. Toxicities were monitored during the first 2 months of therapy. Results: The genotype frequencies of UGT1A1 polymorphism among 78 pts (M: F = 38:40) were 44.9% (35/78)*1/*1, 43.5% (34/78)*1/*28 and 10.2% (8/78) *28/*28. 88% had colorectal cancer. All pts had prior chemotherapy, (47% had ≥2). 60 pts treated were dosed according to guidelines. Dosing schedules were as follows: weekly (10), bi-weekly (48), q 3 weeks (2). For the 54 patients with complete records, the rate of all grade, gr 3 and gr 4–5 ANC are indicated in the table below. Only 5 of 8 patients with *28/*28 received IRI. All were treated with reduced starting doses (Dose - 1) and none developed grade 4–5 ANC. Three heavily pretreated pts (1 *1/*1; 2 *1/*28) developed Gr 4 ANC after only 1 dose of IRI 180 mg/m2, 2 died of neutropenic toxicities. Conclusions: Prospective genotyping to guide dosing decisions has a positive effect in reducing the incidence and severity of toxicities. This study is ongoing and will be expanded to other institutions to further validate these results. UGT1A1 n % all Gr ANC % Gr 3 ANC %Gr 4–5 ANC *1/*1 27 40.7% (11) 7.4% (2) 3% (1) *1/*28 22 59.1% (13) 13.6% (3) 9% (2) *28/*28 5 60% (3) 40% (2) 0 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Third Wave Technologies Pfizer, Third Wave Technologies Third Wave Technologies Pfizer" @default.
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• W2257229045 date "2008-05-20" @default.
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• W2257229045 title "UGT1A1 genotype-based dose modification of irinotecan regimens: Impact on hematologic toxicities" @default.
• W2257229045 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.13500" @default.
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