The Radiation Therapy Oncology Group 9804 Trial

• The Radiation Therapy Oncology Group 9804 trial:

•Which was closed early due to low accrual:

• Investigated outcomes of RT omission in the setting of low-risk DCIS

• Randomizing 636 patients with low-risk disease to either RT or observation after surgery

• In this study, low risk consisted of:

• Low- or intermediate-grade DCIS measuring less than 2.5 cm with resection to negative margins of ≥ 3 mm

• Median tumor size was 5 mm

• While recurrence rates were decreased with RT:

• The recurrence rate was also low in the control group

• With a median follow-up of seven years, RT resulted in:

• A reduced risk of a local recurrence compared with observation:

• 0.9% versus 6.7% (HR 0.11, 95% CI 0.03-0.47)

• A higher rate of mild to moderate (grade 1 or 2) toxicities (76% versus 30%):

• Although the rate of serious toxicities was similar in both arms (4%)

• Of patients treated with RT, grade 1, 2, or 3 late toxicities were seen in 30%, 5%, and 0.7%, respectively

No difference in either:

• Disease-free survival or

• Overall survival

• Results at longer follow-up:

• Also showed lower local recurrence rates with RT:

• 15-year ipsilateral breast recurrence rates of:

7.1% versus 15.1% without versus with RT, respectively (HR 0.36, 95% CI 0.20-0.66)

#Arrangoiz #BreastSurgeon #CancerSurgeon #RTOG9804 #DCIS #OmissionRadiation

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