Abstract
Although this might mistakenly be seen as an issue for the radiation oncology community, all of us who share in the treatment of women with early stage breast cancer should be concerned about the upcoming NRG BR007 trial, a “Phase III Randomized Trial: Evaluating De-escalation of Breast Radiation (DEBRA) for Conservative Treatment of Stage I, HR+, HER2-, RS ≤ 18 Breast Cancer), which is due to open in July. I am very supportive of the concept of using genomic testing to determine which patients between the ages of 50 and 70 with T1 N0 ER and/or PR positive breast cancers following breast conserving surgery with negative margins can be safely treated with endocrine therapy without adjuvant radiation therapy. Conceptually it is an exciting and well needed study. I am deeply concerned about the non-inferiority threshold of 4%. This has never previously been considered to be an acceptable difference in ipsilateral breast tumor recurrence (IBTR) for women between the ages of 50 and 70 with stage I, low risk cancers...
Highlights
Why we should Boycott DEBRAI am very supportive of the concept of using genomic testing to determine which patients between the ages of 50 and 70 with T1 N0 estrogen receptor (ER) and/or PR positive breast cancers following breast conserving surgery with negative margins can be safely treated with endocrine therapy without adjuvant radiation therapy
This might mistakenly be seen as an issue for the radiation oncology community, all of us who share in the treatment of women with early stage breast cancer should be concerned about the upcoming NRG BR007 trial, a “Phase III Randomized Trial: Evaluating De-escalation of Breast Radiation (DEBRA) for Conservative Treatment of Stage I, HR+, HER2, RS ≤ 18 Breast Cancer), which is due to open in July
I am very supportive of the concept of using genomic testing to determine which patients between the ages of 50 and 70 with T1 N0 estrogen receptor (ER) and/or PR positive breast cancers following breast conserving surgery with negative margins can be safely treated with endocrine therapy without adjuvant radiation therapy
Summary
I am very supportive of the concept of using genomic testing to determine which patients between the ages of 50 and 70 with T1 N0 ER and/or PR positive breast cancers following breast conserving surgery with negative margins can be safely treated with endocrine therapy without adjuvant radiation therapy It is an exciting and well needed study. I am deeply concerned about the non-inferiority threshold of 4% This has never previously been considered to be an acceptable difference in ipsilateral breast tumor recurrence (IBTR) for women between the ages of 50 and 70 with stage I, low risk cancers. Doi: 10.1136bmj.m2836) reported an IBTR of 2.11% with IORT compared to 0.95% with whole breast radiation, a difference of 1.16% This was accomplished with far broader criteria than the more restrictive ASTRO guidelines.
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