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Preliminary results of centralized HER2 testing in ductal carcinoma in situ (DCIS): NSABP B-43.

Abstract：

:NSABP B-43 is the first prospective, randomized phase III multi-institution clinical trial targeting high-risk, HER2-positive DCIS. It compares whole breast irradiation alone with WBI given concurrently with trastuzumab in women with HER2-positive DCIS treated by lumpectomy. The primary aim is to determine if trastuzumab plus radiation will reduce in-breast tumor recurrence. HER2-positive DCIS was previously estimated at >50 %, occurring primarily in ER-negative, comedo-type DCIS of high nuclear grade. There has been no documented centralized multi-institutional HER2 analysis of DCIS. NSABP B-43 provides a unique opportunity to evaluate this in a large cohort of DCIS patients. Patients undergoing lumpectomy for DCIS without evidence of an invasive component are eligible. A central review of each patient's pure DCIS lesion is carried out by immunohistochemistry analysis. If the lesion is 2+, FISH analysis is performed. Patients whose tumors are HER2 3+ or FISH-positive are randomly assigned to receive two doses of trastuzumab during WBI or WBI alone. NSABP B-43 opened 11/9/08. As of 7/31/2013, 5,861 patients have had specimens received centrally, and 5,645 of those had analyzable blocks; 1,969 (34.9 %) were HER2 positive. A total of 1,428 patients have been accrued, 1,137 (79.6 %) of whom have follow-up information. The average follow-up time for the 1,137 patients is 23.3 months. No grade 4 or 5 toxicity has been observed. In NSABP B-43 the HER2-positive rate for pure DCIS among patients undergoing breast-preserving surgery is 34.9 %, lower than the previously reported rate. No trastuzumab-related safety signals have been observed. Interest in this trial has been robust.

journal_name

Breast Cancer Res Treat

journal_title

Breast cancer research and treatment

authors

Siziopikou KP,Anderson SJ,Cobleigh MA,Julian TB,Arthur DW,Zheng P,Mamounas EP,Pajon ER,Behrens RJ,Eakle JF,Leasure NC,Atkins JN,Polikoff JA,Seay TE,McCaskill-Stevens WJ,Rabinovitch R,Costantino JP,Wolmark N

doi

10.1007/s10549-013-2755-z

subject

Has Abstract

pub_date

2013-11-01 00:00:00

pages

415-21

issue

eissn

0167-6806

issn

1573-7217

journal_volume

142

pub_type

杂志文章,多中心研究,随机对照试验

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Preliminary results of centralized HER2 testing in ductal carcinoma in situ (DCIS): NSABP B-43.