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

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.

Evaluation of a Technology-Based Survivor Care Plan for Breast Cancer Survivors: Pre-Post Pilot Study.

BACKGROUND: As of 2016, almost 16 million individuals were cancer survivors, including over 3.5 million survivors of breast cancer. Because cancer survivors are living longer and have unique health care needs, the Institute of Medicine proposed a survivor care plan as a way to alleviate the many medical, emotional, and care coordination problems of survivors. OBJECTIVE: This pilot study for breast cancer survivors was undertaken to: (1) examine self-reported changes in knowledge, confidence, and activation from before receipt to after receipt of a survivor care plan; and (2) describe survivor preferences for, and satisfaction with, a technology-based survivor care plan. METHODS: A single group pretest-posttest design was used to study breast cancer survivors in an academic cancer center and a community cancer center during their medical visit after they completed chemotherapy. The intervention was a technology-based survivor care plan. Measures were taken before, immediately after, and 1 month after receipt of the survivor care plan. RESULTS: A total of 38 breast cancer survivors agreed to participate in the study. Compared to baseline levels before receipt of the survivor care plan, participants reported increased knowledge both immediately after its receipt at the academic center (P<.001) and the community center (P<.001) as well as one month later at the academic center (P=.002) and the community center (P<.001). Participants also reported increased confidence immediately following receipt of the survivor care plan at the academic center (P=.63) and the community center (P=.003) and one month later at both the academic center (P=.63) and the community center (P<.001). Activation was increased from baseline to post-survivor care plan at both the academic center (P=.05) and community center (P<.001) as well as from baseline to 1-month follow-up at the academic center (P=.56) and the community center (P<.001). Overall, community center participants had lower knowledge, confidence, and activation at baseline compared with academic center participants. Overall, 22/38 (58%) participants chose the fully functional electronic survivor care plan. However, 12/23 (52%) in the community center group chose the paper version compared to 4/15 (27%) in the academic center group. Satisfaction with the format (38/38 participants) and the content (37/38 participants) of the survivor care plan was high for both groups. CONCLUSIONS: This study provides evidence that knowledge, confidence, and activation of survivors were associated with implementation of the survivor care plan. This research agrees with previous research showing that cancer survivors found the technology-based survivor care plan to be acceptable. More research is needed to determine the optimal approach to survivor care planning to ensure that all cancer survivors can benefit from it.