Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer?

BACKGROUND: Oncotype DX is a 21-gene assay that calculates a risk of distant recurrence in women with estrogen-receptor-positive, lymph node-negative breast cancer. The purpose of this study was to determine whether the results of Oncotype DX influence the decision to administer chemotherapy. METHODS: A retrospective study was performed on 85 consecutive patients with estrogen-receptor-positive, lymph node-negative breast cancer who had an Oncotype DX recurrence score (RS) obtained. Tumor size, tumor grade, and treatment were then compared within each risk category. Statistical analysis was performed using STATA software. RESULTS: Tumors that were high grade and Her-2/neu positive more frequently had a high RS. Treatment was changed as a result of Oncotype DX in 44% of patients. CONCLUSIONS: Oncotype DX RS is significantly related to tumor grade and Her2/neu status. In this study, the treatment of 44% of patients was altered as a consequence of Oncotype DX RS.

The significance of surgical margins for patients with atypical ductal hyperplasia.

BACKGROUND: The significance of surgical margins for patients with atypical ductal hyperplasia is unknown. PATIENTS AND METHODS: We reviewed our experience with atypical ductal hyperplasia and correlated the margin status of the specimens removed with the risk of recurrence as atypical ductal hyperplasia, ductal carcinoma in situ, and invasive carcinoma. Seven hundred forty-seven patients were identified between February 1995 and September 2005 as having biopsy proven atypical ductal hyperplasia (ADH). One hundred fifty-five of these patients were found to have "pure" atypical ductal hyperplasia without associated premalignant or malignant breast disease or a history of ipsilateral disease. Margin status of the initial excisional biopsy was noted and was correlated with the risk of recurrence. RESULTS: Of the 155 patients whose excisional biopsy specimens were "pure" atypical ductal hyperplasia, 44% (68) had negative margins, 5% (7) had positive margins, and 52% (80) were not reported. No patient underwent re-excision for close or positive margins. Follow-up ranged from 0 to 119 months, with a mean of 26 months. Seven patients (5%) presented with new findings at the site of their initial excisional biopsy, 1 of whom was found to have an invasive ductal carcinoma and 6 of whom had benign findings. Of the 87 patients with margins positive or unknown for ADH at surgical excision, none went on to develop malignancy. CONCLUSION: Our results suggest that clear surgical margins at surgical excision for atypical ductal hyperplasia did not affect the risk of subsequently developing a malignancy.

The consequence of multiple re-excisions to obtain clear lumpectomy margins in breast cancer patients.

BACKGROUND: Microscopically clear lumpectomy margins are critical for optimizing local control with breast conservation for cancer. Re-excisions are often necessary to achieve clear surgical margins. Factors that contribute to nonnegative margins and necessitate re-excision may increase the risk of local recurrence. METHODS: Patients who were treated with breast conservation for breast cancers were identified from a prospective database maintained by one of the authors. Factors associated with local recurrence were evaluated in 459 consecutive patients with attention to the number of re-excisions required to obtain clear margins. RESULTS: Twenty-eight patients (5%) developed local recurrences at a mean follow-up of 78 months. In multivariate analysis, local recurrence was most significantly associated with the omission of radiotherapy (19% vs. 5%; relative risk [RR], 3.64; 95% confidence interval, 1.6-8.2), followed by young age (52 vs. 58; 95% confidence interval, -.83 to -10.6 years) and the number of re-excisions required to obtain clear margins (none, 4%; one, 7% [RR, 2.05; 95% confidence interval, .86-4.89]; two or more, 17% [RR, 5.20; 95% confidence interval, 1.44-18.8]). Tumor size, the number of involved nodes, pathology, and adjuvant chemotherapy were not significantly related to local recurrence. CONCLUSIONS: The risk of local recurrence after breast conservation for breast cancer increases progressively with the number of re-excisions needed to achieve clear margins. Patients in whom the cancer is fully excised with clear margins in the first excision will have less of a chance of local recurrence compared with patients who need further re-excision to achieve clear margins.

Breast cancer patients with pN0(i+) and pN1(mi) sentinel nodes have high rate of nonsentinel node metastases.

BACKGROUND: The recent American Joint Committee on Cancer revision of the staging system for breast cancer classifies sentinel node metastases < 0.2 mm (pN0[i+]) as node negative and those > 0.2 mm but < 2 mm are designated pN1(mi). We examined the association between size of sentinel node metastases and rate of nonsentinel node metastases, specifically in the subgroup of patients with micrometastases. STUDY DESIGN: We examined the nonsentinel nodes of 124 patients with positive sentinel nodes and correlated the likelihood of nonsentinel node involvement with the size of the metastasis in the sentinel node and primary tumor characteristics. RESULTS: Nonsentinel node metastases were found in 19% (6 of 31) of patients with sentinel node metastases 2 mm. Multivariate analysis found that involvement of the majority of sentinel nodes (p = 0.01) and sentinel metastases > 2 mm (p = 0.001) were significantly related to presence of metastases in nonsentinel nodes. Age, tumor size, pathology, multifocality, satellites, and lymphovascular invasion were not significantly related to nonsentinel node metastases in multivariate analysis. CONCLUSIONS: These findings indicate that frequency of nonsentinel node metastases with sentinel node metastases 0.2 to 2 mm. Omitting complete axillary dissection in pN1(mi) and pN0(i+) patients may leave residual disease in up to 20% of these patients.

Touch preparation or frozen section for intraoperative detection of sentinel lymph node metastases from breast cancer.

BACKGROUND: The preferred technique for intraoperative evaluation of the sentinel lymph node has not been determined. The purpose of this study was to compare the sensitivity and accuracy of intraoperative evaluation of the sentinel lymph node by touch preparation cytology and frozen section. METHODS: A total of 117 patients with clinically node-negative breast cancer or ductal carcinoma-in-situ undergoing sentinel lymph node biopsy had intraoperative evaluation of the sentinel node by touch preparation, frozen section, or both. The results of the intraoperative evaluation were compared with the final histological results of hematoxylin and eosin (H&E) paraffin section and immunohistochemistry (IHC). RESULTS: Twenty-six (57%) of the 46 patients with nodal involvement had metastases detected during surgery. The sensitivity of touch preparation for detecting macrometastases was 78%; for detecting all H&E metastases, including micrometastases, was 57%; and for detecting all metastases, including those seen on IHC, was 40%. The sensitivity of frozen section for detecting macrometastases was 83%; for detecting all H&E metastases, including micrometastases, was 78%; and for detecting all metastases, including those seen on IHC, was 64%. Both have a low sensitivity for micrometastases seen by H&E paraffin section: 57% and 78%, respectively. Neither detected micrometastases diagnosed by IHC only. CONCLUSIONS: Both touch preparation and frozen section seem to be accurate in detecting macrometastases, but not micrometastases. Intraoperative evaluation of the sentinel lymph node by touch preparation allows for a quick evaluation of the node without wasting significant tissue and without detecting occult microscopic metastases, which may be beneficial because the clinical importance of these has yet to be elucidated.

Breast conservation in patients with multiple ipsilateral synchronous cancers.

BACKGROUND: Because breast cancer survival after breast conservation has proved comparable to mastectomy, contraindications to mastectomy are increasingly being challenged. We treated the majority of our patients with multiple synchronous ipsilateral cancers with breast conservation and we compared them with patients who underwent mastectomy for comparable disease during the same interval. STUDY DESIGN: Patients with multiple ipsilateral synchronous breast cancers between 1989 and 2002 were identified from prospective databases maintained by us. A comparison was made between 36 patients treated with lumpectomy and 19 patients treated with mastectomy. RESULTS: There were no significant (all p values >0.2) differences between mastectomy and breast conservation patients in age, racial distribution, size of cancers, pathology, tumor differentiation, nodal involvement, or hormone receptor positivity. The majority of patients treated with breast conservation underwent at least one reexcision to obtain clear pathologic margins, and they were more likely to receive postoperative radiotherapy than patients treated with mastectomy. There were no significant differences in the local (97% versus 100%, p = 0.54) or distant (97% versus 95%, p = 0.20) 5-year disease- free survival between the group treated with breast conservation and the group treated with mastectomy. One patient in each group developed distant metastases. One patient in the breast conservation group developed local recurrence at both primary sites simultaneously 39 months after lumpectomies. She is free of disease 78 months after mastectomy. The remaining 52 patients are alive and free of disease. CONCLUSIONS: Breast conservation is an effective treatment for patients with synchronous ipsilateral breast cancers.