Purpose To present guidance for patients and physicians regarding the use of accelerated partial-breast irradiation (APBI), based on current published evidence complemented by expert opinion. Methods and Materials A systematic search of the National Library of Medicine's PubMed database yielded 645 candidate original research articles potentially applicable to APBI. Of these, 4 randomized trials and 38 prospective single-arm studies were identified. A Task Force composed of all authors synthesized the published evidence and, through a series of meetings, reached consensus regarding the recommendations contained herein. Results The Task Force proposed three patient groups: ( 1 ) a "suitable" group, for whom APBI outside of a clinical trial is acceptable, ( 2 ) a "cautionary" group, for whom caution and concern should be applied when considering APBI outside of a clinical trial, and ( 3 ) an "unsuitable" group, for whom APBI outside of a clinical trial is not generally considered warranted. Patients who choose treatment with APBI should be informed that whole-breast irradiation (WBI) is an established treatment with a much longer track record that has documented long-term effectiveness and safety. Conclusion Accelerated partial-breast irradiation is a new technology that may ultimately demonstrate long-term effectiveness and safety comparable to that of WBI for selected patients with early breast cancer. This consensus statement is intended to provide guidance regarding the use of APBI outside of a clinical trial and to serve as a framework to promote additional clinical investigations into the optimal role of APBI in the treatment of breast cancer.

https://www.journalacs.org/article/S1072-7515(09)00331-7/pdf

Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO).

Background:The standard of care for breast cancer patients with sentinel lymph node (SLN) metastases includes complete axillary lymph node dissection (ALND). However, many question the need for complete ALND in every patient with detectable SLN metastases, particularly those perceived to have a low risk of non-SLN metastases. Accurate estimates of the likelihood of additional disease in the axilla could assist greatly in decision-making regarding further treatment.

A Nomogram for Predicting the Likelihood of Additional Nodal Metastases in Breast Cancer Patients With a Positive Sentinel Node Biopsy

BACKGROUND

Axillary lymph node dissection for staging the axilla in breast carcinoma patients is associated with considerable morbidity, such as edema of the arm, pain, sensory disturbances, impairment of arm mobility, and shoulder stiffness. Sentinel lymph node biopsy electively removes the first lymph node, which gets the drainage from the tumor and should therefore be associated with nearly zero morbidity.



METHODS

Postoperative morbidity (increase in arm circumference, subjective lymphedema, pain, numbness, effect on arm strength and mobility, and stiffness) of the operated arm was prospectively compared in 35 breast carcinoma patients after axillary lymph node dissection (ALND) of Level I and II and 35 patients following sentinel lymph node (SN) biopsy.



RESULTS

Patient characteristics were comparable between the two groups. Postoperative follow-up was 15.4 months (range, 4–28 months) in the SN group and 17.0 months (range, 4–28 months) in the ALND group. Following axillary dissection, patients showed a significant increase in upper and forearm circumference of the operated arm compared with the SN patients, as well as a significantly higher rate of subjective lymphedema, pain, numbness, and motion restriction. No difference between the two groups was found regarding arm stiffness or arm strength, nor did the type of surgery affect daily living.



CONCLUSIONS

SN biopsy is associated with negligible morbidity compared with complete axillary lymph node dissection. Cancer 2000;88:608–14. © 2000 American Cancer Society.

/pdf/morbidity-following-sentinel-lymph-node-biopsy-versus-1fzilzj7py.pdf

Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma.

BACKGROUND

Findings of isolated (disseminated or circulating) tumor cells (ITC) by immunocytochemistry and molecular pathology methods have led to varied interpretations and different applications of the TNM system.



METHODS

An analysis of the relevant literature was undertaken. In addition, optional proposals for the classification of ITC, micrometastasis, and cytologic results in pleural and peritoneal washings are presented.



RESULTS

Immunocytochemistry has a lower false-positive rate than nonmorphologic methods such as flow cytometry or the polymerase chain reaction; therefore the method(s) used always should be recorded. At the current time, the independent prognostic significance of ITC in regional lymph nodes and in the general circulation (blood, bone marrow, and other distant sites) is difficult to assess. To enable comparisons of treatment results and to avoid variation in staging, a finding of ITC should not be considered in the TNM and residual tumor (R) classifications, at least not at the current time. However, for future evaluation of their prognostic significance, the respective findings should be documented according to uniform criteria.



CONCLUSIONS

ITC should be distinguished from micrometastasis. To investigate the independent prognostic significance of ITC and of positive lavage cytology, uniform data collection according to the proposed coding schema is recommended. [See editorial on pages 2589–92, this issue.] Cancer 1999;86:2668–73. © 1999 American Cancer Society.

https://acsjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/1097-0142%2820000801%2989%3A3%3C707%3A%3AAID-CNCR30%3E3.0.CO%3B2-U

Classification of isolated tumor cells and micrometastasis.

Background Findings of isolated (disseminated or circulating) tumor cells (ITC) by immunocytochemistry and molecular pathology methods have led to varied interpretations and different applications of the TNM system. Methods An analysis of the relevant literature was undertaken. In addition, optional proposals for the classification of ITC, micrometastasis, and cytologic results in pleural and peritoneal washings are presented. Results Immunocytochemistry has a lower false-positive rate than nonmorphologic methods such as flow cytometry or the polymerase chain reaction; therefore the method(s) used always should be recorded. At the current time, the independent prognostic significance of ITC in regional lymph nodes and in the general circulation (blood, bone marrow, and other distant sites) is difficult to assess. To enable comparisons of treatment results and to avoid variation in staging, a finding of ITC should not be considered in the TNM and residual tumor (R) classifications, at least not at the current time. However, for future evaluation of their prognostic significance, the respective findings should be documented according to uniform criteria. Conclusions ITC should be distinguished from micrometastasis. To investigate the independent prognostic significance of ITC and of positive lavage cytology, uniform data collection according to the proposed coding schema is recommended.

International Union Against Cancer. Classification of isolated tumor cells and micrometastasis.

BACKGROUND

The presence or absence of regional lymph node metastases has been one of the most important determining factors in recommending adjuvant chemotherapy for patients with breast carcinoma. However, because of the 15-20% failure rate at 5 years for lymph node negative patients, other tumor-related prognostic factors have gained greater significance in this decision-making process. Many investigators have reported finding micrometastases that were not detected by routine sectioning of the lymph nodes but were identified by multiple sectioning and additional staining. This review attempts to evaluate the role of occult lymph node micrometastases and their relevance to disease recurrence.



METHODS

A literature search of the entire MEDLINE data base was conducted. All relevant articles were reviewed for the criteria they used to define micrometastases. The frequency of detection of micrometastases by various methodologies and the prognostic significance of such deposits were examined.



RESULTS

Tumor deposits involving the lymph nodes were found to be arbitrarily categorized as either micrometastases or macrometastases, with the cutoff point ranging from 0.2-2.0 mm. The detection rate of such deposits by conventional techniques was inadequate. Serial sectioning and immunohistochemistry appeared to increase the detection rate by 9-33%. A definite survival disadvantage was noted for patients with such occult metastases.



CONCLUSIONS

Current routine histologic examination of regional lymph nodes underestimates breast carcinoma metastases. Serial sectioning and immunohistochemistry increase the yield but are too labor-intensive and expensive for routine use. However, the introduction of the sentinel lymph node biopsy in lieu of axillary lymph node dissection in cases of breast carcinoma holds promise for making these methods practical and cost-effective. Cancer 1997; 80:1188-97. © 1997 American Cancer Society.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/%28SICI%291097-0142%2819971001%2980%3A7%3C1188%3A%3AAID-CNCR2%3E3.0.CO%3B2-H

Lymph Node Micrometastases from Breast Carcinoma Reviewing the Dilemma

BACKGROUND

Thirty percent of lymph node negative patients with operable breast carcinoma experience disease recurrence within 10 years. Retrospective serial sectioning of axillary lymph nodes has revealed undetected metastases in 9–30% of these patients. These occult metastases have been shown to have an adverse effect on survival. Serial sectioning (SS) is impractical for all axillary lymph nodes harvested from Levels I and II, but it is feasible if applied only to sentinel lymph nodes.



METHODS

Sentinel lymph nodes from 52 patients with invasive breast carcinoma were cut at 2 mm intervals, fixed in 10% formalin, and embedded in paraffin. Sections were taken from the blocks, stained with hematoxylin and eosin (H & E), and compared with cytokeratin-stained sections taken at 0.25 mm intervals throughout the entire blocks.



RESULTS

Tumor metastases were found in 6 patients (12%) when the sentinel lymph nodes were sectioned at 2 mm intervals and stained with H & E, compared with 30 patients (58%) when the same lymph nodes were serially sectioned at 0.25 mm intervals and stained with cytokeratin. Of 24 patients whose metastases were detected by SS and cytokeratin staining, 12 had isolated tumor cells and 12 had colonies of several thousand malignant cells.



CONCLUSIONS

Routine histologic examination of axillary lymph nodes, including sentinel lymph nodes, in cases of breast carcinoma significantly underestimates lymph node metastases. This deficiency may be overcome by SS of the entire lymph nodes and staining with a specific monoclonal antibody. The percentage of patients found to have colonies of cells that were missed by routine sectioning corresponds closely to the percentage of “lymph node negative” patients who would be expected to relapse. The true clinical significance of these occult metastases will be determined by long term follow-up. [See editorial on pages 905–7, this issue.] Cancer 1999;86:990–6. © 1999 American Cancer Society.

Occult metastases in the sentinel lymph nodes of patients with early stage breast carcinoma: A preliminary study.

BACKGROUND

Eighty-seven institutions participated in a Registry Trial that was designed to collect data on the clinical use of the MammoSite™ breast brachytherapy catheter for delivering breast irradiation Patient demographics, technical reproducibility, cosmesis, and early toxicity were evaluated



METHODS

From May 4, 2002 through July 30, 2004, 1419 patients with Stage 0, I, or II breast carcinoma who were undergoing breast-conserving therapy were enrolled on the trial The device was placed in 1403 of these patients The 1237 patients (87% of enrolled patients) who received accelerated partial breast irradiation (APBI) (34 grays prescribed to 10 cm in 10 fractions; 95% of patients who received APBI) constituted the study population; 86% of those patients (1068) had Stages I–II breast carcinoma (median tumor size, 10 mm), and 14% of those patients (169) had Stage 0 breast carcinoma Ninety-one percent of the patients with invasive carcinoma (977 of 1068 patients) had negative lymph node status, and 99% of all patients had negative margins The median patient age was 65 years Systemic chemotherapy alone was administered to 79 patients with invasive carcinoma (7%), hormone therapy was administered to 501 patients (45%), and both were administered to 39 patients (4%) The median follow-up was 5 months



RESULTS

Five hundred fifty-four catheters (45%) were placed with an open cavity at the time of lumpectomy, and 683 catheters (55%) were placed with a closed cavity after lumpectomy Skin spacing ranged from 2 mm to 75 mm (median, 10 mm) In 89% of patients, there was a minimum balloon-to-skin distance of 7 mm (2% of patients had distances < 5 mm) In terms of cosmetic assessment, 95% of patients (1030 of 1084 patients) who had a cosmetic assessment had a good/excellent result (last follow-up visit) Cosmetic results at 12 months were good/excellent in 92% of 248 evaluable patients The median skin spacing (≥ 7 mm vs < 7 mm) was associated significantly with a good/excellent cosmetic result (961% vs 868%; P = 00001) overall and at 6 months (P = 0006) Increasing skin spacing was associated with a good/excellent cosmetic result as a continuous variable (P < 00001) In total, 92 of 1140 evaluable patients (81%) developed an infection in the breast, which was device-related in 53% of patients (60 of 1140 patients) Good/excellent cosmetic results were noted in 86% of these patients (last follow-up visit) Fifteen of 442 evaluable patients (34%) developed a radiation recall reaction Good/excellent cosmetic results were noted in 93% of these patients at their last follow-up visit One local recurrence (01%) was reported (new primary carcinoma)



CONCLUSIONS

Clinical evaluation of the ability of the MammoSite™ breast brachytherapy catheter to deliver APBI demonstrated acceptable technical reproducibility between multiple institutions and use in appropriate groups of patients Cosmetic results at 12 months (92% good/excellent) were comparable to those reported with whole-breast RT Early toxicity rates (infections, radiation recall) appeared to be acceptable Cancer 2005 © 2005 American Cancer Society

https://acsjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/cncr.21289

First analysis of patient demographics, technical reproducibility, cosmesis and early toxicity: Results of the American Society of Surgeons MammoSite Breast Brachytherapy Registry Trial

Howard C. Snider

Papers

Lymph Node Micrometastases from Breast Carcinoma Reviewing the Dilemma

Occult metastases in the sentinel lymph nodes of patients with early stage breast carcinoma: A preliminary study.

First analysis of patient demographics, technical reproducibility, cosmesis and early toxicity: Results of the American Society of Surgeons MammoSite Breast Brachytherapy Registry Trial