Reoperative sentinel lymph node biopsy after previous mastectomy

BACKGROUND: Sentinel lymph node (SLN) biopsy is the standard of care for axillary staging in breast cancer, but many clinical scenarios questioning the validity of SLN biopsy remain. Here we describe our experience with reoperative-SLN (re-SLN) biopsy after previous mastectomy. STUDY DESIGN: Review of the SLN database from September 1996 to December 2007 yielded 20 procedures done in the setting of previous mastectomy. SLN biopsy was performed using radioisotope with or without blue dye injection superior to the mastectomy incision, in the skin flap in all patients. In 17 of 20 patients (85%), re-SLN biopsy was performed for local or regional recurrence after mastectomy. RESULTS: Re-SLN biopsy was successful in 13 of 20 patients (65%) after previous mastectomy. Of the 13 patients, 2 had positive re-SLN, and completion axillary dissection was performed, with 1 having additional positive nodes. In the 11 patients with negative re-SLN, 2 patients underwent completion axillary dissection demonstrating additional negative nodes. One patient with a negative re-SLN experienced chest wall recurrence combined with axillary recurrence 11 months after re-SLN biopsy. All others remained free of local or axillary recurrence. Re-SLN biopsy was unsuccessful in 7 of 20 patients (35%). In three of seven patients, axillary dissection was performed, yielding positive nodes in two of the three. The remaining four of seven patients all had previous modified radical mastectomy, so underwent no additional axillary surgery. CONCLUSIONS: In this small series, re-SLN was successful after previous mastectomy, and this procedure may play some role when axillary staging is warranted after mastectomy.     

Needle-guided breast biopsy for mammographic abnormalities in 561 patients

Between 1977 and 1983, 561 consecutive patients underwent 595 surgical biopsies for suspicious mammographic lesions with negative clinical correlation. The procedure consisted of preoperative needle localization, with or without immediate radiologic examination of the biopsy specimen, depending on the presence or absence of microcalcifications in the mammographic lesion. Eighty-four carcinomas were found. Of these, 60 (71%) were infiltrating carcinoma and 24 (29%) were noninvasive carcinoma. The carcinoma yield was 24.2% in the patients with lesions involving foci of microcalcifications and 9% in those lesions without calcifications. Surgical treatment of infiltrating carcinoma consisted of 39 modified radical mastectomies, 10 (25.6%) of which were associated with positive nodes, 16 partial mastectomies with axillary dissection, 3 (18.7%) of which were associated with positive nodes, and 5 wedge resections. Treatment of noninvasive carcinoma consisted of 19 partial mastectomies with axillary dissection and 5 modified radical mastectomies. None of these were associated with positive nodes. Modified radical mastectomy was used with decreasing frequency. Of the 10 patients with infiltrating carcinoma and positive axillary nodes treated by modified radical mastectomy, 7 had one to three involved nodes and 3 had four or more; of those with positive nodes treated by partial mastectomy, 1 had one to three involved nodes and 2 had four or more. These results confirm the correlation between suspicious mammographic non-clinical lesions and breast carcinoma.     

Incidence of intramammary nodes in completion mastectomy specimens after axillary node sampling: implications for breast conserving surgery

BACKGROUND: Axillary node sampling (ANS) is widely used in conjunction with breast conserving surgery in the treatment of primary breast cancers in the UK. Some evidence suggests that axillary staging techniques can miss intramammary nodes contained within the axillary tail of the breast. This study aims to assess the incidence of such nodes in completion mastectomy specimens in women who have had previous breast conserving surgery and ANS. METHODS: One hundred and fifty-seven completion mastectomy specimens were obtained from women who had previous breast conserving surgery and ANS, at the Nottingham Breast Institute over a 3-year period. The pathology samples underwent detailed histological examination to identify lymph nodes, and determine their disease status. RESULTS: Seventy-six (48%) of completion mastectomy specimens contained intramammary lymph nodes. Fifteen patients were upstaged (lymph node stage) because of the histological findings at completion mastectomy. One patient from the study population received additional systemic treatment, as a result of the upstaging. CONCLUSION: The incidence of intramammary nodes in this series correlates with previous data. This study shows that in breast cancer patients who undergo ANS, intramammary nodes, if present and more so positive, are unlikely to change systemic treatment decisions, but may increase the number of patients needing radiotherapy and or further axillary dissection.     

Surgical treatment of ductal carcinoma in situ of the breast. 10- to 20-year follow-up.

Between 1967 and 1977, 36 patients received treatment at the Virginia Mason Medical Center in Seattle, Wash, for ductal carcinoma in situ of the breast. Twenty-five patients had modified radical mastectomies, 10 had radical mastectomies, and one had a simple mastectomy. Twenty-seven patients have been followed up for at least 10 years and are without known recurrence (mean follow-up, 17.7 years; range, 8 to 24 years), eight patients died without known recurrence (mean follow-up, 10.6 years; range, 6 to 14 years), and one patient with a prior contralateral mastectomy for infiltrating cancer of the breast had a recurrence in the scalene nodes on the side of the infiltrating cancer and died of metastatic cancer. No patients with ductal carcinoma in situ had local recurrences in the ipsilateral breast or chest wall, and no patients developed cancers in the contralateral breast; one patient had axillary metastasis. Twenty-eight (78%) of 36 patients had multicentric ductal carcinoma in situ in their mastectomy specimens. Twenty-three (88%) of 26 patients with comedocarcinoma-type ductal carcinoma in situ had multicentric lesions. Conversely, patients with low-grade nuclear papillary ductal carcinoma in situ did not have multicentric lesions. Five (14%) of 36 patients had incidental microinvasion discovered in the mastectomy specimens; all had comedocarcinoma. In summary, our study of patients with ductal carcinoma in situ revealed that (1) mastectomy provided excellent local and systemic control; (2) cancer in the contralateral breast was infrequent; (3) axillary metastasis was rare; and (4) histologic features of tumors markedly affected the frequency of multicentricity and chance for microinvasion.     

Breast cancer in a 6-year-old child

A 6-year-old girl presented for a second opinion with a 1-year history of an enlarging soft tissue mass just lateral to the right areola. She had been seen by a pediatric surgeon elsewhere who reassured the parents that the lesion was benign. Ultrasound scan showed a 1.5- x 1.5-cm cystic structure adjacent to the right breast bud. Excisional biopsy results showed secretory ductal adenocarcinoma. Modified radical mastectomy with axillary node dissection was performed. All 11 nodes were negative for metastatic disease. She is now disease free 3 years after diagnosis. Estrogen-progesterone receptors were negative, as was screening for BCR 1 and 2. This is the first report of cytogenetics showing an abnormal cell line with a reciprocal translocation between 12p and 15q. Although breast cancer is extremely rare in children, a history of a painless, enlarging, firm breast mass should raise concern about possible neoplastic disease. Cystic appearance on ultrasound scan caused by the pseudocapsule around the tumor may be a marker for secretory carcinoma. Histological evaluation of all suspicious masses should be obtained. Because of the risk of local recurrence and axillary metastases, the authors recommend modified radical mastectomy with axillary node dissection for children with secretory carcinoma of the breast.     

Clinical Benefits of Mastectomy on Treatment of Occult Breast Carcinoma Presenting Axillary Metastases

Abstract: Occult breast carcinoma presenting axillary metastases is uncommon and accounts for less than 1% of newly diagnosed breast carcinoma. However, it continues to be a challenging diagnostic and therapeutic problem. In this study, we analyzed retrospectively on 51 cases of occult breast cancer from 1990 to 2003 in our hospital. All these patients had a palpable axillary nodule, no dominant breast mass, and no abnormal mammograms and breast ultrasonograph. Histological examination of axillary mass revealed metastasis from breast. The positive rate of estrogen receptor, progesterone receptor and the monoclonal antibody M4G3 against human breast cancer showed 62.7%, 66.7%, and 93.1% positive respectively. Among 51 cases, 38 cases received mastectomy whereas 13 cases had no local treatment of the breast. The primary tumors were detected in 28 of 38 cases having mastectomy by pathology. Seventy‐seven percent of patients who had no local treatment of the breast had a tumor recurrence, compared with 26% who had a mastectomy. The mean disease‐free survival was 23 months in patients who had no local treatment of the breast, compared with 76 months in patients who had mastectomy. Eight of the 13 patients who had no treatment with breast died whereas seven of the 38 who had local treatment died, with a mean follow‐up of 73 months. It was found that patients having mastectomy had a better disease‐free survival (p < 0.001) and overall survival (p < 0.001) compared with those having no local treatment of the breast. Once the diagnosis of occult breast carcinoma is clarified, an axillary dissection and the local treatment of breast should be carried out.     

乳腺癌再手术的探讨

目的探讨乳腺癌手术后局部复发、腋窝淋巴结转移或可疑转移者的预防及再手术的可行性。方法对1994年6月～2003年4月我院收治的再次手术的23例乳腺癌病人临床资料加以分析并随访。结果全组病例腋窝淋巴结再清扫17例有淋巴结转移,占74%。其中,12例原改良根治术中淋巴结阳性者8例;4例原Halsted根治术淋巴结阳性者3例;4例原单纯乳房切除术中,淋巴结阳性3例;原象限切除加腋窝淋巴结清扫和象限切除术各1例,淋巴结均有阳性发现;原单纯乳房切除加前哨淋巴结活检术中,淋巴结阳性1例。再次手术者中,发现原切口疤痕或胸肌有残留或复发癌6例。17例曾行腋窝清扫病人中,经手术再清扫共得淋巴结283枚,平均每例16.6枚。结论恰当的手术方式、规范化的切除范围、精细的手术操作和无瘤技巧是预防和减少局部复发转移的重要措施。对局部复发、腋窝淋巴结转移或可疑转移者再补作手术有助于控制和减少局部病情的发展,改善病人的生存质量。     

Is Routine Sentinel Lymph Node Biopsy Indicated in Women Undergoing Contralateral Prophylactic Mastectomy? Magee-Womens Hospital Experience

INTRODUCTION: The routine use of sentinel node biopsy (SLNB) at the time of prophylactic mastectomy remains controversial. This retrospective study was undertaken to determine if SLNB is justified in patients undergoing CPM. METHODS: Between 1999 and 2004, 155 patients underwent contralateral prophylactic mastectomy (CPM) at the Magee-Womens Hospital of University of Pittsburgh Medical Center. Eighty patients (51.6%) had SLNB performed at the time of CPM. The therapeutic mastectomy and the CPM specimens were evaluated for histopathology. Goldflam's classification was used to determine the risk of malignancy in the CPM specimens. RESULTS: Pathology in the therapeutic mastectomy specimens included 105 (68%) invasive carcinomas and 50 (32%) in-situ carcinomas. Multicentricity and/or multifocality were reported in 49.7%, and 70% were estrogen receptor positive. Two invasive breast cancers and three cases of DCIS were diagnosed in 155 CPM specimens (n = 5, 3.2%). The median number of SLN identified was 2 (range 1-6) from the CPM axilla. Two patients had positive SLNB for metastatic carcinoma (n = 2/80, 2.5%) with no primary tumor identified in the prophylactic mastectomy specimen. In both patients the therapeutic mastectomy was for recurrent invasive carcinoma in patients with a prior history of axillary node dissection. Occult carcinoma was found in five prophylactic mastectomy specimens: two invasive and three DCIS. Only 1 out of the 75 patients not undergoing SLNB at the time of their initial surgery would have required axillary staging for a previously undiagnosed invasive cancer in the CPM specimen on final pathology. Of all 155 patients undergoing CPM, only 4 (2.5%) had identified final pathologic findings where axillary staging with SLNB was beneficial. There was no evidence of arm lymphedema in any patient who had undergone CPM and SLNB at a median follow-up of 24 months. CONCLUSION: Although SLNB is a minimally invasive method of axillary staging, this retrospective study does not support its routine use in patients undergoing CPM.     

Occult carcinoma of the breast presenting as an axillary node enlargement

The authors discuss ten cases of occult carcinoma of the breast which presented initially as the axillary node enlargement. All cases were proven as adenocarcinoma. Both mammography and ultrasonography revealed the tumor in 3 cases, while in the remaining 7 cases malignant lumps were not visualized. Multiple studies to detect an extra mammary site proved to be negative. A concealed carcinoma of the breast was found in 9 patients with careful sectioning of the resected breast specimens. Only one patient in whom carcinoma of the breast could not be detected has survived well for 6 years after the mastectomy. Parasternal node involvement was not identified in all 7 patients of who had received an extended radical mastectomy. Three patients died of the disease within 45 mo. Seven patients are free of recurrence for 1 to 10 years (average 6 1/2 Y). Prognosis of the patients in this group are as good as and/or sometimes better than those of the patients with axillary nodes pathologically positive.     

Level of axillary involvement by lymph node metastases from breast cancer is not an independent predictor of survival

We examined the relationship of axillary level of lymph node metastases from clinical stage I and II breast cancer to overall survival and disease-free survival rates in 135 patients who underwent complete axillary lymph node dissection to determine if anatomic level of axillary involvement (I vs II vs III) is an independent prognostic factor. All patients underwent either modified radical mastectomy or lumpectomy with axillary dissection and whole breast radiotherapy for breast cancer. Median follow-up was 6.9 years. We found no difference in overall survival or disease-free survival between patients whose highest or only level of axillary involvement was level I compared with patients whose highest or only level was II. Although patients whose highest level of nodal involvement was III had significantly worse overall survival and disease-free survival rates than patients whose highest nodal involvement was I or II, when patients were stratified by the total number of positive nodes (one to three vs four or more), there was no difference in overall survival or disease-free survival rates between levels I, II, and III. These findings indicate that the level of axillary involvement for stage II breast cancer is not of independent prognostic significance.     

Sentinel lymph node mapping following neoadjuvant chemotherapy for breast cancer

The purpose of this study was to evaluate the feasibility of sentinel lymph node mapping in patients undergoing neoadjuvant chemotherapy for breast carcinoma prior to lumpectomy or mastectomy and sentinel lymph node mapping followed by complete axillary dissection. A retrospective analysis of 14 patients from February 1998 to July 2000 with stage I to stage IIIB breast cancer diagnosed by core biopsy underwent neoadjuvant chemotherapy (doxorubicin/cyclophosphamide) prior to definitive surgery, including lumpectomy or mastectomy and sentinel lymph node mapping, followed by full axillary dissection. Thirteen of 14 patients had successful sentinel lymph node identification (93%), and all 14 underwent full axillary dissection. An average of 2.2 sentinel nodes and a median of 16 axillary lymph nodes (including sentinel nodes) were found per patient. Of the 13 patients in whom a sentinel lymph node was identified, 10 were positive for metastases (77%). Only 4 of the 10 had further axillary metastases (40%). Three patients had negative sentinel lymph nodes shown by hematoxylin and eosin and cytokeratin stainings and had no axillary metastases (0% false negative). The single patient in whom a sentinel lymph node could not be identified had stage IIIA disease with extensive lymphatic tumor emboli. Sentinel lymph node mapping is feasible in neoadjuvant chemotherapy breast cancer patients and can spare a significant number of patients the morbidity of full axillary dissection. Further study to evaluate sentinel lymph node mapping in this patient population is warranted.     

Immediate microsurgical breast reconstruction and simultaneous sentinel lymph node dissection: issues with node positivity and recipient vessel selection

Sentinel lymph node dissection (SLND) during mastectomy has been increasing given the decreased risk of lymphedema. Simultaneous reconstruction with a microsurgical breast reconstruction is often performed, but with node positivity a completion axillary lymph node dissection (ALND) must be performed subsequently. This study examines the potential risks especially in relation to microsurgical reconstruction. All patients undergoing microsurgical breast reconstruction at an academic institution from 2004 to 2010 were evaluated in a prospective database. Patients with immediate reconstruction and SLND were identified. Management of positive lymph node status was ascertained through extensive chart review. There were 610 reconstructions performed, 170 delayed and 440 immediate. From the immediate reconstructions, 110 patients (25%) had SLND and of these patients, 16 (14.55%) had a positive SLND. All 16 patients had internal mammary recipient vessels for free tissue transfer. Seven patients had intraoperative completion ALND, while nine patients had staged completion ALND at a later date. There were no adverse affects from completion ALND. Simultaneous mastectomy, SLND, and microsurgical reconstruction can be performed safely. The internal mammary vessels are preferred recipient vessels as node positive patients may require subsequent completion ALND. If a thoracodorsal anastomosis is performed, a potential risk exists for vessel injury and flap loss with completion ALND.     

Axillary nodal metastasis of occult breast primary cancer

Occult breast cancer presenting with axillary metastases is an unusual presentation and can be a diagnostic and therapeutic challenge. A comprehensive work-up, including mammogram, sonogram, magnetic resonance imaging, and even pathologic examination of the mastectomy specimen may not disclose the primary tumor in up to one third of patients. We report a case of a 42-year-old female with occult breast cancer presenting axillary nodal metastasis. She complained of a swelling of the right axillary lymph node, but no breast mass was palpable. Biopsy of the lymph node was performed and histological examination showed a metastatic carcinoma. Estrogen receptor of the lymph node was positive. Calcifications were obtained by mammography and ultrasonography of the right axillary node contained metastasis. All these data suggested an occult carcinoma of the breast and modified radical mastectomy was performed. Pathological findings of the removed specimen failed to find the primary breast cancer lesion. Our case is one more example of this rare occurrence. We assume that the primary carcinoma is so small as to escape detection by histology. It is doubtful if mammography can help to localize these elusive lesions. More refined high resolution methods, are needed to solve this oncologic problem.     

Juvenile secretory carcinoma of the breast

Juvenile secretory carcinoma of the breast, a rare tumor in infants and children, has an unusual histological appearance and clinical behavior. Isolated case reports and small series have appeared since this lesion was first described by McDivitt and Stewart in 1966. Our case of a 3-year-old boy with axillary metastasis and 17 cases in children, from the literature, provide the basis of this review. Of the 18 patients, there were three boys and 15 girls. Their ages ranged from 3 to 17 years (mean 9.8 years). All patients presented with an asymptomatic mass in the breast. None had nodes which were clinically involved. Eight patients had excisional biopsy only. Two patients had quadrantectomy. Four had simple mastectomy; one of whom received postoperative axillary irradiation, and one of whom had axillary nodal sampling (our patient). One patient had a modified radical mastectomy and three had radical mastectomy. Two of eight children who had excisional biopsy alone developed local recurrences. In the first patient, the recurrences occurred at 2 and 8 years following initial therapy. In the second, they occurred at 4 and 21 years. Axillary nodal metastases were found in three of the six patients in whom nodal biopsies were performed. In only one patient were estrogen receptors measured and they were negative. No deaths have been reported in children during a follow-up period ranging from 0 to 22 years (mean 6.5 years). Secretory carcinoma of the breast in this group of patients appears to be a slow growing, locally recurring malignancy. Adults with histologically similar tumors also have a good prognosis. Excisional biopsy is probably inadequate therapy.(ABSTRACT TRUNCATED AT 250 WORDS)     

Breast carcinoma in situ

A total of 150 patients with in situ breast cancer were treated from 1970 through 1976, with a median follow-up of 11.5 years. There were 42 patients with microinvasion and 25 with bilateral disease, analyzed separately. Eight patients who became unavailable for follow-up within five years (but who had no evidence of disease [NED]) were excluded. Eighty-five patients had ductal carcinoma in situ, 43 had lobular carcinoma in situ, and 22 had a mixed type. Modified radical mastectomy was done in 112 cases. One of 128 patients had positive axillary nodes; axillary dissection is not indicated for in situ breast cancer. Of the 150 patients, one with ductal disease died of disease. Six died of other causes, free of disease. Of 18 treated by excision alone, two underwent mastectomy for recurrence and had NED. Patients with microinvasion had involved nodes in 10%, and 94% had NED. However, all bilateral cases had NED.     

Magnetic Resonance Imaging Facilitates Breast Conservation for Occult Breast Cancer

Introduction: Occult primary breast cancer, i.e., isolated axillary adenocarcinoma without detectable tumor in the breast by either physical exam or mammography, represents up to 1% of operable breast cancer. Modified radical mastectomy (MRM) is generally the accepted treatment for this condition although tumor is identified in only two-thirds of mastectomy specimens. Breast magnetic resonance imaging (MRI) can identify occult breast carcinoma and may direct therapy. This study examined the ability of breast MRI to detect occult breast cancer and to facilitate breast conservation therapy.Methods: Forty women with biopsy-proven metastatic adenocarcinoma to an axillary lymph node and no evidence of primary cancer were studied. All patients had a physical examination, mammography, and MRI of the breast. Using a dedicated breast coil, MRI imaging was performed with and without gadolinium enhancement. Positive MRI scans were compared with histopathologic findings at the time of operation (n 5 21).Results: MRI identified the primary breast lesion in 28 of 40 women (70%). Of these 28 patients, 11 had MRM, 11 had lumpectomy/axillary lymph node dissection (ALND)/radiotherapy (XRT), 2 had ALND/XRT alone, and 4 had no local treatment secondary to stage IV disease. Two women initially treated with lumpectomy/ALND subsequently had mastectomy for positive margins. Of the women with positive MRI who had breast surgery, 21 of 22 (95%) had tumor within the surgical specimen. Twelve women had negative MRI of the breast. Five of these 12 underwent MRM, of whom 4 had no tumor in the mastectomy specimen. The remaining 7 patients had ALND and whole breast radiation (ALND/XRT) (n 5 5), or were observed (n 5 2). Overall, 18 of 34 women surgically treated had MRM, while 16 (47%) preserved their breast. Tumor yield for patients having breast surgery was 81%.Conclusions: MRI of the breast can identify occult breast cancer in many patients and may facilitate breast conservation in select women. Negative breast MRI predicts low tumor yield at mastectomy.     

Sentinel Node Biopsy is Important in Mastectomy for Ductal Carcinoma In Situ

Background There is uncertainty about the utility of sentinel node biopsy (SNB) for ductal carcinoma in situ (DCIS) and its potential to avoid axillary lymph node dissection (ALND) in patients undergoing mastectomy for DCIS. Methods A review was conducted of 179 patients who underwent mastectomy with sentinel node biopsy for DCIS without invasion or microinvasion on premastectomy pathology review. Results The sentinel node identification rate was 98.9% (177/179). Twenty (11.3%) of 177 mastectomies for DCIS had a positive SNB: two micrometastasis (pN1mi) and 18 isolated tumor cells [pN0(i+)]. Unsuspected invasive cancer was found in 20 (11.2%) of 179 mastectomies, eight T1mic, five T1a, three T1b, and four T1c tumors. Sentinel nodes were identified in 19 of 20 patients with invasive cancer and four were positive: one pN1mi and three pN0(i+). Eighteen of 19 patients with unsuspected invasive cancer were able to avoid axillary dissection on the basis of SNB results. Of the 159 patients whose final pathology revealed DCIS without invasion, a sentinel node was identified in 158 (99.4%). The SNB was positive in 16 patients (10.1%): one pN1mi and 15 pN0(i+). Three patients underwent ALND on the basis of positive SNBs and in each the SNB was the only positive node. Conclusions 11% of patients undergoing mastectomy for DCIS were found to have invasive cancer on final pathology. The use of SNB during mastectomy for DCIS allowed nearly all such patients to avoid axillary dissection. These results support routine use of SNB during mastectomy for DCIS.     

乳腺癌组织中组织金属蛋白酶抑制剂-1的表达及其意义

目的探讨组织金属蛋白酶抑制剂 1(TIMP 1)在乳腺癌患者病程进展中的意义。方法对 4 8例原发性乳腺癌患者癌组织石蜡标本 ,采用标准链霉菌抗生物素蛋白 过氧化物酶亲合免疫组织化学法检测肿瘤组织中TIMP 1的表达情况 ,分析其与临床病理特征间的关系。结果 4 8例乳腺癌中TIMP 1阳性表达率为 2 9% ;本组患者无腋淋巴结转移者、高分化者、无远处转移者及 5年生存者TIMP 1表达水平低于有腋淋结转移者、低分化者、远处转移者及死亡者 ,差异有显著性意义 (P <0 0 5 )。结论TIMP 1表达水平与乳腺癌患者的转移和预后相关     

超声刀在乳腺癌腋窝Ⅲ组淋巴结清扫中的应用研究

目的:研究应用超声刀行乳腺癌腋窝Ⅲ组淋巴结清扫的近期疗效及安全性。方法:将2009年3月至2013年6月入住我院的80例乳腺癌病人随机分为超声刀组和电刀组,在Auchincloss改良根治术式基础上行腋窝Ⅲ组淋巴结清扫,对两组病人的手术时间、术中出血量、术后引流量和术后并发症等临床资料进行统计学分析。结果:超声刀组病人的手术时间和引流时间较电刀组明显缩短,出血量和引流总量均减少,差异均有统计学意义(P<0.05)。结论:超声刀在乳腺癌改良根治术中的应用能提高手术的精确度和安全性,值得推广。     

Surgical management of early stage invasive breast cancer: a practice guideline.

OBJECTIVES: To assess the available evidence on sentinel lymph-node biopsy, and to examine the long-term follow-up data from large randomized phase III trials comparing breast-conserving therapy with mastectomy in order to make recommendations on the surgical management of early invasive breast cancer (stages I and II), including the optimum management of the axillary nodes: for the breast--modified radical mastectomy or breast-conserving therapy; for the axilla--complete axillary node dissection, axillary dissection of levels I and II lymph nodes, sentinel lymph-node biopsy or no axillary node surgery. OUTCOMES: Overall survival, disease-free survival, local recurrence, distant recurrence and quality of life. EVIDENCE: MEDLINE, EMBASE, the Cochrane Library databases and relevant conference proceedings were searched to identify randomized trials and meta-analyses. Two members of the Practice Guidelines Initiative, Breast Cancer Disease Site Group (BCDSG) selected and reviewed studies that met the inclusion criteria. The systematic literature review was combined with a consensus process for interpretation of the evidence to develop evidence-based recommendations. This practice guideline has been reviewed and approved by the BCDSG, comprising surgeons, medical oncologists, radiation oncologists, pathologists, a medical sociologist, a nurse representative and a community representative. BENEFITS, HARMS AND COSTS: Breast-conserving therapy (lumpectomy with levels I and II axillary node dissection, plus radiotherapy) provides comparable overall and disease-free survival to modified radical mastectomy. Levels I and II axillary dissection accurately stages the axilla and minimizes the morbidity of axillary recurrence but is associated with lymphedema in approximately 20% of patients and arm pain in approximately 33%. Currently, there is insufficient data regarding locoregional recurrence and long-term morbidity associated with sentinel-node biopsy to advocate it as the standard of care. Breast-conserving therapy may offer an advantage over mastectomy in terms of body image, psychological and social adjustment but appears equivalent with regard to marital adjustment, global adjustment and fear of recurrence. RECOMMENDATIONS: Women who are eligible for breast-conserving surgery should be offered the choice of either breast-conserving therapy with axillary dissection or modified radical mastectomy. Removal and pathological examination of levels I and II axillary lymph nodes should be the standard practice in most cases of stages I and II breast carcinoma. There is promising but limited evidence to support recommendations regarding sentinel lymph-node biopsy alone. Patients should be encouraged to participate in clinical trials investigating this procedure. VALIDATION: A draft version of this practice guideline and a 21-item feedback questionnaire was circulated to 201 practitioners in Ontario. Of the 131 practitioners who returned the questionnaire, 98 (75%) completed the survey and indicated that the report was relevant to their clinical practice. Eighty (82%) of these practitioners agreed that the draft document should be approved as a practice guideline.