byq - thank you very much! 非常感谢白大夫，I didn't mean that you need to provide the information to my questions.  我的意见可能对你也没有什么具体的帮助，But, the information should be useful to all the readers. 但是这些信息应该对其它读者有帮助，Breast cancer is a huge problem in China and the world. 乳腺癌在中国和世界一样都是非常麻烦的，It affects many young and middle aged women. 对全世界的中青年妇女都有非常大的影响，I trust that the practice in China will be more evidence-based, guideline-driven, and more in line with the western standards in the next few years.  我相信：不久的将来中国的乳腺癌诊治会和世界接轨，会更加循证，会更加标准化，会接近到西方的诊治标准。

byq - thank you very much! I didn't mean that you need to provide the information to my questions.  But, the information should be useful to all the readers. Breast cancer is a huge problem in China and the world. It affects many young and middle aged women. I trust that the practice in China will be more evidence-based, guideline-driven, and more in line with the western standards in the next few years. 

Thanks 曹大夫 and 力刀 for the comments and support.

It's unlikely that the routine frozen section practice in China will change in a short time. The only way to avoid mistake is to get well trained in breast pathology, when you in doubt - get consultations, be conservative, tell the surgeons that "it is difficult to be certain, wait for permanent paraffin sections"

 Good information from Dr. Shen. I copied writing below.

Current diagnostic and treatment flow for breast lesions in US

·          Patient had abnormal mammographic finding (microcalcification), mass/nodule or nipple discharge

·          Core needle biopsy for routine H&E stain and diagnosis, also for ER/PR/Her-2/neu stains

·          Confirmed by pathologist to be benign or malignant (in situ or invasive carcinoma)

·          If benign, discussion with patient –  options are surveillance or conservative excision

·          If malignant, plan for appropriate surgery either by lumpectomy or mastectomy with or without sentinel

Lymph node biopsy with or without axillary dissection for staging

·          Planning for Rx or chemotherapy based on diagnosis, TNM stage and other risk factors

How do we do in our hospital

The steps for breast mass or abnormal:

1. Clinical examination

2. Imaging study. In fact many women were found to have abnormal mamogram including calcification et al in the  the mamogram screening.

3. Fine needle aspiration (down due to the core bx) or breast core biopsy to make the diagnosis. If it is cancer, the immunostains for ER, PR, Her2 are performed.

4. Based on above information, partial (or excisional) mastectomy or total mastectomy  with or wothout axillary lymph node dissection will be performed. Some time the patients will have chemotherapy or hormon treatment before the surgery.

Pathologists will be asked to evaluate the margins grossly. If tumor is close to (for example <5mm) or positive in the margins grossly, surgens will take another margin. Some times we do frozen for sentinel lymph node. If it is positive, axillary dissection will be performed. We almost never do frozen for breast mass to evaluate maligant or benign and never do frozen to evaluate tumor margins. Breast pathologists will fell difficulty to make diagnosis in perminent slides in many cases. How can pathologists make diagnosis in cluding the margins in few frozen sections in these cases?

Above is my experience in a large breast/GYN center. I think most hospitals in the US have the similar ways to deal with breast lesions.

I met several Chinese pathologists  here to know that the ways to deal with breat mass are very similar in most hospitals in China now. I felt unbeliveable in the begining. I talked with some older physician to know in the US they had the similar ways to deal with breast lesions before 1978-1981. We will have a long way to go.

It is not the question of our pathologists. It is the question for patient care, surgens, hosptal leaders, and pathologists. it is a concept we should change. Just like that cytotechnicians cannot rerease the abnormal Pap reports. Abnormal Pap results must be reviewed and sigin-out by well trained cytopathologists and pathologists.

Now I think the knowing or learning the priciple and concept is much more important than learning one case.

 乳腺的冰冻相对而言不容易, 因为有很多脂肪组织，　冰冻的形态学有很多假象。

还有冰冻是诊断肿瘤本身还是看手术边界，看边界可能更难，看肿瘤本身因为有一个肿块．　美国很多大医院不做乳腺手术边界的冰冻，肿块一般先用活检诊断，然后根据活检结果和其他因素如影响学决定手术方法．　国内的情况不一样，可能是病人的负担，还有就是外科大夫的知识（说实话很多只是一手术工具，根本谈不上算一个医生）．　

冰冻谁都会犯错误，是人就会犯错误，多少和大小的问题，难道外科大夫做手术不犯错，只是关了手术谁也不知道罢了．

当然做冰冻要小心，＂上山容易下山难＂，叫上去了就下不来了．　

Thanks for Dr. Yuexin and Dr. Lili0321's comments.  I have read some of the other discussions and comments in previous postings in frozen and breast sections, particularly by byq and  Dr. 力刀. Here is a summary and hope this will be helpful for your practice.   If intraoperative frozen section is required, we have to realize it is a dangerous area for making diagnosis, get well trained and be conservative and avoid some of the common pitfalls and mistakes.  We welcome comments form colleagues from China and US.

Current diagnostic and treatment flow for breast lesions in US

·          Patient had abnormal mammographic finding (microcalcification), mass/nodule or nipple discharge

·          Core needle biopsy for routine H&E stain and diagnosis, also for ER/PR/Her-2/neu stains

·          Confirmed by pathologist to be benign or malignant (in situ or invasive carcinoma)

·          If benign, discussion with patient –  options are surveillance or conservative excision

·          If malignant, plan for appropriate surgery either by lumpectomy or mastectomy with or without sentinel

Lymph node biopsy with or without axillary dissection for staging

·          Planning for Rx or chemotherapy based on diagnosis, TNM stage and other risk factors

Potential problems with frozen section of breast lesions

·          For small mass lesion, easily to be lost during freezing and cutting

·          For non-palpable (microcalcification), sampling for frozen a huge problem

·          Very poor quality slides and frozen artifacts

·          Difficult for pathologist to make a accurate diagnosis  

·          The results are unacceptably high false negative and false positive or deferred diagnosis

 (Very rare frozen dx for breast lesion in US!)

Current practice in the smaller community hospital in China (thanks to byq)

·          乳腺包块的病人到医院来了

·          临床医生开个单子叫他先到病理科做细针穿刺 (fine needle aspiration cytology – cannot differentiated DCIS or invasive carcinoma)

·          如果有问题 (suspicious for DCIS or Invasive Ca)，临床医生就让病人住院手术 (what if not diagnostic, benign, atypical hyperplasia or DCIS or LCIS, what next?)

·          术中为了保险起见，(incisional biopsy specimen?), 做个冰冻 (if confirm malignant – DCIS and invasive?) 再把乳房切掉 (breast conservation surgery or not?)。

·          What about if frozen diagnosis is benign? What’s next

·          现在对乳腺癌的治疗提倡新辅助化疗 (neoadjvant chemotherapy): what the inclusion criteria?

国内开展粗针活检还不是很普遍，原因是多方面的:

Ø       一是耗材较贵 (did anybody actually perform a comparison cost analysis with current practice)

Ø       二是粗针穿刺标本也是很小的标本，出现漏诊的几率据报道可达7% (where are the data from?)

Ø       标本送到病理科我们感觉组织太小 (size of core and number of core, bx technique)

Ø       做起来非常困难 (diagnostically)，切片出来有时候根本看不到肿瘤细胞，

Ø       No tissue left for下一步要做免疫组化染色等也就无从做起

Do we need to and how to improve the breast cancer care in China

Ø       First we have to have evidence to support that the practice in US and Europe are better for the patient care

Ø       Cost-benefit analysis comparison between current practice in China and standard practice in US

Ø       The conclusion may be frozen diagnosis may be acceptable and practical in China

Ø       Identify what are the challenge areas for adoption of abandoning routine frozen section

o         Core biopsy (by radiologist or surgeon)

§          Biopsy equipment and instrument

§          Size of cutting needle

§          Experience and training (radiologist or surgeon)

o         Diagnostic skill (pathologist training)

§          Training course

§          Pitfalls and problems

§          Clinico-pathologic-clinical correlation

 The data from consecutive 13243 cases of breast lesions diagnosed with intra-operative frozen sections between 1988 to 2002 were compared with paraffin sections in a case by case manner. 天津肿瘤研究所，从1988--2002做13243 例冰冻切片，The causes of false negative and positive diagnoses as well as delayed diagnoses were analyzed. 分析其误诊原因，RESULTS: One hundred and seventeen cases (0.9%)  were falsely diagnosed, with one false positive case and 116 false negative cases. 结果误诊率为117例 (0.9%) ，1例假阳性，116例假阴性。The diagnosis of 47 cases (0.4%) was delayed.  (0.4%) 47例术中冰冻不能诊断，需要等常规病理。天津肿瘤研究所这么高的水平，还有这么高的误诊，给我们一颗定心丸。

我们如果误诊一例，临床和病人都想打死我们。

This is an article published last year and I will read it also.  I will post a few other articles from Europe and US and hope they are helpful to you.  

Niu Y, Fu XL, Yu Y, Wang PP, Cao XC. Intra-operative frozen section diagnosis of breast lesions: a retrospective analysis of 13,243 Chinese patients. Chinese Medical Journal, 2007, Vol. 120 No. 8 : 630-635 (From Tianjin Cancer Institute, Tianjin Medical University, Tianjin, China.)

BACKGROUND: Although cytological methods for breast oncology have been used in recent decades, intra-operative frozen section has been playing a vital role in making therapeutic decisions. We analyzed a large series of frozen section diagnoses for Chinese cases of breast lesion within the last 15 years. The experience was expected to increase the diagnostic accuracy of cases with breast lesions. METHODS: The data from consecutive 13243 cases of breast lesions diagnosed with intra-operative frozen sections between 1988 to 2002 were compared with paraffin sections in a case by case manner. The causes of false negative and positive diagnoses as well as delayed diagnoses were analyzed. RESULTS: One hundred and seventeen cases (0.9%) were falsely diagnosed, with one false positive case and 116 false negative cases. The diagnosis of 47 cases (0.4%) was delayed. The proportion of several lesions had the features of the patients' ages. Six types (false invasion, peri-papilloma, adenoma of nipple duct, florid adenosis, sclerosing adenosis, and granulose cell tumor) of lesions may lead to false positive, and four types (morphological changes responding chemotherapy, well differentiated papillary carcinoma, invasive lobular carcinoma, and tubular carcinoma) to a false negative. Gross and microscopic findings may be inconsistent in two types of lesions (radial scar and florid adenosis) microscopic and clinical findings in three types (ganulomatous mastitis mammary, duct ectasia, and fat necrosis), and three types (abundant fat or sclerous tissues; borderline lesions and changes of post-chemotherapy) were likely wrongly classified. CONCLUSIONS: Intra-operative frozen section can accurately identify breast lesions in many instances, leading to fewer errors on account of more diagnostic experience and understanding of diagnostic limitations.