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10.1245/s10434-006-9263-x
Annals of Surgical Oncology 14:1045-1050 (2007)
© 2007 Society of Surgical Oncology
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Original Article

Intra-operative Touch Preparation Cytology; Does It Have a Role in Re-excision Lumpectomy?

Edna K. Valdes, MD1, Susan K. Boolbol, MD1, Jean-Marc Cohen, MD2 and Sheldon M. Feldman, MD, FACS1

1 Louis Venet Comprehensive Breast Service, Department of Surgery, Beth Israel Medical Center, New York, NY 10003, USA
2 Louis Venet Comprehensive Breast Service, Department of Pathology, Beth Israel Medical Center, New York, NY 10003, USA

Correspondence: Address correspondence and reprint requests to: Edna K. Valdes, MD, E-mail: edvaldes{at}chpnet.org


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Objective: Breast carcinoma is the most frequently diagnosed malignancy in women of North America. The combination of breast conservation surgery and radiotherapy has become a standard of treatment for the majority of breast cancers. It is critical to obtain clear margins to minimize local recurrence. However, avoiding multiple re-excisions for margin clearance helps optimize cosmetic results in patients undergoing breast conservation surgery. Intra-operative touch preparation cytology (IOTPC) may decrease the need for multiple re-excisions and thereby improve cosmesis. The literature suggests that IOTPC can be useful in evaluation of margins. Klimberg et al. evaluated the touch preparation technique prospectively in 428 patients undergoing breast biopsy for undiagnosed breast masses. Margin evaluation was correct in 100% of the lesions and was used to re-excise the margins when touch prep results were positive. They reported a diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 100% for the touch prep technique.

To the best of our knowledge, there has been no published data on the role of IOTPC for evaluation of margins in re-excision cases. This report describes our experience with IOTPC for margin assessment for re-excision partial mastectomy at Beth Israel Medical Center (BIMC). The purpose of this study is to determine whether IOTPC is reliable for evaluating margins in patients undergoing re-excision for involved or close margins.

Methods: A prospective study of 30 patients, who have undergone re-excision partial mastectomy for involved or close margins after breast conservation surgery with the use of IOTPC for margin assessment at BIMC was performed. The re-excision lumpectomy specimens were oriented by the surgeon intra-operatively and were submitted fresh to pathology for cytologic assessment. The touch prep method consisted of touching the corresponding margin onto the glass slide. The principle of this technique is that if cancer cells are present they will stick to the slide, while fat cells will not. A slide was prepared for each re-excision specimen. Air-dried samples were stained immediately using the Diff-Quik method and examined under the microscope by a cytopathologist.

Results: Thirty patients underwent re-excision lumpectomy for involved or close margins with touch preparation cytology for assessment of 68 margins. Twenty-six patients had invasive ductal carcinoma and/or ductal carcinoma in situ, three patients had invasive lobular carcinoma and the remaining one patient had a combination of invasive lobular and ductal carcinoma. There was a correlation between touch prep cytology and final pathology in 56/68 margins, which accounts for 82.4% of the cases.

Conclusion: Intra-operative touch preparation cytology for assessment of margins in patients undergoing re-excision lumpectomy for involved or close margins has a sensitivity of 75%, specificity of 82.8%, positive predictive value of 21.4%, and negative predictive value of 98.2%. This high negative predictive value and a single false negative margin are quite significant. Therefore, based on our experience, IOTPC can be a useful tool for intra-operative assessment of margins for patients undergoing re-excision partial mastectomy.


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Breast carcinoma is the most frequently diagnosed malignancy in women of the North America and the second most common cause of cancer death. In 2005, over 212,000 new cases of invasive breast cancer were diagnosed. The incidence of in situ and small (<1 cm) carcinomas has increased significantly, from 2% prior to 1970s to 20% of mammographically detected cancers, due the increased use of screening mammography over the last 25 years.1–5

The 1990 Consensus Conference of the NIH recommended conservative surgery (lumpectomy and radiation, with or without axillary lymph node dissection) as the preferred procedure, for stage I and II breast cancer. Thus, the combination of breast conservation surgery and radiotherapy has become a standard of treatment for most breast tumors.1–3,6–9

Several prospective randomized studies have revealed that disease-free survival, distant-disease-free survival, and overall survival rates, are equivalent in breast conservation therapy and radical or modified radical mastectomy. However, the lifelong risk of local recurrence still remains in patients undergoing breast conservation surgery.1,6,8,10–15

Several controlled retrospective studies have shown significantly increased recurrence rate if no re-excision was performed for focally positive or close margins. Microscopic residual disease at margins seems to be responsible for a local recurrence rate of up to 25%, 3–5 years after breast conservation surgery and radiotherapy as compared to 3.7%, when negative margins were obtained. The National Surgical Breast and Bowel Project B-17 demonstrated that positive or close margins increased the risk of local recurrence regardless of whether radiation therapy was given (4% for negative margins vs. 10% for involved margins) or not (11 vs. 25%, respectively). The risk of recurrence is reduced, by removing more normal tissue surrounding the tumor; however, cosmetic results are adversely affected by larger volume excision. Therefore, to balance between risk of local recurrence, avoiding multiple re-excisions and psychological issues associated with it, cost, and acceptable cosmesis, a reliable method is necessary for assessing margins intra-operatively.1,3,5,6,8,9,11–13,16–22 Development of partial breast radiation such as mammosite, interstitial brachytherapy, and intra-operative radiation therapy (IORT) further emphasizes the importance of an accurate method to assess margins intra-operatively.

Frozen section is not reliable for assessing the margins intra-operatively, due to technical problems involved in freezing adipose tissue and possibility of compromising the final diagnosis by leaving insufficient tissue for permanent section. It is expensive, less specific, time consuming, and serial sectioning is cumbersome.1,3,5,16,23–26

Most non-cytological techniques5,9,27 assess approximately 10–15% of the lumpectomy specimen surface. In 1986, Carter proposed inking the periphery of the specimen and then peel it like an orange, embedding the inked surface for parallel sectioning for complete histological examination. However, this technique is tedious and time consuming and is not feasible intra-operatively.9,16,19,22,28 Some authors advocate sampling the tumor bed by shaving samples from all five walls of the cavity rather than the tumor itself.9

A method, wet film cytology, was first described by Shaw in 1910 and later was introduced as a method of pathologic evaluation by Dudgeon and Patrick in 1927. This can potentially assess all the margins.5,9,24,29,30 This method has been described in the literature using different terms, including imprint cytology,3–5,9,16,29 touch prep,5,9,22,27 scrape cytology 5,9,16,28, cytologic smear, and Scrimp technique.5,9 Several investigators have shown its accuracy and practicality to evaluate lumpectomy margins intra-operatively5,9. This method has also been used for evaluation of sentinel lymph nodes and its sensitivity for detection of micro-metastases ranges from 90.9 to 100% and specificity of 100%. The reported false negative rate is 4.9%.23,29

Klimberg et al. evaluated the touch prep technique prospectively in 428 patients undergoing breast biopsy for undiagnosed breast masses. Margin evaluation was correct in 100% of the lesions and was used to re-excise specific margins when touch prep results were positive. They reported a diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 100% for the touch prep technique. In cases where multiple attempts to obtain clear margins were unsuccessful, touch prep was useful in determining that mastectomy was the appropriate option1,5,9.

Cox et al.27 reported their experience comparing touch prep with frozen section for margin assessment in 114 patients. These included 82 infiltrating ductal carcinomas (IDC), 24 intraductal carcinomas (DCIS), 2 lobular carcinoma in situ (LCIS), 4 infiltrating lobular carcinomas (ILC), and 2 mixed infiltrating ductal and lobular carcinomas. Of the 114 lumpectomy specimen evaluated, three were categorized as unsatisfactory and excluded from analysis. There were three false-positive cases evaluated with touch preparation cytology, two of which were in fact associated with lesions less than 1 mm from the margin. The histology of these cases included one multifocal DCIS and two IDC. The authors suggested that the margins might have truly been positive. They reported the sensitivity and specificity of touch preparation cytology of lumpectomy margins as 100 and 96.6%, respectively, with an overall diagnostic accuracy of 97.3%. The predictive values for cytologically detected absence and presence of tumor cells were 88 and 100%, respectively22,27.

Creager et al.3 reported their experience with imprint cytology on 758 margins in 141 lumpectomy specimens. The histology consisted of 106 IDC, 23 DCIS, 6 ILC, and 6 mixed ILC and IDC. In this study, imprint cytology had an accuracy of 85%, a sensitivity of 80%, a specificity of 85%, a positive predictive value of 40%, and a negative predictive value of 97%.

Weinberg et al.31 reported their experience on 1,713 patients who underwent breast conservation surgery for breast cancer. Of these patients, 1,193 had their surgery performed at the author’s institution, Moffit Cancer Center (MCC), where margins were evaluated by IOTPC. The remaining 520 patients had their surgery performed at an outside institution where conventional margin analysis such as frozen sections and permanent analysis was performed and were subsequently referred to MCC for radiation therapy and/or chemotherapy. The authors reported that the use of IOTPC resulted in decreased incidence of overall 5-year local recurrence from 8.8 to 2.8% (P < 0.0001). This decrease in local recurrence was seen in various histologic subgroups such as DCIS, IDC, and ILC in different degrees. The authors concluded that based on their experience, IOTPC proved to be superior to conventional histopathologic methods in evaluating lumpectomy specimens for negative margins to prevent local recurrence of disease.

A study in Finland was reported by Saarela et al.17 on touch prep for margin assessment on 55-lumpectomy specimen in 53 patients. The histologic types were 31 IDC, 5 ILC, 5 tubular, 2 mucoid, 1 papillary, 1 metaplastic, 6 DCIS, and 4 LCIS. The sensitivity, specificity, positive and negative predictive value and overall diagnostic accuracy of touch preparation cytology were 37.5, 85.1, 37.5, 88.9, and 78.2%, respectively. Based on their experience, the authors concluded that touch prep cannot be recommended for routine assessment of lumpectomy margins because of its poor correlation with histologic margins.

Overall with the exception of Dr. Saarela’s experience, the literature suggests that intra-operative touch preparation cytology (IOTPC) can be useful in evaluation of margins. To our knowledge, there is no published data on utility of IOTPC for margin assessment in re-excision partial mastectomy. This report describes our experience with IOTPC for margin assessment in re-excision partial mastectomy at Beth Israel Medical Center (BIMC). The purpose of this study is to determine whether IOTPC is reliable in assessment of margins in patients undergoing re-excision for involved or close margins.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
A prospective review of 30 patients (total of 68 margins), who have undergone re-excision partial mastectomy for involved or close margins after breast conservation surgery with the use of IOTPC for margin assessment at BIMC from 10/03 to 12/05 was performed. The re-excision partial mastectomy specimens were oriented by the surgeon intra-operatively using suture material and were submitted fresh to pathology for cytologic assessment. Glass slides were labeled to correspond to the margin of interest. The touch prep method consisted of touching the corresponding margin onto the glass slide (Fig. 1Go). The principle of this technique is that if cancer cells are present they will stick to the slide, while fat cells will not. A slide was prepared for each re-excision specimen. Air-dried samples were stained immediately, using the Diff-Quik method and examined under the microscope by a cytopathologist (Fig. 2Go).


Figure 1
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  		FIG. 1. Touch preparation cytology technique.

 

Figure 2
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  		FIG. 2. Stained slides (Diff-Quik method).

 
Final cytologic results were reported by a board-certified cytologist within 15 min, intra-operatively. Cytological features of malignancy include loosely cohesive and individually scattered malignant cells, malignant epithelial cells arranged in three-dimensional clusters, syncytial grouping and acinar pattern, tumor diathesis and non-polar naked nuclei. Diagnostic categories used in reporting cytologic results included negative, atypical, suspicious, or malignant. Atypical, suspicious, and malignant categories were used by the surgeon as an indication to excise additional tissue from the indicated margins intra-operatively. After the resected margins were evaluated by touch prep, they were subsequently inked and the specimen underwent serial sectioning and was evaluated by a pathologist.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
Thirty patients underwent re-excision lumpectomy for involved or close margins with touch preparation cytology for assessment of 68 margins (Table 1Go). Twenty-six patients had invasive ductal carcinoma (IDC) and/or ductal carcinoma in situ (DCIS), three patients had invasive lobular carcinoma (ILC) and the remaining one patient had a combination of invasive lobular and ductal carcinoma. There was a correlation between touch prep cytology and final pathology in 56/68 margins, which accounts for 82.4% of the margins.


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  		TABLE 1. Result summary
 
There were 11 margins, in seven patients, with positive touch prep but negative pathology (Table 2Go). Two of the 11 margins showed atypia on IOTPC and negative pathology with no further surgical intervention. One margin with atypia on IOTPC showed DCIS with less than 1 mm from the margin, the patient refused mastectomy in this case. Two margins in the same patient revealed ductal cancer on IOTPC with pathology showing DCIS 4 mm from the margin on one margin and ADH on the second margin. This patient subsequently underwent mastectomy with residual DCIS in the specimen. Two margins with atypia and one suspicious on IOTPC in the same patient showed residual DCIS on pathology, this patient ultimately underwent a mastectomy for a second lesion. One margin with cancer on IOTPC revealed residual DCIS within 2 mm from the margin and the patient subsequently underwent a mastectomy with no residual tumor in the specimen. Two margins, in the same patient, suspicious on IOTPC revealed LCIS in one and no residual cancer in the other margin on pathology. Additional margins were taken intra-operatively based on the IOTPC results with no residual carcinoma on pathology and therefore this patient did not require further surgery.


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  		TABLE 2. Summary of the 11 margins with positive intra-operative touch preparation cytology and negative pathology
 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
Breast carcinoma is the most frequently diagnosed malignancy in women of the North America and the second most common cause of cancer death. The combination of breast conservation surgery and radiotherapy has become a standard of treatment for most breast tumors.1,2,3,6–9 However, the lifelong risk of local recurrence still remains in patients undergoing breast conservation surgery.1,6,8,10–15 Therefore, to balance between risk of local recurrence, avoiding multiple re-excisions and psychological issues associated with it, cost, and acceptable cosmesis, a reliable method is necessary for assessing margins intra-operatively.1,3,5,6,8,9,11–13,16–22 Development of partial breast radiation such as mammosite, interstitial brachytherapy, and intra-operative radiation therapy (IORT), further emphasizes the importance of an accurate method to assess margins intra-operatively.

Intra-operative touch preparation cytology was first described by Shaw in 1910 and later was introduced as a method of pathologic evaluation by Dudgeon and Patrick in 1927.5,9,24,29,30 Several investigators have shown its accuracy and practicality in evaluating lumpectomy margins intra-operatively.5,9 Based on the published literature touch prep cytology can assess the entire surface of lumpectomy margins: it is highly reliable, it is less expensive than frozen section, it is quick and easy, it preserves tissue, it is highly specific, there is no freeze-thaw artifacts, it is easy to perform multiple slides, and it can obviate the need for repeated surgeries for histologically involved margins and potentially lower the local recurrence rate in breast conservation surgery.3–5,9,16,22,23,27,31 However, there is no published data on the utility of IOTPC for margin assessment in re-excision partial mastectomy.

In the 11 margins with positive IOTPC and negative pathology, residual DCIS was present in six margins and ADH or LCIS was present in two margins. A possible explanation for these findings is that IOTPC assesses the entire margin and perhaps it is more accurate than permanent pathology, which only evaluates representative of the margin.


   CONCLUSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
Intra-operative touch preparation cytology for assessment of margins in patients undergoing re-excision lumpectomy for involved or close margins has a sensitivity of 75%, specificity of 82.8%, positive predictive value of 21.4%, and negative predictive value of 98.2%. In the 11 margins with positive IOTPC and negative pathology, residual DCIS was present in six margins and ADH or LCIS was present in two margins. The high negative predictive value and a single false negative margin are quite significant. Therefore based on our experience, IOTPC can be a useful tool for intra-operative assessment of margins for patients undergoing re-excision partial mastectomy.


   FOOTNOTES
 
Poster presentation at the 28th Annual san Antonio Breast Cancer Symposium, December 8–11, 2005, San Antonio, Texas.

Received for publication January 26, 2006. Accepted for publication September 28, 2006.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 

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