Japanese Journal of Clinical Oncology 31:527-531 (2001)
© 2001 Foundation for Promotion of Cancer Research
Breast Biopsy for Mammographically Detected Non-palpable Lesions Using a Vacuum-assisted Biopsy Device (Mammotome) and an Upright-type Stereotactic Mammography Unit
Departments of 1Surgery and 2Pathology, National Shikoku Cancer Center, Matsuyama, Japan
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Background: It is planned to start screening mammography throughout Japan in the near future. However, a minimally invasive biopsy procedure for mammographically detected non-palpable breast lesions is not available in almost all Japanese hospitals. It is crucial to develop a useful minimally invasive biopsy method which can be applied without difficulty.
Methods: Eighty-nine biopsies for 88 mammographically detected non-palpable breast lesions, consisting of 70 lesions with microcalcifications alone, eight masses without calcifications and 10 with both masses and microcalcifications, were performed using the combination of a vacuum-assisted biopsy device (Mammotome) and an upright-type stereotactic mammography unit.
Results: Microcalcifications were confirmed radiographically in the tissue obtained from 78 biopsies among 81 biopsies for the lesions with microcalcifications (96.3%). All the lesions without calcifications were considered to be biopsied successfully. Five patients complained of nausea or fainted during the localization or biopsy procedure and an additional patient suffered from hyperventilation syndrome. Five cases experienced mild subcutaneous bleeding in the breasts.
Conclusions: The biopsy technique using the combination of a vacuum-assisted biopsy device and an upright-type stereotactic mammography unit is a cost-effective, safe and very useful method for mammographically detected non-palpable breast lesions. It is expected to be a standard method of biopsy for such lesions in many developed countries other than the USA. However, it is important to make the patients relaxed during the biopsy to prevent mental strain.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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In many developed countries, breast cancer is the commonest malignancy of women. Nowadays most North American and Western European countries perform screening mammography, because several randomized controlled trials have demonstrated that it reduced the mortality of breast cancer at least in women who are 50–74 years old (1–3). In most parts of Japan, where breast cancer is the second commonest female malignancy following gastric cancer, mammography is not yet used for screening, but it is planned to start it in the near future throughout the country.
While non-palpable breast lesions are detected with mammography, biopsy is necessary to make a diagnosis in most of them. Either open biopsy using a hook wire or stereotactic core needle biopsy with a prone-type stereotactic mammography unit was used to obtain the tissue of non-palpable lesions until the vacuum-assisted biopsy device (Mammotome, Johnson & Johnson, USA) (Fig. 1) became available. The upright-type stereotactic mammography unit was not suitable for stereotactic core needle biopsy because it is difficult to keep the breast position strictly stable. The vacuum-assisted biopsy device could overcome the shortcomings of the upright-type stereotactic mammography unit because of the large volume of tissue obtained.
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We report 2-year results of biopsy for mammographically detected non-palpable breast lesions using a combination of an upright-type sterotactic mammography unit and a vacuum-assisted biopsy device.
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PATIENTS AND METHODS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Eighty-eight mammographically detected non-palpable breast lesions of 86 patients (two patients had the lesions bilaterally) were biopsied with a combination of a Mammotome and a Mammomat 3000 (Siemens, Germany) (Fig. 2) as an upright-type sterotactic mammography unit between May 1999 and April 2001. An additional two biopsies were attempted but abandoned because the patients complained of nausea during the localization procedure. The mean age of the patients was 51.6 years (range: 30–77 years). On the mammograms, 70 lesions showed microcalcifications alone, eight had masses without calcifications and 10 showed both masses and microcalcifications.
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The size of the lesion was measured on the mammograms. The size of the lesions with microcalcifications was defined as the largest size of the microcalcified area. The locations of the lesions were classified into the quadrants where they existed. If they extended to two or more quadrants, all the quadrants where they existed were recorded.
Technical Procedures
A patient sits at the Mammomat 3000 with the bare affected breast. Spot mammograms of the lesion are taken at ±15° from the zero position for stereotaxis (Fig. 3). The set of two spot mammograms is used to read the 3-D position of the lesion with a device exclusively used by the Mammomat 3000. We used a film-based method rather than a digital image method. The Mammotome is fixed to the Mammomat 3000. The skin overlying the lesion and the mammary gland around the lesion are anesthetized with 1% lidocaine. The skin is cut with a knife. The incision is usually 3–4 mm in length. The tip of the needle of the Mammotome is moved towards the position at which Mammomat 3000 shows 
X, Y, Z zero (Fig. 4). The distance between the tip of the needle and the lesion is confirmed with the spot mammograms (Fig. 5). If the distance between them is more than a few millimeters, the position of the needle is corrected. Then the needle is fired. The tip of the needle moves forward ~2 cm on firing and tissue is obtained. After biopsy, the biopsied area is pressed with the fingers for hemostasis. The incision in the skin is closed with Steri-Strip tape.
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In cases with microcalcifications, the tissue obtained is examined radiographically to determine whether the lesion has been biopsied correctly (Fig. 6).
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RESULTS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Eighty-nine biopsies were performed for 88 lesions in 86 patients; one of the microcalcified lesions was biopsied twice because the first biopsy failed to obtain the calcifications. All the biopsies were done by two of the authors (S.O. and K.A.). Eighty-five biopsies were performed using an 11-gauge needle and the remaining three with a 14-gauge needle. The mean and median numbers of pieces obtained per biopsy were 6.7 and 6, respectively (range: 3–12). Although we did not measure the time required for the procedure exactly, it took approximately 30–45 min, including the time for hemostasis, for each case.
Information on the size and location of the lesions was obtained in all cases but one with microcalcifications alone. The mean size of the lesions with microcalcifications was 1.3 cm (range: 0.3–5.3 cm). The mean size of the lesions with mass alone was 1.2 cm (range: 0.8–1.6 cm). The locations of 79 lesions with microcalcifications were as follows: upper-outer quadrant (UO), 30 lesions; lower-outer quadrant (LO), five lesions; upper-inner quadrant (UI), 24 lesions; lower-inner quadrant (LI), six lesions; UO and UI, four lesions; LO and LI, four lesions; UO and LO, five lesions; UI and LI, one lesion.
Microcalcifications were confirmed radiographically in the tissue obtained from 78 biopsies among 81 biopsies for the lesions with microcalcifications (96.3%) and calcifications were also found on the microscope slides of all the biopsies with microcalcifications but two (93.8%). The sizes of the three lesions missed by Mammotome biopsy were 1.8, 2.3 and, 1.7 cm, their locations being UO and LO, UI and UO, respectively.
All the eight masses without calcifications were judged to have been biopsied successfully according to the findings of the post-biopsy mammograms and histological appearance of the biopsied materials.
Pathological diagnoses of the biopsied materials were invasive ductal carcinoma in four lesions, ductal carcinoma in situ (DCIS) in 24, atypical ductal hyperplasia (ADH) in three, unable to differentiate invasive carcinoma from sclerosing adenosis in one and benign breast lesions in 56. Biopsy diagnoses by the mammographic findings are shown in Table 1. All the non-calcified masses were benign. Two microcalcified lesions that were not obtained by biopsy correctly and not biopsied again were diagnosed benign histologically. The cases diagnosed as benign were followed by physical examination and mammography periodically without event.
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All the cases who were diagnosed as malignant or ADH underwent surgery except for one patient with bilateral DCIS who rejected surgery. The pathological diagnoses of Mammotome biopsy materials were essentially identical with those of the surgical diagnoses in 24 of 30 resected lesions (80.0%), if the diagnosis of DCIS with microinvasion in the surgical materials is considered to be DCIS. Five other lesions were underestimated on Mammotome biopsies and one was overdiagnosed (Table 2).
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Mild subcutaneous bleeding was seen after Mammotome biopsy in five biopsies (5.5%). Five cases including two patients who did not receive biopsy complained of nausea or fainted (5/91, 5.5%). In two of them biopsy was not performed because they complained of nausea during the localization procedure. Another patient experienced hyperventilation syndrome immediately after biopsy (1.1%). All of the complications were self-limited.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Most developed countries in North America and Europe are using mammography in screening of breast cancer based on data from randomized controlled trials evaluating the role of mammography (1–3). The reduction in mortality due to breast cancer is believed to be attributable to detection of breast cancer at a very early stage. Most breast cancers of very early stage are non-palpable. It is usually necessary to obtain the tissue of the lesions in order to make a diagnosis in the case of suspicious non-palpable breast lesions.
The development of techniques to take the tissue of non-palpable lesions found by mammography has been a critical issue since the introduction of screening mammography. In the USA, a needle localizer was invented to localize the non-palpable lesions (4). At present Kopans’ hook wire is most frequently used for this purpose. Although surgical excisional biopsy using a hook wire has been a good method to obtain a non-palpable lesion precisely, it sometimes causes deformity of the breast (5). On the other hand, the rate of breast cancer is ~20% of non-palpable biopsied lesions (6,7).
Core needle biopsy became an alternative method after development of a stereotactic mammography unit. At first an upright-type stereotactic mammography unit, which is usable to take routine mammograms, was used (8). However, it was very difficult to keep the position of the lesion strictly stable during the biopsy procedure. Subsequently, a prone-type stereotactic mammography unit was utilized to hold the breast rigidly (9). The drawbacks of the prone-type unit include a very high cost [~50 million yen (~$400 000)] and unsuitability for routine mammographical examination. Although the success rate of core needle biopsy for non-palpable breast lesions was reported to be close to 100%, it was still difficult to obtain them correctly even with the prone-type stereotactic unit.
Recently a vacuum-assisted biopsy device (Mammotome) has been introduced into the field of breast biopsy (10). By using the device it has become possible to take a large volume of tissue because vacuum and the large size of the needle, which is up to 11-gauge, help to increase the volume of the tissue obtained. The combination of a Mammotome and a prone-type stereotactic mammography unit has made the biopsy of non-palpable breast lesions, especially those with microcalcifications, easier because the large size of the tissue obtained does not require strictly precise localization of the needle. Also, the large size of the materials biopsied with the Mammotome has made pathological diagnosis easier.
In the USA, many institutions have a prone-type stereotactic mammography unit in combination with a Mammotome and it has become a routine biopsy procedure for non-palpable breast lesions. However, only a few hospitals have a prone-type unit in Japan. We thought that the combination of an upright-type unit and a Mammotome could be used for breast biopsy of non-palpable lesions because the Mammotome would not require strict stability of the lesion during the procedure owing to the large volume of tissue obtained. We tried to use this combination for biopsy of non-palpable breast lesions, and demonstrated that this combination provided very high success rate with little difficulty. Our early experience was reported in Japanese. In our first report, 27 mammary lesions were biopsied. Twenty-four were non-palpable and three were barely palpable. Of these 24 were microcalcified. The success rate of biopsy for the lesions with microcalcifications was 92% (11). The present work confirmed the usefulness of this combination. To our knowledge, this report is only the second in the English-language literature to describe the usefulness of a combination of a Mammotome and an upright-type stereotactic unit. Nisbet et al. in the UK reported in 2000 the biopsy results for 21 patients with microcalcified breast lesions using a Mammotome and an upright-type mammography unit with optional digital imaging equipment (12). The success rate was 86%, which was lower than that of our results, for unknown reasons.
The use of the upright-type unit has advantages over the prone-type unit in terms of the ability to biopsy lesions of extremely lateral location and cost. The lesions biopsied in this series included some of extremely lateral location, which might not have been biopsied with the prone-type unit. The cost of the use of the upright-type unit is much less than that of the prone-type unit because the latter is extremely expensive as mentioned above and a film-based method rather than a digital image method is usable in the upright-type unit. The cost of stereotactic localization using the film-based method is less than 1000 yen (~$8) for a biopsy because only four or five films are necessary. Therefore, it will cost less than 1 million yen (~$8000) for 1000 biopsies, e.g. if 100 biopsies per year are performed for 10 years. On the other hand, with the digital image method it costs at least ~20 million yen (~$160 000) even for the optional equipment of the upright-type unit. Moreover, if the prone-type unit is used, the cost will be very much higher.
The only problem related to the upright-type procedure is the patients’ mental pressure during the biopsy because they see the wound and blood. Five of our patients complained of nausea or fainted and another experienced hyperventilation syndrome. We believe that it is very important to make the patients relaxed throughout the biopsy procedure. The risk factor of these symptoms is thought to be past history, because all the patients who showed these symptoms during the procedure reported that they had experienced the same symptoms previously when they had seen blood, etc. Also, we believe it is not related to the time required for the procedure because two patients complained of nausea immediately after a skin incision. We are now trying to reduce the patients’ mental pressure by explaining the procedure in advance and by keeping speaking to the patients during the biopsy, especially for the patients with a past history of adverse symptoms. We also ask the patients to cover their eyes, if necessary.
We used a 14-gauge needle three times. We believe that the 11-gauge needle is better for the biopsy of non-palpable breast lesions because in one case differential diagnosis between invasive cancer and sclerosing adenosis was not possible because of the very small volume of the material biopsied with the 14-gauge needle.
As described above, many Japanese hospitals including our institution already have an upright-type stereotactic mammography unit, but only a few institutions have a prone-type unit. We surmise that the situation in many developed countries other than the USA is rather similar to that of Japan. We hope that the combination that we used here will become a standard biopsy technique for non-palpable breast lesions detected mammographically in many developed countries other than the USA.
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Acknowledgement |
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This study was supported by a Grant-in-Aid for research on cancer treatment from the Ministry of Health, Labour and Welfare of Japan (No. 13-10).
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FOOTNOTES |
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+ For reprints and all correspondence: Shozo Ohsumi, Department of Surgery, National Shikoku Cancer Center, 13 Hori-no-uchi, Matsuyama, Ehime 790-0007, Japan. E-mail: sosumi@shikoku-cc.go.jp
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Received June 4, 2001; accepted July 31, 2001.
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