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EJSO 34 (2008) 1289e1292
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Intraoperative ultrasound is an effective and preferable technique to localize non-palpable breast tumors L. Fortunato a,*, R. Penteriani b, M. Farina a, C.E. Vitelli a, F.R. Piro c a Department of Surgery, S. Giovanni Addolorata Hospital, Via Amba Aradam 4, 00184 Rome, Italy Department of Gynecology, S. Giovanni Addolorata Hospital, Via Amba Aradam 4, 00184 Rome, Italy c Department of Pathology, S. Giovanni Addolorata Hospital, Via Amba Aradam 4, 00184 Rome, Italy
b
Accepted 27 November 2007 Available online 14 January 2008
Abstract Introduction: Non-palpable breast tumors represent an increasing management problem in modern Breast Units. Therefore, a simple and accurate procedure to localize these lesions is needed. To date, the most commonly used technique is wire localization, but there are some disadvantages. Methods: We conducted a prospective study on patients with malignant or benign non-palpable breast tumors who were surgically treated and underwent intraoperative ultrasound (IOUS) from May 2006 to June 2007. Margins of excision were inked and specifically assessed by the pathologist, and were considered positive if 1 mm. Results: There were 77 patients (60 malignant and 17 benign lesions), with a median age of 54 years (36e87), and a median diameter of 9 mm (4e17). All lesions were correctly identified and localized by IOUS, and free margins of excision were obtained in 75/77 cases (97%). Only two patients required a re-excision, one for multifocal disease and one for margins of excision of 1 mm. In the remaining cases, the median distance from the tumor to the closest margins of excision, with exclusion of the posterior (fascial) and anterior (skin) margins, was 1.3 cm (0.3e3.2). Conclusions: IOUS is a simple and accurate procedure that can be used to identify most non-palpable breast tumors, and has many advantages over the more commonly used wire-localization technique. Ó 2007 Elsevier Ltd. All rights reserved. Keywords: Breast cancer; Ultrasound; Non-palpable tumors; Intraoperative localization
Introduction Breast cancer screening has dramatically increased the diagnosis of suspicious, non-palpable lesions of the breast.1 Screening mammography can reduce mortality by 20% in women with breast cancer,2 and early diagnosis of small, non-palpable tumors is associated with both a lower stage of disease and a decreased incidence of lymph node involvement, compared with the palpable counterpart. This maximises breast conservation, allows minimally invasive surgery on the sentinel lymph node, and enhances
* Corresponding author. Tel.: þ39 06 7705 5265; fax: þ39 06 7705 5914. E-mail addresses:
[email protected] (L. Fortunato), penteriani@ libero.it (R. Penteriani),
[email protected] (M. Farina),
[email protected] (C.E. Vitelli),
[email protected] (F.R. Piro). 0748-7983/$ - see front matter Ó 2007 Elsevier Ltd. All rights reserved. doi:10.1016/j.ejso.2007.11.011
acceptability and quality of life of patients with this disease.3 To date, wire localization (WL), either under ultrasound or stereotaxic guidance, has been the most common technique used for preoperative localization of these tumors. However, WL has some disadvantages such as pain and discomfort in some patients, and occasionally carries risks of complications including dislodgement of the wire, intraoperative wire transaction, retention of wire fragments, thermal injury with the use of cautery, hematoma and even syncope. The procedure is performed in most institutions as an additional step outside the operating room, with further organization and scheduling problems. Therefore, a procedure with the same accuracy, a higher rate of free margins and less discomfort for the patient would seem preferable. Intraoperative ultrasound localization (IOUS) of nonpalpable breast lesions has been first described more
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than 10 years ago, and preliminary reports have been favourable.4e6 We report, herein, a prospective study and describe our experience with IOUS.
removal of the lesion and gain additional information regarding the status of the margins.
Patients and methods
Every specimen was inked by the pathologist and a frozen section was performed to confirm the diagnosis or to grossly evaluate the margins of excision, but intraoperative histological assessment of the margins was not required. The exact distance of the index lesion from the inked margins of excision was recorded by a dedicated pathologist. A distance of 1 mm or less was considered to be an involved margin. A completion ultrasonography was then performed on the breast surrounding the surgical bed to rule out the possibility of other non-palpable lesions. We never performed X-ray of the specimens.
Patients Consecutive patients with both benign or malignant nonpalpable breast lesions, who underwent IUL, were prospectively studied in our Institution from May 2006 to June 2007. All patients who had sonographically visible lesions, not necessarily noted by mammography, were included. Patients with benign lesions were considered for surgery because they had growing breast lesions, because results of fine-needle aspiration biopsy were inconclusive, or because of patients’ preference. Intraoperative ultrasound technique Esaote Technos MPX equipment (Esaote SpA e Genova, Italy) with an 8e12 MHz linear array transducer was used. Before starting the surgical procedure, the lesion was localized by ultrasound and the skin above the lesion marked with a pen. The transducer was draped first with a sterile glove filled with sterile acoustic gel, and then covered with a sterile plastic sheath. The tip of the sheath was cut off to expose the footplate of the transducer. Instead of sterile acoustic gel, iodine solution was used during the surgical procedure. Surgery was guided by real-time ultrasonography during the procedure, and right-angle scanning allowed us to modify the procedure if the margins seemed to be too close to the lesion (Fig. 1). At the end of the procedure, the specimen was marked with sutures for orientation at the superior (short) and lateral (long) margins, and a right-angle ultrasound scanning of the specimen was performed to confirm complete
Pathology examination
Results Patients’ characteristics Seventy-seven patients were operated during the period of the study. The median age of the patients was 54 years (36e87), while the median diameter of the lesions was 9 mm (4e17). There were 60 malignant and 17 benign lesions (Table 1). Among the former group, there were 54 invasive ductal, 4 invasive lobular, and 2 pure ductal in situ (DCIS) cancers. All these patients underwent sentinel lymph node biopsy after intradermal injection of 0.6 mCi of Tc-99 filtered nanocolloid (Nanocoll e Nycomed AmershameSorin, Saluggia e VC). Sonographic localization and the breast tumor and assessment of the surgical strategy required approximately 5 min for each patient, with additional time needed to assess the completeness of surgical excision both during and after the removal of the lesion. IOUS results All lesions were identified and removed with IOUS. Nine patients had tumors staged pT1a (diameter 5 mm), and they were all identified by IOUS and removed with negative margins. Free margins of excision were obtained in all patients but two. In one case, a 39-year-old woman, there was
Table 1 Patients’ characteristics N
Figure 1. The draped ultrasound transducer is used to identify the lesion and to follow planes of excision during surgery.
Patients Age (years) Diameter (mm) Malignant lesions Benign lesions
77 54 9 60 17
(36e87) (4e17) (78%) (22%)
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a non-palpable infiltrating ductal carcinoma 17 mm in diameter situated deep in a huge breast, with several foci of DCIS (cribriform and with necrosis) at a distance from the inked margins inferior to 1 mm. This patient underwent mastectomy and sentinel lymph node biopsy, and other foci of DCIS were diagnosed in the final specimen. In a second patient, the margin of excision was at a 1 mm distance from the inked margin, and a re-excision was performed with a negative histologic finding. Seventeen patients with invasive cancers (28%) had peritumoral foci of DCIS and/or in situ lobular neoplasia (LIN). The median distance from the tumor to the closest margins of excision, with exclusion of the posterior (fascial) and anterior (skin) margins, was 1.3 cm. (0.3e3.2). Discussion In our experience, IOUS was an excellent tool to identify non-palpable breast lesions, to remove them with satisfactorily margins in almost all cases, while the re-excision rate was only 3%. This is a key factor to minimize both an undesirable return to the operating room and an associated decrease in the cosmetic result in the case of breast conservation.7 Furthermore, patients with breast cancer removed with clear margins at the first excision seem to have a decreased risk of local recurrence compared with patients who need further re-excisions to achieve negative margins.8 This represents a hot topic in breast surgery, since approximately 50% of breast cancers in modern surgical practices are non-palpable, and this incidence is certainly destined to increase.9 Today, preoperative confirmation of malignancy is almost always achieved by fine-needle or core biopsy, and we need to localize these small cancers to allow a one-step precise and directed excision. Although suspicious breast lesions are usually detected by mammography, an increasing role of ultrasonography to identify small tumors has been reported, particularly in dense breasts.10e12 While US, in the screening setting, may detect only 0.4e2% of non-palpable breast cancer in the face of a negative mammogram,13,14 it is a very sensitive tool to identify an infiltrating breast cancer, both ductal and lobular, although far less sensitive in the case of intraductal carcinoma.12 The ideal technique for intraoperative localization of these small breast lesions should be simple, accurate, cost effective, comfortable for the patient, and carry a minimal risk of procedure related complications. Traditionally, non-palpable lesions have been localized by WL, but while the distance from the wire to the lesion may be up to 1 cm in 11% of cases,15 a successful localization with free margins of resection is not always achieved with WL, failures are reported16,17 and re-excision is needed in up to 33% of cases.9,18 This high incidence is in part explained by lack in the past of a preoperative diagnosis of cancer, as this is a factor known to be associated with an increased incidence of margin involvement by cancer,19
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and by the presence of multifocality in the case of intraductal carcinoma associated with biopsy for microcalcifications. However, a precise localization of a breast tumor with the wire is not always possible, the angle of access and trajectory of the wire is left to the best judgement and technical skill of the radiologist, while sometimes lack of coordination and communication among physicians involved in this process can represent an additional interference with the success of the procedure. Moreover, the introduction of the wire directly above the lesion may be technically problematic, especially under stereotaxic guidance for lesions of the inferior quadrants of the breast, and this faces the surgeon with additional problems in planning the skin incision.20 We found that IOUS satisfies most requirements for an ideal technique to localize non-palpable breast tumors which are well visualized by ultrasound, while allowing real-time visualization of the margins of resection and, therefore, directing planes of surgery during the excision. This in turn is helpful in guaranteeing both negative margins and an adequate contour of resection in order to minimize the volume of excision. Several previous experiences have been favourable with IOUS. Initial experiences published less than a decade ago have reported that IOUS is an accurate method to identify nonpalpable breast cancers.21e23 In 2002, a randomized study on 49 patients with a preoperative diagnosis of non-palpable breast cancer reported that IOUS seems to be superior to WL with respect to margin clearance, preventing the patient from the unpleasant wire placement before surgery.9 More recently, three studies have confirmed that IOUS allows identification of non-palpable breast tumors in 100% of cases, while negative margins of excision are achieved in 90e93% of cases, with a re-excision rate ranging between 4% and 9%.24e26 Obviously, only sonographically visible lesions can be localized with IOUS. Therefore, all lesions visible only by mammography, such microcalcifications or parenchymal distortions, not associated with sonographic signs, are not candidates for IOUS. However, microcalcifications are sometimes associated with sonographic alterations that can be detected, and removal of the lesion under ultrasound guidance can be safely performed.27 Interestingly, there have been recent experiences with hematoma-guided lumpectomies after removal of microcalcifications, by vacuum assisted or core biopsy under stereotaxis, to indicate the superiority of this technique compared with WL in obtaining adequate margins of resections while minimizing volume of resection.28 Recently, other techniques conceptually very similar to IOUS have been described to localize non-palpable tumors, such as radio-guided technique after peri-lesional injection of Tc-99 (ROLL).29e31 A randomized study comparing ROLL and WL concluded that they were similarly effective,
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but the former was easier for both the radiologist and the surgeon, and less painful for the patient.31 Although the small number of patients involved in our study does not allow definitive conclusions, we confirm that IOUS is a preferable and effective technique because it is easy and accurate, avoids the unpleasant insertion of a wire, and it is associated with a very low re-excision rate for close or positive margins. Conflict of interest There are no conflicts of interest to be reported by all authors of this manuscript. All authors contributed significantly to this paper.
Acknowledgements This study was supported by a grant from the Prometeus Foundation, ONLUS, for the development of training and cancer research.
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