needle biopsy in patients with breast cancer in up to 50% of cases. ... Preoperative core needle biopsy did not significantly influence the local free recurrence ...
Ó Springer 2006
Breast Cancer Research and Treatment (2006) DOI 10.1007/s10549-005-6935-3
Report
Preoperative core needle biopsy does not increase local recurrence rate in breast cancer patients Florian Fitzal1, Emanuel P. Sporn1, Wolfgang Draxler2, Martina Mittlbo¨ck2, Susanne Taucher1, Margaretha Rudas3, Otto Riedl1, Thomas H. Helbich4, Raimund Jakesz1, and Michael Gnant1 1
Department of Surgery; 2Bioinformatics; 3Pathology; 4Radiology, University of Vienna, General Hospital, Vienna, Austria
Key words: breast biopsy, breast cancer diagnostic, breast conserving surgery, cancer biopsy, sure cut
Summary Objective. Several case reports and clinical studies in the literature demonstrate needle track seeding after core needle biopsy in patients with breast cancer in up to 50% of cases. The impact of this observation on local recurrence and overall survival rate is, however, not fully investigated. Patients and design. We retrospectively analysed 719 patients after breast conserving surgery and postoperative radiotherapy for stage I and II breast cancer. We divided this group into patients with (189) and without (530) preoperative core needle biopsy. Demographic data, local recurrence and overall survival rate were compared between these two groups. Result. Preoperative core needle biopsy did not significantly influence the local free recurrence rate (median follow-up time of 78 and 71 months, respectively). The prognostic factors and the postoperative therapy did not differ significantly between the two groups. Conclusion. Preoperative core needle biopsy seems to have no detrimental impact on local recurrence and overall survival after breast conserving surgery and postoperative radiotherapy.
Background Multiple randomised trials have demonstrated that screening mammography reduces breast carcinoma mortality by approximately 25% [1]. However, several lesions in the breast detected by mammography and classified as suspicious show a benign tumor at final surgery. Thus, preoperative core or fine needle biopsy may eliminate unnecessary surgery in up to 60% of patients with a false negative rate of 5% and may significantly reduce costs [2–4]. In addition, preoperative diagnosis of invasive breast cancer increases the likelihood of clear margins at definitive surgery [2–4]. This reduces the need for a two-stage procedure and improves the surgical and oncological outcome [5,6]. Biopsy techniques have a sensitivity between 93 and 100% and a specificity between 98 and 100% [2,7,8]. Core needle biopsy for histological prove of breast carcinoma is also necessary for neoadjuvant chemotherapy. If indicated, neoadjuvant chemotherapy has been shown to significantly increase breast conservation surgery and reduce disease free and overall survival in patients with complete pathological response [9].
The concern about needle track seeding during core needle biopsy of breast cancer is not unfounded. In the literature, several case reports demonstrated needle track seeding after core biopsy [10–14]. Recently, a prospective study with 35 patients demonstrate histological proof of tumour cell displacement in 6 patients outside the tumor within the needle track after fine needle biopsy [10]. Clearly, there are several technical issues complicating the methodology in such studies. Thus, here is still uncertainty about the clinical value of needle track seeding. Only a few studies provide information about the risk of local recurrence and overall survival rates in patients with preoperative core needle biopsy of breast cancer. Available data suggest that a core needle biopsy has little impact on the local recurrence rate [15–19] and overall survival rate [20]. The number of patients in these studies, however, were small and there have been differences in the prognostic factors within the groups in each study, especially with respect to tumor size, age, hormone status and grading as well as postoperative therapy. The aim of our study was to investigate whether core needle biopsy increases the likelihood of local recurrence after breast conserving surgery for breast cancer.
F Fitzal et al. Patients and methods All patients operated between 01. 01. 1995 and 01. 08. 2001 on breast cancer stage I and II at the Department of Surgery Medical University of Vienna were eligible for retrospective analysis (n = 1387). Patients who underwent breast conserving R0 resection (at least 1 mm free margin) and subsequent radiotherapy (50 Gray during 5 weeks) with or without chemo- and/or hormone therapy were included. All patients who underwent mastectomy were excluded. More over we have excluded patients with neoadjuvant therapy to obey the bias of a possible effect of chemotherapy on needle track seeding. Out of the remaining cohort (n = 719) we defined a group with (n = 189) and one without preoperative core needle biopsy (n = 530). In principal, only those patients with histological proof of cancer cells in the core biopsy were eligible. Patient characteristics and follow up data are saved in a central computer at the Department for Bioinformatics at the University Hospital Vienna. We compared local recurrence and overall survival rate between patients with and without preoperative core needle biopsy.
Core needle biopsy Core needle biopsy has been offered to all patients with radiological diagnosed BIRADS IV breast lesions [21]. Whether a patient underwent core needle biopsy or not has been decided on the patients’ personal preference after informed and written consent. The tumor size did not influence the decision for the use of core needle biopsy. Percutaneous biopsy was performed using stereotactic guidance or sonographic guidance after written informed consent was obtained from each patient. The choice of guidance depended on a number of factors including lesion location, imaging characteristics, scheduling considerations, and individual preference. All biopsies were performed by one of five of attending radiologists specialized in breast imaging. Stereotactic biopsy was introduced at our institution in 1994. From 1994 to 1997 all biopsies were performed with 14-gauge needle (BIP, Bard Urological, Covington, Georgia). The 14-gauge vacuum-assisted probe (Mammotome, Ethicon Endosurgery) was introduced in July, and the 11gauge vacuum-assisted biopsy probe in September 1997. All biopsies were performed after disinfection and local anaesthesia with patients prone on a dedicated examination table (Fischer Imaging Mammotest, Denver, Colorado) [22]. In cases of palpable lesions core needle biopsy was immediately performed in the outpatient clinic with a detachable core needle biopsy system (ASAP DETACHABLE; Meditech, Watertown MA) containing a 14-gauge needle. Briefly, after disinfection and local anaesthesia and written informed consent of each patient the skin was incised with a scalpel and the biopsy
system was inserted through the skin incision into the breast. Under the control by local palpation, the lesion was punctured one to three times (median two times).
Surgery Regarding patients with preoperative core needle biopsy, surgery was performed in cases in which core needle biopsy results were considered discordant because the histological result did not provide sufficient explanation for the imaging features. Surgery was also performed in cases in which histological results of core needle biopsy yielded a high risk lesion (atypical ductal hyperplasia, intraductal carcinoma, phylloides tumor and atypical papilloma) or invasive carcinoma. High risk lesions and invasive carcinoma were both treated by breast conserving surgery with margins of at least 1mm of normal breast tissue surrounding the lesion (R0 resection). In patients without preoperative core needle biopsy, surgery was performed according to the BIRADS classification [21] or due to the patient’s preference and treatment was done as described above. In all patients the results of intraoperative frozen section analyses (FSA) defined the subsequent treatment procedure. If the result of the FSA after lumpectomy showed a benign or an in situ lesion with clear margins, the surgery was discontinued. In case of an invasive tumor, a sentinel node biopsy (=SNB) as described previously [23] and according to the St Gallen guidelines [24] was performed additionally. If the pathologist detected malignant cells at one of the resection margins or close margins below 1 mm, the surgeon immediately performed another excision at this specific site in order to establish free margins. If the sentinel node showed malignant cells in the FSA, level I and II axillary dissection was immediately carried out. Non-palpable tissue masses or microcalcifications were marked with a hooked wire preoperatively. During surgery (open biopsy or lumpectomy), the excised breast specimen was marked with sutures for orientation and immediately sent for pathological examination. In case of microcalcification, the specimens were immediately sent to radiology department for tissue mammography. In conjunction with the pre-operative wire localization technique, this procedure further helps the pathologist to define suspected areas for intraoperative FSA.
Follow up During the first 3 years after surgery, all patients were evaluated every 3 months. At 3 years after surgery, evaluation was done every 6 months and thereafter, annually follow-up was performed. At each follow up, clinical examination and complete blood analyses were done including tumor marker CA 15-3 and CEA. Every 6 months chest X-ray and liver ultrasound were
Preoperative breast core needle biopsy and recurrence In patients with preoperative core biopsy, the local recurrence rate was 1.1% with a median follow up of 78 months (46–108 months). Breast cancer locoregional recurrence rate in patients without preoperative core biopsy was 2.1% with a median follow up of 71 months (8–128 months). There were no statistically significant differences between those two groups in this respect. No deaths were seen in the group of patients with preoperative biopsy, while the mortality rate of patients without preoperative biopsy was 4.7%. Kaplan Meier curves for disease free and overall survival are shown in Figures 1 and 2. Preoperative core needle biopsy reduced the number of two-stage procedures from 5.3% to 3.1% without any significant differences (p = 0.356 v2 test). Table 3 shows tumor characteristics of the breast cancer patients with a local recurrence (n = 13). About 7% had a T4 cancer at the time of the first surgery, 61% of the primary cancer had intraductal components, 46% were nodal positive, 38% had a low grade dysplasia, 46% were progesterone receptor positive and 38% estrogen receptor positive. Tumour characteristics differed slightly in the recurrent breast cancer when compared with their primary breast cancer. About 38% were T4 cancer, 15% had intraductal components, 69% showed a low grade dysplasia, only 23% had an estrogen receptor positive breast cancer and only 7% were progesterone receptor positive. It was not possible to perform any kind of statistics due to the low number of
performed and once a year patients underwent mammography plus breast ultrasound.
Statistic analysis Overall and recurrence free survival was analyzed with Kaplan Meier curves and significance was tested with the log-rank test. Differences between demographic data and adjuvant therapy were measured with the v2 test. A p < 0.05 demonstrated significant differences with a power of 0.8.
Results A total of 1387 patients with breast cancer were operated on in our department between 1. 1. 1995 and 1. 8. 2001. Of which 719 patients met the inclusion criteria of this study and 189 patients underwent successful preoperative core needle biopsy of breast cancer. The demographics are shown in Table 1. There were no significant differences in prognostic factors such as age, grading, pTNM (according to UICC 4th edition Springer 1998) or receptor status [25] between the two groups except for progesterone status. Postoperative endocrine treatment or chemotherapy were also similar in both groups (Table 2).
Table 1. Demographic data compared with the v2 test demonstrates no differences in prognostic factors between the two groups except for the progesterone receptor status No biopsy
Biopsy
p
n
% (n = 530)
>35
521
98
>35
183
97
