Surgery For Non-palpable Breast Cancer Research Articles

Combined use of magnetic seed and tracer in breast conserving surgery with sentinel lymph node biopsy for non-palpable breast lesions: A pilot study describing pitfalls and solutions

BackgroundsTraditionally, breast conserving surgery for non-palpable breast cancer is guided by wire or radioactive seed and radioactive tracer for sentinel lymph node biopsy (SLNB). Alternatively, a stain-less magnetic seed and superparamagnetic iron oxide tracer (SPIO) can be combined as a radioactive-free technique. The aim of this study was to define the pitfalls we encountered during implementation of this combined technique and provide solutions resulting in an instruction manual for a radio-active free procedure. MethodsBetween January and March 2021, seventeen consecutive patients with cN0 non-palpable breast cancer were included. The magnetic seed was placed to localize the lesion and SPIO was used to identify the sentinel lymph node (SLN). A lymphoscintigraphy with Technetium-99m nano colloid was performed concomitantly in all patients as a control procedure for SPIO. Surgical outcomes are reported, including problems with placing and retrieval of the seed and SPIO and corresponding solutions. ResultsSurgical excision was successful with invasive tumor-free margins in all patients. SLN detection was successful in 82% patients when compared to Technetium-99m. The most challenging issue was an overlapping magnetic signal of the seed and SPIO. Solutions are provided in detail. ConclusionsCombined use of magnetic seed and SPIO for wide local excision and SLNB patients with non-palpable breast lesions appeared challenging due to overlapping magnetic signals. After multiple adaptations, the protocol proved to be feasible with an added advantage of eliminating the use of radioisotopes. We described the pitfalls and solutions resulting in an instruction manual for a totally radioactive-free procedure.

Indocyanine Green Fluorescence-Guided Lumpectomy of Nonpalpable Breast Cancer Versus Ultrasound-Guided Excision.

The purpose of this study was to evaluate the use of indocyanine green-guided nonpalpable breast cancer lesion localization (INBCL) and to compare it with ultrasound localization (US). We retrospectively reviewed 78 consecutive patients undergoing breast-conserving surgery for nonpalpable breast cancer (NBC). Of all 78 excisions, 42 cases were guided by INBCL and 36 by US. The rate of clear margins was 90.5% (38/42) in the INBCL group compared to the 83.3% (30/36) in the US (P = .548). A comparison of the margins at first excision for both INBCL and US, in the INBCL series, 92.9% (39/42) of cases had a margin less than 5mm, whereas for US series, it was 72.2% (26/36) (P = .033). When results of the excised tissue are taken into account, the mean specimen volume for INBCL was 58cm3, but for US it was 73cm3, with difference in mean volume being 15cm3 (P = .062). INBCL for NBCs was more accurate than US because a smaller volume of the tissue may be excised by using the technique, without compromising margin status in nonpalpable lesions.

Cost-effectiveness of radioguided occult lesion localization using 125I seeds versus hookwire localization before breast-conserving surgery for non-palpable breast cancer.

The aim was to determine the cost-effectiveness of radioguided occult lesion localization using 125I-labelled seeds (125I seeds) versus hookwire localization in terms of incremental cost per reoperation avoided for women with non-palpable breast cancer undergoing breast-conserving surgery. This study was based on a multicentre RCT with eight study sites comprising seven public hospitals and one private hospital. An Australian public health system perspective was taken. The primary effectiveness outcome for this study was reoperations avoided. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were used to explore uncertainty. The willingness to pay (additional cost of localization using 125I seeds justified by reoperation cost avoided) was set at the weighted, top-down cost of reoperation. Costs were in 2019 Australian dollars ($1 was equivalent to €0.62). The reoperation rate was 13.9 (95 per cent confidence interval 10.7 to 18.0) per cent for the 125I seed group and 18.9 (14.8 to 23.8) per cent for the hookwire localization group. The ICER for 125I seed versus hookwire localization was $4474 per reoperation averted. The results were most sensitive to uncertainty around the probability of reoperation. Accounting for transition probability and cost uncertainty for 125I seed localization, there was a 77 per cent probability that using 125I seeds would be cost-effective, with a willingness to pay of $7693 per reoperation averted. Radioguided occult lesion localization using 125I seeds is likely to be cost-effective, because the marginal (additional) cost compared with hookwire localization is less than the cost of reoperations avoided.

Ultrasound-Guided Versus Wire-Guided Breast-Conserving Surgery for Nonpalpable Breast Cancer

PurposeTo determine the efficacy of ultrasound (US)-guided excision of nonpalpable breast cancer and compare it to standard wire-guided breast-conserving surgery (BCS). MethodsOne hundred fifty-eight women with nonpalpable breast cancer who underwent BCS were retrospectively studied. Positive surgical margins and reexcision rates were investigated. ResultsOf the total cohort, 68 patients were treated with wire-guided and 90 with US-guided tumor excision. The tumor and patient characteristics were similar in the 2 groups; 13.2% and 12.2% of patients in the wire-guided and US-guided groups, respectively, had positive margins. Patient age, menopausal status, tumor size, histologic type, and histologic grade were associated with increased risk of positive margins. The shave margins were reexcised at the time of original operation more often by wire-guided localization (26.5%) than in the US-guided group (10.0%) (P = .010). The surgeon was able to identify correctly the problematic margin in 100% via intraoperative US and in only 27.8% when the wire-guided surgery was used (P < .001). The reexcision rate by a second operation was similar in 2 groups (P = .798). Eight (11.8%) of 68 patients in the wire-guided group and 9 (10.0%) of 90 patients in the US-guided underwent a second operation. ConclusionUS-guided BCS is as effective and safe as standard wire-guided excision of nonpalpable breast tumors.

Prediction of positive resection margins in patients with non-palpable breast cancer

BackgroundIn patients undergoing breast conserving surgery for non-palpable breast cancer, obtaining tumour free resection margins is important to prevent reexcision and local recurrence. We developed a model to predict positive resection margins in patients undergoing breast conserving surgery for non-palpable invasive breast cancer. MethodsA total of 576 patients with non-palpable invasive breast cancer underwent breast conserving surgery in five hospitals in the Netherlands. A prediction model for positive resection margins was developed using multivariate logistic regression. Calibration and discrimination of the model were assessed and the model was internally validated by bootstrapping. ResultsPositive resection margins were present in 69/576 (12%) patients. Factors independently associated with positive resection margins included mammographic microcalcifications (OR 2.14, 1.22–3.77), tumour size (OR 1.75, 1.20–2.56), presence of DCIS (OR 2.61, 1.41–4.82), Bloom and Richardson grade 2/3 (OR 1.82, 1.05–3.14), and caudal location of the lesion (OR 2.4, 1.35–4.27). The model was well calibrated and moderately able to discriminate between patients with positive versus negative resection margins (AUC 0.70, 95% CI, 0.63–0.77, and 0.69 after internal validation). ConclusionThe presented prediction model is moderately able to differentiate between women with high versus low risk of positive margins, and may be useful for surgical planning and preoperative patient counselling.

Should We Abandon Wire-Guided Localization for Nonpalpable Breast Cancer? A Plea for Wire-Guided Localization

To evaluate wire-guided localization for nonpalpable breast cancer regarding procedure and surgery-related outcome in a nonteaching community hospital in the Netherlands. A consecutive series of 117 patients who were treated with breast-conserving surgery after wire-guided localization for nonpalpable breast cancer between January 2006 and December 2010 was retrospectively analyzed. The patients' digital records were reviewed for patient, radiological, histological, and surgical characteristics. In order to quantify the excess resected tissue, a calculated resection ratio was determined by dividing the total resection volume by the optimal resection volume. The optimal resection volume was defined as a spherical tumor volume with an added 1.0 cm margin. The total resection volume was defined as the corresponding ellipsoid. There were no procedure-related complications. There were two postoperative hemorrhages. Margins were clear in 92.3% of the cases after the first surgical procedure. Eight (6.8%) patients required two operations and one (0.9%) patient required three operations in order to obtain negative margins. Breast conservation was possible in 113 (96.6%) patients. The median calculated resection ratio was 1.87 (range 0.47-14.92). This study proves that it is possible to obtain excellent results performing breast-conserving surgery for nonpalpable breast cancer regarding margin status, total amount of operations, and the ratio between tumor and resected tissue volume using wire-guided localization as a localization tool.

What is the clinical significance of the volume of tissue excised in ROLL?

To the Editor, I read with great interest the article by Postma et al. [1], entitled, ‘Efficacy of ‘‘radioguided occult lesion localisation’’ (ROLL) versus ‘‘wire-guided localisation’’ (WGL) in breast conserving surgery for non-palpable breast cancer: a randomised controlled multicentre trial’, in Breast Cancer Res Treat (2012) 136:469–478. This is without doubt the most robust randomised controlled trial (RCT) out of the six RCTs performed to date comparing ROLL to WGL [1– 6]. The authors comprehensively reviewed this very important subject area of the management of non-palpable breast cancers. The authors concluded that ROLL cannot replace WGL as the standard of care because of larger volume excisions. This was based on their finding that the median volume of specimens excised was 71 versus 64 cm for the ROLL and WGL groups, respectively and this was statistically significant (P \ 0.017). However, what is the true clinical significance of this difference? Traditionally the concern has always been due to the risk of poor cosmetic outcomes. Postma et al. [1] state clearly that despite the differences in volumes of excised specimens, there is no measurable difference in cosmetic outcome. It is true that several studies have demonstrated the relationship between poor cosmetic outcome and greater volumes of excised tissue [7–9]. However, the latest of these studies was performed over 10 years ago [7–9] and the oldest nearly 20 years ago [8]. Twenty years in a rapidly evolving specialty like breast surgery is the equivalent of a lifetime. In particular, a dramatic shift from purely oncological considerations to also consideration of patient psychological morbidity from poor cosmetic outcome has evolved into the specialist breast surgeon’s mindset. This has led to a separation from the performance of breast surgery by the general surgeon who could achieve oncological control but was not trained in plastic reconstruction techniques, to the oncoplastic surgeon who has not only the skills to achieve oncological clearance but also the skills to achieve appropriate cosmetic outcomes. Indeed, one can consider extreme examples of breast-conserving surgery where oncoplastic techniques have been applied to achieve excellent cosmetic outcomes. Clough et al. [10] in their cohort of 101 patients requiring extensive resections in breast-conserving surgery were able to achieve favourable cosmesis in 82 % of patients who required extensive resections with mean weights of excised specimens of 222 g. Petit et al. [11] demonstrated that from 111 patients treated with quadrantectomy and concomitant oncoplastic surgery, the global outcome of cosmetic assessment was good in 77.5 %, fair in 17 %, and poor in only 5.5 % of their patients with median specimen weights of 157 g. Clough et al. [10] used contralateral symmetrization in all cases whereas Petit et al. [11] used it in 88.2 % of cases. Woerdeman et al. [12] in their breast-conserving treatment of 20 large T2 and T3 breast cancers were able to achieve a mean patient satisfaction cosmetic score of 2.8 out of 3 without contralateral symmetrization. It has to be accepted that the armoury of techniques available to the oncoplastic surgeon is now extensive, with the use of contralateral symmetrization available for extensive resections. Since some oncoplastic techniques can achieve satisfactory cosmetic outcomes with very large volume excisions, it is very unlikely that a median greater volume excision of 7 cm in ROLL as observed by Postma et al. [1] would be detrimental to cosmetic outcome, and even Postma et al. [1] concede M. Ahmed (&) M. Douek Department of Research Oncology, King’s College London, Guy’s Hospital Campus, Great Maze Pond, London SE1 9RT, UK e-mail: muneer.ahmed@kcl.ac.uk

Cost-Effectiveness of Radioguided Occult Lesion Localization (ROLL) Versus Wire-Guided Localization (WGL) in Breast Conserving Surgery for Nonpalpable Breast Cancer: Results from a Randomized Controlled Multicenter Trial

Accurate preoperative localization of nonpalpable breast cancer is essential to achieve complete resection. Radioguided occult lesion localization (ROLL) has been introduced as an alternative for wire-guided localization (WGL). Although efficacy of ROLL has been established in a randomized controlled trial, cost-effectiveness of ROLL compared with WGL is not yet known. The objective of this study was to determine whether ROLL has acceptable cost-effectiveness compared with WGL. An economic evaluation was performed along with a randomized controlled trial (ClinicalTrials.gov, No. NCT00539474). Women (>18 years) with histologically proven nonpalpable breast cancer and eligible for breast conserving treatment with sentinel node procedure were randomized to ROLL (n = 162) or WGL (n = 152). Empirical data on direct medical costs were collected, and changes in quality of life were measured over a 6-month period. Bootstrapping was used to assess uncertainty in cost-effectiveness estimates, and sensitivity of the results to the missing data approach was investigated. In total, 314 patients with 316 invasive breast cancers were enrolled. On average ROLL required the same time as WGL for the surgical procedure (119 vs 118 min), resulted in a 7 % higher reinterventions risk, and 13 % more complications. Quality of life effects were similar (difference 0.00 QALYs 95 % CI (-0.04-0.05). Total costs were also similar for ROLL and WGL (+<euro>26 per patient 95 % CI <euro>-250-311). ROLL is comparable to WGL with respect to both costs and quality of life effects as measured with the EQ5D and will therefore not lead to more cost-effective medical care.

Abstract P5-15-03: Cost-effectiveness of ‘radioguided occult lesion localization’ (ROLL) versus ‘wire-guided localization’ (WGL) in breast conserving surgery for non-palpable breast cancer: results from a randomized controlled multicentre trial

Abstract Background: Accurate pre-operative localization of non-palpable breast cancer is essential to achieve complete resection. Radio-guided occult lesion localization (ROLL) has been introduced as an alternative for wire-guided localization (WGL). Although efficacy of ROLL has been established in a RCT, cost-effectiveness of ROLL compared with WGL is not yet known. Objective. To determine whether ROLL has acceptable cost-effectiveness compared with WGL. Methods. An economic evaluation was performed alongside a randomized controlled trial (ClinicalTrials.gov, number NCT00539474). Women (&amp;gt;18 years) with histologically proven non-palpable breast cancer and eligible for breast conserving treatment with sentinel node procedure were randomized to ROLL(n = 162) or WGL (n = 152). Empirical data on direct medical costs was collected, and changes in quality of life were measured over a 6 months period. Bootstrapping was used to assess uncertainty in cost-effectiveness estimates, and sensitivity of the results to the missing data approach was investigated. Results. In total, 314 patients with 316 invasive breast cancers were enrolled. On average ROLL required the same time as WGL for the initial procedure (119 vs. 118 min.), resulted in a 7% higher re-interventions risk (27% vs. 20%, p = 0.163), a 13% higher complication risk (30% vs. 17%, p = 0.006) but showed similar health effects (difference 0.00 QALYs 95%CI (−0.04 to 0.05). Total costs were also similar for ROLL and WGL (+ €26 per patient 95% CI-250 to 311). Conclusion. ROLL is comparable to WGL with respect to both costs and quality of life, and will therefore not lead to more cost-effective medical care. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P5-15-03.

Efficacy of ‘radioguided occult lesion localisation’ (ROLL) versus ‘wire-guided localisation’ (WGL) in breast conserving surgery for non-palpable breast cancer: a randomised controlled multicentre trial

For the management of non-palpable breast cancer, accurate pre-operative localisation is essential to achieve complete resection with optimal cosmetic results. Radioguided occult lesions localisation (ROLL) uses the radiotracer, injected intra-tumourally for sentinel lymph node identification to guide surgical excision of the primary tumour. In a multicentre randomised controlled trial, we determined if ROLL is superior to the standard of care (i.e. wire-guided localisation, WGL) for preoperative tumour localisation. Women (>18 years.) with histologically proven non-palpable breast cancer and eligible for breast conserving treatment with sentinel node procedure were randomised to ROLL or WGL. Patients allocated to ROLL received an intra-tumoural dose of 120 Mbq technetium-99 m nanocolloid. The tumour was surgically removed, guided by gamma probe detection. In the WGL group, ultrasound- or mammography-guided insertion of a hooked wire provided surgical guidance for excision of the primary tumour. Primary outcome measures were the proportion of complete tumour excisions (i.e. with negative margins), the proportion of patients requiring re-excision and the volume of tissue removed. Data were analysed according to intention-to-treat principle. This study is registered at ClinincalTrials.gov, number NCT00539474. In total, 314 patients with 316 invasive breast cancers were enrolled. Complete tumour removal with negative margins was achieved in 140/162 (86 %) patients in the ROLL group versus 134/152 (88 %) patients in the WGL group (P = 0.644). Re-excision was required in 19/162 (12 %) patients in the ROLL group versus 15/152 (10 %) (P = 0.587) in the WGL group. Specimen volumes in the ROLL arm were significantly larger than those in the WGL arm (71 vs. 64 cm(3), P = 0.017). No significant differences were seen in the duration and difficulty of the radiological and surgical procedures, the success rate of the sentinel node procedure, and cosmetic outcomes. In this first multicentre randomised controlled comparison of ROLL versus WGL in patients with histologically proven breast cancer, ROLL is comparable to WGL in terms of complete tumour excision and re-excision rates. ROLL, however, leads to excision of larger tissue volumes. Therefore, ROLL cannot replace WGL as the standard of care.

Isotope‐guided Surgery for Nonpalpable Breast Cancer

The hook-wire technique is used to guide surgical excision of nonpalpable breast lesions. Recently, isotope has been used to guide the excision, and when sentinel node biopsy is performed during the same operation, the procedure is termed Sentinel Node and Occult Lesion Localization (SNOLL). We evaluated the use of this procedure for nonpalpable cancers in Chinese women. Seventy-four patients underwent SNOLL before breast-conserving surgery. Intratumoral injection of sulfur colloid and lymphoscintigraphy (LSG) were performed. A gamma probe was used for resection planning and localization of the sentinel node (SN). Blue dye mapping was used in patients with negative LSG. Complete excision was defined as a tumor-free margin greater than 1 mm. The primary breast lesion was successfully removed in 73 patients (99%). Complete excision was achieved in 61 patients (82%). Drainage to axilla was detected by LSG in 53 patients (72%). The gamma probe was more sensitive than LSG and had an 82% SN identification rate. Patients with a positive LSG had a higher chance of SN localization by gamma probe than patients with a negative LSG (100% vs. 38%, p < 0.001). In patients with a negative LSG, supplementary blue dye mapping increased the SN localization rate from 38 to 90%. The SN identification rate was 97% in the whole series. Isotope-guided surgery was reliable, with a 99% localization rate for nonpalpable breast lesions and an 82% SN localization rate. The success rate of SN identification could be improved to 97% with the addition of blue dye mapping for patients with negative drainage on lymphoscintigraphy.

0102 Isotope-guided surgery for non-palpable breast cancer in Chinese women

0102 Isotope-guided surgery for non-palpable breast cancer in Chinese women

The efficacy of 'Radio guided Occult Lesion Localization' (ROLL) versus 'Wire-guided Localization' (WGL) in breast conserving surgery for non-palpable breast cancer: A randomized clinical trial – ROLL study

BackgroundWith the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL) is the standard of care in most countries. Radio guided occult lesion localization (ROLL) is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care.The aim of this study is to compare the ROLL technique with the standard of care (WGL) regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome.Methods/designThe ROLL trial is a multi center randomized clinical trial. Over a period of 2–3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (dis)comfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure.The rationale, study design and planned analyses are described.Trial Registration(, study protocol number NCT00539474)

Hematoma-directed and ultrasound-guided breast-conserving surgery for nonpalpable breast cancer after Mammotome biopsy

Stereotactic vacuum-assisted (Mammotome) breast biopsy is a powerful diagnostic tool for detecting microcalcifications on mammography, but it is difficult to remove the targeted lesion precisely when subsequent breast-conserving surgery is to be carried out. We achieved satisfactory results by performing hematoma-directed breast-conserving surgery after stereotactic Mammotome biopsy in seven patients. To identify the exact location of the Mammotome biopsy during the breast-conserving surgery, we created an iatrogenic hematoma in the biopsy cavity using patient's blood. This hematoma was detected easily on intraoperative ultrasonography in all patients, and was palpable as a soft mass in five of the seven patients. The microcalcifications were completely removed in all patients, and no cancer cells were found in the margin surfaces after breast-conserving surgery. There were no complications during the injection of the patient's blood into the biopsy cavity or during the hematoma-directed surgery. We describe this new procedure of hematoma-directed breast-conserving surgery following Mammotome biopsy for nonpalpable cancer with microcalcifications.

Radio-guided occult lesion localization in patients undergoing breast-conserving surgery and sentinel node biopsy

Background The objective of the study was to evaluate the feasibility of radio-guided occult lesion localization (ROLL) in breast-conserving surgery for nonpalpable breast cancer. Methods Altogether 215 breast cancer patients were included in a prospective study. Ultrasonographically guided intratumoral injection of radioactive tracer was used for tumor localization in 64 patients with nonpalpable tumors, visible in breast ultrasonography (the ROLL group). Nonpalpable tumors, visible only in mammography, were localized with a help of a guidewire in 14 patients (the WGR group). The remaining 137 patients had palpable tumors. Results The proportion of specimens with close or involved margins (0 to 3 mm) was the same in the ROLL group (6%) and among cases with palpable tumors (5%). In addition the median length of the closest margin did not differ significantly between the groups. Conclusions The results of ROLL for nonpalpable breast cancer are comparable with those for resection of palpable tumors.

Radio-guided occult lesion localization in patients undergoing breast-conserving surgery and sentinel node biopsy

Background The objective of the study was to evaluate the feasibility of radio-guided occult lesion localization (ROLL) in breast-conserving surgery for nonpalpable breast cancer. Methods Altogether 215 breast cancer patients were included in a prospective study. Ultrasonographically guided intratumoral injection of radioactive tracer was used for tumor localization in 64 patients with nonpalpable tumors, visible in breast ultrasonography (the ROLL group). Nonpalpable tumors, visible only in mammography, were localized with a help of a guidewire in 14 patients (the WGR group). The remaining 137 patients had palpable tumors. Results The proportion of specimens with close or involved margins (0 to 3 mm) was the same in the ROLL group (6%) and among cases with palpable tumors (5%). In addition the median length of the closest margin did not differ significantly between the groups. Conclusions The results of ROLL for nonpalpable breast cancer are comparable with those for resection of palpable tumors.