Surgical outcomes after radioactive 125I seed versus hookwire localization of non-palpable breast cancer: a multicentre randomized clinical trial

Abstract

Background Previous studies have suggested improved efficiency and patient outcomes with 125I seed compared with hookwire localization (HWL) in breast-conserving surgery, but high-level evidence of superior surgical outcomes is lacking. The aim of this multicentre pragmatic RCT was to compare re-excision and positive margin rates after localization using 125I seed or hookwire in women with non-palpable breast cancer. Methods Between September 2013 and March 2018, women with non-palpable breast cancer eligible for breast-conserving surgery were assigned randomly to preoperative localization using 125I seeds or hookwires. Randomization was stratified by lesion type (pure ductal carcinoma in situ (DCIS) or other) and study site. Primary endpoints were rates of re-excision and margin positivity. Secondary endpoints were resection volumes and weights. Results A total of 690 women were randomized at eight sites; 659 women remained after withdrawal (125I seed, 327; HWL, 332). Mean age was 60.3 years in the 125I seed group and 60.7 years in the HWL group, with no difference between the groups in preoperative lesion size (mean 13.2 mm). Lesions were pure DCIS in 25.9 per cent. The most common radiological lesion types were masses (46.9 per cent) and calcifications (28.2 per cent). The localization modality was ultrasonography in 65.5 per cent and mammography in 33.7 per cent. The re-excision rate after 125I seed localization was significantly lower than for HWL (13.9 versus 18.9 per cent respectively; P = 0.019). There were no significant differences in positive margin rates, or in specimen weights and volumes. Conclusion Re-excision rates after breast-conserving surgery were significantly lower after 125I seed localization compared with HWL. Registration number: ACTRN12613000655741 (http://www.ANZCTR.org.au/).

Multicentre evaluation of magnetic technology for localisation of non‐palpable breast lesions and targeted axillary nodes

“…Results of this study showed the re‐excision rate of HWL was 18.9% and radioactive seeds 13.9%. This indicates that Magseeds are comparable to these modalities 29 . Results are also comparable to a recent systemic review of 16 studies, which found the overall re‐excision rate was 11.25% 13 …”

“…This re‐excision rate is less than the 19.5% overall re‐operation rate following breast conserving surgery published by one of the participating institutions prior to the use of Magnetic technology 27 . Our re‐excision rate is similar to recently published Australian studies, 28,29 including a study comparing the re‐excision rate of HWL and radioactive seeds for non‐palpable breast cancers. Results of this study showed the re‐excision rate of HWL was 18.9% and radioactive seeds 13.9%.…”

Optimal localization strategies for non-palpable breast cancers –A network meta-analysis of randomized controlled trials

“…In total, 24 RCTs fulfilled our inclusion criteria and were included in this systematic review and NMAs ( Fig. 1 ) [ 16 , 27 , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] , [55] , [56] , [57] , [58] , [59] , [60] , [61] , [62] ]. Of the 24 RCTs included in this analysis, almost 40.0% were conducted in European surgical research institutions (37.5%, 9/24).…”

“…There was low to moderate risk of bias among the included RCTs: Overall, 10 of the included RCTs had low-risk of bias (41.7%) [ 27 , 42 , 45 , 50 , 51 , 53 , 54 , 57 , 61 , 62 ], 12 of the RCTs included some concerns for bias (60.0%) [ 16 , 24 , 41 , 44 , [47] , [48] , [49] , 52 , 55 , [58] , [59] , [60] ], while 2 RCTs were considered high-risk of bias (10.0%) [ 46 , 56 ]. Risk of bias assessment is illustrated in the Supplementary Appendix 1 .O.…”

Breast surgery: a narrative review

“…Not all of these, however, are funded, all have advantages and disadvantages, but only radioactive iodine seeds have been shown to be more accurate than hookwires in a randomised trial, thus decreasing re-excision rates. 36 About 30 years ago, it was postulated that delivering chemotherapy upfront before surgery may have a number of advantages over the usual policy of surgery first. This neoadjuvant approach is now offered to 10-20% of patients diagnosed with breast cancer.…”