Randomized controlled trial comparing magnetic marker localization (MaMaLoc) with wire‐guided localization in the treatment of early‐stage breast cancer

Abstract

Wire‐guided localization (WGL) is the standard of care in the surgical treatment of nonpalpable breast tumors. In this study, we compare the use of a new magnetic marker localization (MaMaLoc) technique to WGL in the treatment of early‐stage breast cancer patients. Open‐label, single‐center, randomized controlled trial comparing MaMaLoc (intervention) to WGL (control) in women with early‐stage breast cancer. Primary outcome was surgical usability measured using the System Usability Scale (SUS, 0–100 score). Secondary outcomes were patient reported, clinical, and pathological outcomes such as retrieval rate, operative time, resected specimen weight, margin status, and reoperation rate. Thirty‐two patients were analyzed in the MaMaLoc group and 35 in the WGL group. Patient and tumor characteristics were comparable between groups. No in situ complications occurred. Retrieval rate was 100% in both groups. Surgical usability was higher for MaMaLoc: 70.2 ± 8.9 vs. 58.1 ± 9.1, p < 0.001. Patients reported higher overall satisfaction with MaMaLoc (median score 5/5) versus WGL (score 4/5), p < 0.001. The use of magnetic marker localization (MaMaLoc) for early‐stage breast cancer is effective and has higher surgical usability than standard WGL.

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.…”

“…Moreover, these results must be interpreted with caution, as just 32 patients in this NMA underwent ML, with further RCTs required to fully establish the risk profile and efficacy associated with ML overall. Similarly, caution must be taken with interpretating the results of the localization strategies with small sample sizes: Only 3 of the 24 studies randomized patients to USGL [ 27 , 41 , 42 ] and just 1 trial randomized patients to ML [ 45 ], IL [ 53 ], CAL [ 61 ], and AGL [ 16 ] respectively (all versus WGL). Moreover, the total number of randomized patients in some of these trials included less than 100 patients [ 41 , 42 , 45 , 53 ].…”

“…Similarly, caution must be taken with interpretating the results of the localization strategies with small sample sizes: Only 3 of the 24 studies randomized patients to USGL [ 27 , 41 , 42 ] and just 1 trial randomized patients to ML [ 45 ], IL [ 53 ], CAL [ 61 ], and AGL [ 16 ] respectively (all versus WGL). Moreover, the total number of randomized patients in some of these trials included less than 100 patients [ 41 , 42 , 45 , 53 ]. In total, just 2 patients had positive margins following ML (6.3%) [ 45 ] as did 5 patients undergoing AGL (9.6%).…”

“…Moreover, the total number of randomized patients in some of these trials included less than 100 patients [ 41 , 42 , 45 , 53 ]. In total, just 2 patients had positive margins following ML (6.3%) [ 45 ] as did 5 patients undergoing AGL (9.6%). Although USGL may appear advantageous in this setting, well described disadvantages of breast ultrasound include operator variability, lack of standardization and difficulties identifying ductal carcinoma in-situ must be taken into consideration [ [66] , [67] , [68] ], Furthermore, included RCTs varied in that one involved both surgeons and radiologists localizing the lesion intraoperatively [ 41 ], while others relied solely upon surgeons to conduct the localization [ 27 , 42 ], likely explaining the prolonged operation times observed in this systematic review (USGL increased the mean duration of surgery to 73.0 min).…”