Intraoperative Image-Guided Breast-Conservation Surgery Should be the Gold Standard

Abstract

The COBALT trial 1 is a small randomized multicenter trial (134 patients) for unicentric palpable breast cancers conducted in the Netherlands primarily to demonstrate the superiority of intraoperative ultrasound (US)-guided breastconservation surgery (BCS) in terms of both cosmesis and patient satisfaction. Indeed, the cosmesis was better for the image-guided surgery than for the palpation-guided surgery, as judged by a three-member panel, a computer program, and self-evaluation (odds ratio, 0.55; p = 0.067). This was primarily due to less volume of excision with US-guided BCS, less reexcision due to positive margins, and improved patient satisfaction. This ultimately led to lower cost, although this datum is not presented in the report. Likewise, Rubio et al. 2 demonstrated utility in the neoadjuvant setting using a USVisible marker placed at the original biopsy. IMPLEMENTATION IN CLINICAL PRACTICEAs described in both reports, the study results would not be difficult to implement in a busy clinical practice. A variety of ultrasound machines are currently available in most operating rooms that could be used for US-guided surgery. This is how I started in my practice more than 20 years ago. I did not charge for such procedures because they were part of my learning curve and because at that time, no certification for surgeons or US courses were available. It made sense that any image-guided procedure was better than what I could feel with my hands.One thing that received no comment in the reports was the use of ex vivo US confirmation of excision completeness immediately on the operating table that could then direct reexcision of a specific margin. How many times has each of us removed a mass only to find that it was not in the center of the lumpectomy specimen. Ultrasound both in vivo and ex vivo help to direct and redirect our efforts, respectively. FURTHER USE OF IMAGE-GUIDED US IN BOTH THE OPERATING ROOM AND THE CLINICThe two studies demonstrate the most rudimentary of uses for surgical US. As proficiency with US is gained by the surgeon, primary lesions and those demonstrated only by US can be removed with the same level of confidence. Many articles attest to the ability to do so. 3 The obvious benefit for the patient is that he or she does not need to undergo a secondary localization procedure. 4 We and others have demonstrated the usefulness of intraoperative US after a positive stereotactic core biopsy that results in the need for BCS therapy. The patients traditionally require needle localization breast biopsy (NLBB), a most barbaric procedure during which 10-20 % of patients faint or vomit due to vasovagal reflex. 5Many procedures have used clips, coils, cryoablation, and radioactive seeds as second procedures to locate nonpalpable lesions, all with results similar to those for NLBB. 6 Our group has demonstrated the usefulness of using the hematoma created in almost all patients after a core biopsy that lasts up to 5 weeks for most patients. We termed this the hematoma-directed ultrasound-guided (HU...

Breast‐specific factors determine cosmetic outcome and patient satisfaction after breast‐conserving therapy: Results from the randomized COBALT study

“…Since the initial studies in the 1990's, substantial evidence has accumulated which supports the superiority of USS over other localization techniques in reducing the amount of positive margins as well as excision volumes in non‐palpable and palpable tumors …”

“…accumulated which supports the superiority of USS over other localization techniques in reducing the amount of positive margins as well as excision volumes in non-palpable and palpable tumors 21,23,[38][39][40][41][42][43][44][45][46][47][48][49]. Due to the low excision volumes achievable with USS, the wide excision of normal healthy breast tissue involved in oncoplastic breast surgery (OPBS) means that the utility of OPBS is now questionable.…”

Factors influencing reoperation following breast‐conserving surgery

“…The guideline recommendation of "no ink on tumour" as the acceptable margin could significantly reduce reoperation rates [34][35][36] and healthcare costs ASBrS CALLER conference recommended that intraoperative imaging be used to allow identification of close margins and allow immediate shave of the particular margin 29 . Intraoperative specimen radiography 17,18 and cavity ultrasound [19][20][21][22] have been the most widely studied to date.…”

“…Factors cited to increase the likelihood of involved margins and re-excision include younger patient age, non-palpable tumours, lack of pre-operative diagnosis, neo-adjuvant chemotherapy, mammographic microcalcifications, multifocal lesions, lobular histology, hormonal status, cancers with a ductal carcinoma in situ (DCIS) component and resection volume [10][11][12][13][14][15][16] . The use of intraoperative radiography 17,18 , ultrasound [19][20][21][22] , frozen section 23 , imprint cytology 23 and cavity shave 24, 25 have improved margin status and reduced the re-excision rate in some studies.…”

Intraoperative ultrasound in breast cancer surgery—from localization of non-palpable tumors to objectively measurable excision

“…In her article, Klimberg [ 33 ] claimed that an excised tumor is rarely in the center of the lumpectomy specimen in daily surgical practice and that ultrasound could help in adequate excision, used in vivo or for specimen examination.…”