Complete Surgical Excision Is Necessary following Vacuum-Assisted Biopsy for Breast Cancer

Round 1

Reviewer 1 Report

Comments for author File: Comments.pdf

Author Response

The article clearly analyzes the limits of the VABB procedure in the radical removal of breast tumor lesions, offering a correlation between some preoperative dimensional characteristics and the residual disease found after surgery.

The limitations of the study certainly concern the low sample size together with the lack of a selection of patients based on clinical and radiological criteria (mammographic MRI size). Please implement this part.

Response:

We thank the reviewer for reviewing our manuscript. In the limitation part, we mentioned that the statistical power was too low to identify the factors associated with residual tumor after complete excision. We could not indicate radiological criteria because there was no difference between the lesions with or without residual tumor (Table 1). Small tumor size on the VABB specimen was associated with no residual tumor (Table 3). However, we advocate complete surgical resection even for the tumors less than 0.5cm, because the proportion of residual tumors is high.

In this context it is important to specify that patients with invasive lobular neoplasia were excluded from the study. Please implement this part

Response:

We thank the reviewer for the critical comment. We excluded a case of lobular carcinoma in situ and specified that patients with lobular neoplasia were excluded from the study. Because we excluded just one case, the conclusion did not change.

However, the analysis of the predictive potential of the radiological methods available to identify residual disease remains interesting.

It may be also interesting to offer in the discussion some specific points of view on the prospect of using the vacuum assisted excision tool to verify data on selected patients in the future.

Response:

We fully agree with the reviewer’s suggestion. To identify a subset of patients who does not need complete surgical excision after VABB, further study with prospective design is needed. The risk of recurrence should be balanced against the surgical complication of scarring and deformity. Vacuum-assisted excision for breast cancer should be performed for selected low-risk patients. We expect positive results for the clinical trials that recruited low-grade DCIS. Considering that it takes long hours for low-grade DCIS to recur, long-term follow-up is needed.

The article shows that in a percentage of cases, in the diagnosis of lesions at an early stage, there is no residual tumor and this can give further impetus to conservative surgery techniques, to the use of real-time ultrasound-guided surgery and to the increasingly important role of markers (clips, seeds) in the treatment of non-palpable lesions.

Further studies are needed to define patient risk classes, dimensional, molecular and histological to better determine the type of treatment.

I agree with the authors' conclusion to still support the need for resective surgery in breast cancer patients.

Response:

We thank the reviewer for a good suggestion. Genomic assays can be used for identifying patients with a high risk of recurrences. Complete resection is required to apply genomic risk stratification.

The manuscript clear, relevant for the field and presented in a well-structured manner.

The cited references mostly recent publications (within the last 5 years) are relevant.

The manuscript scientifically sound and is the experimental design appropriate to test the hypothesis.

The manuscript’s results reproducible based on the details given in the methods section.

The figures/tables/images/schemes are appropriate and they properly show the data( easy to interpret and understand)

The statistical analysis or data acquired are appropriate.

The conclusions are consistent with the evidence and arguments presented the ethics statements and data availability statements to ensure they are adequate.

In conclusion the question original and well-defined and the results provide an advancement of the current knowledge. In this regard the work fit the journal scope. The results interpreted appropriately and are significant. All conclusions are justified and supported by the results and the hypotheses carefully identified. The article written in an appropriate way and the data and analyses presented appropriately.

The conclusions interesting for the readership of the journal and will the paper attract a wide readership.

The English language appropriate and understandabl

Author Response File: Author Response.docx

Reviewer 2 Report

Thank you for giving me the opportunity to read and comment a report “Complete surgical excision is necessary following vacuum-asisted biopsy for breast cancer.”, by Ho Park J, et al.

In the reviewed manuscript, identify the subset of patients who do not require complete surgical excision after VABB, has been evaluated.

This paper is well written, correctly structured with a suitable research concept, the study limitations are addressed, and it is of relevance to readers of the journal. However, I include a few comments for your consideration.

·         It would be desirable for the authors to provide more detail on the main aim of the study.

·         It would be useful to provide more information about the electronic medical record database used.

·         The Discussion section should begin with a brief summary of the main results of the study.

Author Response

Thank you for giving me the opportunity to read and comment a report “Complete surgical excision is necessary following vacuum-asisted biopsy for breast cancer.”, by Ho Park J, et al.

In the reviewed manuscript, identify the subset of patients who do not require complete surgical excision after VABB, has been evaluated.

This paper is well written, correctly structured with a suitable research concept, the study limitations are addressed, and it is of relevance to readers of the journal. However, I include a few comments for your consideration.

• It would be desirable for the authors to provide more detail on the main aim of the study.

Response:

We thank the reviewer for reviewing our manuscript and giving suggestions. The ultimate goal of our study was to know whether surgery can be substituted by VABB for breast cancer. In standard practice, a clear resection margin should be guaranteed after surgical excision. When margin is involved, repeated excision is still needed to obtain a clear resection margin. However, assessing margin status is nearly impossible after VABB. To identify a subset of patients who do not need complete surgical excision, we retrospectively reviewed the patient who underwent VABB and were subsequently diagnosed with breast cancer.

• It would be useful to provide more information about the electronic medical record database used.

Response:

Between 2003 and 2021, we identified 3,289 patients with breast cancer who underwent surgery at our institution.

• The Discussion section should begin with a brief summary of the main results of the study.

Response:

We thank the reviewer for indicating a critical point. We rearranged the sentences in the discussion part. The discussion part starts with “We showed that a high proportion of residual tumors”.

Author Response File: Author Response.docx

Reviewer 3 Report

The entire description of your interesting work, starting from the title of the paper, describes the rate of residual tumor following VABB procedures, but as far as I understand, 14% of the sample underwent a fine-needle aspiration and 34% a core-needle biopsy. Only 26 patients (52% of the sample) underwent VABB; if my interpretation is correct, you should reformulate your results/conclusions. In addition, it would be useful for clinical purposes to know the ranges of patients' age (rather than pre- or post-menopausal status). Globally, I find the paper well written, except the "Conclusions" which could be improved.     

Author Response

The entire description of your interesting work, starting from the title of the paper, describes the rate of residual tumor following VABB procedures, but as far as I understand, 14% of the sample underwent a fine-needle aspiration and 34% a core-needle biopsy. Only 26 patients (52% of the sample) underwent VABB; if my interpretation is correct, you should reformulate your results/conclusions.

Response:

We thank the reviewer for the careful review and for pointing out a critical issue. We would like to resolve a misunderstanding. All 52 patients underwent VABB with subsequent surgical excision for the same lesion. The “biopsy method” in the Table 1 was initial biopsy method. Seven (14%) were benign in initial fine-needle aspiration and subsequently underwent VABB. Seventeen (34%) were benign in initial core-needle biopsy and subsequently underwent VABB. Twenty six (52%) were assessed as probably benign in ultrasonography and underwent upfront VABB.

In addition, it would be useful for clinical purposes to know the ranges of patients' age (rather than pre- or post-menopausal status). Globally, I find the paper well written, except the "Conclusions" which could be improved.

Response:

We thank the reviewer for a good comment. We classified the patients into two groups: those with and without residual tumor on excision. We presented patients’ age as mean and standard deviation. To compare the age of the two groups, we performed Student’s t-test. However, there was no statistically significant difference between the two groups.

Author Response File: Author Response.docx