New Insight for Axillary De-Escalation in Breast Cancer Surgery: “SoFT Study” Retrospective Analysis

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The present study represents a comprehensive analysis of axillary surgical de-escalation in early breast cancer (EBC), emphasizing the evolving role of Sentinel Lymph Node Biopsy (SLNB) and the potential for its omission.

It reviews historical and recent trials, including ACOSOG Z0011, the SINODAR-ONE and the recent SOUND study, which support reduced axillary surgery without compromising patient outcomes.

The authors conducted a retrospective study (SOFT 1.23) involving 160 EBC patients to identify preoperative prognostic factors predictive of SLN metastasis. Findings revealed that factors such as tumor size, multifocality, ER and PR expression, are significantly associated with SLN involvement.

Congratulations to the authors of the present study. I have come comments:

- The title is misleading and I suggest a modification 'New Insight for axillary de-escalation in Breast Cancer Surgery: the SoFT retrospective analysis';

- Line 52, the ACOSOG Z0011 trial has a longer follow-up, not 5 years. Please revise;

- The results of your study are very interesting also in the light of a recent retrospective analysis which similarly evaluated the predicors of additional axillary lymph node metastasis in EBC. Please cite this study PMID: 38883951 to improve the quality of your study and considering the novel adjuvant combination therapies;

- You adequately acknowledged the limitations of your study:

- Conclusions need revision. You state that you improved your patients' quality of life. However, no comparative analysis were made to prove that your patients' quality of life improved by SLNB omission. Futher analysis are required. Please modify.

Comments on the Quality of English Language

minor editing of the English language is required to improve clarity

Author Response

Rebuttal letter Reviewer #1

Dear Reviewer, we are delighted to answer your revision regarding our manuscript submitted for Current Oncology named: “New Insight for axillary de-escalation in Breast Cancer Surgery: “SoFT study” retrospective analysis”. We hope the changes we provided improved the overall quality of the manuscript. As requested, a revision by native speaker was made.

Comment #1: The title is misleading and I suggest a modification 'New lnsight for axillary de-escalation in Breast Cancer Surgery: the SoFT retrospective analysis';

Response #1: Thanks for the suggestion. We changed the title.

Comment #2: Line 52 , theACOSOG Z00 11 trial has a longer follow-up, not 5 years. Please revise

Response #2: Thanks for the suggestion, we are aware that 10 years results were published in 2017 and we changed the manuscript as needed.

Comment #3  - The results of your study are very interesting also in the light of a recent retrospective analysis which similarly evaluated the predicors of additional axillary lymph node metastasis in EBC. Please cite this study PMID: 38883951 to improve the quality of your study and considering the novel adjuvant combination therapies

Response #3: Dear reviewer, thank you for the attention you gave to our manuscript. As for our work group, many other groups evaluated the role of predictors in additional axillary lymph node metastasis in EBC. For instance, in Italian NHS guidelines required under certain circumstances more than 4 Lymph nodes (LN) involved to obtain CDK Inhibitors. While Axillary LNs status is still the strongest predictors of Axillary involvement, other predictors may reduce the need of axillary clearance providing non-invasive surrogate marker of ALN involvement. We added this aspect in our manuscript, we carefully read the manuscript you suggested, and we added in our discussion.

Comment #4: - You adequately acknowledged the limitations of your study.

Response #4: Dear Reviewer, thank you for this note, we are delighted for your note.

Comment #5: Conclusions need revision. You state that you improved your patients' quality of lite. However, no comparative analysis were made to prove that your patients' quality of life improved by SLNB omission. Futher analysis are required. Please modify.

Response #5: Dear reviewer, as correctly stated, no inference regarding quality of life in our patients may be made. Therefore our manuscript was modified accordingly.

Dear Review #1 we would like to thank you again for your valuable time and your inspiring suggestions. We hope our manuscript will fulfils the criteria for publication.

Best Regards

Reviewer 2 Report

Comments and Suggestions for Authors

This is a retrospective review of a prospectively enrolled data base to determine predictive factors for axillary node surgery de-escalation the study is clearly written and presented - it would benefit from a table comparing the study resullts with other similar studies in this active area of interest in breast cancer therapeutics

Comments on the Quality of English Language

minor english edits required in text 

Author Response

Rebuttal letter Reviewer #2

Dear Reviewer, we are delighted to answer your revision regarding our manuscript submitted for Current Oncology named: “New Insight for axillary de-escalation in Breast Cancer Surgery: “SoFT study” retrospective analysis”. We hope the changes we provided improved the overall quality of the manuscript. As requested, a revision by native speaker was made.

Here are all the answer.

Comment #1: This is a retrospective review of a prospectively enrolled data base to determine predictive factors tor axillary node surgery de-escalation the study is clearly written and presented - it would benefit from a table comparing the study resullts with other similar studies in this active area of interest in breast cancer therapeutics

Response #1: Thanks for the suggestion. We added a table with the recent trial published in the last five years and available in PubMed. Firstly we perfom a search in PUBMED applying this query “("Breast Neoplasms"[Mesh] OR "Breast cancer"[Title/Abstract] OR "Breast carcinoma"[Title/Abstract]) AND ("Sentinel Lymph Node Biopsy"[Mesh] OR "Sentinel lymph node"[Title/Abstract] OR "Sentinel node"[Title/Abstract]) AND ("Risk Factors"[Mesh] OR "Risk factors"[Title/Abstract] OR "Predictive factors"[Title/Abstract]) AND ("Nodal positivity"[Title/Abstract] OR "Lymph node metastasis"[Title/Abstract]) AND ("2019/07/18"[PDat] : "2024/07/18"[PDat])” to include all the paper published in the last 5 years. Search results included 52 different articles indexed in PUBMED. Finally, two different authors (MM and FP) reviewed all the abstracts and included all the similar studies active in this area. In one case, a third author (GV) reviewed the article when there was discordance between the first two authors. All the results were included in the manuscript. We hope this table may answer your question.

Dear Reviewer we would like to thank you again for your valuable time and your inspiring suggestions. We hope our manuscript will fulfils the criteria for publication.

Best Regards

Reviewer 3 Report

Comments and Suggestions for Authors

New Insight for axillary de-escalation in Breast Cancer Surgery “SoFT study” preliminary data

Article Review 

This article addresses an important topic in healthcare – breast cancer treatment, axillary de-escalation to be more precise.

It is an interesting and well written article, with useful results that are correctly interpreted and discussed.

However, there are some minor adjustments to be made in order refine this already good article:

1.      In line 31 – “LN+” and “LN-“ should be used in the full form and abbreviated afterwards

2.      In line 52 – The year in 2017 not 2012

3.      In line 69 – The citation nr 10 (Halsted, W.S. I. A Clinical and Histological Study of Certain Adenocarcinomata of the Breast: And a Brief Consideration of the Supraclavicular Operation and of the Results of Operations for Cancer of the Breast from 1889 to 1898 at the Johns Hopkins Hospital. Ann. Surg. 1898, 28, 557–576, doi:10.1093/bjs/znad391) is unnecessarily used and I think it is a mistake and should be removed

4.      In line 77 – “Sentinel Omission risk FacTor” is not necessary and should be removed and just the abbreviation used (SOFT)

5.      In lines 79-80 – “and surgical theatre occupancy” should be removed because it is a secondary outcome, and it is also mentioned there

In conclusion, the article is well designed and carried out, with interesting and valuable results. The discussion section is thoroughly redacted with pertinent arguments and different points of view that completes this article. Although more robust and randomized clinical trials are needed to conclude the matter of axillary de-escalation strategy in breast cancer treatment, this article is an important step towards that goal.

Author Response

Rebuttal letter Reviewer #3

Dear Reviewer, we are delighted to answer your revision regarding our manuscript submitted for Current Oncology named: “New Insight for axillary de-escalation in Breast Cancer Surgery: “SoFT study” retrospective analysis”. We hope the changes we provided improved the overall quality of the manuscript. As requested, a revision by native speaker was made.

Here are all the answer.

Comment #1:  In line 31 “LN+" and •LN-" should be used in the full fonn and abbreviated afterwards

Response #1: Dear reviewer, we changed the line as requested.

Comment #2. In line 52 - The year in 2017 not 2012

Response #2: Thanks for the suggestion, we are aware that 10 years results were published in 2017 and we changed the manuscript as needed.

Comment #3. In line 69- The citation nr 10 (Halsted, WS. I. A Clinicaland Histological Study of Certain Adenocarcinomata of the Breast: And a Brief Consideration of the Supraclavicular Operation and of the Results of Operations for Cancer of the Breast from 1889 to 1898 at the Johns Hopkins Hospital. Ann. Surg. 1898, 28, 557-576, doi:10.1093/bjs/znad391) is unnecessarily used and I think it is a mistake and should be removed

Response #3: Dear Reviewer, thank you for your carefull revision. The work written by halsted is a miliary stone of Breast Cancer treatment, but of course the present publication does not fit the discussion of our introduction. We changed with the correct reference.

Comment #4. In line 77 - "Sentinel Omission risk FacTor'' is not necessary and should be removed and just the abbreviation used (SOFT)

Response #4: Dear Reviewer, thank you for your carefull revision. We removed the part requested.

Comment #5. In lines 79-80 - "and surgical theatre occupancy" should be removed because it is a secondary outcome, and it is also mentioned there.

Response #5: Dear Reviewer, thank you for your carefull revision. We removed the part requested and we left in secondary outcome.

Dear Reviewer we would like to thank you again for your valuable time and your inspiring suggestions. We hope our manuscript will fulfils the criteria for publication.

Best Regards

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

The manuscript can be accepted in the present form