Axillary Management in Breast Cancer Patients Undergoing Upfront Surgery: Results from a Nationwide Survey on Behalf of the Clinical Oncology Breast Cancer Group (COBCG) and the Breast Cancer Study Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO)
, Riccardo Ray Colciago 2,3, Sara Lucidi 1,2, Eliana La Rocca 2,4, Agnese Prisco 2,5, Elisabetta Bonzano 2,6, Bruno Meduri 2,7, Maria Carmen De Santis 2,3, Samantha Dicuonzo 8,9, Nadia Pasinetti 2,10, Isabella Palumbo 9,11, Icro Meattini 2,12,13 and Pierfrancesco Franco 2,14,*
Round 1
Reviewer 1 Report
Thank you for letting me review this manuscript. The topic is interesting even if it only concerns one European country.
Some comments:
All numbers of answers should be presented in all table- and figure-legends to make it more understandable. Also, in the abstract it is difficult to understand “a third of the responders (17/56)”. Who were these responders out of all 101. (same for line 157)
Introduction: line 89, The abbreviation BLS has to be explained.
Results. The two sentences on line 142-144 “From……..surgery was not given” have to be rephrased. Expand wording to make them understandable.
Line 152. Only one digit necessary in 30.91%.
Discussion: Address the low response rate. Was there a non-responder analysis?
Author Response
Thank you for letting me review this manuscript. The topic is interesting even if it only concerns one European country.
Some comments:
All numbers of answers should be presented in all table- and figure-legends to make it more understandable. Also, in the abstract it is difficult to understand “a third of the responders (17/56)”. Who were these responders out of all 101. (same for line 157)
Answer: We thank the reviewer for these comments. Absolute Numbers were added and the abstract were corrected, accordingly. Regarding the number of responders, as we specified in “materials and methods”, the use of adaptive questioning (only conditionally displayed based on responses to other items – question 10 and 15) explain the fewer number of responders for certain items. Specifically, 63/101 responders continued the survey after question 10 (see Appendix A):
Q10: In your Institution, is axillary dissection performed in patients with early-stage breast cancer after conservative surgery (BCS)/mastectomy and 1-2 macrometastases after sentinel lymph node biopsy (SLNB)?
- a) Yes, always
- b) No, never
- c) In selected cases
If you answered “Yes, always”, you finish the survey here
If you answered “No, never” or “in selected cases”, you can continue the survey
Then, a total of 56 out of 63 responders answered to the question about radiotherapy indications among patients who did not undergo ALND.
Introduction: line 89, The abbreviation BLS has to be explained.
Answer: Thanks for the annotation. The abbreviation was corrected.
Results. The two sentences on line 142-144 “From……..surgery was not given” have to be rephrased. Expand wording to make them understandable.
Answer: Thank you for this observation. The sentence was rephrased.
Line 152. Only one digit necessary in 30.91%.
Answer: Thanks for the suggestion. The centesimal digit was deleted.
Discussion: Address the low response rate. Was there a non-responder analysis?
Answer: Thank you for this comment. We added a sentence discussing the low response rate in the Discussion. Unfortunately, we did not perform any analysis of the non-responders.
Author Response File: 
Author Response.docx
Reviewer 2 Report
De-escalation of axillary surgery is a hot point in breast cancer treatment. Although AMAROS trial suggested that for macro metastases in the axilla it if safe to perform only radiotherapy of the axilla, they are still controversies and practical issues that put this practice in discussion.
It would be interesting to know if the questionnaire was taken before/after the published AMAROS trial results.
Sometimes choosing ALND instead of radiotherapy is secondary to practical issues: access to radiotherapy, patient's preference, co-morbidities. Therefore it would be interesting to know how are these problems managed in Italy.
Moreover for patients with 1 or 2 positive sentinel lymph nodes, not performing neither ALND, neither radiotherapy is at least disputable.
Introduction: Is there any consensus in Italy regarding axillary management?
Material and methods: Maybe it would be interesting to include in your study surgeons that could answer the questionnaires.
Results: It needs to be edited in order to be concise and clear.
Conclusions: What is the outcome of this heterogenous practice?
Author Response
De-escalation of axillary surgery is a hot point in breast cancer treatment. Although AMAROS trial suggested that for macro metastases in the axilla it if safe to perform only radiotherapy of the axilla, they are still controversies and practical issues that put this practice in discussion.
It would be interesting to know if the questionnaire was taken before/after the published AMAROS trial results.
Answer: The survey-based questionnaire was administered from August to September 2022, about 7 months before the publication of the updated AMAROS trial results (10-year analysis).
Sometimes choosing ALND instead of radiotherapy is secondary to practical issues: access to radiotherapy, patient's preference, co-morbidities. Therefore it would be interesting to know how are these problems managed in Italy.
Answer: In almost all areas there are no problems in terms of access to radiotherapy centres. Patient’s preferences, co-morbidities and lack of a general consensus on the axillary management in patients with 1-2 macrometastases after SLNB, could play a role in the decision-making process.
Moreover for patients with 1 or 2 positive sentinel lymph nodes, not performing neither ALND, neither radiotherapy is at least disputable.
Introduction: Is there any consensus in Italy regarding axillary management?
Answer: Thank you for this comment. In 2020, the Italian Senonetwork study group updated a document on axillary management to underline the importance of a multidisciplinary discussion in case of 1-2 macrometastases after SLNB, considering the omission of ALND after breast conserving therapy in patients that received whole breast irradiation, as reported in more recently AIRO Breast Cancer Group Best Clinical Practice. A careful evaluation of risk factors (age, co-morbidities and molecular subtype) was recommended to properly define the therapeutic strategy and the role of regional nodal irradiation. We added this sentence in the Introduction.
Material and methods: Maybe it would be interesting to include in your study surgeons that could answer the questionnaires.
Answer: Thank you for this comment. Actually, international guidelines (ASCO and NCCN) support the omission of ALND in presence of positive SNL for macrometastases in case of breast conserving therapy and there are ongoing studies to corroborate the results of Z0011. Thus, starting from this emerging change in surgical practice, our survey was focused on the consequent change in the role of regional nodal irradiation, with respect to indications and extension of the treatment volumes. For this reason, we decided to involve only the radiation oncologists.
Results: It needs to be edited in order to be concise and clear.
Answer: Thank you for this observation. The text was revised according to the different items of the survey questionnaire.
Conclusions: What is the outcome of this heterogenous practice?
Answer: Thank you for this comment. Currently, we have no clear data refer to this heterogeneous practice. We just conducted the e-mail survey to create the background for multidisciplinary clinical investigation in this debated field.
Author Response File: Author Response.docx
Round 2
Reviewer 1 Report
I am happy with the changes made.
Author Response
Thank you very much.
Reviewer 2 Report
The authors have offered answers to all the issues that I first identify.
Author Response
Thank you very much
