Author's response to reviews

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1 Author's response to reviews Title: Classifying breast cancer surgery: a novel, complexity-based system for oncological, oncoplastic and reconstructive procedures, and proof of principle by analysis of 1225 operations in 1166 patients Authors: Jürgen Hoffmann (j.hoffmann@med.uni-tuebingen.de) Diethelm Wallwiener (diethelm.wallwiener@med.uni-tuebingen.de) Version: 4 Date: 21 November 2008 Author's response to reviews: see over

2 Dr. med. Jürgen Hoffmann Tel.: Operativer Oberarzt Fax: Universitäts-Frauenklinik Tübingen Calwerstr Tübingen Germany Melissa Norton, MD Editor-in-Chief, BMC Cancer c/o BioMed Central Middlesex House Cleveland Street London W1T 4LB 18 November 2008 BMC Cancer manuscript , Revision 1: Hoffmann J, Wallwiener D. Classifying breast cancer surgery: a novel, complexity-based system Dear Doctor Norton, On behalf of my co-author, I am today submitting our revised manuscript for publication in BMC Cancer. We are grateful to the reviewers for their time, careful assessment of our manuscript, and valuable remarks on our work. Below please find our point-by-point responses to the comments and suggestions for manuscript improvement made by Reviewer 1. In addition to the revised manuscript itself we are also uploading a PDF version containing all changes to the text of the original manuscript in the track changes mode so they can readily be identified. Changes were only made to Table 1. Corrections to the EndNote formatting (journal title abbreviations) have also been carried out in the revised manuscript, but these changes are not indicated. As requested by Dr Scott Edmunds in his of 14 November 2008, we have ensured that our revised manuscript conforms to the journal style. Dr Edmunds also requested that we address the following policy issues in the manuscript: (1) acknowledgement of medical writers/persons who assisted with the preparation of the manuscript content; and (2) independent ethics committee (IEC) approval. Our responses are as follows: (1) No-one other than my co-author and myself contributed to the manuscript content to any extent that would justify personal mention in the Acknowledegments section. Dr Habicht s role was limited to handling the process of manuscript submission and to ensuring timely response to reviewers comments on our behalf. (2) This was a study was designed as a prospective analysis of existing hospital treatment records and was noninterventional. Also, no patient-identifiable data were extracted from the records or used in the present analysis. The study therefore required neither approval by an ethics committee or institutional review board nor informed patient consent. We hope our responses and the changes we have made to the manuscript will be considered satisfactory and our manuscript will now be acceptable for publication in BMC Cancer. Please do not hesitate to contact us with any queries you may have. We greatly look forward to your reply. Yours sincerely, Jürgen Hoffmann, MD Consultant in Obstetrics and Gynaecology

3 BMC Cancer MS Classifying breast cancer surgery:... Authors replies to Reviewers comments Page / Editor's Comments to Author: No specific comment or suggestion to be addressed. Reviewer 1: Colleen McCarthy ( The authors suggest that it has not been possible to achieve for breast surgery, particularly oncoplastic surgery, the high levels of evidence demanded by the advocates of quality-assured treatment and others. They have taken on the challenge of devising a comprehensive classification system capable of accommodating any major oncological, oncoplastic or reconstructive procedure used in the surgical treatment of primary and locally recurrent breast cancer. Of note, the purpose of the paper is well defined, the writing is acceptable and the title accurately reflects what is found in the manuscript. The proposed classification system is intended to classify surgical procedures based on complexity. Based on the current text, however, it appears that the determination of surgical complexity or technical difficulty was made based solely on the authors opinion - prior to the review of their clinical case load. No specific comment or suggestion to be addressed.

4 It is this reviewer s opinion that the proposed classification system is at times confusing, is not comprehensive and is not particularly user-friendly. The field of breast cancer surgery comprises a multitude of individual procedures and techniques. We therefore took a possibly unusual approach in using technical difficulty, or complexity, as the primary principle of classification. We also considered this approach natural and practical from a surgeon s point of view. Our classification system has officially been in use at our breast centre since 1 January, Every breast cancer operation performed at our department has since been classified accordingly. In our experience, the system is well accepted by our colleagues and they have found it plausible and have readily adopted it.

5 More specifically 1. It is curious that that authors state that "no IRB review was required as existing" hospital treatment records were reviewed especially as the authors outline the Inclusion Criteria as being all women who underwent surgery for breast cancer at the Breast Center.. and state that patient s operative reports (presumably containing personal health information) were reviewed. The reviewer will defer to the editor here to determine if the need for IRB approval can simply be ignored in this study. 2. If the idea is to classify procedures based on surgical complexity so that surgical outcomes can be measured in homogenous patient populations (comprised of those patients who have had similar surgical procedures), then each classification category should represent a homogenous group of procedures. It is this reviewer s opinion that the performance of a modified radical mastectomy is a more complex surgical procedure than the excision of a local recurrence. The same could be said for the performance of a radical mastectomy compared to the excision of a local recurrence. On what basis did the authors conclude that these procedures were similarly complex? 3. Please clarify: How would one classify the excision of a local recurrence after ablation? Would this procedure be classified as an A1 or and A2? Does this procedure classification depend on what procedure was previously performed and/or if the pectoral muscles are removed during the excision of the recurrence? 4. The authors have excluded the procedures SSM and tissue expander placement and NSM and tissue expander placement. Our study was non-interventional and did not involve the collection, analysis or disclosure of any personal data from the patients operative reports. Each surgical procedure was classified retrospectively and recorded without any reference to the patient s identity. German law does not require IRB or Ethics Committee approval for this type of study. An MRM involves local excision of breast tissue and skin, including resection of muscular fascia. We see no difference in complexity between MRM and local excision for local recurrence; they differ only with regard to the amount of resected tissue. Following an MRM as the initial procedure, the procedure would be classified as an A.1. Yes. If resection of muscular tissue is necessary, the procedure would be classified as A.2. In the context of our classification, the term implant is used in a generic sense to refer to both expanders and permanent implants.

6 5. It is unclear whether the authors are referring to the performance of capsulotomy and/or capsulectomy in 3.d.2. when they mention breast remodeling. Please define breast remodeling. 6. The authors give an example which suggests that 4.4., Free Skin Transplants refers to Skin grafts. If that is what is meant here, then skin grafts should not be included under the heading defect repair with local flaps. The term flap is reserved for tissue that has its own circulatory system; by contrast, grafts do not. Category A.3.d.2 includes both procedures, capsulotomy and capsulectomy, and refers to repeat reconstruction (with a new implant) of the breast shape subsequent to deformation of the reconstructed breast by capsular contracture. We accept the reviewer's terminological objection and have amended the category title accordingly to accommodate this justified criticism. Category A.4 now reads: Complex oncoplastic ablative breast cancer surgery involving defect repair with local flaps or free skin grafts (also in extensive chest wall recurrence) 7. The authors should also clarify what is meant by Transposition flap versus Axial transposition flap. See point The authors have not included Advancement Flaps in the classification system. This appears to be a linguistic problem, axial transposition being the usual German term whereas English prefers the term local advancement flap. To clarify this, we have changed category title A.4.4 from axial transposition flaps to local advancement flaps. 9. The authors have not included Implant removal alone (i.e. without exchange for a second implant following the development of a peri-prosthetic infection, exposure, leak/rupture, capsular contracture, patient preference, etc). Similarly, the authors have not included the Premature removal of a tissue expander (i.e. following the development of a peri-prosthetic infection, exposure, leak/rupture, failed expansion, etc.) in their schema. Please clarify. The reviewer addresses the extent to which our classification system accounts for potential complications after implant surgery. However, implant-related postoperative complications are not within the scope of our classification. If they were, this would call for similar extension of all other categories in order to accommodate all possible complications. It was not the aim of our classification system to accommodate all conceivable types of complication management.

7 10. The authors should define what is meant by Conventional versus Extended LD flaps. By Conventional LD flap we mean that the harvested flap consists of the LD muscle including a skin island. This technique is often used in combination with an implant (see definition 4.) Extended LD flap means that the harvested flap consists of the LD muscle plus additional fat tissue and a skin island. This latter technique more readily permits the replacement of the entire breast tissue without additional use of an expander/implant and has been described by several authors (e.g. Marshall DR, Anstee EJ, Stapleton MJ. Soft tissue reconstruction of the breast using an extended composite latissimus dorsi myocutaneous flap. Br J Plast Surg 1984;37:361. Hokin JAB, Silfverskiold KL. Breast reconstruction without an Implant: Results and complications using an extended latissimus dorsi flap. Plast Reconstr Surg 1987;79:58. Delay E, Gounot N, Bouillot A, Zlatoff P, Rivoire M. Autologous Latissimus breast reconstruction: a 3-year cinical experience with 100 patients.plast Reconstr Surg 1998;102:1461) 11. The procedure, Endoscopic harvest of an LD flap, is included in category B, but not in A. Please clarify. 12. The definition of 5.a.4 needs to be clarified. The current definition describing the Conventional LD flap with or without an implant for autogenous reconstruction is confusing. This procedure is mostly used for tissue replacement in a breast-conserving procedure but is indeed also an option for covering an implant with soft tissue in ablative surgery. We thank the Reviewer for this point and have therefore extended Category A.5.a to Conventional latissimus dorsi (LD) flaps (surgical or endoscopic harvest). We have changed category title A.5.4 to: Conventional LD flap without or with an implant for autologous reconstruction or combined autologous and alloplastic reconstruction in prosthesis-related complications.

8 13. The authors have not included the procedure Conventional LD flap with placement of a tissue expander. This procedure could be performed on either an immediate or delayed basis. In the context of our classification, the term implant is used in a generic sense to refer to both expanders and final implants (see 4 above). Categories A.5.a.1 and A.5.a.3 accommodate immediate and delayed breast reconstruction, respectively. 14. The authors should explain what is meant by a Modified B Mammoplasty. This refers to a technique published by Regnault (Regnault P. Breast reduction: B technique. Plast Reconstr Surg 1980;65: ) Originally developed as a cranial pedicle technique, the modified technique enables both wide segmental excision including skin resection and nipple centralisation and lifting in practically any area of the breast. The name of the technique is derived from the shape of the incision pattern, which is reminiscent of a capital B. 15. Under 4.a. the authors have not included the use of a Medial or Lateral pedicle. We consider this point debatable. In our opinion, pedicles do not exist in purely medial or lateral forms. We therefore subsume these techniques under cranial and inferior pedicles, depending on which type of blood supply is the anatomically dominant one. Introducing additional types and subtypes of pedicles would, in our opinion, unnecessarily complicate the classification system without significant gain in precision.

9 16. Section 4.a. is defined as a tumor-adapted mastopexy (breast lift). Please clarify how 4.a.5. is performed to achieve a breast lift. 17. Finally, the classification system does not include the excision of a local recurrence in the setting of reconstruction. Please clarify. Category B.4.a.5 refers to the free transfer of a confirmed tumour-free nipple-areola complex in cases where the chosen access is via a mastopexy pattern (vertical, segmental or inverted-t) and there is no adequate, circulationsustaining NAC pedicle, e.g. due to tumour resection, but where the NAC can be transferred to the newly created centre of the breast. The skin envelope is thus reduced, the breast lifted and the NAC freely moved to the centre of the breast. Subcategories A.5.a.2, A.5.b.2, A.5.c.2 and A.6.2 explicitly address the repair of chest wall defects. However, for greater clarity, Categories A.5 and A.6 have been modified to include extensive chest wall recurrence as follows: A.5: Complex oncoplastic ablative breast cancer surgery with reconstruction or defect repair using distant pedicled flaps (also in extensive chest wall recurrence) A.6: Complex oncoplastic ablative breast cancer surgery involving reconstruction or defect repair using free flaps with microvascular anastomosis (e.g. DIEP, SIEA, SGAP or free TRAM flaps) (also in extensive chest wall recurrence)