The diagnostic value of core needle biopsy in cervical cancer: A retrospective analysis

Massimiliano Lia; Lars-Christian Horn; Paulina Sodeikat; Michael Höckel; Bahriye Aktas; Benjamin Wolf

doi:10.1371/journal.pone.0262257

Peer Review History

Original SubmissionFebruary 21, 2021
19 Jul 2021 Decision Letter - Giovanni Delli Carpini, Editor PONE-D-21-05840 The diagnostic value of core needle biopsy in cervical cancer: a retrospective analysis PLOS ONE Dear Dr. Lia, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Sep 02 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please state whether patients provided written informed consent in the ethics statement in the manuscript Methods." 3. In your Methods section, please provide additional information about the participant recruitment method and the demographic details of your participants. Please ensure you have provided sufficient details to replicate the analyses such as the recruitment date range (month and year). 4. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. 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Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. 5. We noted in your submission details that a portion of your manuscript may have been presented or published elsewhere. "The abstract of this manuscript has been submitted to the 2021 ASCO Annual Meeting. The abstract submitted to the 2021 ASCO Annual Meeting is slightly different, due to different formatting guidelines, compared with the abstract of the manuscript herby submitted to PLOS ONE. However, title, authors and results are exactly the same, making it clear for every reader that the two abstracts describe the same study. Furthermore, the ASCO guidelines allow the submission of a pre-published abstract. Finally, we feel the whole study should be accessible, since the abstract alone can´t possibly reflect all aspects of the results of this study. " Please clarify whether this conference proceeding was peer-reviewed and formally published. If this work was previously peer-reviewed and published, in the cover letter please provide the reason that this work does not constitute dual publication and should be included in the current manuscript. 6. Thank you for stating the following in the Competing Interests section: "I have read the journal's policy and the authors of this manuscript have the following competing interests: MH and BW received payments from the non-profit-organization “Stiftung gynäkologische Onkologie”. BA received honoraria from Pfizer Inc, Roche AG, Novartis AG, AstraZeneca PLC, Amgen Inc and Daiichi Sankyo Co Ltd. LCH, PS and ML have no conflicts to disclose." Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Overall interesting study on the use of CNB in newly diagnosed cervical cancer treated with primary surgery. The concept of having pre-operative tumor information is important and the study adds new data to the literature. However, some comments are due: Abstract/Introduction - LVSI and grade have a prognostic impact, but can the Authors clarify how this can impact surgery and therapeutic decision? - Can the Authors clarify what is the primary endpoint of the study? How was the “performance” assessed? - Authors at Line 70 state that “no studies evaluating the accuracy of CNB in cervical cancer have been published”; however, an initial description of such technique has been reported in the following study: Mascilini F, Quagliozzi L, Moro F, et al. Role of transvaginal ultrasound-guided biopsy in gynecology. Int J Gynecol Cancer. 2020;30(1):128-132. doi:10.1136/ijgc-2019-000734 Methods - Authors should clearly state whether the study was prospective or retrospective as it is not clear in the methodology - Can the Authors specify it in the methods the criteria to take more than one core needle biopsy for each patient? - Line 82: was classification from FIGO 2018 or 2009 used? Can the Authors clarify in the text? Discussion - Line 214: Authors state that CNB can be useful to determine peri neural infiltration, but they did not report it in the results and they did not report reference for this statement - Discussion could be shortened to 2/2.5 pages. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes:** Nicolò Bizzarri [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0262257.r001
Revision 1
12 Oct 2021 Author Response Dear editor, dear reviewer, thank you very much for your supportive feedback which consistently improves this article. We have integrated the changes proposed by you in the manuscript and, as requested, an answer to every point raised by you has been added to this rebuttal letter (answers are written in bold) and some are also addressed in the revised cover letter. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Done 2. Please state whether patients provided written informed consent in the ethics statement in the manuscript Methods." Line 93 3. In your Methods section, please provide additional information about the participant recruitment method and the demographic details of your participants. Please ensure you have provided sufficient details to replicate the analyses such as the recruitment date range (month and year). Recruitment: Line 94-98 Details partecipants: Line 159-166 and Table 1 4. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. The sharing of raw data, even anonymized, is not supported by the ethical committee of the university hospital in Leipzig (Stephanstraße 9A.1, 04103 Leipzig, Germany), as it contains sensitive patient information including medical history and oncological details. Thus, sharing of raw data was not part of the written consent form signed by the patients. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. Done b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Minimal anonymized data has been uploaded We will update your Data Availability statement on your behalf to reflect the information you provide. 5. We noted in your submission details that a portion of your manuscript may have been presented or published elsewhere. "The abstract of this manuscript has been submitted to the 2021 ASCO Annual Meeting. The abstract submitted to the 2021 ASCO Annual Meeting is slightly different, due to different formatting guidelines, compared with the abstract of the manuscript herby submitted to PLOS ONE. However, title, authors and results are exactly the same, making it clear for every reader that the two abstracts describe the same study. Furthermore, the ASCO guidelines allow the submission of a pre-published abstract. Finally, we feel the whole study should be accessible, since the abstract alone can´t possibly reflect all aspects of the results of this study. " Please clarify whether this conference proceeding was peer-reviewed and formally published. If this work was previously peer-reviewed and published, in the cover letter please provide the reason that this work does not constitute dual publication and should be included in the current manuscript. It has been included in the revised cover letter. 6. Thank you for stating the following in the Competing Interests section: "I have read the journal's policy and the authors of this manuscript have the following competing interests: MH and BW received payments from the non-profit-organization “Stiftung gynäkologische Onkologie”. BA received honoraria from Pfizer Inc, Roche AG, Novartis AG, AstraZeneca PLC, Amgen Inc and Daiichi Sankyo Co Ltd. LCH, PS and ML have no conflicts to disclose." Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. It has been included in the revised cover letter. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests Reviewers' comments: Abstract/Introduction - LVSI and grade have a prognostic impact, but can the Authors clarify how this can impact surgery and therapeutic decision? The role of LVSI in therapeutic decision making has been clarified in line 261-267. The role of grade is less clear, but evidence has been discussed in line 280-284. - Can the Authors clarify what is the primary endpoint of the study? How was the “performance” assessed? The performance of histological subtype was performed by sensitivity and specificity For lymphovascular space invasion and tumor-grading we calculated the sensitivity, specificity, accuracy, positive/negative predictive value and the kappa-value (chance corrected agreement between CNB and hysterectomy-specimen). This has been clarified in the methods section (line 136-144). - Authors at Line 70 state that “no studies evaluating the accuracy of CNB in cervical cancer have been published”; however, an initial description of such technique has been reported in the following study: Mascilini F, Quagliozzi L, Moro F, et al. Role of transvaginal ultrasound-guided biopsy in gynecology. Int J Gynecol Cancer. 2020;30(1):128-132. doi:10.1136/ijgc-2019-000734 You are absolutely right and we have included this article as references in the introduction (line 69-72). Methods - Authors should clearly state whether the study was prospective or retrospective as it is not clear in the methodology This has been included in the methodology (line 77). - Can the Authors specify it in the methods the criteria to take more than one core needle biopsy for each patient? The number of biopsies were determined in order to ensure a proper tissue sample for a complete histological classification of the tumor. Usually, the number of biopsies performed was higher than one. - Line 82: was classification from FIGO 2018 or 2009 used? Can the Authors clarify in the text? The classification of 2009. We included this in the text (line 102). Discussion - Line 214: Authors state that CNB can be useful to determine peri neural infiltration, but they did not report it in the results and they did not report reference for this statement This is a general statement about the CNB not referring exclusively to cervical cancer. Perineural infiltration was not analysed in this study, as it is not routinely assessed in CNB-tissue in cervical cancer. The reviewer is completely right to criticize the lack of a proper citation or study data backing this statement. Thus, we deleted this part as it is superfluous for this study. - Discussion could be shortened to 2/2.5 pages. Done. While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Done Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0262257.r002
21 Dec 2021 Decision Letter - Giovanni Delli Carpini, Editor The diagnostic value of core needle biopsy in cervical cancer: a retrospective analysis PONE-D-21-05840R1 Dear Dr. Lia, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Giovanni Delli Carpini Academic Editor PLOS ONE Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Overall interesting study on the use of CNB in newly diagnosed cervical cancer treated with primary surgery. The concept of having pre-operative tumor information is important and the study adds new data to the literature. Thanks for the answers provided. The manuscript has improved. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes:** Nicolo Bizzarri https://doi.org/10.1371/journal.pone.0262257.r003
Formally Accepted
26 Dec 2021 Acceptance Letter - Giovanni Delli Carpini, Editor PONE-D-21-05840R1 The diagnostic value of core needle biopsy in cervical cancer: a retrospective analysis Dear Dr. Lia: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Giovanni Delli Carpini Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0262257.r004

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