Pyrotinib versus lapatinib therapy for HER2 positive metastatic breast cancer patients after first-line treatment failure: A meta-analysis and systematic review

Ye Yuan; Xumei Liu; Yi Cai; Wenyuan Li

doi:10.1371/journal.pone.0279775

Peer Review History

Original SubmissionSeptember 2, 2022
21 Nov 2022 Decision Letter - Nabil Elhadi Elsayed Ali Omar, Editor PONE-D-22-24109Pyrotinib versus lapatinib therapy for HER2 positive metastatic breast cancer patients: A systematic review and meta-analysisPLOS ONE Dear Dr. Yuan, 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 Jan 05 2023 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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Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. 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 Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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: No Reviewer #2: 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 Reviewer #2: 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: dear authors, this is an interesting work on new HER2-directed TKI relevant for the use in China, post-trastuzumab. While data on post-pertuzumab or other HER2 drugs approved in US are not available, the trials reported well fit with the local situation. Comparison with lapatinib is appropriate. The authors should emphasize that this is a combined analysis of randomized and non-randomized trials. They should report in the sensitivity analysis, the finding in randomized versus non randomized trials, to ensure consistency. Reviewer #2: The research idea is novel, and it is important to the field of oncology. I appreciate your efforts to do this SRMA. The language and structure of the manuscript are appropriate. I have some comments that I hope may improve your paper. Language: There are some writings that need improvement. For instance, the abbreviation AEs is used without writing what it is referring to. Title: The title is clear and included all important elements, I would suggest adding that it is “after first-line treatment failure” Introduction: There are many statistical results mentioned in the introduction, I prefer to use them in the discussion and show fewer numbers in the introduction. Rationale: Valid and well described including existing knowledge and evidence Objective: I would prefer to see a clear objective of why you would like to do SRMA. Since it is reported as different objective, efficacy and safety should be considered different objectives and that should be stated clearly in the introduction Methods: I appreciate that you used Chinese search terms and did not limit the search to English only. Inclusion criteria: did you include only articles that studied the two medications as second-line after treatment failure? Statistical analysis and models used in the SRMA were well established and explained in the context. Please specify the outcomes to be assessed in the Methods section. In results, I found that you have defined primary and secondary outcomes, but that was not mentioned in the methods. Also, you did not mention that you will assess the adverse events which surprisingly appeared in the results too. I recommend that these outcomes and mentioned first in the methodology. Results: I would prefer to include the data in tables to make it easier for the reader. A table for the primary outcomes, a table for the secondary outcomes, and a table for the adverse events. Discussion: It is relevant and well written, however, there is a great focus on the safety outcomes, I suggest shortening this paragraph and working more on the primary outcomes. In addition, I recommend separating the conclusion for the discussion, adding a conclusion section where you summarise the findings and suggest future studies would be helpful for the reader. ****** 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: No Reviewer #2: Yes: ******** [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.0279775.r001
Revision 1
26 Nov 2022 Author Response 1.Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. Answer: I have changed style of my manuscript totally. The figures were re-uploaded with new file names. 2.Please upload a copy of Figures 11, 12 and 19 to which you refer in your text on page 7 and 8. If the figure is no longer to be included as part of the submission please remove all reference to it within the text. Answer: I am sorry for my careless. I have resubmitted the Figs 11 and 12 (see page 12, lines 6 and 14) in the manuscript. All reference to figure 19 within the text was removed. 3.Please ensure that you refer to Figures 50, 61 and 72 in your text as, if accepted, production will need this reference to link the reader to the figure. Answer: I am so sorry. It is a mistake. The wrong numbers were named to these figures. I have corrected them in revised manuscript. 4.We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 4 in your text; if accepted, production will need this reference to link the reader to the Table. Answer: Table 4 was Sensitivity analysis. It is Table 5 now (see page 15, line 13), because a new table was added. 5.Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Answer: Thanks for your comment. I reviewed my reference list. I found reference 14 was same with reference 27, and reference 20 was same with reference 23. Thus, I removed the references 23 and 27. I removed some contents according to the comments of reviewer 2. Thus, the relevant references (references 30, 34 and 35) were removed either. The rest of references can be found in PubMed and Chinese electronic databases, like CNKI and Wan Fang. 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 Reviewer #2: Yes ________________________________________ 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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: No Reviewer #2: Yes Answer: Thanks for your comments. All data can be found in public repository without restriction in this manuscript. I will provide all PDF of included studies, if there is any need. ________________________________________ 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 Reviewer #2: Yes Reviewer #1: dear authors, this is an interesting work on new HER2-directed TKI relevant for the use in China, post-trastuzumab. While data on post-pertuzumab or other HER2 drugs approved in US are not available, the trials reported well fit with the local situation. Comparison with lapatinib is appropriate. The authors should emphasize that this is a combined analysis of randomized and non-randomized trials. They should report in the sensitivity analysis, the finding in randomized versus non randomized trials, to ensure consistency. Answer: It is a very important comment for us! I have re-performed my sensitity analysis after removing RCTs and non-RCTs (See page 15, lines 6-11). In addition, the table of sensitivity analysis was changed too (Table 5). Reviewer #2: The research idea is novel, and it is important to the field of oncology. I appreciate your efforts to do this SRMA. The language and structure of the manuscript are appropriate. I have some comments that I hope may improve your paper. Language: There are some writings that need improvement. For instance, the abbreviation AEs is used without writing what it is referring to. Answer: Thanks for your comment. I have corrected these mistakes (see page 3, line 17; page 9, line 1; page 10, line 7; page 11, lines 3, 16 and 29). Title: The title is clear and included all important elements, I would suggest adding that it is “after first-line treatment failure” Answer: Your suggestion is very important. I have added “after first-line treatment failure” in my title. I removed “A systematic review and meta-analysis”, because this title seems too long. Introduction: There are many statistical results mentioned in the introduction, I prefer to use them in the discussion and show fewer numbers in the introduction. Answer: I have deleted the statistical results mentioned in the introduction (see page 2, lines 18-23 and 29-32) and added them in my discussion (see page 20, lines 9-15, 17-19 and 33-38). Rationale: Valid and well described including existing knowledge and evidence Answer: Thank you for your comment. Objective: I would prefer to see a clear objective of why you would like to do SRMA. Since it is reported as different objective, efficacy and safety should be considered different objectives and that should be stated clearly in the introduction Answer: Thanks for your comment. I have reported my objective again in the introduction (see page 2, lines 36-38). Methods: I appreciate that you used Chinese search terms and did not limit the search to English only. Inclusion criteria: did you include only articles that studied the two medications as second-line after treatment failure? Answer: Yes, I did. I added this in my inclusion criteria (see page 3, lines 18-19). Statistical analysis and models used in the SRMA were well established and explained in the context. Please specify the outcomes to be assessed in the Methods section. In results, I found that you have defined primary and secondary outcomes, but that was not mentioned in the methods. Also, you did not mention that you will assess the adverse events which surprisingly appeared in the results too. I recommend that these outcomes and mentioned first in the methodology. Answer: Thank you, this comment is very helpful. I have added these outcomes in the methodology (see page 3, lines 16-17). Results: I would prefer to include the data in tables to make it easier for the reader. A table for the primary outcomes, a table for the secondary outcomes, and a table for the adverse events. Answer: Thanks for your comment. I have added a new table where findings from the meta-analysis are summarized (see page 13, line 9). Discussion: It is relevant and well written, however, there is a great focus on the safety outcomes, I suggest shortening this paragraph and working more on the primary outcomes. In addition, I recommend separating the conclusion for the discussion, adding a conclusion section where you summarise the findings and suggest future studies would be helpful for the reader. Answer: Thanks for your comment. I have shorten the content about safety (see page 21, lines 24-32) and worked more on the primary outcomes (see page 20, lines 33-38). In addition, I have separated the conclusion (see page 22, lines 1-3). Attachments Attachment Submitted filename: Response to Reviewers.doc https://doi.org/10.1371/journal.pone.0279775.r002
14 Dec 2022 Decision Letter - Nabil Elhadi Elsayed Ali Omar, Editor Pyrotinib versus lapatinib therapy for HER2 positive metastatic breast cancer patients after first-line treatment failure PONE-D-22-24109R1 Dear Dr. Ye Yuan 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, Nabil Elhadi Elsayed Ali Omar, PharmD.,BCOP.,PhD(C) Academic Editor PLOS ONE Additional Staff Editor Comments : "Please confirm that you have identified the study as a meta-analysis or systematic review in the title." Reviewers' comments: https://doi.org/10.1371/journal.pone.0279775.r003
Formally Accepted
20 Dec 2022 Acceptance Letter - Nabil Elhadi Elsayed Ali Omar, Editor PONE-D-22-24109R1 Pyrotinib versus lapatinib therapy for HER2 positive metastatic breast cancer patients after first-line treatment failure: a meta-analysis and systematic review Dear Dr. Yuan: 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. Nabil Elhadi Elsayed Ali Omar Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0279775.r004

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