Five-year clinical outcomes of scanning carbon-ion radiotherapy for prostate cancer

Yosuke Takakusagi; Hiroaki Koge; Kio Kano; Satoshi Shima; Keisuke Tsuchida; Nobutaka Mizoguchi; Daisaku Yoshida; Tadashi Kamada; Hiroyuki Katoh

doi:10.1371/journal.pone.0290617

Peer Review History

Original SubmissionFebruary 1, 2023
21 Jun 2023 Decision Letter - Calogero Casà, Editor PONE-D-23-02959Five-year Clinical Outcomes of Scanning Carbon-ion Radiotherapy for Prostate CancerPLOS ONE Dear Dr. Takakusagi, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, 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 Aug 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). 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Please include your amended Competing Interests Statement within your cover letter. We will change the online submission form on your behalf. 7. 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 If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references.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 If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Additional Editor Comments: Dear Authors Thank you for submitting your manuscript to PLOS ONE. After careful evaluation, we believe that the manuscript has all the elements to meet, after minor revision, the publication criteria of PLOS ONE in a minimally modified form. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. We look forward to receiving your revised manuscript. Kind regards, Calogero Casà Academic Editor PLOS ONE [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 Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know 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: Yes 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: This study presents an interesting single-center institutional experience with carbon-ion radiotherapy for prostate cancer. As cancer treatment continues to evolve, this study is a noteworthy addition. I see that the authors previously published preliminary results in 2020 and I agree that long-term follow-up is necessary especially in terms of prostate cancer. I have few comments. The authors report that 62.1% of patients were in the high-risk category and were treated for prostate only between 2015-2017. 1- Now according to current standards of care and guidelines (NCCN), prophylactic nodal radiation is recommended for high-risk prostate cancer patients. It is suggested that the authors briefly discuss this issue/limitation in the discussion section, particularly in relation to carbon-ion therapy. 2- Additionally, the discussion section should briefly mention the overall current radiotherapy treatment approach for prostate cancer patients and that caution should be exercised when interpreting the data due to the high degree of heterogeneity between this treatment (carbon ion) and photon therapy (such as direct comparison of fractionation, dose constraints) in the current literature. Reviewer #2: I congratulate the authors on their project. Their data update confirms their previously published data (2020, Radiation Oncology) Carbon ion radiotherapy (CIRT) has been used to treat prostate cancer since 1995. To date, only 14 institutes have implemented CIRT worldwide. Notably, this study evaluates the use of CIRT using the spot scanning. Despite the limitations of the study highlighted by the authors (single center retrospectively study, only five years follow-up and small size of low-risk patients), the present study shows a good toxicity profile and a good efficacy of carbon ions for prostate cancer. For these reasons this work could be interesting for the scientific community and could be the starting for prospective trial in this setting. In Discussion section (lines 220-223) please specify that PSA bounce occurs also post-SBRT. Reference recommened: “Jiang NY, Dang AT, Yuan Y, Chu FI, Shabsovich D, King CR, Collins SP, Aghdam N, Suy S, Mantz CA, Miszczyk L, Napieralska A, Namysl-Kaletka A, Bagshaw H, Prionas N, Buyyounouski MK, Jackson WC, Spratt DE, Nickols NG, Steinberg ML, Kupelian PA, Kishan AU. Multi-Institutional Analysis of Prostate-Specific Antigen Kinetics After Stereotactic Body Radiation Therapy. Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):628-636. doi: 10.1016/j.ijrobp.2019.06.2539.” ****** 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: No ******** [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.0290617.r001
Revision 1
13 Jul 2023 Author Response Reviewer #1: We thank the reviewer for evaluating our manuscript. According to the suggestion, we revised the manuscript as follows. “1- Now according to current standards of care and guidelines (NCCN), prophylactic nodal radiation is recommended for high-risk prostate cancer patients. It is suggested that the authors briefly discuss this issue/limitation in the discussion section, particularly in relation to carbon-ion therapy.” Thank you for your precise comments. We had added the sentence in Materials and Methods section to explain that prophylactic pelvic irradiation was not performed as follows: “Prophylactic irradiation of the pelvic region was not performed as in previous studies [7-16].” (Lines 87 to 88) “2- Additionally, the discussion section should briefly mention the overall current radiotherapy treatment approach for prostate cancer patients and that caution should be exercised when interpreting the data due to the high degree of heterogeneity between this treatment (carbon ion) and photon therapy (such as direct comparison of fractionation, dose constraints) in the current literature.” Thank you for your precise comments. We had added the sentence in Discussion section to explain that it cannot be compared our study with previous studies using conventional X-rays as follows: “Fifth, RT is one of the definitive treatments for prostate cancer, however, the results of conventional RT with X-rays and CIRT in this study cannot be directly compared because of differences in dose fractionation and dose constraints.” (Lines 264 to 267) Reviewer #2: We thank the reviewer for evaluating our manuscript. According to the suggestion, we revised the manuscript as follows. “In Discussion section (lines 220-223) please specify that PSA bounce occurs also post-SBRT. Reference recommened: “Jiang NY, Dang AT, Yuan Y, Chu FI, Shabsovich D, King CR, Collins SP, Aghdam N, Suy S, Mantz CA, Miszczyk L, Napieralska A, Namysl-Kaletka A, Bagshaw H, Prionas N, Buyyounouski MK, Jackson WC, Spratt DE, Nickols NG, Steinberg ML, Kupelian PA, Kishan AU. Multi-Institutional Analysis of Prostate-Specific Antigen Kinetics After Stereotactic Body Radiation Therapy. Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):628-636. doi: 10.1016/j.ijrobp.2019.06.2539.”” Thank you for your precise comments. We had added the sentence in Discussion section to explain that PSA bounce was also observed after SBRT as follows: “PSA bounce has also been reported after stereotactic body radiotherapy for prostate cancer [21].” (Lines 224 to 225) And we have added the reference #21 as your recommendation in Lines 362 to 364 Attachments Attachment Submitted filename: Responce to Reviewers.docx https://doi.org/10.1371/journal.pone.0290617.r002
14 Aug 2023 Decision Letter - Calogero Casà, Editor Five-year Clinical Outcomes of Scanning Carbon-ion Radiotherapy for Prostate Cancer PONE-D-23-02959R1 Dear Dr. Takakusagi, 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. 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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: (No Response) Reviewer #2: 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 Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know Reviewer #2: 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 Reviewer #2: 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 Reviewer #2: 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: Thanks for adding clarifying statements. Still there is a room for improvement and limitations of carbon ion therapy in terms of pelvic nodal radiation can be briefly discussed. Reviewer #2: The manuscript is interesting and confirms that Carbon-ion radiotherapy is associated with favorable clinical outcomes in patients with prostate cancer even if a longer follow-up is needed to assess these data. It would be interesting to start a prospective trial for stronger evidence. The requested changes were made. Great work! ****** 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: No Reviewer #2: No ******** https://doi.org/10.1371/journal.pone.0290617.r003
Formally Accepted
28 Feb 2024 Acceptance Letter - Calogero Casà, Editor PONE-D-23-02959R1 PLOS ONE Dear Dr. Takakusagi, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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. Calogero Casà Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0290617.r004

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