Reviewer ’s report  
 
Title: Evaluation of dose -efficacy of sorafenib and effect of transarterial chemoembolization in  
hepatocellular carcinoma patients: A retrospective study  
 
 
Version: 0 Date: 13 Feb 2016  
 
 
Reviewer: Mohamed  Bouattour   
 
 
Reviewer's report:  
 
In this paper, Hsiao et al. reported the results of different doses of sorafenib in patients with HCC 
and the effect of TACE.  
 
The issue proposed by the authors is interesting. However, this study suf fers from some 
methodological shortcoming and the design should be clearly exposed.  
 
 Following some comments  
 
 
Background:  
 
The association of sorafenib and TACE was not currently approved and the authors should 
clearly justify the choice of this approach.  T he aim of the study was not clearly exposed.  
 
 
Methods:  
 
The design of the study was not clear. Is it a retrospective or prospective study? Is there any 
randomization and how performed? Did patients sign consent? The study flow chart should be 
exposed more cl early….The duration of the study (from …to….) should be described, the 
population should be more clearly defined….. The period of follow -up? All this information 
about the study design are absent or lacking precise description…  
 
In the group I, the sorafeni b was continued despite sides effects, however there are 
recommendations to modify treatment dosing in cases of severe side effects… How the authors 
explain the maintain if treatment..  
 
The authors should give information according what the soarfenib doses were modified and how 
they manages theses side effects.  
The authors used only RECIST to assess response; however, with sorafenib, a very response rate 
is observed… The authors should use other criteria to assess the response (mRecist, EASL or 
Choi criteria ..) 
 
 
Results  
 
The authors should give the details results of safety: in one patients there is different side effects 
with different grade. They should give a table with all side effects rate and according to grade…  
 
The tolerability of TACE was not described..  
 
The authors should expose their results more clearly  
 
The discussion needs to be improved  
 
The conclusion: did not sound clearly with the authors findings  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in  your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional st atistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality o f language in the manuscript:  
 
Needs some language corr ections before being published  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from  
an organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I  declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
reimbursements and occasional fees from Bayer Pharma  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my rep ort to the authors and, if the manuscript is accepted for publication, my named report  
including any attachments I upload will be posted on the website along with the authors'  
responses. I agree for my report to be made available under an Open Access Creat ive Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I agree to t he open peer review policy of the journal  
Reviewer ’s report  
 
Title: Evaluation of dose -efficacy of sorafenib and effect of transarterial chemoembolization in  
hepatocellular carcinoma patients: A retrospective study  
 
 
Version: 0 Date: 13 Feb 2016  
 
 
Reviewer: Mohamed  Bouattour   
 
 
Reviewer's report:  
 
In this paper, Hsiao et al. reported the results of different doses of sorafenib in patients with HCC 
and the effect of TACE.  
 
The issue proposed by the authors is interesting. However, this study suf fers from some 
methodological shortcoming and the design should be clearly exposed.  
 
 Following some comments  
 
 
Background:  
 
The association of sorafenib and TACE was not currently approved and the authors should 
clearly justify the choice of this approach.  T he aim of the study was not clearly exposed.  
 
 
Methods:  
 
The design of the study was not clear. Is it a retrospective or prospective study? Is there any 
randomization and how performed? Did patients sign consent? The study flow chart should be 
exposed more cl early….The duration of the study (from …to….) should be described, the 
population should be more clearly defined….. The period of follow -up? All this information 
about the study design are absent or lacking precise description…  
 
In the group I, the sorafeni b was continued despite sides effects, however there are 
recommendations to modify treatment dosing in cases of severe side effects… How the authors 
explain the maintain if treatment..  
 
The authors should give information according what the soarfenib doses were modified and how 
they manages theses side effects.  
The authors used only RECIST to assess response; however, with sorafenib, a very response rate 
is observed… The authors should use other criteria to assess the response (mRecist, EASL or 
Choi criteria ..) 
 
 
Results  
 
The authors should give the details results of safety: in one patients there is different side effects 
with different grade. They should give a table with all side effects rate and according to grade…  
 
The tolerability of TACE was not described..  
 
The authors should expose their results more clearly  
 
The discussion needs to be improved  
 
The conclusion: did not sound clearly with the authors findings  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in  your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional st atistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality o f language in the manuscript:  
 
Needs some language corr ections before being published  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from  
an organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I  declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
reimbursements and occasional fees from Bayer Pharma  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my rep ort to the authors and, if the manuscript is accepted for publication, my named report  
including any attachments I upload will be posted on the website along with the authors'  
responses. I agree for my report to be made available under an Open Access Creat ive Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I agree to t he open peer review policy of the journal  
Please review this paper.
user
Reviewer ’s report  
 
Title: Evaluation of dose -efficacy of sorafenib and effect of transarterial chemoembolization in  
hepatocellular carcinoma patients: A retrospective study  
 
 
Version: 0 Date: 13 Feb 2016  
 
 
Reviewer: Mohamed  Bouattour   
 
 
Reviewer's report:  
 
In this paper, Hsiao et al. reported the results of different doses of sorafenib in patients with HCC 
and the effect of TACE.  
 
The issue proposed by the authors is interesting. However, this study suf fers from some 
methodological shortcoming and the design should be clearly exposed.  
 
 Following some comments  
 
 
Background:  
 
The association of sorafenib and TACE was not currently approved and the authors should 
clearly justify the choice of this approach.  T he aim of the study was not clearly exposed.  
 
 
Methods:  
 
The design of the study was not clear. Is it a retrospective or prospective study? Is there any 
randomization and how performed? Did patients sign consent? The study flow chart should be 
exposed more cl early….The duration of the study (from …to….) should be described, the 
population should be more clearly defined….. The period of follow -up? All this information 
about the study design are absent or lacking precise description…  
 
In the group I, the sorafeni b was continued despite sides effects, however there are 
recommendations to modify treatment dosing in cases of severe side effects… How the authors 
explain the maintain if treatment..  
 
The authors should give information according what the soarfenib doses were modified and how 
they manages theses side effects.  
The authors used only RECIST to assess response; however, with sorafenib, a very response rate 
is observed… The authors should use other criteria to assess the response (mRecist, EASL or 
Choi criteria ..) 
 
 
Results  
 
The authors should give the details results of safety: in one patients there is different side effects 
with different grade. They should give a table with all side effects rate and according to grade…  
 
The tolerability of TACE was not described..  
 
The authors should expose their results more clearly  
 
The discussion needs to be improved  
 
The conclusion: did not sound clearly with the authors findings  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in  your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional st atistical review?  
If an additional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality o f language in the manuscript:  
 
Needs some language corr ections before being published  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from  
an organisation that may in any way gain or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I  declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
reimbursements and occasional fees from Bayer Pharma  
 
I agree to the open peer review policy of the journal. I understand that my name will be included  
on my rep ort to the authors and, if the manuscript is accepted for publication, my named report  
including any attachments I upload will be posted on the website along with the authors'  
responses. I agree for my report to be made available under an Open Access Creat ive Commons  
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments  
which I do not wish to be included in my named report can be included as confidential comments  
to the editors, which will not be published.  
 
I agree to t he open peer review policy of the journal  
assistant