Reviewer ’s report  
 
Title: Validity of St Gallen risk categories in prognostication of breast cancer patients in 
Southern Sri Lanka  
 
Version: 1 Date: 22 Oct 2017  
 
Reviewer: Sanjeewa A Seneviratne  
 
Reviewer's report:  
 
This study ex plores an important area which has very limited data at present. To date this 
appears to be the most comprehensive study looking at breast cancer outcomes in Sri Lanka. 
However, there are many areas which need further attention before the manuscript would 
become suitable for publication.  
Overall the language of the article needs further attention and suggest proofreading for spelling 
and grammatical (e.g. introduction 1st sentence - commvonest) errors.  
 
Specific comments  
Abstract  
1. Authors have mentioned that there are no published data on treatment and survival of breast 
cancer in Sri Lanka. Please note that there have been some studies previously which have 
looked at these albeit with smaller samples and short follow ups. These needs referencing  
e.g: Wij esinghe H, et al. Prognostic indices predictive of short term survival in breast 
carcinoma in the Sri Lankan setting. Journal of Diagnostic Pathology. 2016;11(2).  
 
Background  
1. 1st para 2nd sentence - is the mortality rate for all cancers or only for brea st cancer  
2. 1st para 4th sentence - if 100% are females there can't be any males  
3. 1st para 5th sentence - are these survival rates for 5 years, 10 years  
4. 2nd para 2nd sentence - these are not local references, however to the reader it implies so  
5. Introduction last para - same as for the abstract, please consider previous literature  
 
Method  
1. What is retro -prospective - please be explicit  
2. Were patients included prospectively? Recruitment is not clear. Were they recruited at the 
time of diagno sis and followed up or were they recruited later on (retrospectively)  
Any idea which patients were not included, if any?  
Rate of metastatic breast cancer is only 1% which is much lower than reported national figure of 
5%. This may indicate that included sa mple is prone to selection bias  
3. How were the cause of death ascertained? This is especially applicable for non -hospital 
deaths. Was the cause given in the death certificate was taken as the cause of death. Were 
there any mismatches? How were the follow ups were done? What about the missing 
patients? Were they contacted to get follow up data?  
4. What definitions were used to diagnose local and metastatic recurrences? Were they clinical, 
imaging or histological?  
5. Statistical analysis - were the patients receiving neoadjuvant therapy excluded?  
 
Results  
1. 2nd para - please include endocrine therapy  
2. Please indicate the numbers of patients in each category in addition to the percentage  
3. Table 1 - indicate the missing data proportions as percentages with in brackets  
4. Radiotherapy has been given to 99% even when 99% had undergone mastectomy. Post 
mastectomy irradiation in general is recommended for node positive disease. This appears 
highly excessive especially when 133 patients had stage I disease  
5. Were there time related changes in the rates of trastuzumab usage?  
 
Discussion  
1. 1st para - Wide local excision and sentinel LN biopsy for management of breast cancer has 
been in practice in Sri Lanka for well over a decade now, although is not practiced in all 
units. 99% mastectomy + ALND is a regional phenomenon  
2. If adjuvant therapy had been decided based on St Gallens criteria 99% radiotherapy usage 
cannot be explained -  this is from the guideline - "In practical terms this was felt to justify 
post-mast ectomy radiation therapy for all patients with 4 or more involved lymph nodes, 
while the indication for such therapy with 1 -3 nodes was less clear and patients with node -
negative disease do not require post -mastectomy irradiation if not otherwise indicated  (e.g. 
T4). Modern radiation therapy techniques allow reduction of normal tissue damage to heart 
and lungs"  
3. 2nd para - there is no uniform recommendation to use Oncotype DX or Endopredict. These 
are used in selective situations where benefit from chemot herapy is doubtful - i.e-
intermediate risk cancers. Adjuvant online is obsolete and even the website is non functional 
at present. Even in many developed countries decisions are mostly based on the 
characteristics described in this article which are not 'h igh-flown'  
4. Authors have not compared the findings of this study e.g. distribution of hormone receptor 
status with previously published local data. This is important as these figures differ 
substantially from western data  
5. Low risk group include only 1 5 women and hence 5 year survival figures for this group are 
not valid  
6. There is no mention of any limitations of this study - following are some I feel should be 
included  
a. Coverage - selection bias  
b. Treatment bias - may not reflect the country, not in keeping with recommended guidelines 
e.g - 99% have received RT even when 99% have received a mastectomy. Post mastectomy 
radiation seems excessive, reasons  
c. Follow up - missing data, missing follow ups  
d. Causes of death - inaccuracies, especially in local setup where there is no proper cause of 
death identification process for out of hospital deaths  
e. High proportions of missing data for some of the variables  
f. Follow up duration and numbers of wome n in some categories are inadequate to draw the 
conclusions mentioned  
7. Graphs - need further improvement, remove duplicate graphs, reduce the duration to make 
the differences clearer  
 
 
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.  
 
Yes 
 
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 y ou recommend an  
additional statistical 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 of language in the manuscript:  
 
Needs some language corrections 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 tha t 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 com peting 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.  
 
I declare that I have no competing interests  
 
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