TITLE: PET2015UZ: Prognostic value of pre-treatment 18FDG-PET in operable breast cancer
AUTHORS: Vincent  Vinh-Hung, Hendrik  Everaert, Mark  De Ridder

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block">This retrospective-observational study hypothesizes that preoperative 18FDG-PET for breast cancer has significant prognostic value for the prediction of survival. Data from patients who had breast surgery and had a preoperative FDG-PET examination at the UZ Brussel in 2002-2008 and in 2009-2015 will be analyzed without restriction on age or sex. Data collection for the cohort 2002-2008 has been finalized and will be shared on Mendeley (Reserved DOI: 10.17632/sfvtmrd8z9.1 ). Data for the cohort 2009-2015 will be collected by end of 2020.</div><br/><div class = "text-block">Detailed and referred to in:</div><br/><div class = "text-block"># Breast cancer preoperative 18FDG-PET, overall survival prognostic separation compared with the lymph node ratio.</div><div class = "text-block"># Vinh-Hung V, Everaert H, Gorobets O, Van Parijs H, Verfaillie G, Vanhoeij M, Storme G, Fontaine C, Lamote J, Perrin J, Farid K, Nguyen NP, Verschraegen C, De Ridder M.</div><div class = "text-block"># Breast Cancer. 2021 Jul;28(4):956-968. doi: 10.1007/s12282-021-01234-z</div><div class = "text-block"># PMID: 33689151</div><div class = "text-block"><a href="https://link.springer.com/article/10.1007%2Fs12282-021-01234-z" style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;">https://link.springer.com/article/10.1007%2Fs12282-021-01234-z</span></a></div><br/><div class = "text-block"># Is there a utility of [18F]FDG-PET before surgery in breast cancer? A 15-years overall survival analysis.</div><div class = "text-block"># Perrin, Farid K, Van Parijs H, Gorobets O, Vinh-Hung V, Nguyen NP, Djassemi N, De Ridder M, Everaert H.</div><div class = "text-block"># World J Clin Oncol. Pending.</div><br/><div class = "text-block">Study registration:</div><div class = "text-block"><a href="https://www.isrctn.com/ISRCTN17962845" style = "text-decoration:underline;color:blue;cursor:pointer;"><span style = ":;">https://www.isrctn.com/ISRCTN17962845</span></a></div><br/></div>

[STEPS]
?. [Review medical records]
Check inclusion criteria
?. [Review medical records]
Participating center
?. [Review medical records]
Period of diagnosis: 2002-2015
?. [Review medical records]
Primary breast cancer
?. [Review medical records]
Histologically confirmed
?. [Review medical records]
Operable - curative surgery
?. [Review medical records]
Pre-treatment FDG-PET or PET/CT
?. [Review medical records]
Check exclusion
?. [Review medical records]
Previous history of cancer
?. [Review medical records]
The breast tumor is a primary sarcoma
?. [Review medical records]
Surgery was done for palliation, for symptom control
?. [Review medical records]
No histopathological confirmation of cancer
?. [Review medical records]
Non-invasive carcinoma
?. [Review medical records]
Metastatic disease demonstrated by imaging modes other than FDG-PET
?. [Data collection]
Clinical-pathological characteristics
?. [Data collection]
Age at diagnosis
?. [Data collection]
Sex
?. [Data collection]
Disease presentation (screening or symptomatic)
?. [Data collection]
Laboratory markers
?. [Data collection]
Source material of initial pathology (cytological/biopsy/excision)
?. [Data collection]
FDG-PET characteristics
?. [Data collection]
Histological tumor type
?. [Data collection]
Pathological grade
?. [Data collection]
Hormone receptor status
?. [Data collection]
Her2/neu status
?. [Data collection]
Lymphovascular invasion
?. [Data collection]
Breast inflammation
?. [Data collection]
Breast skin invasion
?. [Data collection]
Tumor laterality
?. [Data collection]
Tumor location
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Clinical tumor size
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Pathological tumor size
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Number of examined axillary lymph nodes
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Number of involved axillary lymph nodes
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Neoadjuvant therapy
?. [Data collection]
Type of surgery
?. [Data collection]
Adjuvant chemotherapy
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Adjuvant hormone therapy
?. [Data collection]
Adjuvant radiation therapy
?. [Data collection]
Type of exam (PET only / PET-CT)
?. [Data collection]
Pattern of PET positivity (visual pathologically increased uptake):     breast,     axillary-supraclavicular region,     internal mammary nodes,     distant.
?. [Data collection]
Standard uptake value (SUV) based on regions of interests:    SUVmax global (whole body).    SUVmax within breast, right and left.    SUVmax axillary-supraclavicular region, right and left.    SUVmax internal mammary nodes.
?. [Data collection]
Outcomes
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Local (in-breast) recurrence
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Regional (axillary, supraclavicular, internal mammary nodes) recurrence
?. [Data collection]
New primary tumor (breast/non-breast)
?. [Data collection]
Censor status at last follow-up (alive/died)
?. [Data collection]
Disease status at last follow-up (NED, no evidence of disease/WD, with cancer)
?. [Data collection]
Cause of death
?. [Data analyses]
Statistics
?. [Data analyses]
Descriptive statistics.Clinical- pathological characteristics and patterns of PET uptake.
?. [Data analyses]
Relationships:between the characteristics and the patterns of PET uptake.
?. [Data analyses]
Disease-free survival (DFS): event defined as any local-regional or distant recurrence, new primary tumor, or death from any cause.
?. [Data analyses]
Overall survival (OS):event defined as death from any cause.
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Explorative analyses:Multivariate Cox regression analyses of DFS and OS. Evaluate the prognostic value of patterns of PET positivity using the Akaike information criterion (AIC) and using indexes of the proportion of variation explained by covariates.
?. [Data analyses]
Handling of missing data:If missing in