1. Surgical Cancer Treatment
July 25, 2017

2. Outline Analytical questions Sources
Treatment episodes (eras)
Formal connection between diagnosis and treatment
Response to treatment
Sources
Critical dimensions and attributes
Representation in OMOP CDM
Is granularity of the respective domain/vocabulary sufficient to represent all treatment attributes and dimensions
Mapping

3. Sources EMR, Billing Procedures Cancer Registry Clinical Trials
Billing focused
Provides all treatment information
No identification of a primary procedure
Few treatment dimensions for analysis
Time lag depends on a billing cycle (45 days)
Cancer Registry
Epidemiology/treatment focused
Provides selected treatment information: only reportable cancer types, mostly first treatment course at best and sometimes following
Clear identification of a primary procedure
Multiple treatment dimensions for analysis
Time lag 6 months
Clinical Trials
EMR, Medical History

4. Dimensions Temporal: In relation to other treatment modalities Purpose
first treatment course vs. others
initial/primary surgery and re-surgeries
In relation to other treatment modalities
Radiation (before, after, together
systemic
endocrine/transplant
Purpose
treatment: resection vs. delivery of other treatment type (e.g. radiation)
diagnostic
non-cancer
palliative procedures
Treatment site: primary, metastatic sites, lymph node biopsy or removal.

5. Surgical method: Robotic, Laparoscopic, Open
Dimensions
Surgical method: Robotic, Laparoscopic, Open
State of surgical margins after the surgery
Why surgery (or any other treatment) was not performed)
Data QA and more. Example: Surgery of the primary site was not recommended/performed because it was contraindicated due to patient risk factors (comorbid conditions, advanced age, etc.).

6. Primary Procedure Types
10-19 Site-specific codes. Tumor destruction; no pathologic specimen produced.
20-80 Site-specific codes. Resection. Path specimen produced.
90 Surgery, NOS; surgical treatment of the primary site was done, but no information on the type of procedure is provided.
98 Site specific codes; special.

7. Lymph Node Procedure Types
1 Biopsy or aspiration of regional lymph node, NOS 2 Sentinel lymph node biopsy 3 Number of regional lymph nodes removed unknown, not stated; regional lymph nodes removed, NOS 4 1 to 3 regional lymph nodes removed 5 4 or more regional lymph nodes removed 6 Sentinel node biopsy and code 3, 4, or 5 at same time or timing not noted 7 Sentinel node biopsy and code 3, 4, or 5 at different times

8. Non-Primary Procedure Types
1 Non-primary surgical procedure performed 2 Non-primary surgical procedure to other regional sites 3 Non-primary surgical procedure to distant lymph node(s) 4 Non-primary surgical procedure to distant site 5 Any combination of codes 2, 3, or 4

9. State of Margins after Surgery
0 No residual tumor
1 Residual tumor, NOS
2 Microscopic residual tumor
3 Macroscopic residual tumor
7 Margins not evaluable
8 No primary site surgery
9 Unknown or not applicable

10. In Relation to Systemic Treatment
0 No systemic therapy and/or surgical procedures; unknown if surgery and/or systemic therapy given 2 Systemic therapy before surgery 3 Systemic therapy after surgery 4 Systemic therapy both before and after surgery 5 Intraoperative systemic therapy 6 Intraoperative systemic therapy with other therapy administered before and/or after surgery 7 Surgery both before and after systemic therapy 9 Sequence unknown, but both surgery and systemic therapy given

11. NAACCR Data Dictionary http://datadictionary.naaccr.org/?c=10
References
FORDS
NAACCR Data Dictionary

12. Appendix

13. In Relation to Radiation
No radiation and/or no surgery; unknown if surgery and/or radiation given
2 Radiation before surgery
3 Radiation after surgery
4 Radiation both before and after surgery
5 Intraoperative radiation
6 Intraoperative radiation with other radiation given before and/or after surgery
7 Surgery both before and after radiation
9 Sequence unknown, but both surgery and radiation were given

14. Treatment Categories Intent Curative Palliative Settings
Neoadjuvant (curative)
Administered prior to surgery
Adjuvant (curative)
Administered after surgery
Advanced/metastatic (palliative)
When surgery is not recommended

15. Treatment Types Surgery Radiation Therapy Chemotherapy Immunotherapy
Targeted Therapy
Hormone Therapy
Active surveillance
Palliative care

16. CDISC Breast Cancer Treatment Map

17. Representation in OMOP CDM
Representation in OMOP CDM (target)
Vocabulary and domain for each treatment modality
Is granularity of the respective domain sufficient to represent all treatment attributes (e.g. radiation dose and frequency)
Representation of treatment episodes (eras)
Single modality regimens
Multiple modality regimens
Regimen/treatment number
Formal connection between diagnosis and treatment
Response to treatment
Identification in the source and mapping

18. Representation in OMOP CDM
Issues
Insufficient granularity of procedure domain
Identification and representation of treatment episodes/regimens
No mechanism to identify treatment episodes/regimens based on disjoint medication and procedure records in the source
Presently, no structures to represent “treatment eras”