Surgical Cancer Treatment July 25, 2017

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

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

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.

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.).

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.

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

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

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

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

NAACCR Data Dictionary http://datadictionary.naaccr.org/?c=10 References FORDS https://www.facs.org/~/media/files/quality%20programs/cancer/ncdb/fords%202016.ashx NAACCR Data Dictionary http://datadictionary.naaccr.org/?c=10

Appendix

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

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

Treatment Types Surgery Radiation Therapy Chemotherapy Immunotherapy Targeted Therapy Hormone Therapy Active surveillance Palliative care https://www.cancer.gov/about-cancer/treatment/types

CDISC Breast Cancer Treatment Map https://www.cdisc.org/standards/therapeutic-areas/breast-cancer

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

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”