16.1 Treatment Types, First Course of Treatment & Evidence-Based Guidelines (NCCN)
Key Takeaways
First course of treatment includes all therapies in the documented treatment plan that are given before disease progression or recurrence; with no plan, protocol or guideline, STORE uses "initial treatment must begin within four months of the date of initial diagnosis."
Active surveillance is coded Rx Summ–Treatment Status [1285] 2, and treatment given after a period of active surveillance is subsequent treatment, not first course.
SEER*Rx decides whether a drug is chemotherapy, hormone therapy or immunotherapy; replacing a chemotherapy agent with one from a different subcategory starts subsequent therapy, but switching hormone agents (for example, tamoxifen to anastrozole) stays first course.
Prednisone is hormone therapy only when given with chemotherapy for cancer, thyroid hormone given to suppress TSH is hormone therapy (01), and hormone replacement given only to restore normal function is not coded.
NCCN guideline recommendations are graded as Category 1, 2A, 2B or 3; CoC Standard 7.2 requires an annual physician review of concordance with evidence-based guidelines (up to 100 cases of one site).
First course of treatment (STORE)
- Definition: all methods of treatment recorded in the treatment plan and administered before disease progression or recurrence.
- Treatment plan sources: physician notes, consultations, clinic and outpatient records, and discharge plans. An established protocol or accepted management guideline can serve as the plan if there is no other written documentation.
- No plan at all, and no physician advisor available: use the principle "initial treatment must begin within four months of the date of initial diagnosis."
- Plan changes after improvement: if palliative chemotherapy shrinks a tumor and a resection is then added, without progression, the resection is still first course.
- Leukemia: all remission-inducing and remission-maintaining therapy is first course. Treatment after a relapse is subsequent.
- Maintenance therapy that is part of the first-course plan is first course and makes the case analytic at the facility that gives it (Section 11.2).
No treatment, surveillance and refusal
- Rx Summ–Treatment Status [1285]: 0 = no treatment, 1 = treatment given, 2 = active surveillance, 9 = unknown.
- Treatment given after a period of active surveillance is subsequent treatment.
- "No therapy" is a first-course option when the patient or family refuses, the patient dies before treatment, the physician recommends no treatment, or only palliative pain management is recommended.
- If the patient refuses all treatment, code "refused" (7 or 87) in every modality.
- Date of First Course of Treatment [1270] is the earliest treatment date. If no treatment was given, it is the date of the decision not to treat, the date of refusal, or the date of death before treatment. For active surveillance, it is the date of that decision.
Treatment modalities and STORE items
| Modality | Main STORE items | Examples |
|---|---|---|
| Surgery | Rx Summ–Surg 2023 [1291], Scope of Regional LN Surgery [1292], Surgical Procedure/Other Site [1294], Margins [1320], Reason for No Surgery [1340] | Lumpectomy, colectomy, lobectomy, prostatectomy |
| Radiation | Phase I–III items (1501–1527), Number of Phases [1532], Radiation/Surgery Sequence [1380], Reason for No Radiation [1430] | External beam, brachytherapy, radioisotopes |
| Chemotherapy | Chemotherapy [1390] | Single-agent or multiagent cytotoxic drugs; many targeted agents per SEER*Rx |
| Hormone therapy | Hormone Therapy [1400] | Tamoxifen, aromatase inhibitors, androgen deprivation |
| Immunotherapy | Immunotherapy [1410] | Immune checkpoint inhibitors, interferon, BCG for bladder cancer |
| Transplant and endocrine | Hematologic Transplant and Endocrine Procedures [3250] | Autologous or allogeneic stem cell transplant; orchiectomy for hormone control |
| Other | Other Treatment [1420] | Therapies that fit no other item; phlebotomy for polycythemia vera |
| Palliative | Palliative Care [3270] | Recorded in addition to the modality item when intent is symptom relief |
Classifying systemic agents
- SEER*Rx Interactive Drug Database is the reference for whether an agent is chemotherapy, hormone therapy or immunotherapy (BRM), and for ancillary drugs that are not coded, such as antiemetics.
- Chemotherapy regimen changes: chemotherapy agents are grouped into subcategories (alkylating agents, antimetabolites, natural products, and miscellaneous). If an agent is replaced by one from a different subcategory, the new regimen is subsequent therapy. This rule does not apply to hormone therapy: STORE's example is a change from tamoxifen to anastrozole (Arimidex), which is still first course.
- Prednisone is coded as hormone therapy only when given in combination with chemotherapy for cancer (for example, in lymphoma or myeloma regimens). It is not coded when given for other reasons, such as nausea or inflammation.
- Thyroid replacement that suppresses TSH is coded as hormone therapy 01. Hormone replacement given only to restore normal body function after tumor or treatment destroyed a gland is not coded.
- Chemoembolization is chemotherapy (01, 02 or 03 by the number of agents). Alcohol embolization is Other Treatment. Presurgical embolization of hypervascular tumors is not coded.
Typical first-course patterns (recognition, not coding rules)
| Cancer | Common first-course approaches |
|---|---|
| Breast | Breast-conserving surgery plus radiation, or mastectomy; sentinel node biopsy or axillary dissection; endocrine therapy for ER/PR-positive; HER2-targeted therapy for HER2-positive; chemotherapy by stage and biology; neoadjuvant systemic therapy for larger or HER2-positive or triple-negative tumors |
| Colon | Colectomy with regional lymphadenectomy; adjuvant chemotherapy for stage III (node-positive) disease |
| Rectum | Neoadjuvant chemoradiation or total neoadjuvant therapy, then total mesorectal excision, for locally advanced disease |
| Lung (NSCLC) | Lobectomy or stereotactic body radiation for early disease; concurrent chemoradiation, often followed by immunotherapy, for unresectable stage III; biomarker-driven targeted therapy or immunotherapy for stage IV |
| Prostate | Active surveillance for low-risk disease; radical prostatectomy or radiation (with or without androgen deprivation) |
| Leukemia and lymphoma | Induction, consolidation and maintenance chemotherapy; chemoimmunotherapy for lymphoma; tyrosine kinase inhibitors for CML; stem cell transplant for selected patients |
| Myeloma | Multiagent induction, often followed by autologous stem cell transplant (3250 = 11) and maintenance |
Evidence-based guidelines and the registry
NCCN Clinical Practice Guidelines
The National Comprehensive Cancer Network publishes site-specific guidelines that CoC lists among applicable guidelines. The recommendations are graded:
- Category 1: high-level evidence and uniform NCCN consensus.
- Category 2A: lower-level evidence and uniform consensus. This is the default category.
- Category 2B: lower-level evidence and NCCN consensus.
- Category 3: major NCCN disagreement.
ASCO, ASTRO and other societies also publish guidelines.
CoC quality standards that use treatment data
- Standard 7.1 (Quality Measures): the cancer committee monitors the program's Estimated Performance Rates on quality measures selected by CoC, using NCDB reporting tools, and writes an action plan when a rate falls below the expected EPR. Measure specifications are on the NCDB website. Examples include colon resections with at least 12 regional nodes examined, and radiation after breast-conserving surgery for eligible women.
- Standard 7.2 (Monitoring Concordance with Evidence-Based Guidelines): each year, a physician performs an in-depth retrospective review of either all cases of one site or stage (up to 100) or a defined concern. The review checks whether the diagnostic evaluation and first course of treatment follow national guidelines, and the results go to the cancer committee in the same calendar year. Tumor board discussions do not meet this standard.
Registrar responsibilities
- Record what was actually given, when, and where, even if it differs from a guideline.
- Record why recommended treatment was not given (codes 82, 85, 86 and 87), and follow 88 ("recommended, unknown if given") to completion.
- Keep treatment text detailed enough for guideline and quality studies.
A breast cancer patient starts tamoxifen as planned adjuvant therapy, and eight months later her oncologist switches her to anastrozole because of side effects. There is no recurrence. How is the change handled?
Both are first-course hormone therapy; STORE's regimen-change rule for different subcategories does not apply to hormone therapy
Anastrozole is subsequent treatment because it belongs to a different drug class
Only anastrozole is coded because it was the final agent
The switch is recorded in Other Treatment [1420]
A patient with low-risk prostate cancer chooses active surveillance at diagnosis. Fourteen months later, a rising PSA leads to radical prostatectomy. How is first-course treatment recorded?
Radical prostatectomy as first-course surgery, because it was the first definitive treatment
Rx Summ–Treatment Status 2 (active surveillance), with the prostatectomy considered subsequent treatment
Treatment Status 1, because treatment was eventually given
Treatment Status 0, because the patient refused initial treatment
Under CoC Standard 7.2, which activity meets the requirement?
Presenting 15% of the analytic caseload at multidisciplinary cancer conferences
Monitoring the NCDB Estimated Performance Rates for selected quality measures
A physician's annual in-depth review of up to 100 cases of one cancer site, checking whether the diagnostic evaluation and first course of treatment follow national guidelines
A registrar's quality control review of 10% of abstracts
Sections you finish are checked off in the contents.