Table 2.
Assessments of feasibility and performance by disease for a random sample of patients meeting inclusion/exclusion criteria
| mBC (Total N = 884) |
aMela (Total N = 152) |
SCLC (Total N = 359) |
mRCC (Total N = 323) |
aGEC (Total N = 370) |
|
|---|---|---|---|---|---|
| Evaluation cadence (months), median (95% CI) | |||||
| NCCN guideline recommended evaluation cadence for tumor type/stage corresponding to Flatiron Health datasetb | Baseline: cross-sectional imaging and bone scan | Baseline: cross-sectional and brain imaging | Baseline: cross-sectional and brain imaging | Baseline: cross-sectional imaging | Baseline: cross-sectional imaging and PET as clinically indicated |
| CT chest/abdomen/pelvis with contrast: baseline prior to new therapy and every 2–4 cycles (chemotherapy) or every 2–6 months (ET) | Treatment response assessment for active treatment other than complete surgical resection: clinical examination and/or imaging (cross-sectional ± brain) | Treatment response assessment during systemic therapy: CT chest/abdomen/pelvis with contrast after every 2–3 cycles of systemic therapy and at completion of therapy | Treatment response assessment: chest, abdominal, and pelvic CT or MRI imaging every 6–16 weeks as per physician discretion, patient clinical status, and therapeutic schedule. Imaging interval adjusted according to rate of disease change and sites of active disease | Treatment response assessment: as clinically indicated | |
| Bone scan: baseline prior to new therapy and every 4–6 cycles (chemotherapy) or every 4–6 months (ET) | Imaging during treatment (at clinically appropriate intervals) recommended for: | For patients with asymptomatic brain metastases receiving systemic therapy before brain RT: brain MRI (preferred) or CT with contrast every 2 cycles of systemic therapy and at completion of therapy | Consider MRI (preferred) or CT of head at baseline and as clinically indicated | ||
| PET/CT: As clinically indicated | Stage III (clinical satellite or in-transit) primary or local, satellite, and/or in-transit recurrence | Annual surveillance scans at physician discretion | |||
| Nodal recurrence in previously dissected nodal bed that is unresectable or incompletely resected | MRI of spine as clinically indicated | ||||
| Limited (resectable) distant metastatic disease | Bone scan as clinically indicated | ||||
| Disseminated (unresectable) distant metastatic disease | |||||
| 1st imagec | 2.0 (1.8, 2.1) | 1.4 (1.2, 1.8) | 1.1 (1.0, 1.3) | 1.6 (1.5, 1.9) | 1.4 (1.3, 1.5) |
| 2nd imagec | 4.7 (4.4, 5.0) | 3.2 (2.9, 4.0) | 3.0 (2.6, 3.3) | 3.8 (3.4, 4.4) | 3.3 (3.0, 3.6) |
| 3rd imagec | 7.3 (6.9, 8.0) | 5.2 (4.7, 6.8) | 4.6 (4.1, 5.1) | 6.2 (5.7, 7.0) | 5.4 (5.1, 5.8) |
| 1st note | 0.2 (0.2, 0.3) | 0.2 (0.2, 0.3) | 0.2 (0.2, 0.2) | 0.3 (0.2, 0.4) | 0.1 (0.1, 0.2) |
| 2nd note | 1.0 (0.9, 1.1) | 0.9 (0.9, 1.0) | 0.8 (0.7, 0.9) | 1.0 (0.9, 1.2) | 0.6 (0.5, 0.7) |
| 3rd note | 1.8 (1.6, 1.8) | 1.5 (1.4, 1.6) | 1.3 (1.2, 1.4) | 1.9 (1.7, 2.1) | 1.2 (1.0, 1.2) |
| Occurrence of rwP, % (95% CI) | |||||
| ≥ 1 rwP event | 72 (69, 75) | – | 58 (53, 64) | 60 (54, 65) | 55 (50, 60) |
| Patients with a 2L treatment start date | 630 | 152 | 129 | 167 | 147 |
| ≥ 1 rwP event in patients who started 2L treatment | 89 (87, 92) | 94 (89, 97) | 94 (88, 97) | 90 (85, 94) | 90 (85, 95) |
| Inter-abstractor agreement, % (95% CI) | |||||
| Patients abstracted in duplicate (i.e., reviewed by two independent abstractors) | n = 184 | n = 101 | n = 112 | n = 101 | n = 105 |
| Event agreementd | 92 (89, 96) | 97 (94, 100) | 92 (87, 97) | 88 (82, 94) | 95 (91, 99) |
| Date agreement, ne | 127 | 93 | 60 | 63 | 54 |
| Date, exact | 65 (57, 74) | 60 (50, 70) | 68 (57, 80) | 73 (62, 84) | 65 (52, 78) |
| Date, ± 15 days | 75 (67, 82) | 80 (71, 88) | 80 (70, 90) | 81 (71, 91) | 76 (65, 87) |
| Date, ± 30 days | 77 (70, 84) | 84 (76, 91) | 85 (76, 94) | 86 (77, 94) | 78 (67, 89) |
| Patients with rwP event | n = 640 | n = 89 | n = 210 | n = 193 | n = 202 |
| Downstream events, % (95% CI) | 72 (69, 75) | 56 (46, 66) | 59 (53, 65) | 64 (57, 71) | 68 (62, 74) |
1L first line, 2L second line, aGEC advanced gastric/esophageal cancer, aMel advanced melanoma, CT computed tomography, ET endocrine therapy, mBC metastatic breast cancer, mRCC metastatic renal cell carcinoma, MRI magnetic resonance imaging, NA not applicable, PET, positron emission tomography, RT radiation therapy, rwP real-world progression, SCLC small cell lung cancer
aAll patients with aMel were required to have at least two lines of therapy; as a result, the aMel analyses are indexed to the start of 2L
bNCCN recommendations reported in this table are for the following stages for each tumor type: mBC, “metastatic disease”; aMel, “stage IV or recurrence with distant metastatic disease”; SCLC, “extensive stage”; mRCC, “relapsed or stage IV and surgically unresectable disease”; aGEC, NA
cAn image is defined as EHR document titles that included mention of “radiology”
dEvent agreement was calculated on all patients abstracted in duplicate as the proportion of instances where both abstractors agreed on whether a rwP event did or did not occur, regardless of date documented for the event
eDate agreement was calculated on a subset of patients abstracted in duplicate for whom both abstractors agreed that at least one rwP event occurred