Table 3.

Discrepancy of tumor recurrence data

Patient	Indications in the databases		Blinded MD review
	Trial	CR	Clinical Dx	Method of Dxa	Notes
COST trial
1	Rec	Rec-free	New primary	CT, biopsy	Squamous cell CA of lung
2	Rec	Rec-free	New primary	Operative pathology	Metastatic breast CA; NED (colon CA)
3	Rec	Rec-free	New primary	Operative pathology	Adeno CA, transverse colon, T1N0
4	Rec	Rec-free	Rec	Operative pathology	Liver and lung metastatic disease, both resected (10/1999)b
Z0030 trial
1	Rec	Rec-free	Rec	Bronchoscopy, biopsy	Local, previous resection margin
2	Rec	Rec-free	Rec	Operative pathology	Distant, right cerebellum
3	Rec	Rec-free	Rec	PET positive	Local/regional metastases to mediastinal nodes
4	Rec	Rec-free	Rec	Biopsy	Local, surgical scar
5	Rec	Rec-free	Rec	Bronchoscopy, biopsy	Metastatic in lung
6	Rec	Rec-free	Rec	Biopsy	Metastatic in lung/pleura
7	Rec-free	Rec	Rec	CT, biopsy	Local, previous resection margin
8	Rec	Rec-free	NED	CT	Clinician and radiologist per re-review of CT
9	Rec	Rec-free	New primary	Bronchoscopy, brushing	Opposite lung
10	Rec	Rec-free	Rec vs new primary	Treated with radiation	Too advanced to differentiate
11	Rec	Rec-free	Rec vs new primary	Treated with radiation	Too advanced to differentiate

Rec, recurrence; CA, carcinoma; NED, no evidence of disease; CT, computer tomography; and PET, positron emission tomography.

^aAll cases with discrepancies had radiographic imaging and a clinical impression by the treating MD. For all except two cases, the clinical impression was followed by additional confirmatory biopsies and histology or by treatment.

^bClinical Dx, NED with Level 2 clinical impression based on 06/02/2008 medial record notes.