Diagnostic and therapeutic path of breast cancer: effectiveness, appropriateness, and costs – results from the DOCMa study

Figures & data

Table 1 Baseline characteristics of the 143 enrolled subjects

Age, years
Mean ± SD (range)	47.5±13.6 (16–86)
16–29, n (%)	10 (7%)
30–39, n (%)	29 (20%)
40–49, n (%)	39 (27%)
50–59, n (%)	37 (26%)
≥60, n (%)	28 (20%)
Education
University degree, n (%)	28 (19.6%)
High school, n (%)	71 (49.6%)
Intermediate school, n (%)	15 (10.6%)
Primary school, n (%)	6 (4.2%)
Not reported, n (%)	23 (16.0%)
Motivation for accessing Sant’Andrea
Request for checkup, n (%)	97 (70%)
Pain, n (%)	9 (6%)
Self-inspection leading to suspect, n (%)	5 (3%)
Reevaluation after previous US, n (%)	10 (7%)
Suspect lesion detected by previous exam, n (%)	7 (5%)
US after MRx, n (%)	9 (6%)
Other, n (%)	2 (1%)
Missing, n (%)	4 (2%)

Abbreviations: SD, standard deviation; US, ultrasound; MRx, X-ray mammography.

Table 2 Number of examinations (medicals, US, MRx, FNAC) undergone by the patients in the 2-year period before enrollment in the study

Number of examinations	Number of subjects	% of total patients (n=143)
0	6	4%
1	16	11%
2	24	17%
3	27	19%
4	41	29%
5	21	14%
6	7	5%
7	1	1%

Abbreviations: US, ultrasound; MRx, X-ray mammography; FNAC, fine-needle aspiration cytology.

Table 3 Outcomes of examinations performed before and after the enrollment

	Examination	Negative outcome	Nodule suspect for malignancy	Undetermined nodule	Malignant lesion	Total
Previous examinations (2005–2006)*	First medical	38 (64.4%)	14 (23.7%)	7 (11.9%)	0	59
	Second medical	8 (66.6%)	1 (8.4%)	3 (25%)	0	12
	First MRx	95 (83.3%)	4 (3.5%)	13 (11.4%)	2 (1.8%)	114
	Second MRx	50 (77%)	3 (4.6%)	12 (18.4%)	0	65
	First US	118 (84.9%)	4 (2.9%)	15 (10.8%)	2 (1.4%)	139
	Second US	54 (75%)	3 (4.2%)	14 (19.4%)	1 (1.4%)	72
	FNAC	30 (66.6%)	5 (11.2%)	3 (6.6%)	7 (15.6%)	45
	VB	3 (50%)	0	1 (16.6%)	2 (33.4%)	6
	CB	1 (16.6%)	1 (16.6%)	0	4 (66.8%)	6
	MRI	5 (83.4%)	0	1 (16.6%)	0	6
	Postsurgery histology	11 (44%)	0	0	14 (56%)	25*
Examinations postenrollment	US	117 (82.4%)	25 (17.6%)	0	0	142
	FNAC	24 (68.6%)	2 (5.7%)	0	9# (25.7%)	35‡
	Biopsy	15 (75%)	1 (5%)	0	4 (20%)	20
	Final histology after surgery	2 (22.2%)	2 (DCIS) (22.2%)	0	5 (55.6%)	9

Notes:

* Number of patients with surgical interventions in 2005–2007 before the start of the study (none of these patients underwent surgery at Sant’Andrea after entering the study);

# two patients presented two malignancies, each confirmed by FNAC procedures;

‡ one patient underwent five FNAC procedures, while six patients underwent two FNAC procedures. In addition to the 35 FNAC procedures reported in the table, four cytologic examinations were performed on lymph nodes showing the following outcomes: two positive, one negative, and one suspect for malignancy. On the 143 patients enrolled in the study, a total of 35 FNAC procedures were performed, revealing nine malignant nodules (two patients presented double malignancies). Final postsurgery histology confirmed malignancies in seven patients.

Abbreviations: US, ultrasound; MRx, X-ray mammography; FNAC, fine-needle aspiration cytology; VB, vacuum biopsy; CB, core biopsy; MRI, magnetic resonance imaging.

Table 4 Final diagnostic results for all the patients enrolled in the study at Sant’Andrea from May to June 2007, by age-group (years)*

Final diagnostic result	16–29 (n=10)	30–39 (n=29)	40–49 (n=39)	50–59 (n=37)	≥60 (n=28)	Subtotal (n=143)
Missing data	0	0	1 (20%)	1 (20%)	3 (60%)	5
No nodules	4 (10%)	9 (22.5%)	9 (22.5%)	10 (25%)	8 (20%)	40
Benign lesion	6 (6.8%)	19 (21.3%)	28 (31.5%)	22 (24.7%)	14 (15.7%)	89
Uncertain	0	1 (50%)	0	1 (50%)	0	2
Malignancy	0	0	1 (14.3%)	3 (42.8%)	3 (42.8%)	7§
Total	10 (7.0%)	29 (20.3%)	39 (27.3%)	37 (25.8%)	28 (19.6%)	143

Notes:

* This table does not report the postsurgery final histology results, but the outcome of the presurgery diagnostic path;

§ one patient refused surgery.

Table 5 Type of examinations and related global cost (€) in either a private or public setting, per age-group (<50 years old, ie, before screening age, and ≥50 years old)

Exam type	Age <50	Age ≥50	Total exams	Costs <50, range (€)	Costs ≥50, range (€)	Total costs, range (€)
Private
Medical exam	18	16	34	810–5,400	720–4,800	1,530–10,200
MRx	30	36	66	1,350–6,000	1,620–7,200	2,970–13,200
US+	31	33	64	1,860–6,200	1,980–6,600	3,840–12,800
FNAC	1	2	3	Not available	Not available	Not available
Public
Medical exam	21	16	37	1,722–2,163	1,312–1,648	3,034–3,811
MRx	42	71	113	5,838–7,308	9,869–12,354	15,707–19,662
US+	154	162	316	22,022–27,566	23,166–28,998	45,188–56,564
FNAC	28	53	81	3,892–4,844	7,367–9,169	11,259–14,013
FNAC sampling	28	53	81	3,780–4,732	7,155–8,957	10,935–13,689
Biopsy‡	17	12	29	2,363–2,076	1,668–2,076	4,031–5,017
Biopsy sampling	17	12	29	3,162–3,944	2,232–2,784	5,394–6,728
MRI	4	2	6	480–784	240–374	720–1,122
Subtotal	391	468	859	47,279–71,017	57,329–84,960	104,608–156,806

Notes:

+ The 54 contralateral US exams carried out in the same patients during the same visit were considered to represent a single US exam in terms of costs generated for the health care system;

‡ core biopsies were in the range reported in the table, but vacuum biopsies with the Mammotome may have resulted in higher costs (not shown in the table).

Abbreviations: US, ultrasound; MRx, X-ray mammography; FNAC, fine-needle aspiration cytology; MRI, magnetic resonance imaging.

Table 6 Operative efficiency indicators and fair economic values of diagnostic paths followed by patients aged ≥50 or <50 years presenting malignant or benign breast lesions at postsurgery histology

	Final diagnosis	Age (years)	Patients undergoing breast surgery	Total number of exams performed	Total costs	Average number of exams performed before surgery	Average costs sustained by the operated patient for diagnostic exams	Operative efficiency	Fair economic value
Other medical facilities	Malignant	<50	3	18	€514.22	6.0	€171.41	−0.50	1.26
		≥50	11	57	€2,676.74	5.2	€243.34	−0.30	1.79
	Benign	<50	5	30	€1,143.47	6.0	€228.69	−0.50	1.68
		≥50	6	29	€714.92	4.8	€119.15	−0.21	0.87
Sant’ Andrea Hospital	Malignant	<50	1	4	€124.50	4.0	€124.50	0.00	0.91
		≥50	6	17	€501.34	2.8	€83.56	0.29	0.61
	Benign	<50	1	3	€89.78	3.0	€89.78	0.25	0.66
		≥50	1	1	€21.17	1.0	€21.17	0.75	0.16

Notes: Green indicates favorable outcomes; red indicates unfavorable outcomes.