Long-term survival and outcome of patients originally given Mycobacterium vaccae for metastatic malignant melanoma

Figures & data

Table 1. Clinic-pathologic characteristics of patients.

		Patients (n = 72)
Sex	Female Male	37 (51.4%) 35 (48.6%)
Age (years)	Median (range) ≤ 52 > 52	52 (23–80) 39 (54.2%) 33 (45.8%)
Primary melanoma site	Head Limb Trunk Unknown	10 (13.9%) 40 (55.6%) 17 (23.6%) 5 (6.9%)
Metastases timing	Synchronous Metachronous	9 (12.5%) 63 (87.5%)
M-stage at study entry (TNM VII. ed)	1a 1b 1c	25 (34.7%) 6 (8.3%) 41 (56.9%)
Number of metastases	≤ 2 > 2	18 (25%) 54 (75%)
Serum LDH	Normal High NA	27 (37.5%) 21 (29.2%) 24 (33.3%)
Neutrophiles/Lymphocites ratio	≤ 5 > 5 NA	45 (62.5%) 7 (9.7%) 20 (27.8%)
Combined medical therapy	No Yes	17 (23.6%) 55 (76.4%)
Surgical resection	No Yes	57 (79.2%) 15 (20.8%)
Radiotherapy	No Yes	57 (79.2%) 15 (20.8%)

NA, not available data.

Table 2. Clinical response assessment after 6 mo of therapy.

		Patients (n = 66)	Median (95% CI) disease specific survival (months)
Clinical response	CR/PR (Best response) SD PD	8 (12.1%) 19 (28.8%) 39 (59.1%)	NR 30.0 (15.8–44.1) 5.0 (3.6–6.3)*

CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NR, not reached *, computed on 38 cases because 1 patient lost at follow-up was excluded.

Figure 1. Kaplan-Meier estimate for disease specific survival.

Table 3. Kaplan-Meier disease specific survival analysis (71 patients).

		n	3 y DSS %	5 y DSS %	p
Sex	Female Male	37 34	43.2 14.7	32.2 14.7	0.006*
Age (years)	≤ 52 > 52	39 32	28.2 31.3	28.2 18.8	0.463
Primary melanoma site	Head Limb Trunk Unknown	10 40 16 5	50.0 27.5 12.5 60.0	50.0 20.0 12.5 40.0	0.020*
Metastases timing	Synchronous Metachronous	9 62	33.3 29.0	22.2 24.2	0.938
M-stage at study entry (TNM VII. ed)	1a 1b 1c	24 6 41	50.0 0.0 22.0	37.5 0.0 19.5	0.002*
Number of metastases	≤ 2 > 2	17 54	76.5 14.8	76.5 6.9	< 0.001*
Serum LDH (48 patients)	Normal High	27 21	51.9 9.5	44.4 4.8	< 0.001*
Neutrophiles/Lymphocites Ratio (51 patients)	≤ 5 > 5	44 7	36.4 28.6	29.5 14.3	0.068
Combined medical therapy	No Yes	17 54	29.4 29.6	29.4 22.1	0.620
Surgical resection	No Yes	56 15	17.9 73.3	12.5 66.7	< 0.001*
Radiotherapy	No Yes	56 15	32.1 20.0	26.8 13.3	0.444
Clinical Response^+ (65 patients)	CR/PR (best response) SD PD	8 19 38	87.5 31.6 5.3	87.5 15.8 2.6	< 0.001*

* , statistically significant log-rank test; ⁺, only patient with measurable disease included (6 patients underwent R0 resection were excluded); CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease.

Table 4. Cox’s multivariate disease specific survival analysis (71 patients).

		HR (95% CI)	p
Sex	Female Male	1 2.667 (1.490–4.775)	0.001
Number of metastases	≤ 2 > 2	1 2.763 (1.137–6.714)	0.025
SRL172 duration (months)	continuous variable	0.960 (0.941–0.980)	< 0.001

Goodness of the model: -2 Log likelihood 350.677; χ² 47.536; p < 0.001. Included variables: sex, primary melanoma site, M-stage at study entry, number of metastases, SRL172 duration, surgical resection.

Table 5. Cox’s multivariate disease specific survival analysis (65 patients).

		HR (95%CI)	p
Sex	Female Male	1 3.345 (1.767–6.332)	< 0.001
M number	≤ 2 > 2	1 3.012 (1.104–8.219)	0.031
Clinical Response	CR/PR (best response) SD PD	1 7.399 (0.911–60.083) 32.420 (4.024–261.181)	< 0.001 0.061 0.001

Goodness of the model: -2 Log likelihood 329.158; χ² 51.039; p < 0.001. Included variables: sex, primary melanoma site, M-stage at study entry, number of metastases, surgical resection, clinical response grade.