Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial

Figures & data

Figure 1.  Patient enrolment and study populations for efficacy analysis.

Table I.  Tabulation of demographic and baseline parameters of the ITT population.

	ITT Population (Tumour Stage IIa–IV; n = 252)
Parameter	Adjuvant Treatment (n = 128)	Controls (n = 124)
Sex (male/female)	73/55	69/55
Mean age (range)	53 (25–86)	54 (23–82)
Mean weight (kg)	77	78
Body mass index	26	27
Histol. subtype:
SSM:	48 (37.5%)	53 (42.7%)
Nodular M.	47 (36.7%)	47 (37.9%)
LMM:	0 (0%)	1 (0.8%)
ALM:	13 (10.2%)	8 (6.5%)
Other:	12 (9.4%)	13 (10.5%)
Missing data:	4 (3.1%)	0 (0%)
Missing report:	4 (3.1%)	2 (1.6%)
Tumour thickness:
Mean (mm):	2.9	3.0
≤ 4 mm	91 (71.1%)	97 (78.2%)
> 4 mm	26 (20.3%)	22 (17.7%)
Missing Report:	11 (8.6%)	5 (4.0%)
Tumour staging:
Stage IIa:	44 (34.4%)	46 (37.1%)
Stage IIb:	12 (9.4%)	8 (6.5%)
Stage IIIa:	15 (11.7%)	16 (12.9%)
Stage IIIb:	53 (41.4%)	52 (41.9%)
Stage IV:	2 (1.6%)	2 (1.6%)
Wrong Diagnosis*:	2 (1.6%)	–
Tumour invasion (Clark level):
II:	3 (2.3%)	3 (2.4%)
III:	24 (18.8%)	23 (18.6%)
III–IV:	5 (3.9%)	5 (4.0%)
IV:	70 (54.7%)	74 (59.7%)
IV–V:	1 (0.8%)	1 (0.8%)
V:	10 (7.8%)	10 (8.1%)
Missing data:	15 (11.7%)	8 (6.5%)
Tumour localisation:
Head/neck:	9 (7.0%)	9 (7.3%)
Chest:	3 (2.3%)	11 (8.89%)
Back:	37 (28.9%)	35 (28.2%)
Upper/lower limbs:	64 (50.0%)	63 (50.8%)
Abdomen:	7 (5.5%)	5 (4.0%)
Genito-anal region:	1 (0.8%)	0 (0%)
Muc. membrane:	2 (1.6%)	0 (0%)
Occult:	3 (2.3%)	0 (0%)
Missing data:	2 (1.6%)	1 (0.8%)

*In two patients (No. 88, initially being diagnosed as stage IIb and No. 703, initially being diagnosed as stage IIIb) the diagnosis malignant melanoma could not been confirmed histologically. Nevertheless both patients were considered during statistical analysis.

Figure 2.  Kaplan-Meier functions of melanoma related mortality in the ITT population (n = 252).

Figure 3.  Kaplan-Meier functions of overall survival in the ITT population (n = 252).

Table II.  Predictor variables and hazard ratio in Final Cox Proportional Model for melanoma-associated mortality.

Predictor variable	p-value	Hazard Ratio	95% Confidence Interval
1. Adjuvant Treatment (forced into model)	0.0018	0.515	0.340–0.782
2. Clark Level at first Diagnosis (IV or V)	0.0036	2.218	1.298–3.793
3. Histology (SSM–LMM)	0.0178	1.677	1.093–2.573
4. Location (Trunk/Head)	<0.0001	2.389	1.564–3.648
5. Not Stage IIa at Randomization	<0.0001	5.214	3.058–8.889

Figure 4.  Kaplan-Meier functions of overall survival in the stage IIa population (n = 90) and the non-stage IIa population (n = 162) including 2 non-melanoma patients and 4 stage IV patients. The results show no contrast interaction of stage vs. treatment in Cox proportional hazard modeling (p > 0.68).