A phase II study of thalidomide in patients with brain metastases from malignant melanoma

Figures & data

Table I.  Baseline patient characteristics (n = 36).

	n
	n
Sex
Male	25
Female	11
Age (years)
Median	48
Range	27–70
Performance status
0	12
1	12
2	12
Type of melanoma
Cutaneous	31
Unknown primary site	5
Anatomic site of metastases
Lung	25
Skin	19
Lymph nodes	16
Liver	14
Bone	4
Other	11
Prior treatment
Thalidomide as 1^st line medical therapy	32
Thalidomide as 2^nd line medical therapy#	4
Palliative whole-brain radiotherapy	22

#Prior IL-2 based therapy.

Table II.  Toxicity profile (n = 32).

	Grade, n (%)
Toxicity	1–2	3
Fatigue	26 (81)	6 (19)
Neuropathy-sens	14 (44)	1 (3)
Neuropathy-motor	8 (25)	3 (9)
Constipation	20 (63)	3 (9)
Dry mouth	22 (69)	2 (6)
Skin rash	3 (9)	0 (0)
Nausea	15 (47)	1 (3)
Anorexia	23 (72)	1 (3)
DVT	0 (0)	0 (0)
Other	8 (25)	0 (0)

Table III.  Patient characteristics of patients with clinical benefit (n = 5).

	PR	NC#1	NC#2	NC#3	NC#4
Primary site	Cutaneous	Cutaneous	Cutaneous	Cutaneous	Unknown
Site of metastases outside CNS	Lungs Liver Lymphnodes	Lymphnodes Skin	Lungs Liver Lymphnodes	Skin	Lungs Lymphnodes
Previous therapy	IL-2	None	None	None	None
Cranial tumour response	NC	NC	NC	NC	NC
Extra cranial tumour response	CR (lungs) PR (liver)	CR (lymphnodes, skin)	PR (lungs)	NC	NC
Duration of treatment (days)	482	143	133	249	28
Maximum dose (mg)	400	400	400	400	200
Survival (months)	18.1	8.4	6.2	8.2	5.5
No. of CNS metastases	multiple	multiple	multiple	multiple	Multiple
Leptomeningeal disease	No	No	No	No	No

Figure 1.  Median time to progression 1.7 months.

Figure 2.  Median overall survival 3.1 months.