Temozolomide for treatment of brain metastases: A review of 21 clinical trials

Table 4 Treatment administration and clinical outcomes of the studies that combined temozolomide with radiotherapy and/or other agents

Trial	Cancer	Treatment administration			Clinical outcomes
		Drug	Dose regimen	Mediancycles	CR	PR	OR	ORR	SD	PD	Other (Median1)
8	NSCLC (n = 15) Breast (n = 12)	TMZ, WBRT	WBRT 30 Gy, TMZ 75 mg/m2 per day, days 1-10; subsequent TMZ 75 mg/m2 per day, days 1-21/28-d cycle	4.2	2 (12/13)	11 (52/63)	13	0.481	6 (32/33)	8 (62/23)	PFS: 6 mo OS: 8.8 mo
9	Lung (n = 13) Colon (n = 1) Melanoma (n = 1) Mixed (prostate, bladder, lung) (n = 1) Unknown (probably lung) (n = 1)	TMZ, WBRT	WBRT 30 Gy, TMZ 95 mg/m2 per day, days 1-14	NA	0	3	3	0.176	10	4	PFS: 2.4 mo OS: 4.1 mo
10	SCLC (n = 4) NSCLC (n = 10) Breast (n = 7) Rectal (n = 5) Melanoma (n = 5) Oral cavity (n = 1) Unknown (n = 1)	TMZ, WBRT	WBRT 36Gy, TMZ 60 mg/m2 per day, days 1-16; subsequent TMZ 200 mg/m2 per day, days 1-5/28-d cycle	NA	8 (32/24 /13/25)	11 (52/26/13 /15/17/18)	19	0.545	2 (15/16)	12 (32/14 /26/53 /15)	PFS: 11 mo OS: 12 mo
11	Melanoma	TMZ, WBRT	WBRT 20 or 30 Gy, TMZ 200 mg/m2 per day, days 1-5/28-d cycle	NA	19	29	39	0.0889	99	179	OS: 8 mo mixed response10: 5
12	NSCLC (n = 16) SCLC (n = 5) Breast (n = 2) Unknown (n = 2)	TMZ, WBRT	WBRT 40 Gy 5 d/wk, TMZ 75 mg/m2 per day, days 1-28; subsequent TMZ 200 mg/m2 per day, days 1-5/28-d cycle	NA	9	14	23	0.959	1	0	OS: 8.6 mo
13	Melanoma	TMZ, WBRT, Thalidomide	WBRT 30 Gy, days 1-5/8-12; TMZ 75 mg/m2 per day, Weeks 1-6; thalidomide 100 mg/d, Weeks 1-4, 100-400 mg/d Weeks 5, 7, 9	NA	1	2	3	0.077	7	29	TTP: 7 wk OS: 4 mo
14	NSCLC	TMZ, WBRT, Cisplatin	WBRT, TMZ 200 mg/m2 per day, days 1-5/28-d cycle, cisplatin 75 mg/m2, day 1/28-d cycle	NA	12/03/04	52/63/84	62/63/84	0.1282 /0.1813 /0.174	212/163 /104	202/113 /294	TTP: 2.3 mo OS: 5 mo
15	NSCLC (n = 17) SCLC (n = 3) Breast (n = 11) Colon (n = 2) Renal (n = 2) Endometrial (n = 1) Bladder (n = 1) Head and neck (n = 1)	TMZ, Vinorelbine	TMZ 150 mg/m2 per day, days 1-7, 15-21/28-d cycle; vinorelbine 25 or 30 mg/m2 per day, days 1, 8/28-d cycle	2	1 (NSCLC)	1 (breast)	2	0.055	5	29	PFS: 1.9 mo OS: 5 mo
16	Melanoma	TMZ, Lomustine	TMZ 150 mg/m2 per day, days 1-5/28-d cycle; lomustine 60 mg/m2 per day, day 5/56-d cycle	NA	09	09	09	09	19	139	OS: 2 mo
17	Breast (n = 8) NSCLC (n = 6) Colo-rectal (n = 3) Melanoma (n = 1) Ovarian (n = 1)	TMZ, Doxorubicin	TMZ 200 mg/m2 per day, days 1-5/28-d cycle; pegylated liposomal doxorubicin 35 mg/m2 per day, day 1/28-d cycle	NA	3	4	7	0.368	8	4	PFS: 5.5 mo OS: 10.0 mo
18	Melanoma	TMZ, arsenic trioxide (ATO)	ATO 0.25 mg/kg per day, days 1-5 in week 0 + 0.35 mg/kg twice weekly/8-wk cycle; TMZ 200 mg/m2 per day, days 1-5 in weeks 1, 5/8-wk cycle	NA	0	0	0	0	0	5	NA
19	Breast (n = 15) NSCLC (n = 11) SCLC (n = 1) Gastric (n = 1) Melanoma (n = 3) Unknown (n = 1)	TMZ, Cisplatin	TMZ 150-200 mg/m2 per day, days 1-5/28-d cycle; cisplatin 75 mg/m2 per day, day 1/28-d cycle	3	19 (NSCLC)	1/89	99	0.428	59	69	TTP: 2.9 mo OS: 5.5 mo
20	Melanoma	TMZ, Thalidomide	TMZ 75 mg/m2 per day, days 1-42/8-wk cycle; thalidomide 200-400 or 100-250 mg/d, days 1-42/8-wk cycle	1	2/011	1/011	3/011	0.214 /011	7/511	4/1011	OS: 6 mo
21	Melanoma	A: TMZ, Docetaxel B: TMZ C: TMZ, Cisplatin	A: TMZ 150 mg/m2 per day, days 1-5/28-d cycle, docetaxel 80 mg/m2 per day, day 1/28-d cycle; B: TMZ200 mg/m2 per day, days 1-5/28-d cycle; C: TMZ 200 mg/m2 per day, days 1-5/28-d cycle, CDDP 75 mg/m2 per day, day 1/28-d cycle	NA	0/211	6/511	6/711	0.25/ 0.29111	5	13	TTP: 2 mo OS: 4.7 mo

¹Median: Data here are median values; Drugs: Chemotherapy and/or radiotherapy;

²NSCLC;

³Breast cancer;

⁴SCLC;

⁵Melanoma;

⁶Rectal cancer;

⁷Unknown;

⁸Oral cavity cancer;

⁹Global response;

¹⁰Mixed response: PR or SD in the brain and PD at other locations;

¹¹Extracerebral response. TMZ: Temozolomide; NA: Not available; NSCLC: Non–small cell lung cancer; SD: Stable disease; PR: Partial response; CR: Complete response; OR: Objective response; ORR: Objective response rate; PD: Progressive disease; PFS: Progression-free survival; TTP: Time to progression; OS: Overall survival.