Current status of granulocyte–macrophage colony-stimulating factor in the immunotherapy of melanoma

Kaufman, Howard L; Ruby, Carl E; Hughes, Tasha; Slingluff, Craig L

doi:10.1186/2051-1426-2-11

Table 3 Studies evaluating GM-CSF in combination with chemotherapy in patients with advanced melanoma

From: Current status of granulocyte–macrophage colony-stimulating factor in the immunotherapy of melanoma

Citation	Evaluable patients	GM-CSF dose schedule	Other agents	Clinical response
Schacter et al. [53]	40	20 μg/m² once daily for 7 d every 3 wk	BCNU, CDDP, DTIC, tamoxifen, IFN-α	9 CR, 11 PR, 2 SD OS:14 mo
Gajewski et al. [60]	7	5 μg/kg for 6 d	DTIC, CDDP, IL-2, IFN-α	1 CR, 1 PR, 2 MR
Gibbs et al. [61]	60	250 μg/m² for 20 d, 28-d cycle	TMZ, CDDP, IL-2, IFN-α	1 CR, 11 PR Median OS: 11 mo
Vaughan et al. [59]	19	Arm 1: 450 μg/m² on days 4, 5, 15, and 16	DTIC, CDDP, IL-2, IFN-α, TAM	2 CR, 4 PR OS: 6.2 mo Trend toward increasing response with higher GM-CSF doses
		Arm 2: 450 μg/m² on days 4, 5, 15, 16; 225 μg/m² on days 6–10 and 17–21, 28-d cycle
		Arm 3: 450 μg/m² on days 4–10 and 15–21, 28-d cycle
Gong et al. [62]	30	5 μg/kg (first 25 patients) or 450 μg/m² (last 8 patients) for 6 d	DTIC, CDDP, IL-2, IFN-α	3 CR, 4 PR, 6 MR, 7 SD Median OS: 15 mo
Groenewegen et al. [63]	31	2.5 μg/kg for 10 d	DTIC, IL-2, IFN-α	4 CR, 6 PR Median OS: 8 mo 1-y survival: 22%
De Gast et al. [64]	74	2.5 μg/kg for 12 d	TMZ, IL-2, IFN-α	4 CR, 19 PR, 13 SD OS: 8.3 mo 1-y survival: 41%
Smith et al. [65]	8	125 and 250 μg/m²/d for 7 d every 2 wk, 28-d cycle	IL-2	0 CR, 0 PR
Fruehauf et al. [54]	10	250 μg/m² for 11 d	DOX, VIN	0 CR, 5 PR Median time to progression: 8 mo
Lewis et al. [66]	71	250 μg/m² for 20 d, 28-d cycle	TMZ, CDDP, IFN-α, IL-2	0 CR, 10 PR Median OS: 8.6 mo
Weber et al. [67]	31	125 μg/m² for 12 d, 28-d cycle	TMZ, IL-2, IFN-α	4 CR, 4 PR, 7 SD OS: 13.1 mo
Jin et al. [55]	18	175 μg/m² for 4 d, 21-d cycle	DTIC, IL-2	4 CR, 8 PR
O’Day [56]	131	Induction: 500 μg/d for 10 d or once daily until ANC >5000/μL	Induction: VBL, CDDP, DTIC, IL-2, IFN-α	10 CR, 47 PR, 38 SD Median OS: 13.5 mo 1-y survival: 57%
O’Day [56]	131	Maintenance: 250 μg/d for 14 d	Maintenance: IL-2	10 CR, 47 PR, 38 SD Median OS: 13.5 mo 1-y survival: 57%
Gunturu et al. [68]	18	250 μg/m² from day 8 until AGC >5000 cells/μL on 2 consecutive days	CTX, FLU, MESNA, IL-2	1 CR, 3 PR
Locke et al. [57]	14	250 μg/m² until WBC >30000/μL or for 10 d, 21-d cycle	OX, DOX	0 CR, 0 PR, 5 SD
Lutzky et al. [69]	30	125 μg/m² for 35 d	IL-2	0 CR, 4 PR, 8 SD Median OS: 10.7 mo 1-y survival: 32.5%

AGC = absolute granulocyte count; ANC = absolute neutrophil count; BCNU = carmustine; CDDP = cisplatin; CR = complete response; CTX = cyclophosphamide; DOX = docetaxel; DTIC = dacarbazine; FLU = fludarabine; GM-CSF = granulocyte-macrophage colony-stimulating factor; IFN-α = interferon-α; IL-2 = interleukin-2; MESNA = sodium 2-mercaptoethanesulfonate; MR = mixed response; OS = overall survival; OX = oxaliplatin; PFS = progression-free survival; PR = partial response; SD = stable disease; TAM = tamoxifen; TMZ = temozolomide; VBL = vinblastine; VIN = vinorelbine.

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