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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%
Maintenance: 250 μg/d for 14 d Maintenance: IL-2
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%
  1. 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.