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

CitationEvaluable patientsGM-CSF dose scheduleOther agentsClinical response
Schacter et al. [53]4020 μg/m2 once daily for 7 d every 3 wkBCNU, CDDP, DTIC, tamoxifen, IFN-α9 CR, 11 PR, 2 SD OS:14 mo
Gajewski et al. [60]75 μg/kg for 6 dDTIC, CDDP, IL-2, IFN-α1 CR, 1 PR, 2 MR
Gibbs et al. [61]60250 μg/m2 for 20 d, 28-d cycleTMZ, CDDP, IL-2, IFN-α1 CR, 11 PR Median OS: 11 mo
Vaughan et al. [59]19Arm 1: 450 μg/m2 on days 4, 5, 15, and 16DTIC, CDDP, IL-2, IFN-α, TAM2 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]305 μg/kg (first 25 patients) or 450 μg/m2 (last 8 patients) for 6 dDTIC, CDDP, IL-2, IFN-α3 CR, 4 PR, 6 MR, 7 SD Median OS: 15 mo
Groenewegen et al. [63]312.5 μg/kg for 10 dDTIC, IL-2, IFN-α4 CR, 6 PR Median OS: 8 mo 1-y survival: 22%
De Gast et al. [64]742.5 μg/kg for 12 dTMZ, IL-2, IFN-α4 CR, 19 PR, 13 SD OS: 8.3 mo 1-y survival: 41%
Smith et al. [65]8125 and 250 μg/m2/d for 7 d every 2 wk, 28-d cycleIL-20 CR, 0 PR
Fruehauf et al. [54]10250 μg/m2 for 11 dDOX, VIN0 CR, 5 PR Median time to progression: 8 mo
Lewis et al. [66]71250 μg/m2 for 20 d, 28-d cycleTMZ, CDDP, IFN-α, IL-20 CR, 10 PR Median OS: 8.6 mo
Weber et al. [67]31125 μg/m2 for 12 d, 28-d cycleTMZ, IL-2, IFN-α4 CR, 4 PR, 7 SD OS: 13.1 mo
Jin et al. [55]18175 μg/m2 for 4 d, 21-d cycleDTIC, IL-24 CR, 8 PR
O’Day [56]131Induction: 500 μg/d for 10 d or once daily until ANC >5000/μLInduction: VBL, CDDP, DTIC, IL-2, IFN-α10 CR, 47 PR, 38 SD Median OS: 13.5 mo 1-y survival: 57%
Maintenance: 250 μg/d for 14 dMaintenance: IL-2
Gunturu et al. [68]18250 μg/m2 from day 8 until AGC >5000 cells/μL on 2 consecutive daysCTX, FLU, MESNA, IL-21 CR, 3 PR
Locke et al. [57]14250 μg/m2 until WBC >30000/μL or for 10 d, 21-d cycleOX, DOX0 CR, 0 PR, 5 SD
Lutzky et al. [69]30125 μg/m2 for 35 dIL-20 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.