Table 3.
Studies evaluating GM-CSF in combination with chemotherapy in patients with advanced 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% |
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.