Cancer Type

No. of. Pts

Results

No. of toxicities
Grade 3/4

Ref.

Colorectal Cancer

CPT-11 40 mg/m²d 1, 8,15 qd29 + 335 mg/m²/d UFT od. Cycles were repeated for 6 months, followed by UFT alone for further 6 months.

49

Overall survival rate stage IIIb group (5-year: 73%), n=35

Distant metastases group (5-year: 62%), n=30

neutropenia 2/0

96

Glioblastoma

Radiotherapy
with concurrent TMZ od followed by six adjuvant cycles of either dose-dense (150
mg/m²days 1 to 7 and 15 to 21) or metronomic (50 mg/m²od) TMZ.
Maintenance doses of 13-cis-retinoic acid were then administered until tumor progression

85

1 year Survival Rate:
Dose dense Arm: 80%
Metronomic Arm: 69%

Median OS
Dose Dense Arm: 17,1 mo
Metronomic Arm: 15,1 mo

G 3+4 combined

Dose dense
lymphopenia 21
leukopenia 6

Metronomic Arm
lymphopenia 17
ASAT/ALAT ↑ 5

97

Prostate Cancer

8 planned vaccination
cycles, once every 4 weeks, with granulocyte-macrophage colony-stimulating factor given
on days 1 to 4 and interleukin 2 (IL-2) at a dose of 0.6MIU/M2 given from days 8 to 21after each
vaccination. Definitive external beam radiation therapy was initiated after the third vaccination
cycle.

18

Metronomic-dose IL-2 in combination with vaccine and radiation therapy is safe,
can induce prostate-specific immune responses, and has immunologic activity similar to
low-dose IL-2, with markedly reduced toxicities.

Grade 3
n= no of cycles

fatigue 7
hyperglycemia 7
lymphopenia 10

98

Breast Cancer

Arm A: DOX 60 mg/m²+ CYC 600 mg/m²d1, q3w, 5 cycles

Arm B: DOX 24 mg/m²weekly x 15, CYC 60 mg/m²od for 15 weeks, G-CSF 5µg/kg/d d2-7 each week

356

pCR

Arm A: 37/179

Arm B: 43/177

Arm A:
febr.neutropenia 10/2
leukopenia 39/23
neutropenia 32/58

Arm B:
hand-foot-skin reaction 25/0
leucopenia 11/5
neutropenia 14/15
stomatitis 19/1

99