GASTROINTESTINAL : PANCREATIC CANCER

Regimen/Number

Of Patients

Drug Dose and Route

Leukopenia/

Neutropenia

Toxicity

Anemia

Toxicity

Other

Grade III-IV Toxicities

Emetogenic

Potential

Consequences of

Adverse Event(s)

FAM

(Oster MW, et al.

Cancer.

1986;57:29-33)

N = 90

5-Fluorouracil 600 mg/m²  IV days 1, 8 29, 36

Doxorubicin 30 mg/m² IV days 1, 29

Mitomycin 10 mg/m² IV day 1

Repeat cycle every 56 days

Leukopenia

Severe 16%

Life-threatening

6%

Thrombocytopenia 30%

Hepatic (severe) 1%

Renal (life-threatening) 2%

Nausea/Vomiting

(severe) 11%

Cardiac 2%

Day 1―

level 4

Days 8, 36―

level 2

Day 29―

level 4

Severe/life-threatening

toxicity was

experienced by 50%

of patients (40% of

patients, severe;

10% of patients,

life-threatening)

Gemcitabine

(Burris HA, et al.

J Clin Oncol.

1997;15:2403-13)

N = 63

Gemcitabine 1000 mg/m² IV over 30 minutes

once weekly for 7 weeks, followed by a

1-week rest period

Subsequent cycles once weekly for 3

consecutive weeks out of every 4 weeks

Neutropenia

Grade III 19%

Grade IV 7%

Leukopenia

Grade III 9.7%

Grade IV 0%

Grade III 6.5%

Grade IV 3.2%

Thrombocytopenia

(Grade III) 10%

increased Bilirubin 3%

Nausea/Vomiting 13%

Diarrhea (Grade III) 2%

Constipation

(Grade III) 3%

Pain (Grade III) 2%

State of Consciousness

(Grade III) 2%

Alkaline Phosphatase

(Grade III) 16.4%

AST 11%

ALT 10%

Day 1―

level 2

27% of patients were

transfused with RBCs

Gemcitabine- irinotecan

(Rocha Lima CMC, et al.

J Clin Oncol.

2002;20:1182-91)

N = 45

Gemcitabine 1000 mg/m² over 30 minutes

on day 1, 8, followed by

irinotecan 100 mg/m² IV over 90 minutes

on day 1, 8

Repeat cycle every 21 days

Neutropenia

Grade III 16%

Grade IV 2%

Thrombocytopenia 9%

Vomiting 4%

Diarrhea (Grade III) 7%

Days 1, 8―

level 5