GASTROINTESTINAL : GASTRIC 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)

EAP

(Bajetta E, et al.

Eur J Cancer.

1994;30A:596-600)

 

 

N= 91

 

Etoposide 120 mg/m2 IV days 4, 5, 6

Doxoruvicin 20 mg /m2 IV days 1, 7

Cisplatin 40 mg/m2 IV days 2, 8

Repeat cycle every 21 days

Leukopenia

Grade III-IV

30 %

 

Neutropenic Sepsis 1%

Thrombocytopenia 9%

Mucositis 10%

Alopecia

(Grade II-III) 100%

Days 1, 7–

Level 3

Days 2, 8–

Level 4

Days 4, 5, 6

–level 2

Septic death 1%

Of patients

Treatment delay due

to myelosuppression

27% of cycles

Decreased dose

11% of cycles

Discontinued therapy

due to toxicity 4%

of patients

ELF

(Wilke H, et al.

Cancer Treat Res.

1991;55: 363-73)

 

N=51

Leucovorin 300 mg/m2/d IV over 10 minutes

Followed by

Etoposide 120 mg/m2 /d IV over 50 minutes

followed by

5-Fluorouracil 500 mg/m2/d IV over 10 minutes

All agents are given on days 1-3

Repeat cycle every 21-25 days

Leukopenia

Grade III 16%

Grade IV 4%

 

Neutropenic infection 2%

Thrombocytopenia 4%

Diarrhea 7%

Alopecia 65%

Stomatitis

(Grade II-IV) 10%

 

Days 1-3–

Level 3

 

FAM

(Coombes RC, et al,

J Clin Oncol.

1990;8:1362-96)

 

N= 133

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 8 weeks

Leukopenia 3%

Grade III 3%

Infection (any)* 20%

Nausea/Vomiting* 58%

Thrombocytopenia 5%

Mucositis* 10%

Diarrhea* 28%

Alopecia* 57%

 

*Grade II-IV toxicity

or unknown

Day 1–

Level 4

Day 8–

Level 2

Day 29–

Level 4

Day 36–

Level 2

Discontinued

Treatment 14%

Delivered dose intensity

less than 75% in

> 50% of patients

FAMTX

(Wils JA, et al.

J Clin Oncol .

1991;9:827-31)

 

N= 105

 

Methotrexate 1500 mg/m2 IV day 1

5- Fluorouracil 1500 mg/m2 IV starting 1

hour after methotrexate, day 1

Leucovorin 15 mg/m2 PO q6h starting

hours after methotrexate dose.

for 48 hours

Doxorubicin 30 mg/m2 IV day 15

Repeat cycle every 28 days

 

 

 

Neutropenic Sepsis 2%

Nausea/vomiting 8%

Mucositis 10%

Diarrhea* 26%

Alopecia 24%

 

*Grade unknown

Day 1–

Level 5

Day 15–

Level 3

Toxic death

(due to sepsis) 1%

Delayed treatment or

decreased  dose 21%