GASTROINTESTINAL : RECTAL  CANCER

Regimen/Number

Of Patients

Drug Dose and Route

Leukopenia/

Neutropenia

Toxicity

Anemia

Toxicity

Other

Grade III-IV Toxicities

Emetogenic

Potential

Consequences or

Adverse Event(s)

5Fluorouracil

Leucovorin +

Radiation

(Wolmark N, et al.

J Natl Cancer Inst.

2000;92:388-396)

N =242

Leucovorin 500 mg/m² IV over

1 hour prior to 5Fluorouracil, every week

x 6 weeks, then 2 weeks off

5Fluorouracil 500 mg/m² IV bolus

every week X 6 weeks, then 2 week off

5Fluorouracil 400 mg/m² IV bolus daily

on days 1-3 and the last 3 days off    Then

radiation therapy

Duration of each cycle: 10 weeks

5Fluorouracil/leucovorin for a total of 6 cycles

Radiation therapy initiated between 3 and

5 weeks following completion of cycle 1

Leucopenia

< 4×10³/mm³

65% Leukopenia

< 2×10³/mm³

3%

Infection

(any) 14%

(systemic and/or

sepsis) 3%

Fever

(any) 9%

(> 40°C or

hypotension) 1%

Thrombocytopenia

< 100K 4%

Nausea/vomiting

(any) 59%

(severe or with

hospitalization) 4%

Diarrhea

(≥ 3 stools/day) 61%

(≥ 7 stools/day) 31%

stomatitis

(any) 25%

(severe) 3%

Days 1-3 ―

level 2

Death ―1 patients