GASTROINTESTINAL : COLORECTAL  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)

Irinotecan

5-Fluorouracil

leucovorin

(Saltz LB, et al.

N Engl J Med.

2000;343:905-14)

N = 231

Irinotecan 125 mg/m² IV over 90 minutes

days 1, 8, 15, 22, following by

leucovorin 20 mg/m² IV

days 1, 8, 15, 22, following by

5-Fluorouracil 500 mg/m² IV

days 1, 8, 15, 22

Repeat cycle every 6 weeks

Neutropenia

Grade III 29.8%

Grade IV 24%

Neutropenic Fever 7.1%

Neutropenic

Infection 1.8%

Diarrhea 22.7%

Vomiting 9.7%

Mucositis (Grade III) 2.2%

Days 1, 8,

15, 22–

level 5

Discontinuation

related to adverse

events 7.6%

Drug-related

deaths 0.9%

Irinotecan (CPT-11)

(Pitot HC, et al.

J Clin  Oncol.

1997;15:2910-2919)

N = 121

Irinotecan 125 mg/m² IV over 90 minutes

on  days 1, 8, 15, 22.

Repeat cycle every 42 days ifications

Note: Dose modifications occurred for any

toxicity > Grade 1.

Leucopenia

Grade III-IV

21.5%

Neutropenia

Grade III-IV

24.8%

Febrile Neutropenia 3.3%

Diarrhea 36.4%

Nausea 24%

Vomiting 15.7%

Anorexia 12.4%

Abdominal Pain 8.3%

Lethargy 7.4%

Dyspnea 5%

Constipation 1.7%

Renal Toxicity 1.7%

Edema 1.7%

Level 4

1 patient died from

complications

due to Grade IV

thrombocytopenia

and leukopenia

2 patients with

pulmonary

metastases had

CPT-11 discontinued

due to DLCO

<40% predicted