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GASTROINTESTINAL : COLON CANCER
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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) |
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Capecitabine ( hoff pm. et al. j c/m oncol. 2001:19:2282-92)
N = 302
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Capecitabine 1250 mg/m2 PO twice daily days 1-14 Repeat cycle every 3 weeks
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Leucopenia Grade III 0.3% Neutropenia Grade III 1.3% Grade IV 1.3% |
Grade III 1.3% |
Thrombocytopenia 1% Diarrhea 15.4% Hand-food Syndrome 18.1% Hyperbilirubinemia17.3% Stomatitis 19% Hyperglycemia 8.7% |
Days 1-14– Level 2
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11.4% of patients hospitalized, the most common reasons being dehydration and diarrhea
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5-fluorouracil (rougier ph, et al. Eur j cancer. 1997:33:1789-93)
N = 64 |
5-fluorouracil 750 mg/m2/ d Iv continuous infusion. days 1-7 Repeat cycle every 21 days |
Grade III-IV 0%
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Diarrhea (grade III) 2% Stomatitis 19% Hand-food Syndrome (Grade III ) 2% |
Days 1-7– Level 2 |
Minimal toxicity
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5-fluorovracil + leucovorin – “ mayo clinic ” (0’Connell MJ, et al. Cancer. 1989:63:1026-30)
N = 70 |
Leucovorin mg/m2/ d iv days 1-5 5-fluorovracil 425 mg/m2/ d iv following leucovorin, days 1-5 repeat cycle at 4 weeks, 8 weeks, then every 5 weeks thereafter
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Leucopenia Grade III-IV 21% |
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Nausea * 10% Vomiting * 9% Diarrhea * 14% Stomatitis * 26% Alopecia 34%
*Toxicity ungraded, but listen as severe |
Days 1-5– Level 2 |
Approximately 2 out Of every 3 patients Experienced Grade II-IV toxicity |
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Irinotecan (Rougier P, et al. J clin oncol. 1997; 15:251–60)
N = 213 |
Irinotecan 350 mg/m2 IV over 30 minutes Repeat cycle every 21 days
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Pretreated Patients Grade III-IV 47%
Naïve patients Grade III-IV 48%
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Pre-treated Patients Grade III-IV 10%
Naïve patients Grade III-IV 8%
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Neutropenic Fever 14% Documented infection 5%
Pre-treated Patients (n = 165) thrombocytopenia 3% Delayed Diarrhea 39% Nausea/vomiting 22% Alopecia 53%
Naïve patients (n = 48)
thrombocytopenia 2% Delayed Diarrhea 35% Nausea/vomiting 13% Alopecia 54%
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Day 1– Level 4 |
Toxic mortaility 2% Hospitalization due to Febrile neutropenia Discontinued treatment due to toxicity 10% |
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GASTROINTESTINAL : COLON CANCER (continued ) : Page 2
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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 (Douillard JY, et al. lancet 2000;355:1041–47)
N = 145 |
Irinotecan 180 mg/m2 IV day 1 5-fluorouracil 400 mg/m2 IV followed by 600 mg/m2 IV infusion over 22 hours, plus leucovorin 200 mg/m2 on days 1 and 2 Repeat cycle every 2 weeks
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Neutropenia 46.2% leukopenia 17.4%
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Grade III-IV 2.1% |
Neutropenic Fever Without infection 3.4% Neutropenic infection 2% Infective without Grade III-IV Neutropenia 2.8% Diarrhea 13% Nausea 2.1% Vomiting 2.8% Asthenia 6.2% Anorexia 2.1% Abdominal pain 0.7% Cholinergic syndrome1.4% Mucositis 4.1% |
Day 1– Level 5 |
Dose reduction due to toxicity 21% Dose intensity was 93% for irinotecan and 92% for 5-fluorouracil Hospitalization due to Diarrhea 11%
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