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Camptosar

Efficacy

Two phase III multicenter, randomized clinical studies confirm significantly improved overall survival with CAMPTOSAR compared with Best Supportive Care (BSC) or 5-FU in patients with metastatic colorectal cancer recurring or progressing after treatment with 5-FU.

SIGNIFICANTLY IMPROVED OVERALL SURVIVAL WITH CAMPTOSAR

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Survival with CAMPTOSAR 350 mg/m2 once every 3 weeks vs Best Supportive Care

camchart1

 

Median survival is 41% greater with CAMPTOSAR vs BSC.

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Survival with CAMPTOSAR 350 mg/m2 once every 3 weeks vs Infusional 5-FU*

camchart2

 

Median survival is 27% greater with CAMPTOSAR vs 5-FU

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Response Rate With CAMPTOSAR 125 mg/m2 Weekly Schedule

Clinical Benefit

AS DEFINED BY A REDUCTION IN DISEASE-RELATED SYMPTOMS

CAMPTOSAR 350 mg/m2 once every 3 weeks vs Best Supportive Care


bulletClinical benefit was evaluated periodically up to 1 year; data were collected prospectively and analyses defined retrospectively.

Significantly Longer Time to Onset Of Pain (median, months)

Significantly Longer Time to Weight Loss 5% (median, months)

gradchart1 gradchart2
bulletPatients evaluated were pain free at baseline.

Significantly Longer Time to Performance-Status Deterioration (median, months)

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CAMPTOSAR 350 mg/m2 once every 3 weeks vs Infusional 5-FU

European Organization For Research And Treatment Of Cancer

QUALITY OF LIFE QUESTIONNAIRE RESULTS

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CAMPTOSAR 350 mg/m2 once every 3 weeks vs Best Supportive Care

Patients periodically completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

FATIGUE (P=.03)

APPETITE LOSS (P=.0007)

CONSTIPATION (P=.03)

PAIN (P=.009)

CAMPTOSAR 350 mg/m2 once every 3 weeks vs Infusional 5-FU

Safety Profile

ADVERSE EVENTS

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Study Table 1

Study Table 2

MANAGEMENT OF SIDE EFFECTS

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Late-Onset Diarrhea (>24 hr after infusion)

Loperamide Regimen

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Myelosuppression

Nausea and Vomiting

Cholinergic Symptom Management

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Dosage And Administration

Two Dosage Options Now Available

Starting Dosage in Compromised Patients

Dosage Modifications

WEEKLY DOSING

125 mg/m2, Weekly x4 CAMPTOSAR® Injection

 

Recommended Dosage Modifications*

A new course of therapy should not begin until the granulocyte count has recovered to 1,500/mm3, and the platelet count has recovered to 100,000/mm3, and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing CAMPTOSAR.

Toxicity: NCI Grade(value)

During a Course of Therapy

At the Start of Subsequent Courses of Therapy

No Toxicity

Maintain dosage level

25 mg/m2 to a maximum of 150 mg/m2

Neutropenia

1 (1,500 to 1,999/mm3)

Maintain dosage level

Maintain dosage level

2 (1,000 to 1,499/mm3)

25 mg/m2

Maintain dosage level

3 (500 to 999/mm3)

Omit dosage, then 25 mg/m2 when resolved to = or < grade 2

25 mg/m2

4 (<500/mm3)

Omit dosage, then 50 mg/m2 when resolved to = or < grade 2

50 mg/m2

Neutropenic Fever

Omit dosage, then 50 mg/m2 when resolved

50 mg/m2

Other Hematologic Toxicities

Dosage modifications for leukopenia or thrombocytopenia during a course of therapy and at start of subsequent courses of therapy are also based on NCI Common Toxicity Criteria and are the same as recommended for neutropenia above.


Diarrhea

1 (2-3 stools/day > pretreatment)

Maintain dosage level

Maintain dosage level

2 (4-6 stools/day > pretreatment)

25 mg/m2

Maintain dosage level

3 (7-9 stools/day > pretreatment

Omit dose, then 25 mg/m2 when resolved to = or < grade 2

25 mg/m2

4 (10 stools/day > pretreatment)

Omit dose, then 50 mg/m2 when resolved to = or < grade 2

50 mg/m2

Other Nonhematologic Toxicities

1

Maintain dosage level

Maintain dosage level

2

25 mg/m2

25 mg/m2

3

Omit dose, then 25 mg/m2 when resolved to = or < grade 2

25 mg/m2

4

Omit dose, then 50 mg/m2 when resolved to = or < grade 2

50 mg/m2

* All dosage modifications should be based on the worst preceding toxicity.
NCI Common Toxicity Criteria version 2.0, Final 1/30/98, NCI revised 3/23/98.
Refers to initial dose used in previous course.

ONCE-EVERY-3-WEEK DOSING

350 mg/m2, Once-Every-3-Weeks CAMPTOSAR® Injection

 

Recommended Dosage Modifications*

A new course of therapy should not begin until the granulocyte count has recovered to 1,500/mm3, and the platelet count has recovered to 100,000/mm3, and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing CAMPTOSAR.

Toxicity: NCI Grade(value)

At the Start of Subsequent Courses of Therapy

No Toxicity

Maintain dosage level

Neutropenia

1 (1,500 to 1,999/mm3)

Maintain dosage level

2 (1,000 to 1,499/mm3)

Maintain dosage level

3 (500 to 999/mm3)

50 mg/m2

4 (<500/mm3)

50 mg/m2

Neutropenic Fever

50 mg/m2

Other Hematologic Toxicities

Dosage modifications for leukopenia or thrombocytopenia at the start of subsequent courses of therapy are also based on NCI Common Toxicity Criteria and are the same as recommended for neutropenia above.

Diarrhea

1 (2-3 stools/day > pretreatment)

Maintain dosage level

2 (4-6 stools/day > pretreatment)

Maintain dosage level

3 (7-9 stools/day > pretreatment)

50 mg/m2

4 (10 stools/day > pretreatment)

50 mg/m2

Other Nonhematologic Toxicities

1

Maintain dosage level

2

50 mg/m2

3

50 mg/m2

4

50 mg/m2

* All dosage modifications should be based on the worst preceding toxicity.
NCI Common Toxicity Criteria version 2.0, Final 1/30/98, NCI revised 3/23/98.


Summary

 

Camptosar


Pharmacia & Upjohn Yakult Daiichi

© 1999 Pharmacia & Upjohn Company


USX 2030.00 January 1999

 

Full Prescribing Information

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