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Living Proof
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Camptosar
Table of Contents
Efficacy
Adverse Effects
Dosage & Administration
Metabolism & Pharmacokinetics


Efficacy

What is CAMPTOSAR® (irinotecan HCl) injection?

CAMPTOSAR is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. It is the first topoisomerase I inhibitor approved for this purpose.1 Topoisomerases are nuclear enzymes that prepare DNA for replication. Topoisomerase inhibitors appear to act by binding to DNA-topoisomerase complexes, leading to DNA damage when replication enzymes collide with the drug-enzyme DNA complex. [2], [3]

What survival benefit does CAMPTOSAR provide?

Two phase III multicenter, randomized trials evaluated CAMPTOSAR 350 mg/m2 once every 3 weeks in a total of 535 patients (intent-to-treat). The primary endpoint in both studies was survival. One trial compared CAMPTOSAR and Best Supportive Care (BSC) with BSC alone; the other compared CAMPTOSAR with Infusional 5-FU-based therapy. In the trial vs BSC, median survival was 9.2 months with CAMPTOSAR and 6.5 months with BSC (P=.0001). CAMPTOSAR increased median survival by 41%.

Survival With CAMPTOSAR 350 mg/m2 once very 3 weeks vs Best Supportive Care
survivalchart1

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In the comparative trial vs 5-FU, median survival was 10.8 months with CAMPTOSAR and 8.5 months with Infusional 5-FU (P=.035). CAMPTOSAR increased median survival by 27%.

Survival With CAMPTOSAR 350 mg/m2 once very 3 weeks vs Infusional 5-FU
survivalchart2

Does CAMPTOSAR reduce disease-related symptoms?

The phase III studies measured clinical benefit as defined by certain disease-related symptoms periodically up to 1 year. The data were collected prospectively and the analyses defined retrospectively:


Months (median)
CAMPTOSAR BSC P
Time to Onset of Pain 6.9 2.0 .003
Time to 5% Weight Loss 6.4 4.2 .018
Time to Performance Status 5.7 3.3 .0001

Symptom-related measurements did not show significant differences between CAMPTOSAR and Infusional 5-FU.

Are there any data on quality-of-life indices for CAMPTOSAR® (irinotecan HCl) injection?

During the phase III studies, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) instrument was utilized. The EORTC questionnaire assessed global health status, functional abilities, and symptoms in a series of 15 subscales. Compared with Best Supportive Care, CAMPTOSAR produced significantly better results in: