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Camptosar
Pharmacia & Upjohn

We are pleased to announce the availability of one of a new class of oncolytic agents for metastatic colorectal cancer. CAMPTOSAR® Injection (irinotecan HCl injection) is indicated for the second-line treatment of patients with metastatic colon or rectal cancer recurring or progressing after initial treatment with fluorouracil (5-FU).

In 1995, there were an estimated 138,000 new cases of cancers of the colon and rectum in the United States. In 20% of the cases, the disease has already metastasized at the time of diagnosis and another 30% eventually develop metastasis.[1] These common malignancies are the second leading cause of cancer-related deaths, killing 55,300 Americans annually.[2]

For more than 40 years, only one drug, fluorouracil (5-FU) injection, has been indicated for the treatment of colon and rectal cancers. Meta-analysis of nine clinical trials showed that approximately 23% of the patients respond to first-line, 5-FU based regimens (eg, 5-FU + leucovorin.).[3] Studies of second-line, single-agent therapies in patients who have already received a first-line, 5-FU containing treatment report response rates that are usually less than 5%. Until CAMPTOSAR, there was no standard second-line therapy for patients whose disease has recurred or progressed following initial 5-FU based therapy.

NEW CAMPTOSAR Injection

For the first time, there is an innovative new drug indicated for metastatic cancer of the colon or rectum for patients who have failed initial 5-FU-based therapy. New CAMPTOSAR Injection provides objective tumor response in 15% of the patients with metastatic colorectal cancer that has recurred or progressed despite therapy with 5-FU-based treatment when given at the recommended starting dose, as shown in three multicenter, phase II, open-label studies. CAMPTOSAR inhibits topoisomerase I, an enzyme that relaxes supercoiled DNA during replication and transcription. Binding of the drug to this enzyme stabilizes topoisomerase I and DNA. When advancing replication enzymes collide with the drug-topoisomerase-DNA complex, double-stranded DNA breaks occur that result in tumor cell death.

CAMPTOSAR can induce severe myelosuppression and both an early and late form of diarrhea that may be severe. Late diarrhea should be treated promptly with loperamide. Administration of CAMPTOSAR should be delayed in the presence of severe diarrhea (NCI grades 3 or 4) until the patient recovers. To help you manage these serious adverse events, patient-education and information materials are available from Pharmacia & Upjohn.

CAMPTOSAR is administered as a 90-minute intravenous infusion. The recommended treatment regimen is administered once weekly for 4 weeks, followed by a 2-week rest (one course). The recommended starting dose of CAMPTOSAR is 125 mg/m².

Please see the full prescribing information for CAMPTOSAR Injection. If you have specific medical inquiries regarding CAMPTOSAR, please contact the Medical and Drug Information unit at 1-800-253-8600, extension 3-8244.

To place an order for CAMPTOSAR or any other Pharmacia & Upjohn Company Oncology Product, please contact Customer Service: 1-800-487-5646.

CAMPTOSAR will be available August 5, 1996 in 100-mg, single-dose, 5-mL vials.

REFERENCES

  1. Tierney LM, McPhee SJ, Papadakis MA, eds. Current Medical Diagnosis and Treatment. 34th ed. Norwalk, CT: Appleton & Lange; 1995:549, 550.
  2. Wingo PA, Tong T, Bolden S. Cancer statistics, 1995. Cancer J Clin. 1995;45:8-30.
  3. Advanced Colorectal Cancer Meta-Analysis Project. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J Clin Oncol. 1992;10:896-903.

USD 4774.00 August 1996

Pharmacia & Upjohn Company
7000 Portage Road
Kalamazoo, MI 49001-0199
USA

Telephone (616)-833-4000


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