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Pharmacia & Upjohn

December 14, 1998

Re: New Clinical Data In Metastatic Colorectal Cancer

Dear Oncology Professional:

Pharmacia & Upjohn Company is pleased top announce the results of two recently published multicenter, randomized, phase III clinical studies, which show significantly improved overall survival with CAMPTOSAR® Injection (irinitecan HCI injection) compared with survival with Best Supportive Care (BSC) or infusional 5-FU, in patients with metastatic colorectal cancer recurring or progressing after treatment with 5-FU. Patients in these studies received 350 mg/m2 of CAMPTOSAR according to the once-every-3-week dosage schedule. The ability of CAMPTOSAR to increase survival led to a recent FDA decision to advance the drug from accelerated to full marketing approval.

The new survival data were presented during the plenary session of this year's ASCO Convention in Los Angeles and recently published in The Lancet.[1,2]

In the study vs BSC, data show that median survival in patients receiving CAMPTOSAR compared with the survival with BSC was 9.2 months vs 6.5 months, representing a median survival increase of 41%. In a second study vs infusional 5-FU, the median survival of patients receiving CAMPTOSAR was 10.8 months vs. 8.5 months, representing a median survival increase of 27%. The survival benefit demonstrated in the two phase III trials significantly favored CAMPTOSAR as shown below:

Survival With CAMPTOSAR vs Best Supportive Care

survivalchart1

Survival With CAMPTOSAR vs Infusional 5-FU

survivalchart2

In the two phase III trials, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assessed global health status, functional abilities, and symptoms in a series of subscales. Global health-status scores were significantly better for patients treated with CAMPTOSAR than for those on BSC alone (P=.03). The EORTC questionnaire did not indicate a statistically significant difference between CAMPTOSAR and infusional 5-FU in global health-care status scores.

There are now two dosing options available with CAMPTOSAR: 350 mg/m2 as a 90-minute infusion, administered once every 3 weeks, or 125 mg/m2 over 90 minutes, administrated weekly for 4 weeks followed by a 2-week rest.

Three phase II, open label clinical studies (n-304) support the use of CAMPTOSAR according to the weekly dosage schedule. CAMPTOSAR provides objective tumor response in 15% of patients when given at the recommended weekly starting dose of 125 mg/m2. These studies were designed to evaluate tumor response rate and do not provide information on actual clinical benefit, such as effect on survival and disease-related symptoms.

CAMPTOSAR can induce severe myelosuppression and both early and late forms of diarrhea that may be severe. Late diarrhea should be treated promptly with loperamide. Patients with severe diarrhea should be carefully monitored for signs of dehydration, and therapy delayed until the patient recovers. Deaths due to sepsis following severe myelosuppression have been reported; therapy with CAMPTOSAR should be delayed if neutropenic fever occurs or if the absolute neutrophil count drops below 1,000/mm3.

In the two phase III trials (350 mg/m2 dosage schedule), clinically significant adverse events (all grades, 1-4) included late diarrhea (84%), nausea (70%), vomiting (62%), and neutropenia/leukopenia (30%). In the three phase II trials (125 mg/m2 dosage schedule), clinically significant adverse events (all grades, 1-4) included late diarrhea (88%), Nausea (86%), vomiting (67%), and neutropenia/leukopenia (63%). It is recommended that patients receive premedication with antiemetic agents for management of nausea and vomiting.

To help you manage your patients' therapy with CAMPTOSAR, patient-education and information materials are available from Pharmacia & Upjohn Company, or visit the Colon Cancer Center of Medicine Online @ http://www.meds.com. Please see the enclosed full prescribing information for CAMPTOSAR. If you have specific medical inquiries regarding CAMPTOSAR, please contact our Medical and Drug Information Unit at 1-800-253-8600, extension 3-8244.

Sincerely,

Jeffrey H. Buchalter

Jeffery H. Buchalter
Group Vice President, Hospital Products

  1. Cunningham D, Pyrohone, S, James RD, et al. Randomized trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. The Lancet, 1998;352:1413-1418.
  2. Rougier P, Van Cutsem E, Bajetta E, et al. Randomized trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. The Lancet. 1998;352:1407-1412.
Camptosar

Pharmacia & Upjohn Yakult Daiichi


USD 2190.00 December 1998

 

Full Prescribing Information

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