The US Food and Drug Administration (FDA) has
approved irinotecan (Camptosar) as first-line therapy for patients
with metastatic colorectal cancer in conjunction with fluorouracil
(5-FU) and leucovorin. The approval follows unanimous recommendation
by the FDAs Oncologic Drugs Advisory Committee (ODAC). The
Committees recommendation was based on survival data from two
prospective, independent studies demonstrating the potential of
irinotecan for extending colorectal cancer patients lives when
used as first-line treatment.
Both Trials Demonstrate Similar Benefits
Data from these two well-controlled, international (one North
American, one European), phase III trials suggested significant
improvements in objective tumor response rates, time to tumor
progression, and prolongation of survival for the regimen of
irinotecan and 5-FU/leucovorin, as compared with 5-FU/leucovorin alone.
It is really exciting that the North American and European
trials independently suggest the same basic benefits. The addition of
irinotecan to 5-FU/leucovorin results in a generally well-tolerated
regimen with superior antitumor activity and prolonged patient
survival, said Leonard Saltz, MD, principal investigator of the
North American phase III trial and associate attending physician at
Memorial Sloan-Kettering Cancer Center.
The trials also used the well-validated European Organization of
Research and Treatment of Cancer (EORTC) Quality of Life
questionnaire to measure such indicators as general health status and
role functioning and such symptoms as pain. Questionnaire data showed
that the addition of irinotecan to 5-FU and leucovorin did not
compromise prespecified quality-of-life indicators for patients in
We are pleased that an additional treatment option is available
for the treatment of colorectal cancer, said Nancy Roach, Board
of Directors, Colon Cancer Alliance. Each new drug approval
gives survivors renewed hope for a longer and better quality of life.
In the North American phase III trial, diarrhea, nausea, and vomiting
occurred more commonly in patients receiving irinotecan and
5-FU/leucovorin than in those given 5-FU/leucovorin alone. However,
less mucositis and less severe neutropenia were associated with the
Irinotecan is associated with both early (during or shortly after
infusion) and late (more than 24 hours after infusion) forms of
diarrhea, which may be severe. Early diarrhea may be accompanied by
such symptoms as sweating, flushing, and abdominal cramping, and may
be treated with atropine. Late diarrhea can be prolonged and life
threatening, and should be treated promptly with loperamide.
In addition to its current colorectal cancer indications, irinotecan
is being studied as an adjuvant treatment option (with 5-FU/leucovorin)
for earlier-stage colorectal cancer through a National Cancer
Institutesponsored intergroup study.