Complete or nearly complete responses
occurred in 41% of patients in a
phase II trial of capecitabine (Xeloda)
and irinotecan (Camptosar) for neoadjuvant
treatment of patients with
locally advanced rectal cancer (abstract
3589). "The efficacy is promising," the
investigators concluded, and the regimen
"is feasible and more convenient
than infusional 5-FU-based chemoradiation."
A total of 36 patients were recruited
to receive weekly neoadjuvant
irinotecan (50 mg/m2) 1 hour before
radiotherapy and capecitabine (1,000
mg/m2 on days 1 to 38) with a concurrent
radiotherapy dose of 50.4 Gy (45
+ 5.4 Gy). Dose reductions and/or
postponement of chemotherapy were
required in 13 patients. Surgery was
scheduled 4 to 6 weeks after completion
Trial participants had clinical stage
T3/4 Nx or N+ rectal cancer. The median
age was 62 years, and the
male:female ratio was 27:9. The Eastern
Cooperative Oncology Group
(ECOG) performance status was 0 in
15 patients, 1 in 18 patients, and 2 in 3
patients. The median distance of the
tumor from the anal verge was 5 cm.
Three patients had local recurrences.
Anemia Tops Toxicity List
According to updated data reported
by Frank Willeke, MD, of the
Mannheim University Clinic in Germany,
34 patients had resection of the
primary tumor and 41% had complete
or nearly complete tumor remission.
One patient refused surgery, and
one patient was diagnosed with metastases
before surgery could be performed.
The most common toxicities were
anemia, diarrhea, and leukopenia. The
only grade 4 toxicities reported were
two cases of leukopenia (see Table 1
on previous page).
Postoperative complications included
bowel atonia and bladder dysfunction.
Five patients needed surgical
revision, and three patients had
fistulas. One patient died postoperatively
due to septic complications concerning
a perirectal abscess.