Journal of Clinical Oncology, Vol 11, 909-913, Copyright © 1993 by American Society of Clinical Oncology
Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. CPT-11 Gastrointestinal Cancer Study Group
Y Shimada, M Yoshino, A Wakui, I Nakao, K Futatsuki, Y Sakata, M Kambe, T Taguchi and N Ogawa
Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
PURPOSE: A phase II study was conducted to evaluate the antitumor effect
and toxicity of CPT-11 in patients with metastatic colorectal cancer.
PATIENTS AND METHODS: From December 1989 to March 1991, 67 patients with
metastatic colorectal cancer were enrolled in this study. Sixty-three
patients were assessable for toxicity and response. Their median age was 57
years (range, 24 to 72). Forty-six patients (73%) had a good performance
status of 0 or 1. Fifty-one patients (81%) had received prior chemotherapy.
The major sites of metastasis were liver (63%) and lung (44%). CPT-11 was
administered as a 100 mg/m2 weekly intravenous infusion, or as 150 mg/m2
every 2 weeks. The dose was reduced based on the grade of leukopenia and
diarrhea, if necessary. RESULTS: A partial response was obtained in 17 of
63 assessable patients (27%; 95% confidence interval, 16% to 38%). The
response rate in patients with prior radiotherapy or chemotherapy was 25%
(13 of 52). Liver metastases showed a 15% (six of 40) response and lung
metastases showed a 39% (11 of 28) response. The median duration of partial
response was 127 days (range, 49 to 353) and the median overall duration of
response was 208 days (range, 99 to 381). The major toxicities (> or =
grade 3) were leukopenia (16%), diarrhea (13%), nausea and vomiting (13%),
and alopecia (11%). Adverse effects were generally well tolerated and
reversible. Treatment could be continued on an outpatient basis for
patients without severe toxicity. Hemorrhagic cystitis was not encountered
in this study. CONCLUSION: CPT- 11 showed promising antitumor activity
against metastatic colorectal cancer that was resistant to prior therapy.
Further clinical trials of combination chemotherapy using CPT-11 are
justified.
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