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A phase II trial of irinotecan in hormone-refractory prostate cancer
Abstract
Irinotecan is a DNA topoisomerase I inhibitor that has a wide spectrum of activity against human tumors in both preclinical and clinical studies. To evaluate the efficacy of irinotecan in hormone-refractory prostate cancer, we conducted a phase II study in 15 men with metastatic, PSA-progressive disease after primary androgen deprivation. Irinotecan was administered at a dose of 125 mg/m2 weekly for four weeks followed by a two-week rest period; cycles were repeated every six weeks. Response was assessed by evaluation of serial changes in the serum PSA. None of fifteen patients had a decline in PSA of greater than 50%; eight patients had stable disease as a best response. None of three patients with measurable disease had a partial or complete response. Toxicity was primarily hematologic and gastrointestinal, with 40% of patients requiring dose modification due to granulocytopenia and 20% requiring intravenous fluid supplementation after development of diarrhea. There were no treatment-related deaths. We conclude that irinotecan in the dose and schedule used in this trial does not have significant activity against hormone-refractory prostate cancer.
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“I-DXd illustrates the potential of TOPI inhibitor payloads in the treatment of CRPC, in contrast to the limited activity of irinotecan, topotecan, and other camptothecins as chemotherapy agents in CRPC97–99.”
From The evolving landscape of antibody-drug conjugates (ADCs) for treatment of prostate cancer (2025) · cites this paper as [99]
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Phase II study of topotecan in metastatic hormone-refractory prostate cancer
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Sorted by citations
The evolving landscape of antibody-drug conjugates (ADCs) for treatment of prostate cancer
Lin, C., Hadfield, M. J., Santopietro, A., Lagos, G., Cheng, L., El-Deiry, W. S., Aggarwal, R., Mega, A., Hyams, E., & Carneiro, B. A. (2025) · npj Precision Oncology · doi:10.1038/s41698-025-01131-0 · Cited by 20
Metadata
- Authors
- Reese, D. M., Tchekmedyian, S., Chapman, Y., Prager, D., & Rosen, P. J.
- Affiliations
- University of California, Los Angeles (US)
- ORCID
- Reese, David M.
- Venue
- Investigational New Drugs
- Published
- 1998-12
- Volume
- 16
- Issue
- 4
- Pages
- 353-359
- ISSN
- 0167-6997 (ISSN-L)
- 1573-0646
- OpenAlex
- W113626925
- Cited by
- 17
- References
- 1
- Citations by year
- 2025: 1 · 2018: 2 · 2017: 2 · 2013: 1 · 2012: 2
- FWCI
- 0.33
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Investigational New Drugs (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cancer therapeutics and mechanisms
- Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
- Keywords
- irinotecan, castration-resistant prostate cancer, metastatic prostate cancer, topoisomerase I inhibitor, androgen deprivation therapy, PSA response, treatment toxicity, granulocytopenia, diarrhea, dose adjustment
- MeSH terms
- Irinotecan, Aged, Aged, 80 and over, Antineoplastic Agents, Phytogenic, Camptothecin, Humans, Male, Middle Aged, Prostatic Neoplasms, Prostate-Specific Antigen
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