Abstract | BACKGROUND: PATIENTS AND METHODS: Forty-two patients (median age, 73 years) received at least 1 dose of 10.6 mg/m2 irofulven per day on days 1-5 of a 28-day course. Eligible patients had pathologically confirmed metastatic hormone-refractory adenocarcinoma of the prostate and had not received prior cytotoxic chemotherapy. RESULTS: Forty-two patients received a median of 3 courses of irofulven. Thirty-two patients received at least 2 courses of therapy and were evaluable for efficacy. Four patients (13%) achieved partial response, with a median duration of 2.9 months (range, 2.6-5.8 months). Twenty-seven patients (84%) had disease stabilization and 1 patient (3%) progressed on study. Median progression-free survival was 3.2 months (95% confidence interval, 2.3-4.2 months), with a median progression-free survival of 4.2 months (range, 3.5-6.9 months) for responders. Grade 4 toxicities consisted of thrombocytopenia, anemia, and neutropenia, occurring in 1 patient each. The most common treatment-related grade 3 nonhematologic toxicities included asthenia (19% of patients), vomiting (14%), nausea (12%), and infection without grade 3/4 neutropenia (10%). CONCLUSION:
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Authors | Neil Senzer, James Arsenau, Donald Richards, Barry Berman, John R MacDonald, Sheri Smith |
Journal | American journal of clinical oncology
(Am J Clin Oncol)
Vol. 28
Issue 1
Pg. 36-42
(Feb 2005)
ISSN: 1537-453X [Electronic] United States |
PMID | 15685033
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Alkylating
- Sesquiterpenes
- irofulven
- Prostate-Specific Antigen
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Topics |
- Adenocarcinoma
(blood, drug therapy, secondary)
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Alkylating
(therapeutic use)
- Humans
- Male
- Middle Aged
- Prostate-Specific Antigen
(blood)
- Prostatic Neoplasms
(blood, drug therapy, pathology)
- Sesquiterpenes
(therapeutic use)
- Survival Analysis
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