"suramin, an active drug for prostate cancer: Interim observations in a phase I trial, "

Mario Eisenberger, L. M. Reyno, D. I. Jodrell

Research output: Contribution to journalArticle

Abstract

The authors wish to correct Table 8. Eisenberger writes: In the original publication, we reported our preliminary findings from a phase I study using a pharmacologically guided regimen with suramin. In Table 8 of that report, the toxic effects described for one of the studies were erroneous. The error involves the report by Myers et al. (l) in which the numbers expressing the incidence of grade 3 and 4 toxic effects are percentages and not actual numbers, as we reported. In the corrected Table 8, all numbers represent percentages." While Table 8 notes the toxic effects of the three studies described, the reader should, in fact, be very cautious with regard to comparisons because of fundamental differences in study design. The study reported by Stein et al. (2) was a phase I trial, while Myers et al. (l) reported on a phase II trial using a pharmacologic end point (suramin plasma concentrations of 300 μg/mL). Our study was a phase I trial using welldefined and traditional clinical end points of dose-limiting toxicity or progression of disease. Thus, comparison of the incidence of toxic effects among these three studies may be flawed by the major differences in study design. The corrected Table 8 describes some of the similarities in the spectrum of toxicity in all three studies and suggests some possible qualitative differences, such as renal, coagulation, and ophthalmologic toxic effects. We cannot conclude from this table that one schedule is safer than another. We subsequently conducted a phase II trial with a pharmacologically based fixed schedule designed to maintain suramin plasma concentrations between 150 and 250 μg/mL for a period of 78 days, essentially in the same manner as in cohort 2 of our original report [see also reference (3)], except that dose-limiting toxicity was not an end point. While toxic effects were qualitatively similar to those encountered in the patients treated at the same target plasma concentrations in our initial pharmacologically guided phase I trial, the incidence of grade 3 and 4 toxic effects was relatively low. We regret the error in our initial publication and wish to apologize to Myers et al. for the unintentional misrepresentation."

Original languageEnglish (US)
Pages (from-to)639-640
Number of pages2
JournalJournal of the National Cancer Institute
Volume86
Issue number8
DOIs
StatePublished - Apr 20 1994
Externally publishedYes

Fingerprint

Phase I Trial
Suramin
Prostate Cancer
Poisons
Toxicity
Prostatic Neoplasms
Drugs
Table
Plasmas
Pharmaceutical Preparations
End point
Incidence
Coagulation
Plasma
Percentage
Publications
Dose
Appointments and Schedules
Schedule
Limiting

ASJC Scopus subject areas

  • Statistics, Probability and Uncertainty
  • Applied Mathematics
  • Physiology (medical)
  • Radiology Nuclear Medicine and imaging
  • Oncology
  • Cancer Research

Cite this

"suramin, an active drug for prostate cancer : Interim observations in a phase I trial, ". / Eisenberger, Mario; Reyno, L. M.; Jodrell, D. I.

In: Journal of the National Cancer Institute, Vol. 86, No. 8, 20.04.1994, p. 639-640.

Research output: Contribution to journalArticle

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