Conflicting Phase II Efficacy Data for Doxil
Authors: Gregory Frykman, Grant Williams, Richard Pazdur, Alan N. Gordon
Journal: Journal of Clinical Oncology (2001)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2001.19.2.596 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 11208859 Conflicting Phase II Efficacy Data for Doxil Gregory FrykmanxGregory FrykmanSearch for articles by this author , Grant WilliamsxGrant WilliamsSearch for articles by this author , Richard PazdurxRichard PazdurSearch for articles by this author Alan N. GordonxAlan N. GordonSearch for articles by this author Show More Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, MDTexas Oncology, Dallas, TX https://doi.org/10.1200/JCO.2001.19.2.596 First Page Full Text PDF Figures and Tables © 2001 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse15012001In Reply:As Drs Frykman, Williams, and Pazdur point out, a description of the evidence supporting the activity of Doxil (doxorubicin HCl liposome injection; Alza Corporation, Mountain View, CA) in platinum- and taxane-refractory ovarian cancer is present in the package insert and the public record from the presentation to the Oncology Drug Advisory Committee in June 1999. This includes the unpublished results from the European study that they have cited. Two other studies were presented: the data from Muggia et al,1 which showed an overall response rate of 26% and a response rate of 21.4% in platinum- and taxane-refractory patients, and our study,2 which reported an 18.2% response rate. When all three studies are combined, the result is the 14% response rate quoted by Frykman, Williams, and Pazdur.We also recently reported the results of a randomized phase III trial of pegylated liposomal doxorubicin compared with topotecan in recurrent ovarian cancer at the 36th Annual Meeting of the American Society of Clinical Oncology in May 2000.3 The response rate in the platinum- and taxane-refractory subset was 12.1% for pegylated liposomal doxorubicin compared with 6.8% for topotecan. This difference was not statistically significant.Although the reasons for the difference in the European study are not clear, we believe that the other phase II studies, which demonstrated activity along with the comparable results in the phase III trial, clearly support a role for liposomal doxorubicin in platinum- and taxane-refractory ovarian cancer. NOTE. The views expressed herein do not necessarily represent the views or findings of the United States Food and Drug Administration or the United States Government. 1. Muggia FM, Hainsworth JD, Jeffers S, et al: A phase II study of liposomal doxorubicin in refractory ovarian cancer: Antitumor activity and toxicity modification by liposomal encapsulation. J Clin Oncol 15:: 987,1997-993, Link, Google Scholar2. Gordon AN, Granai CO, Rose PG et al: Phase II study of liposomal doxorubicin in platinum and paclitaxel refractory epithelial ovarian cancer. J Clin Oncol 18:: 3093,2000-3100, Link, Google Scholar3. Gordon AN, Fleagle JT, Guthrie D, et al: Interim analysis of a phase III randomized trial of Doxil/caelyx versus topotecan in the treatment of patients with relapsed ovarian cancer. Proc Am Soc Clin Oncol 19:: 380a,,2000 (abstr 1504) Google Scholar