Randomized, Open-Label, Phase III Study Comparing Patupilone (EPO906) With Pegylated Liposomal Doxorubicin in Platinum-Refractory or -Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian Tube, or Primary Peritoneal Cancer

Abstract

Patupilone did not demonstrate significant improvement in OS compared with the active control, PLD. No new or unexpected serious AEs were identified.

Evaluation bias in objective response rate and disease control rate between blinded independent central review and local assessment: a study-level pooled analysis of phase III randomized control trials in the past seven years

“…Based on article identification and selection, we totally included 28 trials from 35 articles (9-30), involving 17,466 randomly assigned patients ( Figure 1) (31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43).…”

Cancer of the ovary, fallopian tube, and peritoneum

“…The reported response rates are low, about 10%, with a median time to progression of 3-4 months and a median survival of 9-12 months. Over the last 5 years there have been a number of trials carried out with new agents in patients with platinum-resistant ovarian cancer, including epothilones, trabectedin [86] and permetrexed [87] with no significant increase in response rates or progression-free survival. No new cytotoxic agent has been approved to treat recurrent ovarian cancer for many years.…”

Transforming the Future of Treatment for Ovarian Cancer

“…More specifically, a combined trabectedin and PLD regimen demonstrated an enhanced response in platinum sensitive patients [62], suggesting that it is a new chemo-treatment option for ovarian cancer in late relapse. However, patupilone failed to improve the outcome of relapsed patients [63]. A phase III study on canfosfamide showed a promising improvement of overall survival time over PLD suggesting its potential as a third line treatment for platinum-refractory orresistant ovarian cancer [64].…”