当前位置： SCI文献检索 > GYNECOLOGIC ONCOLOGY期刊下所有文献 > Docetaxel plus trabectedin appears active in recurrent or persistent ovarian and primary peritoneal cancer after up to three prior regimens: a phase II study of the Gynecologic Oncology Group.

Docetaxel plus trabectedin appears active in recurrent or persistent ovarian and primary peritoneal cancer after up to three prior regimens: a phase II study of the Gynecologic Oncology Group.

Abstract：

OBJECTIVE:This study aims to estimate the activity of docetaxel 60mg/m(2) IV over 1h followed by trabectedin 1.1mg/m(2) over 3h with filgrastim, pegfilgrastim, or sargramostim every 3weeks (one cycle). METHODS:Patients with recurrent and measurable disease, acceptable organ function, PS≤2, and ≤3 prior regimens were eligible. A two-stage design was utilized with a target sample size of 35 subjects per stage. Another Gynecologic Oncology Group study within the same protocol queue involving a single agent taxane showed a response rate (RR) of (16%) (90% CI 8.6-28.5%) and served as a historical control for direct comparison. The present study was designed to determine if the current regimen had an RR of ≥36% with 90% power. RESULTS:Seventy-one patients were eligible and evaluable (prior regimens: 1=28%, 2=52%, 3=20%). The median number of cycles was 6 (438 total cycles, range 1-22). The number of patients responding was 21 (30%; 90% CI 21-40%). The odds ratio for responding was 2.2 (90% 1-sided CI 1.07-Infinity). The median progression-free survival and overall survival were 4.5months and 16.9months, respectively. The median response duration was 6.2months. Numbers of subjects with grade 3/4 toxicity included neutropenia 7/14; constitutional 8/0; GI (excluding nausea/vomiting) 11/0; metabolic 9/1; pain 6/0. There were no treatment-related deaths nor cases of liver failure. CONCLUSIONS:This combination was well tolerated and appears more active than the historical control of single agent taxane therapy in those with recurrent ovarian and peritoneal cancer after failing multiple lines of chemotherapy. Further study is warranted.

journal_name

Gynecol Oncol

journal_title

Gynecologic oncology

authors

Monk BJ,Sill MW,Hanjani P,Edwards R,Rotmensch J,De Geest K,Bonebrake AJ,Walker JL

doi

10.1016/j.ygyno.2010.11.012

subject

Has Abstract

pub_date

2011-03-01 00:00:00

pages

459-63

issue

eissn

0090-8258

issn

1095-6859

pii

S0090-8258(10)00838-3

journal_volume

120

pub_type

杂志文章

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Docetaxel plus trabectedin appears active in recurrent or persistent ovarian and primary peritoneal cancer after up to three prior regimens: a phase II study of the Gynecologic Oncology Group.