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Old 06-08-2009, 07:08 AM   #14
Lani
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Join Date: Mar 2006
Posts: 4,778
believe 51--thought this might be of interest --in addition check out my post in your

previous update thread on appetite stimulation

hope this helps!
Unfortunately doesn't comment what percent were her2+

Ixabepilone Plus Bevacizumab Demonstrates Encouraging Activity Relative to Paclitaxel Plus Bevacizumab for Metastatic Breast Cancer: Presented at ASCO
[Doctor's Guide]
ORLANDO, Fla — June 5, 2009 — Ixabepilone plus bevacizumab given as a weekly or every-3-week schedule demonstrates encouraging activity relative to weekly paclitaxel plus bevacizumab in patients with metastatic breast cancer, researchers stated here at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).
The overall safety profiles of the 3 phase 2 trial arms were similar, as well, said Hope Rugo, MD, University of California, San Francisco, San Francisco, California, on May 31.
The trial's primary objective was to evaluate objective response rates of ixabepilone/bevacizumab given weekly or every 3 weeks relative to paclitaxel/bevacizumab as first-line therapy for women with advanced breast cancer.
A total of 122 women (~59 years) with measurable disease and no prior chemotherapy for advanced breast cancer (locally advanced or metastatic) were included in the study.
They were randomised 3:3:2 to ixabepilone 16 mg/m2 IV (days 1, 8, and 15 then every 28 days)/bevacizumab 10 mg/kg IV (every 2 weeks); ixabepilone 40 mg/m2 IV (every 3 weeks)/bevacizumab 15 mg/kg IV (every 3 weeks); or paclitaxel 90 mg/m2 IV/bevacizumab 10 mg/kg IV every 2 weeks. Treatment was continued until disease progression or unacceptable toxicity.
Grade 3/4 neutropenia was reported in 11.1% of women in the weekly ixabepilone arm, 54.8% in the every-3-weekly ixabepilone arm, and in 21.9% of the paclitaxel-containing arm. Febrile neutropenia occurred rarely, at a 2.2% rate for the every-3-weekly ixabepilone/bevacizumab arm, and at 0.0% for the other 2 arms.
Overall response rates were 50% for weekly ixabepilone/bevacizumab, 71% for ixabepilone/bevacizumab every 3 weeks, and 56% for the paclitaxel/bevacizumab arm.
"Ixabepilone combined with bevacizumab as first-line therapy for patients with metastatic breast cancer given as a weekly or every-3-week schedule demonstrated encouraging activity relative to weekly paclitaxel and bevacizumab. Overall safety was similar between arms," Dr. Rugo concluded.

ASCO 2009: ABSTRACT #1029: Randomized phase II study of weekly versus every-3-week ixabepilone plus bevacizumab (ixa/bev) versus paclitaxel plus bev (pac/bev) as first-line therapy for metastatic breast cancer (MBC)
[American Society of Clinical Oncology]
Background: Pac/bev is superior to pac alone as first-line therapy for MBC. Ixa/bev has greater preclinical activity than pac/bev in human tumor models. The primary objective of this trial was to evaluate objective response rates (ORR) of ixa/bev given weekly or every 3 weeks relative to pac/bev as 1st line therapy for women with advanced breast cancer.
Methods: Women with measurable disease and no prior chemotherapy for advanced breast cancer (locally advanced or MBC) were randomized in a 3:3:2 ratio to Arm A (ixa 16 mg/m2 IV on days 1, 8 & 15 q28 days/ bev 10 mg/kg IV q 2 wks), Arm B (ixa 40 mg/m2 IV q3 wks / bev 15 mg/kg IV q 3 wks) or Arm C (pac 90 mg/m2 IV, schedule/bev as in Arm A). Treatment was continued until disease progression or unacceptable toxicity.
Results: Key efficacy and safety results from a pre-planned analysis of all randomized subjects after at least 24 weeks of follow-up are presented. Baseline characteristics were balanced between arms except for liver metastasis.
Conclusions: The combination of ixa/bev weekly or q 3 wks demonstrated encouraging clinical activity and safety comparable to 1st line pac/bev in E2100. Final PFS will be provided when data is mature. These results support ongoing clinical trials of ixa given weekly or q 3wk in 1st line MBC, and in combination with bev.
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