Nancy,
Looks like T-DM1 is the answer for heavily pre-treated patients:
J Clin Oncol. 2011 Feb 1;29(4):398-405. Epub 2010 Dec 20.
Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy.
Burris HA 3rd,
Rugo HS,
Vukelja SJ,
Vogel CL,
Borson RA,
Limentani S,
Tan-Chiu E,
Krop IE,
Michaelson RA,
Girish S,
Amler L,
Zheng M,
Chu YW,
Klencke B,
O'Shaughnessy JA.
Source
Sarah Cannon Research Institute, Nashville, TN 37203-1632, USA.
howard.burris@scresearch.net
Abstract
PURPOSE:
The antibody-drug conjugate trastuzumab-DM1 (T-DM1) combines the biologic activity of trastuzumab with
targeted delivery of a potent antimicrotubule agent, DM1, to human epidermal growth factor receptor 2 (
HER2)-overexpressing
cancer cells. Based on results from a phase I study that showed T-DM1 was well tolerated at the maximum-tolerated dose of 3.6 mg/kg every 3 weeks, with evidence of efficacy, in
patients with
HER2-positive metastatic
breast cancer (MBC) who were previously treated with trastuzumab, we conducted a phase II study to further define the safety and efficacy of T-DM1 in this patient population.
PATIENTS AND METHODS:
This report describes a single-arm phase II study (TDM4258g) that assessed efficacy and safety of intravenous T-DM1 (3.6 mg/kg every 3 weeks) in
patients with
HER2-positive MBC who had tumor progression after prior treatment with
HER2-directed
therapy and who had received prior chemotherapy.
RESULTS:
With a follow-up of ≥ 12 months among 112 treated
patients, the objective response rate by independent assessment was 25.9% (95% CI, 18.4% to 34.4%). Median duration of response was not reached as a result of insufficient events (lower limit of 95% CI, 6.2 months), and median progression-free survival time was 4.6 months (95% CI, 3.9 to 8.6 months). The response rates were higher among
patients with confirmed
HER2-positive tumors (immunohistochemistry 3+ or fluorescent in situ hybridization positive) by retrospective central testing (n = 74). Higher response rates were also observed in
patients whose tumors expressed ≥ median
HER2 levels by quantitative reverse transcriptase polymerase chain reaction for
HER2 expression, compared with
patients who had less than median
HER2 levels. T-DM1 was well tolerated with no dose-limiting cardiotoxicity. Most adverse events (AEs) were grade 1 or 2; the most frequent grade ≥ 3 AEs were hypokalemia (8.9%), thrombocytopenia (8.0%), and fatigue (4.5%).
CONCLUSION:
T-DM1 has robust single-agent activity in
patients with
heavily pretreated,
HER2-positive MBC and is well tolerated at the recommended phase II dose.
__________________
Jackie07
http://www.kevinmd.com/blog/2011/06/doctors-letter-patient-newly-diagnosed-cancer.html
http://www.asco.org/ASCOv2/MultiMedi...=114&trackID=2
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