Navigation Links
Eribulin mesylate demonstrated anti-tumor activity in patients with advanced breast cancer

Woodcliff Lake, N.J., May 15, 2008The investigational chemotherapeutic agent eribulin mesylate (E7389) demonstrated activity in a heavily pretreated population of women with locally advanced or metastatic breast cancer, according to results of a multi-center Phase II clinical trial. The study also suggests that eribulin mesylate has a manageable tolerability profile, with a low incidence of Grade 3 (severe) and no Grade 4 (disabling or life-threatening) neuropathy. These data (abstract #1084) will be presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) on Monday, June 2 from 2 to 6 p.m. at S Hall A1 of McCormick Place.

The anti-tumor activity of eribulin mesylate, as observed in this study, is encouraging, given the limited treatment options for women with advanced breast cancer who have previously received multiple lines of therapy, said lead investigator Linda T. Vahdat, MD, of Weill Cornell Medical College in New York. The subjects in this trial had received a median of four prior chemotherapy regimens that included an anthracycline, a taxane and capecitabine.

About Study 211 Study 211 is a Phase II, open-label, single-arm study evaluating the efficacy and safety of eribulin mesylate in patients with locally advanced or metastatic breast cancer who had received an anthracycline, a taxane and capecitabine as prior therapy, and who were refractory to their last chemotherapy regimen, as documented by progression on or within six months of that therapy.

Of 299 patients enrolled in the study, 291 were treated with eribulin mesylate. The median age of those patients was 56 years (range: 26-80 years). Eribulin mesylate was administered at a dose of 1.4mg/m2 as a 2- to 5-minute intravenous infusion on Days 1 and 8 of a 21-day cycle. Patients received a median of four cycles of eribulin mesylate (range 1-27). No premedication to prevent hypersensitivity was required.

Two-hundred sixty-nine patients met the key inclusion criteria. In patients who received a median of four cycles of eribulin mesylate, Overall Response Rate (ORR) by Independent Review (IR) was 9.3% (all Partial Responses (PR); 95% confidence interval [CI]: 6.1%-13.4%). Investigator-assessed ORR was 14.1% (1 CR; 95% CI: 10.2%-18.9%). Nearly half (46.5%) the patients had stable disease (SD) after treatment with eribulin mesylate. The clinical benefit rate (CBR, defined as CR+PR+SD 6 months) was 17.1% (95% CI: 12.8%-22.1%).

The median duration of response was 4.2 months (126 days, range: 42 -258 days; 95% CI: 86-147). Median progression-free survival (PFS) was 2.6 months (79 days, range: 1*-397 days), and the median overall survival (OS) rate was 10.3 months (315 days, range: 19-604 days; 95% CI: 279-350). The six-month PFS and OS rates were 16.0% (95% CI: 8.6-17.0) and 72.3%, respectively (95% CI: 66.9-77.6).

The safety analysis included all 291 patients who received treatment with eribulin mesylate. Patients with up to Grade 2 peripheral neuropathy were included in the study. The most frequently reported Grade 3 (severe) or Grade 4 (disabling or life- threatening) adverse events were neutropenia (a decrease in the number of granular white blood cells, 54%); febrile neutropenia, 5.5%, leukopenia (low white blood cell count, 14%), and weakness/fatigue (10%; no Grade 4 events). Grade 3 peripheral neuropathy (a functional disturbance or damage to nerves outside the brain and spinal cord) was reported in 5.5% of patients. No Grade 4 peripheral neuropathy events were reported. No correlation was seen between Grade 2 peripheral neuropathy and deterioration.

"In this study, eribulin mesylate appeared to have an acceptable tolerability profile, particularly with regard to the low incidence of peripheral neuropathy," noted Vahdat. "None of the reported cases of neuropathy were disabling, suggesting that eribulin mesylate, if approved, may be a useful addition to the treatment armamentarium for advanced breast cancer."


Contact: Judee Shuler
Eisai Inc.

Related biology news :

1. UM coral scientist Peter Glynn wins award for scholarly activity
2. Blood pressure drug telmisartan shows powerful activity against stroke
3. Cold Spring Harbor Protocols highlights a method that captures cell growth and activity
4. CAPHOSOL relieves oral mucositis and improves quality-of-life in cancer patients
5. Cell-based therapy shows promise in patients with Parkinsons disease
6. Scientists test device to track medication adherence in patients with HIV/AIDS
7. Three Dimensional Visualization of Right Ventricle Provides Important Information for Treatment of Patients with Tetralogy of Fallot, According to a Study in The American Journal of Cardiology
8. New chemotherapy combo produces side effects, but no extra efficacy, in early breast cancer patients
9. Pregnant patients lose out in breast cancer treatment; a new approach is needed
10. Mental stress reduces blood flow to the heart in patients with gene variation
11. 2 new therapies show promise for cancer patients
Post Your Comments:
(Date:11/9/2015)... 09, 2015 ... the "Global Law Enforcement Biometrics Market ... --> ) has announced the ... Biometrics Market 2015-2019" report to their ... ( ) has announced the addition ...
(Date:10/29/2015)...   MedNet Solutions , an innovative SaaS-based eClinical ... research, is pleased to announce that it has been ... one of only three finalists for a 2015 ... Growing" category. The Tekne Awards honor Minnesota ... innovation and leadership. iMedNet™ eClinical ...
(Date:10/29/2015)... Oct. 29, 2015  Connected health pioneer, Joseph ... explosion of technology-enabled health and wellness, and the business ... The Internet of Healthy Things . ... smartphones even existed, Dr. Kvedar, vice president, Connected Health, ... care delivery, moving care from the hospital or doctor,s ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... --> --> ... by Transparency Market Research, the global non-invasive prenatal testing ... 17.5% during the period between 2014 and 2022. The ... Analysis, Size, Volume, Share, Growth, Trends and Forecast 2014 ... to reach a valuation of US$2.38 bn by 2022. ...
(Date:11/24/2015)... ... November 24, 2015 , ... In harsh industrial ... points for in-line sensors can represent a weak spot where leaking process media ... of retractable sensor housings , which are designed to tolerate extreme process conditions. ...
(Date:11/24/2015)... LOS ANGELES , Nov. 24, 2015 ... a biotechnology company focused on the discovery, development and ... Marban , Ph.D., Chief Executive Officer, is scheduled to ... December 1, 2015 at 10:50 a.m. EST, at The ... York City . . ...
(Date:11/24/2015)... ... , ... Whitehouse Laboratories is pleased to announce that it has completed construction ... dedicated to basic USP 61, USP 62 and USP 51 testing specific to raw ... and micro testing performed by one supplier. Management has formally announced that ...
Breaking Biology Technology: