*Tomosynthesis gives "200 one-millimeter-thick images for an average sized breast, compared to 4 images in a regular 2-D digital mammogram" leading to 41 to 61% increase of cancer detection compared to standard 2-D digital mammography. It also reduces the return for additional imaging, according to a report by Donna Plecha, MD, Director of the Dept. of Radiology at UH, Case Western School of Medicine.
*Thomas Bachelot et al. submitted results of a phase II study related to use of Capecitabine and Lepatinib as first line therapy for patients with Brain metastasis from HER-2 positive Breast cancer. 45 patients enrolled, Median follow-up 21 months. 65.9% of patients had a partial response noted.
*Another Disparity: Although white Americans have twice as high an incidence of Bladder cancers, at similar grade and stage of disease, Black Americans do have a higher mortality!". There is a 5 fold relative risk for those who smoked 20cigarettes/day for over 40 years, compared, of course, to non smokers.
*Marginal Zone Lymphoma.includes:
-MALT
-Nodal type
-Primary splenic type which can have villious cells that can be confused with Hairy cell morphologically on peripheral blood.
has CD20+, CD5-, CD10-, CD23-
In extranodal cases, 60% have Trisomy 3 and t(11;18) which produce fusion API2and MLT, and will mark resistance to Antibiotics
API2 is an inhibitor of Apoptosis
MALT1 (procaspase) bind to Bcl-10 leading to activation of NF-bK which ultimately impair Apoptosis
Associated to Sjogren disease in some cases, in the stomach, associated with H.Pylori
Rituxan as a single agent, local RT,
A blog about research, awareness, prevention, treatment and survivorship of Breast Cancer and all cancers, including targeted scientific research and a grassroots approach to increase screening for cancer, especially in the low income and under-insured population of El Paso, Texas, with a view to expand this new health care model to many other 'minority' populations across the United States and beyond
Showing posts with label capecitabine. Show all posts
Showing posts with label capecitabine. Show all posts
Tuesday, February 5, 2013
Wednesday, January 16, 2013
FDA Approval for Ixabepilone
Brand name: Ixempra™ (this is old news)
- Approved for breast cancer
On October 16, 2007, the U.S. Food and Drug Administration (FDA) approved ixabepilone for injection (Ixempra™, made by Bristol-Myers Squibb) for the following two indications:
- Ixabepilone is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.
- Ixabepilone is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
Treatment arms were balanced with regards to prior therapies, disease sites, hormone receptor status and HER2 expression. Patients receiving combination therapy had a statistically significant improvement in progression-free survival (PFS), defined as radiologic progression or death from any cause (hazard ratio 0.69, p<0.0001). The median PFS was 5.7 months in the combination arm and 4.1 months in the capecitabine alone arm. Patients in the combination arm also had an increased objective tumor response rate. Survival data for this trial are not yet mature.
Ixabepilone monotherapy was evaluated in a single arm trial of 126 patients with metastatic or locally advanced breast cancer who had previously received an anthracycline, a taxane and capecitabine, and who had disease progression or, in the case of the anthracycline, received a minimum required cumulative dose. Ixabepilone was administered at the same dose and schedule as in the combination trial. The objective response rate based on independent radiologic review was 12.4 percent (95 percent CI: 6.9, 19.9). The objective response rate based on investigator assessments was 18.3 percent (95 percent CI: 11.9, 26.1). The median response duration was 6.0 months (95 percent CI: 5.0, 7.6).
Treatment with ixabepilone caused new or worsening peripheral neuropathy in approximately 65 percent of patients treated. Grade 3 or 4 peripheral neuropathy occurred in 23 percent of patients treated with ixabepilone and capecitabine, with no grade 3 or 4 peripheral neuropathy reported in the capecitabine arm. In the ixabepilone monotherapy trial, 14 percent experienced grade 3 or 4 peripheral neuropathy. Neuropathy was generally reversible to grade 1 or better with cessation of therapy.
Ixabepilone in combination with capecitabine resulted in a 68 percent incidence of grade 3 or 4 neutropenia compared to 11 percent with capecitabine alone. Twelve patients receiving ixabepilone in combination with capecitabine died from complications arising from neutropenia.
The incidence of neutropenia related deaths was higher in patients with baseline moderate or severe hepatic impairment when treated with both ixabepilone and capecitabine. This combination should not be used in patients with moderate or severe hepatic impairment. When used as monotherapy, 54 percent of patients treated with ixabepilone experienced grade 3 or 4 neutropenia.
Other commonly observed toxicities (>20 percent) included anemia, leukopenia, thrombocytopenia, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. The following additional reactions occurred in ≥20 percent in the combination treatment arm: palmar-plantar erythrodysesthesia (hand-foot) syndrome, anorexia, abdominal pain, nail disorder, and constipation.
This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.
The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Understanding the Approval Process for New Cancer Treatments.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.
=====================================================from FDA pages.
Ixabepilone,
from Sorangium cellulosum
promote tumor cell death by causing cell arrest in G2/Mphase.
has unique Beta -tubulin binding site
given 16mg/m2 (Vs 40mg Q21D )weekly for 3 weeks every 4weeks. (with Bevacizumab) or in combination with Xeloda as recommended appears to have been used in clinical trial.
The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Understanding the Approval Process for New Cancer Treatments.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.
=====================================================from FDA pages.
Ixabepilone,
from Sorangium cellulosum
promote tumor cell death by causing cell arrest in G2/Mphase.
has unique Beta -tubulin binding site
given 16mg/m2 (Vs 40mg Q21D )weekly for 3 weeks every 4weeks. (with Bevacizumab) or in combination with Xeloda as recommended appears to have been used in clinical trial.
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