Following a priority review, the US Food and Drug Administration (FDA) has approved Herceptin (trastuzumab for infusion, Genentech) in combination with three other agents for the adjuvant treatment of HER2-positive, node-positive breast cancer following lumpectomy or mastectomy.
At the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), researchers presented two analyses showing that in node-positive breast cancer, the nodal ratio—the number of positive nodes divided by the number of nodes resected—is superior to the absolute nodal count as a clinical predictor of treatment outcomes.
Most groups of women with early breast cancer who received radiotherapy after mastectomy in clinical trials conducted in the 1960s to 1980s continued to show fewer local recurrences and somewhat reduced breast cancer mortality after 15 years of follow-up, compared with controls who did not receive radiation, according to the latest analysis of the Early Breast Cancer Trialists Collaborative Group (EBCTCG).
AVEO Pharmaceuticals, Inc., has begun enrolling patients with advanced solid tumors in a phase I clinical study of AV-412, a next-generation oral tyrosine kinase inhibitor of EGFR and HER2. In preclinical studies, AV-412 has shown activity in various tumor models, has a toxicity profile similar to other molecules in its class, and has shown preclinical activity against tumor cells that are resistant to first-generation tyrosine kinase inhibitors, the company said in a press release.
GlaxoSmithKline's New Drug Application for Tykerb (lapatinib), an oral small molecule dual inhibitor of EGFR and HER2, has been granted priority review by the FDA. The designation requires that the agency decide on a drug application no longer than 6 months after submission, which was September 18, 2006, for Tykerb. The Tykerb application is for treatment of advanced or metastatic HER2-positive breast cancer in combination with capecitabine (Xeloda) for patients who have received prior treatment.
A device that displays a holograph-like 3-dimensional (3D) image, created from a CT, MRI, or PET dataset, holds promise for more accurate radiotherapy treatment planning (see image on page 1). James C. H. Chu, PhD, professor of radiation oncology, Rush University Medical Center, presented results of a pilot study of the Perspecta Spatial 3D System, developed by Actuality Systems, Inc. (Bedford, Massachusetts), at the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology
The FDA has approved the marketing of two silicone gel-filled breast implants, Inamed (Allergan) and MemoryGel (Mentor), for use in breast reconstruction in women of all ages and for breast augmentation in women ages 22 and older. The decision supporting the safety and efficacy of the devices came 14 years after FDA placed a moratorium on the use of silicone gel implants except in clinical trials because of concerns they might cause pain, deformity, connective tissue disease, and cancer if they ruptured. Saltwater-filled breast implants remained available.
The University of Texas M.D. Anderson Cancer Center has opened the first clinic in the world dedicated to the research and treatment of inflammatory breast cancer (IBC). The clinic, under the co-direction of Massimo Cristofanilli, MD, associate professor of breast medical oncology, and Thomas Buchholz, MD, professor of radiation oncology, is housed in the Nellie B. Connally Breast Center.
For women with advanced breast cancer, three taxane-based chemotherapy regimens that avoid the potentially cardiotoxic anthracyclines were all equally beneficial as first-line therapy in terms of survival and disease progression
Consuming soy during childhood, adolescence, and adult life is associated with a decreased risk of breast cancer, but the strongest and most consistent effect is childhood consumption, according to a recent collaborative study led by researchers from the National Cancer Institute (NCI)
Immunicon Corporation has announced that a major clinical trial using the CellSearch Assay has opened to enrollment. The randomized phase III trial (S0500), conducted by the Southwest Oncology Group (SWOG), is testing the strategy of changing therapy vs maintaining therapy for metastatic breast cancer patients who have elevated circulating tumors cells (CTCs) at first follow-up assessment. Immunicon will perform CTC testing for participating sites.
In their article, "Trastuzumab and Beyond: New Possibilities for the Treatment of HER2-Positive Breast Cancer," Drs. Morris and Carey provide an excellent summary of therapeutic progress in this disease, and also turn their attention to the challenge now facing us--that of understanding the heterogeneity of HER2-positive breast cancer and mechanisms of resistance to trastuzumab (Herceptin)-based therapy.
Genentech, Inc, recently announced that it received a Complete Response Letter from the US Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) with chemotherapy in first-line metastatic breast cancer.
One of the best examples of the "bench to bedside" process is the development of trastuzumab (Herceptin) for HER2-overexpressed breast tumors. From the identification of the neu oncogene in 1984[1] and its subsequent cloning,[2] to the development of a humanized monoclonal antibody targeting HER2 that improved outcome not only in the metastatic setting[3] but also in the adjuvant setting[4-7] has been a long yet fruitful journey.
Genentech, Inc, announced recently that the US Food and Drug Administration (FDA) approved trastuzumab (Herceptin), as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer.
Celebrating 20 years of providing practical reviews and peer commentaries to the oncology community in an effort to promote optimal cancer education and quality care for persons with cancer
Anthracycline- and taxane-based adjuvant chemotherapy regimens have become the most commonly used regimens in the United States for high-risk, early-stage breast cancer. Growth factor support is an essential component of therapy for several of the most commonly used adjuvant chemotherapy regimens that frequently cause substantial myelosuppression and anemia. Extensive data now exist to demonstrate the efficacy of both long- and short-acting myeloid growth factors in patients receiving dose-dense AC → paclitaxel. This article will explore prophylactic use of both filgrastim (Neupogen) and pegfilgrastim (Neulasta) in recent clinical trials.
Up to 25% of patients diagnosed with breast cancer have tumors that overexpress HER2. HER2-positive breast cancer is highly proliferative, difficult to treat, and confers a poor prognosis. The advent of the anti-HER2 monoclonal antibody trastuzumab (Herceptin) has markedly altered the clinical course of both early and advanced HER2-driven breast cancer. Despite the use of trastuzumab, however, patients with HER2-positive breast cancer still experience disease progression. Overcoming that resistance to therapy is our next challenge. This review examines the current understanding of HER2 biology, the mechanisms of action of and resistance to trastuzumab, as well as new therapies on the horizon.
Grade 3 and 4 neutropenia as well as febrile neutropenia have been demonstrated to occur in all tumor types and are clearly associated with major morbidity and significant mortality; this is particularly true when myelosuppressive regimens are used with curative intent as is the case in most breast cancer and non-Hodgkin's lymphoma regimens. Myeloid colony-stimulating factors (CSFs) substantially decrease the risk of severe and febrile neutropenia. Although the white cell growth factors might not be cost-effective at lower risks of febrile neutropenia, they clearly benefit other outcomes such as the incidence of severe neutropenia and febrile neutropenia, hospitalization, and mortality. Updated guidelines from the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the European Organisation for Research and Treatment of Cancer now recommend primary prophylaxis or first-cycle use of white cell growth factors with regimens where the occurrence of febrile neutropenia is approximately 20% (as well as when other risk factors are present). This article briefly describes the rationale for the development of several of the guideline changes as well as highlights some of the ongoing issues related to the use of CSFs.
Gene expression arrayshave extended the identification ofmolecular subtypes of breast cancerbeyond the presence or absence of theestrogen receptor (ER) and revealed themultiplicity of diseases within the breastcancer umbrella that have different prognoses.
White women havea higher incidence of breast cancer thanAfrican-American women, but African-American women develop the disease ata younger age, are diagnosed later, andare more likely to die of the disease, accordingto the National Cancer Institute.
The oral small-molecule lapatinib (Tykerb), a reversible dual tyrosine kinase inhibitor of HER1 (epidermal growth factor) and HER2 receptors (see mechanism of action image on page 1), produced clinical responses in some women with inflammatory breast cancer (IBC), a rare but aggressive form of the disease that is not usually detected by mammograms or ultrasound.
There is a role forultrasound in breast cancer screening anddiagnosis, but many physicians do notseem to know what it is, according toAnnette Brown, MD, a radiologist in theMammography Division of Long IslandCollege Hospital in Brooklyn. A
Although mastectomy is the preferred method of treatment for most patients with local recurrence of breast cancer in the preserved breast, repeat breast-conserving surgery followed by partial-breast radiotherapy is “generating a lot of excitement,” Seema A. Khan, MD, said at the 8th Annual Lynn Sage Breast Cancer Symposium.
Adding trastuzumab (Herceptin) to anastrozole (Arimidex) as adjuvant therapy for postmenopausal women with so-called copositive (hormone-receptor-positive, HER2-positive) metastatic breast cancer signficantly improved progression-free survival (PFS), compared with anastrozole alone, according to a study presented at the 31st Congress of the European Society for Medical Oncology (ESMO) (Late Breaking Abstract 2).
