Breast Cancer

TOP2A FISH pharmDx assay has received FDA approval for use as an adjunct to existing clinical and pathological information in determining the prognosis for patients with relatively high-risk breast cancer.

Four-year follow-up of the French/Belgian PACS-04 trial in early breast cancer found a trend toward benefit with sequential trastuzumab (Herceptin) in the first 18 months but, somewhat surprisingly, no difference in disease-free survival at 4 years. Marc Spielmann, MD, of the Institute Gustave Roussy, Villejuif, France, reported the findings at the 2007 San Antonio Breast Cancer Symposium (abstract 72).

FDA has given Genentech's antiangiogenesis agent Avastin (bevacizumab) accelerated approval for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.

In one of the most ambitious clinical trial efforts to date, a phase III study involving 8,000 participants in 50 countries across six continents will provide a head-to-head comparison of trastuzumab (Herceptin) and lapatinib (Tykerb) in HER2-positive patients with early-stage breast cancer who have recently completed chemotherapy.

The HER2-positive breast cancer population appears to be a heterogeneous group with a wide variation in response to trastuzumab (Herceptin). Higher levels of HER2 expression as well as HER2:HER2 dimerization were independently correlated with high response rates and longer time to progression in a study reported at the 2007 San Antonio Breast Cancer Symposium (abstract 2007).

In the neoadju-vant setting, adding the investigational agent RAD001 (everolimus) to letrozole (Femara) improves antitumor activity in breast cancer patients, with a tradeoff of some increased toxicity, according to results presented at the San Antonio Breast Cancer Symposium (abstract 2066).

The adjuvant treatment of breast cancer is facing a challenging phase due to the increasing knowledge of breast cancer biology and consequent need to personalize treatments. Medical oncologists are asked to practice evidence-based medicine, but their approach is often based on results of trials conducted in extremely heterogeneous populations.

Two targeted agents designed to treat HER2-positive breast cancer are being tested in a new study involving 8,000 participants in 50 countries across six continents-a clinical trial that investigators hope will provide a new model for global cancer research.

The US Food and Drug Administration (FDA) granted accelerated approval for bevacizumab (Avastin), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.

Breast cancer is the most common life-threatening malignancy in women, and the second leading cancer killer of women, claiming the lives of over 40,000 American women annually. Breast cancer incidence increases with advancing age until age 80, and the median age at diagnosis is 61.

The 21-gene recurrence score assay (Oncotype DX) was applied to early breast cancer patients with hormone-receptor and axillary lymph node positivity in two studies reported at the 2007 San Antonio Breast Cancer Symposium. Their findings suggest that the recurrence score can identify subsets most likely to benefit from chemotherapy.

A rapid molecular assay outperforms frozen sections when it comes to detecting breast cancer metastases in sentinel lymph nodes (SLNs), new data show. Moreover, the assay tends to perform better in cases where detection of metastases by frozen section is known to be difficult, such as cases of lobular carcinoma.

As first-line treatment for metastatic breast cancer in HER2-positive patients, trastuzumab (Herceptin) can be given as a single agent, followed by docetaxel (Taxotere) upon progression, without compromising time to recurrence and providing a better toxicity profile

Greater utilization of dynamic contrast-enhanced MRI at the University of California, San Diego, over a 6-year period helped improve surgery planning for tough breast cancer cases without hiking mastectomy rates

Sequential docetaxel (Taxotere)-based chemotherapy did not lead to better outcomes than standard anthracycline-based chemotherapy among women with resected breast cancer in the Taxotere as Adjuvant Chemotherapy Trial (TACT), the largest primary adjuvant trial of taxanes to date.

If therapeutic agents are documented to be more effective than standard therapies in the advanced breast cancer setting, they will also be effective in the adjuvant setting. This renders randomized phase III adjuvant trials unnecessary in many cases, and means that undue delays in moving new agents up-front are costing lives

Preliminary survival data are encouraging for the triple-drug combination of trastuzumab (Herceptin), docetaxel (Taxotere), and capecitabine (Xeloda) as first-line therapy for locally advanced or metastatic breast cancer

Studies show that thousands of women may be receiving the wrong breast cancer treatment because of faulty laboratory reports. More disturbing, this trend was identified years ago. A 2006 study led by Genentech found 14% to 16% of HER2 tests were false positive and 18% to 23% were false negative.

The FDA has approved a new indication for Genentech's Herceptin (trastuzumab) as a single agent for the adjuvant treatment of HER2-overexpressing, node-negative (ER/PR-negative or with one high-risk feature) or node-positive breast cancer, following multimodality anthracycline-based therapy.

Ixabepilone is indicated in combination with capecitabine(Xeloda) for the treatment of patients with metastatic orlocally advanced breast cancer resistant to prior anthracyclineand paclitaxel treatment (or for whom this treatmentis contraindicated).

MRI has outrun other modalities in a screening trial involving high-risk women. Such research helps justify an estimated $1.4 billion a year in direct costs for the United States if new American Cancer Society guidelines

The combination of capecitabine (Xeloda) and ixabepilone (Ixempra) appears to be robust in patients with the so-called triple-negative breast cancer phenotype

By a 5-4 vote, the Oncology Drugs Advisory Committee failed to recommend that FDA approve Avastin (bevacizumab, Genentech) in combination with paclitaxel as a first-line treatment for locally recurrent or metastatic, HER2-negative breast cancer.

Breast MRI identifies mammographically occult secondary tumors in about 6% of women with early-stage breast cancer who would otherwise qualify for partial breast irradiation

In the neoadju-vant treatment of early breast cancer, fulvestrant (Faslodex) 500 mg effected a greater reduction in biomarkers of proliferation and produced more responses than the standard 250 mg dose

African-American women with early-stage breast cancer are more likely than their Caucasian counterparts to experience a relapse after breast-conserving therapy, but the absolute difference in risk is small

Studies presented at the 2007 San Antonio Breast Cancer Symposium raise new questions about the role of anthracycline-based regimens as adjuvant therapy in early breast cancer, suggesting that these regimens may be appropriate only for a small subset of patients.

Partial breast irradiation (PBI) with concurrent chemotherapy is feasible and is associated with an acceptable rate of toxicity

A cutting-edge prognostic tool called MammaPrint, developed by Agendia, a laboratory located in The Netherlands, uses molecular technology to predict whether breast cancer will metastasize, helping clinicians make more accurate management decisions for their patients.

Use of accelerated partial breast irradiation (APBI) with multicatheter brachytherapy to treat resected early-stage breast cancer is associated with good early outcomes in terms of local control, adverse effects, and cosmesis