Breast Cancer

The National Cancer Institute (NCI) has rejected funding for the proposed P-4 clinical trial in which researchers planned to compare raloxifene (Evista) and letrozole (Femara) as breast cancer prevention agents.

In an ongoing phase I trial in patients with solid tumors and lymphomas, the small-molecule tumor vascular disrupting agent NPI-2358 (Nereus Pharmaceuticals, San Diego, California) was dose escalated without evidence of dose-limiting toxicity

Adding the investigational agent ixabepilone to capecitabine (Xeloda) resulted in a significant improvement in progression-free survival (PFS), compared with capecitabine alone

A new study indicates that the Oncotype DX Recurrence Score (RS) is being used to change treatment decisions regarding adjuvant therapy in patients with early-stage node-negative, estrogen-receptor-positive breast cancer

A biweekly dosing regimen of capecitabine (Xeloda) was well tolerated in a dose-escalation study of metastatic breast cancer patients, allowing safe delivery of higher daily doses than routinely used in practice

42-year-old Caucasian female who was in her usual state of health when her first mammogram showed suspicious calcifications and a spiculated mass in the upper outer quadrant of the right breast. An ultrasound-guided biopsy showed an invasive ductal carcinoma. She underwent a lumpectomy, with the excised tumor measuring 1.2 cm. The tumor was estrogen and progesterone positive and HER2/neu negative.

The recommended primary treatment approach for women with metastatic breast cancer and an intact primary tumor is the use of systemic therapy. Local therapy of the primary tumor is recommended only for palliation of symptoms. However, a series of retrospective studies examining practice patterns for this problem show that about half the women presenting with de novo metastatic disease undergo resection of the primary tumor, and suggest that women so treated survive longer than those who do not undergo resection of the intact primary. In analyses that adjust for tumor burden (number of metastatic sites), types of metastases (visceral, nonvisceral), and the use of systemic therapy, the hazard ratio for death is reduced by 40% to 50% in women receiving surgical treatment of the primary tumor. The benefit of surgical treatment appears to be confined to women whose tumors were resected with free margins. However, these results may simply reflect a selection bias (ie, younger, healthier women with a smaller tumor burden are more likely to receive surgical treatment). In addition, the role of other locoregional therapy such as axillary dissection and radiotherapy is not addressed in these studies. In view of these data, the role of local therapy in women with stage IV breast cancer needs to be reevaluated, and local therapy plus systemic therapy should be compared to systemic therapy alone in a randomized trial.

The US Food and Drug Administration (FDA) has accepted, for filing and priority review, the New Drug Application (NDA) for Bristol-Myers Squibb's investigational compound ixabepilone, an epothilone B analog.

Bristol-Myers Squibb reported results from a large randomized phase III study of the investigational compound ixabepilone in patients with breast cancer whose disease had rapidly progressed through, or did not respond to, prior treatment with chemotherapies (anthracycline and taxane). Results showed that patients treated with ixabepilone in combination with capecitabine (Xeloda), experienced a statistically significant improvement in progression-free survival, the primary endpoint, compared to patients treated with capecitabine alone.

The recommended primary treatment approach for women with metastatic breast cancer and an intact primary tumor is the use of systemic therapy. Local therapy of the primary tumor is recommended only for palliation of symptoms. However, a series of retrospective studies examining practice patterns for this problem show that about half the women presenting with de novo metastatic disease undergo resection of the primary tumor, and suggest that women so treated survive longer than those who do not undergo resection of the intact primary. In analyses that adjust for tumor burden (number of metastatic sites), types of metastases (visceral, nonvisceral), and the use of systemic therapy, the hazard ratio for death is reduced by 40% to 50% in women receiving surgical treatment of the primary tumor. The benefit of surgical treatment appears to be confined to women whose tumors were resected with free margins. However, these results may simply reflect a selection bias (ie, younger, healthier women with a smaller tumor burden are more likely to receive surgical treatment). In addition, the role of other locoregional therapy such as axillary dissection and radiotherapy is not addressed in these studies. In view of these data, the role of local therapy in women with stage IV breast cancer needs to be reevaluated, and local therapy plus systemic therapy should be compared to systemic therapy alone in a randomized trial.

The recommended primary treatment approach for women with metastatic breast cancer and an intact primary tumor is the use of systemic therapy. Local therapy of the primary tumor is recommended only for palliation of symptoms. However, a series of retrospective studies examining practice patterns for this problem show that about half the women presenting with de novo metastatic disease undergo resection of the primary tumor, and suggest that women so treated survive longer than those who do not undergo resection of the intact primary. In analyses that adjust for tumor burden (number of metastatic sites), types of metastases (visceral, nonvisceral), and the use of systemic therapy, the hazard ratio for death is reduced by 40% to 50% in women receiving surgical treatment of the primary tumor. The benefit of surgical treatment appears to be confined to women whose tumors were resected with free margins. However, these results may simply reflect a selection bias (ie, younger, healthier women with a smaller tumor burden are more likely to receive surgical treatment). In addition, the role of other locoregional therapy such as axillary dissection and radiotherapy is not addressed in these studies. In view of these data, the role of local therapy in women with stage IV breast cancer needs to be reevaluated, and local therapy plus systemic therapy should be compared to systemic therapy alone in a randomized trial.

Removal of the primary breast tumor in patients with stage IV breast cancer was associated with significantly longer survival

Repetitive injections of a synthetic peptide vaccine in combination with a strong adjuvant prevented spontaneous tumors and caused established tumors to regress in a mouse model of HER2/neu breast cancer

Xoft, Inc.'s Axxent Electronic Brachytherapy System for accelerated partial breast irradiation (APBI) recently had its first clinical use in two lumpectomy patients treated at WellStar Kennestone Hospital.

Dynamic positron emission tomography (PET) imaging with a novel [18F]-labeled cyclic peptide tracer appears able to detect primary breast tumors and metastatic lesions to a variety of organs.

The third-generation epothilone KOS-1803 may optimize tumor penetration while limiting exposure to other tissues

BRIDGEWATER, New Jersey—Enzon Pharmaceuticals, Inc.'s PEG-SN38, a novel polyethyleneglycol-SN38 conjugate, resulted in significant tumor growth inhibition in mice resistant to irinotecan (Camptosar) (a 25% decrease in tumor volume) and outperformed irinotecan when given as a second-round therapy to mice initially sensitive to irinotecan, the company said in a news release. The data were presented at the American Association for Cancer Research 2007 meeting (abstract 1494). Additionally, PEG-SN38 demonstrated long-lasting anti-tumor activity in mouse models of human breast and pancreatic cancers, the company said.

A novel vitamin E-based paclitaxel emulsion may be less neurotoxic than the currently approved taxanes, including cremophor-based paclitaxel (Taxol), nab-paclitaxel (albumin-bound) (Abraxane), and docetaxel (Taxotere)

We present a case of intracystic papillary carcinoma of the breast associated with low-grade ductal carcinoma in situ in a young woman. This is a distinct subtype of intraductal carcinoma that typically presents in postmenopausal women with a favorable prognosis.

Computer software used to help decipher screening mammograms reduces interpretation accuracy, increases the rate of unnecessary biopsies, and offers no clear improvement in the detection of invasive breast cancer, the largest and most comprehensive community-based study of the technology has found.

Reduced use of hormone replacement therapy (HRT) may explain the significant decline in the age-adjusted rate of new breast cancers that occurred in 2003 and was maintained in 2004.

Issues surrounding magnetic resonance imaging (MRI) for breast cancer and what to do with the BRCA-positive patient

Using the aromatase inhibitor letrozole (Femara) in postmenopausal hormone-receptor-positive breast cancer patients resulted in significantly fewer early relapses than tamoxifen, even after adjusting for significant prognostic factors, researchers for the BIG 1-98 trial

A key issue for oncologists treating breast cancer patients with preoperative chemotherapy remains whether to perform sentinel lymph node (SLN) biopsy before or after administering the drugs.

HER2 testing recommendations and the importance of determining a woman's true menopausal status were the highlights of the updated breast cancer guidelines

Inflammatory breast cancer (IBC) is a rare and aggressive form of the disease. It is diagnosed based on clinical signs of a rapidly enlarging, tender, erythematous, edematous breast that often presents without an underlying breast mass. IBC historically was considered a uniformly fatal disease. With the advent of multimodality treatments including primary systemic chemotherapy, surgery, and radiation therapy, approximately one-third of women diagnosed with IBC will become long-term survivors. This review examines the limitations of the current definition of IBC, explores our current understanding of the biology of IBC, and reviews the many exciting advances in locoregional and systemic treatment of IBC.

Spectrum Pharmaceuticals, Inc, recently announced that the New Drug Application (NDA) for satraplatin has been accepted for priority review by the US Food and Drug Administration (FDA). A Prescription Drug User Fee Act date of August 15, 2007, has been established by the FDA for a decision regarding the approval of the satraplatin application. Satraplatin is an investigational drug for the treatment of hormone-refractory prostate cancer in patients who have failed prior chemotherapy.

The development of imatinib mesylate (Gleevec), a tyrosine kinase inhibitor targeted against the causative Bcr-Abl protein in chronic myeloid leukemia (CML), has resulted in hematologic and cytogenetic remissions in all phases of CML. Following imatinib treatment, more than 90% of patients obtain complete hematologic response, and 70% to 80% achieve a complete cytogenetic response. With 5 years of follow-up, the data are very encouraging, exhibiting a major change in the natural history of the disease. The understanding of at least some of the mechanisms of resistance to imatinib has led to a rapid development of new agents that may overcome this resistance. Combination strategies are currently being investigated in preliminary clinical studies and may prove to be useful. Overall, there are an increasing number of treatment options now available for patients with CML.

Study results published by the Journal of Clinical Oncology show that adding erlotinib (Tarceva) to gemcitabine (Gemzar) chemotherapy significantly improves survival by 22% in patients with advanced pancreatic cancer.

Inflammatory breast cancer (IBC) is a rare and aggressive form of the disease. It is diagnosed based on clinical signs of a rapidly enlarging, tender, erythematous, edematous breast that often presents without an underlying breast mass. IBC historically was considered a uniformly fatal disease. With the advent of multimodality treatments including primary systemic chemotherapy, surgery, and radiation therapy, approximately one-third of women diagnosed with IBC will become long-term survivors. This review examines the limitations of the current definition of IBC, explores our current understanding of the biology of IBC, and reviews the many exciting advances in locoregional and systemic treatment of IBC.