Breast Cancer

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Approximately 212,920 new cases of invasive breast cancer were estimated to occur in the United States in 2006.1 The incidence rate has continued to rise slowly over the past 20 years due to the continued increase of breast cancer in women aged 50 and older (375 cases per 100,000 women), peaking at 75 to 79 years of age (525 per 100,000 women).

Specifically, they looked at lapatinib (Tykerb), which was FDA approved last March for use in patients with metastatic HER2-positive breast cancer in combination with capecitabine (Xeloda).

In the first overall survival analysis of the BCIRG 007 study in metastatic breast cancer, the addition of carboplatin to a docetaxel (Taxotere)/trastuzumab (Herceptin) regimen did not improve overall survival.

Eli Lilly and Co announced that the Oncologic Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted to recommend approval of its osteoporosis drug raloxifene (Evista) for a new use, to reduce invasive breast cancer risk in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer.

After first-line treatment with chemotherapy for metastatic breast cancer, maintenance therapy with pegylated liposomal doxorubicin (Doxil) may significantly improve time to progression (TTP), according to a multicenter phase III study from the Spanish Cooperative group GEICAM reported at the 43rd Annual Meeting of the American Society of Clinical Oncology (abstract 1007).

Schering-Plough Corp announced results from a phase III study that showed maintenance chemotherapy with pegylated liposomal doxorubicin hydrochloride (Doxil, marketed in Canada and Europe as Caelyx) significantly prolonged time to progression (TTP) in patients with metastatic breast cancer with infrequent and manageable clinical toxicity after first-line chemotherapy.

Despite the concerns of some members of the Oncologic Drugs Advisory Committee (ODAC) and the opposition of several advocacy groups, the panel recommended that the Food and Drug Administration approve two cancer-related indications for Evista (raloxifene), Eli Lilly's selective estrogen-receptor modulator (SERM).

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

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.

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.