Your AI-Trained Oncology Knowledge Connection!
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).
A first-in-class HER2 antibody-drug conjugate may represent an effective new strategy in breast cancer therapy, according to phase I data
Nanoparticle albumin-bound (nab) rapamycin (ABI-009) showed antitumor activity in xeno-graft models of breast and colon cancer, according to investigators from Abraxis BioScience
Breast cancer is the most commonly diagnosed cancer in women and is the second leading cause of cancer-related mortality, after lung cancer. The overall incidence of breast cancer was increasing until recently, but mortality has declined since 1990, presumably due to earlier detection and better treatments.
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)
