From the Sugen thieves....
Oct. 13 /PRNewswire/ -- New data on treatments that may limit the growth of existing tumors and prevent cancer development in high-risk patients were presented during a symposium held today as part of the biennial congress of the European Society for Medical Oncology. The latest data on AROMASIN® (exemestane tablets) in breast cancer, SU5416 in colorectal cancer and the promise of COX-2 specific inhibitors were among the features.
AROMASIN®
AROMASIN, the only oral aromatase inactivator, is being studied for the first-line, adjuvant (after surgery) and neoadjuvant (before surgery) treatment of breast cancer. AROMASIN is currently indicated for the treatment of advanced breast cancer in postmenopausal women whose tumors have stopped responding to anti-estrogen therapy such as tamoxifen. It is the first in a new class of oral hormonal inactivator therapies. Aromatase inactivators permanently bind with the aromatase enzyme, preventing it from producing estrogen, which some breast cancer tumors need for growth. This contrasts with aromatase inhibitors that only interfere with the aromatase enzyme in a reversible manner.
Early results from a Phase II study comparing AROMASIN® (exemestane tablets) with tamoxifen in advanced breast cancer indicate improvements in the objective response rate, a measurement of how the tumor optimally reacts to the treatment, (42 percent vs. 16 percent) and average time of tumor growth and spread (8.9 vs. 5.2 months) in favor of AROMASIN, in 63 evaluable patients. Additionally, women treated with AROMASIN experienced fewer side effects (fatigue, pain, hot flashes, sweating and nausea) in comparison to those treated with tamoxifen. Based on this promising preliminary clinical data, the European Organization for Research and Treatment of Cancer (EORTC) expanded this study to a Phase III trial.
``AROMASIN is a promising breast cancer therapy,'' said Per Eystein L0nning, M.D., Professor, Department of Medicine, Section of Oncology, Haukeland University Hospital, Bergen, Norway. ``Our work suggests a role for AROMASIN in many stages of the disease.''
Results from a recently completed Phase II neoadjuvant study were also presented. In this treatment approach, AROMASIN is provided to patients in an effort to shrink large primary breast cancers prior to surgical removal. This method of treatment is important for women who are considering breast conserving surgical options rather than a mastectomy. In a sample of 13 postmenopausal women with estrogen receptor-positive breast cancer, AROMASIN provided over the course of three months resulted in a median tumor volume reduction of 83 percent (as assessed by ultrasound).
The efficacy of AROMASIN in the adjuvant treatment for breast cancer is being examined in worldwide clinical trials involving more than 7,000 patients. In addition, its potential in the prevention of breast cancer is currently being investigated in other clinical trials.
SU5416
Results from clinical studies of SU5416, an angiogenesis signaling inhibitor, in the treatment of advanced colorectal cancer were presented. SU5416 works by inhibiting angiogenesis, the growth of new blood vessels. In cancer, angiogenesis is the process by which tumors create their own blood supply to provide nutrients and oxygen essential for their growth.
In a Phase I/II study of 27 evaluable patients treated with SU5416 in combination with 5-FU/leucovorin, 37 percent of patients had a complete or partial response to treatment as patients' tumors were reduced by greater than 50 percent of their original size. Forty-four percent of patients had stable disease, meaning tumors were unchanged having neither grown nor reduced in size. Only seven percent of patients showed no response to the treatment. Among this group of patients with previously untreated advanced cancer, tumor growth and spread was delayed for a median of 9.0 months. Twenty-one of the 27 patients are still alive, so median survival data is unavailable.
``Our studies suggest that SU5416 may make a significant difference for patients with colorectal cancer,'' said Lee Rosen, M.D., Assistant Professor, Director of Cancer Therapy Development Program, UCLA Medical Center. ``New trials are being initiated across Europe that will allow the European oncology community and patients to participate in the progress of this exciting therapy.''
Trial sites throughout Europe are being enlisted to continue research of SU5416 in advanced colorectal cancer. SU5416 is also currently being studied in the US and Germany for the treatment of acute myeloid leukemia. Oral forms of SU5416 are now being evaluated.
SU5416, a synthetic small molecule inhibitor, is novel because it blocks a protein called the vascular endothelial growth factor receptor (VEGF-R). By blocking the VEGF-R, SU5416 could block the ability of tumors to form blood vessels, thus starving tumors to slow or halt their growth.
COX-2 specific inhibitors
Celebrex® (celecoxib capsules) is the first and only pharmacologic agent approved in the United States to reduce the number of pre-cancerous (adenomatous) polyps in the treatment of familial adenomatous polyposis (FAP), as an oral adjunct to usual care (endoscopic surveillance and surgery). FAP is an inherited condition in which pre-cancerous polyps grow in the colon. Left untreated, virtually all patients with FAP develop colon cancer by age 40 to 50. Adenomatous polyps are a precursor to more than 95 percent of all colorectal cancers(1).
Preclinical data presented suggest a possible role for Celebrex in the potential prevention of several cancers. Celebrex, a COX-2 specific inhibitor, is currently in worldwide clinical trials to determine whether it can reduce the occurrence of other forms of pre-cancerous polyps in the colon. Celebrex is also being investigated across many other pre-malignant conditions.
Celebrex has been available in the United States since January 1999, where it is the number-one prescribed osteoarthritis and adult rheumatoid arthritis medication. Already available in Germany, the United Kingdom, Italy and Spain, it is now being launched throughout Europe. Celebrex is co-promoted by Pharmacia Corporation and Pfizer Inc.
Celebrex has not been shown to reduce the risk of gastrointestinal (GI) cancer or the need for any FAP-related surgeries; therefore, usual endoscopic surveillance and surgery schedules should not be altered.
The symposium, entitled ``Bringing Discovery to Life: Innovative Agents in Development for the Treatment and Prevention of Cancer,'' was sponsored by Pharmacia Oncology in collaboration with the University Clinic of Lubeck in Lubeck Germany.
Pharmacia Oncology is bringing discovery to life for every person touched by cancer.
The current oncology portfolio includes AROMASIN® (exemestane tablets); FARMORUBICIN®/ELLENCE(TM) (epirubicin hydrochloride injection); CAMPTOSAR® (irinotecan hydrochloride injection); IDAMYCIN® (idarubicin hydrochloride injection); and ZINECARD® (dexrazoxane injection). Products in development include signaling inhibitors SU5416 and SU6668 and other compounds for the treatment of patients with cancer occurring in various forms.... |
