Definitely, oncology field is marketing (political?) battleground this days!
Sunday May 19, 10:45 am Eastern Time
Press Release
SOURCE: Novartis Oncology
Head-to-Head Worldwide Study of the Two Leading Aromatase Inhibitors Shows More Women Respond to Femara(R) Than Arimidex(R) in Advanced Breast Cancer
Study in Second-Line Breast Cancer Setting Presented At American Society of Clinical Oncology Meeting Shows Significantly Greater Objective Response Rate with Femara
EAST HANOVER, N.J., May 19 /PRNewswire-FirstCall/ -- In a head-to-head worldwide study of the two leading aromatase inhibitors, data demonstrate that 50% more women respond to Femara® (letrozole tablets) than to Arimidex® (anastrozole) in advanced breast cancer. This means that more women treated with Femara had at least a 50% reduction in the size of their tumor. The data from this multi-center, international study of 713 postmenopausal women with ER+ and/or PgR+ or ER/PgR status unknown receiving second-line treatment for advanced disease were presented today at the 38th annual meeting of the American Society of Clinical Oncology (ASCO).
"It is becoming increasingly evident that aromatase inhibitors are challenging and are likely to replace tamoxifen in the treatment of postmenopausal women with endocrine-dependent breast cancer. Studies like this are critical because they provide evidence to identify the aromatase inhibitor most likely to work best," said Carsten Rose, M.D., Director, Department of Oncology, Universitatkliniken, Onkologiska Klinik, Lund, Sweden, and principal study investigator. "The data in this trial show that more women respond to Femara than to Arimidex, which is important information for physicians to consider when treating advanced breast cancer patients."
Study Design
The data are from a randomized, open-label study of 713 postmenopausal women who were estrogen and/or progesterone receptor positive (ER+ and/or PgR+) or ER/PgR status unknown. The study was conducted in 19 countries and compared the efficacy of Femara vs. Arimidex in women with metastatic breast cancer following failure of anti-estrogen therapy (e.g., tamoxifen). The primary and secondary endpoints of the study were time to disease progression, objective response rate, duration of objective response, overall clinical benefit, time to treatment failure, and survival. Patients were randomly allocated Femara 2.5 mg once-daily or Arimidex 1 mg once-daily.
Fifty percent more women responded to Femara than to Arimidex (based on objective response rate) (Femara group 19% vs. Arimidex group 12%, P=0.013). Complete response rate (complete tumor disappearance) was 7% for Femara vs. 4% for Arimidex. No statistically significant differences were seen in time to disease progression (primary endpoint) or any other endpoints.
Both Femara and Arimidex were generally well-tolerated and there were no statistically significant differences between treatment arms in reported frequencies of adverse events, including serious adverse events.
"The use of aromatase inhibitors is increasing and physicians need compelling data by which they can make the right choice for the treatment of breast cancer," said David Parkinson, M.D., Vice President, Clinical Research, Novartis Oncology. "The consistent efficacy and overall performance of Femara in the various clinical settings is extremely encouraging, and Novartis is looking forward to the results of the ongoing Femara adjuvant studies."
Data Demonstrating Consistent Performance of Femara
Femara Offers Enhanced Inhibition of Estrogen and Aromatase Compared to Arimidex
The head-to-head results represent the most recent data in a series of studies, which have compared the third generation aromatase inhibitors Femara and Arimidex. An earlier head-to-head study compared the ability of Femara and Arimidex to inhibit total body aromatization and suppress plasma estrogen levels in 12 postmenopausal women with metastatic breast cancer. Two out of three estrogen components were more significantly suppressed by Femara. Hormone sensitive breast cancers rely on estrogen for growth, and in this study, Femara was shown to be a more effective inhibitor of total body aromatization and suppressor of plasma estrogen levels as compared to Arimidex. The clinical relevance of this finding is yet to be determined.
The data from the head-to-head study of Femara versus Arimidex presented today at ASCO are the most recent in a series of clinical studies that demonstrate that Femara is a more effective aromatase inhibitor than Arimidex in terms of inhibiting aromatase and achieving a greater objective response rate.
Femara versus Tamoxifen -- Survival Data in First-Line Setting
These new data add to the growing body of medical and scientific knowledge regarding Femara. Reported at the San Antonio Breast Cancer Conference in December 2001 were the results of a study of 907 postmenopausal women comparing Femara to tamoxifen as first-line therapy in women with locally advanced or metastatic breast cancer. The results demonstrated that Femara had a statistically significant survival advantage compared to tamoxifen at one and two years. No other aromatase inhibitor has shown a survival advantage vs. tamoxifen to date. The data also demonstrated that, approximately five years after initiation of the study (November, 1996), more women who had begun their therapy on Femara were still alive and free of tumor progression compared to those who started on tamoxifen. In addition, patients taking Femara had a 78% greater chance of responding to treatment than patients treated with tamoxifen, and the chance that their tumors would progress was 28% less with Femara than with tamoxifen. No differences were seen in duration of tumor response or overall survival.
About Femara
Femara, an aromatase inhibitor, is a once-a-day oral first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. The U.S. Food and Drug Administration (FDA) approved this indication in January 2001. Femara is also approved for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
In postmenopausal women, the primary source of estrogen is from fat, liver, muscle, and breast tissue through a process that converts adrenal androgens into estrogen, which stimulates the growth of certain hormone- dependent cancer cells. A breast tumor itself also may generate estrogen. Femara works by binding to the enzyme aromatase and blocking it from converting adrenal androgens to estrogen in these tissues.
Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients. Femara is generally well tolerated and adverse reactions rates in the first-line study in which Femara was compared to tamoxifen were similar with those seen in second-line studies. The most commonly reported adverse events for Femara vs. tamoxifen were bone pain (20% vs. 18%), hot flushes (18% vs. 15%), back pain (17% vs. 17%), nausea (15% vs. 16%), dyspnea or labored breathing (14% vs. 15%), arthralgia (14% vs. 13%), fatigue (11% vs. 11%), coughing (11% vs. 10%), constipation (9% vs. 9%), chest pain (8% vs. 8%) and headache (8% vs. 7%). Femara may cause fetal harm when administered to pregnant women. There is no clinical experience to date on the use of Femara in combination with other anticancer agents. The incidence of peripheral thromboembolic events, cardiovascular events, and cerebrovascular events was less than or equal to 2%.
Sunday May 19, 12:36 pm Eastern Time
Press Release
SOURCE: AstraZeneca
ASCO Panel Recommends Health Care Providers Discuss ATAC (Arimidex) Adjuvant Breast Cancer Results With Patients
ORLANDO, Fla., May 19 /PRNewswire-FirstCall/ -- Today the American Society of Clinical Oncology (ASCO) issued guidelines on the use of aromatase inhibitors as adjuvant therapy for women with hormone receptor-positive breast cancer. Overall, the panel considers the results of the ATAC (ARIMIDEX and Tamoxifen, Alone or in Combination) trial and the extensive supporting data to be very promising, and they encourage physicians to discuss these results with their patients. The committee felt that it was too early to recommend a wholesale switch from the standard use of tamoxifen in this setting and that physicians and patients need to come to their own conclusions after considering all available data. The panel also stated that ARIMIDEX® (anastrozole) is the only aromatase inhibitor with clinical trial data in the adjuvant setting and it should be considered the preferred agent if an aromatase inhibitor is used in this setting.
The National Comprehensive Cancer Network (NCCN), the alliance of the world's leading cancer centers, updated their breast cancer guidelines in February of this year to include information on the ATAC trial and also recommended that these results be discussed with patients.
"The reason these guidelines are important to post-menopausal women with early breast cancer is that ARIMIDEX gives them a new choice," said committee member and Director of Patient Services at Y-ME National Breast Cancer Organization, Judy Perotti. "The guidelines will help women and their doctors work together to determine the best treatment option."
ARIMIDEX is currently FDA approved for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and also for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. The FDA granted priority review to the sNDA for ARIMIDEX for use in the adjuvant setting based on the results of the ATAC trial.
Overall results from the ATAC trial, involving over 9,300 post-menopausal women, were first presented last December at the San Antonio Breast Cancer Symposium and reported for the first time the effect of ARIMIDEX as an adjuvant treatment in postmenopausal women with early breast cancer. After a median of 33.3 months follow-up and a median duration of treatment of 30.7 months, 317 of 3,125 women in the ARIMIDEX group had a relapse of their breast cancer or died, compared with 379 of 3,116 women in the tamoxifen group (p=0.0129). This represents a 17% reduction in the risk of disease recurrence with ARIMIDEX treatment compared to tamoxifen. The reduction in the risk of recurrence was 22% in women with confirmed hormone-sensitive tumors with ARIMIDEX treatment compared to tamoxifen (p=0.0054). The incidence of contralateral breast cancer, a secondary endpoint in the trial, was 14 of 3,125 women with ARIMIDEX and 33 of 3,116 women with tamoxifen, a 58% reduction in incidence. Study results showed that the ARIMIDEX/tamoxifen combination was no more effective than tamoxifen alone. These data will be featured in a special ASCO session on Monday dedicated to significant new data that has been previously presented at other scientific meetings.
In the ATAC trial, ARIMIDEX was associated with significantly fewer reports of endometrial cancer, thromboembolic events (overall incidence and deep vein thromboses) and vaginal bleeding than tamoxifen. In terms of adverse events, deep vein thrombosis was reported in 1.7% of the patients taking tamoxifen compared to 1.0% of the ARIMIDEX patients. Endometrial cancer occurred at a rate of 0.5% in tamoxifen patients compared to 0.1% in ARIMIDEX. Vaginal bleeding was reported in 8.1% of tamoxifen patients and 4.5% of ARIMIDEX patients. Hot flashes and weight gain were also more common among women treated with tamoxifen compared to those taking ARIMIDEX (hot flashes: 39.7% vs. 34.3%; weight gain 11.0% vs. 9.2%). Women taking ARIMIDEX reported less vaginal discharge and ischemic cerebrovascular events than women taking tamoxifen (vaginal discharge: 2.8% vs 11.4%; IC events: 1% vs 2.1%). Women taking tamoxifen reported fewer musculoskeletal disorders or the types of fractures common in this age group, compared to the women taking ARIMIDEX. Fractures (predominantly of the wrist) were reported in 3.7% of the tamoxifen patients and 5.8% of ARIMIDEX patients. The ARIMIDEX/tamoxifen combination treatment group showed no additional tolerability benefits or issues compared with tamoxifen alone.
ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment, pregnancy must be excluded (see warnings in full prescribing information). Common side effects seen in clinical trials included hot flashes, nausea, asthenia, pain, back and bone pain and increased cough. Joint pain and stiffness has also been reported. |
