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Thread: Novartis Femara (letrozole)
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07-10-2002, 03:57 AM #1
Novartis Femara (letrozole)
Sorry for the blurred pics, but have not mastered the art of focussing yet with my new digicam
Box
D.W.
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07-10-2002, 03:59 AM #2
Blisters.
D.W.
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07-10-2002, 09:11 PM #3Associate Member
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07-11-2002, 01:08 PM #4Junior Member
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EAST HANOVER, NJ -- January 31, 2002 -- Data from a randomized study examining the ability of Femara® (letrozole) to inhibit total body aromatization and suppress plasma estrogen levels in 12 postmenopausal women with metastatic breast cancer compared to Arimidex® (anastrozole) have been published in the February 2002 issue of the Journal of Clinical Oncology.
The data show that Femara (2.5 mg once daily) more effectively inhibits total body aromatization and suppresses plasma estrogen levels compared to anastrozole (1 mg once daily). The differences between the two drugs in inhibiting total body aromatization (ovaries excepted) were statistically significant as was the suppression of two of the three major estrogens.
"We know that 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 anastrozole," said Per Eystein Lonning, MD, professor of oncology, Haukeland University Hospital, Norway.
The primary objective of the study was to compare the effects of the non-steroidal aromatase inhibitors Femara and anastrozole on total body aromatization (the capacity of the whole body to produce estrogens) and plasma estrogen levels.
The trial was a randomized, crossover study of 12 postmenopausal women with metastatic breast cancer whose disease was suitable for treatment with an aromatase inhibitor. Patients were treated sequentially with anastrozole 1 mg followed by Femara 2.5 mg once daily (and vice-versa), each given for six weeks in sequence. Total body aromatization was determined prior to treatment and at the end of each treatment period as were plasma levels of estrone (E1), estradiol (E2) and estrone sulfate (E1S).
The study revealed that whereas on-treatment levels of aromatization were detectable in 11 of 12 patients during treatment with anastrozole (mean percentage inhibition in the whole group 97.3 percent), they were undetectable in all of the 12 patients during treatment with Femara (> 99.1 percent suppression in all patients; Wilcoxon, P = .0022, comparing the two drug regimens).
Treatment with Femara as compared to anastrozole suppressed mean plasma estrogen levels as follows: E1 (84.3 percent versus 81.0 percent), E1S (98.0 percent versus 93.5 percent) and E2 (87.8 percent versus 84.9 percent) respectively. The suppression of plasma levels of E1 and E1S also was found to be better during treatment with Femara compared to anastrozole (P= .019 and P= .0037, respectively). Since the levels of E2 are already very low in postmenopausal women, it was not possible to measure a statistically significant difference for this parameter.
Based on these findings, the authors concluded that Femara is a more effective inhibitor of total body aromatization and suppressor of plasma estrogen levels compared to anastrozole in postmenopausal women with metastatic breast cancer. The clinical relevance of this finding is yet to be determined.
Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. At the 2001 San Antonio Breast Cancer Symposium, Phase III data were presented demonstrating that Femara may improve survival of postmenopausal women with locally advanced or metastatic breast cancer who are appropriate for hormone therapy, when compared to tamoxifen . The data stemmed from the largest single study ever to evaluate a hormonal therapy in advanced breast cancer.
The U.S. Food and Drug Administration (FDA) approved Femara in the first-line indication in January 2001. Femara is currently available in more than 75 countries worldwide, with first-line approval already gained in more than 50 countries.
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 versus tamoxifen were bone pain (20 percent versus 18 percent), hot flushes (18 percent versus 15 percent), back pain (17 percent versus 17 percent), nausea (15 percent versus 16 percent), dyspnea or labored breathing (14 percent versus 15 percent), arthralgia (14 percent versus 13 percent), fatigue (11 percent versus 11 percent), coughing (11 percent versus 10 percent), constipation (9 percent versus 9 percent), chest pain (8 percent versus 8 percent) and headache (8 percent versus 7 percent).
Femara may cause fetal harm when administered to pregnant women. The incidence of peripheral thromoembolic events, cardiovascular events and cerebrovascular events was less than or equal to 2 percent. There is no clinical experience to date on the use of Femara in combination with other anticancer agents.
SOURCE: Novartis Oncology
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07-11-2002, 01:11 PM #5Junior Member
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Plus,
another main positive effect that Femara has over arimidexis that the femara raises IGF-1 levels where arimidex lowers it.
Costwise, femara is slightly more expensive...
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07-11-2002, 01:21 PM #6
Wow N.M. great post buddy!
Yes this stuff is really expensive it says 196 euros on the box..with the current dollar-euro conversion that is about 200 usd a box
D.W.
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07-11-2002, 03:02 PM #7Junior Member
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hhhmmmm...where from is this box?I suppose Spain or Italy, right?
In greece it costs 167euros....still very expensive I guess....
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07-11-2002, 06:46 PM #8Associate Member
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Thank you Norma Man for the sound article. Yeah my arimidex was 228 USD, I'll do a price check on femara in the morning.
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08-18-2002, 05:40 PM #9
that cleared some shit up for me, thanks for taking the time to post that.
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