Femara - Letrozole voorkomt vaker recidief - 43% t.o.v. placebogroep - bij vrouwen met borstkanker, aldus afgebroken fase III studie van Novartis

9 april zie ook informatie over de mammaprint, een genen test specifiek voor borstkanker

d.d. 10-10-2003: Novartis meldt vandaag op de beurs in Amerika dat Femara - Letrozole, een zelfde middel als Anastrozole en Exemestaan: (Femara - Letrozole is de officiële naam, Letrozole wordt verkocht onder merknaam: Femara. Anastrozole wordt verkocht onder merknaam: Arimidex en Exemestaan wordt verkocht onder merknaam: Aromasin) een hoog significant resultaat - 43% minder recidieven t.o.v. de placebogroep - heeft laten zien in het voorkomen van een recidief voor vrouwen met borstkanker. De studieresultaten worden gepubliceerd in november 2003 in The New England Journal of Medicine. De studie is afgebroken volgens Novartis omdat het ethisch niet verantwoord was de vrouwen die een placebo kregen Femara te onthouden. Daarop wordt ook in The New England Journal of Medicine kritiek geuit door twee vooraanstaande oncologen. Zij vinden dat de waarde van de vijfjaars studie hiermee te niet wordt gedaan omdat de volle vijfjaars termijn niet is volgemaakt.

Aan de studie deden 5000 vrouwen mee. 207 vrouwen kregen een recidief binnen zeg maar 2,5 jaar, de datum dat de studie nu is gestopt . Van die 207 vrouwen kregen 75 vrouwen femara, 132 vrouwen uit de placebogroep kregen een recidief. Een positief verschil van 43%.

Bron: Dow-news
-- WSJ(10/10) Novartis Drug Cuts Recurrence Of Breast Cancer --

(From THE WALL STREET JOURNAL)
By Gautam Naik
IN WHAT MAY BE a breakthrough for thousands of women diagnosed with
early-stage breast cancer, a relatively new drug appears to prevent tumors from
recurring in many patients after they have been treated, until now a major
problem in fighting the disease.
In a clinical trial involving 5,000 post-menopausal women, Novartis AG's
once-a-day pill, Femara, was found to lower the risk of the cancer returning by
43%. Femara has been on the market in the U.S. since 1997 andis approved for use
in treating advance-stage breast cancers. The trial was to test Femara's effects
in preventing a recurrence of tumors in patients whose cancer was caught at an
earlier stage and treated.
The results will be published in The New England Journal of Medicine in
November, but the journal released the details of the trial early because of
their significance. The findings were compelling enough that the trial was
stopped halfway through its five-year run so that patients taking placebos could
be put on the drug.
The Femara results "have day-to-day treatment implications for hundreds of
thousands of women," says Harold Burstein, a specialist in breast-cancer at
Dana-Farber Cancer Institute in Boston and author of an accompanying editorial
about the study in the New England Journal.
After lung cancer, breast cancer is the leading cancer killer in women in the
industrialized world. About 1.2 million will be diagnosed with the disease this
year according to the World Health Organization. World-wide, about 80,000 women
die each year from breast cancer, Novartis says.
Thousands of breast cancer patients, once they've undergone surgery or
radiation treatment, are given the standard therapy -- a medicine called
tamoxifen -- to prevent tumors from re-emerging. But after five years, the drug
is stopped because it appears to provide no additional benefit -- leaving
patients with few medical options to guard against the cancer's return. Each
year, about 200,000 American and European women go off tamoxifen, according to
Novartis.
Ten years after halting use of the drug, between 15% and 30% of patients see a
recurrence of cancer, either in the breast or elsewhere in their body, Novartis
says.
The company hopes Femara will reduce those odds. "It probably has to be
decided on a case-by-case basis depending on the risk of recurrence," says Joerg
Reinhardt, head of clinical development for Novartis. "But we believe that this
data will encourage doctors to prescribe Femara" for patients who stop taking
tamoxifen.
Femara, whose generic name is letrozole, is one of a relatively new class of
drugs known as aromatase inhibitors. AstraZeneca PLC's Arimidex also belongs to
that class, and was approved in the U.S. for early-stage breast cancer this past
year. Femara and Arimidex are chemically different, but work very similarly.
Novartis plans to seek fast-track approval in the U.S. for the use of Femara
in patients with early-stage breast cancer. The company said it will provide the
data to the Food and Drug Administration by the middle of next year. If all goes
well, it hopes to get approval by early 2005.
Of course, doctors on their own may prescribe the drug for patients with
early-stage breast cancer. But for women considering it, the decision won't be
clear-cut. Because it blocks estrogen production, Femara can trigger nasty side
effects, including hot flashes, night sweats and impaired sexual function. In
the long run, it also may increase the risk of osteoporosis. But many women who
have the choice of taking the drug after tamoxifen "would rather deal with the
risk of osteoporosis down the road than a breast cancer recurrence," Dr.
Burstein says.
In the latest Femara trial, led by the National Cancer Institute of Canada,
half the women were given the drug and the others were given a placebo. After a
little more than two years, 207 of the women had a recurrence of tumors. Of
those, 75 were given Femara and 132 were on placebo.
Because the study was stopped early, it didn't fully achieve one of its goals:
to determine the disease-free survival and overall survival of patients over the
entire five-year period. Nor does the current data help doctors decide the
duration of treatment with Femara, once the five-year tamoxifen period is up.
The decision to halt the trial "undeniably diminishes the clinical usefulness of
the data," concludes two cancer experts in a second editorial in the New England
Journal.
Novartis stands by its decision to stop the trial early. "It was a dilemma,"
concedes Dr. Reinhardt. "But ethically, it simply wasn't acceptable" to deny the
drug to patients on placebo.
The latest results could be yet another boost to Novartis's cancer business.
The company already has a big hit on its hands with Gleevec, which was approved
for treatment of chronic myeloid leukemia. Another product, Zometa, which is
prescribed to patients with bone metastases in multiple cancers, earned revenues
of $577 million last year.
Femara sales totaled $194 million last year. Novartis originally expected the
drug's peak sales, in five years' time, to reach $400 million to $500 million.
But now, given a potential new use for the drug, "we expect peak sales to be
beyond that number," Dr. Reinhardt says.