Story Published:
Jun 3, 2006 at 3:14 PM PDT
Story Updated:
Aug 31, 2006 at 8:27 AM PDT
ATLANTA - Women with advanced breast cancer soon may have
another treatment option: A novel experimental drug delayed the
growth of tumors nearly twice as long as standard chemotherapy did
in patients who had stopped responding to Herceptin, doctors
reported Saturday.
The experimental drug, Tykerb, worked so well that an
international study of it was stopped early, in March, and all
participants were offered the drug.
In the study, women who received Tykerb plus the chemotherapy
drug Xeloda had no growth of their tumors for an average of 8 1/2
months. That compares to 4 1/2 months for those given only Xeloda,
said Dr. Charles Geyer Jr. of Allegheny General Hospital in
Pittsburgh.
He led the study and reported results Saturday at a meeting in
Atlanta of the American Society of Clinical Oncology.
Tykerb's manufacturer, British-based GlaxoSmithKline PLC, paid
for the study and said it would expand global access to the drug
under compassionate use provisions. The company plans to seek
approval to sell Tykerb in the United States and elsewhere later
this year.
"This is huge," said Dr. Roy Herbst, a cancer specialist at
the University of Texas' M.D. Anderson Cancer Center in Houston,
who had no role in the study but has consulted for Glaxo in the
past.
"The next step will be to use it in patients instead of
Herceptin up front," to see whether it is more effective, he said.
Herceptin and Tykerb are members of a new generation of cancer
medicines that more precisely target tumors without killing lots of
healthy cells. Herceptin has been an important option for many
women with advanced breast cancer, but eventually it stops working
and women succumb to the disease.
Tykerb works in a similar yet completely novel way. Like
Herceptin, it targets a protein called HER-2/neu, which is made in
abnormally large quantities in roughly one-fourth of all breast
cancers.
Herceptin blocks the protein on the cell's surface; Tykerb does
it inside the cell, and blocks a second abnormal protein, too.
The benefits seemed to come without serious side effects - at
least in this study of 321 women, Geyer said. Diarrhea, mostly
mild, and rash were more common in women taking Tykerb.
No patients developed heart failure, but four of the 160 on the
drug combination had a modest decrease in pumping power of the main
chamber of the heart - side effects that also have been seen with
Herceptin.
Tykerb has one big advantage over Herceptin - it's a pill
instead of an intravenous drug, which should make it cheaper and
easier to use, doctors said.
But Dr. Pamela Klein, a vice president at Genentech, Herceptin's
maker, said Tykerb's real value may be not necessarily as a
competitor. She said the drug may be even more effective in
combination with Herceptin, to attack the abnormal protein from
inside and outside a cancer cell at the same time. Studies are
being planned to test this and other possibilities.
"Both of them together may be better than either of them
alone," said Dr. Julie Gralow, specialist in breast cancer at the
University of Washington and Fred Hutchinson Cancer Center in
Seattle.
Breast cancer is the most common major cancer in American women
and the second leading cause of cancer deaths in women. About
213,000 new cases are expected to occur in the United States this
year and more than 1 million worldwide.
Between 10 and 20 percent of breast cancers are advanced or have
already started to spread at the time they are diagnosed. Average
survival with this type of cancer is about two years.
Tykerb produced mixed results when tested in 416 patients with
advanced kidney cancer. It made no difference in survival or
disease progression for the group as a whole, but a subset of
patients with high levels of an abnormal protein the drug targets
had more time before their tumors started to grow, said study
leader Dr. Alain Ravaud of University Hospital of Bordeaux, France.
Doctors at the conference also said that Sutent, a Pfizer drug
recently approved for treating certain stomach tumors and advanced
kidney cancer, showed promise in a small experiment involving 63
patients with lung cancer.
Tumors shrank in six patients and stabilized in another 26
roughly two months after treatment with the drug, said Dr. Mark
Socinski of the University of North Carolina at Chapel Hill.
However, three patients died of bleeding problems, at least one of
which was thought to be related to treatment rather than the
disease.