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Drug Duo May Help Fight Aggressive Form of Breast Cancer

January 17, 2012
By

TUESDAY, Jan. 17 (HealthDay News) — Combining two drugs that
target an aggressive type of breast cancer known as HER2-positive appears
to work better than using either drug alone, researchers report.

The dual-drug approach greatly boosted the chances of eliminating
microscopic signs of early cancer by the time a woman was due to have
surgery, said researcher Dr. Jose Baselga, chief of hematology/oncology at
Massachusetts General Hospital Cancer Center and a professor of medicine
at Harvard Medical School.

The study was published online Jan. 17 in The Lancet.

The two drugs are Tykerb (lapatinib) and Herceptin (trastuzumab). Using
both together resulted in a 51 percent response, compared with a 30
percent response in women given Herceptin alone. Those given Tykerb alone
had a 25 percent response.

“What we observed was a massive improvement in response,” Baselga
said.

GlaxoSmithKline, the maker of Tykerb, helped fund the study.

“Lapatinib was approved for advanced breast cancer in 2007,” Baselga
said. “The question we had was, what is the efficacy if we give it in
early-stage breast cancer prior to surgery?”

Baselga and his colleagues conducted a trial treating 455 women from 23
countries. All had HER2-positive breast cancers. All had tumors larger
than about three-fourths of an inch.

In HER2-positive breast cancer, test results are positive for a
protein called human epidermal growth factor receptor 2, which promotes
cancer cell growth.

In the study, 154 women got Tykerb, 149 Herceptin and the other 152
both drugs. All had the drug regimen before surgery, with Taxol
(paclitaxel), a standard chemotherapy, added after six weeks. After 12
more weeks of treatment, the women had surgery.

At that point, researchers evaluated who had better responses. The
women continued the treatments for one more year, allowing researchers to
follow them and see how the approaches affected survival.

Baselga stressed that the study looked only at women with early-stage
HER2-positive breast cancers, and that the drug Tykerb is approved now
only for advanced breast cancers.

The study is well done and important, said Dr. Len Lichtenfeld, deputy
chief medical officer for the American Cancer Society. The two drugs, he
said, “affect the same pathway but do it in a different way.”

While the combination showed a better response rate, “there is also an
increased level of side effects,” he noted.

While no major heart problems occurred, those on Tykerb alone or the
two-drug combination had more diarrhea. Liver-enzyme alterations were also
more frequent when Tykerb was used.

GlaxoSmithKline notes that liver toxicity with the drug may be severe
and that deaths have been reported, although the cause of the deaths has
not been determined.

The important question, however, has not been answered yet, Lichtenfeld
said. That’s the effect on overall survival in using the two-drug
approach. The researchers are continuing to evaluate that.

In another study, published online Jan. 17 in The Lancet
Oncology
, researchers from Germany reported that Tykerb is less
beneficial than Herceptin as a single-drug therapy.

They assigned 620 women with HER2-positive breast cancer to get
standard chemotherapy plus Herceptin or Tykerb.

They looked to see which drug was better at eliminating invasive cancer
in the breast and metastatic cells in the lymph nodes. While 30 percent
of those in the Herceptin group had this response, 23 percent of the
Tykerb group did. The study was funded by drug makers GlaxoSmithKline,
Roche and Sanofi-Aventis.

Baselga reports receiving honoraria from Roche; other co-authors report
receiving speaking fees or honoraria from GlaxoSmithKline and fees from
other drug companies.

More information

To learn more about breast cancer, including HER2-positive cancers,
visit the American Cancer Society.

Article source: http://news.yahoo.com/drug-duo-may-help-fight-aggressive-form-breast-170425917.html

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