New drug combination controls advanced breast cancers

Drug-combo-controls-breast-cancer-NSMB4M2-x There are no drugs to cure breast cancer as advanced as Elise Winters'; her tumors have spread around her body. But Winters, diagnosed in 2002, says she's grateful that a series of experimental therapies has prolonged her life, even if some drugs have only worked for a year or two.

"I've been the beneficiary of cutting-edge research," says Winters, 64, an artist from New Jersey. "Maybe I'll be lucky enough to benefit from the next thing to come along."

That's why Winters is encouraged by results of two new studies, being presented today at the San Antonio Breast Cancer Symposium. She wasn't involved in either, but she knows how desperately women with advanced breast cancer need more options. Nearly 41,000 U.S. women die of the disease a year. Both drugs keep tumors in check months longer than standard therapies, finds the research.

One drug, pertuzumab, builds on the success of the landmark drug Herceptin, which targets the 25% of breast tumors like Winters', which overproduce a protein called HER2. Winters credits Herceptin with helping her survive this long.

Yet some women with early cancer, and all with advanced tumors, eventually relapse, in spite of Herceptin.

In the new study, pertuzumab delayed relapse in advanced patients by about six months. When combined with Herceptin and standard chemotherapy, pertuzumab kept women in remission for 18.5 months, compared to 12.4 months with Herceptin and chemo alone, says the study, published online Wednesday in The New England Journal of Medicine. Researchers don't yet know whether pertuzumab will help women longer, but they've noticed an early trend in this direction.

"This is hugely positive," says lead researcher Jose Baselga, chief of hematology and oncology at the Massachusetts General Hospital Cancer Center. "It is very uncommon to have this level of improvement."

Drugmaker Genentech applied for Food and Drug Administration approval for pertuzumab Tuesday.

Both Herceptin and pertuzumab are man-made antibodies that block growth signals produced by the HER2 protein, Baselga says. Each blocks that growth in a slightly different way, creating two types of hurdles for the cancer to overcome.

A third drug, GlaxoSmithKline's Tykerb, targets HER2 in yet another way. Patients with metastases sometimes take Tykerb and another chemo drug after Herceptin stops working, or may combine the two, says an accompanying editorial in The New England Journal. It notes that researchers are developing a small army of drugs for patients whose tumors overproduce HER2.

Winters began taking one, TDM1, in March. Her cancer had spread far enough that she could feel small tumors breaking out along the back of her neck. A few months later, they were gone.

Just as drug cocktails have revolutionized the treatment of AIDS, transforming it into a chronic disease, Baselga says combination therapy is likely to be the best hope for keeping cancer in check, as well.

Yet combining even two of these drugs will be incredibly expensive, says Eric Winer, of Boston's Dana-Farber Cancer Institute, who wasn't involved in the new study. Treating advanced cancer with Herceptin typically costs $30,000, says Genentech. Cost hasn't been announced for pertuzumab , but Winer predicts it's likely to "cost at least that much."

And Baselga acknowledges that early successes like this don't always pan out. The FDA recently revoked its approval of Avastin for breast cancer; it was initially approved for its ability to prolong remissions in women with advanced disease. Later studies found Avastin didn't improve overall survival.

Still, Baselga notes that a Herceptin-pertuzumab combination could be attractive to many women, because it caused relatively few serious side effects, compared to traditional chemotherapy. Women who took pertuzumab had no additional heart problems, which have been a concern with Herceptin, the study says, although they were more likely to have diarrhea and a condition in which patients develop a fever and decreased number of white blood cells.

"I cannot imagine addressing the cancer issue seriously without combination therapy," Baselga says. "If we think by blocking one single pathway, we are going to get rid of cancer, we are wrong."

Researchers also described promising results with another drug, Afinitor, which helped control cancer in women with the most common type of breast cancer — those whose growth is fueled by estrogen, which drives about two-thirds of breast tumors.

Metastatic patients who combined Afinitor with another drug commonly used in advanced breast cancer, an aromatase inhibitor called Aromasin, stayed in remission for 7.4 months, according to a study of 724 postmenopausal patients, also published in The New England Journal of Medicine.

By comparison, women given Aromasin and a placebo stayed in remission 3.2 months, the study says.

That's a significant improvement, given that the women in the study had tough tumors that had resumed growing even after treatment with a variety of other therapies, says Baselga, who also led this study.

Based on these results, Afinitor and Aromasin should become the new standard of care for these patients, said study co-author Gabriel Hortobagyi, of Houston's M.D. Anderson Cancer Center, in a press statement.

Other doctors aren't so sure.

Yet Winer notes that those extra months of remission came at a high cost: 23% of those taking Afinitor suffered a serious side effects, compared to 12% of those taking Aromasin alone. The side effects, including mouth sores, fatigue and high blood sugar levels, are "much more like chemotherapy," Winer says. "It will be very important here to see if a survival advantage emerges" over time, as doctors continue to follow patients.

But cancer surgeon Susan Love notes that Afinitor breaks new ground scientifically.

That's because all of the women in the study had run out of an important treatment option. Their tumors had become "resistant" to drugs called aromatase inhibitors, which aim to starve breast tumors by depriving them of estrogen. Afinitor appears to allow Aromasin, an aromatase inhibitor that the women hadn't taken before, to resume blocking their cancers, Baselga says.

Both studies were funded by the drug's manufacturers, including Genentech, which makes pertuzumab, and Novartis, which makes Afinitor. Afinitor is already approved to treat kidney cancer, a type of brain tumor and pancreatic neuroendocrine tumors, the rare cancer that killed Apple's Steve Jobs.

Winer describes the two studies' results as "encouraging news for women with breast cancer today, but not news to be oversold. It comes on the heels of years in which we had relatively little. They provide us with some hope for future drug development."

USA Today

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