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What new breast cancer study means for patients facing chemo

Lori Blass counts herself lucky to be among the thousands of women who may now safely skip chemo treatments for early-stage breast cancer.

The north Fulton grandmother of two watched her husband, Richard, experience the side effects of chemotherapy as he battled multiple myeloma for eight years. Less than two weeks after he died in February, she was diagnosed with early-stage breast cancer.

Doctors performed a lumpectomy, but there was a chance Blass would have to undergo chemo treatments, something she dreaded.

“I was on hold,” she said. Then, she got a message from her oncologist, who was attending a medical conference in Chicago.

“The results are in. You won’t need chemo.”

Those eight words provided “such an enormous relief at this juncture in my life,” said Blass, who must still undergo radiation. “It was great news for me and for thousands of other women to now know precisely how treatment can be carved out. It means so much to have clarity for treatment when you’re dealing with cancer and that clarity is backed by statistics.”

A highly anticipated new study published in the New England Journal of Medicine found that women with early-stage breast cancer may not need chemo after surgery if they fall within a low or mid-range risk for their cancer returning. The change could affect tens of thousands of women a year.

“Now we can look some women in the eye and say, ‘You don’t need chemo,’” said Dr. Jane Lowe Meisel, Blass’ doctor and a medical oncologist/breast cancer expert at Winship Cancer Institute of Emory University. “It is a great feeling. As oncologists, we want to avoid both undertreatment and overtreatment — our goal is to get the right drugs to the right patients. This study goes a long way towards helping us meet that goal.”

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Chemotherapy can save and prolong lives, but its side effects can include nausea, extreme fatigue, hair loss, numbness and diarrhea.

“I felt like hell,” said Janice McKenzie-Crayton, a three-time breast cancer survivor, who wouldn’t be affected by this study but knows women who would.

“Chemo is no walk in the park,” said Meisel. “If you can spare someone those side effects without putting them at risk for recurrence, you’re doing them a great service.”

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Breast cancer is the second-leading cause of cancer-related death for women, according to the American Cancer Society. More than 268,000 people, most of whom are women, will be diagnosed with breast cancer this year. Men can also get the disease. The organization says there will be 41,400 deaths, including women and men, from breast cancer in 2018.

“This is big news,” said Cati Diamond Stone, executive director of Susan G. Komen Greater Atlanta. “It’s yet another tool in the toolbox for women who have been diagnosed with breast cancer. I’m a breast cancer survivor and had 16 rounds of chemo. The side effects are acute and some are long-lasting. At Komen, we’ve been concerned for years about the toxic side effects of chemo.”

The study was based on gene tests on tumors in women with the most common form of breast cancer. More than 10,000 women registered for the study. Winship at Emory University was among those institutions that enrolled women in the trial.

Of the women who registered for the trial, 6,907 had intermediate scores in the gray zone.

This reflects the average distribution “we see in real life … meaning about two-thirds of women who get this test end up with “intermediate” results as defined by the trial, said Dr. Keerthi Gogineni, assistant professor of hematology and medical oncology at Emory University’s Winship.

Blass, 60, fell into what is called the intermediate or gray area. Her genomic test determined that at some point in the future, there was a risk that her breast cancer could return. The test measures 21 genes in the tumor and pinpoints the risk on a scale that ranges from 0 to 100.

Hers was 22.

The gene test (Oncotype Dx) is performed on women who have early-stage breast cancers, typically between 0.5cm and 5cm  and .centimeters in size that have not spread to lymph nodes, are sensitive to estrogen, and test negative for a protein called HER2. In this group of women, it helps to identify those who can safely skip chemo and take only a drug that blocks the hormone estrogen such as tamoxifen or a drug that stops the body from making estrogen.

Dr. Michael Cohen is director of breast imaging at Winship Cancer Institute of Emory University. Winship was among the institutions that enrolled women in the breast cancer treatment trial that's the basis for a groundbreaking study.

“We have known for some time that women with very low-risk Oncotype Dx do not need chemotherapy, and that those with high-risk scores, over 30, do derive benefit,” said Meisel. “However, many patients fall in the ‘intermediate risk’ category, as Ms. Blass did, and whether or not to recommend chemotherapy for women with these intermediate-risk scores has been a critical question in recent times.”

During the trial, researchers followed up with thousands of women. Seventy percent had a score between 11 and 25 and were considered intermediate risk. They underwent surgery , and then were randomly assigned to receive either anti-estrogen therapy alone or anti-estrogen therapy plus chemotherapy. Over time, authors found no difference in outcome between those who got chemotherapy and those who didn’t.

“This makes us feel very confident withholding chemotherapy in patients like Ms. Blass,” she said.

Meisel said the only caveat to this is that there may be some benefit of chemotherapy for women 50 years of age or younger with a recurrence score between 16 and 25.

“It’s groundbreaking,” said Gogineni. “There were many women who were undergoing chemotherapy for their breast cancer that did not need it. Any study that enables us to be more nuanced about treatment — to avoid overtreatment or undertreatment — advances how we care for patients with cancer.”

5 THINGS TO KNOW ABOUT CHEMOTHERAPY

  • Chemo is used to shrink tumors, control and/or stop the cancer from growing and spreading. This can help the person with cancer feel better and live longer. It can also be used to ease symptoms.
  • The most common forms of getting chemo are intravenously as a slow drip in which a thin needle is put in a vein in the hand or lower arm; an injection as a single shot into a muscle in the arm, leg, hip or in the fatty part of your arm, leg or stomach; or by mouth.
  • Cancer can be treated with a single chemo drug, but often several drugs are used in a specific order or combinations. Different drugs that work in different ways can work together to kill more cancer cells. This can also help lower the chance that the cancer may become resistant to any one chemo drug.
  • Unlike radiation and surgery, which target specific areas, chemo can work throughout your body.
  • Chemo can also affect some fast-growing healthy cells, like those of the skin, hair, intestines, and bone marrow. Some of the side effects include hair loss, nausea, fatigue and numbness.

Sources: American Cancer Society, National Cancer Institute

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