The trial results are the latest piece of the puzzle on how to treat early-stage breast cancer. Most patients with the disease have a high survival rate, but their prognoses worsen drastically if their cancer returns in other parts of the body. Because of that, many women with early-stage cancer used to be urged to get chemotherapy in hopes of preventing any spread. But in recent years, as many doctors concluded that women with early-stage cancer were being overtreated, they have reduced their use of chemotherapy, which can cause nausea, fatigue and, in rare cases, more serious complications such as leukemia and heart failure. ­Oncotype DX has spurred the trend and is likely to accelerate it.<doc-sep>Up to 70 percent of women with a certain type of breast cancer may not need chemotherapy, a new study finds. Avoiding chemotherapy may come as a relief to many women who are diagnosed with breast cancer, as the treatment comes with a number of side effects, including nausea, hair loss and anemia. The study, published yesterday (June 3) in The New England Journal of Medicine, included more than 10,000 women with the same type of breast cancer: early-stage, hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. (That mouthful refers to three things: that the cancer was found early, that it could bind to certain hormones and that it didn't have the HER2 receptor.) This type of breast cancer is the most common type, according to the researchers. [10 Do's and Don'ts to Reduce Your Risk of Cancer] All of the women in the study, called the Trial Assigning Individualized Options for Treatment (Rx), or TAILORx, had their breast tumors analyzed with a molecular test. The test looks at 21 genes and then spits out a score, from zero to 100, that predicts the risk that the breast cancer will return after surgery. The researchers were specifically interested in women who scored 10 to 25 on the test — scores that fall in the range of a medium risk of the cancer returning after surgery. Women with low risk scores — those below 10 — don't need chemotherapy after surgery, and instead can be treated with hormone therapy, previous studies have found. Similarly, women with high risk scores — above 25 — should receive chemotherapy in addition to hormone therapy. (Hormone therapy is a treatment that blocks or lowers the amounts of specific hormones in the body that help the cancer grow.) Doctors were unsure, however, whether women in the medium-risk range were benefiting from chemotherapy or just experiencing the side effects. TAILORx Out of the 10,000 women enrolled in the TAILORx study, around 6,700 fell in the medium-risk range. These womenrandomly divided into two groups: One group received only hormone therapy after surgery, and the other group received both hormone therapy and chemotherapy. Then, five and nine years later, the researchers checked in on how the women were doing. They found that there was almost no difference in the cancer-recurrence rates between the women who received just hormone therapy and the women who received both treatments. After five years, 92.8 percent of the women who received hormone therapy alone, and 93.1 percent of those who received hormone therapy plus chemotherapy, were cancer-free. After nine years, the cancer-free rates were 83.3 percent for the hormone-therapy-only group and 84.3 percent for the hormone-therapy-plus-chemotherapy group. At both time points, the difference was so small that it was not considered statistically significant (meaning it could have occurred due to chance), the researchers said in a statement. "Until now, we've been able to recommend treatment for women with these cancers at high and low risk of recurrence, but women at intermediate risk have been uncertain about the appropriate strategy to take," study co-author Jeffrey Abrams, associate director of the National Cancer Institute’s Cancer Therapy Evaluation Program, which supported the trial, said in the statement. "These findings, [which show] no benefit from receiving chemotherapy plus hormone therapy for most patients in this intermediate-risk group, will go a long way to support oncologists and patients in decisions about the best course of treatment," Abrams said. [7 Side Effects of Cancer Treatment, and How to Cope with Them] The researchers noted one caveat to the findings, however: Women who were either premenopausal and/or younger than 50 and fell in the higher part of the medium-risk range (scores of 16 to 25) may have experienced a slight benefit from chemotherapy. These women should discuss chemotherapy with their doctors, the researchers said. Arnie Purushotham, a senior clinical adviser to Cancer Research UK who was not involved in the study, welcomed the TAILORx results as an important step toward making cancer treatment less harsh for patients. "By stratifying these breast cancer patients [by risk] and finding that only those with the highest risk of recurrence need to have chemotherapy based on their tumor genetics, TAILORx shows great potential to ensure more gentle treatment without compromising its effectiveness," Purushotham told Live Science. "We're looking forward to a future where cancer is treated using a personalized approach," he added. "In many cases, we will be able to tailor treatments to the patient and their tumor." According to the TAILORx researchers, 260,000 women who are diagnosed with breast cancer each year around the world fall into the medium-risk category that wouldn't benefit from chemotherapy. While cancer survival rates have doubled over the past 40 years, Purushotham added, researchers hope personalized treatment based on genetic profiling will deliver further improvements. Originally published on Live Science.<doc-sep>CHICAGO (Reuters) - In a disappointment for Roche Holding AG ROG.S, two of its oncology drugs provided only modest protection from disease progression in lung cancer and breast cancer, according to data from separate clinical trials presented on Saturday. FILE PHOTO: Bottles of medications line the shelves at a pharmacy in Portsmouth, Ohio, June 21, 2017. REUTERS/Bryan Woolston Adding Roche’s high-profile immunotherapy Tecentriq to other standard cancer drugs extended by only about three weeks the median time patients with advanced squamous cell lung cancer lived before their disease progressed in one late stage study. Meanwhile, Roche said it was scrapping development plans for its experimental drug taselisib after data showed adding it to hormone therapy extended by just two months the length of time women with advanced breast cancer lived before their disease worsened. Patients on the drug also experienced serious side effects. The taselisib benefit to patients “was more modest than we had hoped for, and there is a risk of considerable side effects,” said Dr. José Baselga, the study’s lead investigator from Memorial Sloan Kettering Cancer Center in New York. Roche in a statement also said the results were disappointing, adding “we will not be pursuing an FDA submission for taselisib based on the data presented at ASCO.” The company also said it had no plans to further test taselisib in other types of cancer. Both studies were being presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. For more coverage of the meeting, see: here Sales of Roche's Tecentriq trail two rival lucrative therapies that also spur the body's immune system to attack tumors: Keytruda from Merck & Co MRK.N and Opdivo from Bristol-Myers Squibb BMY.N. Roche is under pressure to show success for the drug, which is central to replacing falling revenue from older, off-patent medicines. Tecentriq is already approved for previously treated patients with advanced non-small cell lung cancer (NSCLC) and certain patients with advanced bladder cancer. Analysts are forecasting annual Tecentriq sales reaching about $6 billion by 2024, according to Thomson Reuters data. Roche said it will continue to evaluate results from the study presented on Saturday. “The study is one of eight Phase III trials from our extensive research program evaluating Tecentriq alone or in combination with other medicines in different types of lung cancer,” Roche said in a statement. Merck’s Keytruda, in combination with chemotherapy, is approved as an initial treatment for non-squamous NSCLC, the most common form of lung cancer. Keytruda is also approved as a stand-alone treatment for lung cancer patients whose tumors have high levels of a protein known as PDL1. The new Tecentriq trial studied 1,021 patients with late-stage squamous NSCLC, which accounts for about 30 percent of lung cancer and is considered particularly difficult to treat. One group of patients received the Roche drug plus the chemotherapy carboplatin and Celgene Corp's CELG.O Abraxane, while a second group were only treated with carboplatin and Abraxane. After 12 months, 25 percent of patients given the Tecentriq combination had not experienced disease progression compared with 12 percent in the chemotherapy group, Roche said. But median progression-free survival was 6.3 months for Tecentriq patients versus 5.6 months for the standard chemotherapy combination. The modest benefit was observed regardless of tumor PDL1 levels, researchers said. The analysis did not find an overall survival advantage with Tecentriq, although Roche said those data are not yet mature. Merck last month said a study of Keytruda in combination with chemotherapy for squamous NSCLC showed a benefit in both overall survival and progression-free survival. [nL3N1SU48D] In the study of taselisib, patients who received the Roche drug plus the hormone therapy fulvestrant saw their breast cancer worsen after a median of 7.4 months compared with 5.4 months for people who received fulvestrant alone. The trial involved 516 postmenopausal women with advanced estrogen receptor-positive breast cancer, whose disease had progressed or returned after prior treatment. Serious side effects in the taselisib group included diarrhea, high blood sugar and colon inflammation, leading 17 percent of treated patients to drop out of the trial.<doc-sep>
Thousands of women could skip painful and detrimental chemotherapy in treating early-stage breast cancer, according to a groundbreaking study. The decade-long study, discussed Sunday at the American Society of Clinical Oncology conference in Chicago, is hailed as the largest breast cancer treatment trial ever conducted. It showed most patients with an intermediate risk of cancer recurrence can avoid chemotherapy without hurting their chances of beating the disease. That could affect up to 70,000 women a year in the USA and thousands more around the world, the study said. “The impact is tremendous,” said the study's leader, Joseph Sparano of Montefiore Medical Center in New York. Most women in this situation don’t need treatment beyond surgery and hormone therapy, and “the rest of them are receiving chemotherapy unnecessarily.” Jennifer Litton, an associate professor and oncologist at MD Anderson Cancer Center in Houston, said the results will help patients and their doctors make more informed decisions. "Moving forward, when women are making this decision, this study will help us put it into perspective and give them better advice next week than we were able to give them last week," said Litton, who attended the conference where the results were discussed. The study, funded by the National Cancer Institute, foundations and proceeds from the U.S. breast cancer postage stamp, is the latest development in a national trend on cancer treatments. For the past several years, cancer care has evolved away from chemotherapy — older drugs with harsh side effects — in favor of gene-targeting therapies, hormone blockers and immune system treatments. When chemo is used, it’s sometimes for shorter periods or lower doses than it once was. Another study at the conference found that Merck’s immunotherapy drug Keytruda worked better than chemo as initial treatment for most people with the most common type of lung cancer, and with far fewer side effects. The breast cancer study cast doubt on chemo's necessity in treating women in early stages of the disease where it has not spread to lymph nodes, it is hormone-positive and it is not the type that the drug Herceptin targets. Women with early-stage breast cancer tend to have high survival rates, but their case worsens drastically if the cancer returns to other parts of the body. That has prompted many to turn to chemo to avoid the spread of the disease. In recent years, oncologists have warned that women with early-stage breast cancer are possibly being overtreated. The trial results are the latest salvo in a heated debate over when and how to use chemotherapy in combating the spread of the disease. Chemotherapy thwarts cancer's spread but can cause unwanted side effects such as hair loss, anxiety, depression, nausea, fatigue and heart failure. “Oncologists have been getting much smarter about dialing back treatment so that it doesn’t do more harm than good,” Steven Katz, a University of Michigan researcher who examines medical decision-making, told The Washington Post. “That’s important because chemo is toxic; it whacks patients out and can result in long-term job loss.” The breast cancer study gave 10,273 patients a test called Oncotype DX, which uses a biopsy sample to measure the activity of genes involved in cell growth and response to hormone therapy, to estimate the risk that a cancer will recur. For the study, the 67% of women showing an intermediate risk of recurrence had surgery and hormone therapy, and half of them also received chemo. After nine years, 94% of both groups were still alive and about 84% were alive without signs of cancer, meaning the chemo made no difference. Lisa Carey, a breast specialist at the University of North Carolina’s Lineberger Comprehensive Cancer Center, said she would be very comfortable advising patients to skip chemo if they were like those in the study who did not benefit from it. Litton, the MD Anderson oncologist, said doctors need to consider each case on its own merits and cautioned against ruling out chemo too quickly. "This study gives us information on a very specific group of women with a very specific type of cancer," she said, "but it doesn’t tell us chemotherapy is not effective in some cases." Contributing: Associated Press Follow Jervis on Twitter: @MrRJervis.