A blood test five years after breast cancer treatment helped identify some women who were more likely to relapse, long before a lump or other signs appeared, a preliminary study found.
It was the largest experiment so far to use these tests, called liquid biopsies , for breast cancer. Results suggest they someday may help reveal which women need longer preventive therapy and which ones can be spared it.
FILE - In this Tuesday, April 28, 2015 file photo, a patient has her blood drawn for a liquid biopsy at a hospital in Philadelphia. A study released on Friday, Dec. 8, 2017 found that a blood test five years after breast cancer treatment helped identify women who were likely to relapse, long before a lump or other signs appeared. (AP Photo/Jacqueline Larma)
"It could be providing an early warning sign" for some women that cancer is returning, said Dr. Joseph Sparano of Montefiore Einstein Center for Cancer Care in New York.
On the other hand, "if you had a negative test, there was a 98 percent chance you would not have a recurrence in the next two years" and perhaps could skip further treatment, he said.
Sparano led the study and gave results Friday at the San Antonio Breast Cancer Symposium.
The test — CellSearch, sold by Menarini-Silicon Biosystems — looks for stray cancer cells in the blood.
Breast cancer survivors may be tempted to rush out and get it, but doctors say it's too soon for that. Although it's been used for about a decade to monitor certain patients with advanced cancer during treatment, its value for helping to predict breast cancer relapse risk is not well established, and insurers won't pay the $600 to $900 tab.
The new study should spur more research on this right away, said Dr. Massimo Cristofanilli, a breast cancer specialist at Northwestern University in Chicago who has used these tests and consults for another company developing one.
"Clearly, to me, we have to do something" now that this study suggests a wider role for them, he said.
It involved 547 women in long-term follow-up from an earlier cancer drug study. Two-thirds of them had cancers fueled by estrogen, and in most cases it had spread to lymph nodes but not more widely.
All had surgery and chemotherapy followed by hormone-blocking medicines for five years. Guidelines now recommend considering hormone blockers for up to 10 years, but they have side effects and their benefit beyond five years is fairly small. So finding a way to tell who really needs that would be a big help.
Women in the study had a CellSearch test five years on average after their cancer was found and treated.
Among those with estrogen-fueled disease, 5 percent had cancer cells in the blood test, and they turned out to have a 22-fold higher risk of recurrence within roughly two years compared to women whose blood test was negative.
About 65 percent of women with hormone-positive disease and a positive blood test did not have a new breast cancer within two years, but that doesn't mean the blood test gave a false alarm, Sparano said.
"We haven't followed the patients long enough" — it could be that more tumors become evident with more time, he said.
The blood test seemed to do a good job of identifying which of these hormone-positive patients were at low risk of recurrence, suggesting that women who test negative may be able to forgo an additional five years of hormone-blocking medicines.
The test did not predict recurrence risk in the rest of the women in the study, whose tumors were not fueled by estrogen. They have a lower risk of recurrence after five years to start with.
The study was funded by the Breast Cancer Research Foundation, Susan G. Komen Foundation and the National Cancer Institute.
DES MOINES, Iowa (AP) — Stung by paying billions of dollars for settlements and trials, chemical giant Bayer has been lobbying lawmakers in three states to pass bills providing it a legal shield from lawsuits that claim its popular weedkiller Roundup causes cancer.
Nearly identical bills introduced in Iowa, Missouri and Idaho this year — with wording supplied by Bayer — would protect pesticide companies from claims they failed to warn that their product causes cancer, if their labels otherwise complied with the U.S. Environmental Protection Agency’s regulations.
But legal experts warn the legislation could have broader consequences — extending to any product liability claim or, in Iowa’s case, providing immunity from lawsuits of any kind. Critics say it could spread nationwide.
"It’s just not good government to give a company immunity for things that they’re not telling their consumers,” said Matt Clement, a Jefferson City, Missouri, attorney who represents people suing Bayer. “If they’re successful in getting this passed in Missouri, I think they’ll be trying to do this all over the country.”
Bayer described the legislation as one strategy to address the “headwinds” it faces. About 167,000 legal claims against Bayer assert Roundup causes a cancer called non-Hodgkin’s lymphoma, which Bayer disputes. The company has won some cases, settled many others but also has suffered several losses in which juries awarded huge initial judgments. It has paid about $10 billion while thousands of claims linger in court.
Though some studies associate Roundup's key ingredient with cancer, the EPA has regularly concluded it is not likely to be carcinogenic to humans when used as directed.
The costs of “defending a safe, approved product” are unsustainable, said Jess Christiansen, head of communications for Bayer's crop science division.
The legislation was introduced in targeted states pivotal to Bayer's Roundup operations and is at a different stage in each. It passed the Iowa Senate, is awaiting debate in the Missouri House and was defeated in Idaho, where this year's legislative session ended.
Farmers overwhelmingly rely on Roundup, which was introduced 50 years ago as a more efficient way to control weeds and reduce tilling and soil erosion. For crops like corn, soybeans and cotton, it’s designed to work with genetically modified seeds that resist Roundup’s deadly effect.
Missouri state Rep. Dane Diehl, a farmer who worked with Bayer to sponsor the legislation, cited concerns that costly lawsuits could force Bayer to pull Roundup from the U.S. market, leaving farmers to depend on alternative chemicals from China.
“This product, ultimately, is a tool that we need," said Diehl, a Republican.
Iowa Gov. Kim Reynolds, a Republican, said in an email the legislation maintains the integrity of the regulatory process and, without it, “Iowa risks losing hundreds of jobs” in Muscatine, an eastern Iowa city where Roundup is mostly produced.
The Associated Press is seeking public records on Bayer’s communications with governor's offices in Iowa, Missouri and Idaho.
Bayer, like other companies, hires lobbyists in states to advocate for its interests. The company backs this legislation in the states where “we have a big, direct economic impact,” Christiansen said.
Roundup’s key ingredient, glyphosate, is derived from phosphate mined in Idaho. And St. Louis is the headquarters of its North America crop science division, acquired in its 2018 purchase of Monsanto. Because of that, many of the lawsuits are filed in Missouri.
The five lobbyists registered for Bayer in Iowa and three in Idaho is largely consistent with recent years, but the number working in Missouri this year ballooned from four to nine. Lobbyist expenditures exceeded $8,000 in Idaho this year; similar information was not available in Iowa or Missouri.
Led by Bayer, a coalition of agricultural organizations called Modern Ag Alliance also is spending tens of thousands of dollars on radio and print advertisements claiming that trial lawyers and litigation threaten the availability of glyphosate.
On its website, the group asserts that at risk are 500 jobs connected to glyphosate production in Iowa, and 800 jobs in Idaho.
Bayer stopped short of threatening closures. The Iowa facilities, including in Muscatine, “are very critical facilities to our business, so we'll remain at some sort of support level,” Christiansen said.
At issue in the lawsuits and legislation is how Bayer – and any other pesticide company — communicates with consumers about the safety of its products.
Companies are required to register products with the EPA, which evaluates — and then reevaluates every 15 years — a pesticide and its label. The EPA reiterated in 2020 that glyphosate used as directed posed no health risks to humans. But a federal appeals court panel in 2022 ruled that decision “was not supported by substantial evidence” and ordered the EPA to review further.
The debate over glyphosate escalated when a 2015 report by the International Agency for Research on Cancer, part of the World Health Organization, said it's “probably carcinogenic to humans" based on “limited” evidence of cancer in people and “sufficient” evidence in study animals.
Based on that international report, California sought to add a cancer warning label to products containing glyphosate. But a federal appeals court ruled against California last November, concluding such a warning wasn't factual.
Christiansen emphasized that many regulatory agencies worldwide agree with the EPA and insisted Bayer has to stick to EPA labeling to ensure it isn't providing false or misleading information. She added that the company is transparent in the information it does provide.
Critics of the legislation aren't convinced, citing examples such as opioids and asbestos that had been deemed safe for use as directed — until they weren't.
There also are concerns that the legislation could stifle any product liability claim since most rely on the argument that a company failed to warn, said Andrew Mertens, executive director of the Iowa Association for Justice, an organization for trial lawyers.
Jonathan Cardi, a product liability and torts expert at Wake Forest University School of Law, also said a strict reading of the Iowa legislation extends beyond liability claims, and “the way it’s drafted makes it interpretable to mean nobody could bring any suit.”
In lobbying lawmakers and in speaking with the AP, Bayer representatives disputed that the legislation would cut off other legal actions. Several legal experts said the legislation is unlikely to affect the 18,000 lawsuits already pending in Missouri’s capital of Jefferson City, and wouldn’t prevent claims in states that don’t adopt similar legislation.
In Idaho, the Republican-led Senate narrowly defeated the bill amid concerns about relying on federal agencies' safety standards and limiting the ability of harmed individuals to sue.
John Gilbert, who farms in Iowa Falls, Iowa, with limited use of Roundup, called Republicans hypocritical for attempting to protect corporate interests after campaigning on standing up for Iowans.
The bill “invites a lot of reckless disregard," said Gilbert, who is on the board for the Iowa Farmers Union. “No amount of perfume’s gonna make it anything but a skunk."
Lieb reported from Jefferson City, Missouri.
FILE - Soybeans are seen in a field on a farm, Friday, Sept. 2, 2016, in Iowa. The maker of a popular weedkiller is turning to lawmakers in key states to try to squelch legal claims that it failed to warn about cancer risks. (AP Photo/Charlie Neibergall, File)
FILE - The Bayer AG corporate logo is displayed on a building of the German drug and chemicals company in Berlin, Monday, May 23, 2016. Bayer, the maker of a popular weedkiller, is turning to lawmakers in key states to try to squelch legal claims that it failed to warn about cancer risks. Bayer disputes such claims but already has paid about $10 billion to resolve them. (AP Photo/Markus Schreiber, File)
FILE - Phosphate ore is dug up and transported from Monsanto Company's South Rasmussen Mine site near Soda Springs, Idaho, July 16, 2009. Bayer acquired Monsanto in 2018. Bayer, the maker of a popular weedkiller, is turning to lawmakers in key states to try to squelch legal claims that it failed to warn about cancer risks. The company disputes such claims. A key ingredient of the weedkiller, glyphosate, is derived from phosphate mined in Idaho. (Bill Schaefer/The Idaho State Journal via AP, File)
FILE - Containers of Roundup are displayed on a store shelf in San Francisco, Feb. 24, 2019. Thousands of legal claims against drug and chemicals company Bayer assert Roundup causes a cancer called non-Hodgkin’s lymphoma, which Bayer disputes. (AP Photo/Haven Daley, File)
FILE - A soybean field is sprayed in Iowa, July 11, 2013. The maker of a popular weedkiller is turning to lawmakers in key states to try to squelch legal claims that it failed to warn about cancer risks. (AP Photo/Charlie Neibergall, File)
