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Many women with early-stage breast cancer can skip chemotherapy without hurting their odds of beating the disease — good news from a major study that shows the value of a gene-activity test to gauge each patient's risk.
The test accurately identified a group of women whose cancers are so likely to respond to hormone-blocking drugs that adding chemo would do little if any good while exposing them to side effects and other health risks. In the study, women who skipped chemo based on the test had less than a 1 percent chance of cancer recurring far away, such as the liver or lungs, within the next five years.
"You can't do better than that," said the study leader, Dr. Joseph Sparano of Montefiore Medical Center in New York.
An independent expert, Dr. Clifford Hudis of New York's Memorial Sloan Kettering Cancer Center, agreed.
"There is really no chance that chemotherapy could make that number better," he said. Using the gene test "lets us focus our chemotherapy more on the higher risk patients who do benefit" and spare others the ordeal.
The study was sponsored by the National Cancer Institute. Results were published online Monday by the New England Journal of Medicine and discussed at the European Cancer Congress in Vienna.
The study involved the most common type of breast cancer — early stage, without spread to lymph nodes; hormone-positive, meaning the tumor's growth is fueled by estrogen or progesterone; and not the type that the drug Herceptin targets. Each year, more than 100,000 women in the United States alone are diagnosed with this.
The usual treatment is surgery followed by years of a hormone-blocking drug. But many women also are urged to have chemo, to help kill any stray cancer cells that may have spread beyond the breast and could seed a new cancer later. Doctors know that most of these women don't need chemo but there are no great ways to tell who can safely skip it.
A California company, Genomic Health Inc., has sold a test called Oncotype DX since 2004 to help gauge this risk. The test measures the activity of genes that control cell growth, and others that indicate a likely response to hormone therapy treatment.
Past studies have looked at how women classified as low, intermediate or high risk by the test have fared. The new study is the first to assign women treatments based on their scores and track recurrence rates.
Of the 10,253 women in the study, 16 percent were classified as low risk, 67 percent as intermediate and 17 percent as high risk for recurrence by the test. The high-risk group was given chemotherapy and hormone-blocking drugs. Women in the middle group were randomly assigned to get hormone therapy alone or to add chemo. Results on these groups are not yet ready — the study is continuing.
But independent monitors recommended the results on the low-risk group be released, because it was clear that adding chemo would not improve their fate.
After five years, about 99 percent had not relapsed, and 98 percent were alive. About 94 percent were free of any invasive cancer, including new cancers at other sites or in the opposite breast.
"These patients who had low risk scores by Oncotype did extraordinarily well at five years," said Dr. Hope Rugo, a breast cancer specialist at the University of California, San Francisco, with no role in the study. "There is no chance that for these patients, that chemotherapy would have any benefit."
Dr. Karen Beckerman, a New York City obstetrician diagnosed with breast cancer in 2011, said she was advised to have chemo but feared complications. A doctor suggested the gene test and she scored very low for recurrence risk.
"I was convinced that there was no indication for chemotherapy. I was thrilled not to have to have it," and has been fine since then, she said.
Mary Lou Smith, a breast cancer survivor and advocate who helped design the trial for ECOG, the Eastern Cooperative Oncology Group, which ran it, said she thought women "would be thrilled" to skip chemo.
"Patients love the idea of a test" to help reduce uncertainty about treatment, she said. "I've had chemotherapy. It's not pretty."
The test costs $4,175, which Medicare and many insurers cover. Others besides Oncotype DX also are on the market, and Hudis said he hopes the new study will encourage more, to compete on price and accuracy.
"The future is bright" for gene tests to more precisely guide treatment, he said.
WILMINGTON, Del. (AP) —
Court records show a Delaware man who reportedly shot himself and refused commands to drop his weapon before being killed by police while in his wheelchair had previously expressed suicidal thoughts and had a history of being combative with police.
Some people who saw Jeremy McDole, 28, in the days before he was killed Wednesday said he did not appear to be sad or to be acting strangely.
"When I saw him, he was happy," said Bishop Anthony Slaughter, a community evangelist who talked to McDole last Monday. Eugene Smith, an uncle who said he spoke with McDole about 15 minutes before the shooting, also said he did not sense anything unusual.
Court records reviewed by The Associated Press show McDole, who had at least 16 arrests, expressed suicidal behavior in 2010 and was accused of being combative with law enforcement. In pleading guilty in 2011 to a drug charge, McDole was given a form asking him several questions, including whether he had ever been a mental hospital patient. His public defender responded affirmatively, adding in parentheses: "2010 Suicidal." Public defender Kester Crosse also indicated McDole was taking the antidepressants Cymbalta and Zoloft at the time of the plea.
A criminal history form included in another of McDole's case files noted that he "will resist police." The file shows that McDole had a juvenile adjudication for resisting arrest and other crimes in 2004, and that he was charged with resisting arrest in connection with a 2009 drug charge. The latter resisting charge was dropped in a plea deal. In that incident, a police officer wrote that McDole repeatedly pulled his arms away from officers trying to take him into custody, and fought with officers after arriving at a police station. "DON'T DISRESPECT ME!" he shouted as officers tried to prevent him from putting his hands in his crotch area, according to the report.
Law enforcement officials also said in court records that McDole, who was shot in the back by an associate in 2005, used his wheelchair to hide things.
"The last three felony arrests indicate that Mr. McDole has used his disability to enhance his opportunities to become a better drug dealer, as since his shooting incident he can hide contraband easier in his wheel chair," a probation and parole officer wrote in October 2014.
Wilmington Police say they encountered McDole, who was black, on Wednesday after receiving a 911 call about man who had shot himself in the parking lot of an auto parts store and was still armed with a handgun. Officials have released a portion of the call, in which a frantic woman repeatedly says the man still has a gun and warns other people to stay back. Cellphone footage taken by a bystander shows police repeatedly telling McDole to drop his weapon and McDole reaching for his waist area before shots erupt. Authorities have said they recovered a .38 caliber handgun near McDole's body.
Repeated attempts by The Associated Press to talk to the McDole family were unsuccessful. Family members have previously suggested that he did not have a gun, and that police had no reason to kill him.
Wilmington Police chief Bobby Cummings has said he does not know whether McDole was depressed or suicidal, or what might have led him to shoot himself before police arrived.
Slaughter, the community evangelist, said he told McDole on Monday that he would pray for him.
"He said, 'I'm done doing anything crazy.' ... He wanted to change his life," Slaughter recalled.
Delaware Gov. Jack Markell and Mayor Dennis Williams, who attended a peaceful prayer vigil and spoke with McDole's family on Thursday, met relatives again Sunday.
"The governor made a brief visit to Jeremy McDole's grandmother to offer condolences and thank her for working with the NAACP to try to maintain calm," Markell spokeswoman Kelly Bachman said in an email.
The Delaware NAACP is seeking an independent probe of the shooting, which is being investigated by police and the state attorney general's office.
ABOARD THE PAPAL PLANE (AP) —
Pope Francis has defended his words of consolation to U.S. bishops over the priest sex abuse scandal but says — for the first time — that those who covered up for abusers are guilty of wrongdoing.
In a wide-ranging press conference en route to Rome from his first-ever visit to the United States, Francis also declared conscientious objection a "human right," explained his admiration for American nuns and discussed his own star power, which was fully on display during his six-day, three-city tour.
He also invented a new Italian word to describe the exuberant reception he received in New York City: "stralimitata" — roughly, "beyond all limits."
On his last day in the U.S., Francis on Sunday met with five survivors of sexual abuse and issued a warning to bishops that they would be held accountable if they failed to protect their flocks.
"Those who covered this up are guilty," he said. "There are even some bishops who covered this up. It's something horrible."
While the Vatican has cracked down on priests who rape and molest children in recent years, it has long been accused of turning a blind eye to the bishops who moved abusers around rather than report them to police. Francis has agreed to create a tribunal in the Vatican to prosecute these bishops for abuse of office and has accepted the resignations of three U.S. bishops who mishandled abuse cases.
Francis defended his words of consolation to U.S. bishops in Washington earlier in the week, saying he wanted to acknowledge that they had suffered too. Advocates for victims had denounced his praise as tone-deaf.
"The words of comfort weren't to say 'Don't worry, it's nothing.' No, no, no. It was that 'It was so awful, and I imagine that you have wept so much,'" he said.
On Sunday, Francis directed his attention to the victims of abuse themselves, meeting with five survivors, including people who had been molested not only by priests but also abused by family members or educators. He apologized to them that often their accusations weren't taken seriously, and promised to hold bishops accountable.
Francis said he understands how a victim or a relative of a victim could refuse to forgive the priest who abused.
"I pray for them, and I don't judge them," Francis said.
He recalled that in his previous meeting with survivors of sex abuse, in July 2014, one told him that her mother had lost her faith and died an atheist after learning that a priest had violated her child.
"I understand this woman. I understand, and God who is better than me understands," Francis said. "And I am sure that God received this woman. Because what was groped and destroyed was her flesh, the flesh of her daughter. I understand. I cannot judge someone who cannot forgive."
In another issue pressing on the American church, Francis was asked about the case of Kim Davis, the Kentucky county clerk jailed for several days after she refused to issue marriage licenses to gay couples despite the Supreme Court's ruling making same-sex marriage legal nationwide. Davis said such marriages violate her Apostolic Christian faith.
Francis said he didn't know the case in detail, but he upheld conscientious objection as a human right.
"It is a right. And if a person does not allow others to be a conscientious objector, he denies a right," Francis said.
Francis said he was surprised by the warmth of the welcome he received in the U.S. despite criticism from conservatives over his environmental and economic messages.
"In Washington, it was a warm welcome, but a bit more formal," Francis said. "In New York, a bit 'beyond all limits.'"
"In Philadelphia, very expressive. Different ways, but the same welcome."
He said he was also impressed by the piety of Americans and gave thanks there were no incidents during the trip.
"No provocations, no challenges," he said. "They were all well-behaved, normal. No insults, nothing bad."
Conservative American commentators had been deeply critical of Francis' priorities prior to the trip, blasting his eco-focus as flawed and even criticizing his decision to streamline the church's annulment process by saying it amounted to a "Catholic divorce."
Francis denied the change would facilitate divorce, saying it merely simplified the church's process for determining if a marriage was valid.
Francis once again pronounced his admiration for American nuns, saying they had worked "marvels" in education and health care in the United States and were simply "great."
"The people of the United States love their sisters," Francis said. "I don't know how much they love their priests, but they love their nuns. And they are great. They are great, great women."
His praise was noteworthy, given the Vatican under his predecessor had launched a crackdown on the largest umbrella group of U.S. sisters, accusing them of straying from orthodoxy and not emphasizing doctrine enough. Under Francis, the takeover ended two years early without any major changes. A separate Vatican investigation into the quality of life of America's sisters similarly ended up thanking them for their selfless service.
Francis on two occasions during the trip gave the sisters public recognition and thanks. He also visited with one group of nuns, the Little Sisters of the Poor, who have challenged the Obama administration's health care insurance mandate.
After speeches in Congress and at the United Nations, and deeply moving gestures visiting with the homeless, immigrants, prison inmates and schoolchildren, it was suggested to Francis that he had become something of a "star" in America.
Francis dismissed the idea, saying power is a passing thing, and that true power is to serve others.
"I must still go forward on this path of service because I feel like I haven't done all I can," he said.
And besides, he said, stars eventually fade away.
"Being a servant to the servant of God is beautiful. And it doesn't fade away."