Christine
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Silicon Valley / San Jose Business Journal
Telik Inc. said Monday a partial hold on clinical trials for its cancer drug was lifted by the U.S. Food and Drug Administration.
The Palo Alto-based biopharm (NASDAQ:TELK) said it was asked in June to temporarily halt trials for Telcyta, designed to treat ovarian and lung cancer.
The company said the FDA had some safety concerns over the drug.
Telik said that after a complete review of data, regulators permitted clinical development to resume on Telcyta.
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Congrats! That is fantastic news. I am so happy for you.
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I am so sorry for the loss of your mother.
Christine
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Debi,
The news of Tony's passing saddens me. Please accept my sincere condolences. Prayers for you and your family.
Christine
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Christine,
I am so very sorry for the loss of your father.
Christine
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Even though lung cancer can take two decades to develop, when it is detected it is already at such an advanced stage that the chances of successful treatment are very small. An immune system protein may offer the early warning system experts have been looking for.
You can read about this study in the journal Thorax.
Lung cancer kills approximately 900,000 people each year. No effective warning system exists which can detect lung cancer during its early stages - when it is treatable. Sadly, the long-term outlook for current lung cancer patients have not changed much during the last three decades.
In this study scientists analyzed plasma samples from 50 healthy volunteers and 104 people with lung cancer. They were testing for autoantibodies - immune system proteins that are directed at the body's own tissues in response to certain chemical signals in the body. In particular, they were looking for a panel of seven autoantibodies - they are all linked to solid tumors which are found in lung cancer, ovarian cancer, breast cancer and prostate cancer. These seven autoantibodies are triggered when cancerous changes are happening.
They found that 80% of patients with confirmed lung cancer had very high levels of at least one of the seven autoantibodies. These autoantibodies had been found in eight of the nine patients whose cancer had not infiltrated the lymph nodes - when the disease has not yet spread elsewhere and the chance of a cure is much greater. Out of all the healthy volunteers, only one had more than one of these autoantibodies in the blood.
According to previous research, these autoantibodies can be detected five years before the clinical symptoms of lung cancer start to show - in other words, five years before lung cancer is detected.
A previous study had also shown that these autoantibodies can be picked up in patients before their breast cancer is detected.
As the lungs are sensitive to radiation it is not ideal to use x-rays for detecting lung cancer. A blood test, however, has no side effects and is much cheaper than imaging. And the panel can be altered to include more or different autoantibodies for lung and other cancers.
The researchers say the test could be used for higher risk groups, such as smokers and second-hand smokers. If someone gets a positive result, he/she could be referred for more detailed scans, such as a CT (computed tomography) or MRI (magnetic resonance imaging).
"Autoantibodies in lung cancer: possibilities for early detection and subsequent care"
Thorax 2007; doi: 10.1136/thx.2007.083592
Written by: Christan Nordqvist
Copyright: Medical News Today
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Video URL: http://www.13wham.com/mediacenter/local ... wokr13.com
13WHAM.com (Liz Bonis)
A recent discovery could lead to a big breakthrough in treating lung cancer.
As part of a national trial, lab researchers say they've found a pathway that could someday help with targeted treatment in chemotherapy.
Recent studies show that a combination of surgery and chemotherapy may be more effective for some lung cancer patients than treating with either therapy alone.
The problem is chemo treatment can be trial and error; researchers don't know who will benefit from taking these drugs or which drugs might work best in certain patients.
Researcher Dr. Michael Reed said, “It would be ideal to be able to know ahead of time, before treatment which combinations of medications have the highest likelihood of success.”
Reed’s team recently published a study in the journal Cancer Research which details a remarkable discovery. They found that turning off a certain tumor suppressor or pathway that controls the growth of cells, alters the response of lung cancer cells to chemotherapy.
“Right now we are studying the response to specific individual agents. In the real world, we treat with combination therapy. Our next step is to start using a combination of agents to be able to better predict in a more realistic setting response to therapy,” Reed said.
That means, eventually, doctors could target chemo based on a patient’s specific type of tumor.
This study was funded from a grant from the National Institutes of Health. Final results are not expected for at least a couple more years.
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By Vindu Goel
Mercury News
Article Launched: 10/10/2007 01:36:35 AM PDT
If you were dying of cancer and there were an experimental drug that could give you an extra six months to live, you'd want access to it.
You'd still want it even if it had awful side effects, like turning your skin green and making your fingernails fall off - which can happen to people taking Xcytrin, a drug from a Sunnyvale company that shows promise for treating brain lesions caused by the spread of lung cancer.
But is it the government's responsibility to make it easier for you to get such life-prolonging therapies, even if they cost tens of thousands of dollars a year?
That's the question the Food and Drug Administration, Congress and the courts are wrestling with as some drugmakers and patient-rights groups crusade for more flexible rules in evaluating new drugs for terminal diseases.
We all want the best medicine available for ourselves and our loved ones. Yet we don't want to subsidize ineffectual treatments by paying higher hospital bills and insurance premiums. And we certainly don't want the government rushing to approve drugs that aren't safe.
The evidence suggests that when it comes to approving drugs for fatal diseases, especially cancer, regulators at the FDA are being too cautious.
New cancer drugs take an average of seven years to get FDA approval, and 92 percent of all applications are rejected, according to a study by Tufts University. That's a longer review time and a lower approval rate than most drugs face.
In the past year alone, the FDA has turned down or demanded more data on five experimental cancer drugs, including Provenge, a prostate cancer drug that got the thumbs-up from an FDA advisory panel.
The agency's actions have riled Dr. Richard A. Miller, a Stanford oncologist and chief executive of Pharmacyclics, a small publicly held biotech company which has about a year of cash left and badly needs the FDA to approve Xcytrin, its first drug. Miller has launched a Web site, www.yourcanceryourchoice.com, to push for better patient access to new cancer drugs.
In February, the FDA refused to accept his company's application to market Xcytrin. Its clinical trial data didn't pass a predefined test designed to determine whether the extra five months recipients lived was due to the drug or pure chance. Pharmacyclics is demanding a formal FDA review, saying some French doctors didn't follow the study protocols, which unfairly skewed the data.
Miller argues that the FDA is holding drugmakers to rigid, outdated scientific and statistical standards. "If a person is going to die in a few months, it's a different risk-benefit proposition than for someone with a hangnail," he said.
Steve Whitley, a sales manager at a Phoenix cement maker, thinks the trade-offs were worth it. When his wife, Cindy, was diagnosed with lung cancer that had spread to the brain, the couple quickly decided to sign her up for an Xcytrin drug trial.
Instead of living the expected three to six months, she got 25 months to spend with him and their three children. "It meant two more years of birthdays and Christmases," Steve Whitley said.
A 1992 law, passed in response to the U.S. AIDS epidemic, was supposed to speed approval of drugs for fatal diseases. But recently, the FDA has become more cautious just as drugmakers try to tackle more difficult diseases. One explanation is increased scrutiny of the FDA after Merck withdrew painkiller Vioxx in 2004 because of increased risk of heart attacks and strokes.
The agency declined to comment on specific drugs but said it works hard with companies to design measures of effectiveness for each drug and disease. Once those criteria are set, companies have to hit the targets.
"You need to win on what you think you're going to win on," said Dr. John Jenkins, director of the FDA's Office of New Drugs. Changing the rules in the middle of the process or selectively excluding some patients is "just not scientifically sound."
The Abigail Alliance for Better Access to Developmental Drugs disagrees, calling for a new law that would allow patients to buy experimental drugs and overhaul the FDA's scientific and statistical approach.
The advocacy group also has sued to force the FDA to give patients early access to drugs that have passed safety tests but are still being evaluated for effectiveness. Courts so far have backed the FDA.
If I were dying, I'd want the chance to weigh the risks and decide with my doctor whether to try something that might help me. The FDA, so dedicated to its traditional scientific standards, could use a dose of compassion.
As Whitley put it: "What's the risk? You're going to die."
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Dr. Sean Kenniff
Reporting
(CBS4) POMPANO BEACH - When someone is diagnosed with cancer, it can have devastating effects on the body both mentally and physically. Several cancers can spread to the spine creating tumors that cause excruciating pain.
The Food and Drug Administration recently approved a treatment for these tumors which provides some much needed relief and an improved quality of life.
36-year old Eric Plummer is a family man who loves spending time with his three small children.
Recurring back pain was keeping him from playing with his kids.
"I had a real kind of substantial back pain that I had been fighting that had gotten progressively worse over the years," said Plummer.
Visits to the chiropractor didn't help.
So Plummer had an MRI that revealed his problem was much more serious.
"I've got bad news. We know why your back is hurting you and you've got cancer," said Plummer.
The news came one day after Father's day.
Plummer was diagnosed with lung cancer that had spread to the spine.
"The L3 vertebra was so diseased by the cancer that there was risk of it collapsing," said Plummer.
Interventional radiologist Dr. Charles Tate with Holy Cross Hospital in Fort Lauderdale suggested Plummer undergo a procedure called a vertebroplasty.
It was recently improved to treat spine tumors which are extremely painful.
"This procedure allows us to go in and kill a certain area where the tumor is located in the spine and replace that killed tumor with a material we call cement," said Tate.
A wand delivers a radio frequency signal that vaporizes the tumor.
The surgical cement is used to prevent the bone from collapsing which could cause paralysis.
Tate says it not only reduces pain and builds bone; it also rebuilds hope.
"I think for those people who suffer grievously from this particular problem, I think it's a potential godsend for them," said Tate.
A godsend it was for Plummer, who's quality of life has improved tremendously.
“The relief was immediate. I could bend over freely play with the kids it's been liberating," said Plummer.
The best part is it's done on an outpatient basis. Patients can return home a few hours after the procedure.
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From center stage in New York City with Jerry Seinfeld, to the streets of San Francisco, to Detroit radio blasts, Deborah Morosini, MD, is on a mission: to honor her sister, Dana Reeve, and all of those affected by lung cancer by speaking anywhere and everywhere she can to raise funds for research and the awareness of lung cancer.
As the newest board member for the Bonnie J. Addario Lung Cancer Foundation, this mom of two teenage boys, and physician researcher for a major pharmaceutical on the East Coast, is trotting coast-to-coast to cities across the country with one message: “It is time to wipe out lung cancer. Nothing less is acceptable.”
As the older sister of Dana, Deborah has made it her crusade to carry on her sister’s legacy of caring and compassion. As the third generation of doctors in her family – her father is a physician and her grandfather was a doctor too, Deborah works every day as a physician researcher at AstraZeneca trying to find cures for cancer.
All of this comes together to make Deborah a powerful voice for our Foundation. You can hear her emotional plea that “lung cancer matters too,” on more than 1,000 radio stations across the country from Odessa, Texas to New York City. Here’s a glimpse at what Deborah is saying on Public Service Announcements on behalf of our Foundation:
“Somebody just died…while you’re listening to me. And that somebody is somebody’s sister, brother, mom, dad, daughter, son or friend. 450 people die a day. 19 an hour. From Lung Cancer.
Six-hundred and fifty thousand people will die of the world’s DEADLIEST cancer by the year 2010 if we don’t do something now. Where’s the outrage? Lung Cancer Matters Too.
It’s not what you think. It’s not what you’ve heard. Don’t believe that if you don’t smoke you can NEVER get lung cancer. I’m Deborah Morosini and I lost my sister, Dana Reeve, to lung cancer.
Please help us save lives at the Bonnie J. Addario Lung Cancer Foundation. Because we can.”
Deborah is passionate with her message. You can hear it on the airwaves on behalf of our Foundation, and you can hear it in her voice. There is urgency about Deborah, a mission to talk about the tragedy of a lack of funding for research and awareness about this deadly killer. It drives her to the speaker circuit, hoping that if she shouts loud enough, someone will listen, somehow we can beat the mortality rates and battle the ignorance about the facts of lung cancer.
And, she’s also on the appearance circuit getting our Foundation’s message out. During the months ahead, her mission accelerates:
• On October 11, she’ll take the stage on an “Evening with Jerry Seinfeld,” at the Hammerstein Ballroom, 311 W. 34th St. in New York. Proceeds from the evening will benefit the Memorial Sloan-Kettering Cancer Center. The event is being organized by Stand Up For a Cure.
• She’s also doing a pod cast for “Smoke Free Michigan,” for the American Cancer Society. Smoke Free is a grass roots statewide organization working for smoke-free environments wherever the public gathers in this Midwestern state. Deborah will make her plea.
• And she’s coming to San Francisco in November as one of our guests for the Simply the Best Gala: On November 9, Deborah will accept an award in her sister’s behalf at our second annual “Simply the Best Dinner Gala II” at the Fairmont Hotel. SIMPLY THE BEST II celebrates the end of lung cancer through the eyes of the very best doctors, families and friends of our cause because lung cancer matters too.
• On November 30, she will speak at the “State of the Art Lung Cancer Diagnosis and Treatment Medical and Advocacy Conference” at the Ritz Carlton Hotel in Dearborn, Michigan. Her presentation: “Icons of Survival: The Positive Legacy of Dana and Christopher Reeve.” Her participation will provide a valuable opportunity for lung health professionals and individuals affected by lung cancer to hear from the most highly respected experts in the field. The program is sponsored by the American Lung Association of Michigan and the Karmanos Cancer Institute.
“I can’t speak enough; I can’t do enough, until we’re taken seriously and the tragedy of lung cancer is over,” says Deborah.
Dr.Fred Marcus to Present the “Simply the Best Award” to Deborah Morosini
“Lung cancer not only takes victims—it takes parts of whole families that can never be replaced.”–Dr. Fred Marcus
As a physician specializing in Pathology, Dr. Deborah Morosoni has sat behind the microscope to make the very unfortunate diagnosis of lung cancer. Her first-hand experience–previously only from a distance–became up-close and very personal when her 44-year old younger sister, Dana Reeve, was diagnosed with lung cancer in August 2005.
Dana was a very talented actor and singer who had never smoked a single cigarette. Dana’s professional career was put on an abrupt hold, when her husband, Christopher Reeve suffered a severe and debilitating Spinal Cord injury after a tragic fall from his horse. Dana dedicated her life to helping Christopher with his disability and the two of them founded the Christopher and Dana Reeve Foundation to help other victims of spinal cord injuries.
A bright light went out on March 6, 2006, when Dana died from lung cancer. This very moment ignited a new light and on the very same day, Bonnie J. Addario began this Lung Cancer Foundation.
Despite every effort to provide the best medical care for Dana, Deborah halted her career to help her sister in dealing with this illness. After Dana’s death, Deborah decided to go on a mission that would honor her sister and one day bring an end to the tragedy of lung cancer. Deborah decided that she would stand up for all those affected with lung cancer and do everything she can to call attention to the fact that lung cancer is the major cause of cancer deaths in this country and in this world and that every effort and as much funding as possible needs to be mobilized to eradicate lung cancer.
Deborah’s enormous energy and passion for this mission is completely reflective of Dana’s care and compassion. Dana would be so proud of her sister’s dedication to this cause.
As recipient of the very first “Simply the Best Award,”Dr. Fred Marcus has been searching his soul for just the right individual to bestow this great honor upon this year. Conceived to honor those like Marcus by Bonnie J. Addario, this award is intended to honor outstanding performance in the fight to end lung cancer.
This award sends a powerful message, not only to the entire world audience that will soon know about the devastation of lung cancer through the work of this Foundation, but to the individual that receives it. It acknowledges and honors all they have done and all they are continuing to do to make this world a better place. BJALCF Board Member, Dr.Deborah Morosini, is the recipient of this year’s SIMPLY THE BEST award in honor of all of the spirit, compassion, dedication, boundless energy, and unfettered conviction she beholds, to save as many lives as she can through raising awareness of early detection, and ultimately the eradication of lung cancer.
“Think how many things in this country have been considered hopeless before? At first they seem impossible, then they seem improbable, and then if you can summon the will and get the funding–they become inevitable.”–Christopher Reeve
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Science Daily — Researchers at Cold Spring Harbor Laboratory (CSHL) have discovered three genes that interact with cancerous results in 20% of lung cancers. The three genes are located next to each other on human chromosome 14 and two are known to play key roles in fetal lung development. According to CSHL lead investigator David Mu, "lung cancer cells in adults can reactivate genes that are normally active in the earliest stages of lung development. We identified the mutation that triggers this abnormal re-activation of developmental genes and showed that if you turn off these genes, you stop the cancer."
The CSHL research found that the three genes termed TTF1, NKX2-8, and PAX9 interact to reactivate what appears to be an early fetal gene expression pattern that results in cancer tumor growth. "The collaboration of these genes and the fact that they are so close together on the chromosome may explain why this mutation is so common in lung cancer," said CSHL investigator and co-author Scott Powers. In collaboration with Dr. William Gerald at the Memorial Sloan Kettering Cancer Center, the study finds that the mutation is more prevalent in late stage lung cancer and is possibly a risk factor for recurrence.
The CSHL-led research demonstrates that the cancerous results of the mutation can be reversed. In the future, this may lead to new treatment options for patients. Cancer research that looks at one gene at a time ignores the fact that cancers are usually caused by multiple collaborating cancer genes. Mutations in these genes determine the clinical outcome of the cancerous growth and how the cancer responds to treatment.
"At CSHL we are excited about the ability to apply direct genomic analysis to human cancers and discover more about how cancer genes interact," said Howard Hughes Medical Institute Investigator and CSHL Cancer Center Deputy Director Scott Lowe.
Citation: Jude Kendall; Alex Krasnitz; B. Lakshmi; Scott Powers; David Mu; Qing Liu; Amy Bakleh; Ken C. Q. Nguyen, Cold Spring Harbor Laboratory and William L. Gerald Memorial Sloan--Kettering Cancer Center."Oncogenic cooperation and co-amplification of developmental transcription factor genes in lung cancer" Proceedings of the National Academy of Sciences DOI: 10.1073PNAS.0708286104
The research was supported by NCI Cancer Center Funds and the Joan's Legacy Foundation.
Note: This story has been adapted from material provided by Cold Spring Harbor Laboratory.
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Rocky Mountain News
October 9, 2007
Question: I just read about a study which found that CT scans can find early, curable lung cancer. Do you recommend this test for smokers and former smokers?
Dr. Weil's Answer: The study you refer to is an important one. Researchers at New York Presbyterian/Weill Cornell Medical Center in New York City recently published research results suggesting that 80 percent of deaths from lung cancer could be prevented with annual CT scans. The tests can find lung cancer early enough to treat and cure it.
A total of 31,567 people in seven countries participated in the study. Those screened included smokers, former smokers and people considered at risk because they had been exposed to environmental toxins such as radon and secondhand smoke. The scans detected 484 lung cancers, 412 of them at a very early stage. Most of these cases were treated with surgery although some patients had chemotherapy or radiation or both instead.
The question of whether everyone at high risk of lung cancer should be screened annually by CT is still controversial. This study makes a persuasive case because it included a large population and was well designed. But some experts argue that there should have been a control group of similar patients who weren't screened to demonstrate whether or not there really is a benefit to the annual CTs.
My feeling is that the screening is a good idea for people at high risk. Lung cancer is the leading cause of cancer deaths in the United States and is responsible for more than 160,000 deaths every year. This study shows that screening could prevent 80 percent of those deaths if cancers were found early and treated appropriately.
If you think you should have the test, talk to your physician and be sure to have it performed at a facility that has doctors who are experienced in lung scanning and has physicians who can help you decide upon treatment, if necessary. Be forewarned, however: The scans can cost hundreds of dollars, and most insurers don't cover them.
To ask Weil a question, visit his Web site, drweil.com, and click "Ask Dr. Weil" and then "Ask Your Question."
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New tool in fight against lung cancer
Chicago Daily Herald
Published: 10/8/2007 11:24 PM
Whether they know it yet or not, countless numbers of Illinois residents have just been given a powerful weapon in the fight of their lives. On Aug. 27, state Sen. John Cullerton, D-Chicago, state Sen. Kwame Raoul, D-Chicago, and state Rep. Fred Crespo, D-Hoffman Estates, championed and ultimately won passage of Illinois Senate Bill 796, which created the landmark lung cancer research fund. This vital legislation will allow Illinois residents to allocate a portion of their 2007 state income tax to lung cancer research simply by checking a box on their tax return.
Some may ask, "What's so important about the lung cancer research fund?" Its significance lies in its potential to advance cutting-edge research for the most lethal form of cancer, which this year alone will claim over 150,000 lives in the United States. Four years ago, it claimed the life of my energetic and brave father within a period of just 10 months. Often perceived and shunned as a smoker's disease, lung cancer is being increasingly diagnosed at alarming rates in non-smokers and former smokers, especially among women.
Despite the grave statistics surrounding lung cancer -- it kills more Americans every year than breast, prostate and colorectal cancers combined; and 85 percent of those diagnosed with the disease will die within five years without new treatment methods -- the federal government spent just over $1,800 on research per lung cancer death in 2005. By comparison, the federal government spent $23,400 for each breast cancer death and $14,300 for each prostate cancer death. Making matters worse, lung cancer is often caught so late that there is a short window of time for effective treatment.
Beginning this year, every Illinois taxpayer will have the power to help turn the tide against lung cancer. With the lung cancer research fund, broadminded legislators, volunteer advocates, and organizations such as the Respiratory Health Association of Metropolitan Chicago, have taken a big step forward in erasing the unfortunate stigma often associated with this silent killer.
Jennifer A. Moran
Chicago
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URL for this article:
http://online.wsj.com/article/SB119179920110451468.html
Critics Question Objectivity Of Government Lung-Scan Study. Tobacco Companies Paid Key Researchers As Expert Witnesses
By DAVID ARMSTRONG
October 8, 2007; Page B1
In a dispute with broad implications for cancer treatment, patient advocates and congressional overseers are raising questions about the objectivity of a massive federal study that is supposed to determine whether annual CT scans of smokers' lungs can save lives.
The nine-year study, called the National Lung Screening Trial, is tracking 50,000 smokers at a cost of $200 million, and is funded by the National Cancer Institute, or NCI. Due to be finished in 2009, the study is expected to have a major impact on whether regular CT scans for smokers will become a standard of care -- and whether tobacco companies could be forced to pay for them. The 90 million current and former smokers in the U.S. are all potential candidates for such screening.
Since late last year, the Lung Cancer Alliance, a Washington, D.C., nonprofit that supports screening, has asserted in letters to the NCI and its parent, the National Institutes of Health, that two of the study's key researchers have conflicts of interest because they have accepted money from tobacco companies to be expert defense witnesses in lawsuits. The suits sought to force the companies to pay for annual CT screening.
The Alliance, which is funded by individual donations and corporate grants, including $100,000 from General Electric Co., a maker of CT scanners, also charged the study has design flaws that could bias its outcome against screening.
In recent months, staffers of the U.S. House Energy and Commerce Committee, which oversees medical research issues, have also begun making inquiries about the alleged conflicts and design issues, say people familiar with the matter.
The question under consideration in the study is a complex one. CT, or computed tomography, scanning is adept at detecting abnormalities that might be cancerous. But once they are detected, potentially risky lung biopsies are usually needed to confirm the presence of cancer in the lung. Often, the biopsies turn up no cancer.
Skeptics say patients may suffer health problems as a result of universal screening -- such as complications from biopsies or needless surgery -- offsetting any gains from enhanced detection.
The researchers that the alliance and the congressional staffers are focused on are University of California Los Angeles radiologist Denise Aberle, one of the study's two national leaders; and Dartmouth College radiologist William Black, the principal investigator at one of the 30 study sites in the country.
In a 2003 trial of a lawsuit brought in state court in Louisiana, Dr. Aberle testified for the American Tobacco Co., now part of Reynolds American Inc., that "it is reckless or irresponsible to promote" CT screening. Court transcripts in the Louisiana case show that Dr. Aberle's role as co-leader of the government study was highlighted repeatedly. American Tobacco lawyer Gary Long says that what made Dr. Aberle a good witness was "the fact she could talk about the national lung cancer screening trial that is ongoing."
In a similar case in New York, Dr. Black provided an expert report for Philip Morris USA, a unit of Altria Group Inc., in which he warned that CT screening "may do more harm than good."
Smokers lost their bid for screening in the Louisiana case. The New York case is still pending, as is similar case in Massachusetts. The lawsuits haven't been closely followed by the media, and the researchers' roles in the cases weren't widely known until the alliance discovered them.
The NIH doesn't have conflict-of-interest rules for the nongovernment researchers it funds, and relies instead on the institutions where the researchers work to set guidelines. Universities generally require their faculty researchers to disclose consulting arrangements and other financial ties, and some schools ban some relationships outright.
Dr. Aberle denies any bias and says she decided to testify because the screening plan proposed by the plaintiffs in the Louisiana case was "poorly constructed" and "incompletely conceived." Among the flaws, she said, was the lack of a plan for how the patients would be treated following a screening test, or any provision to track patients to find out if screening had any impact. Dr. Aberle and UCLA say her expert work in the case was permissible under UCLA rules.
American Tobacco paid a total of $30,750 for Dr. Aberle's expert work in the Louisiana case, according to her and UCLA. The money, after taxes, was then deposited into a UCLA account. UCLA says she used the money for "academic enrichment," such as business-related travel and entertainment expenses or subscriptions to journals.
Dr. Black said he agreed to be an expert witness because he "felt an obligation that someone needed to stand up and represent the other side of the screening issue." He added, "the other side is getting away with false statements -- that it is a proven technology and saves lives." Dr. Black now says his decision to get involved in the court case was "naive." He has returned the $700 he earned from Philip Morris and stopped working for the company because of his concern the expert work "would be used against me" and the study "by patient advocacy groups on the other side." Dartmouth declined to comment, but in a letter to the Lung Cancer Alliance said the work was permissible under its rules.
In a written response to the Lung Cancer Alliance, the NCI said the expert witness work was appropriate. "Service as an expert witness, presenting independent analyses based on published medical literature, is a commonly accepted activity for physicians, researchers, and other experts and in the instance of the specific circumstances described did not violate the required disclosure guidelines of the organizations involved," NCI director John Niederhuber wrote.
In an interview, an NCI spokesman said the institute has no way of knowing whether any other investigators in the 30-center study have financial ties to tobacco or scanning companies because it does not examine such potential conflicts.
A spokeswoman for Siemens Medical Solutions, a big CT machine maker, said the company works on collaborative research projects with several research institutions but wouldn't say if it has any relationships with individual researchers working on this study. GE, another large CT vendor, declined to comment.
David Rothman, the director of the Center on Medicine as a Profession at Columbia University medical school, said he was "stunned" to learn that the researchers in the government study had testified for tobacco companies and said the NIH should overhaul its rules to prohibit such work.
The Lung Cancer Alliance and others also complain about the trial's design, in part because it compares patients receiving CT scans with those receiving X-rays. If abnormalities are detected by X-ray and a CT confirms cancer, the X-ray, not the CT, will be credited with the discovery. Critics also say that 50,000 patients are too few to detect a benefit.
In its written response to the Alliance, the NCI said that the there are enough patients in the study and that the study is scientifically "very well designed."
Write to David Armstrong at david.armstrong@wsj.com
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Source:Healthcare Exec Date:03/10/2007 11:38:48
Roche, the pharmaceutical giant, is to lower the price of the drug for a limited time while it is re-appraised by the National Institute for Clinical Excellence.
The company says it is making the move to make sure patients are not denied the drug by Primary Care Trusts that are awaiting final NICE guidance.
This decision has been made to prevent the phenomenon known as "NICE blight", where Health Authorities back decisions on funding of a product on the NICE work programme pending a decision by NICE, which is often issued months or even years after grant of a licence.
By lowering the price to the same as its competitors, Roche hopes this process can be sidestepped.
"We do not want to sit back and watch while blocks prevent patients gaining access to Tarceva, while NICE is re-evaluating its clinical and cost effectiveness," said John Melville, Roche General Manager in the UK.
"We are confident that Tarceva is clinically and cost-effective. Yet, by matching the price of current second-line lung cancer chemotherapy, we have taken the issue of cost off the table, while NICE continues its deliberations."
Professor Nick Thatcher, Professor of Medical Oncology, Christie Hospital Manchester commented: "I have had patients whose lives have been transformed by this treatment, who have seen an improvement in their prognosis and a reduction in some of the devastating symptoms that come with the disease.
“I welcome Roche's interim measure and the chance to be given the same freedom as clinicians in Scotland, to prescribe this drug to patients whom I consider eligible for treatment."
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http://www.healthcarerepublic.com/news/ ... er-deaths/
03-Oct-07
A gene that increases susceptibility to breast cancer may also predict worse outcomes in lung cancer patients, a European study has shown.
High levels of the BRCA1 breast cancer gene have been shown to double the risk of mortality over three years following surgery for non-small cell lung cancer (NSCLC).
Outcomes in NSCLC patients could be improved by offering adjuvant chemotherapy to those with high levels of the gene, the researchers suggested.
They analysed tumour samples taken from 126 Polish patients during surgery for NSCLC.
They then measured levels of five genes believed to play a role in progression of NSCLC, including BRCA1.
Of the five genes, only BRCA1 was found to be predictive of survival. Patients with high levels of BRCA1 expression had a 98 per cent increased risk of dying within three years of surgery, compared with patients with low levels of BRCA1.
Event free survival in the 36 patients whose tumours had high levels of BRCA1 was 22 months on average.
Additional study of NSCLC tumour samples from a separate group of 58 patients, confirmed that high BRCA1 expression more than doubled the risk of death.
European J Cancer Supp. 2007; 5 (4); 358
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By Nic Fleming, Medical Correspondent, Telegraph UK
Last Updated: 2:30am BST 02/10/2007
Lung cancer sufferers could be given access to a treatment believed to extend life expectancy after the Government's health watchdog agreed to review a previous decision to deny NHS patients the drug.
Tarceva is a once-daily tablet designed to treat non-small cell lung cancer – the most common form of the disease – if initial attempts to treat it with chemotherapy fail.
Trials suggest patients on the drug were 40 per cent more likely to survive for at least a year after treatment compared to placebo, and that 15 per cent of patients using the drug survived beyond two years.
The National Institute for health and Clinical Excellence (Nice) ruled in March that Tarceva, which costs £1,600 per month or £6,800 for a typical course of treatment, was not cost-effective compared to the existing treatment docetaxel.
But an appeal was lodged by charities Cancerbackup and the Roy Castle Lung Cancer Foundation, the Royal College of Physicians, the Association of Cancer Physicians and Roche, which makes the drug.
The organisations argued that Nice had failed to take into account potential cost savings linked with a reduction in side effects for patients on Tarceva as opposed to docetaxel.
A final decision for England and Wales will be made next year. Nice's Scottish equivalent has already ruled in favour of the drug.
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29 Sep 2007
The Society for Women's Health Research gathered three lung cancer experts on Capitol Hill on September 17, 2007 to inform Congress on the need for increased funding to research lung cancer and its impact on women.
"We focused on lung cancer today because lung cancer is the leading cause of cancer death for both women and men in America," said Phyllis Greenberger, M.S.W, president and CEO of the Society, a Washington, D.C. based advocacy organization. "A growing body of research is showing differences in susceptibility, progression and responsiveness to treatment in lung cancer between women and men."
Laurie Fenton Ambrose, president and CEO of the Lung Cancer Alliance said, "More people are recognizing lung cancer, which has been stigmatized for so long as a self-imposed condition, as a disease. That's the good news." The bad news is that the five-year survival rate has only grown from 12 percent in 1971 to 15 percent today.
According to the Lung Cancer Alliance, lung cancer kills over 70,800 women a year, 30,000 more than breast cancer. Yet lung cancer research is severely under funded. In 2006, the National Cancer Institute spent approximately $13,519 for research on breast cancer per death compared to only $1,638 on research per lung cancer death.
Joan Schiller, M.D., chief of the Division of Hematology and Oncology and deputy director of the Simmons Comprehensive Cancer Center at the University of Texas Southwestern Medical Center in Dallas, pointed to the changing face of lung cancer.
The death of actress and nonsmoker Dana Reeve in 2006 drew attention to the disturbing fact that nonsmokers account for 13-15 percent of new lung cancer cases each year. Unfortunately, there is little information on why nonsmokers develop lung cancer. Air pollution and exposure radon or asbestos have been linked to lung cancer risk, but most experts believe that second hand smoke is the leading risk for lung cancer among individuals who have never smoked.
There is conflicting data about whether women nonsmokers are more susceptible to lung cancer than men, but a study in the Journal of Clinical Oncology last February found that about 20 percent of lung cancer cases in women occur in nonsmokers, compared to eight percent in men.
Research is underway to examine whether the biological traits of being a woman or a man impacts lung cancer susceptibility.
Jill Siegfried, Ph.D., professor and vice chair of pharmacology at the University of Pittsburg School of Medicine and co-director of the Lung and Esophageal Cancer program at the Pittsburgh Cancer Institute, spoke at the briefing about her research involving estrogen's role in lung cancer development.
"We've learned that lung tumors have the ability to use estrogen pathways to stimulate growth," Siegfried said. "Anti-estrogens and aromatase inhibitors, drugs that prevent the body from responding to or making estrogen, may benefit lung cancer patients who have an active estrogen pathway."
All of the experts agreed that more research is needed so that we can save lives with improved diagnosis and treatment.
Society for Women's Health Research (SWHR)
1025 Connecticut Ave. NW, Ste. 701
Washington, DC 20036
United States
http://www.womenshealthresearch.org
--------------------------------------------------------------------------------
Article URL: http://www.medicalnewstoday.com/articles/84050.php
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For Nick C
in HOPE
Happy Birthday Nick. I hope you had a wonderful day!
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Dana-Farber provides "favors" for donations made to The Jimmy Fund. I revised it a bit, but this is similar to what they print on the favors they provide:
A gift has been made
in your honor to
the Lungevity Foundation
in loving memory of "your mother's name".
Here is a link to the website if you would like to take a look at it.
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Proof, in my opinion, that LC screening with CT scans works.
TheStar.com
Lung cancer poses deadliest threat - by far
September 27, 2007
Elvira Cordileone
Staff Reporter
In the time it takes to read the next few paragraphs, someone will die of lung cancer somewhere in the world.
The Global Lung Cancer Coalition says lung cancer consumes one human being every 30 seconds – more than breast and prostate cancer combined, with another 1.2 million new cases diagnosed every year.
If everything goes well, Milton resident Sherry Walker, 57, won't be among the casualties.
In June, surgeons made a crescent-shaped slice along the right side of her upper back, cracked open her ribs and removed the top lobe of one lung, where a 2.5-centimetre tumour festered. Tests later revealed a trace of cancerous cells in a single lymph node, putting her in stage two of the disease.
Walker's early diagnosis came to light by a stroke of good fortune. In March, family doctor Helen Pyle told her about an early lung cancer screening study for people at high risk – former and current smokers included – at Princess Margaret Hospital. As a half-pack-a-day smoker for most of her adult life, she had no trouble qualifying for the study.
The hospital is the only Canadian institution participating in an International Early Lung Cancer Action Program, which aims to prove that early detection saves lives. It uses a CT scan, which shows many cross-sectional images of the lungs from top to bottom. An X-ray shows only two views of the chest, front and side and can miss lung cancers.
Since the program started in 2004, it has detected 20 lung cancers in 1,000 scans, of which the vast majority (78 per cent) were in stage one, says Heidi Roberts, principal investigator. This is when lung cancer has the best cure rate. Usually by the time symptoms appear, it's too late.
Walker, who has now stopped smoking, had the 20-second, low-dose computed tomography (CT) scan in April. Two days later, she got a call telling her she needed an emergency biopsy.
In the year before the diagnosis, Walker experienced a succession of colds, sore throats and fatigue so acute she even quit her beloved bowling league.
Although two chest X-rays revealed nothing, she insists her little Shih Tzu, Maggie, knew better.
"Maggie wouldn't leave my side. She would lie at the edge of the bed beside me, right up along my upper back," Walker recalls. "I remember thinking, `What is she doing?'"
Walker's chemotherapy ends in November, and she now expects to die of something other than lung cancer at a ripe old age. She will be monitored with CT scans every three months.
Lung cancer is the most common – and deadliest – of all cancers, according to Lung Cancer Canada. Last year, almost 23,000 Canadians were diagnosed with the disease and another 27,000 cases are expected to be diagnosed this year.
"That 27,000 is the size of a small town," says Dallas Petroff, Lung Cancer Canada's executive director.
"Visualize losing a small town every year and it's amazing there hasn't been more of an outcry."
The Canadian Cancer Statistics 2007 report predicts the disease will claim about 9,000 Canadian women in 2007.
By contrast, breast cancer deaths will number about 5,300 – even though twice as many women will be diagnosed with breast cancer as lung cancer.
Early detection saves lives, says radiologist Heidi Roberts, Princess Margaret's principal investigator.
Nevertheless, no regular screening programs exist to catch the disease early, when treatment is more successful and less invasive.
Dr. James Gowling, chair of the Cancer Advocacy Coalition of Canada, also points out lung cancer research lacks the lavish funding raised by breast cancer advocacy. That's because most lung cancer patients don't live long enough to advocate for their disease, he says.
"If you look at the amount of money spent on breast cancer, there's a 30-times' difference," says Gowling, a Cambridge-based hematologist and oncologist.
In a recent telephone conversation from Seoul, Korea, while attending a biannual world conference on lung cancer, Gowling says lung cancer treatment is 20 years behind breast cancer. Finding tumour markers and developing drugs targeted to those markers requires a lot more research – and funding.
"Lung cancer is a neglected and stigmatized disease," says Sunil Verma, a medical oncologist at Sunnybrook Hospital's Odette Cancer Centre.
The stigma comes from its association with smoking. According to Lung Cancer Canada, 35 per cent of the people who get it are former smokers and 50 per cent are current smokers. But 15 per cent of those who get lung cancer never smoked.
Susan Managbana belongs to the latter group. She never put a cigarette to her lips but has advanced lung cancer.
Managbana, 45, came from Singapore on a visitor's visa in 2005. She met Toronto resident Peter Laidlaw, and they married last year. Her cancer came to light in a routine immigration chest X-ray. A biopsy in December revealed malignant cells had spread. Surgery wouldn't help.
"I'd had no symptoms at all, only migraine," says Managbana. Nevertheless, she has a good quality of life today, thanks to an experimental drug called erlotinib, (trade name Tarceva), which inhibits cells from growing and multiplying.
"The drug was effective very quickly," says Laidlaw. "In less than a week, the pain disappeared, the size of the tumour reduced and she's stable."
But the couple faces another worry: The drug's clinical trials only admit people who've had chemotherapy, so they have to pay for the drug out of their own pockets. Laidlaw says it costs $1,900 a month – and he's self-employed as a consulting engineer and part-time vintner.
There's no effective screening for lung cancer, and its symptoms, such as a persistent cough or back pain, are vague. Lung Cancer Canada reports about 85 per cent of people diagnosed with lung cancer die within five years of diagnosis.
Walker insists the screening program saved her from early death, but the medical community is divided about whether screening reduces mortality rates.
"It's a statistical feature (the doubters) are looking for," Roberts says. "They want a randomized trial for 10 years."
She points to a study published in the New England Journal of Medicine last October that concluded 92 per cent of those discovered to have early stage lung cancer through CT scans who were treated survived 10 years after diagnosis.
"I totally believe in this work," Roberts states.
Verma goes further: "If we do detect it earlier, we can cure this cancer. But in more than half the cases, it's already advanced."
For more information, visit the website at lungcancercanada.ca.
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Daddy's little girl.... congratulations Nick. You're going to be a WONDERFUL father!
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Attitude
There once was a woman who woke up one morning, looked in the mirror, and noticed she had only three hairs on her head. "Well" she said, "I think I'll braid my hair today." So she did and she had a wonderful day.
The next day she woke up, looked in the mirror and saw that she had only two hairs on her head. "Hmm," she said, "I think I'll part my hair down the middle today." So she did and she had a grand day.
The next day she woke up, looked in the mirror and noticed that she had only one hair on her head. "Well," she said, "today I'm going to wear my hair in a pony tail." So she did and she had a fun, fun day.
The next day she woke up, looked in the mirror and noticed that there wasn't a single hair on her head. "YEA!" she exclaimed, "I don't have to fix my hair my hair today!"
Attitude is everything.
Be kinder than necessary, for everyone you meet is fighting some kind of battle.
Live simply,
Love generously,
Care deeply,
Speak kindly,
Leave the rest to God
Life isn't about waiting for the storm to pass; it's about learning to dance in the rain.
- authors unknown
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By LAURAN NEERGAARD
WASHINGTON (AP) — You've finished the surgery, the radiation, the chemotherapy. You're a winner, a cancer survivor. Now what? A new push is on to provide patients with "survivor plans," long-awaited blueprints for the customized follow-up care they'll require for years.
Few today get that careful send-off as they leave cancer specialists and head back to their regular doctors, even though the Institute of Medicine alerted the nation two years ago that these survivors' special needs weren't being met.
Now a major doctors' group is creating easy-to-fill-out checklists that survivors can hand to future physicians — what checkups to get and when, what late side effects their treatment may trigger, what new symptoms to watch for.
The American Society for Clinical Oncology recently posted the first such documents — for colorectal and breast cancer — on its Web site, free to copy and customize. ASCO is developing guides for other leading malignancies — lung cancer is next — and a more general plan for less common cancers.
"We're at the cusp of a very dramatic change in the way we're going to be delivering coordinated care for cancer survivors," predicts Dr. Patricia Ganz of the University of California, Los Angeles, a cancer survivorship specialist who spearheaded the ASCO guides.
Today, "the patient feels lost," she explains. "If everybody has the same marching orders, it will be a lot easier."
There are roughly 10 million cancer survivors, a population rapidly growing thanks to advances in early detection and treatment.
When active treatment ends, those people too often don't realize their simmering health risks. It's not just the possibility of the initial cancer returning or a new one forming. Treatment may have left infertility, memory or mobility damage, impaired organ function. Some side effects may not appear for years. Then there are psychosocial consequences, from depression to problems keeping health insurance.
Consider the contrasts: Have a baby and you're sent home with care instructions, including when mom and child are to check in with their respective doctors. Have heart surgery, and likewise you receive nutrition and exercise rules, a list of worrisome symptoms and a checkup date.
Cancer treatment typically is far lengthier and complicated. Yet oncologists until now have had no standard way to offer a similar guide. Doctors like Ganz have pioneered survivor plans at specially designated cancer centers, but few people are treated at such hospitals.
"A lot of patients get dropped," says Dr. Aziza Shad, who directs Georgetown University Hospital's cancer survivorship program and writes survivor plans for her own patients.
"I personally think it's the responsibility of every treating oncologist to have this information available," Shad adds. "You did the treatment. ... Your responsibility is also the aftercare."
The new guides come in two parts. First is a detailed treatment summary: The cancer's type and stage; tests of lymph nodes, genes and other indicators of prognosis; how much chemotherapy patients actually received, as side effects often mean skipped or lowered doses.
The second part is a consumer-friendly list of future exams and what symptoms to watch for.
A written document is crucial because even when doctors patiently explain cancer treatment, "patients are notoriously overwhelmed and not hearing half of what was said," says Ellen Stovall of the National Coalition for Cancer Survivorship, herself a repeat survivor.
How can it make a difference?
Say a woman suffers some shortness of breath. Does her family doctor assume it's the 20 pounds she just gained — or do a more sophisticated heart exam because she's a breast cancer survivor? Certain chemotherapy can cause serious heart damage.
Say a breast cancer survivor later gets lymphoma. Her new oncologist would need to know exactly how much of the powerful chemo adriamycin she received before to know if it was safe to try again.
Ganz saw a patient last week who had beaten lymphoma at age 29 with chest radiation, but now has breast cancer in her 50s. She wanted just the tumor removed, but that requires radiation therapy and it's often impossible to radiate the same spot again. Amazingly, the hospital found her old radiation records — and doctors could tell the new rays wouldn't overlap the old, letting her keep her breast.
And Georgetown's Shad recounts a child who disappeared from her clinic's follow-up care for five years — only to reappear with a drastically lopsided face. Radiation had stopped short the bone growth on one side of his body, something his new doctors hadn't anticipated in time to treat.
"Thank god we have plastic surgery," she says with a sigh.
The concern is whether busy oncologists will embrace the guides; they do create more work. Legislation is pending in Congress that would require Medicare to pay for cancer-survivor plans.
"It's going to require a real shift in doctors thinking about how they spend their time with their patients and what they need to know," says Stovall — who urges patients to ask for the guides.
EDITOR'S NOTE _ Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
GSK Receives Approval for HYCAMTIN(R) (topotecan) Capsules
in CLINICAL TRIALS
Posted
GSK Receives Approval for HYCAMTIN® (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer
First FDA Approved Oral Therapy Will Allow Patients to be Treated for This Aggressive Cancer at Home
October 15, 2007: 08:45 AM EST
PHILADELPHIA, Oct. 15 /PRNewswire-USNewswire/ -- GlaxoSmithKline announced today approval by the U.S. Food and Drug Administration (FDA) for oral HYCAMTIN® (topotecan) capsules for the treatment of relapsed small cell lung cancer (SCLC).
Specifically, HYCAMTIN capsules are indicated for patients who had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment. HYCAMTIN capsules are the only oral single-agent chemotherapy approved for the treatment of SCLC after failure of first-line therapy. The product will be available in 2008.
"The approval of HYCAMTIN capsules is particularly important for patients with relapsed small cell lung cancer as they now have an effective treatment option that has been shown to provide a survival benefit and can be conveniently taken at home," said Debasish Roychowdhury, M.D., Vice President, Global Clinical Development, Oncology Medicine Development Center, GSK. "Additionally, this milestone underscores GSK Oncology's commitment to helping improve cancer patients' quality of life."
This approval was based on positive results from a Phase III study comparing HYCAMTIN capsules plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC, in addition to Phase II and Phase III supporting studies. Best supportive care refers to treatments intended to control, prevent and relieve disease complications to improve comfort and quality of life for the patient, but are not intended to have any anti-tumor effects. In the pivotal Phase III clinical trial, HYCAMTIN capsules added to BSC were associated with prolonged survival in patients with relapsed SCLC. This was the first randomized study ever to demonstrate that patients with relapsed SCLC live longer when they are treated with BSC and chemotherapy compared to BSC alone. Study results were published in the December 1, 2006 issue of the Journal of Clinical Oncology.(1)
"In clinical trials, HYCAMTIN capsules have shown the potential to benefit patients with SCLC, many of whom are prone to relapse," said John Eckardt, M.D., Director of Clinical Research for the Center for Cancer Care and Research, St. Louis, MO. "The approval of HYCAMTIN capsules opens up new possibilities for patients battling this disease and provides a convenient alternative to IV therapy."
HYCAMTIN Capsules Clinical Trial Results(1,2)
In the Phase III multicenter trial, 141 patients with relapsed SCLC not considered as candidates for standard IV therapy were randomized to receive BSC alone (n = 70) or HYCAMTIN capsules (2.3 mg/m2/day, days 1 through 5, every 21 days) plus BSC (HYCAMTIN capsules; n = 71). The primary objective was to compare overall survival between the two treatment arms. Patients who received HYCAMTIN capsules plus BSC showed a statistically significant improvement in overall survival compared with the patients who received BSC alone (Log-rank p = 0.0104). Median survival with HYCAMTIN capsules plus BSC was 25.9 weeks (95% CI, 18.3 to 31.6) and was 13.9 weeks (95% CI, 11.1 to 18.6) with BSC alone. The hazard ratio was 0.64 (95% C.I: 0.45, 0.90), indicating a 36% reduction in the risk of death for patients who received HYCAMTIN capsules plus BSC compared with the patients who received BSC alone.(1)
The most common Grade 3 or 4 hematologic adverse reactions with HYCAMTIN capsules were neutropenia (61%), anemia (25%) and thrombocytopenia (37%). The most common (>10%) non-hematologic adverse reactions (all grades) were nausea (27%), diarrhea (14%), vomiting (19%), fatigue (11%) and alopecia (10%).(2)
About Small Cell Lung Cancer (SCLC)(3)
SCLC is caused by an uncontrolled growth of cells beginning on the surface of the lung's breathing tubes (called bronchi) and tends to spread widely through the body. This is important because it means that surgery is rarely used as a treatment option. Chemotherapy is the most common treatment for SCLC. Although SCLC is often responsive to first-line treatments, patients may relapse.
SCLC is most common in current or past smokers, but can also be caused by environmental risk factors such as exposure to radon and air pollution. About 15% of patients with lung cancer have SCLC, a fast-growing form of the disease.
About HYCAMTIN® Capsules
HYCAMTIN capsules belong to a class of drugs known as topoisomerase I (topo-I) inhibitors. Topo-I is a naturally produced protein essential for cell division in both normal and cancer cells. Interaction between topo-I and HYCAMTIN capsules results in permanent damage to the cell's genetic material and the death of dividing cells. Registration dossiers for HYCAMTIN capsules have been submitted in Europe, Canada and other markets around the world.
Important Safety Information
HYCAMTIN capsules can suppress the body's ability to produce disease fighting white blood cells, a condition known as neutropenia. In addition, the amount of clotting cells can decrease (thrombocytopenia). Generally, HYCAMTIN capsules have a mild to moderate non-hematologic toxicity profile. Other common side effects include nausea, vomiting, diarrhea and hair loss (alopecia).