WEDNESDAY, Feb. 15 -- Good dietary advice and supplements can boost nutrition while improving quality of life in malnourished cancer patients, a new study finds.

However, the interventions do not appear to affect survival for these patients, according to the findings published in the Feb. 15 issue of the Journal of the National Cancer Institute.

For the study, Christine Baldwin, a lecturer in the nutritional sciences division at King's College London, and colleagues analyzed data from 13 clinical trials that included a total of more than 1,400 cancer patients who were malnourished or at risk of malnutrition. Some of the patients received oral nutritional support (dietary advice and/or supplements) while others received routine care.

Oral nutritional support had a wide range of effects on both weight and energy intake, and led to improvements in aspects of quality of life, such as emotional functioning, shortness of breath and loss of appetite. However, this type of intervention had no effect on patient death rates, the study authors noted in a journal news release.

The level of benefit varied between patients, and the authors concluded that "it is likely that the factors such as site and stage of disease and, indeed, variations in the duration, nature and intensity of the nutritional intervention will account for difference in effects in patients."

International guidelines have suggested oral nutritional intervention for malnourished cancer patients or those who are at nutritional risk, but these suggestions are based largely on expert opinion as opposed to clinical trials, according to background information in the study.

Commenting in an editorial accompanying the study, Ann O'Mara and Diane St. Germain of the U.S. National Cancer Institute wrote that "until future research provides clearer answers regarding who will benefit from nutritional interventions, the use of a comprehensive assessment, published nutritional guidelines and early interventions are essential."

-- Robert Preidt

SOURCE: Journal of the National Cancer Institute, news release, Feb. 15, 2012

TUESDAY, Feb. 14 -- The U.S. Food and Drug Administration said Tuesday that it was cautiously optimistic that a feared shortage of a life-saving drug used to treat a form of childhood leukemia will be averted.

The drug, methotrexate, is used in combination with other drugs to combat acute lymphoblastic leukemia (ALL), which typically strikes children ages 2 to 5 and is the most common type of cancer in children.

Methotrexate is a linchpin in the treatment of children battling acute lymphoblastic leukemia. In high doses, the generic drug has been successful in curing patients and beneficial in preventing recurrence. Without the drug, a patient's chance for a cure is reduced while the risk of recurrence rises, oncologists report.

"We are seeing the [three] companies [that make methotrexate] respond to this shortage and they are planning on some very large releases, and we are planning on having the situation resolved," said Valerie Jensen, associate director of the FDA's drug shortage program.

"Right now, from what we are understanding from the companies, the releases will resolve these shortages. So we are watching this very closely," Jensen added. "We are expecting some good releases at the end of this month and continuing into March and beyond."

Oncologists are worried that supplies of methotrexate could be gone in as little as two weeks.

One of the three makers of methotrexate, Hospira Inc., based in Lake Forest, Ill., said Tuesday that it had increased production to "make up for the supply gap."

Thomas Moore, president of U.S. Hospira, said in a news release: "Hospira is doing everything it can to help bring more product to market. This includes working with the U.S. Food and Drug Administration to qualify a second supplier of the drug's active ingredient to enable increased production. Hospira believes that it can increase its supply to the market if it can secure additional methotrexate active ingredient supply."

The other two manufacturers are Mylan Inc., of Canonsburg, Penn., and Sandoz US Inc., of Princeton, N.J. Calls from HealthDay to both suppliers were not immediately returned.

Dr. Elizabeth Raetz, an associate professor of pediatric hematology/oncology at NYU Langone Medical Center in New York City, said methotrexate is a "critical component of ALL therapy."

The concern is that there is a 90 percent chance for cure of acute lymphoblastic leukemia, but that's based on the total drug regimen including methotrexate, Raetz said. "There is a deep concern that if that key component is eliminated there would be a reduced chance for cure," she said.

There hasn't been a shortage of the drug at her hospital, Raetz noted, but many other hospitals across the country have reached a critical point, and some centers don't have any at all, she said.

Acute lymphoblastic leukemia is the most common type of cancer in children. It's a disease that affects white blood cells, which help to fight infections in the body. Blood cells are produced in bone marrow. But in leukemia patients, the bone marrow produces abnormal white blood cells, which crowd out healthy blood cells. In acute lymphoblastic leukemia, the excess white blood cells are called lymphocytes or lymphoblasts, according to the U.S. National Library of Medicine.

The potential shortage of methotrexate is just the latest in a series of drug shortages that have existed for several years.

In 2011, prescription drug shortages in the United States hit an all-time high. Last fall, some 200 drug shortages had been reported, compared to 178 in all of 2010, the FDA reported.

Many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are only given in hospitals and are "absolutely critical," Jensen said during a news conference in late September.

More than half (54 percent) of shortages in 2010 were due to quality issues, such as sterility or drug impurities. Some were caused by delays or manufacturing capacity problems, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen said.

Jensen also said the shortages tend to occur in drugs that aren't "economically attractive." This could mean that only one company produces the drug, making it harder to find alternatives if the supply dries up.

A lot of the problems are tied to generic drugs, health experts explained, because few manufacturers make them and profit margins aren't as high as for drugs still under patent protection.

On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The order directed the FDA to "take action" to prevent and reduce the worsening prescription drug shortages.

Specifically, the order directed the FDA to take steps to require drug manufacturers to report any impending shortages or discontinuances six months ahead of the shortage. The agency should also speed up its review of new manufacturing sites, new suppliers and new manufacturing protocols, and also add more staff to its drug-shortage office, the order stated.

SOURCES: Valerie Jensen, R.Ph., associate director, Drug Shortage Program, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Elizabeth Raetz, M.D., associate professor of pediatric oncology, NYU Langone Medical Center, New York City; Feb. 14, 2012, news release, Hospira Inc., Lake Forest, Ill.

TUESDAY, Feb. 14 -- After breast cancer treatment, many women suffer from hot flashes and night sweats, but a type of "talk therapy" might relieve these symptoms for some women, British researchers suggest.

In a new study, women who received this form of psychotherapy, known as cognitive behavioral therapy, had reduced their symptoms by half within six months.

"Hot flashes and night sweats are distressing symptoms, which cause social embarrassment and sleep problems, and they are challenging to treat, especially for women who have had breast cancer" because hormone replacement therapy is generally not recommended for these women, explained lead researcher Myra Hunter.

According to background information in the study, which is published in the Feb. 15 online edition of The Lancet Oncology, 65 percent to 85 percent of women have hot flashes after breast cancer treatment.

Group cognitive behavioral therapy is a safe and effective treatment for women who have hot flashes and night sweats following breast cancer treatment, Hunter said, with additional benefits to mood, sleep and quality of life.

"The women in this trial reported frequent and problematic symptoms and relatively low quality of life," said Hunter, a professor of clinical health psychology at King's College London's Institute of Psychiatry.

Hunter's team randomly assigned 96 women who had been treated for breast cancer and suffered from night sweats and hot flashes to either "talk therapy" or usual care.

The 47 women who received the therapy attended weekly 90-minute sessions for six weeks. For the others, usual care consisted of access to nurses and oncologists, telephone support and cancer support services, the researchers noted.

The therapy sessions included psycho-education, paced breathing, and behavioral strategies to manage hot flashes and night sweats, as well as interactive PowerPoint presentations, group discussion, handouts and weekly homework, Hunter said.

In addition, participants learned how to handle the stress associated with hot flashes and night sweats, and found new ways to decrease anxiety, she explained.

The women were also taught to manage hot flashes in social situations and to understand night sweats and improve sleep habits using mental and behavioral strategies.

The investigators found that the women who had received the cognitive behavioral therapy significantly reduced the number of hot flashes and night sweats they experienced in the nine weeks after the start of the study.

This reduction in symptoms lasted for 26 weeks. At nine weeks there was a 46 percent reduction in symptoms and a 52 percent reduction at 26 weeks, Hunter's team found.

However, among women receiving usual care, hot flashes and night sweats decreased by 19 percent after nine weeks and 25 percent after 26 weeks.

"These reductions were sustained and associated with significant improvements in mood, sleep and quality of life," Hunter said. "This is a safe, acceptable and effective treatment option, which can be incorporated into breast cancer survivorship programs and delivered by trained breast cancer nurses."

Holly Prigerson, director of the Center for Psycho-Oncology and Palliative Care Research at the Dana-Farber Cancer Institute in Boston, wrote an accompanying journal editorial.

"Hot flashes and night sweats are very common, distressing and persistent -- women reported being troubled by them for an average of two years after breast cancer treatment," Prigerson said.

She noted that the new study provides sound evidence upon which to recommend cognitive behavioral therapy for breast cancer patients suffering from these symptoms.

"Adaptations to an online, self-management version of the intervention would allow for more flexible scheduling and greater access at potentially lower cost of delivery," Prigerson said. "Combining the intervention with medications that effectively treat hot flashes and night sweats might produce the most dramatic effects with reductions in symptoms as well as the distress caused by them."

Prigerson said this type of therapy might also be used to treat postmenopausal women suffering from these symptoms.

"Of course, scientifically, we can't generalize beyond the sample of women who experience menopausal symptoms as a result of treatment for breast cancer," she said. "But given that they found that [this type of therapy] worked on the distress associated with hot flashes and night sweats, then it would seem likely to generalize to menopausal symptoms experienced outside of this context."

SOURCES: Myra Hunter, Ph.D., professor, clinical health psychology, King's College London, Institute of Psychiatry, London; Holly G. Prigerson, Ph.D., director, Center for Psycho-Oncology and Palliative Care Research, Dana-Farber Cancer Institute, Boston; Feb. 15, 2012, The Lancet Oncology, online

MONDAY, Feb. 13 -- Patients with a history of heart disease will most likely not reduce their risk for developing cancer by taking vitamin B and/or omega-3 fatty acid supplements, a new French analysis suggests.

"In the population we studied, we found no beneficial effects of either B vitamins or omega-3 fatty acids taken over five years on cancer occurrence or cancer-related death," noted study author Valentina Andreeva, who is with the nutritional epidemiology research unit at the University of Paris XIII in Bobigny, France.

Andreeva and her colleagues report their findings in the Feb. 13 online edition of the Archives of Internal Medicine.

To explore the protective potential of B vitamins and fatty acid supplements, the authors did a secondary analysis of data that had been collected in a previous study involving almost 2,000 French men and 500 women.

All were between 45 and 80 years of age, and all had experienced cardiac trouble ( heart attack, unstable angina or ischemic stroke) in the year leading up to the start of the study.

In turn, the participants were divided into one of four different groups that consumed a daily supplement regimen involving various types of vitamin B and omega-3 fatty acids at "relatively low supplementation doses."

By the end of the original five-year study, 7 percent of the participants had gone on to develop some form of cancer, and just over 2 percent ultimately died of cancer. The vast majority of cancer cases (including prostate, lung, bladder and colorectal cancer) and deaths occurred among men (81 percent and 83 percent, respectively).

The team unearthed no evidence that any form of vitamin B or omega-3 fatty acid supplement improved cancer outcomes in any way.

The investigators noted that there were some indications that cancer risk might have actually gone up, specifically among women taking vitamin B and/or omega-3 fatty acid supplementation. However, the authors stressed that this observation was based on too few cases to substantiate a firm conclusion, and called for further research involving a larger pool of participants.

"The results of our study suggest that individuals should exercise caution when deciding to take dietary supplements, especially over a long period of time and without a physician's advice," advised Andreeva. "Such supplements constitute active substances and might have adverse effects in some populations. To be on the safe side, individuals should strive to achieve dietary recommendations via healthy, balanced diets."

Joseph Su, the Washington, D.C.-based program director of the division of cancer control and population science within the U.S. National Cancer Institute's epidemiology and genomics research program, said that nothing about the findings struck him as surprising.

"So far, study findings have been very inconsistent," he noted. "But most supplement studies, if anything, have shown no beneficial effect whatsoever. Just like this one. So, I don't think there's anything that can really back up the idea that these supplements can prevent cancer."

However, Vicky Stevens, strategic director of laboratory services at the American Cancer Society in Atlanta, expressed some reservations about the French analysis.

"Compared with other trials, they used much lower levels of supplements," she noted. "From the B-vitamin point of view, dramatically lower. So, it could be argued that they just weren't using high enough levels of supplements to see any effects," Stevens suggested.

"And they used a natural form of folate [vitamin B supplement], whereas other trials use a synthetic form," Stevens added. "But the real problem in being able to evaluate the effects they do see is that they don't have enough people. And it's not really a long enough follow-up period to really see an effect of these supplements on cancer onset. Five years isn't really enough. It can take 10 or 20 years in most cases. So, what they may be seeing is an effect on preexisting abnormalities, but not the impact on cancer onset itself."

Duffy MacKay, a naturopathic doctor and vice president of scientific and regulatory affairs for the Council for Responsible Nutrition in Washington, D.C., agreed.

"When you look at an intervention like this, you're definitely not looking at the role of the supplements at preventing tumors, because the tumors likely started well before the trial," he noted. "So really what the trial is about is giving vitamin B and omega 3 and seeing if they altered the outcome, the progression, of these cancers," MacKay explained.

"And with that you have to realize that cancer is a very complex multi-factorial disease," MacKay stressed. "And two supplements would never be expected to be a successful treatment on their own. I would say, however, that proper nutrition is one of your best allies in terms of wellness, period. And while no one ever claimed these were cancer drugs, if you will, supplements make sense, cancer or no cancer."

SOURCES: Valentina Andreeva, Ph.D., nutritional epidemiology research unit, University of Paris XIII, Bobigny, France; Vicky Stevens, Ph.D., strategic director, laboratory services, American Cancer Society, Atlanta; Duffy MacKay, naturopathic doctor and vice president, scientific and regulatory affairs, Council for Responsible Nutrition, Washington, D.C.; L. Joseph Su, Ph.D., program director, division of cancer control and population sciences, epidemiology and genomics research program, U.S. National Cancer Institute; Feb. 13, 2012, Archives of Internal Medicine, online

FRIDAY, Feb. 10 -- People with the condition called Barrett's esophagus who are smokers may have double the risk of developing esophageal cancer, a new study warns.

These people also have twice the risk of developing advanced precancerous cells, according to the study in the February issue of Gastroenterology.

"We found that tobacco smoking emerged as the strongest lifestyle risk factor for cancer progression. Contrary to popular belief, alcohol consumption didn't increase cancer risk in this group of patients with Barrett's esophagus," lead author Helen Coleman, of Queen's University Belfast in Northern Ireland, said in a news release from the American Gastroenterological Association.

In people with Barrett's esophagus, damage caused by stomach acid causes the lining of the esophagus to become similar to the lining of the stomach, according to the U.S. MedlinePlus Medical Encyclopedia. Most people with Barrett's esophagus do not develop esophageal cancer.

For the study, researchers looked at more than 3,000 Barrett's esophagus patients worldwide and identified 117 cases of dysplasia or cancers of the esophagus or stomach.

Current smoking, regardless of the number of cigarettes smoked per day, was significantly associated with an increased risk of esophageal cancer. Therefore, cutting down on cigarette consumption may not be enough to reduce the risk of esophageal cancer in people with Barrett's esophagus, the researchers suggested.

"Tobacco smoking has been long established as highly carcinogenic," Coleman said. "Barrett's esophagus patients who smoke should start a cessation program immediately."

Although the study authors pointed out that more research is needed to confirm the findings, and the association noted in the study did not prove a cause-and-effect relationship between smoking and esophageal cancer in these patients, Coleman's team suggested that smoking should be discouraged.

The investigators also noted that developed countries have seen a rise in the incidence of esophageal cancer.

-- Robert Preidt

SOURCE: American Gastroenterological Association, news release, Jan. 30, 2012