Atopic dermatitis: Tips for managing

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Most children’s eczema does not have a clear cause, such as an allergy, but most eczema will improve with good skin care. These tips from dermatologists can reduce the severity and frequency of your child’s flare-ups.

Bathing tips

  • Bathe your child in warm — not hot — water.
  • Limit your child’s time in the bath to 5 or 10 minutes.
  • Use cleanser only when needed and make sure the cleanser is mild and fragrance-free. Do not use bubble bath.
    • If your child’s eczema is frequently infected, twice-weekly bleach baths may be beneficial. Discuss this option with your child’s dermatologist.
  • After bathing, gently pat your child’s skin partially dry.
  • If your child has medicine that you apply to the skin, apply medicine when your child’s skin is almost dry and use the medicine as directed.
  • Apply moisturizer on top of the medicine and to the rest of your child’s skin.

Tips for choosing a moisturizer

  • When selecting a moisturizer, consider choosing a thick cream or ointment.
  • Some children do better with fragrance-free products, so consider petroleum jelly — an inexpensive, fragrance-free product that works well for many children.
  • When selecting a product, “trial and error” sampling of different types may help to identify the best moisturizer for your child.

Tips to ease discomfort

  • For best results, apply moisturizer at least twice a day. This prevents dryness and cracking. It also can decrease the need for eczema medications.
  • If your child has severe itching and scratching, ask your child’s dermatologist about wet wrap therapy. This can reduce swelling and lessen the desire to scratch.
  • Keep your child’s fingernails short and smooth. This decreases the likelihood that scratching will puncture the skin. Putting cotton gloves on your child’s hands at night may help prevent scratching during sleep.
  • Keep temperature and humidity levels comfortable. Avoid situations in which the air is extremely dry, or where your child may sweat and overheat. This is the most common trigger of the itch/scratch cycle.

Clothes-washing tips

  • Using a laundry detergent made for sensitive skin may be beneficial. Scented fabric softener or dryer sheets may contribute to irritation.
  • Only use the recommended amount of detergent.
  • Use enough water for adequate rinsing.
  • Buy clothes without tags because tags can rub against the skin, causing irritation.
  • Wash your child’s new clothes before wearing. This will remove excess dyes and fabric finishers, which can irritate the skin.

Good skin care is a key part of gaining control of your child’s eczema. If skin care has not been a regular part of your child’s treatment, you should make an appointment for your child to see a dermatologist.

FDA Approves mepolizumab to Treat Severe Asthma

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Food and Drug Administration approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

Asthma is a chronic disease that causes inflammation in the airways of the lungs. During an asthma attack, airways become narrow making it hard to breathe. Severe asthma attacks can lead to asthma-related hospitalizations because these attacks can be serious and even life-threatening. According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the U.S. have asthma, and there are more than 400,000 asthma-related hospitalizations each year.

“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

Nucala is administered once every four weeks by subcutaneous injection by a health care professional into the upper arm, thigh, or abdomen. Nucala is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells. Nucala reduces severe asthma attacks by reducing the levels of blood eosinophils- a type of white blood cell that contributes to the development of asthma.

The safety and efficacy of Nucala were established in three double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies. Nucala or a placebo was administered to patients every four weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalization and/or emergency department visits, and a longer time to the first exacerbation. In addition, patients with severe asthma receiving Nucala experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control compared with patients receiving placebo. Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in one second.

The most common side effects of Nucala include headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness (fatigue). Hypersensitivity reactions can occur within hours or days of being treated with Nucala, including swelling of the face, mouth, and tongue; fainting, dizziness, or lightheadedness; hives; breathing problems and rash. Herpes zoster infections have occurred in patients receiving Nucala. Herpes zoster is the virus that causes shingles.

Nucala is made by GlaxoSmithKline, in Research Triangle Park, North Carolina.

Source: FDA

Belly Fat Is Bad, Even at a Normal Weight

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Can belly fat be a problem even for people who aren’t overweight? New research says yes, excess weight around the middle boosts the risk of premature death even for people considered normal weight.

What’s more, normal weight people with excess stomach fat had an even higher risk of dying early than overweight or obese people did, according to new research published online Nov. 10 in the Annals of Internal Medicine.

“Belly fat is bad fat,” said Dr. Paul Poirier, from the Institute of Cardiology at Laval University in Quebec, Canada, and the author of an accompanying editorial in the same issue of the journal.

Stomach fat has been linked to high cholesterol, inflammation, heart disease, stroke and diabetes, he explained.

“When you have fat around the belly, it’s a lot worse than having the same amount of fat around the hip,” Poirier said. “If your weight is normal, but you have weight around the middle, it’s bad. If you’ve got a belly above 40 inches for men and 34 inches for women, this is obesity [even if your weight measurements seem normal],” Poirier said.

These people may not be obese from a weight perspective, but they are obese from a waist perspective, he said.

For the study, a team led by Dr. Francisco Lopez-Jimenez, a professor of medicine at the Mayo Clinic in Rochester, Minn., used data from a national survey to compare the risk of premature death among more than 15,000 adults. The mean follow-up time was 14 years.

The researchers looked at body mass index (BMI), a rough estimate of body fat based on weight and height measurements. They also looked at waist-to-hip ratios.

The investigators found that normal weight adults with extra stomach fat had the worst long-term survival, regardless of BMI. And, normal weight men with bigger bellies seemed to fare even worse than slender women with more tummy fat.

A normal weight male with more fat around the waist had an 87 percent increased risk of death during the study period compared to a man who was normal weight without extra belly fat. Compared to overweight or obese men (as measured solely by BMI, without specific waist size information), a normal weight man with extra belly fat had more than twice the risk of dying early, the study revealed.

Normal weight women with extra belly fat had nearly a 50 percent increased risk of death during the study period versus a normal weight woman whose weight was more equally distributed throughout her body. Compared to obese women (measured by BMI only), the normal weight women with belly fat had a 32 percent higher risk of early death, the researchers found.

Dr. David Katz, director of the Yale University Prevention Research Center, in New Haven, Conn., and president of the American College of Lifestyle Medicine, said the study findings raise the question: who would have more belly fat and still be at a normal weight according to their BMI?

Some people are more prone to depositing excess fat around the middle, he said. This can lead to fat accumulation in vital organs, especially the liver, he explained.

Another group may be those who have excess body fat and illness, perhaps in early stages, causing loss of lean body mass, Katz said. Although it’s not clear from this study how many people might fall into this category, he added.

Regardless of why someone has gained weight around the middle, Katz said, “We have long known that all varieties of overweight are not created equal with regard to health risk, and that central obesity is the most concerning variety.”

In his editorial, Poirier wrote, “These new data provide evidence that clinicians should look beyond BMI. Although assessing for total fat mass with BMI to identify patients at greater cardiovascular risk is a good start, it is not sufficient

Even Easy Exercise May Lower Blood Pressure in Those With Diabetes

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Just a few minutes of easy exercise daily can help lower blood pressure in overweight and obese people with type 2 diabetes, researchers report.

“It appears you don’t have to do very much,” co-author Bronwyn Kingwell, head of metabolic and vascular physiology at the Baker IDI Heart and Diabetes in Melbourne, Australia, said in an American Heart Association news release.

“We saw some marked blood pressure reductions over trial days when people did the equivalent of walking to the water cooler or some simple body-weight movements on the spot,” she noted.

For the study, the researchers monitored blood pressure levels in 24 overweight and obese adults as they sat for eight hours. The average age of the study participant was 62. All had type 2 diabetes.

The study participants took brief breaks from sitting, and either walked slowly for three minutes or did three minutes of simple resistance exercises every half hour. Again, their blood pressure was monitored.

The resistance exercises included activities such as half-squats, calf raises, knee raises, or gluteal muscle squeezes.

Compared to uninterrupted sitting, light walking led to an average 10-point drop in systolic blood pressure (the top number in a blood pressure reading). Simple resistance exercise led to an average 12-point decrease in systolic blood pressure, the study reported.

“Light activity breaks are not meant to replace regular, purposeful exercise. But they may be a practical solution to cut down on sitting time, especially if you’re at your desk all day,” Kingwell said.

The study was to be presented Monday at the American Heart Association’s annual meeting in Orlando. Fla. Until published in a peer-reviewed journal, findings presented at meetings are usually considered preliminary.

Barbecued, Pan-Fried Meat May Boost Kidney Cancer Risk

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Cooking meats at high temperatures, as in barbecuing or pan-frying, may increase the risk for kidney cancer, a new study suggests.

The World Health Organization warned last month that processed meats — including bacon, hot dogs and sausages — can cause colon cancer. Red meats were also associated with higher risk.

The new study looked specifically at kidney cancer, which is increasing in the United States and other developing nations. “This study, and others like it, suggest that the way we cook our meat could potentially impact kidney cancer risk,” said lead researcher Dr. Xifeng Wu, a professor in the department of epidemiology at the University of Texas MD Anderson Cancer Center in Houston.

Limit the amount of time the meat is cooked at really high temperatures or over an open flame resulting in burning, smoking, or charring of the meat,” Wu suggested.

These new findings support the dietary recommendations for cancer prevention from the American Cancer Society, namely to limit the intake of red and processed meats, she said. Susan Gapstur, vice president for epidemiology at the cancer society, said that when meats are cooked at very high temperatures, certain cancer-causing chemicals are released, some of which are linked to kidney cancer.

This study offers some clues that meat cooked at high temperature might increase the risk for cancer, especially among people with certain genetic mutations,” Gapstur said.

However, this study only shows an association between consumption of meat cooked at high temperatures and kidney cancer risk, not that it actually causes kidney cancer. To show that, larger prospective studies are needed, she said.

The report was published online Nov. 9 in the journal Cancer.

Many previous studies have suggested that aspects of the so-called Western diet — including high intake of meat, starches and processed foods — are partly responsible for the rise in kidney cancer, Wu said. To study this further, Wu and colleagues collected information from more than 650 kidney cancer patients and compared it with data from nearly 700 cancer-free patients.

  • A food questionnaire asked not only about meat intake, but also cooking methods and level of how thoroughly it was cooked, the study authors noted.
  • The researchers found that the kidney cancer patients ate more red and white meat than the others. They also ate more meat cooked at high temperatures or over an open flame — such as pan-fried, grilled or barbecued.
  • The study found that, in particular, two chemical compounds caused by high-heat cooking seemed to raise kidney cancer risk by more than 50 percent.
  • Also, people with certain genetic mutations seemed more susceptible than others to the effects of these chemicals, the researchers said.

However, Gapstur said that the risk for kidney cancer among people with these genetic mutations is not nearly as great as the risk for breast cancer linked to BRCA mutations.

Gapstur said the WHO report should guide meat-eating habits. “Processed meats and red meat, in particular, are carcinogens and are linked to a higher risk of colon cancer — the third most commonly diagnosed cancer in the United States. So, limiting consumption continues to be important,” she said.

In addition, avoid cooking meats at high temperatures, Gapstur suggested. “This study adds to the evidence that cooking methods are perhaps important,” she said.

Widely Used Antibiotics May Raise Heart Risks, Review Finds

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A widely used class of antibiotics is associated with a small but measurable increased risk of sudden cardiac death, researchers report.

These antibiotics — called macrolides — are used to treat infections such as pneumonia, bronchitis and some sexually transmitted diseases. In the new report, the investigators analyzed 33 studies that were conducted between 1966 and 2015, and included a total of more than 20 million patients. The studies compared patients who took macrolides, other types of antibiotics, or no antibiotics.

Macrolides include the antibiotics erythromycin, azithromycin and clarithromycin

The results revealed a small, but statistically significant, association between taking macrolides and increased risk of sudden cardiac death. But the review did not prove a cause-and-effect relationship between these medications and sudden cardiac death.

The study was published Nov. 9 in the Journal of the American College of Cardiology.

The absolute risks of sudden cardiac death and cardiac death are small, so it should likely have limited effect on prescribing practice,” study author Dr. Su-Hua Wu, from the department of cardiology at First Affiliated Hospital at Sun Yat-Sen University in Guangzhou, China, said in a journal news release.

However, given that macrolides are one of the most commonly used antibiotic groups, and millions of patients are prescribed these drugs annually, the total number of sudden cardiac deaths or ventricular tachyarrhythmias and cardiac deaths may not be negligible,” Wu added. An average of 80 cases of rapid heartbeat that can result in sudden cardiac death (or “ventricular tachyarrhythmias”) occurred per 1 million treatment courses among patients who were not taking macrolides, the investigators found.

But, current use of macrolides was associated with an additional 118 ventricular tachyarrhythmias or related sudden cardiac deaths per 1 million treatment courses. And there were 36 additional sudden cardiac deaths from causes other than ventricular tachyarrhythmia, and 38 additional heart-related deaths per one million treatment courses, the findings showed.

Past use of macrolides and use of other antibiotics were not associated with increased heart risk, the researchers found.

To put the findings into perspective, one in 8,500 patients treated with macrolides could develop a serious heart rhythm problem and one in 30,000 might die, Dr. Sami Viskin, from the Tel Aviv Medical Center and Sackler School of Medicine at Tel Aviv University in Israel, explained in an accompanying journal editorial.

Today, when antimicrobial resistance represents a major threat to global health and new treatment options are frighteningly few, losing an entire class of antibiotics would represent a major setback in the fight against infections. Furthermore, it takes years to fully understand the consequences of a drug’s disappearance,” Viskin wrote.

FDA Approves Cotellic (cobimetinib) for the Combination Treatment of Advanced Melanoma

The U.S. Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation)

Melanoma is the most aggressive and dangerous form of skin cancer in the United States. It forms in the skin cells that develop the skin’s pigment and if not diagnosed early, the cancer is likely to spread to other parts of the body.

As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies. Combining two or more treatments addressing different cancer-causing targets may help to address this challenge,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma.”

Cotellic works by blocking the activity of an enzyme known as MEK, which is part of a larger signaling pathway. Abnormal activity of signaling pathways can lead to cancer. Cotellic prevents or slows cancer cell growth. Vemurafenib, marketed in the U.S. as Zelboraf, is a BRAF inhibitor that affects a different part of the same pathway and was approved in 2011 to treat patients with melanoma that has spread to other parts of the body or cannot be removed by surgery, whose tumors express a gene mutation called BRAF V600E, as detected by an FDA approved test. Health care providers should confirm the presence of BRAF V600 E or V600K mutation in their patients’ tumor specimens using one of the available FDA approved tests prior to starting treatment with Cotellic in combination with vemurafenib.

The safety and efficacy of Cotellic taken in combination with vemurafenib were demonstrated in a randomized clinical study of 495 patients with previously untreated, BRAF V600 mutation-positive melanoma that is advanced or cannot be removed by surgery. All study participants received vemurafenib and were then randomly selected to also take either Cotellic or a placebo. On average, patients taking Cotellic plus vemurafenib experienced a delay in the amount of time it took for their disease to worsen (approximately 12.3 months after starting treatment) compared to approximately 7.2 months after starting treatment for those taking vemurafenib only. In addition, patients taking Cotellic plus vemurafenib lived longer, with approximately 65 percent of patients alive 17 months after starting treatment as compared to half of those taking vemurafenib only. Additionally, 70 percent of those taking Cotellic plus vemurafenib experienced complete or partial shrinkage of their tumors, compared to 50 percent among those taking vemurafenib plus placebo.

The most common side effects of treatment with Cotellic in combination with vemurafenib are diarrhea, sensitivity to ultraviolet (UV) light (photosensitivity reaction), nausea, fever (pyrexia) and vomiting.

Cotellic may cause severe side effects including damage to the heart muscle (cardiomyopathy) or to other muscles (rhabdomyolysis), new skin tumors (primary cutaneous malignancies), eye disease (retinal detachment), severe skin rash, liver damage (hepatotoxicity), hemorrhage and severe skin rash due to increased sensitivity to sunlight (photosensitivity). People taking Cotellic should avoid sun exposure, wear protective clothing, and a broad spectrum ultraviolet A/ultraviolet B sunscreen to protect against sunburn. Women taking Cotellic should use effective contraception, as the medication can cause harm to a developing fetus.

Cotellic was reviewed under the FDA’s priority review program that provides for an expedited six-month review of drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

Heavy Drinking May Strain the Heart

Heavy drinking may dramatically increase a person’s risk of heart failure, even if they’re young and healthy, a new study suggests.

People who abuse alcohol are 70 percent more likely to develop heart failure, according to findings that were to be presented Tuesday at the American Heart Association’s annual meeting in Orlando, Fla.

The detrimental effects of hard drinking were particularly pronounced in young and middle-aged adults, and people who were otherwise in good health, said lead researcher Dr. Isaac Whitman, an electrophysiologist at the University of California, San Francisco. However, the study did not prove that heavy drinking causes heart failure.

These results suggest that younger adults need to take it easy on the booze, especially if they don’t have any risk factors for heart disease, Whitman said.

“In the case of alcohol, I don’t think it’s prudent to say I can abuse alcohol because I’m young and healthy,” he said. “You may be hurting yourself relatively more than your older counterparts. You have more to lose.”

Other studies have shown mixed results for heart health when it comes to light or moderate drinking. For example, moderate drinking seems to help lower cholesterol levels, but also increases your risk of irregular heart rate, Whitman said.

Doctors had diagnosed about 4 percent of these people as alcohol abusers. Overall, about 12 percent developed congestive heart failure, the investigators found.

Alcohol abuse emerged as a strong predictor of congestive heart failure, even after researchers adjusted for other risk factors, such as age, high blood pressure, diabetes, smoking and elevated cholesterol levels.

In addition, the study authors found that alcohol abuse was even worse for the hearts of healthy people who don’t have other heart risk factors, Whitman said.

“If you are a healthier person, your heart is disproportionately more susceptible to the toxicities of alcohol,” he said.

For example, people were more affected by heavy drinking if they were younger than 60, had normal blood pressure and didn’t already suffer from heart disease or chronic kidney disease, Whitman said.

“Your heart is already sick, so the added toxicity from alcohol does not have as much of an impact,” he explained.

Heavy drinking can harm the heart in both direct and indirect ways, said Dr. Robert Eckel, a professor and cardiologist at the University of Colorado Anschutz Medical Campus.

Alcohol can make the heart muscle less effective, harming its ability to pump blood, Eckel said.

Whitman added that there’s a condition called alcoholic cardiomyopathy that affects people who have five or more drinks a day over a number of years, in which the heart becomes bloated and enlarged.

“It becomes a sack and it barely squeezes,” Whitman said. “You quit drinking, and it goes away.”

Hard drinking also increases blood pressure, which causes all manner of harm to the heart and blood vessels. “The more you drink, the higher your blood pressure,” Eckel said. “Once you’re drinking three or four drinks a day, your blood pressure elevates.”

“Too much alcohol can take us down 15 to 20 different paths when it comes to detrimental effects on health,” Eckel said.

Research presented at medical meetings is considered preliminary until published in a peer-reviewed journal.

Tramadol: FDA Evaluating Risks of Using in Children Aged 17 and Younger

FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.

Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. Health care professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children.

BACKGROUND: In the body, tramadol is converted in the liver to the active form of the opioid, called O-desmethyltramadol. Some people have genetic variations that cause tramadol to be converted to the active form of the opioid faster and more completely than usual. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death. Recently, a 5-year-old child in France experienced severely slowed and difficult breathing requiring emergency intervention and hospitalization after taking a single prescribed dose of tramadol oral solution for pain relief following surgery to remove his tonsils and adenoids. The child was later found to be an ultra-rapid metabolizer and had high levels of O-desmethyltramadol in his body.

RECOMMENDATION: Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention immediately by taking their child to the emergency room. Parents and caregivers should talk with their child’s health care professional if they have any questions or concerns about tramadol or other pain medicines their child is taking.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Lower Intensity Approach Better Initial Tx for Lymphoma

A significantly more tolerable approach than standard chemotherapy using the combination of lenalidomide and rituximab as initial therapy in mantle-cell lymphoma is highly active and produces durable responses in most patients, an observational cohort study suggests.

Treatment of patients with mantle-cell lymphoma, who are frequently older (median age 65 years) and unsuitable candidates for intensive regimens, remains a clinical challenge,” Jia Ruan MD, PhD, of the Meyer Cancer Center at Weill Cornell Medical College and New York-Presbyterian Hospital in New York City and colleagues wrote in The New England Journal of Medicine.

Our data show that a lower-intensity approach for initial therapy than that usually used in the case of patients with this cancer can be highly active, with durable responses observed in most patients.”

A total of 38 patients who had untreated, measurable mantle-cell lymphoma were enrolled in the study. The median age of the cohort was 65 years (range 42-86 years); 100% of the group had Ann Arbor stage III or IV disease, and 89% had bone marrow involvement.

Rituximab was administered at a dose of 375 mg/m2 once weekly for the first 4 weeks and then once every other cycle until disease progression. During the maintenance phase, lenalidomide was given at a dose of 15 mg a day again on days one through to 21 of every 28-day cycle while rituximab was given once every 8 weeks.

Treatment was continued for at least 36 cycles or until disease progression or unacceptable AEs. For patients with creatinine clearance of 30 to 60 mL/min, lenalidomide was administered at a lower dose of 10 mg day during the induction phase, although the dose was again escalated to 15 mg a day if patients experienced no dose-limiting AEs. During the maintenance phase, lenalidomide was given at a dose of 5 mg a day.

Patients received thromboprophylaxis with aspirin or low-molecular-weight heparin unless they required treatment for known thrombosis,” Ruan and colleagues added, “[while] asymptomatic carriers of hepatitis B virus received antiviral therapy.”

On the other hand, prophylactic growth factors were not administered empirically.

Grade 3 or 4 hematologic AEs included neutropenia, which occurred in half of the group, thrombocytopenia in 13% of patients, and anemia in 11% of the group. The likelihood that patients would develop hematologic toxicity was higher during the induction phase than in the maintenance phase. Similarly, grade 3 and 4 nonhematological toxicities were only reported during the induction phase and included rash in 29% of patients, tumor flare in 11% of patients, serum sickness associated with rituximab in 8%, and fatigue in another 8% of patients.

Grade 3 infections were reported during the maintenance phase but all resolved with the administration of antibiotics and supportive care.

Among the 33 patients with normal renal function, 36% had no unacceptable side effects associated with the dose escalation from 20 mg to 25 mg,” Ruan and colleagues noted.

However, 42% of the group did require a reduction in the dose of lenalidomide from 20 mg to 15 mg or less. Of the eight patients who had disease progression while receiving treatment, all remained alive except for an 86-year-old patient who opted for palliation.

Seven patients responded to retreatment with generally favorable outcomes and no indication that prior receipt of the biologic doublet compromised subsequent treatment outcomes.

The efficacy of lenalidomide plus rituximab in a broad patient population, including patients who were ineligible for intensive approaches, is particularly notable in the context of data reported on patients receiving inpatient-based regimens, including high-dose chemotherapy with autologous hematopoietic-cell transplantation,” Ruan and colleagues observed.

However, the duration of maintenance therapy remains to be determined, and it is unclear whether the combination of lenalidomide and rituximab is more effective than rituximab alone as maintenance therapy.”