Ipilimumab – new option for Metastatic Melanoma patients

Posted on June 9, 2010 by wngai
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At ASCO this past weekend, Dr. Steven O’Day reported that ipilimumab alone or in combination with vaccine increased overall survival (OS) in patients with unresectable stage III/IV melanoma for whom previous treatment had failed (Abstract 4). 

Metastatic (stage IV) melanoma is very difficult to treat with no new approved choices since IL-2 over a decade ago. Ipilimumab, a monoclonal antibody against cytotoxic T-lymphocyte antigen 4 (CTLA-4), is an immune therapy directed against T-cells. Blocking this antigen helps to stimulate the expansion of T-cell populations, potentially increasing tumor-directed immune responses. 

Study design
Two therapeutic approaches — ipilimumab and vaccine therapy with gp100 alone and in combination. 

  • double-blind study randomly assigned patients to receive 1) ipilimumab (137 patients), 2) ipilimumab and gp100 (403 patients), or 3) gp100 alone (136 patients).
  • All patients were required to be HLA-A2 positive.
  • Primary endpoint:  overall survival (OS).

Result
 After 12 months, 46% of patients receiving ipilimumab alone, 44% receiving ipilimumab plus gp100, and 25% receiving gp100 were still alive. (p = 0.0026 for ipilimumab alone versus gp100; p = 0.0004 for the combination versus gp100) [See Fig.1] 

Figure 1

Figure 1 Ipilimumab

 

Adverse events
Adverse events were predominantly immune response–related and included rash, colitis, diarrhea, and hepatitis. More serious immune-related grade 3 or 4 toxicities occurred in 10% to 13% of patients receiving ipilimumab.  Physicians treating melanoma should be familiar with the side effects and its management.  “Even at 3mg/kg, there were potentially life-threatening complications.  Using ipilimumab requires a committed, multidisciplinary team at all times to address toxicity management.” Dr. V. Sondak said. 

Information on clinical trials on ipilimumab 

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Who lived longer? The Emperors, The Chinese Medicine Doctors or The Monk?

Posted on June 6, 2010 by wngai
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Chinese Emperor‘‘Long Live Your Imperial Majesty’’ was the formal address to the Chinese emperors who reigned for more than 2,000 years (between 221 BC and AD 1911) in China. The emperors had the absolute power, as well as supreme rank and utmost dignity. Many emperors also lived in lavish and extravagant lives.  But did the power and wealth of these emperors allow them to live longer than Buddhist monks or traditional Chinese doctors?  

A study published in Aug 2006 issue of the American Journal of Geriatrics Society reviewed the lifestyle, age and cause of death of all the Chinese emperors and compared their age of death with that of the Buddhist monks and the traditional doctors living in the same dynasties. 

259 Chinese emperors reigned during the 24 dynasties from the first Qin Dynasty (221–207 BC) to the last Qing Dynasty (AD 1616–1911), but the age of death were only available for 240 emperors. 

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Benefits of Tea in Reducing Cardiovascular Disease, Obesity, Diabetes and Cancers

Posted on June 2, 2010 by wngai
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Chinese teapot

Chinese teapot

Tea is one of the most widely-consumed beverages in the world.  Beside quenching thirst, tea also contains lots of natural ingredients which might be beneficial to the overall health.  This article reviews the clinical benefits of tea.

Tea

According to Chinese legends, tea was discovered by the Emperor Shen Nong (神農氏) in about 2737 BC, when a gust of wind blew tea leaves into his bowl of boiling water. The emperor took a sip of the cup and was pleasantly impressed by the flavor.

Whenever the Emperor fell ill after taking poisonous food or herbs, he always used tea as an antidote.  He believed that tea can provide “vigor of body, contentment of mind, and determination of purpose”’. Since then tea has been a staple product and the main beverage in China.

Today, tea is the second most widely consumed beverages behind water around the world.  Based on the level of fermentation, tea can be categorized into 6 types (green, white, fragrant, Oolong, black, Pu-erh).  Pur-erh tea undergoes the longest period of fermentation while green tea, produced by steaming, are exposed to least fermentation or oxidation.

Beyond Quenching Thirst

Tea leaves contains many chemicals.  Some of which, such as catechin, amino acids, vitamins (C, E and K) and polysaccharides, are beneficial to human health.  Among all the chemicals, catechin, an antioxidant, is responsible for most of the cardio-protective and cancer preventive effects.

However, not all teas contain the same amount of catechin.  During the fermentation process, some or all of the catechins are destroyed.

Black and Pu-erh teas, which undergo the longest period of fermentation has the least amount of catechins, while green (Lung Chen Tea) and white tea, which are least processed, are able to retained highest amounts.  Thus, the lipid lowering and cancer protective effects are stronger for green than black tea.

Cardiovascular disease

Beside anti-oxidant property, green and white teas also possess blood pressure lowering, lipid-lowering, antithrombogenic and anti-inflammatory properties.

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Alternative Treatment for Diabetes – Traditional Chinese Medicine

Posted on May 31, 2010 by wngai
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Insulin is the cornerstone of diabetic treatment. However, most patients are reluctant to administer insulin due to the fear of injection. This article reviews clinical and pharmacological studies of Traditional Chinese Medicine (TCM) in the treatment of diabetes.

Traditional Chinese Medicine

www.OasisHerb.comTCM is both an art and a science in healing patients. Its diagnosis looks at the well-being of body, mind, and spirit. Even though most Chinese medicines have not been tested under rigorous clinical trials, its clinical value has been evaluated in millions of Chinese patients over the past 5000 years. 

The philosophy of TCM is rooted in Chinese cultures of Taoism (to follow nature’s way) and Confucius (to nurture humanity and morality) and the religion of Buddhism (to free from suffering).

TCM doctors are usually pharmacists and pharmacologists who themselves identify and collect herbs, prepare formulation and follow up their patients. TCM includes Chinese herbal medicine (CHM), acupuncture and specialized disciplines of surgery, orthopedics, pediatrics, and obstetrics and gynecology.

 Chinese Herbal Medicine

CHM is the major modality in TCM practice. A prescription for CHM, referred to as compound recipe (Fu Fang), usually consists of four major types of herbs: 1) principal herbs, 2) assistant herbs, 3) adjuvant herbs, and 4) guiding herbs in order to maximize the therapeutic effectiveness and minimize the toxic effects.

The ingredients and the quantity of herbs in a CHM prescription are individualized and changed on a weekly basis to tailor for the patient’s age, gender, symptoms, anthropological characters, geological location and living environment.

TCM doctors have started documenting the efficacy of Chinese Herbal Medicine (approximately 1,200 recipes and 150 herbs for diabetes) for diabetes, metabolic syndrome and associated complications in western medicine database since 1980. Table 1 lists the Chinese herbs and classic recipes that were used commonly in clinical trials in diabetes and diabetic complications.

Table 1: Traditional Chinese medicine for diabetes mellitus

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Standard Chemo Better Than Oral Capecitabine in Elderly Breast Cancer

Posted on May 30, 2010 by wngai
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Most elderly breast cancer patients would prefer oral chemotherapy such as capecitabine (Xeloda, Roche) over intravenous chemotherapy due to the convenience. 

However, a clinical trial conducted in elderly women with early-stage breast cancer has found that standard adjuvant combination chemotherapy CMF (Cyclophosphamide & Methotrexate & 5-Fluorouracil) or C&D (cyclophosphamide and doxorubicin) were superior to the oral drug capecitabine in improving survival among older women. 

The trial involved 600 women 65 years of age and older, randomized to either adjuvant therapy with capecitabine alone, or to 1 of 2 standard chemotherapy regimens (CMF or C&D). 

After 3 years, the rate of relapse-free survival was 68% in the capecitabine group but 85% in the standard-chemotherapy groups.  The overall survival rate was 86% and 91%, respectively. 

Patients receiving capecitabine were twice as likely to have a relapse or die (HR = 2.09, 95% CI = 1.38 – 3.17; P < .001). 

Nonetheless, the standard chemotherapies were associated with more adverse events.  Twice as many patients receiving standard chemotherapy had moderate to severe toxic effects (64% vs 33% with capecitabine). 

Adverse Effects in the 3 Study Groups:

Adverse Effect

 CMF
(n = 132)		 C&D
(n = 183)		 Capecitabine
(n = 229)
Hematologic, % 52 54 2
Fatigue, % 11 4 5
Nausea and vomiting, % 13 6 4
Diarrhea, % 8 3 7
Hand–foot skin reaction, % <1 0 16
Febrile neutropenia, % 8 9

1

Even though standard chemotherapies were associated with better survival results, these regimens might not be suitable for frail and vulnerable elderly breast cancer patients due to the adverse effects. 

Please visit http://healthreason.com/ for more health related articles. 

Source: N Engl J Med. 2009;360:2055-2065.

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FDA Revised Orlistat Label to include Risk for Severe Liver Injury

Posted on May 30, 2010 by wngai
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The US Food and Drug Administration (FDA) announced today that it has revised the label for orlistat (Xenical) to include new safety information about rare cases of severe liver injury reported with the use of the weight-loss medication. 

Last August, the agency announced that it was studying a possible link between orlistat and liver injury. Today’s announcement is based on a completed FDA review of all available data from preclinical and clinical trials, postmarketing studies, and drug utilization from April 1999 through August 7, 2009. 

Signals of significant liver damage did not emerge in preclinical or clinical trials. However, the FDA identified 13 postmarketing cases of severe liver injury — 12 of them foreign cases involving Xenical and the other a US case involving Alli. Some patients died or needed a liver transplant. 

The FDA stated that it has not yet established a causal relationship between orlistat use and severe liver injury and cited 3 factors making this determination difficult: 

  • The 13 cases of severe liver injury stand alongside an estimated 40 million people who have used some version of orlistat.
  • Some of the 13 patients used other drugs or had conditions that might have contributed to severe liver injury.
  • Severe liver injury can occur without a distinct reason in people not taking drugs.

The FDA is advising clinicians to instruct orlistat users to report any symptoms of hepatic dysfunction such as anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain. Patients should discontinue orlistat therapy if liver injury is suspected.

More information on today’s FDA announcement is available on the agency’s Web site.

To report adverse events related to orlistat, contact MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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Whole Grain, Bran Intake Linked to Lower Mortality in Diabetic Women

Posted on May 30, 2010 by wngai
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It is well known that patients with diabetes face up 2 to 3 times the risk of cardiovascular disease and premature death compared to the general population.  To lower their risk of cardiovascular disease, patients are advised to exercise and to control their diet. 

A new study published in May 10, 2010 of Circulation indicated that the risk of mortality in type 2 diabetes can be reduced by taking whole grain and bran. 

As part of the Nurses’ Health Study, 7,822 US women with type 2 diabetes mellitus completed regularly administered questionnaires evaluating their dietary intakes.  During follow-up lasting up to 26 years, there were 852 all-cause deaths and 295 cardiovascular deaths.

At the end of the study, the investigators found that bran intake was associated with 6% to 38% reduction in all-cause mortality, depending on the amount of bran consumption.  Furthermore, bran intake was also associated with 5% to 35% reduction in cardiovascular mortality. 

This study is the first one to show that whole grain and particularly bran can reduce death and cardiovascular risk in diabetic patients. 

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Source: online May, Circulation, 2010

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New treatment modality (Yttrium-90 Microspheres) Improves Survival in Patients With Liver Cancer

Posted on May 30, 2010 by wngai
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Each year, there are about 18,500 cases of primary liver cancer diagnosed and the most common form is hepatocellular carcinoma.  However, more than 75% of hepatocellular carcinoma patients can not have surgery to remove their liver tumors and chemotherapy and external radiation therapy are not effective in curing inoperable liver cancer. 

In a longitudinal cohort study presented at the Society of Interventional Radiology (SIR) 35th Annual Scientific Meeting, investigators reported treatment using intra-arterial yttrium-90 (Y-90) microspheres (TheraSphere, MDS Nordion) prolonged life for patients with hepatocellular carcinoma. 

This new outpatient treatment involves injecting radiolabelled Y-90 microspheres through a catheter from the groin into the artery supplying blood to the tumor. 

The study enrolled 291 patients (77% male, 25% were more than 75 years old, and 73% had multifocal disease) between December 2003 and December 2008, and administered 526 the radiolabelled Y-90 microspheres. The patients were subdivided by their Barcelona Clinic Liver Cancer (BCLC) staging system (A or B) and Child-Pugh liver function score (A or B). 

Improved Results, Dramatic Tumor Shrinkage 

Overall, the time to progression was 7.9 months (95% confidence interval [CI], 6.0 – 10.3) and the response rate was 42%.  By the standard of this disease, it was considered very promising. 

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Breast-Feeding Reduce Incidence of Fever After Immunizations

Posted on May 30, 2010 by wngai
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Breast-feeding is linked to a lower incidence of fever after immunizations, according to the results of a prospective cohort study reported online May 17 in Pediatrics.

At a pediatric vaccination center in Naples, Italy, mothers of infants scheduled for routine vaccinations were invited to participate in the study and were asked about the incidence of fever of their babies 3 days after the immunizations.

Of 450 infants recruited and reported, fever was reported in 30 (25%) of exclusively breast-fed infants, in 48 (31%) of partially breast-fed infants, and in 94 (53%) of infants who were not breast-fed at all (P < .01).

Among infants who were exclusively breast-fed, the relative risk for fever was 54% lower than infants who were not breast-fed at all (95% confidence interval [CI], 0.33 -0.66).  Likewise, infants who were partially breast-fed infants have 42% lower risk of having fever (95% CI, 0.44-0.77).

This study suggested that breastfeeding is associated with a reduced risk for fever after immunization.

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Source: online, Pediatrics, May 17, 2010.

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Long-Term Metformin Treatment Linked to Vitamin B12 Deficiency

Posted on May 30, 2010 by wngai
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Metformin is the first line agent for type 2 diabetic patients.  It is also one of the few antihyperglycaemic agents that are associated with improvements in cardiovascular morbidity and mortality. 

However, a study recently published in the May 20 issue of the BMJ, indicated that long-term metformin treatment is linked to vitamin B12 deficiency. 

At the outpatient clinics of 3 nonacademic hospitals in the Netherlands, 390 patients with type 2 diabetes being treated with insulin received 850 mg of metformin or placebo 3 times daily for 4.3 years. 

At the end of the study, patients in the metformin group experienced a 19% reduction in vitamin B12 concentration, (95% confidence interval [CI], −24% to −14%; P < .001), a 5% reduction in folate (95% CI, −10% to −0.4%; P = .033), and 5% increase in homocysteine (95% CI, −1% to 11%; P = .091). 

If you have been taking or will take metformin for a long time, remember to ask your doctor to check your vitamin B-12 level regularly.  

Deficiency of vitamin B12 is associated with anemia and central nervous system damage.  Signs and symptoms associated with vitamin B12 deficiency include tiredness, a decreased mental work capacity, weakened concentration and memory, irritability and depression. 

Please visit http://healthreason.com/ for more health related articles. 

Source: online May 2010 BMJ.

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