Vectibix for colorectal cancer
The Untied States Food and Drug Administration (FDA) recently approved panitumumab (Vectibix) for the treatment of patients with colorectal cancer that has metastasized following standard chemotherapy. Vectibix, a monoclonal antibody that binds to an epidermal-growth-factor receptor or EGFR on some cancer cells, received accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor. Approximately 70 percent of all colorectal carcinomas test positive for EGFR.
"Colorectal cancer is the third most common cancer and the third leading cause of cancer mortality in the United States," said Dr. Steven Galson, director of the FDA Center for Drug Evaluation and Research. "This approval adds a treatment option for patients with an advanced stage of a disease that can be life-threatening."
The FDA approved Vectibix based on results of a randomized, controlled clinical trial of 463 patients with metastatic cancer of the colon and the rectum after undergoing treatment with chemotherapy drugs, fluoropyrimidine, oxaliplatin, and irinotecan. The mean time to disease progression or death in patients receiving Vectibix was 96 days versus 60 days in patients receiving the best standard supportive care. Eight percent of the patients on Vectibix experienced tumor shrinkage that in some cases exceeded 50 percent of the pretreatment size. Both groups showed similar overall survival.
The most serious adverse events were pulmonary fibrosis, severe skin rash complicated by infections, infusion reactions, abdominal pain, nausea, vomiting, and constipation. Vectibix is manufactured by Amgen Inc. in Thousand Oaks, California. M
Rimonabant also helps diabetics
PARIS
Rimonabant (Acomplia), a new drug that has generated huge excitement for its apparent effectiveness against obesity, also helps reduce health risks for diabetics, a trial says. The drug reduced body weight and improved control over blood glucose and blood fats among people with type 2 diabetes, according to the study published in The Lancet.
Belgian researcher Andre Scheen and colleagues enrolled 1,047 type 2 diabetics in 11 countries who were obese or overweight. They were given either rimonabant at five mg or 20 mg a day, or a placebo. All were given a diet plan that provided for slightly fewer calories than they needed and were advised to do exercise.
After a year, the five-mg group had lost 2.3 kilos on average; the 20-mg group had lost 5.3 kilos, and the placebo group had lost 1.4 kilos. In each group, about a third of volunteers dropped out. Rimonabant was "generally well tolerated," the study says. The individuals who dropped out because of side effects were most numerous in the 20-mg group, citing depression, nausea, and dizziness. Levels of high-density lipoprotein rose 17 percent among the 20-mg group, more than twice that of the placebo group.
The study recommends a 20-mg daily dose of rimonabant, in addition to diet and exercise, for obese type-2 diabetics.
Rimonabant, made by Sanofi-Aventis, is the first in a new generation of agents called cannabinoid-type-1-receptor blockers, which inhibit brain cells that demand food, alcohol, nicotine, and other pleasure-giving substances. It was licensed by the European Union in June for use as weight-loss pill for people diagnosed as obese and at risk from diabetes. M AFP
COX-2 selectivity with lumiracoxib
Lumiracoxib (Prexige), a new cyclooxygenase-2-selective inhibitor, is now available in the Philippines.
Dr. Eduardo Myesler, associate professor at the University of Buenos Aires and an instructor in medicine at the New York University, described lumiracoxib as "a very efficacious drug with a good safety profile that we can all feel comfortable using in our practice." Myesler discussed the drug's benefits during a recent symposium organized by Novartis Philippines to coincide with the launch of lumiracoxib. He presented results of the Therapeutic Arthritis Research and Gastrointestinal Event Trial of lumiracoxib v. naproxen and ibuprofen (TARGET) published in The Lancet, which he coauthored.
Compared with other cyclooxygenase-2 (COX-2) inhibitors, lumiracoxib was shown to have the greatest selectivity toward COX-2 enzymes. This means that its selective distribution guarantees that it accumulates in inflamed tissue where it is needed the most. It is also rapidly absorbed and eliminated.
TARGET, a multinational, double-blind, randomized, active-controlled, parallel-group study in patients with osteoarthritis, involved 18,325 patients over a 52-week treatment period. Since it was a safety study, a dose four times higher than the usual dosage was given. The study's primary end point was to identify definite or probable upper-gastrointestinal-ulcer complications while its secondary end points included cardiovascular or cerebrovascular events, a combined cardiovascular and gastrointestinal end point, other safety parameters, and efficacy.
At the end of the study, there was a 79-percent reduction in cumulative incidence of upper GI ulcer complications among lumiracoxib users compared with those who were taking naproxen or ibuprofen. Myesler said that the benefits of lumiracoxib in terms of not causing GI complications were evident early on in the study compared with naproxen and ibuprofen, and by day 15 there was already a big difference between the treatment groups. Lumiracoxib did not show any significant difference from naproxen and ibuprofen in terms of myocardial infarction, stroke, deep-vein thrombosis, and pulmonary embolism.
Lumiracoxib's efficacy is comparable with those of other nonsteroidal antiinflammatory drugs (NSAIDs) against osteoarthritis, rheumatoid arthritis, gout, postoperative arthroplasty pain, primary dysmenorrheal pain, and postoperative dental surgery pain. Lumiracoxib has favorable renal and hepatic safety profiles.
In an interview with MEDICAL OBSERVER after the symposium, Myesler expressed his confidence in the drug saying, "I'm very pleased [with lumiracoxib]. No other COX-2 inhibitor has the 12-month data that lumiracoxib has."
Lumiracoxib, manufactured by Novartis, is available in 100-mg and 400-mg capsules. M C. Paraz, MD
Xeloda for stomach cancer
Roche's innovative oral-cancer drug capecitabine (Xeloda), in combination with platinum-based chemotherapy, has received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) for first-line use in patients with advanced gastric cancer.
"The CHMP opinion is encouraging news for European patients fighting advanced gastric cancer, a particularly aggressive and debilitating disease," said Jean-Jacques Garaud, head of global pharma development at Roche. "We look forward to receiving [European Union] approval, another milestone in our commitment to developing effective and safe treatments for the millions of cancer patients throughout the world."
Gastric cancer is a particularly serious form of cancer that affects twice as many men as women and kills as many as 911,000 people each year worldwide.
The positive recommendation was based on results from two phase-III studies-ML17032, which involved 316 patients in 46 centers across 13 countries in Asia, South America, and Europe, and REAL 2, which enrolled 1,002 advanced-gastroesophageal-cancer patients from 61 centers mainly in the UK. The results of ML17032 confirmed that patients receiving the Roche capecitabine/cisplatin combination lived at least as long without the cancer progressing as those treated with 5-FU/cisplatin. REAL 2, the largest phase-III study in advanced gastroesophageal cancer, demonstrated that capecitabine can replace 5-FU, and that patients treated with the combination capecitabine plus oxaliplatin and epirubicin lived significantly longer than patients treated with standard epirubicin, cisplatin and 5-FU.
"As an oral chemotherapy, Roche's Xeloda gives patients a valuable option over the current standard of intravenous treatment," said Dr. Ian Chau of the Royal Marsden Hospital in Sutton, United Kingdom. "Xeloda is as effective as intravenous treatment and reduces the time patients need to spend in the hospital, from five days every three weeks to only one day every three weeks, allowing patients to lead more routine lives and have more personal time. It may also potentially avoid the need of a central intravenous line with its associated inconvenience and complications."
The Bureau of Food and Drugs approved Xeloda for the treatment of gastric cancer in January. Xeloda has earlier been approved for the treatment of patients with locally advanced metastatic breast, colorectal, and head and neck cancer; as a combination treatment with docetaxel for patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy; and as an adjuvant treatment for colon-cancer patients. M
Aminoleban effective for PEM
Patients with chronic diseases such as liver cirrhosis, cancer, kidney disease, and AIDS often suffer from malnutrition-specifically, protein-energy malnutrition (PEM)-arising from poor nutrient intake and the body's impaired ability to process food and nutrients as efficiently as it used to.
The consequences of PEM can be fatal. Studies have shown that if a person suffering from a chronic illness succumbs to malnutrition, a significant deterioration of body functions ensues, which adversely affects recovery. This is particularly true for those suffering from cirrhosis and other liver diseases. A study by Dr. Hisataka Moriwaki showed that 65 to 90 percent of patients with cirrhosis suffer from protein-energy malnutrition (PEM), affecting their quality of life. A person suffering from PEM has low levels of albumin (visceral protein) and decreased skeletal muscle volume (muscular protein). In the treatment of cirrhosis, it is also important to diagnose and manage PEM.
Patients with liver disease, in particular, cannot tolerate high-protein diets because they lack the ability to get rid of the waste products of protein metabolism. Thus, supplementation with BCAAs (marketed as Aminoleban by Otsuka Pharmaceuticals) is recommended for these patients.
Aminoleban is known to be effective in helping address PEM among patients with cirrhosis. It contains amino acids, vitamins and minerals that offer a new pharmaconutritional approach for patients with liver impairment. A study by Dr. Takafumi Ichida and colleagues found that aminoleban prolongs the life of patients with decompensated liver cirrhosis. Ninety-two percent of those who received Aminoleban were still alive at the end of a six-month study. The authors concluded that oral supplementation with a BCAA preparation administered for two years improves event-free survival, serum albumin concentration, and quality of life among patients with decompensated cirrhosis.
Similarly, a study by Dr. Hisataki Moriwaki and his colleagues at the Gifu University School of Medicine showed that BCAA supplementation aids in the synthesis and secretion of albumin, and improves the quality of life and survival of patients with liver cirrhosis.
Similar results were obtained by Dr. Yasutoshi Muto and his colleagues in a study published in the journal Clinical Gastroenterology and Hepatology. The study showed that long-term administration of BCAA supplements slows down the progression of liver failure and is associated with better survival in patients with cirrhosis.
But the timing of intake is important. Recent studies show that when taken at daytime, BCAA tend to be consumed by energy generation for physical exercise of skeletal muscles. Nighttime intake seems more favorable. M
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