Third Head and Neck Indication for Erbitux

Source: The ASCO Post, January 1, 2012, Volume 3, Issue 1, Matthew Stenger   In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.Cetuximab (Erbitux) was recently approved by the FDA for use in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck.1-3 Cetuximab has prior indications in combination with radiation therapy in locally or regionally advanced squamous cell head and neck cancer and in recurrent or metastatic head and neck cancer that has progressed after platinum-based therapy. It also has indications in colorectal cancer. The most recent approval is based primarily on results of a study conducted outside the United States in 442 patients with metastatic or locally recurrent squamous cell carcinoma of the head and neck who were not suitable for curative treatment with surgery or radiation. The study used a European Union (EU)-approved cetuximab rather than the U.S.-approved cetuximab (Erbitux). Erbitux provides approximately 22% higher exposure than the EU-approved cetuximab; these pharmacokinetic data, together with the results of the study conducted in Europe and other data using Erbitux establish the safety and efficacy of Erbitux at the recommended dose.In this trial, the addition of cetuximab (n = 222) to platinum-based therapy plus 5-FU (n = 220) significantly increased median overall survival from 7.4 to 10.1 months, representing a 20% reduction in risk of death [...]

Hypersensitivity Reactions to Erbitux Caused by Tick Bites.

Source: Gastroenterology & Endoscopy News Hypersensitivity reactions to cetuximab (Erbitux, ImClone Systems/Bristol-Myers Squibb), a monoclonal antibody approved for use in colorectal cancer, are not caused by the drug itself but by preexisting immunoglobulin E (IgE) antibodies that may result from tick bites, researchers have found. Cetuximab, like other monoclonal antibodies, is generally associated with a low rate of severe anaphylactic reactions (3%), but reports of such reactions to cetuximab have recently increased in southeastern states, including Tennessee and North Carolina. Researchers found IgE antibodies in pretreatment samples of 68% of patients allergic to cetuximab that were specific for galactose-α-1,3-galactose, an oligosaccharide present on the Fab portion of the cetuximab heavy chain. The authors noted that rates of anaphylactic reaction may be lower with other monoclonal antibodies because cetuximab is produced in the mouse cell line SP2/0, which expresses this oligosaccharide, whereas most other monoclonal antibodies are produced in a Chinese hamster ovary cell line that does not express this molecule. Theories to explain the increased hypersensitivity of patients in the Southeast initially centered on exposure to worms, such as roundworms or tapeworms. However, researchers now believe the true culprit may be ticks, whose bites have resulted in the development of this type of IgE antibody. Pretreatment samples were obtained from 76 people treated with cetuximab at centers mainly in Tennessee, Arkansas and North Carolina; the control group included 72 people in Tennessee, 49 patients with cancer in northern California and 341 women in Boston. Of the patients on cetuximab, 25 [...]

Oral, Head and Neck Cancers Continue to Increase While Most U.S. Cancer Death Rates are on the Decline

Source: SHOTS (NPR's Health Blog) The rate at which Americans die from cancer continues to fall, according to the latest estimates from the American Cancer Society. As a result, nearly 900,000 cancer deaths were avoided between 1990 and 2007, the group figures. Survival gains have come as mortality rates have declined for some of the most common malignancies, including colorectal cancer, breast cancer in women and prostate cancer. Still, the ACS estimates there will nearly 1.6 million new cancers diagnosed this year, and about 572,000 deaths from the disease. The incidence of cancers hasn't budged much for men in recent years, after falling quite a bit during the first half of the last decade. Cancer incidence for women has been falling since 1998. The report was just published online by CA: A Cancer Journal for Clinicians. Lung cancer remains the biggest killer for both men and women. All told, about 160,000 people in the U.S. are expected to die from it this year. Starting in 1987, more women have died from lung cancer each year than breast cancer. One section of the report focuses on a persistent and, in some cases, widening gap in cancer death rates between people with the least education and those with the most. Educational attainment is often used in research as a proxy for socioeconomic status. American Cancer Society epidemiologist Elizabeth Ward, one of the report's authors, tells Shots, "People of a lower socioeconomic status are more likely to smoke and less likely to get [...]

Modest Drinking can Heighten your Risk for Cancer

Source: MedScape.org   April 14, 2011 — "A considerable proportion of the most common and most lethal cancers is attributable to former and current alcohol consumption," concludes a large European study published online April 8 in BMJ. The researchers attribute about 10% of all cancers in men and about 3% of all cancers in women to previous and current alcohol consumption. The estimates come from an analysis of data from the huge ongoing European Prospective Investigation Into Cancer (EPIC) and from representative data on alcohol consumption compiled by the World Health Organization (WHO). The risk increases even with drinking moderate amounts. "This research supports existing evidence that alcohol causes cancer and that the risk increases even with drinking moderate amounts," coauthor Naomi Allen, DPhil, an epidemiologist at Oxford University, United Kingdom, said in a statement. The original data in the EPIC study were collected from 1992 to 2000, so "the results from this study reflect the impact of people's drinking habits about 10 years ago," Dr. Allen noted. "People are drinking even more now than they were then, and this could lead to more people developing cancer because of alcohol in the future," she added. Data From 8 Countries The EPIC study, which is still ongoing, is one of the largest studies of diet and cancer ever conducted. It involved more than half a million people in Europe. For this analysis of alcohol and cancer, the researchers used EPIC data from 363,988 participants from 8 European countries — France, Italy, Spain, [...]

Fatal adverse events with Bevacizumab

Source: Medscape Today Treatment-Related Mortality With Bevacizumab in Cancer Patients: A Meta-analysis Study Summary Although bevacizumab has been shown to improve survival in patients with a variety of solid tumors when added to conventional chemotherapy, it has also been associated with life-threatening and fatal adverse events (FAEs), including bleeding, thromboembolism, and perforation. This improvement in survival has led to the assumption that FAEs are rare and do not significantly affect patients who are receiving treatment. In this large meta-analysis, Ranpura and colleagues identified 10,217 patients with various solid tumors from 16 randomized studies, as follows: Colorectal cancer (5 studies); Non-small cell lung cancer (4 studies); Breast cancer (3 studies); Renal cell cancer (2 studies); Pancreatic cancer (1 study); and Prostate cancer (1 study). A clear increase in FAEs was evident in patients who received bevacizumab compared with those who received standard chemotherapy alone (2.5% vs 1.7%; relative risk [RR] 1.46; P = .01). This association varied with chemotherapy agents but not with tumor type. In particular, FAEs occurred in patients receiving taxanes or platinum agents (RR 3.49; 3.3% vs 1%) but not with other specific agents. Types of FAEs included bleeding (23.5%), gastrointestinal perforation (7.1%), and pulmonary embolism and stroke (5.1% each). Most fatal bleeding events were pulmonary or gastrointestinal in origin. Viewpoint The benefit of bevacizumab is under increased scrutiny given the latest data in patients with metastatic breast cancer. In this large meta-analysis, Ranpura and colleagues documented a clear increase in the rate of FAEs (2.5%) in patients [...]

Aspirin Cuts Death Rate From Several Common Cancers

Source: Web MD Taking aspirin over a long period of time can substantially cut the risk of dying from a variety of cancers, according to a study showing that the benefit is independent of dose, gender, or smoking. It also found that the protective effect increases with age. The study is by Peter Rothwell, MD, PhD, FRCP, of John Radcliffe Hospital in Oxford, England, and colleagues, and has been published online by the journal the Lancet. A previous study by the same authors showed that low doses of aspirin (75-300 milligrams) reduced the number of cases of colorectal cancer by a quarter and deaths caused by the disease by more than a third. The latest study confirms the earlier results and concludes that similar effects can be shown for other types of cancers. The study looked at eight trials examining the effects of a daily dose of aspirin on preventing heart attacks involving 25,570 patients, 674 of whom died from cancer. They showed a 21% reduction in the number of deaths caused by cancer among those who had taken aspirin, compared with people who had not. The investigation also showed that the benefits of taking aspirin increased over time. After five years, death rates were shown to fall by 34% for all cancers and by 54% for gastrointestinal cancers. Participants were also followed up after 20 years, by which point 1,634 of the original participants had died as a direct result of cancer. This 20-year follow-up established that the risk [...]

2010-12-22T11:18:57-07:00December, 2010|Oral Cancer News|

Some question benefit of costly treatments

Source: Indystar.com Author: John Russell Cancer doctors say thousands of dollars may buy little time When a cancer patient is facing a steep, painful decline, the high cost of drugs may seem worth every penny. But some cancer specialists are starting to wonder about the cost-effectiveness of some treatments and are raising pointed questions about Eli Lilly and Co.'s newest cancer drug, Erbitux. Treating a lung-cancer patient with Erbitux costs $80,000 for an 11-week regimen, according to a study published in the June issue of the Journal of the National Cancer Institute. Yet such treatment prolongs survival by 1.2 months, the study found. "Many Americans would not regard a 1.2-month survival advantage as significant progress," wrote the authors, Tito Fojo, an oncologist with the National Cancer Institute, and Christine Grady, a bioethicist at theNational Institutes of Health. The study's findings raise the question: How can the U.S. control ever-growing health costs, particularly at the end of life? When Lilly announced its acquisition of Erbitux last year, the drug maker said it planned to become "an oncology powerhouse." The Indianapolis-based company has two other cancer drugs, Gemzar and Alimta, each with sales of more than $1 billion last year. Some cancer specialists say the widespread use of expensive treatments is questionable. "Erbitux, which costs $10,000 a month for treatment, can lead to what might be described as a marginal benefit," said Dr. Paul Helft, an oncologist at theIndiana University Simon Cancer Center. Some oncologists use various lengths of treatment depending on the [...]

2009-09-14T09:56:42-07:00September, 2009|Oral Cancer News|
Go to Top