Presence of rash associated with improved survival in patients receiving adjuvant Erbitux® for locally advanced head and neck cancer

Source: professional.cancerconsultants.com Author: staff A multicenter randomized trial has shown that patients with locoregionally advanced head and neck cancer receiving adjuvant Erbitux® (cetuximab) and radiotherapy who develop a rash have a better survival than patients receiving this therapy who don’t develop a rash. The details of this five-year follow-up of a Phase III randomized study were published early online in the Lancet Oncology on November 7, 2009.[1] Standard treatment for head and neck cancer is largely determined by the stage and by the specific locations within the head or neck area where the cancer has spread. The patient’s overall medical condition is also a deciding factor. Treatment typically consists of radiation therapy, chemotherapy with surgery, or surgery alone. Erbitux is a monoclonal antibody that binds to the epithelial growth factory receptor (EGFR) and inhibits the receptor’s effects on cellular replication. Erbitux is currently FDA-approved for treatment of head and neck cancer. Researchers involved in an international study have previously reported that the addition of Erbitux to radiation therapy improves survival over radiation therapy alone in the treatment of head and neck cancer. The results of this randomized trial with a 54-month follow-up were published in the February 9, 2006, issue of the New England Journal of Medicine. This trial included 424 patients; approximately half were treated with Erbitux plus high-dose radiation therapy, and the other half received high-dose radiation therapy alone. This study now has a follow-up of more than five years. The Following table summarizes some of the findings [...]

2009-11-17T19:52:44-07:00November, 2009|Oral Cancer News|

Erbitux recognized by ASCO as a 2009 major cancer advance as first SCCHN treatment to improve survival in 30 years

Source: www.vwd.de Author: press release The American Society of Clinical Oncology (ASCO) has once again recognized Erbitux® (cetuximab) as one of the major clinical cancer advances of 2009. This year Erbitux was selected by ASCO for providing the first significant increase in survival for 30 years in the treatment of patients with first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck(SCCHN).1 ASCO Clinical Advances Report1 The ASCO report, ‘Clinical Cancer Advances 2009: Major Research Advances in Cancer Treatment, Prevention and Screening’, published this week in the Journal of Clinical Oncology, is an independent assessment of the most significant clinical cancer research studies of the past year. Erbitux was singled out for the pivotal first-line SCCHN study, the first randomized trial in 30 years to identify a regimen that increases survival for patients with recurrent and/or metastatic SCCHN. The report commented that, “The ability to improve overall survival with chemotherapy has proven elusive over the last 30 years in several randomized trials comparing different chemotherapy regimens in this setting. Thus, the results of this trial are particularly noteworthy and are changing clinical practice.” This is the second consecutive year that Erbitux has featured in the ASCO ‘Advances’ list.3 In 2008 it was recognized for extending survival in the first-line treatment of NSCLC and for the role of KRAS tumor status in predicting whether patients with newly diagnosed metastatic colorectal cancer will respond to Erbitux.2 “Merck Serono is honored that Erbitux is recognized by ASCO two years in a [...]

2009-11-16T22:39:55-07:00November, 2009|Oral Cancer News|

Report highlights cancer advances

Source: www.medpagetoday.com Author: Charles Bankhead, Staff Writer, MedPage Today As the war on cancer enters its fifth decade, 51 studies stood out as examples of progress that occurred in the past year, as determined by the American Society of Clinical Oncology (ASCO) and reported in "Clinical Cancer Advances 2009." Reflecting input from specialists throughout the field, the ASCO annual report highlights research developments for nine types of cancer, as well as cancer disparities, quality of life and quality of care, and cancer prevention and screening. "As this report demonstrates -- and as history shows -- investment in clinical cancer research pays off," ASCO president Douglas Blayney, MD, of the University of Michigan in Ann Arbor, said in a statement included in the report. "Since 1990, cancer mortality rates have declined by 15%. Today, two-thirds of patients survive at least five years after diagnosis, compared to just half of patients 40 years ago." "Thanks to basic research advances, we are entering an era of personalized cancer medicine, in which treatment is tailored to the unique genetics of the individual," Blayney added. The entire report appears online in the Journal of Clinical Oncology, but here is a summary of developments related to some of the most common cancers. In an attempt to provide context and a diversity of viewpoints, MedPage Today, in collaboration with ABC News, solicited comments from cancer specialists who were not involved in developing the ASCO publication. As appropriate, their views are included with the review of cancer research [...]

2009-11-10T08:08:06-07:00November, 2009|Oral Cancer News|

At our throats

Source: www.forbes.com Author: Matthew Herper Oncologist Maura Gillison was looking for patients with tonsil cancer for a clinical study several years ago. The first enlisted was a malpractice lawyer, followed by a doctor, then a scientist. She joked to a colleague that all she needed was a rear admiral. In walked a member of the military brass. All were in their 30s, 40s and 50s. People in their prime didn't used to get throat tumors. Head-and-neck cancer, as doctors call it, was a disease of older problem drinkers who also chain-smoked (more men than women). Years of exposure to scotch and Lucky Strikes would damage the DNA of cells lining the throat, leading to cancer. But Gillison, 44, a professor at Ohio State University, was among the first researchers to make a startling realization: The old cigarettes-and-alcohol form of the disease was being eclipsed by a new form, caused by the same human papilloma virus (HPV) that causes cervical cancer. The tumors grow in the tonsils or in the tissue that remains after tonsillectomy. The only good news is that the prognosis for these patients is better than for the old disease. Gillison and researchers at the National Cancer Institute estimate that 4,000 people, 75% of them men, develop this new form of throat cancer annually. That's only a tenth of head-and-neck cases, but it's half as many people as get cervical cancer in the U.S. More worrisome, Gillison's work shows HPV tonsil cancer is increasing at a rate of [...]

Erbitux® may improve treatment of squamous cell carcinoma of the esophagus

Source: professional.cancerconsultants.com Author: staff Researchers from Germany have reported that Erbitux® (cetuximab) improves response rate, time to disease progression, and overall survival of patients with metastatic squamous cell carcinoma receiving Platinol® (cisplatin) and 5-FU. The details of this study appeared in the October 2009 issue of Annals of Oncology.[1] Esophageal cancer is relatively common and is very deadly. It 1998 there were approximately 12,300 new cases of esophageal cancer diagnosed in the United States and nearly 12,000 esophageal cancer deaths, making esophageal cancer one of the most deadly of all cancers. Most cancers of the upper two-thirds of the esophagus arise from squamous cells. Cancers of the lower esophagus most often arise from columnar epithelium and are adenocarcinomas. In the recent past, squamous cell cancers made up more than 80% of all esophageal cancers. Over the past two decades, there has been a dramatic increase in the incidence of adenocarcinomas, which now account for one-third to one-half of all esophageal cancers. However, squamous cell carcinoma of the esophagus remains a major problem and is difficult to treat when metastatic. Usual treatment for metastatic squamous cell carcinoma of the esophagus includes a platinum compound and 5-FU. Erbitux is a chimeric monoclonal antibody that binds to the outer domain of the epidermal growth factor receptor (EGFR). It is currently approved, in combination with radiation therapy, for the treatment of locally or regionally advanced head and neck cancer, or as a single agent in the treatment of advanced, EGFR-expressing head and neck cancer [...]

Lilly Erbitux cancer drug not worth price, U.S. scientists say

Source: www.bloomberg.com Author: Lisa Rapaport Eli Lilly & Co.’s tumor-fighter Erbitux doesn’t prolong lung cancer patients’ lives enough to justify its $80,000 cost, U.S. scientists said in commentary published today. Erbitux added to other cancer drugs extends survival about 1.2 months more than chemotherapy alone, making the price too high for a “marginal benefit,” commentary in the Journal of the National Cancer Institute said. Erbitux, which Lilly markets with Bristol-Myers Squibb Co., generated $1.3 billion last year as treatment approved for other malignancies. The high price of some of the newest cancer medicines are coming under scrutiny as part of an effort by lawmakers and health officials to rein in overall medical costs. President Barack Obama has set aside $1.1 billion in the U.S. economic stimulus bill to study the comparative effectiveness of treatments for cancer and other diseases. “We must avoid the temptation to tell a patient that a new drug is available if there is little evidence that it will work better than established drugs that could be offered at a miniscule fraction of the cost,” wrote the commentators, Tito Fojo with the National Cancer Institute and Christine Grady at the National Institutes of Health. Lilly, of Indianapolis, and marketing partner Bristol- Myers, of New York, withdrew an application to extend the Erbitux’s use to lung tumors in February after the Food and Drug Administration questioned differences in American and European versions of the treatment. $10,000 a Month The authors projected that Erbitux costs $80,000 based on a [...]

2009-09-27T11:35:34-07:00September, 2009|Oral Cancer News|

Initial COIN study results presented at European Oncology Congress

Source: Drugs.com Author: Staff • Results inconsistent with data from all Erbitux pivotal studies • Further analyses planned by the Medical Research Council that conducted the independent COIN study Berlin/Darmstadt, Germany, September 23, 2009 – The Medical Research Council (MRC), a UK-based, publicly-funded organization dedicated to improving human health, today presented the initial results of the independent Phase III COINa study, which did not meet its primary endpoint of overall survival (OS).1 These findings were presented today at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany. The COIN study was designed to evaluate whether the addition of Erbitux® (cetuximab) to one of two oxaliplatin-based chemotherapy regimens significantly improved outcomes in previously untreated metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors. The median OS was not statistically significant at 17.0 months in the Erbitux treatment arm compared to 17.9 months for the chemotherapy-alone group (hazard ratio [HR] 1.038; p=0.68).1 “Imbalances in the chemotherapy administered between the different study arms were reported previously in the interim safety analysis,” explained Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “Further analysis of the dose intensity and 2nd-line treatment, and other factors, such as the advanced disease of patients in the study, are ongoing to determine why the COIN results are not aligned with existing evidence from the other randomized, 1st-line studies, including the significant increase in overall survival achieved with the CRYSTAL study.” Results [...]

2009-09-24T16:48:29-07:00September, 2009|Oral Cancer News|

U.S. scientists say Lilly Erbitux cancer drug not worth price

Source: Bloomberg Author: Lisa Rapaport Eli Lilly & Co.’s tumor-fighter Erbitux doesn’t prolong lung cancer patients’ lives enough to justify its $80,000 cost, U.S. scientists said in commentary published today. Erbitux added to other cancer drugs extends survival about 1.2 months more than chemotherapy alone, making the price too high for a “marginal benefit,” commentary in the Journal of the National Cancer Institute said. Erbitux, which Lilly markets with Bristol-Myers Squibb Co., generated $1.3 billion last year as treatment approved for other malignancies. The high price of some of the newest cancer medicines are coming under scrutiny as part of an effort by lawmakers and health officials to rein in overall medical costs. President Barack Obama has set aside $1.1 billion in the U.S. economic stimulus bill to study the comparative effectiveness of treatments for cancer and other diseases. “We must avoid the temptation to tell a patient that a new drug is available if there is little evidence that it will work better than established drugs that could be offered at a miniscule fraction of the cost,” wrote the commentators, Tito Fojo with the National Cancer Institute and Christine Grady at the National Institutes of Health. Lilly, of Indianapolis, and marketing partner Bristol- Myers, of New York, withdrew an application to extend the Erbitux’s use to lung tumors in February after the Food and Drug Administration questioned differences in American and European versions of the treatment. $10,000 a Month The authors projected that Erbitux costs $80,000 based on a typical course of treatment for lung [...]

2009-06-30T16:01:21-07:00June, 2009|Oral Cancer News|

Use of Erbitux in head and neck cancer rejected by NICE

Source: Pharmafocus.com Author: Staff Erbitux has failed to win NICE approval for the treatment of head and neck cancer, due to doubts over its cost and clinical effectiveness compared to existing treatments. It was rejected under NICE's new scheme to make more end-of-life drugs available by extending the threshold at which they are considered cost-effective, making it an extra heavy blow for manufacturer Merck Serono. Chief executive Andrew Dillon defended NICE's decision, saying the alternative of approving the medicine for the health service was unviable. He added: "This would mean the NHS making significant funds available for a very expensive treatment which may or may not benefit individual patients. Those funds would not then be available for treating other conditions with greater and more certain benefits for other patients." Erbitux is a monoclonal antibody and one of a new class of cancer drugs which target genetic mutations that allow cancer cells to multiply, and are designed to bypass many of the unpleasant side-effects associated with traditional chemotherapy. Licensed also in colorectal cancer, in 2008 the drug made global sales of nearly $1.6 million in 2008, and is expected to reach sales of $3.4 million by 2014. In the latest appraisal, Erbitux was rejected as a treatment of recurrent and/or metastatic squamous cell cancer of the head and neck and NICE recommended against its use in combination with platinum-based chemotherapy in patients with this cancer. The appraisal committee were uncertain over the clinical effectiveness of the drug and the cost of [...]

2009-06-25T16:43:53-07:00June, 2009|Oral Cancer News|

Monoclonal Antibody Drugs for Cancer Treatment

Source: www.newswise.com Author: staff The strategy of using monoclonal antibodies for cancer treatment was first described in the late 1970s with the promise that they could be developed into therapies that were highly specific to cancer cells, killing them with few or no side effects. For several types of cancer, monoclonal antibodies have already offered this advantage to patients. For other cancer types, they have provided an additional therapeutic weapon, but with smaller benefits and sometimes new side effects. "The first efforts for monoclonal antibody cancer therapy were to find antibodies that would home in on tumors and bind to proteins on the surface of cancer cells," explained physician-scientist David A. Scheinberg. "We looked for unique proteins that were specific only to cancer cells. The idea was that the antibody would be used to stimulate an immune response in the body, which would kill the cancer cell." Dr. Scheinberg, who is Chair of Memorial Sloan-Kettering's Experimental Therapeutics Center and the Molecular Pharmacology and Chemistry Program within the Sloan-Kettering Institute, developed an antibody called M195, which targets a protein on leukemia cells, when working as a research fellow in collaboration with Memorial Sloan-Kettering immunologist Lloyd Old in the 1980s. This approach further evolved when researchers realized they could use the antibody as a carrier to deliver a radioactive isotope or a toxic drug directly to the cancer cell, where it would kill the cell while sparing nearby healthy tissue. Antibodies are proteins that help the immune system to identify foreign substances [...]

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