Category Archives: Genetic Therapy

ASCO Abstract 7503

Study reports first success of targeted therapy in most common genetic subtype of non-small cell lung cancer

Newswise BOSTONA novel compound has become the first targeted therapy to benefit patients with the most common genetic subtype of lung cancer, an international clinical trial led by scientists at Dana-Farber Cancer Institute and other institutions will report at the annual meeting of the American Society of Clinical Oncology (ASCO) June 1-5 in Chicago.

Pasi A. Jnne, MD, PhD, scientific co-director of Dana-Farbers Belfer Institute for Applied Cancer Science, will present the findings from the randomized phase II study (abstract 7503) on Monday, June 4, 3 p.m. CT, E Hall D2, McCormick Place.

A video commentary by Jnne on the findings is available, youtu.be/eqTFj0Gu5Bw.

The study involved 87 non-small cell lung cancer (NSCLC) patients whose tumors carry a mutation in the gene KRAS. Such tumors account for about 20 percent of NSCLC cases, but no targeted therapy has proved effective against them in previous clinical research. The drug under investigation, selumetinib, doesnt attack KRAS directly, but interferes with one of its molecular henchmen, a protein called MEK.

Participants in the study all had advanced stages of the disease. They received the standard chemotherapy agent docetaxel in combination with either selumetinib or a placebo.

By many measures the rate and duration of response to treatment, change in tumor size, and proportion of patients alive and showing no signs of advancing disease the group receiving selumetinib did significantly better than the other group. Most clinically significant were the improved rate of response to treatment (37 percent compared to 0 percent in the placebo arm) and prolonged progression-free survival (5.3 months compared to 2.1 months in the placebo arm). Although patients in the selumetinib group survived longer, on average, than those in the placebo group 9.4 months compared to 5.2 months the improvement was not considered statistically significant.

This clinical trial demonstrates that a combination of chemotherapy and selumetinib is significantly better than chemotherapy alone for this group of patients better in terms of tumor response to therapy and in terms of survival times prior to advance of the disease, says Jnne. It suggests that for the first time we may have an effective treatment for KRAS-mutant lung cancer, which is the largest single subtype of the disease. These impressive clinical findings not only have implications for the treatment of lung cancer but all cancers that harbor KRAS mutations, including pancreatic and colorectal cancer.

Some side effects, such as neutropenia (a white blood cell deficiency), loss of strength, acne, and respiratory problems were more common in the selumetinib group than the other, but the rate of patients dropping out of the study because of severe side effects was similar for both groups.

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First Success of Targeted Therapy in Most Common Genetic Subtype of Non-Small Cell Lung Cancer

Public release date: 31-May-2012 [ | E-mail | Share ]

Contact: Bill Schaller william_schaller@dfci.harvard.edu 617-632-4090 Dana-Farber Cancer Institute

BOSTONA novel compound has become the first targeted therapy to benefit patients with the most common genetic subtype of lung cancer, an international clinical trial led by scientists at Dana-Farber Cancer Institute and other institutions will report at the annual meeting of the American Society of Clinical Oncology (ASCO) June 1-5 in Chicago.

Pasi A. Jnne, MD, PhD, scientific co-director of Dana-Farber's Belfer Institute for Applied Cancer Science, will present the findings from the randomized phase II study (abstract 7503) on Monday, June 4, 3 p.m. CT, E Hall D2, McCormick Place.

The study involved 87 non-small cell lung cancer (NSCLC) patients whose tumors carry a mutation in the gene KRAS. Such tumors account for about 20 percent of NSCLC cases, but no targeted therapy has proved effective against them in previous clinical research. The drug under investigation, selumetinib, doesn't attack KRAS directly, but interferes with one of its molecular henchmen, a protein called MEK.

Participants in the study all had advanced stages of the disease. They received the standard chemotherapy agent docetaxel in combination with either selumetinib or a placebo.

By many measures the rate and duration of response to treatment, change in tumor size, and proportion of patients alive and showing no signs of advancing disease -- the group receiving selumetinib did significantly better than the other group. Most clinically significant were the improved rate of response to treatment (37 percent compared to 0 percent in the placebo arm) and prolonged progression-free survival (5.3 months compared to 2.1 months in the placebo arm). Although patients in the selumetinib group survived longer, on average, than those in the placebo group 9.4 months compared to 5.2 months the improvement was not considered statistically significant.

"This clinical trial demonstrates that a combination of chemotherapy and selumetinib is significantly better than chemotherapy alone for this group of patients better in terms of tumor response to therapy and in terms of survival times prior to advance of the disease," says Jnne. "It suggests that for the first time we may have an effective treatment for KRAS-mutant lung cancer, which is the largest single subtype of the disease. These impressive clinical findings not only have implications for the treatment of lung cancer but all cancers that harbor KRAS mutations, including pancreatic and colorectal cancer."

Some side effects, such as neutropenia (a white blood cell deficiency), loss of strength, acne, and respiratory problems were more common in the selumetinib group than the other, but the rate of patients dropping out of the study because of severe side effects was similar for both groups.

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Dana-Farber: Study reports first success of targeted therapy in type of non-small cell lung cancer

On the heels of a nearly $3 million verdict for a Portland-area couple whose baby was born with Down syndrome, another couple has filed a $6.25 million lawsuit claiming doctors conducting prenatal tests failed to detect a serious genetic disorder in their child.

The suit claims that medical staff at Oregon Health & Science University and Kaiser Permanente misinterpreted a January 2010 amniocentesis and other tests, leading them to tell North Portland residents Anna and Cory Miller that their future child likely wouldn't have major disabilities.

Based on that information, the Millers chose to continue the pregnancy, according to the suit filed Tuesday in Multnomah County Circuit Court. Their daughter was born on May 28, 2010, and days later they learned she had Charge syndrome, a condition that often includes heart defects, breathing problems, swallowing problems and hearing and vision impairments. It occurs in 1 in about 10,000 births, and can require months of hospitalization, repeated surgeries and years of developmental therapy and extra care.

Like in many so-called "wrongful birth" lawsuits, the Millers had to declare that they would have terminated the pregnancy had they known their daughter, now 2, would be born with major disabilities.

The suit seeks $2 million to pay for medical care, therapy, medication, educational expenses and the extra costs of raising a child with a disability; $3 million for their daughter's living, medical and therapy expenses once she becomes an adult; $250,000 for wages Anna Miller has lost and will lose in caring for their daughter; and $1 million for "the emotional distress, anxiety and depression experienced" by the Millers.

Representatives from OHSU and Kaiser Permanente said they could not comment because their organizations hadn't received copies of the complaint.

The suit was filed by Portland attorney David K. Miller, who isn't related to Anna or Cory Miller. David K. Miller declined to comment for this story.

Miller was the same attorney who represented Ariel and Deborah Levy during a 10-day trial that ended in March when a 12-member Multnomah County jury awarded the couple $2.9 million. The jury faulted Legacy Health doctors and genetic specialists for botching a prenatal test, known as a chorionic villus sampling, leading them to assure the Levys they'd have a healthy baby girl. They learned only after she was born in 2007 that she has Down syndrome.

The verdict made international headlines, and attracted hundreds of angry comments. Many who learned of the case were critical of the Levys for seeking compensation for raising a daughter with Down syndrome, while others praised them for fighting to provide for their daughter's developmental needs, including speech and physical therapy.

-- Aimee Green;

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Portland parents sue OHSU, Kaiser Permanente for $6.25 million; suit claims prenatal tests missed baby's genetic ...

29.05.2012 - (idw) Universittsklinikum Heidelberg

Clinical study demonstrates effectiveness of temozolomide in this age group for the first time / Genetic testing facilitates decision between chemotherapy and radiation Older patients over the age of 65 who have been diagnosed with a malignant brain tumor (glioma) benefit from a chemotherapy with the effective ingredient temozolomide as well as younger patients with this type of cancer. Genetic testing can demonstrate whether older patients will respond to the therapy. These were the results of a clinical study undertaken by a study group of the German Cancer Societys Neuro-Oncology Working Group (NOA), headed by Prof. Wolfgang Wick, Heidelberg University Hospital and German Cancer Research Center (DKFZ), and Prof. Michael Weller, University Hospital Zurich. The largest study on the treatment of older patients with malignant brain tumors to date has now been published online in the respected medical journal The Lancet Oncology.

Gliomas are especially aggressive tumors. The average survival time with standard therapy is only about a year, although it can also be much longer in individual cases. Nearly 50 % of the patients with gliomas are over the age of 65. In the past, these patients were usually excluded from clinical studies, because the more intensive treatment did not appear to be promising and was expected to produce severe side effects. As a result, older patients only underwent surgery and radiation.

Chemotherapy is as effective as radiotherapy

Today, many patients over the age of 65 do not have any additional illnesses that would speak against them undergoing chemotherapy, explained Prof. Wick, Medical Director of the Department of Neurooncology at Heidelberg University Hospital. For this reason, the NOA-08 study was initiated. Involving 23 German centers and one Swiss center, it investigated the effectiveness of chemotherapy in older patients with certain gliomas the glioblastoma and the anaplastic astrocytoma. As part of the study, the standard treatment, the removal of the tumor followed by radiotherapy, was compared with chemotherapy with temozolomide after surgery.

In addition, the scientists studied the tumor tissue for a specific genetic mutation, the methylation of the gene of the protein O6-methyl-guanyl-methyltransferase (MGMT), which indicates whether a patient will tend to benefit more from radiotherapy or from chemotherapy with temozolomide.

The results of the NOA-08 study show that after surgery, chemotherapy with temozolomide is as effective as radiotherapy, explained Prof. Weller, Director of the Department of Neurology at University Hospital Zurich. The study therefore points to a new option for treating older patients with malignant gliomas, namely chemotherapy with temozolomide without radiotherapy.

Genetic testing (biomarkers) can help predict the efficacy of chemotherapy

For the scientists, another finding is even more important: the MGMT genetic modification in the tumor can be used to predict the patients response to chemotherapy or radiotherapy. MGMT enhances the efficacy of certain chemotherapies such as temozolomide. Patients with inactive MGMT should therefore always be treated with chemotherapy, while patients with active MGMT should undergo radiotherapy. This means that for older patients as well, we have a biomarker that we can use to help make treatment decisions, Prof. Wick said.

Literature: Prof Wolfgang Wick, MD; Prof Michael Platten, MD; Christoph Meisner, PhD; Jrg Felsberg, MD; Ghazaleh Tabatabai, MD; Matthias Simon, MD; Prof Guido Nikkhah, MD; Kirsten Papsdorf, MD; Prof Joachim P Steinbach, MD; Michael Sabel, MD; Stephanie E Combs, MD; Jan Vesper, MD; Christian Braun, MD; Prof Jrgen Meixensberger, MD; Ralf Ketter, MD; Regine Mayer-Steinacker, MD; Prof Guido Reifenberger, MD; Prof Michael Weller, MD; for the NOA-08 Study Group of the Neuro-oncology Working Group (NOA) of the German Cancer Society. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomised, phase 3 trial. The Lancet Oncology. Published online before print May 9, 2012. dx.doi.org/10.1016/S1470-2045(12)70164-X

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Elderly patients with malignant brain tumors also benefit from chemotherapy

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