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Docs support drug regulator’s move to withdraw Olaparib for some cancer patients

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New Delhi, May 23 (IANS) Oncologists on Thursday supported the Drug Controller General of India’s (DCGI) mandate to state authorities to withdraw AstraZeneca’s anticancer generic drug Olaparib over safety concerns.

Olaparib is a chemotherapy drug and is used to treat certain kinds of cancers of the ovaries, breasts, pancreas and the prostate.

In a letter dated May 16, Dr Rajeev Singh Raghuvanshi, DCGI, wrote to state drug regulators to discontinue marketing AstraZeneca’s Olaparib tablets (100mg and 150mg) sold as Lynparza, due to potential adverse effects on some patients who have received three or more prior lines of chemotherapy.

According to health experts, the drug led to a shorter survival rate in some cancer patients.

The DCGI move comes after clinical studies by AstraZeneca Pharma India also supported its withdrawal in specific cases.

“This decision of withdrawing the use of Olaparib as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy is justified,” Dr. Abhishek Shankar, Assistant Professor, Department of Radiation Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital at AIIMS, Delhi, told IANS.

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The oncologist noted that “patients who were taking Olaparib potentially had a shorter overall survival than patients not on Olaparib, particularly in the subgroup analysis of patients who had received three or more lines of chemotherapy.

“So its use for this indication was withdrawn by the US FDA on March 26, so this order will certainly restrict the use of a drug which is found to be not efficacious for this indication.”

Olaparib was first approved by DCGI in 2018 for patients with gBRCA mutations (breast cancer) and advanced ovarian cancer, especially those who have undergone multiple chemotherapy treatments.

Dr. Shyam Aggarwal, Chairman, Medical Oncology, Sir Ganga Ram Hospital, told IANS that Olaparib aided in “better ovary cancer control and long-term survival advantage” in patients with advanced ovarian cancer with BRCA mutation or HRD positive who have achieved “a response with chemotherapy in the first and second line of treatment”.

Now Olaparib’s use in third-line chemotherapy in metastatic ovary has been withdrawn.

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“Olaparib remains available for all other indications at the same price. Olaparib is also approved for BRCA mutant breast cancer in adjuvant and metastatic settings. The drug is also approved in BRCA mutant advanced prostate and pancreas cancer,” he added.

–IANS

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Avoiding long exposure to severe temperatures vital to save kids' developing brain: Experts

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New Delhi, June 16 (IANS) As exposure to extreme temperatures during early developmental stages can significantly impact neurodevelopment, specifically the integrity of white matter, experts on Sunday suggested that proper insulation, avoiding prolonged exposure to extreme temperatures, and educating parents and caregivers on recognising signs of heat and cold stress are essential measures to protect the developing brain of children.

According to Sreenivas U.M., Consultant — Neurology, MGM Hospital Chennai, heat exposure can lead to hyperthermia, disrupting normal cellular processes and causing neuronal injury, particularly in the developing brain, which has a high metabolic rate and is susceptible to heat-induced oxidative stress.

“Exposure to extreme temperatures during early developmental stages can significantly impact neurodevelopment, specifically the integrity of white matter. In the critical early years of life, the brain undergoes rapid growth, making it vulnerable to environmental stressors like extreme heat or cold, which can impair cognitive functions by damaging myelin,” Sreenivas U.M. told IANS.

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As per experts, young children are especially at risk due to their underdeveloped thermoregulatory mechanisms, which can lead to white matter injury.

“Temperature extremes can disrupt myelination, trigger inflammatory responses damaging myelin, and induce structural brain changes,” said Shivananda Pai, Consultant Neurology, KMC Hospital, B.R. Ambedkar Circle, Mangalore.

In a recent study by the Barcelona Institute for Global Health, which included 2,681 children, the researchers found that exposure to cold during pregnancy and the first year of life, and exposure to heat from birth until three years of age were associated with higher mean diffusivity at preadolescence, pointing to slower white matter maturation.

‘Cold’ and ‘heat’, in this case, was defined as those temperatures that are at the lower and upper end, respectively, of the temperature distribution in the study region.

According to the experts, brain development involves stages such as neurogenesis, migration, maturation, synaptogenesis, pruning, and myelination, with myelination being crucial for efficient nerve signal transmission.

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“This process, starting in the third trimester and continuing into middle age, can be disrupted by extreme temperatures, leading to physiological stress, neuro-inflammation, oxidative stress, cell death, and delayed myelination, all of which underscore the importance of maintaining an optimal thermal environment for healthy brain maturation and function,” said Amrut S.D., Associate Consultant – Neurology, Manipal Hospital, Goa.

–IANS

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Lucknow hospital surgically treats ‘suicide disease’

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Lucknow, June 16 (IANS) Balrampur Hospital in Lucknow has become the first district hospital to offer surgical treatment for Trigeminal Neuralgia, also known as the suicide disease (mainly because of the high-level pain that the patient suffers).

This achievement follows the successful operation of Ashok Kumar, 46, who was suffering from the condition. The patient had to spend merely Rs 400 for the surgery.

Bollywood star Salman Khan also had this disease. Trigeminal neuralgia affects about 10-12 out of 100,000 people and is more frequently found in women.

Ashok was experiencing severe pain on the right side of his face for six years. Despite using painkillers and undergoing treatments since the age of 40, he found no relief. Later, considering his financial constraints, some persons recommended him to visit Balrampur Hospital.

Ashok sought help from Dr Vinod Tiwari, a neurosurgeon at Balrampur Hospital. Dr Tiwari noted that Kumar’s right facial pain was triggered by minor activities such as wind, brushing his teeth, gargling, eating, drinking water, or a light touch on his right cheek, causing him hours of excruciating pain.

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“I told him if it is not cured by medicines, then surgery is the only solution,” said Dr Tiwari.

Further, MRI scan revealed that an artery was compressing the fifth nerve on the right side of Kumar’s brain, leading to unbearable pain. The medical team decided to perform surgery to relieve the compression and ease the patient’s suffering.

“I and my team at Balrampur Hospital decided to perform the surgery to remove the tumour and decompress the nerve,” Dr Tiwari explained.

The operation, which took over three hours under general anaesthesia, was successful. Ashok is currently recovering in ICU ward.

The patient can speak normally and is no longer experiencing pain, Dr Tiwari said.

Dr Pawan Kumar, Chief Superintendent at Balrampur Hospital, said: “Due to this disease, the patient is at risk of paralysis due to brain pressure.”

–IANS

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Protein that boosts body's immunity against cancer discovered

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New Delhi, June 15 (IANS) A team of researchers has discovered a protein which can also play a critical role in the immune system’s defence against cancer.

Researchers at the University of Turku in Finland found TIMP-1, a protein traditionally known to prevent damage to the body’s cells and tissues.

They discovered this protein also has a key role in the body’s immunity against cancer, a finding which can improve the effectiveness of current cancer treatments.

TIMP-1 protein is produced by dendritic cells, which are responsible for initiating immune responses and boosting the immune system’s ability to recognise and destroy cancer cells.

Researcher Carlos Rogerio Figueiredo from the University of Turku said for patients deficient in TIMP-1 expression, our discovery helps create rational therapeutic innovations.

Figueiredo added that the findings are also relevant for fighting infections by viruses and bacteria, as the process is part of a universal mechanism that fights microorganisms and cancer in a similar fashion.

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The study was published in the journal Genes & Immunity, which is part of the Nature Portfolio series.

The study used samples from the Finnish Auria Biobank for clinical-oriented discoveries, which were further validated with the latest biochemical and immunological tools to propose a new molecular view of how the body fights cancer.

–IANS

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How fasting can help immune system better fight cancer

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New Delhi, June 15 (IANS) Fasting has a myriad of benefits, and now, a team of researchers has claimed that it can even reprogramme the metabolism of natural killer cells, helping them to survive in the harsh environment in and around tumours while also improving their cancer-fighting ability

The new study in mice from researchers at Memorial Sloan Kettering Cancer Center (MSK) in New York revealed that fasting may help the body defend against cancer, starving cancer cells of the nutrients they need to grow.

“Tumours are very hungry. They take up essential nutrients, creating a hostile environment often rich in lipids that are detrimental to most immune cells,” according to immunologist Joseph Sun, the study’s senior author.

Fasting reprogrammes these natural killer cells (a type of white blood cell) to better survive in this suppressive environment, he said in a paper published in the journal Immunity.

For the study, mice with cancer were denied food for 24 hours twice a week, and then allowed to eat freely in between fasts.

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Just like humans, the mice saw a drop in their glucose levels and a rise in free fatty acids, which are lipids released by fat cells that can serve as an alternative energy source when other nutrients are not present, according to Rebecca Delconte, lead author of the study.

During each of these fasting cycles, natural killer cells learned to use these fatty acids as an alternative fuel source to glucose.

This optimised their anti-cancer response because the tumor microenvironment contains a high concentration of lipids, and now they were able to enter the tumour and survive better because of this metabolic training, the authors noted.

While more research is needed, the results suggest fasting could be a strategy to improve immune responses to make immunotherapy more effective.

–IANS

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Exercise in evening hours improves glucose regulation, finds study

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New Delhi, June 15 (IANS) For people at risk of developing insulin resistance or type 2 diabetes, here is some good news. Physical activity in the evening has been found to improve glucose regulation, especially in overweight and obese adults.

The results of the new study, published in the journal Obesity, showed that accumulating more moderate-to-vigorous physical activity in the evening — between 6 p.m. and 12 midnight — appears to have a positive effect on glucose regulation in men and women who are overweight or obese.

“Choosing the ideal time of day seems to be an emerging strategy to enhance the benefits of physical activity on glucose metabolism, especially for those with insulin resistance or at risk of developing type 2 diabetes,” the researchers note.

In addition, the benefits of physical activity are greater in people who have some form of impaired glucose metabolism, such as elevated levels of glucose or fasting insulin resistance, according to scientists from the University of Granada (UGR) in Spain.

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The results were similar for both men and women.

A total of 186 overweight or obese adults (50 per cent of whom were women) with an average age of 47 years took part in the study.

These participants wore an accelerometer and a continuous glucose monitor for 14 days in order to measure their physical activity and glucose levels 24 hours a day.

The results highlight the importance of considering the time of day when prescribing physical activity.

“This information may be crucial in improving the effectiveness of exercise interventions in these groups,” the authors noted.

It was previously unknown whether being more active at a particular time of day (morning, afternoon or evening) could maximise the cardio-metabolic benefits of physical activity.

–IANS

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