Tag Archives: lung cancer

Vaccines not linked to menstrual changes; COVID, flu shots can go together

By Nancy Lapid

(Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

No link seen between vaccines and menstrual changes

Many women have reported noticing changes in their menstrual cycle after being vaccinated against COVID-19 but a new study of 1,273 women in the UK found no correlation, according to a report posted on Monday on medRxiv ahead of peer review. The women in the study kept careful records of their cycles and their vaccination dates. “We were unable to detect strong signals to support the idea” that COVID-19 vaccines are linked to changes in timing or flow of women’s periods, said Victoria Male from Imperial College London. It is possible that larger studies, or studies in other countries, might find links, she said. “It is important to note that most people who report such a change following vaccination find that their period returns to normal the following cycle.” Other studies have found no evidence that the vaccines affect female fertility, Male added.

Safe to get COVID-19 vaccine, flu shot together

It is safe to administer COVID-19 vaccines and flu vaccines to patients at the same time, and doing so might increase vaccination rates, according to a report published on Thursday in The Lancet. Researchers randomly assigned 697 adult volunteers to receive their second dose of either the mRNA vaccine from Pfizer/BioNTech or the viral-vector vaccine from AstraZeneca/Oxford, along with one of three influenza vaccines for the 2020-2021 season (FluAd or Flucelvax from Seqirus UK or Flublok from Sanofi) or a placebo. Most reactions to the shots were mild or moderate, and antibody responses to the vaccines were not adversely affected by getting two shots at once, the study found. Giving both vaccines at a single appointment “should reduce the burden on health-care services for vaccine delivery, allowing for timely vaccine administration and protection from COVID-19 and influenza for those in need,” the research team concluded.

Lung cancer patients respond well to COVID-19 vaccines

Lung cancer patients may get good protection from mRNA COVID-19 vaccines even while undergoing treatments that suppress the immune system, a small study suggests. From January through July this year, researchers in France administered the vaccine from Pfizer/BioNTech to 306 lung cancer patients, 70% of whom had recently received immunosuppressive therapies that impair the body’s ability to respond to vaccines. Patients with COVID-19 antibodies from a previous infection received only one dose; most patients, however, received both doses, according to a paper released on Monday and scheduled for publication in the Journal of Thoracic Oncology. About 10% of the patients failed to develop antibodies in response to the first two doses and received a third dose, which successfully induced antibodies in all but three individuals who also had blood disorders known to impair the effect of the vaccines. The researchers noted that before vaccines, the death rate among lung cancer patients who developed COVID-19 was 30%. In this seven-month study, only eight patients, or 2.6% of the total, developed mild cases of COVID-19. Because the study was small and not randomized, the investigators called for more research to confirm their findings.

(Reporting by Nancy Lapid; Editing by Tiffany Wu)

FDA approves Amgen drug for lung cancer with specific mutation

By Deena Beasley

(Reuters) -The U.S. Food and Drug Administration on Friday approved an Amgen Inc drug for lung cancer patients with a specific mutation in a gene known as KRAS whose disease has worsened after treatment with chemotherapy or other medicines.

The drug, sotorasib, which will be sold under the brand name Lumakras, shrank tumors with the KRAS mutation in around 36% of patients in clinical trials.

The medication is designed to target a gene mutation known as KRAS G12C that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.

Amgen estimates that around 25,000 U.S. patients a year will be eligible for the drug. The KRAS mutation is also found in 1% to 3% of colorectal and other cancers.

Lumakras is part of a growing trend of precision medicines that target gene mutations driving cancer regardless of which organ the disease originated.

“Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a statement.

Amgen said the drug will have U.S. list price of $17,900 per month. Wall Street analysts, on average, expect 2022 sales of $240 million, according to Refinitiv data.

Shares of Amgen were up $3, or 1.3%, at $238.35 in late trading on Nasdaq.

The approval, which comes more than two months before the FDA’s target decision date, is for a daily 960 milligram pill.

The agency is also requiring Amgen to conduct a post-approval study to see if a lower dose could be effective.

Cancer drugs are typically developed at the highest tolerable dose, but some oncologists have urged the FDA to do more to require drugmakers to optimize dosing.

“Our sense is this is going to become more common in oncology,” Amgen research chief David Reese told Reuters in a phone interview.

He said Amgen is studying Lumakras in combination with other drugs as an initial treatment for NSCLC patients who have the KRAS mutation, as well as for other types of cancer.

Amgen is also seeking regulatory approval of the drug in Europe, Japan and several other jurisdictions, he said.

Other companies, including Mirati Therapeutics Inc, are also developing cancer drugs targeting KRAS mutations.

(Reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot and Marguerita Choy)

Researchers find elevated radiation near U.S. fracking sites

(Reuters) – Radiation levels downwind of U.S. hydraulic fracturing drilling sites tend to be significantly higher than background levels, posing a potential health risk to nearby residents, according to a study by Harvard researchers released on Tuesday.

The study, published in the journal Nature, adds to controversy over the drilling method known as fracking, which has helped the United States become the world’s biggest oil and gas producer over the past decade but which environmentalists say threatens water and air.

President Donald Trump supports fracking because of its economic benefits, and his Democratic rival Joe Biden has promised to continue to allow it if elected even though he aims to impose an ambitious plan to fight climate change.

Areas within 20 kilometers (12 miles) downwind of 100 fracking wells tend to have radiation levels that are about 7% above normal background levels, according to the study, which examined thousands of the U.S. Environmental Protection Agency’s radiation monitor readings nationwide from 2011 to 2017.

The study showed readings can go much higher in areas closer to drill sites, or in areas with higher concentrations of drill sites.

“The increases are not extremely dangerous, but could raise certain health risks to people living nearby,” said the study’s lead author, Petros Koutrakis.

Radioactive particles can be inhaled and increase the risk of lung cancer.

Koutrakis said the source of the radiation is likely naturally-occurring radioactive material brought up to the surface in drilling waste fluids during fracking, a process that pumps water underground to break up shale formations.

The study found the biggest increases in radiation levels near drill sites in states like Pennsylvania and Ohio that have higher concentrations of naturally occurring radioactive material beneath the surface, and lower readings in places like Texas and New Mexico that have less.

It also found less pronounced increases in particle radiation levels near conventional drilling operations.

Koutrakis said further study was needed to determine whether the radiation was being released during the drilling process, or from wastewater storage nearby.

“Our hope is that once we understand the source more clearly, there will be engineering methods to control this,” he said.

(Reporting by Richard Valdmanis; Editing by Marguerita Choy)