Many Cancer Drugs Still Lack Scientific Evidence Proving They Save Lives

According to new research, many new cancer drugs on the market still lack scientific evidence proving they increase life expectancy or improve the quality of life for patients

In a study (pdf) published Aug. 15, a team of researchers from the University of Gothenburg in Sweden looked at the scientific evidence surrounding 22 new cancer drugs approved in the country between 2010 and 2020.

On average, the scientific evidence examined the drugs for 6.6 years.

They found that many medications received rapid approval before scientists had a chance to conduct long-term tests to understand how the drugs impact the lives of cancer patients.

A total of 7 out of the 22 drugs had at least one study that clearly showed the treatment either improved quality of life or increased life expectancy, according to researchers.

The remaining 15 drugs either lacked randomized controlled trial data or showed no statistically significant improvements in life expectancy or quality of life, the researchers said.

Only one of the drugs demonstrated evidence that it improved the quality of life and extended lifespans for patients, according to researchers.

“A considerable share of reimbursed cancer drug indications continue to lack evidence of improvement in both OS (overall survival) and QoL (quality-of-life),” the researchers wrote. “With limited healthcare resources and an increasing cancer burden, third-party payers have strong incentives to require additional post-reimbursement data to confirm any improvements in OS and QoL.”

Cancer Drug Costs Soar

Researchers noted the cost of cancer drugs tripled in Europe between 2005 and 2018, with cancer drug expenditures amounting to €32 billion ($34.85 billion) in 2018; making up a third of the total direct healthcare costs of cancer.

Larger increases in the cost of such drugs have been seen in the United States, where the average annual cost of new cancer drugs rose by 53 percent between 2017 and 2021, according to a 2022 study published in the peer-reviewed general medical journal, The Lancet.

The findings, according to researchers at the University of Gothenburg, raise questions not only about the effectiveness of various treatments for patients with cancer but also about the drug’s value for money.

“Considering the high costs of cancer drugs, the lack of subsequent data fulfilling the assumptions of improvement in outcomes is troubling, implying substantial uncertainty in the economic evaluations of a considerable share of reimbursed cancer drugs,” they wrote.

The researchers further noted that future research is needed on the justification and rationale of methods used to assess quality-of-life in cancer drug trials.

“Our results suggest a need to discuss the requirements informing reimbursement approvals and continue monitoring reimbursed cancer drugs,” they wrote.

“We have shown that the majority of the drugs launched with limited evidence still lack clear evidence of how they actually affect survival and quality of life in patients,” said Gabriella Chauca Strand, a doctoral student at Sahlgrenska Academy at the University of Gothenburg, and the lead author of the study, in a press release.

Lack of Evidence Is ‘Problematic’

“The lack of confirmatory evidence for important patient outcomes is problematic and creates uncertainty about how these drugs actually contribute to meaningful patient benefit, and ultimately how effectively resources are being used within healthcare,” Ms. Strand added.

The latest study findings come as a separate government-funded study found certain kinds of cancers are being diagnosed at a higher incidence rate among young Americans, particularly among women.

For that study, published on Aug. 16 in JAMA Network Open, researchers analyzed data from 562,145 patients in the United States diagnosed between 2010 and 2019 with early-onset cancer, which is defined as cancers that affected people younger than 50.

They found that overall, early-onset cancer diagnoses rose by nearly 1 percent during the study period, rising from 56,051 patients in 2010 to 56,468 patients in 2019.

The trend was most pronounced among those aged 30 to 39, with an increase of 19 percent, according to researchers.

Among women, there was a 4.4 percent increase in early-onset cases, while men saw a five percent decline.

Breast, Gastrointestinal Cancer Cases Rising

However, cancer rates in patients aged 50 years and older decreased between 2010 and 2019, the researchers found.

Although breast cancer had the highest number of incident cases in 2019, gastrointestinal cancers had the fastest-growing incidence rates among all early-onset cancers, according to researchers.

Researchers believe the increase in early-onset cancers is likely associated with the increasing incidence of obesity, as well as “changes in environmental exposures, such as smoke and gasoline, sleep patterns, physical activity, microbiota and transient exposure to carcinogenic compounds.”

They further stressed the importance of informing healthcare professionals about the increasing incidence of early-onset cancer and the need for investigating potential tumors when clinically appropriate, even in patients younger than 50 years.

“These data will be useful for public health specialists and health care policymakers and serve as a call to action for further research into the various environmental factors that may be associated with this concerning pattern,” they concluded.

An estimated one million new cancer cases were diagnosed in 2022 in the United States, according to the American Cancer Society.

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Comments (1)

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    Tom

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    Most drugs, vaccines and all mRNA substances lack any evidence that they are safe and effective.

    Reply

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