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Adverse events more common in new cancer drugs
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Newly approved cancer drugs increase morbidity and treatment-related mortality, according to results of a meta-analysis.
In the past 20 years, the FDA has approved approximately 150 drugs for cancer treatment. Most drug approvals for advanced cancer depend on improvements in efficacy in phase 3 randomized clinical trials. Despite these improvements, data regarding toxicity in trials often are limited, according to background information on the study.
Researchers analyzed the toxicities of newly approved anticancer drugs reported in randomized clinical trials used for drug registration.
Saroj Niraula, MD, clinical research fellow for the division of medical oncology and hematology at Princess Margaret Hospital in Toronto, and colleagues identified anticancer drug approvals for the treatment of advanced or metastatic solid malignancies in adults on the FDA website from 2000 to 2010.
Niraula and colleagues accessed data related to systematic treatment, treatment discontinuation related to adverse events, and grade-3 or grade-4 adverse events occurrence.
The researchers identified and analyzed 38 randomized clinical trials approved for treatment of cancer.
The odds of toxic death were greater for new drugs compared with control groups (OR=1.40; 95% CI, 1.15-1.70), according to results.
The odds of treatment discontinuation were higher with the use of new agents compared with controls (OR=1.33; 95% CI, 1.22-1.45).
Adverse events increased in the 13 studies that provided data on patients with at least one grade-3 or grade-4 adverse event (OR=1.52; 95% CI, 1.35-1.71), the study findings indicated. Nine reports indicated significant increases in diarrhea, skin reactions and neuropathy.
There were no significant correlations between safety endpoints and OS or PFS, according to the researchers’ findings.
“The balance between efficacy and toxicity may be less favorable in clinical practice because of selection of fewer patients with good performance status and limited comorbidities,” Niraula and colleagues concluded. Patients’ baseline health characteristics should be considered when choosing therapy.”
Although efficacy improvement is important for approval of a new drug by registration agencies, the researchers recommended clinicians weigh those improvements against toxicities leading to morbidity and mortality.
“Biomarkers associated with toxicity should also be explored in future clinical trials in addition to those associated with efficacy,” the researchers wrote.
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