3 risk factors for chemo-induced neuropathy
Low haemoglobin, older age and high BMI are possible risk factors for developing chemotherapy-induced peripheral neuropathy (CIPN), according to an Australian study.
The study of mostly women receiving paclitaxel or oxaliplatin chemotherapy for breast, colorectal and ovarian cancer found most patients (72.8%) reported some neuropathy symptoms.
On multivariate analysis, low haemoglobin, older age and high BMI were the three factors associated with more severe CIPN after both types of chemotherapy.
While the mechanisms underlying CIPN development were not known and might be different with each risk factor, the study said the risk factors were at least easily and routinely available.
“Closer monitoring of those at higher risk in order to allow dose modification may mitigate the development of long-term CIPN among patients receiving paclitaxel or oxaliplatin,” the study concluded.
Can nabiximols improve outcomes in brain tumours?
Experts advise caution despite promising results from a phase 1b study showing improved survival in patients using nabiximols spray for glioblastoma.
A randomised controlled study in 21 patients found 33.3% of patients in the nabiximols group and 33.3% of controls were progression free at six-months. At one year, 83.3% of patients taking nabiximols were alive compared to 44.4% patients taking placebo.
Although the trial was not statistically powered for overall survival, the difference in 1-year survival rate favouring nabiximols was statistically significant (p = 0.042).
The primary focus of the study was the tolerability and safety outcomes. Rates of treatment-emergent adverse effects were similar with both nabiximols (16.7%) and placebo (22.2%) with vomiting, dizziness, nausea and fatigue the most frequently observed.
The study also found no evidence of an effect of nabiximols on the pharmacokinetics of temozolomide.
While the researchers said there was a growing body of preclinical research supporting the antitumour activity of cannabinoids, their findings on efficacy were limited by the small sample size and potentially confounding factors.
Read the research and an editorial in Nature.
Narrow margin of success for oncology drug trials
The difference between success and failure for many oncology drug clinical trials could boil down to just a handful of events, a new study shows.
A review of 81 trials used to support FDA approval of drugs for solid tumours found that in one third of studies the statistical significance would have been reversed by just 20 additional events.
The validity of many cancer drug clinical trial results was also put in doubt when it was found that their ‘fragility index’ was lower than the number of patients lost to follow up or withdrawing consent, said study authors, who included Dr Brooke Wilson of the University of NSW.
“Post-approval randomised trials or real-world data analyses should be performed to ensure that effects observed in registration trials are robust,” they suggested.
Their analysis covered drug trials for lung, breast, prostate, and colon cancers conducted between 2009 and 2019.