In an online paper in JAMA Oncology, Dr. Claire Falandry of Centre Hospitalier Lyon Sud, in France, and colleagues note that the significantly worse progression-free and overall survival outcomes with monotherapy led to premature termination of the trial.
Initially, based on indications that frailty may help in selecting patients appropriate for less aggressive chemotherapy regimens, the team enrolled 120 women with a median age of 80 years and a Geriatric Vulnerability Score of 3 or more. They were randomized to treatment with single-agent carboplatin or either conventional every-three-weeks or weekly carboplatin-paclitaxel doublets.
Median progression-free survival was 12.5 months in the conventional doublet arm, 8.3 months with weekly carboplatin-paclitaxel and 4.8 months with carboplatin alone.
At the time the trial was halted, six cycles had been completed in 48% of the single-agent carboplatin group, 65% of the every-three-weeks doublet group and 60% of the weekly doublet group. The proportion of patients discontinuing treatment for toxic effects before cycle 6 was similar across groups.
There were treatment-related deaths in three patients (5%) in each of the combination groups, but treatment-related adverse events were less common with the standard every-three-weeks combination (43%) than in the single-agent carboplatin and weekly combination therapy groups (58% in both).
"Contrary to the current practice of considering single-agent carboplatin in frail patients," the researchers conclude, "these results suggest that even vulnerable older women with newly diagnosed ovarian cancer should be offered carboplatin-paclitaxel combination therapy."
In an accompanying editorial, Dr. Deborah K. Armstrong and colleagues at Johns Hopkins School of Medicine, in Baltimore, Maryland, observe that methodological issues aside, the study challenges "the conventional wisdom that patients who are both older in age and more vulnerable do not tolerate standard combination chemotherapy for ovarian cancer. Not only is conventional doublet therapy feasible, but it is associated with improved outcomes."
Dr. Armstrong did not respond to requests for comments.
SOURCE: https://bit.ly/3dSzOVh and https://bit.ly/3nrEbK7 JAMA Oncology, online April 22, 2021.
By Reuters Staff
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