A recent study comparing the feasibility, efficacy, and safety of single-agent carboplatin vs carboplatin plus paclitaxel in older patients with ovarian cancer found that single-agent carboplatin is less active with significantly worse survival outcomes than every-3-weeks or weekly carboplatin–paclitaxel regimens (JAMA Oncol. 2021;e210696. doi:10.1001/jamaoncol.2021.0696).
“Single-agent carboplatin is often proposed instead of a conventional carboplatin–paclitaxel doublet in vulnerable older patients with ovarian cancer” wrote Claire Falandry, MD, The National Research Group for the Study of Ovarian and Breast Cancers and Lyon-Sud Hospital Center, France, and colleagues, adding, “Such an approach could have a detrimental effect on outcomes for these patients.”
This international study included 120 women, 70 years and older (mean and median age was 80) with newly diagnosed stage III/IV ovarian cancer, and a Geriatric Vulnerability Score of at least 3. Enrollment took place between December 11, 2013, and April, 2017 in France, Italy, Finland, Denmark, Sweden, and Canada, and data were analyzed between January 2 and May 2, 2019.
This open-label, 3-arm randomized clinical trial stratified participants by country and surgical outcome. Patients were split into 3 groups (40 patients per group), each completing 6 cycles of either carbo carboplatin, area under the curve (AUC) 5 mg/mL·min, plus paclitaxel, 175 mg/m2, every 3 weeks; single-agent carboplatin, AUC 5 mg/mL·min or AUC 6 mg/mL·min, every 3 weeks; or weekly carboplatin, AUC 2 mg/mL·min, plus paclitaxel, 60 mg/m2, on days 1, 8, and 15 every 4 weeks.
Of the participants, 36% had a Geriatric Vulnerability Score of 4, while 11% had a Geriatric Vulnerability Score of 5; 33% had stage IV disease.
The trial was terminated during its third meeting due to single-agent carboplatin’s association with significantly worse survival. Six cycles were completed in 65% of patients in the every-3-weeks combination group, 48% in the single-agent carboplatin group, and 60% in the weekly combination group.
The 3-week combination was associated with less treatment-related adverse events compared to single-agent carboplatin or weekly combination therapy (43% vs 58%). Four patients in each group had treatment-related deaths.
“This randomized clinical trial shows that compared with every-3-weeks or weekly carboplatin–paclitaxel regimens, single-agent carboplatin was less active with significantly worse survival outcomes in vulnerable older patients with ovarian cancer,” concluded Dr Falandry and colleagues.—Marta Rybczynski