Single-agent carboplatin produced inferior survival outcomes, compared with carboplatin plus paclitaxel, in vulnerable older patients with newly diagnosed, stage III/IV ovarian cancer, according to a study published in JAMA Oncology.
The study authors noted that the current standard first-line chemotherapy regimen for advanced ovarian cancer is carboplatin plus paclitaxel, given every 3 weeks. Older or vulnerable patients commonly receive single-agent carboplatin instead, but this approach has yielded conflicting results.
In the phase 2 GINECO/GCIG trial (ClinicalTrials.gov Identifier: NCT02001272), researchers compared results with single-agent carboplatin, carboplatin plus paclitaxel given every 3 weeks, and carboplatin plus paclitaxel given weekly.
The study included 120 patients with newly diagnosed, stage III/IV ovarian cancer who had a Geriatric Vulnerability Score of 3 or higher. The patients’ median age was 80 years (range, 70-94 years).
Patients were assigned 1:1:1 to the 3 treatment arms. The proportion of patients completing 6 treatment cycles was lowest in the single-agent carboplatin arm (48%), compared with the every-3-weeks carboplatin-paclitaxel arm (65%) or the weekly carboplatin-paclitaxel arm (60%).
Patients who received single-agent carboplatin had the worst progression-free survival (PFS). The median PFS was 4.8 months with single-agent carboplatin, 12.5 months with carboplatin-paclitaxel every 3 weeks, and 8.3 months with weekly carboplatin-paclitaxel.
The hazard ratio for PFS when comparing single-agent carboplatin and carboplatin-paclitaxel every 3 weeks was 2.51 (95% CI, 1.56-4.04; Wald test P <.001).
A similar trend was seen for overall survival (OS). The median OS was 7.4 months with single-agent carboplatin, not reached with carboplatin-paclitaxel given every 3 weeks, and 17.3 months with weekly carboplatin-paclitaxel.
The hazard ratio for OS when comparing single-agent carboplatin and carboplatin-paclitaxel every 3 weeks was 2.79 (95% CI, 1.57-4.96; Wald test P <.001).
Treatment-related adverse events were seen less frequently among the patients who received the standard every-3-weeks combination (43%), compared with the patients who received single-agent carboplatin (58%) or weekly combination therapy (58%).
There were 4 treatment-related deaths (5%) in each combination treatment group.
Based on the recommendation of an independent data monitoring committee, the trial was terminated due to the significantly worse survival outcomes associated with single-agent carboplatin.
“Despite relatively high toxic effects, a conventional doublet regimen should be offered to all older adult patients with ovarian cancer, irrespective of vulnerability,” the study authors wrote. “Management of vulnerable older patients with ovarian cancer should include, from cancer diagnosis, a personalized plan for oncogeriatric care, including both oncologic and geriatric treatment plans.”
Disclosures: This research was supported by the French National Cancer Institute and the Nordic Cancer Union. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Falandry, C, Rousseau F, Mouret-Reynier M-A, et al. Efficacy and safety of first-line single-agent carboplatin vs carboplatin plus paclitaxel for vulnerable older adult women with ovarian cancer: a GINECO/GCIG randomized clinical trial. JAMA Oncol. 2021;7(6):853-861. doi:10.1001/jamaoncol.2021.0696