Chicago, Illinois—Carboplatin monotherapy demonstrated less activity and led to a significantly worsened survival than carboplatin plus paclitaxel in vulnerable, elderly patients with ovarian cancer, according to results from a study being presented at the 2019 ASCO Annual Meeting.

According to lead investigator Claire Falandry, MD, PhD, GINECO-Centre Hospitalier Lyon Sud, and colleagues, vulnerable, elderly patients with ovarian cancer have a Geriatric Vulnerability Score (GVS; which combines albumin, lymphocyte count, activities of daily living, instrumental activities of daily living, and Hospital Anxiety and Depression Scale scores) ≥3.

“For such pts [patients], Carboplatin…monotherapy or weekly Cb [carboplatin] plus paclitaxel…are often proposed as an alternative to Cb-Pa [carboplatin plus paclitaxel] given every 3 weeks,” they explained.

In the study by Dr Falandry et al, 120 patients aged ≥70 years with stage FIGO III/IV epithelial ovarian cancer were screened for a GVS ≥3 and randomized to 1 of 3 treatment arms; arm A (carboplatin AUC5-6 plus paclitaxel 175 mg/m²), arm B (carboplatin AUC5-6), or arm C (carboplatin AUC2 plus paclitaxel 60 mg/m²).

There were 40 patients designated to each treatment arm between December 2013 and April 2017, with characteristics well-balanced between arms A, B, and C; median age (79, 82, and 80 years, respectively), FIGO stage IV (32%, 37%, and 27%), and primary surgery (65%, 72%, and 70%).

The primary end point of the study was treatment feasibility (ie, the ability to complete 6 chemotherapy courses without disease progression or stopping therapy early due to unacceptable toxicity or death).

Per protocol, feasibility for arms A, B, and C is 65%, 47%, and 60%, respectively (P = .15). The main reasons why treatment was halted across all 3 arms were toxicity (A, 20%; B, 15%; C, 22.5%; P = .771) and disease progression (A, 7.5%; B, 30%; C, 2%; P = .004).

The median PFS rates were 12.5 months for arm A (95% CI, 10.3-15.3), 4.8 months for arm B (95% CI, 3.8-15.3), and 8.3 months for arm C (95% CI, 6.6-15.3; P <.001). The median OS rates were not reached (NR; 95% CI, 21 to NR), 7.4 (95% CI, 5.3 to NR), and 17.3 (10.8 to NR), respectively (P = .001).

Because survival in arm B was significantly worse than in arms A and C, and because the number of potential patients needed to determine a significant difference between both carboplatin–paclitaxel regimens (arms A and C) was out of reach, the IDMC recommended premature closure of the trial at a pre-planned intermediate analysis.

“Compared to 3-weekly and weekly Cb-Pa [carboplatin plus paclitaxel] regimens, Cb [carboplatin] single agent was reported to be less active with significant worse survival outcome in vulnerable elderly…[patients],” Dr Falandry et al said.

“In this population Cb-Pa [carboplatin plus paclitaxel] combination remains a standard,” they concluded.—Hina Khaliq

Falandry C, Savoye AM, Stefani L, et al. EWOC-1: A randomized trial to evaluate the feasibility of three different first-line chemotherapy regimens for vulnerable elderly women with ovarian cancer (OC): A GCIG-ENGOT-GINECO study. Presented at: the 2019 ASCO Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 5508.