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The ACE trial: A randomized phase II study for advanced endometrial carcinoma

Cancer Sci. 2022 Feb 26. doi: 10.1111/cas.15310. Online ahead of print.

ABSTRACT

This study evaluated the feasibility and efficacy of three postoperative adjuvant chemotherapy regimens for endometrial cancer. Endometrioid cancer patients with intermediate-risk stage I and II or high-risk stage III and IV disease were randomly assigned to receive six cycles of either Paclitaxel-Epirubicin-Carboplatin (TEC), Paclitaxel-Anthracycline (Doxorubicin)-Carboplatin (TAC), or dose-dense paclitaxel-carboplatin (ddTC). The primary endpoint was the completion rate (CRate) of six cycles of treatment. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). One hundred and one patients were treated as follows: 33 received TEC, 33 TAC, and 35 ddTC. The CRates for TEC, TAC and ddTC were 94%, 64% and 69%, respectively (p=0.005). The TEC CRate was significantly higher than for the other two groups. However, the PFS and OS outcomes were not statistically different between the three groups. The two-year survival rates were 94%, 97%, and 97% for TEC, TAC, and ddTC, respectively. When compared to the current standard treatments for endometrial cancer, TEC is a promising candidate for a phase III trial based on its significantly superior CRate and equivalent PFS and OS. This study is registered with UMIN Clinical Trials Registry (UMIN000008911).

PMID:35218673 | DOI:10.1111/cas.15310

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