(Lung Cancer) Topotecan and Topotecan + Berzosertib Treatment Phase II Clinical Trial Results

(Lung Cancer) Topotecan and Topotecan + Berzosertib Treatment Phase II Clinical Trial Results

(Lung Cancer) Topotecan and Topotecan + Berzosertib Treatment Phase II Clinical Trial Results

• October 18, 2023
• Reading time: 2 minutes

Updated: June 16, 2025

On October 12, 2023, Nobuyuki Takahashi et al. from the National Cancer Center East Hospital published in the medical journal 'JAMA Oncology' the efficacy and safety comparison results of a Phase II clinical trial using Topotecan monotherapy and Topotecan + berzosertib combination therapy in patients with recurrent small cell lung cancer who had prior treatment experience.

This Phase II clinical trial randomized patients into two groups: the Topotecan group (21-day treatment cycle with Topotecan 1.25 mg/m² on days 1-5, continued until disease progression or intolerable adverse effects) and the Topotecan + berzosertib group (21-day treatment cycle with Topotecan 1.25 mg/m² on days 1-5 plus berzosertib 210 mg/m² on days 2 and 5, continued until disease progression or intolerable adverse effects). The primary endpoint was progression-free survival in the overall population, and secondary endpoints included overall survival.

The trial included 60 patients with the following baseline characteristics: median age 59 years (34-79 years), 55% male (N=33), 20 patients in the Topotecan group, and 40 patients in the Topotecan + berzosertib group.

At a median follow-up of 21.3 months, the results were as follows:

The median progression-free survival was 3.0 months in the Topotecan group and 3.9 months in the Topotecan + berzosertib group. There was no significant difference between the two groups. The median overall survival was 5.4 months in the Topotecan group and 8.9 months in the Topotecan + berzosertib group, showing a significant improvement.

The adverse events between the two groups were similar. Grade 3-4 thrombocytopenia occurred in 55% (N=11/20) in the Topotecan group and 50% (N=20/40) in the Topotecan + berzosertib group. Vomiting occurred in 45% (N=9/20) in the Topotecan group and 35% (N=14/40) in the Topotecan + berzosertib group.

The incidence of adverse events was similar between the two groups. Severe thrombocytopenia occurred in 55% (N=11/20) in the Topotecan monotherapy group and 50% (N=20/40) in the Topotecan + berzosertib combination group. Vomiting of all grades occurred in 45% (N=9/20) in the Topotecan monotherapy group and 35% (N=14/40) in the Topotecan + berzosertib combination group.

Based on the results of the Phase II clinical trial, Nobuyuki Takahashi et al. stated: "In patients with recurrent small cell lung cancer who had prior treatment experience, although there was no significant difference in progression-free survival between Topotecan monotherapy and Topotecan + berzosertib combination therapy, the Topotecan + berzosertib combination therapy showed an improvement trend in overall survival."

Data source: https://jamanetwork.com/journals/jamaoncology/article-abstract/2810382

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