Adding Nubeqa (darolutamide) to docetaxel and androgen deprivation therapy (ADT) lowered hospitalization rates for metastatic hormone-sensitive prostate cancer but may marginally increase a patient’s length of stay versus placebo, recent study results demonstrated.
Findings from the study, which were presented at the 2024 ASCO Genitourinary Cancers Symposium, also demonstrated that a lower rate of hospitalization was observed after treatment with docetaxel as compared with during docetaxel treatment.
Study highlights:
- Adding Nubeqa (darolutamide) to the treatment for metastatic hormone-sensitive prostate cancer, including docetaxel and androgen deprivation therapy, has shown to lower hospitalization rates.
- Treatment with docetaxel alone may lead to an increased number of hospitalizations, but for those hospitalized during docetaxel treatment, the length of stay is similar to those hospitalized post-docetaxel use.
- During the first four months of treatment, when patients received docetaxel, there was an increased hospitalization for various reasons. However, treatment with Nubeqa was associated with a numerical reduction in hospitalization rates compared to the placebo.
- While Nubeqa demonstrated a marginal increase in the length of hospital stay per hospitalization compared to the placebo, the study suggests that docetaxel itself does not lead to more severe hospitalizations requiring a longer stay.
“Treatment with docetaxel may be linked to an increased number of hospitalizations (approximately 2.4 times greater hospitalization rate),” the researchers wrote in the poster. “However, for those hospitalized during treatment with docetaxel, their (length of stay) is shown to be similar in length to those who are hospitalized post-docetaxel use.”
The first four months of treatment, during which patients received docetaxel, were associated with increased hospitalization for any cause and for adverse events. Treatment with Nubeqa was linked with a numerical reduction in hospitalization rates per year for any reason during docetaxel administration (0.75 days) versus placebo (0.91 days). This was also observed after docetaxel (0.31 days) compared with placebo (0.38 days). Researchers observed a similar trend for adverse event-related hospitalizations.
Regression models estimated that the all-cause hospitalization rate was 2.39-times greater within the first four months of treatment compared with after treatment. These models resulted in similar results for adverse event-related hospitalizations (1.89 times greater).
Compared with placebo, Nubeqa was associated with a marginally longer length of stay per hospitalization (+1.9 days). Results were similar when assessing the length of stay related to adverse events (+1.67 days).
“Our analyses indicate (length of stay) was not found to vary during and post-treatment with docetaxel in ARASENS, which suggests that if the increased hospitalization rate during docetaxel treatment was attributed to docetaxel use, docetaxel does not lead to more severe hospitalizations requiring a longer (length of stay),” the researchers wrote in the poster.
Researchers used data from the ARASENS trial to compare rates of hospitalizations and length of hospital stay per patient either for any reason or related to adverse events during or after treatment with docetaxel.
“We wanted to understand whether the addition of (Nubeqa) to docetaxel and ADT impacts the hospitalization rate and (length of stay) during and post-treatment with docetaxel,” the researchers wrote. “We also wanted to understand whether hospitalization rates and the length of hospital stay differ during treatment with docetaxel compared to post-treatment with docetaxel.”
The objective of the ARASENS trial was to assess the addition of Nubeqa to docetaxel and ADT for patients with metastatic hormone-sensitive prostate cancer. This particular study assessed data from 651 patients randomly assigned to darolutamide, docetaxel, and ADT and 654 patients assigned to placebo, docetaxel and ADT.
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