Clinical trial: Adding ribociclib to hormone therapy improves outcomes in patients with early breast cancer (25% reduction in recurrence)

Medical Xpress / U of Cali, LA / American Society of Clinical Oncology Annual Meeting ^ | June 2, 2023 | Dr. Dennis Slamon et al

[ConservativeMind]

Researchers found when ribociclib, a targeted therapy drug, is added to hormone therapy there are a significant invasive disease-free survival benefit in patients with early hormone-receptor (HR) positive/HER2 negative breast cancer.

Researchers found that patients who took the combination therapy had substantially longer invasive disease-free survival compared to those who were treated with the hormone therapy alone, regardless of whether the cancer has spread to the lymph nodes. The addition of the targeted therapy reduced the risk of recurrence by 25%.

"The results from the clinical trial have immediate implications for patients," said Slamon. "The findings show this combination is a treatment of choice for patients with stage 2 or stage 3 HR positive/HER2 negative breast cancer."

The clinical trial, called NATALEE, involved 5101 patients with stage 2 or stage 3 early HR positive/HER2 negative breast cancer. Invasive disease-free survival was the primary endpoint of the study.

The median duration on study follow-up was 34 months, with three-year and two-year duration of ribociclib completed by 20% and 57% patients respectively. Invasive disease-free survival was evaluated after 426 events.

At the time of this analysis, 189 people in the ribociclib group (7.4% of patients) experienced an invasive disease-free survival event, compared to 237 people in the hormone therapy alone group (9.3% of patients). The data showed a statistically significant improvement in the risk of invasive disease in favor of the combination arm.

The invasive disease-free survival rates at three years were 90.4%, compared to 87.1% for women who were treated with only hormone therapy.

Ribociclib at 400 mg had a favorable safety profile with no new signals.

"Overall, the combination therapy showed more favorable outcomes, significantly reducing the risk of the cancer returning," Slamon said. "These results should change how we evaluate and treat patients."

[ConservativeMind]

Ribociclib (Kisqali and Kryxana) is available today and it did not appear to cause much in the way of added problems.

It reduced the recurrence of cancer by 25%.

[ConservativeMind]

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