Adding Everolimus May Improve Progression-Free Survival in Advanced Breast Cancer

Share this content:
Addition of everolimus notably prolonged progression-free survival in the HR-negative, HER2-positive breast cancer population.
Addition of everolimus notably prolonged progression-free survival in the HR-negative, HER2-positive breast cancer population.

Although progression-free survival was not significantly different between everolimus or placebo in combination with trastuzumab plus paclitaxel, the addition of everolimus notably prolonged progression-free survival in the HR-negative, HER2-positive population, a new study published online ahead of print in the journal The Lancet Oncology has shown.

For the international, double-blind, controlled, phase III trial, researchers enrolled 719 patients with locally assessed HER2-positive advanced breast cancer who had not received previous treatment for advanced disease. 

Participants were randomly assigned 2:1 to receive everolimus once daily or placebo plus weekly trastuzumab and paclitaxel on days 1, 8, and 15 of each 28-day cycle.

Results showed that median progression-free survival was 14.95 months (95% CI: 14.55, 17.91) with everolimus compared with 14.49 months (95% CI: 12.29, 17.08) with placebo (HR = 0.89; 95% CI: 0.73, 1.08; P=0.1166).

Researchers found that in the HR=negative subpopulation, the addition of everolimus prolonged progression-free survival by 7.2 months (HR = 0.66; 95% CI: 0.48, 0.91; P=0.0049), but this was not statistically significant.

In regard to safety, the most common adverse events associated with everolimus use were stomatitis, diarrhea, and alopecia.

RELATED: Similar Patient-Reported Outcomes with Exemestane, Tamoxifen in Breast Cancer

The most frequently reported grade 3 or 4 adverse events with everolimus were neutropenia, stomatitis, anemia, and dirrhea. Four percent of patients in the everolimus group died as a result of a treatment-related adverse event compared with none in the placebo group.

The findings suggest that the addition of everolimus to paclitaxel and weekly trastuzumab should be studied further as first-line treatment for patients with HR-negative, HER2-positive advanced breast cancer.

Reference

  1. Hurvitz SA, Andre F, Jiang Z, et al. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. J Clin Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)00051-0.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters