Buparlisib + Paclitaxel May Be Effective for Advanced HSNCC

Share this content:
The addition of buparlisib to second-line paclitaxel improved progression-free survival in head and neck.
The addition of buparlisib to second-line paclitaxel improved progression-free survival in head and neck.

The addition of buparlisib to second-line paclitaxel improved progression-free survival compared with paclitaxel alone among patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC), according to a study published in The Lancet Oncology.1

Previous studies demonstrated that phosphatidylinositol 3-kinase (PI3K) pathway activation plays a role in treatment resistance and disease progression in HSNCC. The pan-PI3K inhibitor, buparlisib, exhibited antitumor activity in preclinical models and resulted in objective responses among patients with epithelial malignancies.

For this study, investigators evaluated whether adding buparlisib to paclitaxel improves clinical outcomes vs paclitaxel and placebo among patients with recurrent or metastatic HSNCC.

For the multicenter, double-blind, phase 2 BERIL-1 trial (ClinicalTrials.gov Identifier: NCT01852292), investigators enrolled 158 patients with histologically or cytologically confirmed recurrent and metastatic HSNCC who experienced disease progression on or after 1 previous platinum-based chemotherapy regimen.

Treatment with buparlisib significantly reduced the risk of progression or death by 35% compared with paclitaxel alone (hazard ratio, 0.65; 95% CI, 0.45-0.95; P = .011). Median progression-free survival was 4.6 months (95% CI, 3.5-5.3) in the combination arm vs 3.5 months (95% CI, 2.2-3.7) in the placebo arm.

The most frequent grade 3 to 4 adverse events in the buparlisib group were hyperglycemia, anemia, neutropenia, and fatigue. Fifty-seven percent of patients in the buparlisib arm reported serious adverse events compared with 47% in the placebo arm. No deaths were considered treatment-related.

RELATED: Nivolumab Plus Lirilumab Shows Encouraging Activity in Advanced HNSCC

The findings suggest that buparlisib plus paclitaxel could be an effective strategy for the second-line treatment of patients with platinum-pretreated recurrent or metastatic HNSCC. Phase 3 clinical trials are warranted to confirm the results of this study.

Reference

  1. Soulieres D, Faivre S, Mesia R, et al. Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Oncol. 2017 Jan 25. doi: 10.1016/S1470-2045(17)30064-5 [Epub ahead of print]

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