ASCO 2018: SANDPIPER Trial Studies Novel Combination Therapy for Advanced Breast Cancer
Posted: Wednesday, June 6, 2018
Researchers of a phase III clinical trial revealed that women who received taselisib and fulvestrant had a 30% lower chance of having their breast cancer worsen than those who received fulvestrant and placebo. Data from the study were presented by José Baselga, MD, PhD, FASCO, of Memorial Sloan Kettering Cancer Center, New York, at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA1006). Taselisib targets the PIK3CA gene mutation and is the first treatment in a relatively new class of PI3K inhibitors, according to Dr. Baselga and colleagues.
The SANDPIPER trial enrolled 516 postmenopausal women with locally advanced or metastatic estrogen receptor–positive, HER2-negative metastatic breast cancer that worsened or recurred despite initial hormone therapy with aromatase inhibitors. Women were randomly assigned to receive fulvestrant and placebo (n = 176) or fulvestrant and taselisib (n = 340).
Of note, taselisib extended the time until the cancer worsened by a median of 2 months (7.4 months with taselisib/fulvestrant vs 5.4 months with fulvestrant/placebo). The response rate to treatment was more than doubled with the addition of taselisib (28% vs 11.9%). As for toxicity, the most common severe side effects reported in patients who received taselisib were diarrhea, hyperglycemia, and colitis.
“About 40% of all patients with advanced estrogen receptor–positive breast cancer have PIK3CA mutations, which means they could benefit from taselisib,” commented Dr. Baselga in an ASCO press release. “Our findings are proof that targeting this pathway in breast cancer is effective.”
