Data on health-related quality of life (HRQOL) suggest alpelisib plus fulvestrant is a well-tolerated treatment option for patients with PIK3CA-mutated, advanced breast cancer, according to researchers. They reported their findings in the Journal of Clinical Oncology.1

The researchers found no “clinically meaningful differences” in HRQOL between patients who received alpelisib plus fulvestrant and those who received placebo plus fulvestrant in the phase 3 SOLAR-1 trial ( Identifier: NCT02437318).

The trial enrolled 341 patients with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative metastatic breast cancer. The patients were randomly assigned to receive alpelisib plus fulvestrant (n=169) or placebo plus fulvestrant (n=172).

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Prior results from SOLAR-1 showed superior progression-free survival (PFS) in the alpelisib arm.2 The median PFS was 11.0 months with alpelisib-fulvestrant and 5.7 months with placebo-fulvestrant (hazard ratio [HR], 0.65; P <.001).

In the current analysis, researchers assessed HRQOL using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients (EORTC QLQ-C30) and Brief Pain Inventory-Short Form (BPI-SF) questionnaires.

Over time, there was no overall change from baseline in global health status/quality of life (GHS/QOL) scores in the alpelisib arm (-3.50; 95% CI, -8.02-1.02) or the placebo arm (0.27; 95% CI, -4.48-5.02). The overall treatment effect in GHS/QOL was similar between the arms (-3.77; 95% CI, -8.35-0.80; P =.101).

EORTC QLQ-C30 functioning scale scores were similar between the treatment arms at baseline and over time, with one exception. There was a larger deterioration in social functioning in the alpelisib arm over time (treatment difference, 24.98; 95% CI, 28.86-21.09; P =.012).

There were no significant differences between the treatment arms in the time to 10% deterioration of physical functioning (HR, 0.86; 95% CI, 0.58-1.27), emotional functioning (HR, 0.92; 95% CI, 0.62-1.37), or social functioning (HR, 1.06; 95% CI, 0.70-1.61).

There were no differences in baseline EORTC QLQ-C30 symptom subscale scores between the treatment arms. However, patients in the alpelisib arm experienced worsening of some symptoms over time, including diarrhea, loss of appetite, nausea or vomiting, and fatigue. The declines in these symptom scores were consistent with the adverse events observed with alpelisib in clinical trials.

BPI-SF results showed numeric improvements in pain for patients in the alpelisib arm. At week 24, there was a higher numeric improvement (42% vs 32%) and lower numeric worsening (24% vs 35%) in “worst pain” for the alpelisib arm (P =.090). Similar changes were seen at week 8 and week 16.

“Data in this analysis demonstrated no clinically meaningful differences in HRQOL in the alpelisib plus fulvestrant arm versus the placebo plus fulvestrant arm,” the researchers wrote.

“[T]his analysis supports further consideration of alpelisib as a well-tolerated treatment option for this population. Clinical decision-making should include consideration of these results along with the statistically significant and clinically meaningful PFS observed with the addition of alpelisib to fulvestrant in patients with HR+, HER2-, PIK3CA-mutated ABC [advanced breast cancer].”

Disclosures: This research was supported by Novartis Pharmaceuticals Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


  1. Ciruelos EM, Rugo HS, Mayer IA, et al. Patient-reported outcomes in patients with PIK3CA-mutated hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer from SOLAR-1. J Clin Oncol. 2021;39(18):2005-2015. doi:10.1200/JCO.20.01139
  2. Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019;380:1929-1940. doi:10.1056/NEJMoa1813904