medwireNews: Supplementing fulvestrant with alpelisib does not adversely affect the health-related quality of life (HRQoL) of patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, advanced breast cancer, indicate SOLAR-1 trial findings.
“Clinical decision making should include consideration of these results along with the statistically significant and clinically meaningful [progression-free survival] observed with the addition of alpelisib to fulvestrant” in this patient population, writes the research team.
In the phase 3 study, 391 patients who had progressed during or after aromatase inhibitor-based therapy were randomly assigned to receive either the α-selective PI3K inhibitor alpelisib at a daily dose of 300 mg or placebo, where both were given alongside fulvestrant.
As reported in the Journal of Clinical Oncology, the overall least squares mean change from baseline in the EORTC QLQ-C30 global health score was –3.50 points among alpelisib-treated patients and was 0.27 points for those who received placebo, with no significant difference between the groups at any timepoint.
The EORTC QLQ-C30 functional subscale scores were likewise comparable between the treatment arms, with the exception of the social functioning subscale, which showed significantly greater deterioration from baseline in the alpelisib than placebo group (treatment difference of –4.98 points).
The study authors also found no significant between-group differences with regard to time to deterioration of scores for either global health status or on the physical, emotional, or social functioning subscales.
However, the overall mean changes from baseline in scores for the diarrhea (13.39 vs 1.63 points), appetite loss (10.96 vs 1.83 points), fatigue (9.85 vs 3.34 points), and nausea or vomiting (6.97 vs 4.14 points) symptom subscales of the EORTC QLQ-C30 showed significant worsening among alpelisib- compared with placebo-treated patients.
“The declines in these symptom scores were consistent with the AE [adverse event] profiles observed with alpelisib plus fulvestrant treatment,” say the researchers, and they continue: “Recognizing that [gastrointestinal] AEs are associated with poor HRQoL, our observation that overall HRQoL is maintained in patients taking alpelisib plus fulvestrant suggests that the negative impact of AE-related symptoms on HRQoL is mitigated in part by the delay in disease progression.
Fabrice André (Institut Gustave Roussy, Villejuif, France) and co-investigators note that “[o]ther symptom scores indicated no statistical differences between treatment arms,” but pain appeared to worsen to a lesser degree in the alpelisib than placebo group (0.95 vs 4.34 points).
The Brief Pain Inventory-Short Form questionnaire also showed improvement in worst pain in a numerically greater proportion of alpelisib- than placebo-treated participants at week 24 (42 vs 32%), with similar results also observed at weeks 8 and 16.
“Building on previous SOLAR-1 data demonstrating the efficacy and tolerability of alpelisib plus fulvestrant” in these patients, “this analysis supports further consideration of alpelisib as a well-tolerated treatment option for this population,” concludes the team.
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