Health-related quality of life (HRQOL), which measures the impact of health conditions on patients’ functioning, was maintained for longer in patients with HR-positive, HER2-negative breast cancer who were treated with Truqap (capivasertib) plus Faslodex (fulvestrant) compared to those who were treated with a placebo plus Faslodex, according to the patient-reported outcome (PRO) results of the CAPItello-291 trial.
At the 2023 San Antonio Breast Cancer Symposium, Dr. Mafalda Oliveira, discussed the PROs from the phase 3 CAPItello-291 study using data from three PRO questionnaires. These included the EORTC QLQ-C30, EORTC QLQ-BR23 and the Patient Global Impression of Treatment Tolerability.
In previously reported data, patients with aromatase inhibitor (AI)-resistant advanced breast cancer showed significant improvement with Truqap compared with placebo in terms of progression-free survival (PFS; time from treatment until disease worsening or death) in the overall population and in patients with PIK3CA/AKT1/PTEN-altered disease.
“As new targeted drugs are approved for the treatment of breast cancer, assessment of HRQOL and patient experience is of growing importance and can actually supplement evaluation of the risk-benefit profile of treatment,” Oliveira, a medical oncologist in the Department of Medical Oncology at Vall d’Hebron University Hospital in Spain, said in her presentation.
The EORTC QLQ-C30 and EORTC QLQ-BR23 functional and symptom domains, except for diarrhea, were maintained in patients receiving with the Truqap combination longer than for those receiving placebo. There was more than a 10-point change in diarrhea symptom scores in the QLQ-C30 for Truqap, which was consistent with its known safety profile.
In CAPItello-291, 708 patients were randomly assigned to the Truqap/Faslodec arm (355 patients) or the placebo/Faslodex arm (353 patients). For all three PRO assessments, the baseline and overall compliance rates were similarly high between treatment arms, above 80% for each and though compliance was lower up to cycle 6, it was similar between arms.
The mean baseline scores for EORTC QLQ-C30 were similar between the two arms across subscales and both arms had consistent global health status (GHS)/QOL scores maintained from baseline. Truqap was not associated with clinically meaningful changes in the functional and symptom domain scores for EORTC QLQ-C30, except for a worse score for diarrhea.
In the EORTC QLQ-C30 and QLQ-BR23, time to deterioration (TTD; when quality of life decreases) for GHS/QOL was longer for patients in the Truqap/Faslodex arm. Except for diarrhea, the EORTC QLQ-C30 TTD for functional domains and symptom scales favored Truqap numerically, including in pain and fatigue. Diarrhea with Truqap/Faslodex was grade 1/2 in 63.1% of patients and the combination led to low rates of dose reductions, interruptions and discontinuations in 7.9%, 9.9% and 2.0% of patients, respectively. The TTD also numerically favored Truqap in the EORTC QLQ-BR23.
Both treatment arms reported that most patients were either “not at all” or “a little bit bothered by side effects from therapy in the Patient Global Impression of Treatment Tolerability assessment. In the first two cycles, the treatment differences were the highest, with more patients receiving Truqap reporting they were “somewhat,” “quite a bit,” or very much” bothered by side effects. However, these differences subsided after cycle 2.
The methods used for assessment of PROs using EORTC QLQ-C30 and EORTC QLQ-BR23 required patients to complete these questionnaires on day 1 of cycle 1 and every four weeks until second progression and at the progression or discontinuation visit. For the Patient Global Impression of Treatment Tolerability questionnaire, patients were to complete it on day 1 of cycle 1 and every two weeks after, then every four weeks after week 12 until discontinuation, and four weeks after discontinuation.
In the phase 3, double-blind, randomized CAPItello-291 trial, the overall population of patients with HR-positive, HER2-negative, AI-resistant advanced breast cancer given Truqap/Faslodex had a median PFS of 7.2 months compared with 3.6 with placebo/Faslodex. Patients with AKT pathway alterations (69.1%) had a median PFS of 7.3 months compared with 3.1 months for Truqap vs placebo, respectively.
“In conclusion, together with the clinical efficacy and manageable safety profile of (Truqap) plus (Faslodex), the results of this PRO analysis further support positive benefit-risk profile for the combination of (Truqap) and (Faslodex) in AI-resistant, HR-positive, HER2-negative advanced breast cancer,” Oliveira noted.
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