The first and only treatment to show superior efficacy vs standard single-agent chemotherapy in FRα-positive* PROC1-3
*FRα positive is defined as ≥75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining based on an IHC assay.4
FRα=folate receptor alpha; IHC=immunohistochemistry; PROC=platinum-resistant ovarian cancer.
Outcomes reported by patients on ELAHERE VS STANDARD chemotherapy in MIRASOL
Exploratory analysis of ELAHERE and standard chemotherapy: Abdominal and gastrointestinal symptom PROs in MIRASOL
The EORTC QLQ-OV28 is a 28-item, ovarian cancer–specific questionnaire. With 7 multi-item symptom scales, it assesses abdominal and gastrointestinal symptoms, peripheral neuropathy, hormonal or menopausal symptoms, other chemotherapy side effects, body image, attitude toward disease or treatment, and sexual functioning. A 4-point Likert response scale is used for all items on the QLQ-OV28. The QLQ-OV28 has been validated in patients with ovarian cancer.5
The 15.0-point abdominal/GI QLQ-OV28 analysis was a key secondary endpoint of MIRASOL that did not meet statistical significance; therefore, no formal inferences may be drawn from the following numerical differences6
Proportion of patients with 15-point (15%) or greater improvement from baseline in abdominal/GI scores at week 8 or 96:
- ELAHERE 21.0% (n=34; 95% CI: 15.0, 28.1) vs standard chemotherapy 15.3% (n=23; 95% CI: 10.0, 22.1)
A 10% difference in QLQ-OV28 scores can be considered as a minimal clinically important difference.6
Patients with ≥10% improvement from baseline in the QLQ-OV28 sensitivity analysis (11.1-point threshold) at week 8 or 96,7
Exploratory analysis of ELAHERE and standard chemotherapy across multiple PROs in MIRASOL
The EORTC QLQ-C30 is a 30-item, multidimensional, cancer-specific questionnaire. It includes 5 multi-item function scales (physical, role, cognitive, emotional, and social), 3 multi-item symptom scales (fatigue, nausea and vomiting, and pain), 5 single-item symptom scales (dyspnea, insomnia, loss of appetite, constipation, and diarrhea), a financial impact question, and a 2-item global health status/QoL scale. A 4-point Likert scale is used for all items except for the global health status/QoL scale, which uses a 7-point scale. The QLQ-C30 has been validated in patients with ovarian cancer.5
A 10% difference in QLQ-C30 scores has been considered a minimal clinically important difference in other studies.6
Patients with ≥10% improvement from baseline for the QLQ-C30 results6,8,9
CI=confidence interval; EORTC QLQ=European Organization for Research and Treatment of Cancer quality of life questionnaire; GHS-QoL=global health status-quality of life; GI=gastrointestinal; PRO=patient-reported outcome; QoL=quality of life.
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