Updated patient-reported outcomes and the effect of disease progression on health-related quality of life in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Shahin Mark S, Lorusso Domenica, Backes Floor J, Barretina-Ginesta Maria-Pilar, O'Malley David M, Forget Frédéric, Pothuri Bhavana, Hietanen Sakari, McCormick Colleen C, Abadie-Lacourtoisie Sophie, O'Cearbhaill Roisin E, Heitz Florian, Moore Richard G, Amit Amnon, Willmott Lyndsay J, Pérez María-Jesús Rubio, Burger Robert A, Redondo Andrés, Chase Dana M, Romero Ignacio, Moore Kathleen N, Vergote Ignace, Cloven Noelle, Haslund Charlotte A, Graybill Whitney S, Bergamini Alice, Berton Dominique, Braicu Elena I, Lim Jonathan T, Golembesky Amanda K, Shtessel Luda, Monk Bradley J, González-Martín Antonio
Аннотация
METHODS: Patients were randomized 2:1 to niraparib first-line maintenance or placebo. Longitudinal HRQOL was a prespecified secondary endpoint assessed via European Organisation for Research and Treatment of Cancer QOL-Core Questionnaire (EORTC QLQ-C30) and -Ovarian Cancer module (EORTC QLQ-OV28), Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (FOSI), and EuroQol 5-dimension 5-level questionnaire with visual analog scale (EQ-VAS). Post hoc analyses evaluated least-squares mean change from baseline or last on-treatment visit before disease progression (clinical cutoff: April 8, 2024).
RESULTS: Questionnaire completion rates exceeded 89% through cycle 24 and were 80% at end of treatment. Early differences in gastrointestinal symptom scores between arms resolved over time, and no differences in overall HRQOL were observed. Disease progression reduced overall HRQOL across arms, with marked reductions in EORTC QLQ-C30 overall HRQOL, FOSI, and EQ-VAS scores that never recovered to pre-progression levels. Progression also resulted in sustained deterioration across all EORTC QLQ-C30 and QLQ-OV28 functional scales and worsening symptom scores, particularly for fatigue, dyspnea, pain, and appetite loss. Similar results were observed when patients were evaluated by homologous recombination deficiency status.
CONCLUSION: In the final PRIMA PRO analysis, results confirmed that niraparib first-line maintenance did not negatively affect HRQOL versus placebo. Disease progression caused sustained HRQOL deterioration across arms, emphasizing the clinical importance of extending progression-free survival to preserve patient HRQOL.
CLINICAL TRIAL REGISTRATION NUMBER: NCT02655016.