Health-related quality of life in patients with newly diagnosed advanced ovarian cancer receiving maintenance olaparib plus bevacizumab (PAOLA-1/ENGOT-ov25).
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.
Joly Florence, Anota Amélie, Chabaud Sylvie, Cropet Claire, Priou Frank, Harter Philipp, Pignata Sandro, Palacio Isabel, Petru Edgar, Kobayashi Hiroaki, Vergote Ignace, Parma Gabriella, Mäenpää Johanna, Raymond Eric, Ataseven Beyhan, Pisano Carmela, Lainez Nuria, Tsibulak Irina, Yonemori Kan, Vuylsteke Peter, Lapresa Maria Teresa, Mirza Mansoor Raza, Bouchaert Patrick, Buderath Paul, Lorusso Domenica, Herrero Ana, Eberst Lauriane, Burges Alexander, Scambia Giovanni, Ortega Eugenia, Guillemet Cécile, Pujade-Lauraine Eric, Kurtz Jean-Emmanuel, Ray-Coquard Isabelle
Аннотация
METHODS: Health-related QoL and time until definitive HRQoL deterioration, prespecified secondary endpoints, were assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) and Ovarian Cancer module (QLQ-OV28) at baseline and then every 12 weeks for 2 years. Health-related QoL and time until definitive HRQoL deterioration by homologous recombination deficiency status and effect of progression on HRQoL were post hoc analyses.
RESULTS: A total of 806 patients were randomly assigned (olaparib plus bevacizumab n = 537; placebo plus bevacizumab n = 269). There were no clinically meaningful between-group differences in adjusted mean global change from baseline in QLQ-C30 or QLQ-OV28 domains overall (between-group difference in QLQ-C30 Global Heath Status [GHS] score = 1.65, 95% CI = -0.27 to 3.56) or in the homologous recombination deficiency-positive subgroup (between-group difference in QLQ-C30 GHS = 1.23, 95% CI = -1.25 to 3.71). Time until definitive HRQoL deterioration estimates of QLQ-C30 GHS scores did not differ between treatment arms in the modified intention-to-treat population (hazard ratio [HR] = 0.88, 95% CI = 0.72 to 1.07) and favored olaparib plus bevacizumab vs placebo plus bevacizumab in the homologous recombination deficiency-positive subgroup (HR = 0.70, 95% CI = 0.52 to 0.93). Analyses of patients (103 of 465 [22.2%]) following disease progression showed clinically meaningful deterioration in QLQ-C30 emotional and social scores.
CONCLUSION: Adding maintenance olaparib to bevacizumab showed no clinically meaningful detrimental effect on global HRQoL either overall or in the homologous recombination deficiency-positive subgroup.
CLINICALTRIALS.GOV ID: NCT02477644.