Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Patient-Reported Outcomes in FLAURA2: Osimertinib with or without Chemotherapy in Patients with Previously Untreated EGFR-Mutated Advanced Non-Small Cell Lung Cancer.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
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.
Gray Jhanelle E, Laktionov Konstantin, Kim Sang-We, Kato Terufumi, Wang Jialei, Han Zhigang, Mitchell Paul, Kuyama Shoichi, Tan Chun Bing Jerry, Cundom Juan, Pinto Gustavo, Shepherd Frances A, Poole Lynne, Lai Rachel, Albayaty Muna, Amin Neha P, Kobayashi Kunihiko, Lee Chee Khoon
Аннотация
PURPOSE: In FLAURA2, first-line osimertinib plus platinum-pemetrexed induction, with osimertinib plus pemetrexed maintenance, improved progression-free survival versus osimertinib alone in epidermal growth factor receptor (EGFR)-mutated, advanced non-small cell lung cancer (NSCLC; hazard ratio, 0.62; P < 0.001). Combining osimertinib with chemotherapy increased induction grade ≥3 adverse event rates, which reduced during maintenance. We report FLAURA2 patient-reported outcomes (PRO).
PATIENTS AND METHODS: Health-related quality of life (HRQoL) was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (baseline, week 4, week 7, week 10, then every 6 weeks until progression) and QLQ Lung Cancer 13 (baseline, weekly until week 10, then every 3 weeks until progression). Score changes (baseline to progression/19 months) were analyzed by mixed models for repeated measures. Within-patient ≥10-point changes from baseline were considered clinically meaningful. Tolerability was assessed by PRO-Common Terminology Criteria for Adverse Events (CTCAE).
RESULTS: Patients had intermediate-to-high baseline functioning and global health status (GHS)/QoL (mean scores ≥63), with mild symptomatology (≤35). Most key scales showed nonclinically meaningful improvements; average least-squares mean (LSM) changes [95% confidence interval (CI)] for GHS/QoL and physical function, respectively, were 3.32 (1.67-4.98) and 2.37 (0.70-4.04) with combination therapy and 7.38 (5.70-9.07) and 6.74 (5.04-8.43) with monotherapy. Improvements in cough were clinically meaningful with combination therapy and monotherapy from week 5 (except monotherapy at week 73); average LSM changes (95% CI) were -13.23 (-14.85 to -11.62) and -11.19 (-12.83 to -9.55), respectively. Nonclinically meaningful deteriorations in fatigue and appetite loss were seen with the combination during induction. Both treatments were similarly well tolerated (PRO-CTCAE).
CONCLUSIONS: In FLAURA2, osimertinib monotherapy and combination with platinum-pemetrexed as first-line treatment for EGFR-mutated advanced NSCLC had nonclinically meaningful impacts on HRQoL in mildly symptomatic patients.
PATIENTS AND METHODS: Health-related quality of life (HRQoL) was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (baseline, week 4, week 7, week 10, then every 6 weeks until progression) and QLQ Lung Cancer 13 (baseline, weekly until week 10, then every 3 weeks until progression). Score changes (baseline to progression/19 months) were analyzed by mixed models for repeated measures. Within-patient ≥10-point changes from baseline were considered clinically meaningful. Tolerability was assessed by PRO-Common Terminology Criteria for Adverse Events (CTCAE).
RESULTS: Patients had intermediate-to-high baseline functioning and global health status (GHS)/QoL (mean scores ≥63), with mild symptomatology (≤35). Most key scales showed nonclinically meaningful improvements; average least-squares mean (LSM) changes [95% confidence interval (CI)] for GHS/QoL and physical function, respectively, were 3.32 (1.67-4.98) and 2.37 (0.70-4.04) with combination therapy and 7.38 (5.70-9.07) and 6.74 (5.04-8.43) with monotherapy. Improvements in cough were clinically meaningful with combination therapy and monotherapy from week 5 (except monotherapy at week 73); average LSM changes (95% CI) were -13.23 (-14.85 to -11.62) and -11.19 (-12.83 to -9.55), respectively. Nonclinically meaningful deteriorations in fatigue and appetite loss were seen with the combination during induction. Both treatments were similarly well tolerated (PRO-CTCAE).
CONCLUSIONS: In FLAURA2, osimertinib monotherapy and combination with platinum-pemetrexed as first-line treatment for EGFR-mutated advanced NSCLC had nonclinically meaningful impacts on HRQoL in mildly symptomatic patients.