JTO clinical and research reports · 2025
Patient-Reported Symptoms and Quality of Life With Sacituzumab Govitecan Versus Docetaxel in Metastatic NSCLC: The Phase 3, Randomized EVOKE-01 Trial.
СтатьяНазвание и аннотация: Перевод в очереди
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Reinmuth Niels, Couraud Sébastien, Paz-Ares Luis, Garassino Marina Chiara, Baijal Shobhit, Daniel Davey, Garrido Pilar, Kato Terufumi, Percent Ivor, Rittmeyer Achim, Parra Hector Soto, Mekan Sabeen, Patel Mira, Radford Matthew, Zhang Eric, Pelligra Christopher G, Guo Shien, Felip Enriqueta
Аннотация
INTRODUCTION: In the phase 3 EVOKE-01 trial (NCT05089734), sacituzumab govitecan (SG) exhibited a numerical improvement in overall survival and tolerability compared with docetaxel in patients with metastatic NSCLC previously treated with platinum-based chemotherapy and programmed cell death protein (ligand) 1 inhibitors, although results were not statistically significant. This analysis evaluated health-related quality of life (HRQoL) data from EVOKE-01.
METHODS: Patients (N = 603) were randomized 1:1 to SG (n = 299) or docetaxel (n = 304) in 21-day cycles. HRQoL was assessed by the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ), European Organization for Research and Treatment of Cancer Quality of Life questionnaire-Core 30 (QLQ-C30), and EuroQol 5 Dimension 3-level questionnaire. Least square mean changes from baseline at week 25, time to first meaningful deterioration or death, and time to confirmed deterioration were analyzed.
RESULTS: SG exhibited significantly and meaningfully better effects than docetaxel on NSCLC-SAQ shortness of breath (SoB), fatigue, total score, and on QLQ-C30 role functioning, fatigue, and dyspnea. Time to first meaningful deterioration or death favored SG over docetaxel for NSCLC-SAQ SoB (hazard ratio [95% confidence interval ]: 0.75 [0.61-0.91]), fatigue (0.70 [0.57-0.86]), and total score (0.80 [0.66-0.97]); QLQ-C30 fatigue (0.80 [0.66-0.96]) and dyspnea (0.74 [0.60-0.90]); and EuroQol visual analog scale (0.79 [0.65-0.96]). The time to confirmed deterioration favored SG over docetaxel for NSCLC-SAQ SoB (0.59 [0.44-0.77]) and fatigue (0.70 [0.52-0.95]), and QLQ-C30 fatigue (0.75 [0.59-0.95]).
CONCLUSIONS: These exploratory results suggest that SG may benefit HRQoL over docetaxel, supporting SG as an active therapeutic agent for metastatic NSCLC post platinum-based and programmed cell death protein (ligand) 1 inhibitor therapy.
METHODS: Patients (N = 603) were randomized 1:1 to SG (n = 299) or docetaxel (n = 304) in 21-day cycles. HRQoL was assessed by the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ), European Organization for Research and Treatment of Cancer Quality of Life questionnaire-Core 30 (QLQ-C30), and EuroQol 5 Dimension 3-level questionnaire. Least square mean changes from baseline at week 25, time to first meaningful deterioration or death, and time to confirmed deterioration were analyzed.
RESULTS: SG exhibited significantly and meaningfully better effects than docetaxel on NSCLC-SAQ shortness of breath (SoB), fatigue, total score, and on QLQ-C30 role functioning, fatigue, and dyspnea. Time to first meaningful deterioration or death favored SG over docetaxel for NSCLC-SAQ SoB (hazard ratio [95% confidence interval ]: 0.75 [0.61-0.91]), fatigue (0.70 [0.57-0.86]), and total score (0.80 [0.66-0.97]); QLQ-C30 fatigue (0.80 [0.66-0.96]) and dyspnea (0.74 [0.60-0.90]); and EuroQol visual analog scale (0.79 [0.65-0.96]). The time to confirmed deterioration favored SG over docetaxel for NSCLC-SAQ SoB (0.59 [0.44-0.77]) and fatigue (0.70 [0.52-0.95]), and QLQ-C30 fatigue (0.75 [0.59-0.95]).
CONCLUSIONS: These exploratory results suggest that SG may benefit HRQoL over docetaxel, supporting SG as an active therapeutic agent for metastatic NSCLC post platinum-based and programmed cell death protein (ligand) 1 inhibitor therapy.