Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study
Jazyk angličtina Země Irsko Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
32961445
DOI
10.1016/j.lungcan.2020.09.003
PII: S0169-5002(20)30600-0
Knihovny.cz E-zdroje
- Klíčová slova
- CASPIAN, Durvalumab, Health-related quality of life, Patient-reported outcomes, Platinum-etoposide, Small-cell lung cancer,
- MeSH
- cisplatina terapeutické užití MeSH
- etoposid terapeutické užití MeSH
- hodnocení výsledků péče pacientem MeSH
- kvalita života MeSH
- lidé MeSH
- monoklonální protilátky MeSH
- nádory plic * farmakoterapie MeSH
- platina terapeutické užití MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- cisplatina MeSH
- durvalumab MeSH Prohlížeč
- etoposid MeSH
- monoklonální protilátky MeSH
- platina MeSH
OBJECTIVES: In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs). MATERIALS AND METHODS: Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed. RESULTS: In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009). Patients experienced longer TTD with durvalumab plus EP versus EP for all symptoms (hazard ratio [95% CI] for key symptoms: cough 0.78 [0.600‒1.026]; dyspnea 0.79 [0.625‒1.006]; chest pain 0.76 [0.575‒0.996]; fatigue 0.82 [0.653‒1.027]; appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL. CONCLUSION: Addition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL compared with EP.
Asklepios Lung Clinic Munich Gauting Germany
AstraZeneca Gaithersburg MD USA
BHI of Omsk Region Clinical Oncology Dispensary Omsk Russia
Cancer and Hematology Centers of Western Michigan Grand Rapids MI USA
David Geffen School of Medicine at UCLA Los Angeles CA USA
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
Istanbul University Cerrahpaşa Cerrahpaşa School of Medicine Istanbul Turkey
Karl Landsteiner Institute of Lung Research and Pulmonary Oncology Klinik Floridsdorf Vienna Austria
Kyiv City Clinical Oncological Centre Kiev Ukraine
Odessa National Medical University Odessa Ukraine
Okayama University Hospital Okayama Japan
Omsk Regional Cancer Center Omsk Russian Federation
Petrov Research Institute of Oncology St Petersburg Russian Federation
Samsung Changwon Hospital Sungkyunkwan University School of Medicine Changwon Republic of Korea
Semmelweis University Budapest Hungary
Statistical Services Unit University of Sheffield Sheffield UK
Thomayer Hospital 1st Faculty of Medicine Charles University Prague Czech Republic
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