Phase III Study Comparing Cisplatin Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients With Advanced-Stage Non-Small-Cell Lung Cancer
Küçük Resim Yok
Tarih
2023
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Lippincott Williams and Wilkins
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
PURPOSECisplatin plus gemcitabine is a standard regimen for first-line treatment of advanced non-small-cell lung cancer (NSCLC). Phase II studies of pemetrexed plus platinum compounds have also shown activity in this setting.PATIENTS AND METHODSThis noninferiority, phase III, randomized study compared the overall survival between treatment arms using a fixed margin method (hazard ratio [HR] < 1.176) in 1,725 chemotherapy-naive patients with stage IIIB or IV NSCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1. Patients received cisplatin 75 mg/mon day 1 and gemcitabine 1,250 mg/mon days 1 and 8 (n = 863) or cisplatin 75 mg/mand pemetrexed 500 mg/mon day 1 (n = 862) every 3 weeks for up to six cycles.RESULTSOverall survival for cisplatin/pemetrexed was noninferior to cisplatin/gemcitabine (median survival, 10.3 v 10.3 months, respectively; HR = 0.94; 95% CI, 0.84 to 1.05). Overall survival was statistically superior for cisplatin/pemetrexed versus cisplatin/gemcitabine in patients with adenocarcinoma (n = 847; 12.6 v 10.9 months, respectively) and large-cell carcinoma histology (n = 153; 10.4 v 6.7 months, respectively). In contrast, in patients with squamous cell histology, there was a significant improvement in survival with cisplatin/gemcitabine versus cisplatin/pemetrexed (n = 473; 10.8 v 9.4 months, respectively). For cisplatin/pemetrexed, rates of grade 3 or 4 neutropenia, anemia, and thrombocytopenia (P - febrile neutropenia (P =.002); and alopecia (P <.001) were significantly lower, whereas grade 3 or 4 nausea (P =.004) was more common.CONCLUSIONIn advanced NSCLC, cisplatin/pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. This is the first prospective phase III study in NSCLC to show survival differences based on histologic type. © 2023 American Society of Clinical Oncology. All rights reserved.
Açıklama
Anahtar Kelimeler
cisplatin, cyanocobalamin, docetaxel, epidermal growth factor receptor kinase inhibitor, folic acid, gemcitabine, granulocyte colony stimulating factor, pemetrexed, adult, advanced cancer, aged, alopecia, anemia, Article, cancer chemotherapy, cancer patient, cancer staging, controlled study, drug efficacy, erythrocyte transfusion, febrile neutropenia, female, human, large cell lung carcinoma, lung adenocarcinoma, major clinical study, male, multiple cycle treatment, nausea, neutropenia, non small cell lung cancer, non-inferiority trial, overall survival, phase 3 clinical trial, randomized controlled trial, smoking, squamous cell lung carcinoma, thrombocyte transfusion, thrombocytopenia
Kaynak
Journal of Clinical Oncology
WoS Q Değeri
Scopus Q Değeri
Q1
Cilt
41
Sayı
14
