TY - JOUR
T1 - Cisplatin-based first-line treatment of elderly patients with advanced non-small-cell lung cancer
T2 - Joint analysis of MILES-3 and MILES-4 phase III trials
AU - Gridelli, Cesare
AU - Morabito, Alessandro
AU - Cavanna, Luigi
AU - Luciani, Andrea
AU - Maione, Paolo
AU - Bonanno, Laura
AU - Filipazzi, Virginio
AU - Leo, Silvana
AU - Cinieri, Saverio
AU - Ciardiello, Fortunato
AU - Burgio, Marco Angelo
AU - Bilancia, Domenico
AU - Cortinovis, Diego
AU - Rosetti, Francesco
AU - Bianco, Roberto
AU - Gebbia, Vittorio
AU - Artioli, Fabrizio
AU - Bordonaro, Roberto
AU - Fregoni, Vittorio
AU - Mencoboni, Manlio
AU - Nelli, Fabrizio
AU - Riccardi, Ferdinando
AU - Di Isernia, Giuditta
AU - Costanzo, Raffaele
AU - Rocco, Gaetano
AU - Daniele, Gennaro
AU - Signoriello, Simona
AU - Piccirillo, Maria Carmela
AU - Gallo, Ciro
AU - Perrone, Francesco
PY - 2018/9/1
Y1 - 2018/9/1
N2 - Purpose: To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods: Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed a of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results: From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion: The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.
AB - Purpose: To test the efficacy of adding cisplatin to first-line treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC) within a combined analysis of two parallel phase III trials, MILES-3 and MILES-4. Patients and Methods: Patients with advanced NSCLC who were older than age 70 years with Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned to gemcitabine or pemetrexed, without or with cisplatin. In each trial, 382 events were required to detect a hazard ratio (HR) of death of 0.75, with 80% power and two-tailed a of .05. Trials were closed prematurely because of slow accrual, but the joint database allowed us to analyze the efficacy of cisplatin on the basis of intention-to-treat and adjusted by trial, histotype, non-platinum companion drug, stage, performance status, sex, age, and size of the study center. Results: From March 2011 to August 2016, 531 patients (MILES-3, 299; MILES-4, 232) were assigned to gemcitabine or pemetrexed without (n = 268) or with cisplatin (n = 263). Median age was 75 years, 79% were male, and 70% had nonsquamous histology. At a median 2-year follow-up, 384 deaths and 448 progression-free survival events were recorded. Overall survival was not significantly prolonged with cisplatin (HR, 0.86; 95% CI, 0.70 to 1.05; P = .14) and global health status score of quality of life was not improved, whereas progression-free survival (HR, 0.76; 95% CI, 0.63 to 0.92; P = .005) and objective response rate (15.5% v 8.5%; P = .02) were significantly better. Significantly more severe hematologic toxicity, fatigue, and anorexia were found with cisplatin. Conclusion: The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC.
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U2 - 10.1200/JCO.2017.76.8390
DO - 10.1200/JCO.2017.76.8390
M3 - Article
AN - SCOPUS:85052571799
VL - 36
SP - 2585
EP - 2592
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 25
ER -