TY - JOUR
T1 - Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2
T2 - The CAPPA-2 study
AU - Morabito, Alessandro
AU - Gebbia, Vittorio
AU - Di Maio, Massimo
AU - Cinieri, Saverio
AU - Viganò, Maria Grazia
AU - Bianco, Roberto
AU - Barbera, Santi
AU - Cavanna, Luigi
AU - De Marinis, Filippo
AU - Montesarchio, Vincenzo
AU - Costanzo, Raffaele
AU - Sandomenico, Claudia
AU - Montanino, Agnese
AU - Mancuso, Gianfranco
AU - Russo, Paolo
AU - Nacci, Angelo
AU - Giordano, Pasqualina
AU - Daniele, Gennaro
AU - Piccirillo, Maria Carmela
AU - Rocco, Gaetano
AU - Gridelli, Cesare
AU - Gallo, Ciro
AU - Perrone, Francesco
PY - 2013/7
Y1 - 2013/7
N2 - Platinum-based chemotherapy is the standard treatment for patients with advanced non-small cell lung cancer (NSCLC), but the evidence of its efficacy among ECOG performance status (PS)2 patients is weak because these patients are usually excluded from clinical trials; concern exists about tolerability and feasibility of standard chemotherapy in these patients. No prospective randomized trial has tested the addition of cisplatin to single-agent chemotherapy in patients with advanced NSCLC and PS2. CAPPA-2 was a multicenter, randomized phase 3 study for first-line treatment of PS2 patients with advanced NSCLC. Patients, aged 18-70, were eligible if they had stage IV or IIIB with malignant pleural effusion or metastatic supraclavicular nodes (TNM VI edition) and adequate organ function. Patients in standard arm received gemcitabine 1200mg/m2 days 1 and 8. Patients in experimental arm received cisplatin 60mg/m2 day 1 plus gemcitabine 1000mg/m2 days 1 and 8. All treatments were repeated every 3 weeks, up to 4 cycles, unless disease progression or unacceptable toxicity. Primary endpoint was overall survival (OS). To have 80% power of detecting hazard ratio (HR) 0.71, corresponding to an increase in median OS from 4.8 to 6.8 months, 285 deaths were required. The study was stopped in June 2012 after the enrolment of 57 patients, due to the slow accrual and the report of positive results from a similar study. Median OS was 3.0 months with single-agent gemcitabine and 5.9 months with cisplatin plus gemcitabine (HR 0.52, 95% CI 0.28-0.98, p=0.039). Combination chemotherapy produced longer PFS (median 1.7 vs. 3.3 months, HR 0.49, 95% CI 0.27-0.89, p=0.017) and higher response rate (4% vs. 18%, p=0.19), without substantial increase in toxicity. The addition of cisplatin to single-agent gemcitabine improves survival as first-line treatment of PS2 patients with advanced NSCLC.
AB - Platinum-based chemotherapy is the standard treatment for patients with advanced non-small cell lung cancer (NSCLC), but the evidence of its efficacy among ECOG performance status (PS)2 patients is weak because these patients are usually excluded from clinical trials; concern exists about tolerability and feasibility of standard chemotherapy in these patients. No prospective randomized trial has tested the addition of cisplatin to single-agent chemotherapy in patients with advanced NSCLC and PS2. CAPPA-2 was a multicenter, randomized phase 3 study for first-line treatment of PS2 patients with advanced NSCLC. Patients, aged 18-70, were eligible if they had stage IV or IIIB with malignant pleural effusion or metastatic supraclavicular nodes (TNM VI edition) and adequate organ function. Patients in standard arm received gemcitabine 1200mg/m2 days 1 and 8. Patients in experimental arm received cisplatin 60mg/m2 day 1 plus gemcitabine 1000mg/m2 days 1 and 8. All treatments were repeated every 3 weeks, up to 4 cycles, unless disease progression or unacceptable toxicity. Primary endpoint was overall survival (OS). To have 80% power of detecting hazard ratio (HR) 0.71, corresponding to an increase in median OS from 4.8 to 6.8 months, 285 deaths were required. The study was stopped in June 2012 after the enrolment of 57 patients, due to the slow accrual and the report of positive results from a similar study. Median OS was 3.0 months with single-agent gemcitabine and 5.9 months with cisplatin plus gemcitabine (HR 0.52, 95% CI 0.28-0.98, p=0.039). Combination chemotherapy produced longer PFS (median 1.7 vs. 3.3 months, HR 0.49, 95% CI 0.27-0.89, p=0.017) and higher response rate (4% vs. 18%, p=0.19), without substantial increase in toxicity. The addition of cisplatin to single-agent gemcitabine improves survival as first-line treatment of PS2 patients with advanced NSCLC.
KW - Advanced non-small cell lung cancer
KW - Cisplatin
KW - ECOG performance status 2
KW - First-line chemotherapy
KW - Gemcitabine
KW - Randomized trial
UR - http://www.scopus.com/inward/record.url?scp=84878975454&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84878975454&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2013.04.008
DO - 10.1016/j.lungcan.2013.04.008
M3 - Article
C2 - 23643177
AN - SCOPUS:84878975454
VL - 81
SP - 77
EP - 83
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 1
ER -