Table 4.

Summary of efficacy parameters for patients with nonsquamous disease

Efficacy parameter	JMII PCb/P	S110 PC/P	PARAMOUNT P+BSC mnt
Induction regimen	Carboplatin+pemetrexed	Cisplatin+pemetrexed	Cisplatin+pemetrexed
Induction sample size	106	27	939
Maintenance sample size	60 (56.6%)	22 (81.5%)	359 (66.6%)a)
Efficacy during maintenance therapy
Maintenance regimen	Pemetrexed	Pemetrexed	Pemetrexed
No.	60	22	359
Median PFS (95% CI, mo)	3.9 (3.2-5.2)	4.04 (3.22-5.29)	4.1 (3.2-4.6)
Efficacy during induction+maintenance period
No.	106b)	27	359a)
Median PFS (95% CI, mo)	5.7 (4.4-7.3)	6.83 (5.78-7.98)	6.9 (6.2-7.5)
Median OS (95% CI, mo)c)	20.2 (16.7-NA)	NRd)	13.9 (12.8-16.0)
1-Year survival rate (95% CI, %)c)	70.0 (60.4-77.8)	96.3 (76.5-99.5)	58 (53.0-63.0)
2-Year survival rate (95% CI, %)c)	42.5 (32.8-51.8)	78.0 (54.7-90.2)	32 (27.0-37.0)
Subgroup analysis
Median PFS (95% CI, mo), EGFR mutation-positive patients	5.7 (5.2-7.2)	NAe)	NAe)
Median PFS (95% CI, mo), EGFR mutation-negative patients	6.9 (4.3-7.8)	NAe)	NAe)

PCb/P, pemetrexed+carboplatin followed by pemetrexed; PC/P, pemetrexed+cisplatin followed by pemetrexed; P+BSC mnt, pemetrexed+best supportive care maintenance; PFS, progression-free survival; CI, confidence interval; OS, overall survival; NA, not available; NR, not reached; EGFR, epidermal growth factor receptor.

^a)In PARAMOUNT, 939 patients were enrolled into the induction phase, and 539 patients (57.4%) (pemetrexed [n=359], placebo [n=180]) were randomized,

^b)Efficacy assessment was performed on per-protocol set, which consisted of 106 treated patients without major protocol violations as reported in the JMII manuscript,

^c)In PARAMOUNT, median OS, 1-year and 2-year survival rates are reported for the maintenance period but for the induction+maintenance period for S110 and JMII,

^d)There were insufficient events to calculate median OS in study S110 due to censoring (72.9% cases were censored),

^e)The EGFR mutation analysis was not performed in studies S110 and PARAMOUNT.