. 2015 Jan 29;6:13–25. doi: 10.2147/LCTT.S73268

Table 4.

Phase III studies comparing a maintenance cytotoxic monotherapy with observation alone after induction chemotherapy

Reference	PEP	n	Induction	Maintenance	PFS or TTP (M)	HR P-value	OS (M)	HR P-value
Continuation maintenance
Belani et al¹¹	RR	401 enrolled	3 regimens of CBDCA + PTX (arm 1–3)^a
	TTP	130 randomized		Survival from randomization before induction chemotherapy
		65		w PTX	8.9	P=0.124	17.5	P=0.243
		65		Obs	6.8		14.0
Brodowicz et al¹³ (CECOG trial)	TTP	352 induction	CDDP + GEM ×4 cycles
		257 non-PD
		215 randomized		Survival from first treatment administration
		138		GEM	6.6	HR ND	13.0	HR ND
		68		Obs	5.0	P<0.001	11.0	P=0.195
				Survival from randomization after induction chemotherapy
		138		GEM	3.6	HR ND	10.2	HR ND
		68		Obs	2.0	P<0.001	8.1	P=0.172
Belani et al¹²	OS	519 enrolled	CBDCA + GEM ×4 cycles
		255 randomized		Probably from randomization after induction chemotherapy
		128		GEM	3.9	HR ND	8.0	HR 0.97
		127		Obs	3.8	P-value ND	9.3	P=0.84
Perol et al¹⁴ (IFCT-GFPC0502 trial)	PFS	834 enrolled	CDDP + GEM ×4 cycles
		464 randomized		Survival from randomization after induction chemotherapy
		154		GEM	3.8	HR 0.56	12.1	HR 0.89
		155		Obs	1.9	P<0.001	10.8	P=0.3867
Paz-Ares et al¹⁵,¹⁶ (PARAMOUNT trial)	PFS	939 induction	CDDP + PEM ×4 cycles	OS of randomly assigned patients, from start of induction
		539 non-PD		chemotherapy
		359		PEM			16.9	HR 0.79
		180		Obs			14.0	P=0.0191
				Survival from randomization after induction chemotherapy
		359		PEM	4.4	HR 0.60	13.9	HR 0.78
		180		Obs	2.8	P<0.001	11.0	P=0.0198
Switch maintenance
Ciuleanu et al²⁹ (JMEN trial)	PFS		Plt-based regimens ×4 cycles	Survival from randomization after induction chemotherapy
		441		PEM	4.3	HR 0.50	13.4	HR 0.79
		222		Placebo	2.6	P<0.0001	10.6	P=0.012

Notes:

Arm 1, CBDCA (AUC 6 mg/mL ⋅ min, day 1) plus PTX (100 mg/m², days 1, 8, and 15) every 4 weeks; arm 2, CBDCA (AUC 2 mg/mL min, days 1, 8, and 15) plus PTX (100 mg/m², days 1, 8, and 15) every 4 weeks; arm 3, CBDCA (AUC 2 mg/mL ⋅ min) plus PTX (150 mg/m² in cycle 1 and 100 mg/m² in cycle 2) weekly for 6 of 8 weeks.

Abbreviations: AUC, area under the curve; CDDP, cisplatin; GEM, gemcitabine; HR, hazard ratio; M, months; ND, not described; Obs, observation alone; OS, overall survival; PEP, primary endpoint; PD, progressive disease; PEM, pemetrexed; PFS, progression-free-survival; Plt, platinum; PTX, paclitaxel; RR, overall response rate; TTP, time to progressive disease; w PTX, weekly paclitaxel.