Table 3.

Selected Phase III Trials of Continuation Maintenance Therapy

Trial	Year	Induction Therapy		Maintenance Therapy		Therapy at Progression (poststudy therapy; % of patients)	PFS		OS
		Regimen	No. of Patients	Regimen	No. of Patients		Median	P	Median	P
Belani et al39	2003	CP regimens* for 16 weeks	401	Paclitaxel 70 mg/m2 weekly, 3 of 4 weeks	65	47 (not specified by arm)	38 weeks	NR	75 weeks	NR
				Observation	65		29 weeks		60 weeks
CECOG40	2006	Cisplatin 80 mg/m2 on day 1 plus gemcitabine 1,250 mg/m2 on days 1 and 8 every 21 days × 4 cycles		Gemcitabine 1,250 mg/m2 on days 1 and 8 every 21 days + BSC	138	57	6.6 months (3.6 months†)	< .001	13.0 months (10.2 months†)	.195
				BSC	68	57	5.0 months (2.0 months†)		11.0 months (8.1 months†)
Belani et al30	2010	Carboplatin AUC 5 on day 1 plus gemcitabine 1,000 mg/m2 on days 1 and 8 every 21 days × 4 cycles	519	Gemcitabine 1,000 mg/m2 on days 1 and 8 every 21 days + BSC	128	16	3.9 months† (7.4 months)	.58	8.0 months	.84
				BSC	127	17	3.8 months† (7.7 months; HR, 1.09)		9.3 months (HR, 1.97)
IFCT-GFPC 050233‡	2010	Cisplatin 80 mg/m2 on day 1 plus gemcitabine 1,250 mg/m2 on days 1 and 8 every 3 weeks × 4 cycles	834	Gemcitabine 1,250 mg/m2 on days 1 and 8 every 3 weeks	154	68 (60% pemetrexed [8% RR])	3.8 months	< .001	Median not reported (HR, 0.91)	NR
				Observation	155	82 (76% pemetrexed [15% RR])	1.9 months (HR, 0.58)
PARAMOUNT42§	2012	Cisplatin 75 mg/m2 plus pemetrexed 75 mg/m2 every 21 days × 4 cycles	939	Pemetrexed 500 mg/m2 every 21 days + BSC	359	64 (various)	4.1 months†	< .001	16.9 months	.019
				Placebo + BSC	180	72 (various)	2.8 months† (HR, 0.62; 95% CI, 0.49 to 0.79)		14.0 months (HR, 0.78; 95% CI, 0.64 to 0.96)
AVAPERL43§	2011	Cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 + bevacizumab 7.5 mg/kg × 4 cycles	376	Pemetrexed 500 mg/m2 plus bevacizumab 7.5 mg/kg every 3 weeks	125	NR	10.2 months	< .001	NR	.23
				Bevacizumab 7.5 mg/kg every 3 weeks	120	NR	6.6 months (HR, 0.5)		15.7 months (HR, 0.75)
Point Break (JHMD)43a§	Ongoing	Carboplatin AUC 6 and paclitaxel 200 mg/m2 + bevacizumab 15 mg/kg × 4 cycles	900	Bevacizumab 15 mg/kg every 3 weeks	467		5.6 months	.012	13.4 months	.95
		Carboplatin-pemetrexed 500 mg/m2 + bevacizumab 15 mg/kg × 4 cycles		Pemetrexed 500 mg/m2 + bevacizumab 15 mg/kg every 3 weeks	472		6.0 months (HR, 0.83; 95% CI, 0.70 to 0.96)		12.6 months (HR, 1.00; 95% CI, 0.86 to 1.16)

Abbreviations: AUC, area under the curve; BSC, best supportive care; CECOG, Central European Cooperative Oncology Group; CP, carboplatin and paclitaxel; HR, hazard ratio; IFCT-GFPC, Intergroupe Francophone de Cancerologie Thoracique–Groupe Francais de Pneumo-Cancerologie; NR, not reported; OS, overall survival; PFS, progression-free survival; RR, response rate.

^*Random assignment to carboplatin AUC 6 on day 1 plus paclitaxel 100 mg/m² weekly for 3 of 4 weeks (arm 1); carboplatin AUC 2 plus paclitaxel 100 mg/m² weekly for 3 of 4 weeks (arm 2); or carboplatin AUC 2 plus paclitaxel 150 mg/m² (cycle 1) or 100 mg/m² (cycle 2) weekly for 6 of 8 weeks (arm 3).

^†Measured from random assignment.

^‡IFCT-GFPC 0502 was a three-arm trial randomly assigning patients to maintenance gemcitabine, maintenance erlotinib, or observation. The active maintenance therapy arms were individually compared with observation. Results from the maintenance erlotinib arm are shown in Table 5.

^§Nonsquamous non–small-cell lung cancer only.