Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer

Table 2 Investigator-assessed best tumor response ^a

	Arm I: Axitinib (Continuous) + Pem/Cis	Arm II: Axitinib (Modified) + Pem/Cis	Arm III: Pem/Cis Alone
	n= 55^b	n= 58	n= 57^b
Best overall response, n (%)
CR	0	0	0
PR	25 (45.5)	23 (39.7)	15 (26.3)
SD (≥8 weeks)	18 (32.7)	19 (32.8)	22 (38.6)
PD	4 (7.3)	7 (12.1)	8 (14.0)
Not assessed	0	1 (1.7)	1 (1.8)
Indeterminate^c	7 (12.7)	8 (13.8)	9 (15.8)
Overall confirmed ORR, n (%)	25 (45.5)	23 (39.7)	15 (26.3)
95% CI	32.0–59.4	27.0–53.4	15.5–39.7
Treatment comparison, risk ratio^d (95% CI) vs. arm III	1.75	1.51	–
Treatment comparison, risk ratio^d (95% CI) vs. arm III	(1.05–2.94)	(0.87–2.63)	–
P ^e	0.01	0.07	–

Abbreviations: Pem/Cis Pemetrexed/cisplatin, CR Complete response, PR Partial response, SD Stable disease, PD Progressive disease, ORR Objective response rate, CI Confidence interval.
^aBased on data cutoff date of March 11, 2011.
^bOne patient in arm I and two patients in arm III had no measureable disease at baseline.
^cPatients who did not have evaluable baseline scan or no post-randomization scan or those who had stable disease for <8 weeks.
^dCalculated based on a normal distribution.
^eOne-sided Cochran-Mantel-Haenszel test stratified by Eastern Cooperative Oncology Group performance status and gender.

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